cyrilzakka/clinical-trials huggingface dataset:
Vascular Inflammation in Adolescents With Type 1 Diabetes

The purpose of this study is to find out if diabetes damages the blood vessels of adolescents with good diabetes control compared to adolescents with less optimal control.

Many published studies reveal that adult patients with T1DM can have early, silent and more advanced vessel wall thickness than normal subjects. This is influenced by the degree of their blood sugar control. If this is happening in adolescents, we want to know what proportion of adolescent children with type 1 diabetes show signs of early blood vessel damage. We also want to learn if these signs of damage are linked to other factors such as how long someone has had diabetes, blood sugar control or individual differences because of a difference in genetic make-up.

Eligibility Criteria:
Inclusion Criteria:

* Adolescents ages 12-18 years
* Tanner stage III-V
* T1DM \> 2 years
* HgbA1c \<8 or \>10 for previous 2 years

Exclusion Criteria:

* Subjects with known history of hypercholesterolemia or family history of hypercholesterolemia
* Family history of premature cardiovascular disease
* Hypertension defined as subjects with blood pressure greater than the 90th percentile for age
* Anemia defined as Hgb \<11.0 g/dl
* ADHD
* Congenital heart disease
* Pituitary tumor
* Known allergy to ultrasound gel
* Recent head injury
* Chromosomal abnormalities
Assessment of Osteoblastic Activity With 18F-Fluoride in Aortic Bioprosthesis Structural Valve Dysfunction (SVD)

Structural valve dysfunction (SVD) is the most common and life threatening complication in patients treated by aortic valve replacement. A calcification process is frequently involved in SVD but its pathophysiology remains unclear. In the hypothesis of an active metabolic phenomenon of calcification, as previously shown in native aortic valve stenosis, rather than a passive deposit of calcium in valve tissue, positon emission tomography (PET) imaging with 18F-Fluoride could emphasize increased osteoblastic activity in SVD tissue.

This study will include patients with echocardiography-confirmed SVD. Echocardiographic parameters and other current parameters analyzed in SVD patients such as bioprosthesis calcium scoring derived from CT will be compared to 18F-Fluoride activity.


Eligibility Criteria:
Inclusion Criteria:

* age \> 18
* written informed consent
* SVD defined on echocardiography by an alteration of bioprosthesis leaflets function with a mean transvalvular gradient \> 20 mmHg and maximal velocity ≥ 3 m/s and effective orifice area ≤1.2 cm², and/or an aortic regurgitation more or equal to grade 2 on 4.

Exclusion Criteria:

* Inability to give informed consent
* Pregnancy
* Concurrent antibiotherapy
* Certain infectious endocarditis
* Concurrent anti-inflammatory therapy, including corticosteroid therapy
Brain Excitability During Self-Paced Voluntary Movements

This study will use transcranial magnetic stimulation to examine how the brain controls movement by sending messages to the spinal cord and muscles and what goes wrong with this process in disease. Normal healthy volunteers 18 years of age and older may be eligible to participate.

In transcranial magnetic stimulation, an insulated wire coil is placed on the subject's scalp or skin. Brief electrical currents are passed through the coil, creating magnetic pulses that stimulate the brain. During the stimulation, participants will be asked to tense certain muscles slightly or perform other simple actions. The electrical activity of the muscle will be recorded on a computer through electrodes applied to the skin over the muscle. In most cases, the study will last less than 3 hours.

The purpose of this study is to investigate the influence of volitional movement on excitability of ipsilateral as well as contralateral motor cortical neurons controlling homologous and surrounding muscles. Transcallosal and surrounding inhibitions are well known phenomenon to suppress unwanted movements during voluntary action, which is often disturbed in various movement disorders. Transcranial magnetic stimulation (TMS) has been used to investigate these inhibitory mechanisms, but the inhibitory influence during and after voluntary movement has not been well elucidated yet. In normal volunteers, we plan to determine if voluntary movements of one finger influence the cortical excitability responsible for surrounding as well as contralateral homologous muscles, using voluntary movement-triggered TMS. The primary outcome measures would be any changes in motor evoked potential (MEP) size and intracortical inhibition (ICI) parameters.

Eligibility Criteria:
Normal adult volunteers 18 or more years old.

Subjects must not have medico-surgical illness.

Subjects must not have neurological illness.

Subjects must not have psychiatric illness.

Subjects must not be taking any medication with potential influence on nervous system function.

Subjects must not have a pacemaker.

Subject must not have an implanted medical pump.

Subjects must not have a metal plate or a metal object in the skull or eye.

Subjects must not have a history of seizure disorder.
To Compare the Pharmacokinetics of Budesonide Delivered by BDA MDI to Budesonide Delivered by Pulmicort Respules in Children With Asthma Aged 4 to 8 Years.

To compare the pharmacokinetics of budesonide delivered by BDA MDI to budesonide delivered by Pulmicort Respules in children with Asthma aged 4 to 8 years.


Eligibility Criteria:
Inclusion Criteria:

1. Provision of informed consent prior to any study specific procedures. Children should provide assent to join the study, as applicable. The child's parent(s) or legally authorized representative (LAR) must sign the informed consent form (ICF). The LAR must be aged ≥18 years old.
2. Male or female aged between 4 and 8 years inclusive (not having reached his/her 9th birthday by the time of screening).
3. Weigh at least 14 kg or higher.
4. Clinician diagnosed asthma of at least 3 months.
5. Stable on treatment with albuterol PRN and/or ICS and/or leukotriene receptor antagonists (LTRAs) for 2 weeks prior to screening; children taking budesonide in any form at Visit 1 will be switched to another corticosteroid with a washout of budesonide of 3 to 7 days.
6. Demonstrate ability to correctly use the nebulizer and metered-dose inhaler (MDI) device without a spacer.
7. Willingness and ability of the child and parent(s)/LAR to comply with the demands of the study as described in the informed consent/assent.

Exclusion Criteria:

1. Inability to change from any budesonide therapy to another suitable corticosteroid.
2. History of life-threatening asthma defined as any asthma episode associated with loss of consciousness, intubation or admission to an intensive care unit.
3. Unstable asthma as judged by the Investigator (eg, any change in asthma therapy within 2 weeks prior to screening or use of more than 2 occasions of rescue medication (albuterol) per day within 1 week prior to screening (potential for rescreen).
4. Children receiving regular maintenance treatment with prohibited anti-inflammatory or long-acting bronchodilator asthma medication (inhaled, nebulized, oral, or systemic) within 1 month prior to screening.
5. More than 1 short course of oral/rectal/systemic corticosteroids within 6 months preceding screening (Visit 1), or any oral/rectal/systemic corticosteroids within 30 days prior to screening.
6. Evidence of active concomitant pulmonary disease other than asthma (children with stable allergic rhinitis will be permitted, as long as, there are no changes in the treatment and the medications do not interfere with the analytical assay methods).
7. Upper respiratory infection involving antibiotic treatment not resolved within 14 days prior to Visit 1.
8. Children with a known or suspected hypersensitivity to albuterol/salbutamol, budesonide or any of the excipients used in the IMPs.
Clinical Trial of Thoracoscopic Lobecotmy Under Spontaneous Ventilating Anesthesia

With the development of video-assisted thoracoscopic surgery (VATS) techniques and technology for anesthesia control, non-intubated anesthesia with spontaneous ventilation has been widely applied in VATS. A prospective, multicentre, randomized controlled clinical study was applied in this study to assess the feasibility and safety of thoracoscopic lobectomy under spontaneous ventilation versus intubated single lung mechanical ventilation.

Intubated anesthesia with single lung mechanical ventilation (SLV) is considered the standard of care in VATS. However, this type of anesthesia has been associated with several adverse effects, which can trigger complications and increase the overall surgical risk. In order to avoid intubated-anesthesia related adverse effects, spontaneous ventilation strategies have been proposed in recent years.Encouraged by the satisfactory results with a preliminary experience of spontaneous ventilated VATS, the multicentre randomized controlled clinical controled study is established to comparatively analyze the outcome of patients undergoing either nonintubated intravenous anesthesia with spontaneous ventilation (SV) or SLV VATS lobectomy, especially in safety during operation, lymph nodes resection, complication rate, muscle recovery after surgery, the difference the postoperative hospitalization time.

Eligibility Criteria:
Inclusion Criteria:

* volunteering to participate in clinical trials and having the ability of responsibility can be signed informed consent.
* 18-70 years old • preoperative chest CT diagnosed with "localized lung bulla" and needing surgical treatment
* Eastern Cooperative Oncology Group(ECOG) score standard ≤ 1 • ASA（American Society of Anesthesiologists score） ≤ 2
* Heart ejection fraction( EF)≥ 50

Exclusion Criteria:

* refusing to participate in clinical trials • A history of tuberculosis or other diseases could cause pleural adhesion or more pleural effusion
* BMI ≥ 25 kg/m\^2
* other not suitable situation
Motor Plasticity, Intermittent Hypoxia and Sleep Apnea

The purpose of this study is to learn about the effect of sleep apnea and low oxygen on muscle strength and lung function in people with chronic spinal cord injury.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18 or older,
2. Chronic (≥ 1-year post-injury), non-progressive SCI,
3. Asia Impairment Scale (AIS) C or D,
4. Resting Saturated oxygen (SaO2) ≥ 95%,
5. Cervical injury (C5-C8)

Exclusion Criteria:

1. Currently hospitalized,
2. Resting heart rate ≥120 Beats per minute (BPM),
3. Resting systolic blood pressure \>180 mmHg,
4. Resting diastolic Blood Pressure \>100 mmHg,
5. Self-reported history of unstable angina or myocardial infarction within the previous month,
6. OSA that is being treated with positive airway pressure therapy,
7. Women who know or suspect they may be pregnant or who may become pregnant,
8. Known underlying lung disease,
9. Pregnant Women,
10. Prisoners,
11. Unable to consent
Intratumoral CAN2109 in Subjects With Solid Tumors

A phase 1, dose escalation, open-label study of intratumoral CAN2109 in subjects with unstable or metastatic advanced solid tumors or lymphomas.

The scope of the study is to evaluate the safety of CAN2109 in humans, explore its safety, efficacy and collect data on the pharmacokinetics, as well as on the pharmacodynamic effect of the drug on the immune system locally and systemically, and on tumor markers.

Eligibility Criteria:
Inclusion Criteria:

1. Able and willing to provide written informed consent and willing to comply with the study's requirements.
2. Male or female age ≥ 18 years at screening.
3. Metastatic or locally advanced solid tumor that has progressed on, is refractory to, or for which there is no efficacious standard of care therapy. Preferred tumor types include the following:

   a. Carcinoma of skin, melanoma, Merkel cell carcinoma (MCC), breast cancer, head and neck squamous cell carcinoma (HNSCC), sarcoma, cervical carcinoma, and colorectal cancer
4. Performance status of 0-1 on the ECOG Performance Scale.

Exclusion Criteria:

1. Unresolved toxicities from prior therapy, defined as having not resolved to Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 (v5.0) Grade 0 or 1, with exception of endocrinopathies from prior therapy, alopecia, and vitiligo.
2. Treatment with systemic corticosteroids at doses exceeding 10 mg/day prednisone or equivalent.
3. Has an active infection requiring systemic therapy.
4. Unstable/inadequate cardiac function defined as follows:

   1. New York Heart Association Class 3 or 4 congestive heart failure
   2. uncontrolled hypertension
   3. acute coronary syndrome within 6 months
   4. clinical important cardiac arrhythmia
   5. mean corrected QT (QTc) interval corrected for heart rate \> 480 ms.
5. A history of interstitial lung disease.
6. A history of coagulopathy resulting in uncontrolled bleeding or other bleeding disorders.
7. Participated in a clinical study of an investigational agent within 30 days of screening.
8. Has known psychiatric, substance abuse, or other disorders that would interfere with cooperation with the requirements of the study in the opinion of the investigator.
9. Is pregnant or breastfeeding.
Dynamic Cervical Implant vs. Anterior Cervical Discectomy and Fusion

Comparison between Dynamic Cervical Implant as a recently introduced technique in our department and the conventional Anterior Cervical Discectomy and Fusion in management of single-level cervical disc prolapse.

Anterior cervical discectomy and fusion (ACDF) is considered to be a highly successful surgical technique for cervical spondylosis associated with brachialgia and/or myelopathy. Non-union accounts for more than two-thirds of failures in ACDF surgeries and iliac bone graft morbidity is also reported in about one-third of multilevel fusion operations. There are many types of cages used to avoid the complications associated with iliac bone grafting.These problems include persistent donor-site pain, infection, hematoma formation, iliac crest fracture, and neuralgia parasthetica.

However, in spite of being successful for many years, ACDF has its own complications in the form of non-union, implant failure, and adjacent level disease which occurs due to the excessive motion observed at the levels immediately above and/or below the index level. It has been proven to provide clinical stability after decompression.. However, although it achieves long-term success, ACDF is not without complications as there have been reports of pseudoarthrosis, implant failure, and adjacent level disease which occurs due to the significant amount of increased motion observed at the levels immediately above and below the fusion. However, greater compensation occurred at the inferior segments compared to the superior segments for the lower level fusions.

Dynamic cervical Implant (DCI) is a titanium implant, originally invented in 2002 by Dr. Guy Matgé, Luxembourg. It was introduced in clinical use, in 2004. The design was modified to better accommodate the normal disc anatomy. The DCI implant with its motion preservation characters is unique implant. It stabilizes the cervical spine while still offering a limited, controlled flexion and extension movements allowing the spine to dynamically perform its function. It also acts as a shock absorber, preventing accelerated degeneration in adjacent segments. Thus, the DCI implant aims at combining the advantages of the gold standard "fusion" with a motion preservation philosophy.

This study aims to

* compare the clinical and radiographic outcomes of ACDF versus DCI in patients with degenerative cervical radiculopathy and/or myelopathy operated upon at Assiut University Hospital.
* Give the effective treatment, pain control and can detect the best method could be used in such cases.

I.

• Improve the outcome of these patients and decease rate of recurrence and complications

Eligibility Criteria:
Inclusion Criteria:

1. Patients with single level cervical disc prolapse in the subaxial cervical vertebrae (C3 - C7) confirmed by MRI.
2. Age of the patient is between 18- 60 years old of both sex.
3. Patients are fit for surgery..

Exclusion Criteria:

1. Patients with multilevel cervical disc prolapse.
2. Patients with recurrent disc prolapse.
3. Spinal deformity
4. Spinal instability.
5. Patients who are unfit for surgery
Test Safety of Biodegradable and Permanent Limus-Eluting Stents Assessed by Optical Coherence Tomography

The objective of the study is to assess the superiority of the biodegradable polymer based limus-eluting stent (Nobori®) compared with the permanent polymer based everolimus-eluting stent (XIENCE V®) regarding absolute percentage of uncovered stent strut segments.

The mid-term efficacy of drug-eluting stents has been well-established, but there is an ongoing debate on the potential of an increased incidence of late stent thrombosis, particularly after discontinuation of thienopyridine therapy, as well as of delayed onset of restenosis or catch-up phenomenon with permanent polymer-based DES. The extent of strut coverage with reduction of exposed thrombogenic material has been shown to be associated with the inflammatory reaction grade and with the incidence of stent thrombosis. The optical coherence tomography (OCT) is an intravascular imaging modality based on light. The principle is similar to intravascular ultrasound, but due to the much shorter wave length of light, it offers a much better resolution up to 10µm, enabling the exact determination of strut coverage, neointimal thickness, vessel size, presence of dissections, and even the presence of inflammation.

Eligibility Criteria:
Inclusion Criteria:

* Patients older than age 18 with ischemic symptoms or evidence of myocardial ischemia in the presence of ≥ 50% stenosis located in native coronary vessels
* Written, informed consent by the patient or her/his legally-authorized representative for participation in the study
* In women with childbearing potential a negative pregnancy test is mandatory

Exclusion Criteria:

* Lesion length \>16mm requiring a stent length \>18mm
* Target lesion located in the left main trunk
* In-stent restenosis
* Acute myocardial infarction
* Malignancies or other comorbid conditions (for example severe liver, renal and pancreatic disease) with life expectancy less than 12 months or that may result in protocol non-compliance
* Known allergy to the study medications: rapamycin, everolimus, biolimus, stainless steel or cobalt chrome
* Inability to take dual antiplatelet therapy for at least 6 months
* Pregnancy (present, suspected or planned) or positive pregnancy test
* Previous enrollment in this trial
* Patient's inability to fully cooperate with the study protocol
Telemedicine Enhanced Asthma Management - Uniting Providers

This research study is an innovative school-based program for urban children with moderate to severe persistent or difficult-to-control asthma. The Telemedicine Enhanced Asthma Management-Uniting Providers (TEAM-UP) program enhances a school-based, primary care directed asthma program with specialist-supported care to ensure optimal guideline based treatment. This study is a full-scale randomized trial of TEAM-UP versus an enhanced care comparison group. Primary care physicians (PCP) of all enrolled children (n=360, 4-12 yrs.) will be prompted to initiate directly observed therapy (DOT) of preventive asthma medication through school and to make a specialist referral. For children in the TEAM-UP group, the specialist visits will be facilitated via telemedicine at school. The telemedicine specialist visit will be scheduled after 4 weeks of initiating DOT, in order to allow for accurate guideline-based assessments of medication and care needs once adherence with a daily controller medication is established. There will also be 2 telemedicine follow-up specialist visits to assess the child's response to treatment and make needed adjustments. The study will use the existing community infrastructure by implementing both telemedicine and DOT in school, and maintaining collaboration with PCPs. Blinded follow-ups will occur at 3-, 6-, 9- and 12-months after baseline, and the primary outcome is the comparison of symptom-free days (SFD) at each follow-up time point.


Eligibility Criteria:
Inclusion Criteria:

1. Physician-diagnosed asthma (based on parent report with validation from the child's physician).
2. Age \>=4 and =\<12 years.
3. Residence in the City of Rochester and surrounding suburbs, with a. primary residence within the following zip codes: 14445, 14604, 14605, 14606, 14607, 14608, 14609, 14610, 14611, 14612, 14613, 14614, 14615, 14616, 14617, 14618, 14619, 14620, 14621, 14622, 14623, 14624, 14625, 14626.
4. Moderate-severe persistent severity (requiring Step 3 or higher care) or difficult to control asthma despite therapy (based on age-specific NHLBI guidelines).

Exclusion Criteria:

1. Inability to speak and understand English or Spanish. (\*Parents unable to read will be eligible, and all instruments will be given verbally.)
2. Current participation in an asthma study.
3. Planning to leave the Rochester city school district area in fewer than 6 months.
4. Having received asthma specialist care in the prior 3 months.
5. Having other significant medical conditions, including congenital heart disease, cystic fibrosis, or other chronic lung disease, that could interfere with the assessment of asthma-related measures.
6. In foster care or other situations in which consent cannot be obtained from a guardian.
Biomechanical and Viscoelastic Properties of Plantar Fascia in Diabetes Mellitus

In this study, an attempt has been made to analyze the changes in soft tissue biomechanical properties of plantar surface in diabetes. The second aim of this study was to explore the relationships between fear of falling, physical performance, and plantar stiffness in patients with diabetes.

Chronic diabetes can lead to ulceration in the plantar region and may result in amputation. Diabetes-related foot ulcerations are one of the most challenging complications of diabetes mellitus. Myotonometry, a technique to measure dynamic stiffness is preferred due to its noninvasiveness, easy employability, and rapid investigation. In this study, an attempt has been made to analyze the changes in soft tissue biomechanical properties of the plantar surface in diabetes. Increased plantar tissue stiffness is thought to alter the distribution of tensile stresses in the plantar soft tissues during gait. Combined with a reduction in plantar tissue thickness, these changes could collectively decrease the mechanical loads required to initiate soft tissue breakdown and thus lead to foot ulceration formation. Diabetes mellitus is a significant risk factor for falls in adults and is associated with an increase in fear of falling. Microvascular complications associated with DM result in multiple impairments including sensory deficits and muscle weakness due to peripheral neuropathy, loss of visual acuity due to retinopathy, and impaired postural control and falls due to vestibulopathy. The prevalence of falls and fear of falling are significantly higher in adults with diabetes mellitus. Assessment of mechanical properties of plantar tissues can aid in the early diagnosis of ulceration. In this study, an attempt has been made to analyze the changes in soft tissue biomechanical properties of the plantar surface in diabetes. The second aim of this study was to explore the relationships between fear of falling, physical performance, and plantar stiffness in patients with diabetes.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with diabetes mellitus for more than three years
* Individuals without a history of diabetes mellitus affirmed by a normal range of fasting blood sugar and hemoglobin A1C levels.
* Age≥18 years

Exclusion Criteria:

* History of central nervous system conditions
* No visual and vestibular impairments
* Amputation of the lower limb
* History of fracture
* Surgery of lumbar and lower limb
* Having pain resulting in movement difficulty