bioihbjkbjnl/mcl2 huggingface dataset:
Tap to "Tap", Pathobiome Associates Health Care
Condition: Otorhinolaryngologic Diseases
MeSH terms: Otorhinolaryngologic Diseases
Study type: Interventional

Summary: 
      The bacteria live in community and in some cases it is the combination of several
      microorganisms that facilitates transmission and pathogenicity. The concept of pathobiome
      follows from this finding. Investigators hypothesize that the microbial community water point
      is a pathobiome influencing installation and transmission of pathogens associated with care
    

Detailed description: 
      Goals :

      Key: To study the impact of bacterial communities on the risk of transmission of waterborne
      pathogenic bacterium Pseudomonas aeruginosa in patients hospitalized from a contaminated
      water source by this bacterium.

      secondary:

        1. Assess the role of communities on installing the water points in P. aeruginosa by
           comparing contaminated and uncontaminated water sources.

        2. To evaluate the effect of the quality of water and the conditions of use of water points
           network on the composition of bacterial communities associated or not with P.
           aeruginosa.

      Experimental Study conducted from 6 points of water, contaminated deliberately experimental
      backs onto the project to assess conventional and alternative measures decontamination
      network and water points
    

Intervention name(s): mouth swab
Intervention type(s): Other
Intervention description(s): Levy to make inside of the mouth with a swab on the day of admission to hospital and the day of release at the patients in the Otorhinolaryngology
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Continuous GlucoseMonitor for Measurement of Blood Glucose Level
Condition: Other Surgical Procedures
Study type: Interventional

Summary: 
      This study will be the first study in which the new central venous microdialysis-based
      continuous glucose monitoring system (Continuous GlucoseMonitor) is used to investigate the
      performance of this Continuous GlucoseMonitor, as the measurements will be compared with a
      point of care reference (RAPIDLab® 1265 blood gas analyser). Further important points are
      also much less blood samplings / blood loss for the patient and personnel costs.
    

Detailed description: 
      The current standard for measuring blood glucose concentrations on ICU is to manually draw a
      blood sample from an arterial catheter and analyse the sample using a point of care blood gas
      analyser. This technique has several disadvantages as causes considerable blood loss and does
      not produce a continuous blood glucose profile and it is labour intensive (multiple samples
      over time are needed to follow the changes in blood glucose concentration). The monitoring
      system (Continuous GlucoseMonitor) based on the microdialysis technique has the advantage
      that not blood, but a physiological fluid such as saline is used as test medium. In brief, a
      physiological fluid, called the perfusate is continuously perfused through the microdialysis
      probe. At the membrane of the probe, glucose (as other low-molecular weight molecules)
      diffuses from the surrounding sample into the perfusate, now called dialysate, and is
      transported outside the probe for ex vivo monitoring.
    

Intervention name(s): continuous GlucoseMonitor
Intervention type(s): Device
Intervention description(s): The blood glucose and blood lactate levels will be taken continuously by the Continuous GlucoseMonitor and will be recorded twelve times.
Other intervention name(s): blood glucose examination stand
Intervention model: Single Group Assignment
Masking: None (Open Label)
Neurophysiological Evaluation of Schizophrenia Patients After Cognitive and Physical Intervention
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      Neurophysilogical, neuropsychological evaluation and cognitive and physical training
    

Detailed description: 
      24 sessions (8 weeks, 3 times per week) of cognitive and physical training via computer. Each
      session consisted of 45 minutes of cognitive traing (BrainHQ platform
      https://www.brainhq.com/) and 45 minutes of physical training (FitForAll platform
      https://www.fitforall.gr/play/app/). Cognitive training included memory, attention, velocity,
      intelligence etc. Physical training included aerobic, strength flexibility and other
      excercises. All evaluations were performed 1-14 before the initiation of the interventions
      and 1-14 after their completion. Neurophysiological evaluation consisted of EEG with the use
      of 128 electrode-machine and the protocol included 5 minuted of eyes closed and 5 minutes of
      eyes open. Neuropsychological evaluation included Trail Making Test (A & B), Verbal Fluency,
      Stroop test, Wechsler Memory - Cubes (visuospatial), MoCA, FAB (Screening for frontal damage)
      and Eyes Test (Theory of Mind). Also, the physical condition evaluation included 6-Minute
      Walking Distance (6MWD), ΒΜΙ, HandGrip Strength Test, Short Physical Performance Battery
      Protocol.
    

Intervention name(s): Cognitive Training; Physical Training
Intervention type(s): Other; Other
Intervention description(s): Cognitive training included memory, attention, velocity, intelligence; Physical training included aerobic, strength, flexibility and balance.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Electroencephalography; Cognitive training; Physical training; Resting state networks
The Effects of Nateglinide and Acarbose on the Post-Prandial Glucose Control in Type 2 Diabetic Patients
Condition: Diabetes Mellitus; Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      In type 2 diabetic patients, tight blood glucose control often requires both fasting and
      post-prandial glucose control separately. In the diabetic patients already on the insulin
      glargine treatment for the control of fasting blood glucose, additional measures for the
      control of post-prandial glucose level are often required. Nateglinide and acarbose are
      frequently used for this purpose. We hypothesized that the short acting sulfonylurea
      "nateglinide" may be more efficacious in diabetic patients with appreciable endogenous
      insulin secretion, while acarbose may be more efficacious in patients with lower endogenous
      insulin secretion. And we also want to clarify the clinical and biochemical parameters that
      can predict the responsiveness to each agent in this multi-center randomized open cross-over
      clinical study.
    


Intervention name(s): nateglinide; acarbose
Intervention type(s): Drug; Drug
Intervention MeSH terms: Acarbose; Nateglinide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Percutaneous Irreversible Electroporation to Treat Liver Cancer Close to the Gallbladder
Condition: Hepatic Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the safety and efficacy of irreversible
      electroporation for unresectable Hepatic carcinoma close to the gallbladder, also Progress
      Free Survival (PFS) will be recorded.
    

Detailed description: 
      Hepatic carcinoma is the fifth most common cancer worldwide and a large proportion of
      patients are unsuitable for tumor resection because of factors such as poor hepatic
      reserve(cirrhosis), multicentric tumors or near vital structures such as vessels,
      diaphragmatic dome and gallbladder. Direct ablative treatments include radiofrequency
      ablation, microwave (MW) ablation and cryotherapy and irreversible electroporation had been
      used successful as a therapeutic choice for unresectable patients. At the same
      time，Irreversible electroporation(IRE)，which was applied with a novel ablation technology,
      can induce tissue necrosis by utilizing short pulses of high-voltage electrical energy. The
      technique also had many advantages, including Short ablation time, preservation of vital
      structures within IRE-ablated zone, avoidance of heat/cold-sink effect, complete ablation
      with well-demarcated margin and real-time monitoring of IRE ablation.
    

Intervention name(s): NanoKnife
Intervention type(s): Device
Intervention description(s): Irreversible electroporation (IRE) is a new, minima-invasive image-guided treatment method for tumors not amenable for surgical resection or thermal ablation, due to vicinity near vital structures such as vessels,bile ducts and the gallbladder .
Other intervention name(s): IRE
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Alteration of Myocardial Deformations in Diabetes: Relationship to Micro-angiopathy
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      Despite careful monitoring of patients with diabetes, it is so far difficult to predict the
      occurrence of cardiac events in the evolution. As shown by various studies conducted in
      patients with diabetes, cardiac involvement can be detected by abnormalities of diastolic or
      systolic functions using non-invasive investigations such as echocardiography. For 4 years,
      the evaluation technique of myocardial deformations by two-dimensional speckle tracking
      strain by echocardiography is the subject of high hopes in the earlier detection of still
      asymptomatic cardiomyopathies. In the present study, the investigators hypothesized that this
      technique would improve the detection of myocardial contraction abnormalities in patients
      with insulin-dependent diabetes mellitus (IDDM), and would establish their association with
      micro-angiopathy, frequently encountered in these patients.
    

Detailed description: 
      This is a single center case-control study based on routine care, designed to recruit
      patients with type 1 diabetes mellitus free from any other myocardiopathy. The inclusion will
      take place over a period of 24 months. No monitoring of patients (no follow-up) is provided
      under this protocol. The analysis will focus on the combination of the left ventricle
      myocardial deformations alteration revealed by the echocardiographic 2D strain analysis (<
      18% in absolute value), with the existence of micro-angiopathy in type 1 diabetes mellitus
      patients with preserved left ventricular ejection fraction ( ≥ 60%).

      Two hundred subjects with type 1 diabetes mellitus will be recruited: 100 subjects with
      impaired left ventricular myocardial deformation by 2D strain analysis (< 18% in absolute
      value), constituting the 'cases' group and 100 subjects without alteration in myocardial
      deformation (global strain ≥ 18%).
    

Intervention name(s): Echocardiographic 2D strain analysis
Intervention type(s): Device
Intervention description(s): Conventional transthoracic echocardiography with acquisitions for strain analysis by speckle tracking (2D strain)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Normal Values of Facial Thermography
Condition: Healthy; Allergy; Allergic Rhinoconjunctivitis
MeSH terms: Conjunctivitis, Allergic; Hypersensitivity
Study type: Observational

Summary: 
      An objective of this study is to standardize temperature values derived from thermograms of
      the facial region. It is anticipated that the mean temperature of a defined region of
      interest, such as the eyes, nose, or sinuses, might be useful for future applications.

      The investigators will attempt to determine normal temperature ranges based on participants'
      age and gender.
    

Detailed description: 
      Medical thermography is a noninvasive technique that allows an examiner to visualize and
      estimate the temperature of the skin surface. An infrared scanning device is used to convert
      infrared radiation emitted from the skin surface into electrical impulses that can be
      captured as an image called a thermogram. During the past 20 years medical thermography has
      been used to study the pathology in the vascular, muscular, neural and skeletal systems.

      An objective of this study is to standardize temperature values derived from thermograms of
      the facial region. It is anticipated that the mean temperature of a defined region of
      interest, such as the eyes, nose, or sinuses, might be useful for future applications. This
      protocol addresses the definition of overall health, symptomology, and anthropometrical
      features (age, weight, height, body mass index and gender), and what effect, if any, each has
      on mean temperature. Environmental conditions, mapping procedures, and image evaluations will
      also be standardized. We will attempt to determine normal temperature ranges based on
      participants' age and gender. Future use of standardized values will be to assess the
      severity of rhinoconjunctivitis symptoms being experienced by a subject.

      Subjects will make one visit to our clinic. They will be asked to acclimate to room
      temperature for at least 30 minutes. Subjects are requested not to consume hot drinks or food
      for at least an hour before imaging and not to use any skin preparations such as creams or
      talcum powder. A picture of the participant's face will be taken using the thermal camera
      which will demonstrate the temperature of each facial area of interest.

      Please note that participants in this study will take part on a completely voluntary basis.
      No payment will be provided.
    

Intervention name(s): Thermography
Intervention type(s): Procedure
Intervention description(s): Subjects will have a picture of their face taken with a thermal camera
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        outpatient subjects at Allegheny General Hospital
      
Keywords: Healthy; Allergy; Allergic Rhinoconjunctivitis
The Modulatory Effect of Oxytocin on Interoception
Condition: Interoception
Study type: Interventional

Summary: 
      This study is designed to investigate oxytocin's effects on interoception and whether these
      effects vary as a function of different emotional valence.
    

Detailed description: 
      The present study will use a double-blind, between-subject, placebo-controlled design to
      investigate the modulatory effect of oxytocin on interoception and whether this effect will
      vary as a function of emotional valence. In Experiment 1, subjects will perform a heartbeat
      detection task and the group differences between oxytocin and placebo groups of the
      interoceptive accuracy and neural activity in the core interoceptive network will be
      investigated. In Experiment 2, subjects will be asked to watch emotional faces while perform
      the heartbeat detection task. Investigators will examine whether oxytocin's effects on
      interoception will be varied as a function of different emotional valence.
    

Intervention name(s): oxytocin; placebo
Intervention type(s): Drug; Drug
Intervention description(s): self-administration of oxytocin (nasal spray); self-administration of placebo (nasal spray)
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Oxytocin
Comparison of PFS and ART in Adhesive Capsulitis in Diabetic Patients
Condition: Adhesive Capsulitis
MeSH terms: Bursitis
Study type: Interventional

Summary: 
      To determine the technique that will have better effects in realigning the muscle kinematics
      and to normalize the muscle activity along with reducing muscle stiffness with mobilizations
      techniques
    

Detailed description: 
      There is a very limited literature available Active release technique (ART) and Post
      Facilitation Stretch (PFS) in frozen shoulder. Additionally there is a very limited
      literature on the evaluation of ART in comparison with PFS in adhesive capsulitis of diabetic
      patient. Disease such as rheumatoid arthritis (RA), osteoarthritis (OA) etc that cause
      stiffness of the shoulder joint also present with altered muscle activity, that in long run
      becomes one of the main causes of reduces joint range of motion. With this study, we will be
      able to determine the technique that will have better effects in realigning the muscle
      kinematics and to normalize the muscle activity along with reducing muscle stiffness with
      mobilizations techniques. This study will also fulfill that research gap and will provide
      clinicians with an alternative approach in treatment of adhesive capsulitis.
    

Intervention name(s): Post facilitation stretch; Active release technique
Intervention type(s): Other; Other
Intervention description(s): Post facilitation stretch with maitland mobilization Grade I & II Maitland mobilization of shoulder joint in 1st and 2nd week progressing to Grade III oscillatory mobilization of shoulder joint in 3rd week. It will further progress to Grade IV Maitland oscillatory mobilizations in the 4th or 5th week.
Treatment will be provided 3 session/week for 6 weeks with 40 minutes/session; Active release technique with maitland mobilization Grade I & II Maitland mobilization of shoulder joint in 1st and 2nd week progressing to Grade III oscillatory mobilization of shoulder joint in 3rd week. It will further progress to Grade IV Maitland oscillatory mobilizations in the 4th or 5th week.
Treatment will be provided 3 session/week for 6 weeks with 40 minutes/session
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Shoulder; Pain; Fibrosis; Disability
Changes to Vulva, Vestibule, Urethral Meatus and Vagina 20 Weeks Post Daily Prasterone in Women With Dyspareunia
Condition: Dyspareunia
MeSH terms: Dyspareunia
Study type: Interventional
Phase: Phase 4

Summary: 
      Open label study at a single research center. Subjects meeting inclusion and exclusion
      criteria will receive 6.5 mg prasterone vaginal inserts daily for twenty weeks. A physical
      examination and vulvoscopy with photography of the vulva, vestibule, urethral meatus and
      vagina will be performed at baseline and every 4 weeks for 20 weeks. Pain diaries will be
      completed between visits.
    

Detailed description: 
      This is an open label study to be conducted at a single research center, San Diego Sexual
      Medicine. Subjects meeting inclusion and exclusion criteria will receive 6.5 mg prasterone
      vaginal inserts daily for twenty weeks. After the informed consent is signed, a baseline
      physical examination and vulvoscopy with detailed photography of the vulva, vestibule,
      urethral meatus and vagina will be performed. Physical examination and vulvoscopy with
      detailed photography of the vulva, vestibule, urethral meatus and vagina will be repeated
      prospectively every 4 weeks for a total of 20 weeks. Therefore, physical examination and
      vulvoscopy with detailed photography of the vulva, vestibule, urethral meatus and vagina will
      be performed prospectively at baseline (vulvoscopy session 1), 4 weeks (vulvoscopy session
      2), 8 weeks (vulvoscopy session 3), 12 weeks (vulvoscopy session 4), 16 weeks (vulvoscopy
      session 5) and 20 weeks (vulvoscopy session 6) following daily administration of 6.5 mg
      prasterone. In addition, pain diaries will be dispensed at each visit and collected at the
      following visit, with questions regarding pain during sexual activity.
    

Intervention name(s): Prasterone
Intervention type(s): Drug
Intervention description(s): 6.5 vaginal insert prasterone (dehydroepiandrosterone)
Other intervention name(s): Intrarosa
Intervention MeSH terms: Dehydroepiandrosterone
Intervention model: Single Group Assignment
Intervention model description: Open label study of daily administration of 6.5 mg prasterone, approved for moderate to severe dyspareunia for vaginal atrophy in menopausal women, to see if there are changes to the vulva, vestibule, urethral meatus and vagina on vulvoscopy after 20 weeks
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: vulvovaginal atrophy; dyspareunia; prasterone; vulvoscopy
HAL-MPE1 First-in-human
Condition: Peanut Allergy
MeSH terms: Hypersensitivity; Peanut Hypersensitivity
Study type: Interventional
Phase: Phase 1

Summary: 
      Currently, there is no effective causal treatment for peanut allergy. A chemically modified,
      aluminium hydroxide adsorbed peanut extract (HAL-MPE1) for subcutaneous administration has
      been developed. Results from in vitro and in vivo preclinical studies demonstrate the
      immunotherapeutic potential of HAL-MPE1. Therefore, a phase I, single-centre clinical trial
      has been designed to assess the safety and tolerability of HAL-MPE1 in peanut allergic
      patients.
    


Intervention name(s): HAL-MPE1; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Subcutaneous administration of increasing doses of HAL-MPE1; Subcutaneous administration of increasing doses of placebo
Other intervention name(s): HAL-MPE1: modified peanut extract; HAL-MPE1 placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Combination Chemotherapy and Thalidomide in Treating Patients With Stage I, Stage II, or Stage III Multiple Myeloma
Condition: Multiple Myeloma and Plasma Cell Neoplasm
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell; Plasmacytoma
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy work in different ways to stop cancer cells from
      dividing so they stop growing or die. Thalidomide may stop the growth of cancer by stopping
      blood flow to the tumor. Combining chemotherapy with thalidomide may kill more cancer cells.

      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and
      thalidomide in treating patients who have newly diagnosed stage I, stage II, or stage III
      multiple myeloma.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the overall response rate in patients with newly diagnosed stage I, II, or III
           multiple myeloma treated with vincristine, doxorubicin, dexamethasone, and low-dose
           thalidomide.

        -  Determine the ability to collect peripheral blood stem cells in patients after treatment
           with this regimen.

      OUTLINE: This is an open-label, nonrandomized study.

      Patients receive vincristine IV and doxorubicin IV continuously on days 1-4 and oral
      dexamethasone on days 1-4, 9-12, and 17-20. Patients also receive low-dose oral thalidomide
      daily on days 1-28. Treatment repeats every 4 weeks for 4-6 courses in the absence of disease
      progression.

      Patients are followed until disease progression or bone marrow transplantation.

      PROJECTED ACCRUAL: Approximately 17-37 patients will be accrued for this study.
    

Intervention name(s): dexamethasone; doxorubicin hydrochloride; thalidomide; vincristine sulfate
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Thalidomide; Dexamethasone; Doxorubicin; Liposomal doxorubicin; Vincristine
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage I multiple myeloma; stage II multiple myeloma; stage III multiple myeloma