bioihbjkbjnl/mcl2 huggingface dataset:
VFI in Healthy Vessels
Condition: Carotid Artery Stenosis; Superficial Femoral Artery Stenosis
MeSH terms: Carotid Stenosis; Constriction, Pathologic
Study type: Observational

Summary: 
      There is a wealth of evidence implicating the important role of blood flow throughout all
      stages of the process of atherogenesis. Two locations along the vascular tree at which
      atherosclerotic plaques are typically found are the carotid artery (CA) and the superficial
      femoral artery (SFA). Nowadays, ultrasound is the technique of choice for assessing the
      vascular condition in the CA and SFA. However, clinically used ultrasound techniques show a
      large variability in estimating the blood flow velocity, due to multiple limitations. With
      the advent of ultrafast ultrasound imaging, (almost) all elements of the transducer can be
      activated simultaneously. These so-called plane wave acquisition acquires thousands of images
      per second and makes continuous tracking of blood flow velocities in all directions in the
      field of view possible. This high-frame-rate acquisition opened up new possibilities for
      blood flow imaging at the CA and SFA, such as blood Speckle Tracking (bST) and ultrasound
      Particle Image Velocimetry (echoPIV). Both these vector flow imaging (VFI) techniques enable
      the quantification of 2D blood flow velocity profiles, where bST uses no contrast agents
      compared to echoPIV. Beside these novel ultrasound based techniques, 4D Phase Contrast
      Magnetic Resonance Imaging (4D flow MRI) enables a non-invasive quantification of the 4D
      blood flow velocity profiles (3D + time) and can be used as reference standard for blood flow
      assessments in-vivo. We therefore aim to evaluate the performance of both VFI techniques in
      comparison to 4D flow MRI measurements in the CA and SFA of healthy volunteers.
    


Intervention name(s): Blood speckle tracking; Ultrasound particle Imaging Velocimetry; 4D flow MRI; Conventional duplex
Intervention type(s): Diagnostic Test; Diagnostic Test; Diagnostic Test; Diagnostic Test
Intervention description(s): Blood speckle tracking measurements will be acquired of the carotid artery and superficial femoral artery; Ultrasound particle imaging velocimetry will be acquired of the carotid artery and superficial femoral artery; 4D flow MRI will be acquired of the carotid artery and superficial femoral artery; Conventional duplex measurements will be acquired of the carotid artery and superficial femoral artery
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The study population will include twenty healthy subjects divided in two different age
        groups.

        All volunteers will be recruited within Rijnstate hospital and Radboudumc.
      
Keywords: Vector Flow Imaging; Ultrasound Particle Image Velocimetry; Blood Speckle Tracking; 4D flow MR
Early Initiation of Post Sternotomy CArdiac Rehabilitation
Condition: Coronary Artery Disease; Aortic Valve Disease; Mitral Valve Disease
MeSH terms: Coronary Artery Disease; Aortic Valve Disease
Study type: Interventional

Summary: 
      The main objective of this trial is to investigate the effects of starting exercise
      rehabilitation earlier than current practice after coronary artery bypass graft(CABG) or
      Aortic/Mitral valve replacement (VR) surgery.
    

Detailed description: 
      The trial will compare health improvements after cardiac rehabilitation, (CR) between
      participants randomly allocated to one of two groups: an early CR group starting exercise
      after 2 weeks, and a usual care group starting at 6 weeks. It will also collect information
      on the financial cost of earlier CR to both the health service and the patients.

      All primary and secondary outcome measures will be taken at baseline (1 week) and repeated at
      the start and end of 8 weeks exercise rehabilitation program (2 and 10 weeks from baseline
      for the early group, 6 and 14 weeks in the usual care group respectively) and at 12 months
      follow-up.
    

Intervention name(s): timing of initiation of cardiac rehabilitation
Intervention type(s): Behavioral
Intervention description(s): earlier timing of cardiac rehabilitation
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A single blinded parallel group randomised controlled trial will be used to determine non-inferiority of early (2 weeks post operation) vs usual care (6 weeks post operation ) CR for a period of 8 weeks.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: cardiac rehabilitation
Clinical Evaluation of RFAL of Breast Envelope and NAC Position
Condition: Breast Lift
Study type: Interventional

Summary: 
      This single center clinical study is intended to determine the safety and efficacy of using
      Radiofrequency (RF) energy for minimally invasive breast lift procedure.
    

Detailed description: 
      The purpose of this study is to evaluate the safety and efficacy of RFAL for the Breast
      Envelope and Nipple-Areolar Complex (NAC) Position as measured by Vectra 3D circumferential
      imaging system (Canfield, NJ)
    

Intervention name(s): InModeRF
Intervention type(s): Device
Intervention description(s): InModeRF minimally invasive treatment based on Radiofrequency-assisted lipolysis (RFAL) technology
Intervention model: Single Group Assignment
Intervention model description: Subjects will receive the treatment and outcome will be followed
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Effectiveness of Cyclosporin in the Management of COVID19 ARDS Patients in Alexandria University Hospital
Condition: COVID-19 Acute Respiratory Distress Syndrome; Cytokine Release Syndrome; Pulmonary Fibrosis
MeSH terms: COVID-19; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Pulmonary Fibrosis; Syndrome; Cytokine Release Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      The study to evaluate the effect of cyclosporine ( IL2 inhibitor and antiviral) verse
      standard care treatment on decrease ADRS, hyper inflammation, hypercytokinemia, and the
      mortality rate
    

Detailed description: 
      To test the efficacy of IL-2 inhibitors (Cyclosporine) compared to the Standard of care
      according to hospital protocol on COVID-19 patients concerning the clinical outcome
      (cytokines level, clinical improvement, and PCR of SARS-CoV-2 through the study period).

      AIM:

      The slow progression of the disease, improving survival among COVID-19 patients, and Standard
      assessment of patient improvement.

        -  Standard assessment of patient improvement:

        -  PCR-SARS-CoV-2 negative

        -  No fever

        -  No cytopenia (Hb ≥90 g/L, ANC ≥0.5x109/L, platelets ≥100x109/L) •

        -  No hyperferritinemia ≥500 μg/L

        -  (Decrease of IL2)
    

Intervention name(s): cyclosporine
Intervention type(s): Drug
Intervention description(s): Dose of Cyclosporine oral capsule of 6 mg/kg/day divided into two doses with normal kidney function for 8-14 days
Other intervention name(s): interleukin-2
Intervention MeSH terms: Cyclosporine; Interleukin-2; Cyclosporins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: COVID-19; Cyclosporine; secondary haemophagocytic lymphohistiocytosis (sHLH); acute respiratory distress syndrome (ARDS)
Myofascial Release and Mobilization With Impulse Technique Torsion in Low Back Pain
Condition: Low Back Pain; Chronic Disease
MeSH terms: Back Pain; Low Back Pain; Chronic Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the current randomized clinical trial was to compare the effectiveness of
      myofascial soft tissue release versus mobilization with impulse technique torsion (anterior)
      on pain, disability, and kinesiophobia in individuals with chronic non-specific low back
      pain.
    

Detailed description: 
      Design: Randomized Clinical Trial. Objective: to determine the effects of myofascial soft
      tissue release versus mobilization with impulse technique torsion (anterior) on pain,
      disability and kinesiophobia in individuals with chronic non-specific low back pain.

      Methods and Measures: sixty-four individuals will be randomly assigned to one of two groups.

      Intervention: For 12-week, the group 1 will undergo treatment comprising a myofascial soft
      tissue release protocol (1/week) and the group 2 will receive a mobilization with impulse
      technique torsion (anterior) (1/week).

      Main Outcome Measures: Intensity of pain, disability, fear of movement, isometric endurance
      of trunk flexor muscles and lumbar mobility in flexion data will be collected at baseline,
      and 24hr after the last manual therapy application. Mixed-model analyses of variance will be
      used to examine the effects of the treatment on each outcome measure.
    

Intervention name(s): Myofascial Soft Tissue Release; Mobilization with impulse technique.
Intervention type(s): Other; Other
Intervention description(s): Protocol: Transverse Plane-Level Clavicular Release. Diaphragmatic Transverse Plane Release. Square the Lumbar Fascia Release. Gluteal Fascia Release. Hint Of Pubic Region Release. Fascia Psoas Release. Lumbo-sacral Decompression. Pelvic Floor Release.; Subject in lateral decubitus with extension and lower limb traction contact the couch with contralateral lower limb was performed triple flexion and left trunk rotation. This technique reduces the slack (tension joints) of the ventral pelvis, head and into the contralateral side of the sacrum support (base) with the forearm.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Low Back Pain; Chronic Pain; Manipulation; Manual Therapy; Randomized Controlled Trial
Bioavailability of [14C]-SK-1404 ADME & IV Microtracer Study
Condition: Nocturia
MeSH terms: Nocturia
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objectives of the study are:

        -  To determine the absolute bioavailability of SK-1404

        -  To assess the mass balance recovery after a single oral (PO) dose of carbon-14
           (14C)-SK-1404

        -  To provide plasma, urine and faecal samples for metabolite profiling and structural
           identification

      The secondary objectives of the study are:

        -  To determine the routes and rates of elimination of [14C]-SK-1404

        -  To identify the chemical structure of each metabolite with an exposure (AUC) of more
           than 10% of circulating total radioactivity

        -  To explore the intravenous (IV) pharmacokinetics (PK) of [14C]-SK-1404

        -  To further explore the PO PK of SK-1404

        -  To provide additional safety and tolerability information for SK-1404
    

Detailed description: 
      This is a single-centre, 2-part, open-label, non-randomised, sequential, single dose study in
      healthy male subjects. It is planned to enrol a single cohort of 6 healthy male subjects who
      will participate in Parts 1 and Part 2 of the study.

      In Part 1, each subject will receive a single PO dose of SK-1404 followed by an IV
      microtracer dose of [14C]-SK-1404.

      In Part 2, each subject will receive a single PO dose of [14C]-SK-1404.
    

Intervention name(s): [14C]-SK-1404
Intervention type(s): Drug
Intervention description(s): In Part 1, each subject will receive a single PO dose of SK-1404 followed by an IV microtracer dose of [14C]-SK-1404.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: nocturnal polyuria
Intranasal Desmopressin vs IV Ketorolac in Renal Colic Pain Control
Condition: Renal Colic
MeSH terms: Colic; Renal Colic
Study type: Interventional

Summary: 
      The aim of this study is the comparison of efficacy of intravenous ketorolac and intranasal
      desmopressin in renal colic patients pain control.
    

Detailed description: 
      40 renal colic patients have been divided into 2 groups randomly, one group has been received
      30mg intravenous Ketorolac and 4 puffs nasal Normal Saline while other has been received 40
      micrograms nasal Desmopressin and 1cc intravenous Normal Saline. Pain Score before drug
      administration,also 10, 30 and 60 minutes after drug administration has been measured bye
      Visual Analogue Scale ( VAS ).
    

Intervention name(s): Desmopressin; Ketorolac; Normal Saline; Normal Saline
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 40 micrograms Nasal Desmopressin.; 30mg intravenous Ketorolac.; 1cc intravenous Normal Saline.; 4 puffs nasal Normal Saline.
Other intervention name(s): Ddavp; Toradol; NaCl; NaCl
Intervention MeSH terms: Ketorolac; Deamino Arginine Vasopressin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
A Study for Patients With Type 1 Diabetes
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 2

Summary: 
      Comparison of blood glucose levels in patients with Type 1 diabetes when they take a new
      basal insulin analog and when they take insulin glargine
    

Detailed description: 
      Prestudy treatment for patients who enter this study will be once daily insulin glargine
      along with mealtime insulins. Patients will continue to use their mealtime insulins
      throughout the study. The study will consist of 16 weeks of treatment and 4 weeks of
      follow-up. The 16 weeks of treatment will consist of two 8-week periods (Periods 1 and 2)
      during which patients will receive insulin glargine for 8 weeks and LY2605541 for 8 weeks in
      a random sequence. During the 4-week follow-up period, patients will return to insulin
      glargine or another basal insulin recommended by the investigator.
    

Intervention name(s): LY2605541; Insulin glargine
Intervention type(s): Drug; Drug
Intervention description(s): Administered subcutaneously every morning with dose titration based on blood glucose measures for 8 weeks in each of 2 study periods.; Administered subcutaneously every morning with dose titration based on blood glucose measures for 8 weeks in each of 2 study periods.
Intervention MeSH terms: Insulin Glargine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Urinary Markers for Unilateral Kidney Obstruction
Condition: Renal Colic; Acute Renal Failure
MeSH terms: Renal Insufficiency; Acute Kidney Injury; Renal Colic
Study type: Observational

Summary: 
      Renal colic is usually caused from an obstructing stone along the ureter. Some of the
      patients present with a high level of creatinin in the blood, even though there is a normal
      functioning contralateral kidney. Furthermore creatinin is not an ideal marker for renal
      function during acute changes.

      Several works have shown that modern urinary markers such as NGAL (neutrophil
      gelatinase-associated lipocalin), KIM-1 (Kidney Injury Molecule-1) and others rise earlier
      and are much more sensitive for kidney insult. There is a lack of research on their role in
      acute kidney obstruction
    

Detailed description: 
      The study population will include 100 men and women that will be recruited during the
      upcoming year, with a follow up of up to 3 months.

      The study population will be divided into 2 groups:

        1. The stone group: about 80 patients, aged 18-65, with normal creatinine for the past year
           that presented in our ER because of renal colic, and their imaging shows a ureteral
           stone.

        2. The non-stone group: about 20 patients that present in our department for elective
           surgery not related to stones or bladder outlet obstruction.

      The stone group:

      ---------------- In the ER the patients will be examined, undergo blood and urine workup and
      imaging as usual. If they are applicable according to our inclusion and exclusion criteria
      and admitted and they will be included in our stone group. After signing an informed consent,
      either as patients with a ureteral stone and normal creatinine or as patients with a ureteral
      stone and an abnormal creatinine, Their urine sample will be sent for the urinary markers:
      NGAL, KIM-1, ENdothelin and Cystatin C.

      At this point it will be decided to admit or discharge them according to their clinical
      imaging and laboratory findings, as acceptable. The admitted patients will be followed for 48
      with additional blood and urine tests.

      The admitted patients that will undergo renal drainage will be a specific subgroup in which a
      selective urine test will be taken from the drained kidney

      The non stone group:

      -------------------- These are our control group from which we will take a single blood and
      urine test before their elective surgery.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        100 men and women - 80 presented in the ER with a unilateral ureteral stone and 20
        presented for ambulatory surgery not related to urinary stones or bladder outlet
        obstruction
      
Biospecimen description: 
      urine
    
Keywords: renal colic; acute renal failure; Neutrophil gelatinase associated lipocalin
Non-Invasive Assessment of Wound Healing With Optical Methods
Condition: Diabetic Foot Ulcers
MeSH terms: Diabetic Foot; Foot Ulcer
Study type: Observational

Summary: 
      The objective of this project is to further the development of a non-invasive optically based
      NIR (Near Infrared) device to enable the quantitative diagnosis, monitoring and treatment
      optimization of chronic wounds (especially diabetic) in a clinical setting. The end goal of
      this project is a portable and compact device that would be simple to operate by minimally
      trained health care personnel. Our animal studies have shown that the early healing of
      chronic wounds can be characterized by absorption and scattering of light at near infrared
      wavelengths ranging from 680 nm to 950 nm. If our project is successful we will be providing
      the clinician the ability to predict if a wound is healing and if a particular treatment is
      successful in accelerating healing before any changes are observed by wound size contraction
      or other visible clinical signs. Our hope is that the fNIR optical device will provide
      conclusive therapeutic treatment information as early as 5 weeks after initial evaluation,
      before it would be obvious on gross examination of the patient.
    


Intervention name(s): diffuse near infrared spectroscopy measurements
Intervention type(s): Device
Intervention description(s): Measure blood flow to diabetic wounds
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Recruited patients will be patients with diabetes who have chronic wounds and will likely
        have other co-morbidities associated with chronic diabetes.

        Control subjects do not have diabetes and do not have wounds.
Phase I-II Study of Carboplatin, Vinorelbine and Capecitabine in Patients With Metastatic Breast Cancer
Condition: Breast; Cancer
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      1. Determine the response rate with this regimen in an anthracycline and taxane resistant
      cohort of patients.
    

Detailed description: 
      1. Determine the response rate with this regimen in an anthracycline and taxane resistant
           cohort of patients.

        2. Determine a maximum tolerated dose of capecitabine in combination with vinorelbine and
           carboplatin for this patient population.

        3. Determine the time to relapse after the administration of this regimen.
    

Intervention name(s): Carboplatin; Capecitabine; Vinorelbine
Intervention type(s): Drug; Device; Drug
Intervention description(s): Carboplatin given at 300mg/m2 IV over 30 minutes day 1, q 21 days; Capecitabine is administered at 1500mg/m2 PO qd in 2 divided doses day 1-14 q 21 days; Vinorelbine: 25mg/m2 IV over 10 minutes day 1, 8 q 21 days
Other intervention name(s): Xeloda; Navelbine
Intervention MeSH terms: Carboplatin; Capecitabine; Vinorelbine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Breast metastatic
Growth Hormone Treatment of Children Born With Retarded Intrauterine Growth at Age 2-5 Years
Condition: Foetal Growth Problem; Small for Gestational Age
Study type: Interventional
Phase: Phase 3

Summary: 
      This trial is conducted in Europe. The aim of this trial is to evaluate the efficacy and
      tolerance of a new growth hormone (GH) formulation, in the treatment of children born with
      retarded intrauterine growth, starting at age 2 to 5 years. Trial Design: The study will be
      multicenter, open label, parallel, randomized, Phase IIIb, controlled.
    


Intervention name(s): somatropin
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Rehabilitative Ultrasound Imaging: Measurements of Articular Movement of the Shoulder
Condition: Disorder of Shoulder
Study type: Interventional

Summary: 
      The purpose of this study is to measure the amount of movement between the bones of the
      shoulder joint when mobilization techniques are applied by a physical therapist.
    

Detailed description: 
      The purpose of this study is to image the articular joint movement of the glenohumeral joint
      utilizing ultrasound imaging (USI). Specific aims include: 1) measurement of the distance
      between the articular surfaces at rest; 2) measurement of the distance between the articular
      surfaces during manually applied glides of those surfaces; and 3) analysis of any association
      between the amount of glide and reported joint mobility, force application, or joint
      position.

      Subjects will be recruited from a population of convenience. After consenting to participate,
      eligible subjects will complete a demographic questionnaire and pretesting of scapular and
      shoulder mobility. Two days of testing will be scheduled. On the first day, three grades of
      glenohumeral mobilization will be applied in the following directions: distraction, posterior
      and inferior. A handheld dynamometer will measure force; ultrasound imaging will record
      glenohumeral joint position. Each grade and direction will be repeated three times on the
      right and the left shoulder. On the second day, the mobilizations will be repeated.
      Measurements of humeral movement will be calculated from the ultrasound images.
    

Intervention name(s): Manual Mobilization
Intervention type(s): Device
Intervention description(s): Stabilization of the glenoid fossa with movement of the humerus using varying degrees of force as applied by a physical therapist. Subject is positioned with the shoulder in 55 degrees of abduction and 30 degrees of horizontal adduction. Manual force is applied by a physical therapist on the proximal humeral head moving the humeral head posterior, inferior or lateral (distraction). An ultrasound transducer placed over the anterior shoulder joint provides imaging of the humeral head and the glenoid fossa. This manual intervention is repeated three times in each direction on each arm.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment