bioihbjkbjnl/mcl2 huggingface dataset:
Transfusion Requirements in Transcatheter Aortic Valve Implantation (TRITAVI) Study
Condition: Transcatheter Aortic Valve Implantation (TAVI); Blood Transfusion; AKI; Prognosis; Aortic Valve Stenosis
MeSH terms: Aortic Valve Stenosis
Study type: Observational

Summary: 
      Periprocedural bleeding events are frequent during transcatheter aortic valve implantation
      (TAVI), mainly driven by vascular complications and are associated to a worse prognosis.
      Therefore, red blood cell (RBC) transfusion is often required, although it is associated with
      worsened outcomes.

      There is no consensus on the optimal transfusion strategy after bleeding. The Transfusion
      Requirements in Transcatheter Aortic Valve Implantation (TRITAVI) will be a multicenter
      retrospective registry enrolling consecutive patients who underwent TAVI; the primary aim of
      the study will be to test whether RBC transfusion is a marker or an independent predictor of
      adverse events.
    

Detailed description: 
      Periprocedural bleeding events are frequent during transcatheter aortic valve implantation
      (TAVI), mainly driven by vascular complications and are associated to a worse prognosis.
      Therefore, red blood cell (RBC) transfusion is often required, although it is associated with
      worsened outcomes.

      There is no consensus on the optimal transfusion strategy after bleeding: among patients
      undergoing cardiac surgery, the Transfusion Requirements in Cardiac Surgery (TRICS) III trial
      documented that a restrictive RBC transfusion strategy (if hemoglobin level was <7.5 g/dl)
      was noninferior to a liberal approach (if hemoglobin level was <9.5 g/dl) with respect to the
      composite occurrence of death, myocardial infarction (MI), stroke, or new-onset renal failure
      with dialysis.

      The Transfusion Requirements in Transcatheter Aortic Valve Implantation (TRITAVI) will be a
      multicenter retrospective registry enrolling consecutive patients who underwent TAVI; the
      primary aim of the study will be to test whether RBC transfusion is a marker or an
      independent predictor of adverse events. Patients will be stratified according to their
      lowest hemoglobin value (>9.5 g/dl, 7.5-9.5 g/dl and <7.5 g/dl) and to whether they received
      or not periprocedural RBC transfusion.

      The primary endpoint will be the 30-day occurrence of major adverse cardiovascular events
      (MACE), as death, myocardial infarction (MI), stroke, or acute kidney injury (AKI, as
      absolute increase in serum creatinine ≥0.3 mg/dL [≥26.4 μmol/L] or ≥50% increase ≤72 hours).
    

Intervention name(s): Blood Transfusion
Intervention type(s): Procedure
Intervention description(s): Blood Transfusion in patients who underwent transcatheter aortic valve implantation (TAVI)
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        All-consecutive patients referring at the participants centers undergoing transcatheter
        aortic valve implantation (TAVI)
Use of Adapted Controllers for Active Video Gaming in People With Physical Disabilities
Condition: Physical Disability
Study type: Interventional

Summary: 
      The purpose of this study is to compare the effectiveness of off-the-shelf (OTS) and adapted
      game controllers on quality of game play, enjoyment, and energy expenditure during active
      video gaming in persons with mobility impairments. The controllers to be evaluated include
      off-the-shelf and adapted gaming mats and off-the-shelf and adapted Wii Fit balance boards.
    

Detailed description: 
      Previous studies have shown that individuals with disabilities have lower levels of physical
      activity and fitness and higher levels of obesity compared to their non-disabled peers.
      Research has also shown that engaging this population in physical activity can be extremely
      challenging due to physical impairments associated with their disability, as well as fewer
      opportunities to participate.

      Active video games (AVG), also known as exergames, are a category of video games that require
      much more body motion for successful play than the traditional pushbutton or joystick
      actions. The recent introduction of motion controlled AVGs allow a much greater variety of
      physical activity to be part of play. These games hold promise for promoting higher levels of
      energy expenditure, weight management and fitness. However, many current AVGs are
      inaccessible or offer limited play options for individuals who are unable to stand, have
      balance issues, poor motor control, or cannot use their lower body to perform game
      activities. Making AVGs accessible to people with disabilities offers an innovative approach
      to overcoming various barriers to participation in beneficial physical activity.

      A recent publication by Dr. Rimmer in the Physical Medicine and Rehabilitation journal
      examining the use of AVGs as a means to increase energy expenditure in non-ambulatory young
      adults with disabilities suggested that clinically significant increases in energy
      expenditure could be achieved with AVGs.
    

Intervention name(s): Active video gaming
Intervention type(s): Other
Intervention description(s): Participants will engage in active video game play using two off-the-shelf (OTS) and two adapted controllers using the Wii gaming console. Controllers are: OTS balance board, OTS gaming mat, Adapted balance board, Adapted gaming mat.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Active video gaming; Energy expenditure
Study Of PF-06817024 In Healthy Subjects, In Patients With Chronic Rhinosinusitis With Nasal Polyps And in Patients With Atopic Dermatitis
Condition: Healthy; Chronic Rhinosinusitis With Nasal Polyps; Atopic Dermatitis
MeSH terms: Sinusitis; Nasal Polyps; Dermatitis, Atopic; Dermatitis; Eczema; Polyps
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate safety, tolerability, pharmacokinetics, and
      pharmacodynamics of PF-06817024 in healthy volunteers, in participants with chronic
      rhinosinusitis, with nasal polyps and in participants with moderate-to-severe Atopic
      Dermatitis
    

Detailed description: 
      The purpose of the study for Part 1 is to evaluate the safety and tolerability of PF-06817024
      in healthy subjects.

      The purpose of the study for Part 2 is to evaluate the safety and tolerability of PF-06817024
      in patients with chronic rhinosinusitis with nasal polyps.

      The purpose of the study for Part 3 is to evaluate the safety and tolerability of PF-06817024
      in patients with moderate-to-severe Atopic Dermatitis
    

Intervention name(s): PF-06817024; Placebo for PF-06817024; PF-06817024; Placebo for PF-06817024; PF-06817024; Placebo for PF-06817024; PF-06817024; Placebo for PF-06817024; PF-06817024; Placebo for PF-06817024
Intervention type(s): Biological; Other; Biological; Other; Biological; Other; Biological; Other; Biological; Other
Intervention description(s): Subjects will be given one dose of PF-06817024 intravenously; Subjects will be given one dose of placebo for PF-06817024 intravenously; Subjects will be given one dose of PF-06817024 subcutaneously; Subjects will be given one dose of placebo for PF-06817024 subcutaneously; Subjects will be given two doses of PF-06817024 intravenously; Subjects will be given two doses of PF-06817024 intravenously; Subjects will be given 2 doses intravenously; Subjects will be given 2 doses intravenously; Subjects will be given doses of PF-06817024 intravenously; Subjects will be given doses of Placebo intravenously
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: FIH, Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, Atopic Dermatitis, Chronic Rhinosinusitis, Nasal Polyps
Reducing Preoperative Anxiety in Parents of Surgical Patients
Condition: Anxiety
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      Aims and objectives: To investigate preoperative anxiety in parents of paediatric surgical
      patients, testing whether the provision of information (using video and story books)
      regarding the surgical process can impact on reducing anxiety. Analyse if some personal
      factors influence the reduction of anxiety.

      Background: Attending a surgical theatre generates anxiety in all types of patients,
      especially in the case of children. The effect of different preoperative intervention
      procedures in children that attempt to reduce their anxiety level have been studied a great
      deal. However, although their parents also suffer high anxiety levels, potential intervention
      to reduce their levels have not received the same attention.

      Study design: Randomised Clinical trial Methods: One hundred and twenty-five parents of
      children (8-12 y.o.) undergoing surgery in Hospital Universitario Central de Asturias
      hospital (Oviedo, Spain) were randomly assigned to the control group (34 individuals) or one
      of the 3 experimental groups (91). After the pre-anaesthesia consultation, children and
      parents of the experimental groups were provided with a story book, a video with additional
      information of nursing, or both. In the antechamber of the operating room and prior to the
      surgical intervention, the State Anxiety and Trait Anxiety of the parents and children were
      measured using the STAI and STAIC questionnaires respectively. The data collection, including
      different demographic variables was carried out for 12 months starting in October 2016
    


Intervention name(s): Story book with information about surgery techniques; Video with information about surgery techniques; Story book and Video with information about surgery techniques
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Presurgery use of Story book. The parents with the child read a book with information about surgery techniques the days before surgery.; Presurgery use of video. The parents with the child watch a video with information about surgery techniques the days before surgery.; Presurgery use of video and story book. The parents with the child watch a video and read a book (both) with information about surgery techniques the days before surgery.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A randomised and blind clinical trial. The parents could be randomly assigned to the control group, and received the standard procedure, or to the experimental groups. Three experimental groups were possible regarding the various types of interventions: story book (IG1), video (IG2), or both instruments (IG3)
Masking: Single (Investigator)
Primary purpose: Treatment
The Use of Platelet-rich-fibrin in Lower Third Molar Surgery.
Condition: Facial Swelling; Tooth Position Anomalies; Tooth, Impacted; Tooth Extraction Status Nos; Tooth Avulsion
MeSH terms: Tooth, Impacted; Tooth Avulsion
Study type: Interventional

Summary: 
      The present study aims to analyze the effect of PRF (Platelet-rich-fibrin) in terms of facial
      swelling, trismus and pain after surgical removal of mandibular third molar (M3M) in a
      split-mouth randomized controlled clinical trial.
    

Detailed description: 
      The present study aims to analyze the effect of PRF (Platelet-rich-fibrin) in terms of facial
      swelling, trismus and pain after surgical removal of mandibular third molar (M3M) in a
      split-mouth randomized controlled clinical trial. Facial swelling will be assessed using an
      innovative three-dimensional digital technique.
    

Intervention name(s): PRF
Intervention type(s): Biological
Intervention description(s): Post-operative PRF placement in the post-extraction socket after third molar surgery
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: third molar surgery; facial swelling; 3D facial swelling evaluation; PRF; tooth impacted; platelet rich fibrin
A Study of Pegylated Interferon Alfa-2A in Combination With Lamivudine or Entecavir Compared With Untreated Control Group in Children With Hepatitis B Envelope Antigen (HBeAg)-Positive Chronic Hepatitis B (CHB) in the Immune-Tolerant Phase
Condition: Pediatric Immuno-Tolerant Chronic Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 3

Summary: 
      This randomized, controlled, parallel group, open-label multicenter study will evaluate the
      efficacy and safety of a combination of pegylated interferon alfa-2A (Pegasys) plus
      lamivudine or entecavir compared with an untreated control group in participants with HBeAg
      positive CHB in the immune tolerant phase. NOTE: STUDY RECRUITMENT HAS BEEN TERMINATED
    


Intervention name(s): Entecavir; Lamivudine; Pegylated Interferon Alfa-2A
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Participants will receive entecavir, either as a film-coated tablet or oral solution, once daily at a dose of 0.015 milligrams per kilogram (mg/kg) (maximum daily dose of 0.5 mg).; Participants will receive lamivudine, either as a film-coated tablet or oral solution, once daily at a dose of 3 mg/kg (maximum daily dose of 100 mg).; Participants will receive pegylated interferon-alfa-2A at a body surface area (BSA) based dose of 180 micrograms per 1.73 square meter (mcg/1.73m^2) BSA.
Other intervention name(s): Pegasys, Peg-IFN-Alfa-2A
Intervention MeSH terms: Interferons; Interferon-alpha; Lamivudine; Interferon alpha-2; Peginterferon alfa-2a; Entecavir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Ziprasidone in Bipolar Disorder With Comorbid Lifetime Panic or Generalized Anxiety Disorder(GAD)
Condition: Bipolar Disorder; Panic Disorder; Generalized Anxiety Disorder
MeSH terms: Anxiety Disorders; Bipolar Disorder; Panic Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      The specific aim of this study is to evaluate the efficacy, tolerability, and safety of
      ziprasidone monotherapy in comparison to placebo in the treatment of ambulatory bipolar
      disorder with co-morbid lifetime panic disorder or generalized anxiety disorder and current
      at least moderately severe anxiety.
    

Detailed description: 
      This is a randomized, double-blind, placebo controlled, parallel-group, 8-week trial of
      ziprasidone compared to placebo in outpatient subjects with a lifetime bipolar I, II, or NOS
      disorder, a lifetime panic or generalized anxiety disorder, and current diagnosis at least
      moderately severe anxiety symptoms. Approximately 50 subjects will be randomized. Subjects
      will be randomized to ziprasidone or placebo in a 1:1 ratio. No concomitant psychotropic
      medication will be allowed throughout the study except for prn lorazepam during the first two
      weeks for the management of affective and anxiety symptoms, prn zolpidem and zaleplon for the
      management of insomnia and benztropine for the management of EPS. Throughout the study,
      psychiatric scales will be used to assess psychiatric symptoms and the presence of
      treatment-emergent adverse events will be monitored and recorded.
    

Intervention name(s): Ziprasidone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): The minimum dose during study participation will be 40 mg/day, and the maximum dose allowed will be 160 mg/day.; Inactive control
Other intervention name(s): Geodon; Zeldox; sugar pill
Intervention MeSH terms: Ziprasidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Bipolar disorder; Anxiety; Panic; GAD; Generalized Anxiety Disorder
Monitoring Changes in Physiological Parameters by Utilization of the Combined Physiological Activity Index (CPAI)
Condition: Healthy Subjects
Study type: Observational

Summary: 
      A clinical trial to validate the MCPM (Multi-parameter Combined Physiological Signal-based
      Monitoring), in estimating physiological activity level, at rest, previous and following
      stimuli.
    

Detailed description: 
      The Multi-parameter Combined Physiological Signal-based Monitoring (MCPM) system is a
      non-invasive multi-parameter physiological monitoring system, intended for continuous .
      acquisition, analysis and display of physiological signals and a Combined Physiological
      Activity Index (CPAI).

      Subjects who meet the study inclusion and exclusion criteria will be enrolled to the study
      and their physiological measures, at rest and during exposure to the thermal and stressogenic
      physical stimuli will be recorded by the MCPM system. All subjects will be recorded according
      to a standard procedure; subjects will be lying in the supine position and will be instructed
      to avoid any movements. The experimenter will connect the sensors (MCPM finger probe). During
      the experimental session, different thermal stimuli will be administrated via the cold
      pressor test, with 10-20 minutes of non-stimuli interval. The last stimuli is an stressogenic
      physical preformed by the subject.

      1-2 weeks following the first visit, about half of the subjects will be invited to a second
      visit, identical study visit, to assess the between session test-retest reliability of the
      signals. During the second visit, CPAI will be measured again under randomize thermal stimuli
      and an additional 3 Celsius degrees cold stimuli.
    

Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        healthy subjects, age: 18-65.
Association of Two Desensitizing Protocols to Control Dentinal Hypersensitivity in Non-carious Lesions
Condition: Dental Hypersensitivity
MeSH terms: Hypersensitivity
Study type: Interventional

Summary: 
      This randomized, double-blind clinical trial evaluated the effect of photobimodulation
      associated with 8% strontium acetate in the treatment of dentin hypersensitivity in
      non-carious lesions and analyzed the risk factors with the patient's quality of life.
    


Intervention name(s): Photon Laser III-DMC (without radiation emission) + My First- Colgate; Photon Laser III-DMC (without radiation emission) + Sensodyne® Rapid Relief / GSK; Photon Laser III-DMC (with irradiation emission) + My First- Colgate; Photon Laser III-DMC (with irradiation emission) +Sensodyne® Rapid Relief / GSK
Intervention type(s): Other; Other; Radiation; Combination Product
Intervention description(s): Positioning of the FBM (Photon Laser III / DMC) without emitting radiation, the equipment's sound was mimicked with the Beep application (Foncannon Inc, Google, © 2018), followed by the use of fluoride-free toothpaste (My First- Colgate) and brushing three times a day.; Positioning of FBM (Photon Laser III / DMC) without emitting radiation, the equipment's sound was mimicked with the Beep application (Foncannon Inc, Google, © 2018), followed by the application of toothpaste containing strontium acetate (Sensodyne® Rapid Relief / GSK) and brushing three times a day.; Emission of FBM therapy (Photon Laser III / DMC), followed by the use of fluoride-free toothpaste (My First- Colgate) and brushing three times a day.; Emission of FBM therapy (Photon Laser III / DMC), followed by the application of toothpaste containing strontium acetate (Sensodyne® Rapid Relief / GSK) and brushing three times a day.
Intervention MeSH terms: Listerine; Sodium Fluoride
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
A Study of Pain Relief in Osteoarthritis
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare the safety and pain-relieving ability of Vicodin CR
      to placebo in subjects with osteoarthritis (OA) of the hip or knee.
    


Intervention name(s): hydrocodone / acetaminophen extended release; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 2 tablets twice daily; 2 tablets twice daily
Other intervention name(s): ABT-712
Intervention MeSH terms: Acetaminophen; Acetaminophen, hydrocodone drug combination; Hydrocodone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Osteoarthritis of the hip or knee
Serum Aluminum Concentration of Pediatric Patients Receiving Long-Term Parenteral Nutrition
Condition: Aluminum Contamination of Parenteral Nutrition
Study type: Observational

Summary: 
      The purpose of this study is to determine whether children on long-term parenteral nutrition
      (>6 weeks) have serum aluminum concentrations that are higher than children (aged and gender
      matched) that have never received parenteral nutrition.
    

Detailed description: 
      Aluminum contamination of parenteral nutrition (PN) solutions has been a concern for decades
      because of its link to metabolic bone disease (MBD) due to it's high aluminum content.
      Currently in the United States, FDA regulations are in place to protect American patients on
      PN from the effects of aluminum (AL) toxicity. Despite these regulations, pediatric patients
      on PN are still receiving higher than recommended AL intakes from PN.

      Unlike the United States, there are no regulations governing AL content of or intakes from PN
      solutions in Canada. Consequently, the investigators are unaware of the AL content of the
      various PN solutions given to our patients. The investigators (the authors) have observed
      that a significant number of our patients on long-term PN (Home PN), have MBD. Some of our
      patients have also had bone fractures. The investigators have also observed alteration in
      calcium and phosphate concentrations as well as suppressed PTH. In an effort to understand
      the etiology of the MBD the investigators have measured serum AL concentrations in our
      patients and have found them to be high; between 900 - 2000 nmol/L compared to 0 to 220
      nmol/L reported in healthy adults. This has led us to believe that there is a significant
      problem of AL contamination in PN solutions in Canada. Because the investigators are unable
      to obtain information on the AL content of the various PN solutions from the PN suppliers,
      the investigators have decided to report on the serum AL concentrations of our patients as
      well as the AL concentration of a random sample of PN solutions provided to patients. Plasma
      aluminum concentrations have already been analyzed in each of the cases. Blood was drawn for
      routine clinical monitoring on each subject after they had been on PN for six weeks or more.

      This is the first step towards raising awareness of the potential problem. It is our hope
      that this will provide initial evidence to help guide Health Canada's decision regarding
      regulations on AL content in PN solutions in Canada.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients followed in the Home-TPN program at the Hospital for Sick Children
      
Biospecimen description: 
      serum
    
Keywords: serum aluminum; parenteral nutrition; children