bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Aromatherapy on Venopuncture Pain and Anxiety
Condition: Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      The effect of aromatherapy with lavender essential oil on pain and anxiety during
      venipuncture will be evaluated.
    

Detailed description: 
      The anxiety and pain during venipuncture may be cause to the avoidance of the medical therapy
      in patient as well as adult. Aromatherapy with lavender was shown that beneficial effects on
      chronic pain and anxiety. It's effect on acute pain and anxiety is not exactly known. In this
      study, the aromatherapy with the lavender will be compared with placebo to evaluate the
      analgesic and anxiolytic effect during peripheral venous cannulation before surgery.
    

Intervention name(s): peripheral venous cannulation; Aromatherapy with lavender essential oil; Placebo
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): The 18 gauge venous cannula will be inserted in a peripheral vein on the back of right hand of the patient.; The two drops of lavender essential oil will be dropped into the gauze and the patient will inhale it for 5 minutes and during venous cannulation.; The two drops of water will be dropped into the gauze and the patient will inhale it for 5 minutes and during venous cannulation.
Other intervention name(s): cannulation; lavender
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: pain; anxiety; Catheterization, Peripheral
Arterial to End-Tidal Carbon Dioxide Difference During Pediatric Laparoscopic Surgeries
Condition: Intraoperative Ventilation
Study type: Observational

Summary: 
      Studying the arterial to end-tidal carbon dioxide difference in children undergoing
      laparoscopic surgeries under different intra-abdominal pressures is of extreme importance.
      This is because both hyper and hypocarbia are detrimental in this vulnerable age group.
    

Detailed description: 
      Capnography provides a non-invasive estimate of arterial CO2 levels and allows clinicians to
      modify mechanical ventilation settings in order to maintain normocapnia. Normally, a positive
      gap between arterial CO2 and ETCO2 of approximately 0.5 kPa is assumed in a healthy patient
      and ventilation settings are adjusted accordingly. However, the correlation between PaCO2 and
      PetCO2 during laparoscopic surgery is inconsistent mainly due to inter- and intra-individual
      variability. Discrepancies between arterial carbon dioxide and End-tidal carbon dioxide
      measures have been demonstrated in ventilated children with cyanotic congenital heart disease
      , infants with respiratory failure and during visceral and urological laparoscopic surgery.
      Moreover, as the increase in PaCO2 is directly proportional to the level of intra-abdominal
      pressure (IAP) used, variations in the arterial to end-tidal carbon dioxide difference can be
      also expected with different levels of IAP used.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Children scheduled for laparoscopic surgery of Weight: 10-30 kg, Age: 1-6 years, both males
        and females,ASA physical status: I, II.
Comparison of Two Toric Contact Lenses on Current Toric Wearers
Condition: Ametropia
MeSH terms: Refractive Errors
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate and compare the clinical performance of two toric
      contact lenses amongst 110 subjects, 2-week, single masked (subject), daily wear, randomized,
      bilateral, crossover study; 4 weeks duration. Hypotheses include equal or better performance
      of the test lens over the control lenses for comfort, vision, and toric fit characteristics
      as well as corneal integrity
    

Detailed description: 
      Up to 7 sites in the US will participate. Each investigator will have both test and control
      lens types. There will be a maximum of 6 scheduled visits:

      Visit 1: Habitual lens evaluation / Baseline / Trial fitting Visit 2: Dispensing (to be
      combined with Visit 1 where possible), Visit 3: Questionnaire only (no exam) 7 days (±2)
      after dispensing, Visit 4: 2 week follow-up 14 days (±3) after dispensing, and dispense
      second lens type, Visit 5: Questionnaire only (no exam) 7 days (±2) after 2nd lens dispense,
      Visit 6: 2 week follow-up 14 days (±3) after 2nd lens dispense
    

Intervention name(s): senofilcon A toric; alphafilcon A toric
Intervention type(s): Device; Device
Intervention description(s): silicone hydrogel toric lens, 2 wk replacement, daily wear; hydrogel toric lens, 2 wk replacement, daily wear
Other intervention name(s): ACUVUE OASYS; SofLens Toric
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: toric contact lenses; vision; comfort; toric fit characteristics; slit lamp findings
Study to Assess Safety & Immunogenicity of GSK Biologicals' Boostrix (dTpa) Vaccine vs. Chinese DT Vaccine
Condition: Diphtheria; Acellular Pertussis; Tetanus
MeSH terms: Diphtheria
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the safety and immunogenicity of a booster dose of GSK Biologicals'
      reduced antigen content diphtheria, tetanus, acellular pertussis (dTpa) vaccine - Boostrix in
      comparison with Chinese DT vaccine, in children 6-8 years of age.
    


Intervention name(s): Boostrix; Chinese DT vaccine
Intervention type(s): Biological; Biological
Other intervention name(s): Boostrix
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Chinese DT vaccin
Study of the Bioequivalence of Two Tablet Forms of MK0431 (0431-027)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will establish that the MK0431 100 mg anhydrous formulation tablets are
      bioequivalent to the MK0431 100 mg monohydrate final market image (FMI) tablets.
    


Intervention name(s): Sitagliptin phosphate anhydrous formulation; Comparator: sitagliptin phosphate monohydrate form
Intervention type(s): Drug; Drug
Intervention description(s): Single dose sitagliptin 100 mg tablets (anhydrous form) in one of two treatment periods.; Single dose sitagliptin 100 mg tablets [monohydrate Final Market Image (FMI) form] in one of two treatment periods.
Intervention MeSH terms: Sitagliptin Phosphate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Characterization of the Variability of Insulin Secretory Parameters in the Meal Tolerance and the Maximal Stimulation Tests of Healthy Subjects
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Study type: Observational

Summary: 
      A multi-year clinical study to improve tools for measuring the function of insulin-producing
      beta cells in people with type 2 diabetes mellitus.
    

Detailed description: 
      A three-year observational study to standardize the meal tolerance and maximum stimulational
      tests for measuring beta cell function in the clinical setting. It also aims to improve
      methods for the early prediction of the long-term response to an intervention and for
      identification of patients at risk for rapid beta cell function deterioration, thereby
      enabling future clinical studies that examine diabetes progression.
    

Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Healthy obese individuals
      
Keywords: type 2 diabetes; beta cell function; meal tolerance test; maximum stimulation test; method standardization; insulin secretion
Fascia Iliaca Compartment Block in Acute and Chronic Pain Management in Hip Fracture Patients
Condition: Chronic Hip Pain
MeSH terms: Chronic Pain; Hip Fractures
Study type: Interventional

Summary: 
      This study evaluates the effect of fascia iliaca compartment block (FICB) in the management
      of acute post -surgical pain in hip fracture patients and in the appearance of chronic post
      -surgical hip pain, by means of von Korff Graded Chronic Pain Scale -modified for hip pain in
      Greek.

      Half of the patients will not receive fascia iliaca compartment block.
    


Intervention name(s): Fascia iliaca compartment block; Ropivacaine; ultrasound; Placebo
Intervention type(s): Drug; Drug; Device; Drug
Intervention description(s): 40 ml ropivacaine 0,5% injected under fascia iliaca using ultrasound
Intervention MeSH terms: Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
The Psychological Effect of the Covid-19 Pandemic
Condition: Psychological Distress
MeSH terms: COVID-19
Study type: Observational

Summary: 
      At the end of 2019, the novel coronavirus disease (Covid-19), which emerged in China, has
      become a public health emergency of international concern. Disease outbreaks both affect the
      physical and psychological health of individuals. The aim of this study was to investigate
      the levels of stress, anxiety, depression, and Covid-19 fear in health sciences intern
      students during the Covid-19 pandemic.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        intern students at the Faculty of Health Sciences of Kutahya Health Sciences University
      
Biospecimen description: 
      The unstimulated saliva samples of the participants were collected using the spitting method
      into the supplied polypropylene eppendorf tubes. Saliva samples collected in eppendorf tubes
      were centrifuged at 3,220 rpm for 10 minutes and stored at -20°C until the day of analysis.
    
Keywords: psychological distress; Covid-19; saliva cortisol
Effect of Recruitment Maneuvers Plus Optimal PEEP Versus Optimal PEEP Alone in One Lung Ventilation
Condition: Mechanical Ventilation Complication
Study type: Interventional

Summary: 
      The intraoperative driving pressure (∆P) has been recently identified as the greater
      independent predictor of postoperative pulmonary complications after one lung ventilation
      (OLV). The application of a positive end-expiratory pressure (PEEP) level of 5 or 10 cmH2O
      has been shown to reduce the ∆P and the V/Q mismatch (Spadaro 2017); however, the "optimal"
      PEEP level able to minimize the ∆P may change significantly across patients. The aim of this
      study is to describe the optimal PEEP levels in patients undergoing thoracic surgery
    


Intervention name(s): Recruitment manoeuvers; incremental PEEP
Intervention type(s): Procedure; Procedure
Intervention description(s): Recruitment manoeuvers will be performed as follow Recruitment manoeuvers
set FIO2 at 1.0
Ppeak limit at 45 cmH2O
Respiratory rate set at 6
I:E set at 1:1
Raise the VT at step of 2 ml/kg PBW until the Pplat is between 30-40 cmH2O
If the maximum VT is set without rasing the Pplat, raise PEEP
Allow three respiratory cycles with Pplat between 30 and 40 cmH2O
End of RM
The recruitment manouvers will be performed after 20 minutes of OLV. At the end of the RM, the VT will be set back to 5 ml/kg while the PEEP will be chosen according to the best static compliance with a decremental trial (from 16 cmH2O, lowering PEEP with steps of 2 cmH2O each until the best compliance is reached).; In this group the a PEEP level will be added after 20 minutes from OLV. PEEP values will be chosen according to the best static compliance with an incremental trial (i.e. starting from ZEEP, the PEEP values will be increased in step of 2 cmH2O each until the best compliance is reached
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Tolerability and Pharmacokinetic Study of Econazole Nitrate and Benzydamine HCl Intravaginal Cream
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the study is to evaluate local tolerability of the new
      Econazole/Benzydamine product, in comparison with the Econazole and Benzydamine stand-alone
      products and placebo. Pharmacokinetics of the study products after single and repeated
      applications once a day for 15 days, safety of the investigational products and comfort of
      use will also be evaluated as secondary objectives.
    


Intervention name(s): Econazole nitrate 1% plus Benzydamine HCl 0.12% intravaginal cream; Placebo plus Econazole nitrate 1% intravaginal cream; Placebo plus Benzydamine HCl 0.12% intravaginal cream; Placebo intravaginal cream
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Econazole; Benzydamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Pharmacokinetics; Econazole nitrate 1%; Benzydamine HCl 0.12%; Intravaginal cream; Antimycotic; Tolerability
PAIN Empathy Assessment in Sleep Deprived Emergency & Acute Care Clinicians
Condition: Empathy; Sleep; Pain
Study type: Observational

Summary: 
      Cognitive Empathy is relevant in clinical practice and will be assessed based on the accuracy
      of pain recognition and the pain intensity evaluation in a computerised task using facial
      expressions. Repeated measures across day and night shifts will provide the basis to
      understand the impact of shift work on those abilities in health care professionals.
    

Detailed description: 
      Assessment and management of the pain patients experience is one of the key skills needed in
      the field of anesthesiology. The consideration of non-verbal cues is essential, especially
      the recognition of facial expressions. The human ability to recognize emotions in others
      depends on the capacity for empathy of an individual, specifically cognitive empathy. In the
      clinical context empathy is understood as a set of skills and competences rather than a
      character trait. It may therefore vary due to various parameters. Currently there is no
      research available on the influence of shift work on the human ability to recognize pain in
      facial expressions. However, work schedules that do not fit the natural circadian rhythm are
      known to alter the processing of emotions. In particular the ability to judge the intensity
      of an emotion is influenced. Therefore, the hypothesis of the present study will be, that
      shift work impairs the pain assessment performance of an individual. To test this hypothesis,
      the effect of shift work on the performance in recognizing and assessing pain intensity of
      faces by health care professionals in the anesthesia department will be assessed. A repeated
      measures assessment will be used.
    

Intervention name(s): Night shift work
Intervention type(s): Behavioral
Intervention description(s): Subjects are exposed to irregular sleep and sleep misalignment due to hospital night shifts.
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Health Care Professionals:

        Nurses, nursing assistants, child care nurses and volunteer doctors from the department of
        anesthesia and general resuscitation and thoracic cardiac pediatric
      
Keywords: cognitive empathy; health care professionals; pain recognition; pain assessment; sleep misalignment; quality of care
The Association Between Delivery Method and Maternal Rehospitalization
Condition: Hospitalization
Study type: Observational

Summary: 
      Hypothesis: The rates of rehospitalization after cesarean section are significantly higher
      than those following spontaneous vaginal delivery and are due mainly to late bleeding and
      less to infection.
    

Detailed description: 
      To determine if there is an association between delivery method and maternal
      rehospitalization rate, the type of association and the reasons for rehospitalization.

      The study population will consist women who were rehospitalized in the Western Galilee
      Hospital following cesarean section and after a vaginal delivery. Demographic data and
      hospitalization characteristics will be analyzed.
    

Intervention name(s): Cesarean section; Vaginal delivery
Intervention type(s): Procedure; Procedure
Observational model: Defined Population
Time perspective: Retrospective
Keywords: Rehospitalization; Cesarean; Vaginal delivery
Galantamine Bioequivalence Study of Dr. Reddy's Under Fed Condition
Condition: Fed
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      Galantamine Hydrobromide Tablets, Bioequivalence study of Dr. Reddy's under Fed condition.
    

Detailed description: 
      Comparative, Randomized, Single-Dose, 2-way Crossover Bioavailability Study of Dr.Reddy's
      Laboratories, ltd. and Janssen Pharmaceutical Products, l.P. (Reminyl®)4 mg Galantamine HBr
      Tablets in Healthy Adult Male Volunteers under Fed Conditions
    

Intervention name(s): Reminyl
Intervention type(s): Drug
Intervention description(s): Galantamine Hydrobromide Tablets of Dr. Reddy's Laboratories Limited
Other intervention name(s): Reminyl 4 mg
Intervention MeSH terms: Galantamine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Ventricular Electrical Synchronization by Stimulating Left and Right Bundle Branches Area in Pacing-indicated Patients
Condition: Cardiac Pacing; Pacing Therapy; Pacemaker
Study type: Observational

Summary: 
      This is a prospective, single-site, non-randomized, acute feasibility clinical study. The
      purpose of this study is to explore the electrocardiogram (ECG) characteristics of
      simultaneous stimulation of right and left bundle branches area.
    

Detailed description: 
      Many pacemaker patients have cardiac conduction system disease and thus need ventricular
      pacing. Traditional ventricular pacing causes ventricular dyssynchrony that in turn causes
      cardiac contraction dysfunction. CRT pacing provides better ventricular synchronization, but
      not the optimal, especially in patients with narrow QRS. CRT non-response rate is at 30%. His
      bundle pacing utilizes naturel His bundle-Purkinjie system to provide optimal physiological
      pacing. But many pacing-indicated patients have abnormal His bundle-Purkinje system, thus His
      bundle pacing cannot provide optimal pacing in patients with abnormal cardiac conduction
      system. Moreover, the pacing threshold is high during His bundle pacing. More recently, left
      bundle branch pacing is proposed. However, LBBP will generate right bundle branch block
      pattern, another kind of weak ventricular synchronization. Thus, the investigators propose to
      excite the left and right bundle branches area simultaneously to normalize ventricular
      synchronization. The purpose of this study is to explore the electrocardiogram (ECG)
      characteristics of simultaneous stimulation of right and left bundle branches area.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        This study will enroll subjects who have pacing indications or indications for CRT.
Spot Reduction in Male Adults
Condition: Healthy
Study type: Interventional

Summary: 
      Spot reduction, referring to local body fat reduction, pertains to subcutaneous adipose
      tissue utilization from specific body parts during exercise. Its existence has been keenly
      debated, although generally accepted not to occur during exercise. However, it is based on
      not only equivocal data - commonly the training protocol typically applied is based on
      strength rather than endurance training. The investigators sought to test this assumption by
      utilizing endurance based exercise controlling for energy expenditure and using dual x-ray
      absorptiometric measures to assess body composition before and after training.
    


Intervention name(s): Abdominal aerobic endurance exercise; Control training intervention
Intervention type(s): Other; Other
Intervention description(s): Subjects combined treadmill running at 70% HRmax (27 minutes) with 4x4minutes (30-40% maximal strength, 1RM) of torso rotation and abdominal crunches (57 minutes), 4 days per wk for 10 weeks; Subjects performed treadmill running (45 minutes) at 70% HRmax 4 days per week for 10 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Keywords: endurance exercise; subcutaneous tissue utilization
Tobacco Constituents and Biomarkers
Condition: Smoking
Study type: Observational

Summary: 
      This proposal addresses several research priorities related to the regulatory authority of
      the Food and Drug Administration (FDA) Center for Tobacco Products as mandated by the Family
      Smoking Prevention and Tobacco Control Act. Scientific evidence supports the important role
      of tobacco and cigarette smoke carcinogens in the development of cancers associated with
      cigarette smoking. Regulation of the levels of harmful constituents in cigarette smoke is one
      of the tobacco control strategies that now can be employed by the FDA and may serve to reduce
      tobacco carcinogen exposures in those smokers who are unable or unwilling to quit smoking.
      Such regulation will require a valid and robust approach to the assessment of comparative
      toxicity and carcinogenicity among various cigarette brands. This proposal will help develop
      a testing approach that can produce meaningful predictions of changes in human exposure due
      to changes in constituent levels in cigarette smoke, and hence serve as a reliable measure
      for product regulation. Thus, the proposed research will generate findings and data that are
      directly relevant to inform the FDA's regulation of the manufacture, distribution, and
      marketing of tobacco products to protect public health. The human trial deals with Aims 2 and
      3 of this study.
    


Intervention name(s): FTC Method Smoking Regimen; Massachusetts Method Smoking Regimen; Health Canada Intense Smoking Regimen
Intervention type(s): Other; Other; Other
Intervention description(s): cigarettes are smoked by drawing 35 mL puff volumes over 2 s, with 60 s interval between puffs and no blocking of filter ventilation holes; 45-mL puffs drawn over 2 s, with 30 s interval between puffs and 50% blocking of filter ventilation holes; 55-mL puff volumes of 2-s duration, with 30 s interval between puffs and 100% blocking of filter ventilation holes
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adult smokers from Minneapolis-St. Paul metro area