bioihbjkbjnl/mcl2 huggingface dataset:
Oral Prophylactic Measures on the Occurrence of Pre-eclampsia (OP-PE)
Condition: Pregnancy Complications
MeSH terms: Eclampsia; Pre-Eclampsia; Pregnancy Complications
Study type: Interventional

Summary: 
      Pre-eclampsia (PE) remains a major source of maternal and perinatal morbidity and mortality
      especially in low- and middle-income settings. PE, a pregnancy-specific hypertensive
      disorder, characterized by the development of placental endothelial dysfunction resulting in,
      among the most common diagnostic features, concomitant hypertension and proteinuria that may
      evolve into organs with fluctuating clinical specificities. Current studies indicate that
      periodontal disorders during pregnancy and particularly periodontal pathogens may be related
      to the risk of PE. Standard oral hygiene methods, based mainly on the joint use of
      toothbrushes and interdental brushes, reduce periodontal inflammatory risk, modulate of the
      dysbiotic oral microbiome. The purpose of the present study is to compare the PE outcomes in
      high-risk pregnant women receiving oral prophylactic measures to a control group. One
      specific question is addressed as follows according to the PICO principles: In high-risk
      pregnant women (Population), does oral prophylactic measures (Intervention) have a beneficial
      effect on PE parameters (Outcome) compared to pregnant women without any specific oral
      prophylactic measures (Control)?
    


Intervention name(s): Oral prophylactic intervention
Intervention type(s): Other
Intervention description(s): The oral prophylactic intervention will consist of the provision of specific package including a soft-bristled manual toothbrush, toothpaste, and a kit of calibrated interdental brushes (IDBs)(Curaprox CPS; Curaden) of sizes corresponding to the diameter of their interdental spaces. The participants will be instructed to brush their teeeth twice-daily and to realise a daily interdental brushing until delivery. The instructions for the use of the toothbrush and IDBs comprised verbal instructions supported by practical demonstration. The first use of the material will be conducted under the supervision of a qualified public health professor.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This trial is designed as an two-arm parallel cluster randomized controlled trial with antenatal obstetric clinic as the unit of randomisation and an allocation ratio of 1:1
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: pre-eclampsia; pregnant; periodontal disease; interdental microbiota
INVEST Feasibility - Minimally Invasive Endoscopic Surgery With Apollo in Patients With Brain Hemorrhage
Condition: Intracranial Hemorrhage
MeSH terms: Intracranial Hemorrhages; Hemorrhage
Study type: Interventional

Summary: 
      The primary objective of this multicenter single arm feasibility study is to provide an
      assessment of enrollment and follow up feasibility for this patient population being treated
      with the Apollo Minimally Invasive Surgical Treatment (MIES). Patients who do not qualify for
      the INVEST Feasibility Study will be referred to the INVEST Registry study.
    

Detailed description: 
      Objective: The primary objective of this multicenter single arm feasibility study is to
      provide an assessment of enrollment and follow up feasibility for this patient population
      being treated with the Apollo or Artemis Minimally Invasive Surgical Treatment (MIES).
      Patients who do not qualify for the INVEST Feasibility Study will be referred to the INVEST
      Registry study.

      Study Design: This study will be a prospective, multi-centered trial that will enroll 50
      patients at up to 10 United States (US) centers.

      Patient Population: Patients with moderate-large volume (20-80 cc) supratentorial
      intracerebral hemorrhage (ICH) who present within 24 hours of symptom onset. Enrolled
      patients will receive minimally invasive endoscopic evacuation with the Apollo system or
      Artemis Device.

      Indication: The Artemis Neuro Evacuation Device is used for the controlled aspiration of
      tissue and/or fluid during surgery of the Ventricular System or Cerebrum in conjunction with
      a Penumbra Aspiration Pump. The Penumbra Aspiration Pump is indicated as a vacuum source for
      the Penumbra Aspiration Systems. The Apollo system has been cleared for the controlled
      aspiration of soft tissue and/or fluid during endoscopically guided neurosurgery of the
      ventricular system or cerebrum. In the present study, the researchers propose to investigate
      the feasibility of studying this patient population for eventual implementation of efficacy
      trials.
    

Intervention name(s): Apollo MIES; Medical Management
Intervention type(s): Device; Other
Intervention description(s): Subjects will receive best medical management plus MIES (minimally invasive endoscopic surgery with use of the Apollo System.; Subjects will receive best medical management for intracranial hemorrhage
Other intervention name(s): ICH - Apollo System; MM; ICH - Medical Management
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: intracranial hemorrhage; neurosurgery
Knowledge on Preventive Measures of Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      Hypertension among children and adolescents is on the rise in both developed and developing
      countries. Childhood and adolescent obesity, a key factor for hypertension in this population
      results largely from unhealthy dietary and physical inactivity behaviours. Adequate
      knowledge, a component for behavior change, has been found to be crucial to improving one's
      confidence to tackle these improper behaviours. Despite this, there are gaps in knowledge on
      hypertension and its risks factors in Ghanaian adolescents. Using an educational intervention
      (health talk), the study therefore sought to improve knowledge on preventive measures of
      hypertension among senior high school students in Ghana.
    

Detailed description: 
      A pre-post interventional study using health talks was carried out among 345 adolescents aged
      13 to 20 years. Participants included both male and female students aged 13 to 20 years.
      Owing to the large number, the students were divided into two groups. The Pre-test was then
      administered. Following this, two health education sessions were delivered by two registered
      nurses for each session. A week after these health talks, the research team went back to the
      school to collect data for the post-intervention. Questionnaires used for both pre and post
      assessment collected data on demographic factors and knowledge on dietary and physical
      activity behaviours linked to hypertension.
    

Intervention name(s): Education/Training
Intervention type(s): Other
Intervention description(s): It consisted of a brief overview of hypertension, risk factors, complications and much emphasis placed on the preventive measures (what they include and why it is necessary to practice them).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Comparison of Two Sedation Versus Placebo Techniques During Cataract Surgery Under Local Anesthesia
Condition: Sedation; Cataract
MeSH terms: Cataract
Study type: Interventional

Summary: 
      Check the sedation conditions during topic cataract surgery
    


Intervention name(s): Cataract surgery
Intervention type(s): Drug
Intervention description(s): Patient's satisfaction and surgeon's satisfaction was assessed by four Lickert's scales, ranging from one to four. hemodynamic parameters before incision, 10 min post-incision and at the end of the surgery
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Investigate the Effect of AZD1305 on Patients With Left Ventricular Dysfunction
Condition: Left Ventricle Function
MeSH terms: Ventricular Dysfunction; Ventricular Dysfunction, Left
Study type: Interventional
Phase: Phase 2

Summary: 
      To explore if AZD1305 compromises left ventricular performance in patients with left
      ventricular dysfunction
    


Intervention name(s): AZD1305; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): iv single infusion: initial iv loading dose which will be followed by a maintenance dose given for a maximum of 90 minutes; iv single infusion: initial iv loading dose which will be followed by a maintenance dose given for a maximum of 90 minutes
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: AZD1305; anti-arrhythmics; safety
The Screening of Neuroprotective Biomarkers After Acute Ischemic Stroke
Condition: Acute Ischemic Stroke
MeSH terms: Stroke; Ischemic Stroke; Cerebral Infarction; Ischemia
Study type: Observational

Summary: 
      Neuroprotection is expected to be an important therapeutic strategy for acute ischemic
      stroke(AIS), but almost all neuroprotective drugs proved effective in rodent models have
      failed after entering clinical trials. This study aims to screen the differentially expressed
      proteins in peripheral blood of patients with acute ischemic stroke and with further study in
      the animal model of non-human primate cerebral infarction, we may determine the biomarkers
      that can evaluate the efficacy of neuroprotective drugs.
    

Detailed description: 
      Acute ischemic stroke (AIS), is a major disease which cause death and disability. Globally,
      ischemic stroke is the second most common cause of death from vascular diseases and the third
      most common cause of disability. For decades, neuroprotection has been highly expected as an
      important treatment for cerebral ischemia, but almost all neuroprotective drugs proved
      effective in rodent models have failed in clinical trials. In this study, we enrolled
      patients with acute ischemic stroke, collecting their peripheral blood samples at 1 day and 3
      months of onset. Neuropsychological scales evaluation and imaging evaluation were also
      completed at 1 day, 7 day and 3 months of onset respectively. Correlation research in
      combination with the patient's clinical information were conducted to preliminarily screen
      the proteins related to the prognosis of neurological function, which was reflected by
      patients' mRS scores at 3 months of onset, in peripheral blood. Further study in the animal
      model of non-human primate cerebral infarction may determine the biomarkers that can evaluate
      the efficacy of neuroprotective drugs.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with acute ischemic stroke
      
Biospecimen description: 
      patients' peripheral blood
    
Keywords: acute ischemic stroke; neuroprotective biomarkers
Desflurane and Postoperative Sleep Quality in Patients Undergoing Elective Breast Surgery
Condition: Desflurane; Propofol; Postoperative Sleep; PSQI; Breast Tumor
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      This study intends to investigate the effects of desflurane on postoperative sleep quality to
      guide perioperative patient management.
    


Intervention name(s): Desflurane Inhalation
Intervention type(s): Drug
Intervention description(s): Subjects were randomized in a 1:1 ratio to undergo breast surgery under maintenance of anesthesia with the classical intravenous anesthetic drug propofol (reference group) or the inhaled anesthetic drug desflurane (test group).
Intervention MeSH terms: Desflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Improving Activity and Quality of Life Following Orthopaedic Trauma: The Trauma Collaborative Care Study (TCCS)
Condition: Severe Orthopedic Trauma
MeSH terms: Wounds and Injuries
Study type: Interventional

Summary: 
      The study uses a multi-site, cluster design to determine the effectiveness of an intervention
      based on a Trauma Collaborative Care (TCC) model in improving patient outcomes for persons
      with severe orthopedic trauma and enhancing both patient and provider satisfaction with
      overall care. The study will also determine the cost and cost-effectiveness of the
      intervention.

      Primary Hypothesis: Compared to standard treatment alone, access to the TCC Program plus
      standard treatment will result in lower rates of the composite outcome (i.e. positive for
      poor function, depression, and/or PTSD).

      Secondary Hypotheses: Compared to standard treatment alone, access to the TCC Program plus
      standard treatment will result in lower levels of pain and higher rates of return to usual
      major activity and higher levels of health related quality of life. In addition, both primary
      and secondary outcomes will correlate strongly with the intermediate outcome of
      self-efficacy.
    


Intervention name(s): Trauma Collaborative Care Plus Treatment as Usual
Intervention type(s): Behavioral
Other intervention name(s): TSN
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Nasal Mask Ventilation During the Induction of General Anesthesia
Condition: Mechanical Ventilation Complication; Upper Airway Obstruction
MeSH terms: Airway Obstruction
Study type: Interventional

Summary: 
      Recently, the investigators demonstrated that nasal route ventilation is superior to the
      nasal-oral combined ventilation in the absence of jaw thrust and chin up maneuvers. The
      investigators hypothesize nasal mask ventilation may reduce the incidence of difficult mask
      ventilation during the induction of general anesthesia by: 1) producing a better seal than
      full face mask, and 2)establishing a greater airway patency and more effectively ventilate
      than full face mask ventilation. The investigators intend to test this hypothesis on adult
      patients during the induction of general anesthesia in the absence of muscle relaxation.
    


Intervention name(s): nasal mask; full face mask
Intervention type(s): Procedure; Procedure
Intervention description(s): Using the nasal mask instead of the full face mask during the induction of general anesthesia; using a standard full face mask during the induction of general anesthesia.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: General anesthesia; Positive-pressure ventilation; Masks
Lung Protection and Pediatric Cardiac Surgery
Condition: Lung Injury, Acute
MeSH terms: Lung Injury; Acute Lung Injury
Study type: Interventional

Summary: 
      The lung is at risk for ischemic insults during total cardiopulmonary bypass because lung
      perfusion is maintained solely by the bronchial arterial system
    

Detailed description: 
      The study will be performed in the pediatric cardiothoracic unit, pediatric Assiut University
      Hospital. After obtaining approval from the local ethics committee and written informed
      parents consent 60 patients will be included in this study according to the following
      criteria:
    

Intervention name(s): cardiopulmonary bypass; cardiopulmonary bypass
Intervention type(s): Procedure; Procedure
Intervention description(s): Low flow of mixed oxygen / air (1:1L) will be used during the period of cardiopulmonary bypass; Low rate (4\min) with low tidal volume ( 2ml/kg ) will be used during the period of cardiopulmonary bypass.
Other intervention name(s): Control group; Low frequency group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Lung; Cardiopulmonary Bypass; Pediatric; Cardiac surgery
Impact of Antibiotic Treatment of Group A Streptococcal Blistering Distal Dactylitis in Children
Condition: Blistering Distal Dactylitis
MeSH terms: Blister
Study type: Interventional

Summary: 
      Single-center prospective study to assess the clinical course of group A streptococcal
      blistering distal dactylitis in children after antibiotic treatment.
    

Detailed description: 
      Blistering distal dactylitis are very common in children. About 60% are caused by
      Staphylococcus aureus and some are caused by Group A Streptococcus (GAS) or Streptococcus
      pyogenes. While these forms have been known for fifty years, few publications are interested
      in it. Some studies have confirmed that a single antibiotic treatment against the SGA allows
      the healing of these dactylitis but few surgical teams have adopted this strategy. As all
      streptococcal infections, they face the risk of acute complications (septicemia,
      streptococcal toxic shock, etc.) or late (post-streptococcal glomerulonephritis, acute
      rheumatic fever, etc.). The involvement of the SGA in these dactylitis is easy to demonstrate
      through the use of rapid GAS test already widely used in other GAS infections (tonsillitis,
      scarlet fever, streptococcal perianal infections).

      This study aims to assess the clinical course of positive GAS test blistering distal
      dactylitis in children after antibiotic treatment.
    

Intervention name(s): Positive rapid GAS test; Negative rapid GAS test
Intervention type(s): Procedure; Procedure
Intervention description(s): If TDR positive, the child will be treated with antibiotics alone:
Amoxicillin 50mg / kg / day in 2 divided doses for 10 days (maximum dose 3 g / day in 2 divided doses) Or if allergic to penicillins and in the absence of cross-known allergy to cephalosporins
Cefpodoxime 8mg / kg / day in 2 divided doses for 10 days (maximum dose 400mg / day in 2 divided doses) J10 A control visit will review all the children included in the study. If the surgeon deems it necessary, the patient will be reviewed in consultation up to three months.; Usual care
Allocation: Non-Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: blistering distal dactylitis; Streptococcus pyogenes; antibiotics
Metyrapone as Additive Treatment in Major Depression
Condition: Major Depressive Disorder
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to test whether metyrapone is an effective and safe augmenting
      agent in the treatment of major depression.
    

Detailed description: 
      The investigators' understanding of the neuroendocrine pathophysiology of depression has made
      significant progress in recent years, which should help to develop new remedies. Alterations
      of the hypothalamic-pituitary-adrenocortical (HPA) axis are the most consistent pathological
      endocrine findings in depression. Hence, attempts have been made to treat depression by
      directly targeting HPA-axis activity. Currently, three major pathways are investigated:

        -  Administration of CRH-antagonists;

        -  Administration of glucocorticoid-receptor-antagonists; and

        -  Treatment with steroid-synthesis inhibitors like ketoconazole, aminogluthethimide or
           metyrapone.

      The investigators' aim was to conduct the first prospective, randomized, placebo-controlled,
      double-blind clinical trial of metyrapone as additive treatment in depression. Metyrapone was
      preferred, since this compound inhibits selectively the 11β-hydroxylase and the
      11β-hydroxysteroid dehydrogenase type 1 (11β-HSD-1), thereby exerting direct effects within
      the central nervous system (CNS). The additive approach was applied because the intended
      inclusion of severely depressed patients made a pure placebo group ethically challenging.
      Furthermore, the continuous use of an antidepressant allowed a standardized follow up after
      the double-blind period.

      The hypotheses to be tested were, whether metyrapone exerts potentiating effects during a
      standard antidepressant therapy and whether an earlier onset-of-action and an improved
      overall and sustained treatment response can be achieved. Since GR/MR distribution as well as
      11β-HSD-1 activities are subject to sexual dimorphism in humans, the sample was prospectively
      stratified for gender and balanced for treatment with two selected serotonergic
      antidepressants, allowing further analysis of gender effects and neuroendocrine treatment
      effects.
    

Intervention name(s): Metyrapone
Intervention type(s): Drug
Intervention MeSH terms: Metyrapone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Clinical trial; double-blind; randomized placebo-controlled trial; metyrapone; Major Depression
Safety and Efficacy of the ToothWave Power Toothbrush for Extrinsic Stain Reduction
Condition: Tooth Discoloration
MeSH terms: Tooth Discoloration
Study type: Interventional

Summary: 
      This study is a single blind, prospective study aimed to evaluate the safety and efficacy of
      the Silk'n ToothWave Power Toothbrush for stains reduction and improvement of teeth shade.
    

Detailed description: 
      The study includes 84 treatment sessions, twice a day, and 4 clinic visits over a period of 6
      weeks.

      One treatment group (Silk'n power toothbrush - ToothWave) and 1 control group (an ADA
      approved power toothbrush (PTB)) will participate in the study.

      For each patient, efficacy assessment data will be collected at baseline, 4 weeks, and at 6
      weeks. The average stain data will be calculated for each group.

      Treatment is defined as a timed, 2 minute brushing of the teeth according to the
      manufactur-er's instructions, twice daily (morning and evening). Brushing will be undertaken
      using the Silk'n toothbrush and standard fluoride toothpaste. The control group will use an
      ADA ac-cepted PTB and the same standard fluoride toothpaste.
    

Intervention name(s): ToothWave; powered toothbrush
Intervention type(s): Device; Device
Intervention description(s): RF-utilizing powered toothbrush for teeth whitening; regular powered toothbrush with no RF
Other intervention name(s): RF toothbrush
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double arm, single blind prospective study
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment