bioihbjkbjnl/mcl2 huggingface dataset:
A Comparison of Two Sedation Techniques in Children Undergoing Transthoracic Echocardiography (TTE)
Condition: Heart Disease
MeSH terms: Heart Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The study will examine the quality of two sedation techniques (dexmedetomidine and
      pentobarbital) used for children aged 3 to 24 months who are undergoing a transthoracic
      echocardiography (TTE).
    

Detailed description: 
      Currently there are two sedation methods used for children less than 24 months of age
      undergoing transthoracic echocardiography (TTE).

        -  One method provides sedation by mouth with the drug pentobarbital,

        -  The other provides sedation through the nose with the drug dexmedetomidine.

      The choice of which method is used is based on evaluation of the patient's medical history
      and the preference of the anesthesiologist. To our knowledge, no study has compared these two
      sedation techniques for quality of care. The proposed study will help us determine which
      method yields the best quality and will allow us to improve the healthcare experience of our
      patients.
    

Intervention name(s): Dexmedetomidine; Pentobarbital; Oral Placebo; Nasal Placebo
Intervention type(s): Drug; Drug; Other; Other
Intervention description(s): Nasal administration; Oral administration; Oral placebo will be cherry syrup; Nasal placebo will be nasally atomized saline
Other intervention name(s): Cherry Syrup; Nasally atomized saline
Intervention MeSH terms: Pentobarbital; Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Pediatric; Sedation; Transthoracic echocardiography; TTE; Dexmedetomidine; Pentobarbital
Assessment of OHIR Score to Predict a Prolonged Intensive Care Unit Stay
Condition: ICU Stay
Study type: Observational

Summary: 
      A prolonged stay in intensive care unit (ICU) after cardiac surgery with cardiopulmonary
      bypass increases not only cost of patient care but also morbidity and mortality of patients.
      The ability to predict which patient has the tendency to have a prolonged ICU stay would help
      in patient and resource management of the hospital. There are many predictive models aiming
      at identifying patient at risk of prolonged ICU stay after cardiac surgery with
      cardiopulmonary bypass but almost all involve the preoperative assessment for proper resource
      management with one model, Open-Heart Intraoperative Risk (OHIR) Scoring concerning
      intraoperative manipulatable risk factors to improve anesthetic care and patient outcome. The
      OHIR model comprises 6 risk factors, 5 of which can be managed intraoperatively, with total
      score of 7 and a score of ≥ 3 indicating a likely prolonged ICU stay. The objective of this
      study was to re-validate the performance of OHIR score in the recent context.
    

Detailed description: 
      This will be a retrospective, observational, analytical study. The study protocol was
      approved by the Human Research Ethics Committee, Khon Kaen University (HE581287).

      The investigators will review all eligible medical records at Srinagarind Hospital and Queen
      Sirikit Heart Center of the Northeast, Khon Kaen University during January 2013 and December
      2014. The extracted data consist of patient's clinical data and all risk factors in the OHIR
      score. The investigators will apply the OHIR scoring to the data to assess its performance.
      The investigators will use the same criteria for a prolonged ICU stay as in the previous
      study, i.e. a stay longer that the median.
    

Intervention name(s): adult cardiac surgery with cardiopulmonary pump
Intervention type(s): Procedure
Intervention description(s): Open-heart surgery both coronary artery bypass graft (CABG) and valve surgery
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Adult patients undergoing open-heart surgery both CABG and valve surgery with
        cardiopulmonary pump
Ph1 Marinol Interaction Study - Part 2 - 1
Condition: Marijuana Dependence
MeSH terms: Marijuana Abuse
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will examine the effects of oral dronabinol tetrahydrocannabinol (THC) on
      withdrawal symptoms in marijuana dependent volunteers, and evaluate the safety,
      pharmacokinetics (PK), and cardiovascular effects of the combination of oral dronabinol and
      smoked marijuana to determine if there are potential significant drug interactions before
      conducting outpatient studies.
    


Intervention name(s): Placebo; Dronabinol
Intervention type(s): Drug; Drug
Other intervention name(s): Placebo comparator arm; Medication intervention
Intervention MeSH terms: Dronabinol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: Marijuana dependence
Club Fit: Physical Activity and Healthy Eating at an After School Program
Condition: Childhood Obesity; Physical Activity; Dietary Habits
MeSH terms: Pediatric Obesity
Study type: Interventional

Summary: 
      Background: Youth from low-income and minority families are disproportionately affected by
      obesity and its complications. This study presented pilot work to develop and implement a
      multi-component physical activity and healthy eating intervention at a Boys & Girls Club
      (BGC) after school program.

      Methods: Using a community-based participatory approach, BGC staff and academic researchers
      developed intervention components informed by formative studies and based on a social
      ecological theory framework. Components included healthy eating and physical activity policy
      implementation, staff training, a challenge/self-monitoring program for healthy behaviors, a
      peer-coaching program for healthy behaviors, and a social marketing campaign. Preliminary
      intervention efficacy was assessed through a single group, pre-post study design with
      measured collected at baseline and 6 months.
    


Intervention name(s): Physical activity and healthy eating intervention
Intervention type(s): Behavioral
Intervention description(s): Using a community-based participatory approach, BGC staff and academic researchers developed intervention components informed by formative studies and based on a social ecological theory framework. Components included healthy eating and physical activity policy implementation, staff training, a challenge/self-monitoring program for healthy behaviors, a peer-coaching program for healthy behaviors, and a social marketing campaign.
Other intervention name(s): Club Fit
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: community based participatory research; Childhood obesity
Effect of Plant Stanol Ester-Containing Spread on Estimated Cardiovascular Risk in Comparison to Mediterranean Diet
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 4

Summary: 
      Since it is very difficult to have the real thing (Mediterranean diet) we need to find an
      alternative to reduce cardiovascular disease (CVD) risk in subjects with moderate
      hypercholesterolaemia (a major CVD risk factor) living in western countries. Therefore, this
      proposed study is designed to assess if giving olive oil supplements, with or without stanol
      ester, is equivalent to following a Mediterranean diet. Furthermore, the stanol-olive oil
      combination may prove to be superior to olive oil alone.
    

Detailed description: 
      Design: Randomised, double blind, placebo controlled study Number of participants: 150 (3
      groups with 50 subjects each). Intervention: One group will be assigned to stanol ester
      spread (2 g/day) based on olive oil, another on spread with olive oil containing placebo
      stanol ester (in identical containers with the stanol ester spread). In the third group, a
      structured effort will be made to improve adherence to Mediterranean diet by at least 2
      points in a 10-level scale. Adherence to the Mediterranean diet will be improved by a
      dietician with detailed explanation of the composition of the diet, preparation of several
      week specific programs according to dietary preferences of the specific subject. Dietician
      interviews with a 5 day questionnaire on consumed foods will establish the degree of
      adherence to Mediterranean diet.

      Duration: 16 weeks (4 weeks of lifestyle advice and 12 weeks of treatment).

      Prespecified analyses:

        1. Postmenopausal women vs women with child bearing potential.

        2. Older (>65 years of age) vs younger subjects,

        3. Subjects with impaired fasting glucose levels.
    

Intervention name(s): Stanol ester spread; Placebo spread; Mediterranean Diet
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Stanol ester spread 20 g every day; Placebo spread 20 g every day; Mediterranean Diet every day
Other intervention name(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Cholesterol, stanol-ester, mediterranean diet, cardiac risk
Interferon Alpha Lozenges in the Prevention of Winter Colds and Flu
Condition: Upper Respiratory Tract Infections
MeSH terms: Respiratory Tract Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of the study is to see if lozenges containing a low dose of interferon-alpha can
      prevent and/or reduce the severity of colds and flu. Starting about 1 month before the
      expected start of the winter colds and flu season in Perth, Australia, healthy volunteers
      will allow a lozenge containing interferon, or a lozenge containing no medicine (a placebo),
      to dissolve in their mouth once a day for 16 weeks. Blood tests at the start and end of
      treatment will determine whether interferon was able to prevent infections with cold/flu
      viruses. Once a week, volunteers will complete a survey about their cold/flu symptoms,
      medications taken, days of work missed, etc. to see if interferon was able to make their
      winter colds and flu less severe.
    


Intervention name(s): interferon-alpha; placebo
Intervention type(s): Drug; Other
Intervention description(s): a lozenge for oral dissolution containing 150 international units of human interferon-alpha taken once daily for 16 weeks; placebo lozenges for oral dissolution taken once daily for 16 weeks
Other intervention name(s): IFN-alpha lozenge; Maltose lozenge
Intervention MeSH terms: Interferons; Interferon-alpha
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Prophylaxis; Treatment; Symptoms; Winter Colds and Flu
A Study to Explore the Effect of Acid-reducing Agents
Condition: Healthy Adults
Study type: Interventional
Phase: Phase 1

Summary: 
      A Phase 1 Study of the Effect of Acid-reducing Agents on the Pharmacokinetics of a Single
      Oral Dose of Sitravatinib in Healthy Adult Subjects. The study is a single-center,
      open-label, 2-period, 2-treatment, fixed-sequence crossover, parallel-group study.
    


Intervention name(s): Sitravatinib; Pantoprazole; Famotidine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 100 mg sitravatinib on Day 1; 40 mg QD on Day 1 to Day 7 of Period 2 in Group 1; 40 mg PO 2 hrs after sitravatinib in Period 2 of Group 2
Other intervention name(s): MGCD516; Protonix; Pepcid
Intervention MeSH terms: Pantoprazole; Famotidine
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Intervention model description: 2 period crossover
Masking: None (Open Label)
Primary purpose: Other
Optical Spectroscopy in Evaluating Tumor Margins in Patients Who Have Undergone Surgery for Breast Tumors
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      RATIONALE: Diagnostic procedures, such as optical spectroscopy, may help learn the extent of
      disease and allow doctors to plan better treatment.

      PURPOSE: This phase I trial is studying optical spectroscopy to see how well it works in
      evaluating tumor margins in patients who have undergone surgery for breast cancer.
    

Detailed description: 
      OBJECTIVES:

        -  To develop a non-invasive detection tool that evaluates breast tumor margins in
           real-time to guide tumor resection during partial mastectomy procedures.

        -  To conduct an ex vivo optical spectroscopic study in operating rooms on breast tissue
           samples obtained immediately following resection to assess the efficacy of using this
           tool in differentiating breast tumor or tumor margins from normal breast tissue.

      OUTLINE: Breast tissue samples obtained immediately following resection are examined in the
      operating room using optical spectroscopy to evaluate the margin tissue. During spectroscopy,
      all lights, except for the surgical lights, are turned off and the lateral, superior, medial,
      inferior, deep, and anterior margins of the breast tissue sample are examined using a
      fiber-optic probe, a nitrogen laser, and a broad band white light source. Reflectance and
      fluorescence spectra are measured at each of these margins by a system operator. The measured
      margins are then immediately marked by sutures placed by the surgeon. Additional margins may
      be measured at the surgeon's and system operator's discretion. The breast tissue sample is
      then delivered to surgical pathology, where shave biopsies are performed at the suture-marked
      sites to provide a direct correlation between spectroscopy measurements and tissue pathology.

      Data collected in this study, including spectral data, gross diagnosis of the patient's
      tumor, and histological identities of all specimens collected, will be kept in the research
      record for at least 6 years after the study is finished.
    

Intervention name(s): breast biopsy; histopathologic examination; light-scattering spectroscopy; therapeutic conventional surgery
Intervention type(s): Procedure; Procedure; Procedure; Procedure
Intervention model: Single Group Assignment
Intervention model description: Optical spectroscopy is applied to evaluate tumor margins in consenting patients who undergo surgery for breast tumors
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: male breast cancer; stage IA breast cancer; stage IB breast cancer; stage II breast cancer; stage IIIA breast cancer; stage IIIB breast cancer; stage IIIC breast cancer; stage IV breast cancer
Comparison of Liraglutide Injected at Three Different Injection Sites in Healthy Volunteers
Condition: Diabetes; Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. the aim of this trial is to compare the pharmacokinetic
      profile of liraglutide between administrations in the thigh versus the abdomen and between
      administrations in the upper arm versus the abdomen.
    


Intervention name(s): liraglutide
Intervention type(s): Drug
Intervention description(s): Single dose of 0.60 mg administered subcutaneously in three different injection sites on three separate dosing visits
Intervention MeSH terms: Liraglutide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Impact of an Integrated Intervention on Mental Health in Survivors of Intimate Partner Violence
Condition: Domestic Violence
Study type: Interventional
Phase: Phase 2

Summary: 
      Intimate partner violence (IPV) against women have negative mental health consequences for
      survivors; interventions designed to improve survivors' depressive symptoms and health status
      are limited.Present study evaluate the effectiveness of an integrated intervention in
      reducing intimate partner violence (IPV) improving health status.
    


Intervention name(s): Intervention Group
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Effects of Vitamin D3 Supplementation on Cognitive Function in Community Dwelling Older Adults
Condition: Healthy
Study type: Interventional

Summary: 
      Ireland is predicted to have the highest older adult population growth of any European Union
      country. A substantial economic and social challenge of this projected growth is the
      increased incidence of cognitive impairment and the likelihood of progression to dementia.
      Dementia's, such as Alzheimer's disease, typically have a long prodromal stage with brain
      changes identifiable from the earliest stages of neuropathology, providing an opportunity for
      intervention. Switching to a strategy of earlier identification and prevention would
      significantly reduce prevalence and the associated cost.

      The purpose of this pilot study is to evaluate the use of vitamin D supplements in community
      dwelling older adults as a lifestyle approach that may support cognitive and physical
      functioning. The research will incorporate several stages including an initial in-depth
      screening process, a novel and sensitive cognitive battery, 6 month double blind placebo
      controlled intervention of vitamin D3 (cholecalciferol) and a concluding participant feedback
      interview.

      These results will be used to assess the feasibility of recruiting and assessing community
      dwelling older adults for extensive nutrition related cognitive studies.
    


Intervention name(s): Cholecalciferol -Vitamin D3; Placebo -gel capsule containing no vitamin D.
Intervention type(s): Dietary Supplement; Other
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Vitamin D supplementation; Cognitive function; Physical function; Successful ageing; Prevention; Cholecalciferol; Dementia; Muscle mass
Questionnaire of the Section Perioperative Intensive Care of the European Society of Intensive Care Medicine (ESICM) on Standardized Drug Labelling
Condition: Drug Labelling
Study type: Observational

Summary: 
      Medication errors are common in intensive care (Valentin A et al., BMJ. 2009;338).
      Standardized color coded labels for user applied syringes enjoy strong support from many
      health professionals, thinking that this might increase patient safety. Whether this is true
      or not warrants further research.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Members of the European Society of Intensive Care Medicine (ESICM)
      
Keywords: drug labelling; standardized drug syringe labelling; European ICU
Mixed Reality With Hololens® Exercise Protocol
Condition: Healthy Volunteers
Study type: Interventional

Summary: 
      The study design is a cross-over pilot study with 15 asymptomatic subjects. There will be 2
      groups, mixed reality group and conventional cervical exercise program. Both groups received
      2 sessions per week with an interval of 48 hours between them during 3 consecutive weeks.
    

Detailed description: 
      The study design is a cross-over pilot study. The study was approved by the ethical committee
      of the Centro Superior de Estudios Universitarios La Salle. People were recruited by referral
      from different places of the local community of Madrid according to the CONSORT statement
      (Consolidated Standards of Reporting Trials). Three assessors were trained during 300 minutes
      about how to perform the measurements (Investigator A) and the concerned intervention to each
      group (Investigator B and C). The whole procedure was conducted in the Centro Superior de
      Estudios Universitarios La Salle. After meeting the eligibility criteria for the study,
      participants were randomly allocated by an external investigator to one of the two groups:

        -  Mixed reality group

        -  Conventional Exercise group
    

Intervention name(s): Mixed reality; Conventional exercise group
Intervention type(s): Other; Other
Intervention description(s): This group received 6 exercise sessions over 3 weeks, 2 days/week with an interval of 48 to 72 hours between sessions, using the Microsoft Hololens "Roboraid" game. The duration of the sessions will be 10 minutes.; This group received 6 exercise sessions over 3 weeks, 2 days/week with an interval of 48 to 72 hours between sessions. This program will consist on stabilisation exercises of the cervical region, in neck deep flexors and neck deep extensors muscles to provide them with strength and resistance
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: cross-over pilot study
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Mixed reality; Exercise