bioihbjkbjnl/mcl2 huggingface dataset:
Hemodynamic Survey Cardiac Surgical Scenarios
Condition: Low Cardiac Output
MeSH terms: Cardiac Output, Low
Study type: Observational

Summary: 
      The purpose of this study is to find out the Lidco Rapid ( monitoring tool gives cardiac
      output) is as equivalent in determining the hemodynamic assessment in cardiac surgical
      scenarios as the most often used pulmonary artery catheter, which is much more invasive than
      the Lidco Rapid. This will be accomplished through online surveys which have different
      cardiac surgery scenarios and will be distributed to cardiac fellowship trained
      anesthesiologists. The online based survey will include a specific scenario and details on
      the scenario represented in image format and a brief description of the patient to aid with
      their analysis of the situation.
    

Detailed description: 
      Data from PA catheter such as PA pressure, pulmonary wedge pressure and cardiac output has
      been widely used in the various clinical situations warranting advance hemodynamic
      monitoring. It is considered as gold standard but unfortunately there is always risk
      associated with PA catheter and time lag between the clinical events and interpretation.
      Lidco Rapid is one of the non-invasive hemodynamic tools to measure various parameters. It is
      widely used in the intensive care set up for goal directed therapy but unfortunately there is
      not enough data to show whether it is useful in various peri-operative clinical conditions.
      In the online based survey, responses from the participants are recorded in the nominal scale
      ( 1 to 5 where 3 represents near normal). This survey will help to determine whether
      Investigators can replace the Lidco in any clinical situation warranting advance hemodynamic
      monitoring.

      No previous study was done to specifically find out the hemodynamic component that differs
      between these tools intraoperatively in varying hemodynamic conditions during cardiac surgery
      although there were few studies compared the trend in the cardiac output with difference in
      opinion on their accuracy.
    

Intervention name(s): LIDCO Rapid, Pulmonary artery catheter
Intervention type(s): Device
Intervention description(s): Hemodynamic monitoring systems
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Cardiac Fellowship trained Anesthesiologists
Effect of Interscalene Block on Heart Rate Variability (HRV)
Condition: Shoulder Surgery; Beach Chair Position; Interscalene Block; HRV; Autonomic Nervous System
Study type: Observational

Summary: 
      The Left interscalene block has a different effect on heart's autonomic nervous system, as
      measured with Heart Rate Variability, compared to Right interscalene block
    


Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients for elective shoulder surgery
      
Keywords: Shoulder surgery; Beach chair position; Interscalene block; HRV; Autonomic nervous system
Safety and Efficacy Study of Botulinum Toxin Type A as Treatment for Osteoarthritis Knee Pain
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study will evaluate the efficacy and safety of a single intra-articular (IA) injection
      of botulinum toxin Type A compared with placebo as treatment for osteoarthritis (OA) knee
      pain.
    


Intervention name(s): botulinum toxin Type A; Normal Saline
Intervention type(s): Biological; Drug
Intervention description(s): A single 200U (2 mL) dose of botulinum toxin Type A injected into the intra-articular space of the study knee on Day 1.; A single 2 mL dose of Normal Saline (placebo) injected into the intra-articular space of the study knee on Day 1.
Other intervention name(s): BOTOX®
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effect of Transmagnetic Stimulation on Conditioned Pain Modulation (CPM)
Condition: Headache; Migraine
MeSH terms: Headache
Study type: Interventional

Summary: 
      While some indications of the neural circuits involved in the Conditioned Pain Modulation
      (CPM) process are now available, there is still need to clarify what parts of the brain are
      essential for this process, whether the spino-brainstem loop is largely sufficient to explain
      CPM or whether other cerebral and spinal regions such as frontal, somatosensory and other
      cortical regions contribute substantially. Whereas mere observation of correlation between
      these circuits while activated by brain imaging is still of considerable interest, direct
      experimental manipulations by repetitive transcranial magnetic stimulation (rTMS) could even
      establish insights into causal relationships.
    

Detailed description: 
      rTMS of different intensities, frequencies and location will be applied during CPM to
      evaluate the central mechanisms of pain modulation, their location and role in pain reduction
      through enhancement or suppression of activity in the relevant brain regions. In other words,
      cortical regions that may be implicated in CPM will be determined by augmenting or
      interrupting their activity via rTMSapplied to the areas under investigation. The regions
      will be the pain network sites, which are assumed to control the top-down influence on CPM
      and are superficial enough to be stimulated by the magnetic coil. These include primarily
      DLPFC (dorsolateral prefrontal cortex) and OFC (orbitofrontal cortex), with possible later
      addition of other relevant sites such as ACC (anterior cortex cinguli), insula and
      somatosensory cortices, etc. Since rTMS may be administered in a manner that either reduces
      or enhances the excitability of the stimulated cortical region, it should be possible to
      clarify the inhibitory or excitatory role of these regions in the CPM process. In summary,
      the planned studies should allow for identifying the cortical regions of the descending pain
      system, which are critical as starting points for the top-down modulation of CPM.
    

Intervention name(s): TMS system MagPro x100, Tonica Elektronik A/S, Denmark; TMS system MagPro x100, Tonica Elektronik A/S, Denmark
Intervention type(s): Device; Device
Intervention description(s): repeated TMS (rTMS); repeated TMS
Other intervention name(s): Transcranial Magnetic Stimulator; Transcranial Magnetic Stimulator
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: TMS; CPM; headache; migraine; EEG; psychophysics
Prevention of Combat-related PTSD Using Attention Bias Modification (ABM): A Randomized Controlled Trial
Condition: PTSD
Study type: Interventional

Summary: 
      Military deployment to combat zones involves exposure to trauma at a higher than average rate
      and therefore presents a unique opportunity to study predisposing factors to posttraumatic
      stress reactions and test strategies designed to prevent and ameliorate posttraumatic
      symptoms. Decades of scientific research on the origins of resilience and vulnerability to
      combat-related posttraumatic stress symptoms revealed various predisposing and protective
      factors. All these factors however, offer limited opportunity for systematic pre-deployment
      prevention efforts. Considering the magnitude of psychological adjustment difficulties
      encountered by combat personnel in deployment and the limited access to existing
      evidence-based therapies for PTSD, the development and testing of a novel evidence-based and
      theory-driven prevention protocol for these problems is of considerable significance. The
      current study translates cognitive-neuroscience knowledge and attention bias modification
      research into a novel computerized training tool that could be easily delivered to soldiers
      during different stages of the deployment cycle. If proved efficacious in reducing risk for
      posttraumatic symptoms ABMT could be integrated into the Army's resilience training program.
      Thus, we propose a longitudinal double-blind randomized controlled study of ABMT in soldiers.
      We will assess attention bias and symptoms before deployment, will randomly assign soldiers
      to either 8 ABMT sessions, 4 ABMT sessions, 8 Placebo training sessions, or no training.
      Following 6 months of deployment to combat zone symptoms will be assessed again.
    


Intervention name(s): Active ABMT8; Active ABMT4; Placebo
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Active ABMT8 8 active ABMT sessions (10 min. each, over 7-8 weeks) designed to promote adaptive threat attendance; Active ABMT4 4 active ABMT sessions (10 min. each, over 7-8 weeks) designed to promote adaptive threat attendance; Placebo: will receive 4 training sessions(10 min. each, over 7-8 weeks) using the same task and stimuli as in the active arms, but not designed to change attention patterns
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Attention bias modification; resilience; combat; PTSD; Depression; Anxiety
Tolerability, Pharmacokinetics and Pharmacodynamics of BIA 9-1067
Condition: Parkinson's Disease (PD)
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the tolerability of BIA 9-1067 after multiple rising
      dose regimens of BIA 9-1067.
    

Detailed description: 
      Single centre, double-blind, randomised, placebo-controlled study of four dosage regimens of
      BIA 9-1067 in four groups of healthy male volunteers. In each group, the study will consist
      of an once-daily (o.d.) 8-day multiple-dose period. Progression to the next dose level will
      only occur if the previous dose level was considered to be safe and well tolerated. An
      appropriate interval (will separate the investigation of doses to permit a timely review and
      evaluation of safety data prior to proceeding to a higher dose level.
    

Intervention name(s): BIA 9-1067; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): OPC, Opicapone; PLC, Placebo
Intervention MeSH terms: Opicapone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Parkinson's disease (PD); Opicapone; Bial; BIA 9-1067
Betaferon/ Betaseron (Interferon Beta-1b) in Patients With Chronic Viral Cardiomyopathy
Condition: Cardiomyopathies; Heart Diseases
MeSH terms: Heart Diseases; Cardiomyopathies
Study type: Interventional
Phase: Phase 2

Summary: 
      Chronic viral cardiomyopathy is a disease where the cardiac muscle is attacked by a virus and
      this may result in a reduction in the output of the heart (pump function) thereby causing
      complaints such as chest pain, shortness of breath and palpitations.

      Betaferon (interferon beta-1b) is marketed for the treatment of Multiple Sclerosis already,
      but until now, it has not been proven whether it is also effective in patients with chronic
      viral myocardial disease.

      This study will be conducted to examine the efficacy and safety of Betaferon in patients with
      this disease. The aim of the treatment is to eliminate the virus from the heart so that the
      heart function and clinical status can gradually improve.
    

Detailed description: 
      The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been
      renamed to Bayer Schering Pharma AG, Germany.

      Bayer Schering Pharma AG, Germany is the sponsor of the trial.
    

Intervention name(s): Interferon beta-1b (Betaferon/Betaseron, BAY86-5046); Interferon beta-1b (Betaferon/Betaseron, BAY86-5046); Placebo; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 2 MIU per application in week 1 and 4 MIU per application in weeks 2 to 24 given subcutaneously every other day; 2 MIU per application in week 1, 4 MIU per application in weeks 2 to 3 and 8 MIU per application in weeks 4 to 24 given subcutaneously every other day; 0.25 ml in week 1 and 0.50 ml in weeks 2 to 24 given subcutaneously every other day; 0.25 ml in week 1, 0.50 ml in weeks 2 to 3 and 1.00 ml in weeks 4 to 24 given subcutaneously every other day
Intervention MeSH terms: Interferons; Interferon-beta; Interferon beta-1b
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cardiomyopathy; idiopathic chronic heart failure; Adenovirus; Enterovirus; Parvovirus
Muscle Weakness Duration After Single Botulinum Toxin Injection in Masseter
Condition: Bite Force; Botulinum Toxins, Type A
MeSH terms: Muscle Weakness; Paresis
Study type: Interventional

Summary: 
      This study aimed to evaluate the duration of a reduced maximal voluntary bite force after a
      botulinum toxin intervention. Methods: In an intervention group, 25 units of Xeomin® (Merz
      Pharma GmbH & Co KGaA, Frankfurt am Main, Germany) botulinum neurotoxin type A were injected
      into the masseter muscles bilaterally (to a total of 50 units).
    

Detailed description: 
      This study aimed to evaluate the duration of a reduced maximal voluntary bite force (MVBF)
      after a botulinum toxin intervention. Methods: In an intervention group, 25 units of Xeomin®
      (Merz Pharma GmbH & Co KGaA, Frankfurt am Main, Germany) botulinum neurotoxin type A were
      injected into the masseter muscles bilaterally (to a total of 50 units). A control group did
      not receive any intervention. MVBF was measured in Newtons using a strain gauge meter at the
      incisors and first molars. The intervention group was comprised of individuals seeking
      aesthetic treatment for masseter reduction (n = 20), and the control group (n = 12) comprised
      of volunteers.
    

Intervention name(s): Botulinum toxin type A
Intervention type(s): Drug
Intervention description(s): Single intervention
Other intervention name(s): Xeomin
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Quadratus Lumborum Block Type 2 Versus Posterior Transversus Abdominus Plane Block
Condition: Regional Block
Study type: Interventional

Summary: 
      This patient population are at risk of adverse effects secondary to inadequate pain
      management such as inadequate maternal bonding and late ambulation.

      Regional analgesia is preferred due to their opioid sparing effects and reduction in related
      adverse effects but the analgesia from these blocks is not known which one is superior to the
      other in the context of cesarean section
    

Detailed description: 
      The aim of this study is to compare the effect of posterior transversus abdominus plane block
      and quadratus lumborum type 2 for cesarean delivery.

      The transversus abdominus plane(TAP) block provides sensory block from T6 to L1 for lower
      abdominal surgeries.

      Quadratous lumborum type 2 block, the injection is posterior to the quadratus lumborum
      muscle. This method has the advantage of a more superficial point of injection with better
      ultrasonographic resolution.

      Only one RCT was done in this context by Kalpana Verma and his colleagues comparing quadratus
      lumborum type 2 and posterior transversus abdominus plane block. That shows marked
      discrepancy with time to first analgesic request from the quadratus lumborum block in other
      abdominal surgeries
    

Intervention name(s): Posterior transversus abdominus plane block; Quadratus lumborum block type 2
Intervention type(s): Procedure; Procedure
Intervention description(s): Twenty mL of bupivacaine 0.25% will be injected in the plane between the transverses abdominus muscle and the fascia deep to the internal oblique muscle on each side; Twenty mL of bupivacaine 0.25% will be injected on the posterior surface of quadrates lumborum muscle on each side
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: patients will be randomly allocated via sealed opaque envelop into 2 groups of 50 patients each; Posterior transversus abdominus block (TAP) group and Quadratus lumborum block type 2 is the second group (QLB)group
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Musical Training to Enhance Resilience in Children From Low-income Families
Condition: Resilience
Study type: Interventional

Summary: 
      Child poverty is a prominent global health issue owing to its detrimental impact on a child's
      physical and psychosocial well-being. Nearly 356 million children lived in extreme poverty
      globally before the pandemic and this is estimated to worsen significantly. children growing
      up in poverty are more vulnerable to its effect and have an increased risk of psychosocial
      and developmental problems than children from affluent families. The impact of poverty is not
      only immediate during childhood but can persist into adulthood. Previous studies have shown
      that Chinese children from low-income families reported significantly higher levels of
      depressive symptoms, lower levels of self-esteem, quality of life, and life satisfaction than
      children from affluent families.

      Recent studies have revealed the promising effects of musical training to promote
      psychological well-being among children and adolescents and paediatric brain tumour
      survivors, improving psychosocial skills of children with autism, to enhance the quality of
      life and psychological health by promoting positive emotions and cognitive and social
      development.

      Promoting the psychological health of school-aged children from low-income families through
      enhancing their resilience has received limited research attention. Additionally, there is a
      lack of intervention studies to promote resilience in school-aged children from low-income
      families. This proposed research, therefore, aims to conduct a pilot randomised controlled
      trial to determine the feasibility, acceptability and preliminary effects of a musical
      training programme in enhancing resilience and self-esteem, reducing depressive symptoms and
      improving the quality of life among children from low-income families.

      The findings from the study could inform the policymakers and healthcare professionals in
      health services design and the importance of advocating the psychological needs of children
      from low-income families by providing adequate community resources and support. If the
      programme demonstrates its effectiveness in promoting resilience and self-esteem among
      children from low-income families, further implementation could be done to maintain its
      sustainability in the community. Most importantly, the programme may potentially enhance the
      resilience of the vulnerable children from low-income families to combat poverty and hence
      break the intergenerational transmission of poverty.
    


Intervention name(s): Musical training
Intervention type(s): Behavioral
Intervention description(s): The musical training intervention comprised songs, rhythm and visual creativity to encourage the children to experience music-making as fun.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Single and Multiple Dosing Study in Hemodialysis Patients With Hyperphosphatemia in Japan
Condition: Chronic Kidney Disease; Hyperphosphatemia Undergoing Hemodialysis
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Hyperphosphatemia
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to assess PK, safety and tolerability of a single oral dose of
      ASP3325 and to assess PD, PK and safety of repeated oral doses of ASP3325 administered t.i.d.
      before or just after each meal
    

Detailed description: 
      [Part 1] This part is an open-label, uncontrolled study to evaluate PK and safety with single
      dosing of ASP3325 in hemodialysis patients. After washout period of therapeutic medication
      for hyperphosphatemia, six subjects will receive single oral administration of ASP3325
      (Tablet A) on a non-dialysis day (Day 1).

      [Part 2] This part is a 2-arm, open-label, uncontrolled study to evaluate PD, PK and safety
      with dosing ASP3325 Tablet B t.i.d. before or just after each meal.

      Eligible subjects at screening will be entered into the washout period for stopping their
      phosphate-binding treatment. 20 subjects with serum inorganic phosphorus (Pi) level between
      ≥6.0 and <10.0 mg/dL during the washout period (washout period week 1 or washout period week
      2) will be randomized to each treatment group and ASP3325 will be administered for 2 weeks
      until Day 14.
    

Intervention name(s): ASP3325
Intervention type(s): Drug
Intervention description(s): oral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hyperphosphatemia; ASP3325; Chronic Kidney Disease; pharmacodynamics; pharmacokinetics
An Evaluation of the Adrenal Suppression Potential and PK of CB-03-01 Cream in Pediatric Patients With Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is designed to determine the hypothalamic-pituitary-adrenal (HPA) axis suppression
      potential and pharmacokinetic (PK) properties of CB-03-01 Cream, 1%, applied every twelve
      hours for two weeks, in pediatric patients 9 to less than 12 years of age with acne vulgaris.
      Adrenal suppression effects and systemic safety are an important safety concern. The current
      study is designed to investigate these potential concerns under maximal use conditions.
    


Intervention name(s): cortexolone 17α-propionate
Intervention type(s): Drug
Intervention description(s): CB-03-01 cream is a topical steroidal antiandrogen that is being developed for the potential treatment of acne vulgaris, an androgen-dependent skin disorder.
Other intervention name(s): CB-03-01
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: acne; cortexolone; anti-androgen