cyrilzakka/clinical-trials huggingface dataset:
Study of the Endovascular QUANTUM LP™ Stent Graft System in Abdominal Aortic Aneurysms (AAA)

The objective of this clinical study is to assess the safety and effectiveness of the Cordis Endovascular Quantum LP™ Stent Graft System.


Eligibility Criteria:
Inclusion Criteria (Surgical Patients):

1. Non-emergent surgical candidate (aneurysm has not ruptured)
2. Patients 21 years of age or older
3. Male or infertile Female
4. Aneurysm \>/=4.5 cm in diameter, or
5. Aneurysm \>/= twice the normal aortic diameter directly above the aneurysm, or
6. Aneurysm \>/= 4.0 cm in diameter and rapidly growing (0.5 cm in 6 months), or
7. Saccular aneurysm \> 3.0 cm

Inclusion Criteria (Stent Graft Patients)

1. Patient meets all inclusion criteria for surgical candidate
2. Aneurysm starts \>/= 10 mm below the most distal main renal artery and the diameter of aorta within that aortic neck segment is not variable
3. Diameter of aortic fixation zone (neck) \>/= 22mm and \</= 30 mm
4. Supra renal aortic diameter \</= 34 mm
5. The required device coverage length \>/= 13 cm extending from most distal main renal artery ostium to the distal anchoring site within the common iliac artery (or external iliac artery if planned occlusion of internal iliac artery)
6. Aortic neck angulation \< 60° as estimated from CT scan images or angiogram
7. Iliac artery attachment zone diameter \</= 20 mm
8. Iliac arteries with a length of \>/= 10 mm of non-aneurysmal vessel located at the iliac graft attachment sites
9. Iliac arteries with adequate peripheral access to accommodate a 22 Fr catheter delivery system
10. Aortic bifurcation \> 18 mm in diameter
11. Creatinine level \< 2.5 mg/dl

Exclusion Criteria (Surgical and Stent Graft Patients):

1. Weight \> 350 lbs. (159 Kg)
2. Mycotic, ruptured or traumatic aneurysm
3. Life expectancy \< 2 years
4. MI, cerebral vascular accident or transient ischemic attack (TIA) within 6 months
5. Expected occlusion or the need for re-implantation of significant mesenteric or renal arteries originating from the AAA

Exclusion Criteria (Stent Graft Patients only)

1. Aneurysm is symptomatic or tender
2. Creatinine \> 2.5 mg/dl or patient on dialysis
3. Thrombus in proximal and distal attachment area covering greater than 50% of the endoluminal surface
Validation of Non-invasive Hemoglobin (SpHb) Measurement in Children

The purpose of this study is to evaluate the value of the new technique of non-invasive measurement of Hb in children undergoing a surgical procedure.

Several surgical procedures require haemoglobin monitoring due to possible blood loss and the need of blood transfusion. The standard for monitoring hemoglobin (Hb) is the measurement of blood samples. The novel technique of non-invasive continuous measurement of Hb using Pulse CO-Oximetry may allow measuring Hb without obtaining blood samples.

This new technique has not been tested yet in children undergoing anesthesia for elective surgical procedures. In this study the investigators compare the non-invasive Hb measurement with Masimo® technology (SpHb) with the standard Hb measurement using ABL-800 Flex (BGA) and Siemens Advia (labHb, reference method) before the children undergo the surgical procedure.

Eligibility Criteria:
Inclusion Criteria:

* children (\>= 3 kg until 8 years)
* ASA I-III
* written informed consent of legal representative

Exclusion Criteria:

* children \<= 3kg or \> 8 years
* emergency surgery
* allergy against sensor of SpHb(®)
* artery occlusive disease
* sepsis
* haemoglobinopathy
* specific medical or psychological circumstances which do not allow the consent of the legal representative or the performance of the study
Clinical Evaluation of CARESTREAM Dual Energy and Digital Tomosynthesis

The purpose of this study is to evaluate the imaging performance of Dual Energy and Digital Tomosynthesis (DE-DT) application against the commercially available predicate devices.

The acquisition system will consist of using site equipment including the CARESTREAM DRX-Evolution x-ray system, and the predicate CARESTREAM DRX Plus detector and the investigational DE-DT application.

DE Study Design Thirty to forty (30-40) patients will receive a DR standard of care chest exam using the DRX Plus detector and a DE exam. Each DE patient exam includes high energy and low energy image exposures using the investigational device. These images are used by the DE console software to generate additional DE images (e.g. bone and soft tissue).

DT Study Design Fifteen to twenty (15-20) patients will receive a DR standard of care chest exam using the DRX Plus detector, and a DT exam. Each DT patient exam includes a scout image (chest PA) and a DT scan using the investigational DT SW. The DT scan is used by the DT console software to generate tomographic images.

11 phantoms of various anatomy will be imaged with linear tomography (LT) as predicate and DT for investigational.

Eligibility Criteria:
Inclusion Criteria:

Age 18 years and older. Subject has provided informed consent. Study participant is scheduled to have a chest CT exam. Study participant is able to stand and be still during the exams.

Exclusion Criteria:

Human subject specific:

Not able or willing to provide Informed Consent, or consent is withdrawn. Study participant is a female of child bearing age.
MINIMALLY INVASIVE SURGERY in Total Knee Arthroplasty

Overall study design:

A prospective, randomized, multi-center clinical studies comparing the minimal invasive and the standard surgical total knee replacement technique (control) using the Genesis II total knee system. The study will collect efficacy, safety and socio-economical data over 2 years. An additional 5 years follow-up interval is optional. The objectives (short-term follow-up) of the study are to:

1. Assess whether the improvement in Pain and Range of motion per Knee Society scoring system and VAS score.
2. Assess whether there are any differences between the surgical techniques as regards complication rate.
3. Assess whether the hospital stay and the rehabilitation time (Straight leg raise, Active/passive ROM) of the patients differs between the two techniques.
4. Assess the x-ray mechanical alignment between the two techniques.

Attempts will be made to assess whether the collected peri-operative data (including incision length, blood loss, wound appearance, hospital readmissions and operative time) differs between the two surgical techniques.

The primary objectives (mid-term follow-up) of the study are to:

1. Improvement in Pain and Function per Knee Society Scoring system
2. Number and Extent of Radiographic Lucencies \>2mm
3. Revision and knee-related adverse events
4. Improvement in Quality-of-life via the VAS score

5 investigational sites will participate and enroll a total of approximately 250 patients over a 12 months period. Thus, each site will enroll 50 patients.


Eligibility Criteria:
Inclusion Criteria:

* require primary uni- or bilateral total knee arthroplasty; available for 2 year follow up; provide informed consent; is in stable health for cardio-pulmonary conditions.

Exclusion Criteria:

* inefficient femoral or tibial bone stock; BMI \>35; fixed flexion deformity \>15 degrees; knee flexion of \<90 degrees; varus/valgus deformity \>20 degrees; active local infection; conditions that would compromise the 2 years follow up.
US Vs MRI in Diagnosis of TMJ Internal Derangement

Compare the accuracy of ultrasonography and magnetic resonance imaging in the diagnosis of temporomandibular joint internal derangements.

Temporomandibular disorders (TMDs) are conditions that affect the temporomandibular joint (TMJ), often leading to pain and dysfunction. The most common cause of TMJ problems is internal derangements.

The term "internal derangements" refers to conditions with the articular disc displaced from its original position on the mandibular condyle.

Disc displacement may occur anteriorly, anterolaterally, laterally, anteromedially, medially, or posteriorly, but the latter is very rare.

Anterior disc displacement (ADD) is the most common ID condition and is usually divided into two categories: with reduction and without reduction. Each category has special features during closed and opened mouth positions. Therefore, the examination should include both positions.

Clinical examination alone isn't enough to diagnose TMJ problems, therefore additional imaging tests are often needed.

Magnetic resonance imaging (MRI) is the gold standard modality, however because of its limited availability, long scan time, and high cost, it is difficult to use MRI as a screening technique.

Ultrasound (US) has been recommended as an alternate diagnostic imaging modality for TMJ problems as it is less costly, non-invasive and capable of providing real-time imaging, presents an alternative diagnostic tool. Thus, the articular disc may be seen as the patient is opening and closing their mouth

Eligibility Criteria:
Inclusion Criteria:

* Patients showing signs of TMJ internal derangements

Exclusion Criteria:

* contraindications for MRI such as claustrophobia, heart pacemaker and metallic foreign body carriers.
* patients in which the misaligned images or distortions due to motion artifacts made the interpretation of the MRI unreliable.
* Previously operated TMJ.
Neck Joint Position Error Among Taibah Students University; Saudi Arabia; Cross Section Design

this study was done to answer the following: Is there a difference between students without and with varying degrees of text neck in cervical proprioception defect? Is there a correlation between JPE and severity of text neck among Taibah students University?


Eligibility Criteria:
Inclusion Criteria:

* A convenient sample of 68 female students
* the age was between 18-25 years

Exclusion Criteria:

* Any students with neck pain or previous neck or back surgery or a history of a previous accident were excluded
* Also, we excluded any student with a history of fracture injury of the cervical column, scoliosis, severe thoracic kyphosis, rheumatic disease, torticollis, loss of standing balance, use of hearing aid, and persistent respiratory problems.
Effects of Power-velocity Muscle Characteristics During Ageing

The purpose of this project is to investigate the age-related differences in force-velocity muscle characteristics during isolated knee extensions variable in speed and load, during cyclic movements on a usual and recumbent bike variable in speed and velocity development and a functional test battery with healthy participants aged between 20-80 years.


Eligibility Criteria:
Inclusion Criteria:

* healthy volunteers age 20 to 80 years

Exclusion Criteria:

* Knee or hip prothesis
* Systematic training
* Cardiovascular disease
* Acute lower back pain
* Acute knee pain
* Dementia
Effect of Individualized Training Versus Non-individualized Training to Improve Quality of Life of Sedentary Employees

The practice of a physical activity, even moderate, plays an important role in the prevention and the management of the main chronic non-communicable diseases (cardiovascular diseases, certain cancers, diabetes, obesity, osteoporosis ...) as well as by improving psychological health. Several studies have shown that physical activity has a positive impact on the economy of companies via the reduction of absenteeism and the improvement of productivity. However, it seems important to individualize these recommendations in order to prescribe the best possible dose of physical activity for each individual. In this project, the investigators want to test the physical qualities of employees in order to prescribe the best possible dose of physical activity with the ultimate goal of improving quality of life.

Physical activity (PA) is one of the major determinants of health. Indeed, the practice of a physical activity, even moderate, plays an important role in the prevention and the management of the main chronic non-communicable diseases (cardiovascular diseases, certain cancers, diabetes, obesity, osteoporosis ...) as well as by improving psychological health. The effects are beneficial regardless of age, gender and state of health. Moreover, in addition to the well-being of employees, several studies have shown that physical activity has a positive impact on the economy of companies via the reduction of absenteeism and the improvement of productivity. Today, the World Health Organization (WHO) prescribes 150 min of physical activity per week regardless of the person's profile (active employee, employee working in his office, construction worker, etc.).. In this project,the investigators therefore want to test the physical qualities of employees in order to prescribe the best possible dose of physical activity with the ultimate goal of improving quality of life.

Eligibility Criteria:
Inclusion Criteria

* Sedentary people
* Affiliate to health care organism
* Subject who gave their consent

Exclusion Criteria:

* People with degenerative disease
* Pregnant women
* Cardiovascular trouble
* Subject who are not able to understand the proceeding of the study or to give their consent
Analysis of naïve Patients With Age-related Macular Degeneration of the Neovascular Type and Treated With Aflibercept (Eylea®) in "Treat-and-extend" at CHU Brugmann

Age-related macular degeneration (AMD) is a leading cause of blindness in people over 50. Neovascular AMD, the most serious and severe form, is characterized by the appearance, spread and growth of subretinal new vessels. One of the major molecular mediators is vascular endothelial growth factor (VEGF).

Intra-vitreous (IVI) injection of an anti-VEGF can slow the progression of neovascular AMD and stabilize vision in the majority of cases. Aflibercept (Eylea®) is one of the anti-VEGF molecules approved in Belgium to treat neovascular AMD.

At the start of its use, aflibercept was first injected monthly and then according to the PRN "reactive" protocol (Pro Renata). Over time, a new treatment strategy has emerged: the "treat-and-extend" (T\&E). This is individualized patient care, the objective of which is to reduce the frequency of injections while ensuring inactivity of the disease. This begins with the loading dose, i.e. 3 injections given 4 weeks apart. Thereafter, the interval is lengthened in increments of 1 or 2 weeks provided that the visual and anatomical results remain stable. In the event of deterioration, the interval is shortened while keeping a minimum of 4 weeks between each IVI.

The efficacy and safety of aflibercept, when used in a proactive T\&E regimen, was demonstrated in the randomized controlled trial, ALTAIR. However, data on T\&E used in practice is still lacking. routine, and particularly the number of injections and treatment intervals over a minimum 24 month treatment period.

The aim of this retrospective study carried out at the CHU Brugmann is to determine the number of injections and the intervals necessary to have encouraging results in terms of visual acuity, over a treatment period of at least one year.


Eligibility Criteria:
Inclusion Criteria:

* Patients\> 50 years old diagnosed with neovascular age related macular degeneration,
* Patients who have never received anti-VEGF treatment,
* Patients who started intra-vitreous injections of aflibercept between 01 January 2014 and November 30, 2019,
* Treatment by "treat-and-extend" directly after the loading dose of aflibercept,
* Availability of the medical file reporting treatment with aflibercept.

Exclusion Criteria:

* Participation in an interventional clinical study during treatment with aflibercept,
* Patients with ocular pathologies who required surgery during the first 24 months of treatment with aflibercept (eg advanced glaucoma or cataracts).
Study of DE-089 Ophthalmic Solution in Patients With Dry Eye

Safety and efficacy of DE-089 ophthalmic solution in patients with dry eye will be evaluated in comparison with sodium hyaluronate ophthalmic solution.


Eligibility Criteria:
Inclusion Criteria:

* Those who show:

  * Keratoconjunctival disorder confirmed with vital dye staining
  * Abnormal Schirmer score results

Exclusion Criteria:

* Eye disease that needs therapy other than that for dry eye
* Those who need to wear contact lenses during the clinical study
Influence of Vaginal Lactoferrin on Amniotic Fluid Cytokines to Avoid Pregnancy Complications

Objective: To evaluate the influence of vaginal Lactoferrin administration on amniotic fluid concentration of 47 cytokines, chemokines and growth factors.

60 women undergoing genetic amniocentesis will be enrolled at the Obstetric Unit, University of Ferrara. The selected patients will be randomly assigned to receive 300 mg of vaginal Lactoferrin to obtain 3 groups: A, 20 untreated patients; B and C (20 patients each one) respectively treated 4 and 12 h before amniocentesis. Cytokines, chemokines and growth factors concentrations will be quantified by a magnetic bead Luminex multiplex immunoassays panel technology.

Amniotic fluid samples will be obtained by transabdominal amniocentesis and the sample not required for clinical purposes will be centrifuged to remove particulate material and the supernatants will be aliquoted and stored at -80°C until assay.

Eligibility Criteria:
Inclusion Criteria:

* singleton physiological pregnancy;
* maternal age as the only indication to foetal karyotyping

Exclusion Criteria:

* assumption of drugs interfering with the immune system;
* previous miscarriages;
* pregnancy at risk for maternal or foetal disease;
* lactose intolerance.
Early UVFP Management Based on Neurological Evidences (UVFP = Unilateral Vocal Fold Paralysis)

The aim of this study is to understand how early intervention could impact reinnervation of the recurrent laryngeal nerve (which innervates the vocal cord), recovery of mobility of the paralyzed vocal cord and / or vocal recovery in the case of unilateral vocal fold paralysis. To achieve this goal we must therefore carry out a complete outcomes assessment of different intervention methods (voice therapy and injection laryngoplasty), which are offered to UVFP (unilateral vocal fold paralysis) patients in the early stage (\< 3 months). Their respective impacts on the central and peripheral nervous system and on the voice quality will be assessed, taking into account factors related to the severity of the paralysis.


Eligibility Criteria:
Inclusion Criteria:

- Unilateral paralysis in abduction of the vocal cords may be included in the study.

Exclusion Criteria:

* Wear a pacemaker or other implanted devices (prostheses ...).
* Wear metal clips, metal in the head, or an adjustable brain drain.
* Wear non-removable dental appliances (except fillings).
* Wear cardiac valve prostheses.
* Have worked the metals.
* Have a tattoo containing metal particles.
* Have implanted jewelry (e.g., piercing).
* Being prone to epileptic seizures.
* Take medications that alter cortical excitability.
* Have had a brain surgery.
* Suffer from intracranial hypertension.
* Be pregnant or breastfeeding recently.
* Present allergies that are incompatible with the experimental protocol.
* Have an abnormal hearing loss in view of their age, identified with tonal and / or vocal audiometry.
Zenith® Fenestrated Abdominal Aortic Aneurysm (AAA) Endovascular Graft Continued Access Study

The Zenith®Fenestrated AAA Endovascular Graft Clinical Study is a clinical investigation approved by the US FDA to study the safety and effectiveness of the Zenith® Fenestrated AAA Endovascular Graft in the treatment of abdominal aortic and aorto-iliac aneurysms.


Eligibility Criteria:
Inclusion Criteria:

* Abdominal aortic and aortoiliac aneurysms with diameter greater than or equal to 5 cm

Exclusion Criteria:

* Proximal neck less than 4 mm or greater than or equal to 15 mm in length unless otherwise compromised to preclude seal
* Renal artery stenosis greater than 50 percent
A Study to Learn About Whether BAYH006689 Causes Skin Irritation When Applied as a Topical Gel in Healthy Participants

Researchers are looking for a better way to treat muscle and joint pains. Researchers have seen that medicines which help reduce pain and inflammation could be safer when applied directly to the skin, called topical application, than when taken by mouth. However, recent studies have found that using these medications on the skin can sometimes cause skin reactions such as redness, itching, or irritation in the area where the medication is applied.

BAYH006689 topical gel is under development for the treatment of muscle and joint pains.

In this study, participants will be healthy and will not benefit from BAYH006689. However, the study will provide information about how to test BAYH006689 in future studies with people who have muscle and joint pain.

The main purpose of this study is to check whether BAYH006689 topical gel causes any irritation to the skin in healthy participants using a patch test called cumulative irritant patch test design. To do this, researchers will apply gel to participants' skin once a day for 21 days. Skin reactions will be assessed using a scale which will provide a score for redness, swelling, and other signs of skin irritation.

In this study, researchers will randomly assign 4 sites adjacent to each other, on the back of the participants' bodies just below the shoulder blades.

The following treatment gels will be applied using a patch.

* BAYH006689
* Placebo, which looks like the study drug, but does not have any medicine in it.
* 0.2% sodium lauryl sulfate (is a common ingredient in personal care products and when in contact with skin it could cause some skin irritation)
* 0.9% saline

Each participant will be in this study for 22 days, which includes:

* a visit to the clinic within 21 days of the study start, to confirm if the participant can take part in the study.
* participants will receive their assigned treatment gels at the identified skin site for 21 days.
* an end of study visit on Day 22, during which the researchers will remove the designed patches and assess any signs of skin irritation.

During the study, the doctors and their study team will:

* do physical examinations
* check participants' health by performing urine tests
* ask the participants questions about how they are feeling and what adverse events they are having An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatment.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adult
* Is 18 years of age or older
* Free of any systemic or dermatological disorder that may interfere with results or increase risk of adverse events (AEs)

Exclusion Criteria:

* Has a condition and/or is using medications that may interfere with the study results
* Pregnant or planning to get pregnant or breastfeeding
* Is currently participating in any clinical testing
irAE Prediction of Anti-PD-1/L1 in Lung Cancer

the purpose of this study is to identify multi-dimensional immunological biomarkers including cytokines, autoantibodies, and immune cell subtypes of immune-related adverse events (primary) and prognosis(secondary) in the anti-PD-1/anti-PD-L1 immunotherapy for lung cancer

After being informed of the study and potential risk, all patients giving written informed consent will undergo peripheral blood sample collection at baseline (before treatment ), 1month and 3month after treatment initiation, and when immune-related adverse events ever occur. The follow-up period will be 1 year for any occurrence of immune-related adverse events and 2 years follow-up for the prognosis.

Eligibility Criteria:
Inclusion Criteria:

* 18-80 years of age
* Stage I-IV Lung Cancer confirmed by histopathology or imaging techniques
* Receiving anti-PD-1/anti-PD-L1 immunotherapy (with indication and no contraindication)

Exclusion Criteria:

* Other cancer treatment
* Other malignancies