bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Opioids on Experimental Hyperalgesia in Oesophagus, Skin and Muscles
Condition: Pain
MeSH terms: Hyperalgesia
Study type: Observational

Summary: 
      The study is a multi-modal multi-tissue human experimental pain study in 24 healthy
      volunteers. The study is a randomized cross-over study. The effect of 2 opioids will be
      compared on pain stimuli in skin, muscle an oesophagus. Hyperalgesia will be induced in skin
      and oesophagus, to sensitize these tissues. The pain thresholds before and after opioid
      administration will be compared. The hypothesis is that the difference in effect of the
      opioids is more pronounced in the presence of hyperalgesia. As hyperalgesia is a common
      phenomenon the clinic, the findings in this study may lead to a better understanding of the
      treatment of pain. The study will include an explorative study of the effect of Morphine of
      pain processing in the brain, this will provide us with new insight in the effect of the
      opioids of pain processing in the brain.
    

Detailed description: 
      The study is a multi-modal multi-tissue human experimental pain study in 24 healthy
      volunteers. The study is a randomized cross-over study. The effect of 2 opioids, Oxycodone
      and Morphine will be compared on pain stimuli in skin, muscle an oesophagus. Hyperalgesia
      will be induced in skin by capsaicin and in oesophagus by a mixture of capsaicin and acid, to
      sensitize these tissues. The pain thresholds before and after opioid administration will be
      compared. The hypothesis is that the difference in effect of the opioids is more pronounced
      in the presence of hyperalgesia. As hyperalgesia is a common phenomenon the clinic, the
      findings in this study may lead to a better understanding of the treatment of pain. The study
      will include an explorative study of the effect of Morphine of pain processing in the brain,
      this will provide us with new insight in the effect of the opioids of pain processing in the
      brain.
    

Observational model: Case-Crossover
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Healthy volunteers
      
Biospecimen description: 
      Blood samples are collected to study the pharmacokinetic of the drugs
Assessing the Effect of Met DR on Plasma Glucose and PK in Subjects With T2DM
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study compared the effects of delayed-release metformin (Met DR, EFB0027) administered
      once daily in the morning (qAM), administered once daily in the evening (qPM), and
      administered twice daily (BID) on circulating glucose concentrations and metformin
      pharmacokinetics (PK) in subjects with type 2 diabetes mellitus (T2DM).
    


Intervention name(s): Met DR
Intervention type(s): Drug
Intervention description(s): metformin delayed-release tablets
Other intervention name(s): EFB0027
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Ultrasonic Versus Monopolar Energy-based Surgical Device in Colpotomy
Condition: Gynecologic Diseases
MeSH terms: Genital Diseases, Female
Study type: Interventional

Summary: 
      The aim of this randomized trial was to compare the degree of surgical smoke obstructing
      vision and thermal damage caused by two different ESDs (ultrasonic versus monopolar ESD) in
      colpotomy during total laparoscopic hysterectomy.
    

Detailed description: 
      According to previous studies performed in porcine and bovine tissues, ultrasonic energy
      based surgical devices (ESDs) created less surgical smoke, involved less visual obstruction,
      and produced less lateral thermal damage than monopolar ESDs. However, there was no study
      comparing ultrasonic ESD and monopolar ESD in laparoscopic colpotomy in terms of surgical
      smoke and lateral thermal damage. Therefore, the aim of this randomized trial was to compare
      the degree of surgical smoke obstructing vision and thermal damage caused by two different
      ESDs (ultrasonic versus monopolar ESD) in colpotomy during total laparoscopic hysterectomy.
    

Intervention name(s): Laparoscopic colpotomy by ultrasonic ESD; Laparoscopic colpotomy by monopolar ESD; Monopolar ESD; Ultrasonic ESD
Intervention type(s): Procedure; Procedure; Device; Device
Intervention description(s): In this intervention, laparoscopic colpotomy was performed by ultrasonic ESD (Harmonic Synergy Hook Blades; Ethicon Endo-Surgery, Cincinnati, OH, USA).; In this intervention, laparoscopic colpotomy was performed by monopolar ESD (hook electrode with 90 watts of unmodulated current; Karl Storz, Tuttlingen, Germany).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Biological Age in Health Promotion - Novel Health Technology
Condition: Aging; Healthy
Study type: Observational

Summary: 
      The purpose of this cross-sectional study is to collect relevant molecular markers of aging
      and measures of physiological function. Together these biomarkers are used to develope a new
      Biological Age model, useful in health promotion interventions in the public health sector .
    

Detailed description: 
      Study design: 100 participants representing the healthy danish working adult population. This
      study seek to include both men and women equally distributed in the range of 18-65 of age.

      Data collection: After recruitment, participants need to attend once to the laboratory,
      overnight fasted and without having exercised for the previous 24 hours.

      All analyse are done in investigators lab (Xlab) at the department of Biomedical Sciences,
      Copenhagen University. When analyzes are done, the results are used in algorithm developement
      in cooperation with Technical university Denmark.
    

Intervention name(s): Health Assessment
Intervention type(s): Other
Intervention description(s): The protocol includes measurements of body composition, strength test, functional and fitness test as well as biochemical measurements from blood samples and AGEreader
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Sample size representing the general healthy danish population
      
Biospecimen description: 
      Blood sample will be drawn from a vein in the elbow
    
Keywords: Health; Risk of disease; Prediction; Lifestyle
Biotin Sample Collection Study
Condition: Healthy Volunteers; Biotin Excretion
Study type: Interventional

Summary: 
      This protocol has been designed for a collection of urine samples from volunteers who will be
      given high dose biotin supplements over a period of 5 days, in order to provide a research
      sample bank to examine for biotin excretion rates
    

Detailed description: 
      This is a sample collection study from a minimum of 10 volunteers who will be required to
      take a Biotin supplement daily for a period of 5 days.

      Each volunteer will be asked to read the volunteer information sheet and if they wish to
      participate in the study, the study admission form will be completed and the volunteer will
      be asked to sign a consent form.

      After informed consent each volunteer will be assigned a unique volunteer number for the
      duration of the trial to provide anonymity. The volunteer will be provided with a daily
      diary, urine collection material and a full set of volunteer instructions.

      The daily diary will collect the following information;

        -  Date

        -  Whether or not supplement was taken and time taken

        -  sample collection times during the day

      Volunteers will be requested to:

      Day 1: Collect a urine sample from every void during the day. Days 2-6: Take biotin
      supplements with their evening meal and collect a urine sample from every void during the day
      Day 7: Collect a urine sample from every void during the day

      All samples will be stored in the SPD Bio-bank until required for analysis.
    

Intervention name(s): Biotin
Intervention type(s): Dietary Supplement
Intervention description(s): Biotin supplements (2) to be taken daily
Intervention MeSH terms: Biotin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
COVID-19 Pandemic and Medical Students
Condition: the Effect of COVID-19 Pandemic
MeSH terms: COVID-19
Study type: Observational

Summary: 
      Little is known about changes in levels of academic, financial, psychological, & hygienic
      impact on medical students during this pandemic.
    

Detailed description: 
      this is a cross-sectional, questionnaire-based study. It is conducted on a random targeted
      sample of medical students at medical schools in Universities of Jordan, classified by their
      academic years (from the 1st to the 6th academic year). A score of 10 points was constructed
      to reflect the perspective about the items in each group of variables. SPSS version 25.0 was
      used for the statistical analysis.
    

Intervention name(s): Naser Al-Husban
Intervention type(s): Other
Intervention description(s): voluntary completion of an online questionnaire
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Medical students
A Comparability Study of the Phase 3 Lot and a Single Commercial Lot of NicVAX in Healthy Adult Smokers
Condition: Smoking
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the comparability of the phase 3 lot and a single
      commercial lot of NicVAX in healthy smokers.
    


Intervention name(s): NicVAX Vaccine
Intervention type(s): Biological
Intervention description(s): NicVAX Vaccine given 6 times over 6 months
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Smoking; NicVAX; Smoking vaccine
Investigation of the Effects of Selective Exercise Training in Multiple Sclerosis
Condition: Multiple Sclerosis; Exercise
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      Selective exercise programs specific to muscle groups, with the workload to be done in line
      with the muscle's own structure, can enable more strength to be released with less fatigue in
      MS, and this increase in strength can increase balance and functional activities. to
      determine the effects of type training (selective exercise training), eccentric and
      concentric training on function, balance, fatigue and muscle architecture.
    

Detailed description: 
      Recovery and enhancement of muscle function in MS is one of the main goals in physiotherapy
      and rehabilitation. In literature studies, it is stated that eccentric and concentric
      exercises are effective exercise approaches in increasing strength and reducing fatigue.
      However, the best exercise method is not yet clear in terms of providing better performance
      adaptation with less fatigue. Considering the architectural features of the lower extremity
      muscles, it is aimed to increase the angle of pennation with programs that include concentric
      strengthening of the quadriceps, gastro-soleus and gastrocnemius muscles, which are suitable
      muscle groups to produce large forces by design. With programs that include eccentric
      strengthening of the hamstring and tibialis anterior muscles that function in a wide range of
      motion and have high excursion ability, it is aimed to increase fiber length.
    

Intervention name(s): exercise
Intervention type(s): Other
Intervention description(s): exercise training for 8 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: multiple sclerosis; muscle architecture; Eccentric Exercise; Concentric Exercise
A Small Changes Weight Loss Program and Message Dissemination Via Facebook in Chicago's West Side
Condition: Obesity
MeSH terms: Weight Loss
Study type: Interventional

Summary: 
      African-American communities experience a greater burden of obesity-related diseases such as
      type 2 diabetes mellitus and cardiovascular disease and higher rates of obesity, compared to
      other race groups. There is a need for interventions that show promise in mitigating these
      disparities. The primary goal of this project is to pilot test whether an existing
      "small-changes" intervention for weight loss can be modified and delivered within the West
      Side ALIVE churches.
    


Intervention name(s): Small changes weight loss program
Intervention type(s): Behavioral
Intervention description(s): This intervention uses a "small-changes" approach to calorie reduction (operationalized as 6 100-calories changes per day) along with increasing leisure-time physical activity and self-regulation strategies to produce weight loss. The intervention will be delivered via 12 face-to-face group sessions.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Simultaneous Application of HD-tDCS and Robot-assisted Gait Training on Gait Function in Stroke Patients
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      The purpose of this study was to investigate the effects of simultaneous application of
      transcranial direct current stimulation (tDCS) with robotic gait training in stroke patients
      with gait impairment.
    


Intervention name(s): Brain stimulation; Treadmill gait training
Intervention type(s): Device; Device
Intervention description(s): tDCS brain stimulation on leg motor areas was applied to stroke patients.; Lokomat robot training was applied to stroke patients.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Computational Tools for Early Diagnosis of Memory Disorders
Condition: Alzheimer Disease; Frontotemporal Dementia; Dementia, Vascular; Mild Cognitive Impairment
MeSH terms: Alzheimer Disease; Dementia; Frontotemporal Dementia; Aphasia, Primary Progressive; Pick Disease of the Brain; Dementia, Vascular; Cognitive Dysfunction
Study type: Observational [Patient Registry]

Summary: 
      The Virtual Physiological Human: DementiA Research Enabled by IT (VPH-DARE@IT) is a four-year
      IT-project funded through the European Union (EU). The project consortium involves a total of
      21 universities and industrial partners from 10 European countries. The project delivers the
      first patient-specific predictive models for early differential diagnosis of dementia and
      their evolution. An integrated clinical decision support platform will be validated / tested
      by access to a dozen databases of international cross-sectional and longitudinal studies. As
      a part of the VPH-DARE@IT project, a new prospective cohort will be collected in Kuopio. This
      prospective cohort will be used to test further the modeling approaches and tools developed
      by using the retrospective databases.
    

Detailed description: 
      The Virtual Physiological Human: DementiA Research Enabled by IT (VPH-DARE@IT) is a four-year
      IT-project funded through the European Union (EU). The project will develop multiscale models
      of the ageing brain in order to account simultaneously for the patient-specific biochemical,
      metabolic and biomechanical brain substrate, as well as for genetic, clinical, demographic
      and lifestyle determinants. An integrated clinical decision support platform will be
      validated and tested by access to a dozen databases of international cross-sectional and
      longitudinal studies.

      Modeling approaches developed by using the retrospective databases will be tested using a new
      prospective cohort that will be collected in Kuopio as a part of the VPH-DARE@IT project. The
      study population at university of Eastern Finland (UEF) will be a total of 120 subjects: 20
      healthy controls (HC), 20 mild to moderate Alzheimer's disease (AD) patients, 20 vascular
      dementia (VAD) patients, 20 fronto-temporal dementia (FTD) patients and 40 subjects with mild
      cognitive impairment (MCI). This study is referred as VPH-DARE@IT Prospective study in Kuopio
      or "ProsKuopio".
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Control subjects with normal cognition

        The Alzheimer's disease, Fronto-temporal dementia, Vascular dementia, and Mild Cognitive
        Impairment will be recruited during their visit in the Neurological clinic at the Kuopio
        University Hospital.
      
Biospecimen description: 
      whole blood, serum, plasma, white cells
    
Keywords: Alzheimer Disease; Frontotemporal Dementia; Dementia, Vascular; Mild Cognitive Impairment; Diagnosis; Risk factors; Biomarkers; AD; FTD; VAD; MCI
Rotating Frame Relaxation and Diffusion Weighted Imaging of Human Gliomas
Condition: Low Grade Glioma; Malignant Glioma
MeSH terms: Glioma
Study type: Observational

Summary: 
      Grading of gliomas is of significant clinical importance since the prognosis as well as the
      treatment of choice are distinct in low-grade and high-grade gliomas. With standard MRI
      modalities, however, a reliable distinction is often impossible. Moreover, the gold standard
      for glioma grading by histopathology may also have limitations due to unrepresentative tumor
      samples. Therefore, more advanced MRI techniques are urgently needed that would have higher
      sensitivity and specificity in the definition of tumor type, grade and extent.

      Assessment of radiologic response for high-grade gliomas utilizes the updated RANO criteria
      12 weeks after completion of chemoradiotherapy. However, there is an urgent need to identify
      nonresponding patients earlier, preferentially midtreatment in order to consider alternative
      treatment strategies. Imaging biomarkers, such as diffusion weighted MR imaging (DWI), have
      provided promising results in assessing early treatment response. Furthermore, a serum
      biomarker with diagnostic value could improve tumor follow-up and clinical management of
      gliomas.

      The aim of our study is to develop novel imaging protocols suitable for the magnetic
      resonance imaging (MRI) of glioma using advanced MRI techniques such as rotating frame
      imaging, novel DWI acquisition and post-processing methods We also study the correlation
      between advanced MRI parameters and histopathology of the tumor specimen. In addition, early
      treatment response is assessed with advanced MRI parameters at 3 week and 10 week after
      initiation of radiotherapy. Finally, our objective is to study the association between serum
      biomarkers and corresponding MRI with potential tumor progression.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with a brain tumor scheduled for a surgical resection at the Turku University
        Hospital, Finland.
      
Biospecimen description: 
      Whole blood, frozen tumor tissue
    
Keywords: Glioma; MRI; Rotating frame relaxation; DWI; treatment response
Application of High-flow Nasal Oxygen in Cesarean Section
Condition: Fetal Acidemia
MeSH terms: Acidosis
Study type: Interventional

Summary: 
      The study propose that the using the high-flow nasl oxygen to provide oxygen for maternal can
      improve the fetal acidemia and the neonatal outcomes during cesarean section with combined
      spinal-epidural anesthesia.
    

Detailed description: 
      Maternal oxygen supplementation is widely used intrauterine resuscitation technique in
      clinical, which can improve fetal oxygenation and prevent fetal acidemia. The incidence of
      hypotension is high in cesarean section with combined spinal-epidural anesthesia. Hypotension
      contributes to insufficient perfusion of uterus and placenta, resulting in decreased fetal
      oxygen supply and neonatal acidemia. High flow nasal oxygen have a better improvement
      oxygenation of patients by providing high flow oxygen airflow with heating and humidification
      through nasal cannula.
    

Intervention name(s): Optiflow high-flow nasal cannula system
Intervention type(s): Device
Intervention description(s): Using the Optiflow high-flow nasal cannula system to supply oxygen for maternal.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: high-flow nasal oxygen; cesarean section; oxygen; umbilical artery; acidemia
Safety, Reactogenicity and Immunogenicity of Flublok Quadrivalent (Recombinant Influenza Vaccine,Seasonal Formulation)
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 3

Summary: 
      Flublok was studied previously in children 6 -59 months of age and demonstrated less than
      satisfactory immunogenicity results, especially in the 6-36 month age group. Thus, the
      initial introduction of Flublok Quadrivalent Formulation (RIV4) into the pediatric population
      will evaluate immunogenicity and safety older children and adolescents, aged 6-17. This
      clinical trial is designed to demonstrate safety and non-inferior immunogenicity of Flublok-Q
      in pediatric subjects 6-17 years of age as compared to IIV4. Positive results in this study
      may support further studies in younger children.
    

Detailed description: 
      The U.S. Advisory Committee on Immunization Practices (ACIP) recommends that all people ≥6
      months of age receive influenza vaccine annually. Recommendations for influenza immunization
      of children vary somewhat among countries in the European Union, but immunization of children
      at high risk for complications of influenza infection is recommended by WHO and according to
      criteria in most countries. Currently, the immunization practices are progressing to
      quadrivalent formulations of inactivated influenza vaccines (IIV4) which are approved in the
      US for most of the indicated population. Additionally, live attenuated vaccine (LAIV4) is
      approved in the U.S. for individuals aged 2-49 years and Flublok®(RIV3), a purified trivalent
      recombinant hemagglutinin protein vaccine is approved in the U.S. for adults 18-49 years of
      age. Children are at particular risk of complications of influenza, including the B lineages,
      so expansion of the Flublok indication into the pediatric age group with a quadrivalent
      formulation is warranted.
    

Intervention name(s): Flublok® Quadrivalent Influenza Virus Vaccine; Fluarix Quadrivalent® Influenza Virus Vaccine
Intervention type(s): Biological; Biological
Intervention description(s): Intramuscular (Relevant year formulation); Intramuscular (Relevant year formulation)
Other intervention name(s): Recombinant Influenza Vaccine (RIV4); Flublok Influenza Vaccine; rHA; rHA0; Recombinant Hemagglutinin
Intervention MeSH terms: Hemagglutinins; Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Prevention