bioihbjkbjnl/mcl2 huggingface dataset:
Psychometric Evaluation of the IPPAQ in Pediatric Patients With Sickle Cell Disease Hospitalized With Vasoocclusive Pain
Condition: Sickle Cell Disease; Pain
MeSH terms: Anemia, Sickle Cell
Study type: Observational

Summary: 
      Historically, sickle cell disease has not been viewed in the chronic pain paradigm because of
      its recurrent nature. Patients with sickle cell disease may be hospitalized for extended
      periods of time. As the hospital stay progresses, patients with SCD pain are often observed
      by clinicians to have improvements in function in areas such as self-care, mobility, and
      recreation despite continued self-report of high pain scores. This pattern of functional
      improvement with continued report of high pain intensity scores is common in patients with
      recurrent and chronic pain. A functional assessment tool that can assess function in the
      acute inpatient setting is needed.

      The purpose of this study is to evaluate the Inpatient Pediatric Physical Activity
      Questionnaire (IPPAQ), as a measure of daily function in children with sickle cell disease
      hospitalized with vasoocclusive pain.
    

Detailed description: 
      Refer to Brief Summary
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children, adolescents, and young adults with sickle cell disease.
      
Keywords: Sickle Cell Disease; Pain; Assessment
Accuracy of Pulse Oximeters With Profound Hypoxia at Rest
Condition: Hypoxia
MeSH terms: Hypoxia
Study type: Observational

Summary: 
      The aim of this study is to determine the accuracy of devices called pulse oximeters, which
      measure blood oxygen by shining light through fingers, ears or other skin, without requiring
      blood sampling. Study will be used with patients at rest.
    

Detailed description: 
      This study is intended to evaluate performance of a new design pulse oximeter (test device)
      manufactured by Nihon Kohden Corporation sufficiently to support performance claims for an
      FDA 510K submission or ISO technical file. Specifically, SpO2 and pulse rate accuracy will be
      assessed for a Nihon Kohden OLV-4202 pulse oximeter with adult patients under a controlled
      setting of varying levels of inhaled oxygen concentration levels for patients at rest.
    

Intervention name(s): Pulse oximeter
Intervention type(s): Device
Intervention description(s): OLV-4202 pulse oximeter (SW version: 01-11)
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy adult volunteers. At least 10 subjects will be recruited to complete the study. Of
        these 2 will be dark pigmented. If the number of samples is less than the required 200 or
        if less than 2 of dark pigment subjects successfully complete the study, subjects will be
        added to include 2 of dark pigmented subjects and at least 200 data points.
Biomarkers in Phototherapy of Barrett's Esophagus
Condition: Barrett's Esophagus; High Grade Dysplasia
MeSH terms: Barrett Esophagus
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study is being done to find out if Photodynamic Therapy (treatment with a red light and
      a drug called photofrin) or Radiofrequency ablation works the same for patients who have
      biomarkers (abnormalities in molecules of cells that may or may not help predict cancer)
      present in their Barrett's esophagus as for patients who do not have biomarkers.
    


Intervention name(s): Photodynamic therapy; radiofrequency ablation of barrett's esophagus
Intervention type(s): Procedure; Procedure
Intervention description(s): Photofrin 2mg/kg Photoradiation The light dose delivered will be a total of 200 joules per centimeter fiber which has previously been shown to ablate Barrett's mucosa.; radiofrequency ablation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Barrett's Esophagus; High Grade Dysplasia; Photodynamic Therapy
Postprandial Blood Cell Transcriptome of Normal Weight and Obese Subjects to 3 Caloric Doses of a High-fat Meal
Condition: Obesity; Nutritional Intervention
Study type: Interventional

Summary: 
      The study will quantitatively evaluate the metabolic response of normal weight and obese
      subjects to three high-fat meals differing in caloric dose by analysing the postprandial
      blood transcriptome.
    


Intervention name(s): high-fat meal A; high-fat meal B; high-fat meal C
Intervention type(s): Other; Other; Other
Other intervention name(s): high-fat meal consisting of 500 kcal; high-fat meal B consisting of 1000 kcal; high-fat meal C consisting of 1500 kcal
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
HPV Self-Sampling for Cervical Cancer Screening Among Lesbian, Bisexual, and Queer (LBQ) Women
Condition: Cervical Cancer Screening
MeSH terms: Uterine Cervical Neoplasms
Study type: Interventional

Summary: 
      The proposed study will examine the implementation of a Human Papilloma Virus (HPV)
      self-sampling intervention for under screened LBQ women living in South Florida. The study
      will enroll participants to receive the self-sampling intervention in community venues. The
      purpose of this study is to pilot the self-sampler for feasibility and acceptability within
      this underserved population.
    


Intervention name(s): HPV self-sampling
Intervention type(s): Behavioral
Intervention description(s): All participants will receive HPV self-sampling intervention. HPV self-sampling is a cervical cancer screening that can be done in private, using a device that is similar to a tampon. This intervention tests for high-risk HPV, the primary cause of cervical cancer. Each participant will complete the intervention one time only.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Neural Dynamics Technique for the Treatment of Chronic Radicular Low Back Pain
Condition: Low Back Pain; Sciatica
MeSH terms: Sciatica; Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      Low back pain ( LBP) is a significant health problem which affects about 70%-80% of the
      population during the course of their life . The majority of LBP is resolved within 3 months;
      however, up to 40% of LBP becomes chronic. One subgroup of chronic LBP is patients with
      sciatica. Sciatica is characterized by radiating pain to the buttock and lower limb, with or
      without low back pain.

      It has been shown in the upper limb that by positioning the contra-lateral arm in tension the
      investigators actually reduce tension in the ipsilateral arm. Patients, who present with
      symptoms like sciatica, can benefit from this maneuver (neural dynamics techniques) that
      reduces tension through the contra-lateral leg.

      Working Hypothesis: Compared with a placebo maneuver of the upper limb, the neural dynamics
      techniques will result in better rehabilitation of individuals with radicular LBP.
    

Detailed description: 
      Objectives: To evaluate the efficacy of neural dynamics techniques, using the contra-lateral
      leg, in the treatment of sub-acute/chronic Low back pain with radiation to the leg. Study
      Methodology: Eligible individuals will be assessed by a physiotherapist that will be blinded
      to the treatment allocation; treatment (either intervention or placebo) will be provided by a
      physiotherapist that will be blinded to the patient's assessment. The treated individuals and
      the referring physician will also be blinded to the treatment allocation;
    

Intervention name(s): neural dynamics techniques treatment; placebo treatment
Intervention type(s): Procedure; Procedure
Intervention description(s): Treatment group- will receive neural mobilizations techniques, to improve movement of the sciatic nerve.; Control group- will receive placebo treatment that will include mobilization to the upper limb. After the placebo treatment, these patients will receive neural mobilizations techniques.
Other intervention name(s): Physiotherapy; physiotherapy
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Low back pain; Sciatica; Pain; Physiotherapy
Study to Learn More About the Potential of Antifungal Cream V61-044 Containing Trolamine to Cause Irritant Reaction of the Skin to Ultra Violet Light in Healthy Human Subjects
Condition: Dermatitis, Phototoxic
MeSH terms: Dermatitis; Dermatitis, Phototoxic
Study type: Interventional
Phase: Phase 3

Summary: 
      In this study researchers want to gather information about the potential of Antifungal Cream
      V61-044 containing Trolamine to produce a phototoxic reaction on the skin. A phototoxic
      reaction is an irritant reaction of the skin to ultra violet light. In order to find this out
      the study drug will be applied to the skin of healthy human subjects. By using a solar
      simulator to generate a UV spectrum similar to that of sunlight the potential of the study
      drug to produce a superficial reddening of the skin will be measured.
    


Intervention name(s): Butenafine HCl 1% (BAY1896425)
Intervention type(s): Drug
Intervention description(s): Approximately 60 μl of Butenafine HCl 1% applied twice to the treated irradiated site and to the treated non-irradiated site for a total application of 240 μl of Butenafine HCl 1%.
Other intervention name(s): Antifungal Cream V61-044 containing Trolamine
Intervention MeSH terms: Butenafine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Personalized Glucose Predictive and Therapy Advisory System - DIAdvisor 2
Condition: Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The primary purpose of this study is to see whether a tool that predict blood glucose and
      suggest therapy advices can help type 1 diabetic patients.
    

Detailed description: 
      During this study, we would like to assess the efficacy in keeping blood glucose in a safe
      range (70-180 mg/dL) of the second generation of a Glucose Predictive and Therapy Advisory
      system in diabetic patients treated by basal-bolus insulin regimens using pumps or multiple
      daily injections. We want to compare the time spent in safe range while using the predictor
      and advisor outputs and when the patient is not using them. This is a randomized controlled
      crossover trial. Patient will come for two admissions of 3 days, one with the DIAdvisor
      system fully activated, and one with the prediction and advice features disabled.
    

Intervention name(s): Personalized Glucose Predictive and Therapy Advisory System (DIAdvisor); Personalized Glucose Predictive and Therapy Advisory System (DIAdvisor)
Intervention type(s): Device; Device
Intervention description(s): Glucose predictions and therapy advices will not be displayed. Patient will decide his need of insulin according to the results given by the HemoCue glucometer and CGM trends. He/She will inject insulin at mealtimes or program a bolus on his/her pump by him/herself and will adapt his/her basal insulin doses or pump delivery rates as usual. As needed or on request and more particularly if hypo or hyperglycaemia occurs, the subject will be advised and helped by nurses and physicians.; Glucose predictions and therapy advices will be displayed to the patient. Patients will be asked to follow the advices suggested by DIAdvisor system according to their own judgement. Patient will decide his need of insulin according to the results given by the HemoCue glucometer, CGM trends, glucose predictions as well as therapy advices. In case of any doubt with the predictions displayed or the advices suggested, the patients will be invited to ask study personal and/or the study physician for help.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: diabetes; diadvisor; type 1 diabetes; type 2 diabetes; glucose prediction; cgm prediction; algorithm; therapy advices
Study of the Laboratory-based Evaluation of the Degrees of Activity of Osteoarthritis
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Observational

Summary: 
      This study evaluates laboratory-based method to estimate the degrees of activity of medium
      and large joint osteoarthritis.
    

Detailed description: 
      Osteoarthritis (OA) is a chronic progressive disease, characterized by degradation of joint
      cartilage, synovial inflammation and joint dysfunction. This study evaluates laboratory-based
      method to estimate the degrees of activity of medium and large joint OA. Samples of synovial
      fluid (SF) from the patients with the OA (ICD-10 codes: M15, M16 and M17) will be assessed
      for T-cell subsets, msast cells, fibroblast-like synoviocytes (FLS) and macrophage-like
      synoviocytes (MLS) by flow cytometry. Subpopulations of blood T-cells involved in the
      inflammation will also be assayed. Standard clinical investigation will be performed and the
      results will be used to estimate the laboratory criteria or degrees of activity of medium and
      large joint OA.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with medium and large joint osteoarthritis
      
Biospecimen description: 
      Synovial fluid samples stored in the tube with sodium heparin. Venous blood samples drained
      into tube with sodium heparin.
    
Keywords: Osteoarthritis; Flow cytometry; Synovial fluid
Evalution of Immunogenicity, Safety and Booster Response of a Rabies Vaccine Administered Concomitantly With Japanese Encephalitis Vaccine in Toddlers
Condition: Rabies; Japanese Encephalitis; Pre-Exposure Prophylaxis
MeSH terms: Rabies; Encephalitis, Japanese; Encephalitis
Study type: Interventional
Phase: Phase 2

Summary: 
      This study evaluated the safety and immunogenicity of rabies vaccine and Japanese
      encephalitis vaccine in toddlers. All children developed adequate immune responses. Rabies
      vaccination with PCECV did not interfere with the antibody response to Japanese encephalitis
      vaccine. The rabies vaccine PCECV and Japanese encephalitis vaccine are safe and immunogenic
      when administered concomitantly to toddlers.
    


Intervention name(s): Three 1 mL doses of Rabies vaccine and two JE vaccine; Three 0.5 mL doses of Rabies vaccine and two JE vaccine; Three 0.1mL doses of Rabies Vaccine and two JE vaccine; Two 0.1mL doses of Rabies vaccine and two JE vaccine; Two doses of JE vaccine
Intervention type(s): Biological; Biological; Biological; Biological; Biological
Intervention description(s): Vaccination with purified chick embryo cell rabies vaccine 1.0 mL intramuscularly on Day 0, Day 7 and Day 28 (a total of 3 doses) and Beijing 1 strain of inactivated, lyophilized Japanese Encephalitis vaccine 0.25 mL subcutaneously on Day 0 and Day 7 (a total of 2 doses); Vaccination with purified chick embryo cell rabies vaccine 0.5 mL intramuscularly on Day 0, Day 7 and Day 28 (a total of 3 doses) and Beijing 1 strain of inactivated, lyophilized Japanese Encephalitis vaccine 0.25 mL subcutaneously on Day 0 and Day 7 (a total of 2 doses); Vaccination with purified chick embryo cell rabies vaccine 0.1 mL intradermally at one site on Day 0, Day 7 and Day 28 (a total of 3 doses) and Beijing 1 strain of inactivated, lyophilized Japanese Encephalitis vaccine 0.25 mL subcutaneously on Day 0 and Day 7 (a total of 2 doses); Vaccination with purified chick embryo cell rabies vaccine 0.1 mL intradermally at one site on Day 0 and Day 28 (a total of 2 doses) and Beijing 1 strain of inactivated, lyophilized Japanese Encephalitis vaccine 0.25 mL subcutaneously on Day 0 and Day 7 (a total of 2 doses); Vaccination with Beijing 1 strain of inactivated, lyophilized Japanese Encephalitis vaccine 0.25 mL only subcutaneously on Day 0 and Day 7 (a total of 2 doses)
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: rabies vaccination; pre-exposure prophylaxis; rabies virus neutralizing antibody
Pharmacodynamic Interaction of REMI and DMED
Condition: Anesthesia
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective is to map the pharmacokinetic / pharmacodynamic interaction between
      dexmedetomidine and remifentanil by observing changes in anesthetic depth. These changes will
      be related to drug concentrations using pharmacokinetic/pharmacodynamic (PKPD) modeling.
    

Detailed description: 
      This study is designed to investigate whether the use of a combination of dexmedetomidine and
      remifentanil is clinically useful to provide anesthesia during surgical and diagnostic
      procedures and whether it could be used for anesthetic induction. Furthermore the aim is to
      gain better insights in the required dosing regimens, the inter-individual variability in
      response towards the combination and the associated side effects. Better characterization of
      this drug-drug interaction will presumably lead to more precise dosing regimens, which in
      turn, will lead to a reduction in the occurrence of oversedation, side effects and recovery
      times.

      The objective is to map the pharmacokinetic / pharmacodynamic interaction between
      dexmedetomidine and remifentanil by observing changes in anesthetic depth, measured by
      hypnotic and analgesic endpoints such as modified observer's assessment of alertness and
      sedation scale (MOAA/S), response to electrical stimuli, response to laryngoscopy and
      electroencephalogram (EEG) derived indices. These effects will be related to drug
      concentrations using pharmacokinetic/pharmacodynamic (PKPD) modeling.
    

Intervention name(s): Dexmedetomidine; Remifentanil
Intervention type(s): Drug; Drug
Intervention description(s): Single drug administration; Single drug administration
Other intervention name(s): Dexdor; Ultiva
Intervention MeSH terms: Dexmedetomidine; Remifentanil
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Intervention model description: All volunteers will receive 2 standardized anesthesia sessions with a washout period of at least one week between sessions. During the first session volunteers will receive dexmedetomidine, during the second session they will first receive remifentanil and afterwards the combination of drugs will be administered. Anesthetic depth will be evaluated by MOAA/S scores (see table 2), testing of tolerance to electrical stimuli and laryngoscopy. Furthermore multichannel EEG-data will be collected to get insight in the drug dependent characteristics. Measured effects will be related to drug plasma concentrations.
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Dexmedetomidine; Remifentanil; Pharmacodynamics; Interaction
The Effects of Vertebral Manipulation and Pain Education in Chronic Neck Pain
Condition: Neck Pain
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      This study aims to investigate the effects of vertebral manipulation and pain education on
      subjects with neck pain. For this purpose, 90 subjects who present chronic neck pain will be
      selected and allocated randomly into 2 groups: vertebral manipulation group and pain
      education group.
    


Intervention name(s): Spinal Manipulation; Pain Education; Sham
Intervention type(s): Other; Other; Other
Intervention description(s): High-velocity and low-amplitude (HVLA) manipulation techniques to the cervical and thoracic region; Subjects will receive pain education based in biopsychosocial approach; A simulation of spinal manipulation (sham), involving manual contact over the cervical and thoracic region totaling 10 minutes.
Other intervention name(s): Vertebral Manipulation; Pain Neuroscience Education
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Non-Interventional Study to Evaluate Safety and Efficacy of NOVOCART 3D in Patients With Cartilage Defects
Condition: Cartilage Diseases
MeSH terms: Cartilage Diseases
Study type: Observational

Summary: 
      Non-interventional study to evaluate safety and efficacy of NOVOCART 3D in adult and
      adolescent patients with full thickness cartilage defects after the treatment with NOVOCART
      3D.
    

Detailed description: 
      A 36-month post treatment follow up of adverse and serious adverse effects as well as the
      measurement of efficacy with the International Knee Documentation Committee (IKDC) Score.
    

Intervention name(s): NOVOCART 3D
Intervention type(s): Biological
Intervention description(s): Autologous Chondrocyte Implantation
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        specialist clinical centre
      
Keywords: Cartilage Defect in the Knee; MACT