cyrilzakka/clinical-trials huggingface dataset:
Test of Digital Breast Tomosynthesis vs. Common Mammography to Detect Breast Cancer for Women Undergoing Breast Biopsy

Comparison of the ability of DBT and FFDM to detect breast cancer.

Enrolled women will undergo bilateral DBT. Prior breast imaging data (screening and diagnostic mammography) must have been conducted on GE equipment and the images must be available (or imaging must be repeated). DBT images will be read on-site by one or more qualified radiologists. All subjects who undergo biopsy will be asked to return in approximately 1 year for a follow-up mammogram. Images will be processed and evaluated by independent readers.

Eligibility Criteria:
Inclusion Criteria:

* Women ≥18 years or older and has underwent screening/diagnostic mammography and referred for breast biopsy
* Able and willing to comply with study procedures, and have signed and dated the informed consent form
* Surgically sterile or postmenopausal

Exclusion Criteria:

* Pregnant or trying to become pregnant
* Has signs or symptoms of breast cancer
* Has been previously included in this study
* Has breast implants
* Has a history of breast cancer and is in active treatment
* Has breasts too large to be adequately positioned for the DBT examination
Strategies for Optimal Lung Ventilation in ECMO for ARDS: The SOLVE ARDS Study

Due to lack of studies on mechanical ventilation strategies in patients with severe Acute Respiratory Distress Syndrome (ARDS) supported with Veno-Venous Extra-Corporeal Membrane Oxygenation (VV ECMO), ventilator settings in this patient population are set arbitrarily.

In this two-phases prospective, interventional, pilot study we hope to gain physiologically relevant data on two aspects of mechanical ventilation in patients with severe ARDS supported with VV ECMO: (1) the use of tidal ventilation and (2) the level of Positive End-Expiratory Pressure (PEEP).

1. PHASE 1: impact of tidal ventilation on VILI (10 patients) We hypothesized that a CPAP strategy that minimizes end-tidal pulmonary stress and strain mitigates VILI compared to the current mechanical ventilation practice that employs tidal ventilation in patients with severe ARDS on ECMO.

   In this first phase we will test whether administering a distending inspiratory pressure to produce tidal ventilation is superior to a strategy where only continuous positive airway pressure (CPAP) is applied for ventilation induced lung injury (VILI) mitigation, as assessed by its impact on biotrauma (serum cytokines) and physiologic measurements.
2. PHASE 2: impact of PEEP on VILI (10 patients) We also hypothesized that adjusting PEEP to maximize respiratory system compliance reduces VILI in patients with severe ARDS on ECMO.

In the second phase we will therefore gain more insight as to whether a strategy that utilizes a PEEP level that correspond to best compliance is beneficial over Zero End-Expiratory Pressure (ZEEP). We will test the impact of both strategies on biotrauma (serum cytokines), physiologic parameters, and right ventricular function (transesophageal echocardiographic assessment).

Because ARDS patients supported with VV ECMO can be hemodynamically unstable, the use of imaging techniques that require transport, such as computed tomography, is limited. Therefore, bedside imaging techniques, such as pleural and lung ultrasound (PLUS) and focused bedside cardiac ultrasonography, are important tools for clinicians who care for these patients. This study will allow us to learn whether these techniques are feasible and valid in this patient population.

Furthermore, the knowledge gained from this study will allow us to assess the rationale and feasibility of performing a similar larger, randomized study in the future.


Eligibility Criteria:
Inclusion Criteria:

* Severe ARDS (Berlin Definition)
* VV ECMO \< 72 hours
* Endotracheal intubation or tracheostomy

Exclusion Criteria:

* Thoracic surgery/lung transplantation during the current hospitalization
* Contraindications to a RM (MAP \< 60 mmHg despite administration of fluids and vasopressors; Active air leak through a thoracostomy tube; Pneumothorax, or subcutaneous or mediastinal emphysema, (if chest tube has not been inserted))
* Contraindications to TEE
* Age \< 16 years
A Study Comparing Fusion Rates of Two Lumbar Fusion Procedures

The purpose of this study is to demonstrate the relative efficacy of two lumbar fusion procedures: transacral lumbar interbody fusion when used in conjunction with unilateral or bilateral posterior pedicle screw fixation as an adjunct to fusion, in comparison to transforaminal lumbar interbody fusion (TLIF) when used in conjunction with unilateral or bilateral supplemental screw fixation as an adjunct to fusion.

Subject candidates are those who had previously required and received fusion at L4-L5-S1 where these were the only lumbar levels treated for pseudoarthrosis, spinal stenosis, spondylolisthesis, or degenerative disc disease (DDD).

Consecutive subjects who were treated with the transsacral lumbar interbody fusion or TLIF procedures at least 2 years prior to the date the data is collected will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Adult 18 years of age or older
* Male or female subject that had previously received the transsacral two-level procedure when used in conjunction with pedicle screw or facet screw fixation or TLIF two-level procedure with unilateral or bilateral supplemental screw fixation (e.g. pedicle screws, facet screws at L4-L5-S1 to treat pseudoarthrosis, spinal stenosis, spondylolisthesis, or degenerative disc disease (DDD)
* Subject that was treated no less than 2 years prior to this evaluation with an transsacral or TLIF procedure by the participating surgeons
* Subject that had a diagnosis that required a transsacral or TLIF procedure at the L4-L5-S1 levels and did not require treatment at any other lumbar levels at the time of surgery

Exclusion Criteria:

* Subject who did not receive the transsacral or TLIF procedure for fusion of L4-L5-S1
* Subject who received lumbar fusion procedures at levels other than L4-L5-S1 at the time of surgery
Noraxon myoRESEARCH™ Software Gait Analysis Evaluation and Orthotic Gait Correction in Reducing Diabetic Foot Ulceration Or Subsequent Amputation in Patients With a History of a Diabetic Foot Ulceration

Determining whether the utilization of Noraxon myoRESEARCH Software gait analysis Evaluation and orthotic gait Correction can reduce diabetic foot ulceration Or subsequent amputation in patients with a history of a diabetic foot ulceration.

The purpose of this study is to identify emerging abnormal structural pathology of the vulnerable re-ulcerative diabetic foot incorporating physical therapy evaluation as well as the Noraxon gait analysis to generate quantitative and qualitative gait data. Once peak foot pressures and gait pathology is identified, gait remedy is fabricated including either a foot orthotic and/or an ankle foot prosthesis. Evaluation of constructed remedy will then be evaluated focusing on gait analysis data to validate decreased plantar foot peak pressures and gait realignment towards the reduction of the diabetic foot re-ulceration and subsequent foot or limb loss.

Eligibility Criteria:
Inclusion Criteria:

* History of healed diabetic foot ulceration
* Over 18 years of age

Exclusion Criteria:

Patients who are:

* under 18 years of age
* non-diabetic
* non-ambulatory
* non-healed wounds.
Myosteatosis in Oeso-gastric Cancer: Clinical Impacts

The aim of this project is to study the presence of cancer-associated adipocytes in oesogastric cancers and their possible links with myosteatosis. This research project has a retrospective component, the aim of which is to analyse the body component based on imaging in patients with oesogastric neoplasia in order to determine the incidence of myosteatosis and to study the relationship with oncological and prognostic data. The second part of the project is prospective and will collect biological material (skeletal muscle, adipose tissue, tumour, blood) for histological, molecular and genomic analyses and will analyse muscle function in patients with oesogastric cancer. It will address the role of adipocytes in the tumour microenvironment of oesogastric cancer, focusing on their interactions with the observed muscle myosteatosis and prognosis. In the future, it will help to identify signalling pathways, targets and patients who could benefit from appropriate treatment.

Oesophageal and gastric cancer pose a significant challenge to caregivers, both in terms of the complexity of its presentation and its treatment. At diagnosis, patients often present with malnutrition associated with sarcopenia, which has a significant impact on morbidity and mortality. Although loss of muscle mass has received much attention in cancer, muscle quality, particularly the accumulation of fat in muscle named "myosteatosis", may be considered as a better predictor of a patient's physical condition and ability to recover from cancer treatments. Studying the tumor microenvironment is essential to understanding the mechanisms underlying disease progression. Cancer-associated adipocytes (CAA), a major component of this tumor microenvironment, provide an interface for dialogue with the tumor through the secretion of pro-inflammatory cytokines, metalloproteases and the release of free fatty acids. They have been described as capable of stimulating tumor progression, particularly in breast cancer. However, their presence in oesogastric cancer and possible links with myosteatosis have not been described.

Eligibility Criteria:
Inclusion Criteria:

* Patients with cancer of the oesophagus, oeso-gastric junction or stomach
* Treatment and estimated survival of more than 3 months
* Signed informed consent
* \> 18 years of age

Exclusion Criteria:

* Neuromuscular or orthopedic pathology
* Cognitive disorders
* Psychiatric disorders
* Inability to communicate in French or English
Knowledge, Perception, Usage And Concerns Of Artificial Intelligence Applications In Periodontology

Statement of problem: knowledge gap about knowledge, perception ,usage and concerns of artificial intelligence applications in periodontology among periodontists.

Aim of the study:

To investigate ' periodontists' knowledge, perception , usage and concerns towards AI systems' applications in periodontology.

Materials and Methods This will be done by a self-administered, 33-item questionnaire . The questionnaire is divided into five sections.The first section, known as Part A, focus on five open-ended questions on sociodemographic characteristics, where participants enter their age, gender, academic affiliation. Part B consists of closed-ended questions, identifying the basic knowledge of the periodontists participating in AI using a Likert three-point scale (yes / no / maybe) . Part C consists of questions assessing the perception of periodontists towards the use of AI using a Likert three-point scale (yes / no / maybe). Part D consists of questions focusing on the usage of AI applications . part E consists of questions assessing concerns of AI applications in periodontology using a Likert three-point scale (yes / no / maybe) .

This study will be conducted in accordance with the code of ethics of the research ethics committee at the faculty of dentistry, at Ain Shams University. This survey aims to assess the knowledge, perception , usage and concerns of AI applications among periodontists.

The questionnaire will be distributed to periodontologists in the faculty of dentistry at Ain Shams University. Participants will be voluntary and anonymous. The questionnaire consists of five parts and the average time to complete the questionnaire is 10-12 min


Eligibility Criteria:
Inclusion Criteria:

* All participants should be post-graduate periodontists.
* Periodontists at Egypt

Exclusion Criteria:

* Any undergraduate dental student
Swept Source Enhanced Depth Imaging Optical Coherence Tomography

The investigators would be interested in applying the enhanced depth imaging technique to swept source optical coherence tomography, by modifying the acquisition protocol. Doing so, the investigators hope to improve the visualization of the choroid and perhaps even of the sclera.

A structurally and functionally normal choroidal vasculature is essential for retinal function. The status of the choroid appears to be a crucial determinant in the pathogenesis of diseases such as age-related choroidal atrophy, myopic chorioretinal atrophy, central serous chorioretinopathy, chorioretinal inflammatory diseases, and tumors.

The in vivo structure of the choroid in health and disease is incompletely visualized with traditional imaging modalities, including indocyanine green angiography and ultrasonography.

Optical coherence tomography (OCT) is an established medical imaging technique that uses light to capture micrometer-resolution, three-dimensional images from within optical scattering media. OCT is based on low-coherence interferometry. Nowadays, it is essential for managing retinal conditions.

Unfortunately, standard spectral domain optic coherence tomography (SD-OCT) is of limited use in imaging choroidal morphology.

A modification to the standard technique, termed enhanced depth imaging optical coherence tomography (EDI-OCT), is able to image the choroid with better clarity using commercial SD-OCTs.

With the advent of enhanced depth imaging optical coherence tomography (EDI-OCT), detailed visualisation of the choroid in vivo has been made possible possible. Measurements of choroidal thickness (CT) have also enabled new directions in research to study normal and pathological processes within the choroid.

However, EDI-OCT has its own limitations: the outer choroidal border cannot always be visualized and choroidal details sometime lack clarity.

A new generation of OCTs has been made available, based on swept-source technology.

Swept source OCT (SS-OCT) has been shown to be more precise than spectral domain EDI-OCT in measuring choroidal thickness.

Our department is now using two OCTs, one is a SD- OCT (Canon HS-100), the other one a SS- OCT (Topcon DRI Atlantis).

The investigators would be interested in applying the EDI technique to SS- OCT, by modifying the acquisition protocol. Doing so, the investigators hope to improve the visualization of the choroid and perhaps even of the sclera.

This modification is based on the technique described by Spaide for SD-OCT.

From the patient's perspective, it only involves spending more time fixing the green stimulus (about 4 minutes instead of 2, in order to follow the swept-source EDI protocol in addition to standard swept source).

Eligibility Criteria:
Inclusion Criteria:

* Ability to sit for OCT

Exclusion Criteria:

* Media opacities precluding fundus view
Heartfulness Meditation to Improve Resilience Among Health Care Students: A 90 Day Program

This investigation will examine the feasibility of delivery and effect on resilience, depression and anxiety of a 90-day Heartfulness Practice delivered virtually for health care students. It is hypothesized that by providing this program on-line, students will be able to attend easily and complete the sessions. It is also hypothesized that those students who participate in the meditation program will increase resilience.

This investigation will examine the feasibility of delivery and effect on resilience, depression and anxiety of a 90-day Heartfulness Practice delivered virtually for health care students.

SPECIFIC AIMS (SA) SA1: Determine feasibility and acceptability of delivering the 90-day Heartfulness Meditation Program virtually. Feasibility will be assessed by participant compliance, retention, and acceptability to the participants.

Criteria: Feasibility will be achieved by Compliance with average of at least 3 trainer led meditations / week Retention of 75% of participants at the end of 45 days (intermediate point) and 90 days (primary end point).

Criterion: Acceptability will be indicated by a CSQ8 score \> 17. SA2: Examine the benefits of Heartfulness meditation on improving resilience, decreasing depression, and decreasing anxiety of health care students.

H2: At the end of 90 days (primary end point), students who participate in the Heartfulness Resilience Training (HEART) will have better resilience (CD-RISC) compared with students who do not participate and will have less anxiety and depression (HADS).

SA3: Examine the association between the number of sessions completed and changes in resilience, depression, and anxiety at 45 and 90 (primary end point) days.

H3: Changes in resilience, depression, and anxiety will be significantly correlated (Pearson correlation coefficients) with total number of sessions completed (H3a) and with number of one-on-one sessions with a trainer (H3b).

Eligibility Criteria:
Inclusion Criteria:

* Men and women ages 20-70
* Student in one of the health care programs on the Anschutz Medical Campus at the University of Colorado.

Exclusion Criteria:

* Students who are currently engaged in any formal meditation practice (e.g., Transcendental Meditation, Mindfulness Based Stress Reduction, (MBSR) more than once per week
* Unable to use the technology without special accommodations.
Dendritic Cell Based Therapy of Metastatic Breast Cancer

The study aim to show if vaccination with autologous dendritic cells pulsed with onco-peptides in combination with adjuvant cytokine can induce a measurable immune response in patients with metastatic breast cancer, and to evaluate the clinical effect (objective response rate) of the vaccination regime.

HLA A2 positive patients are treated with PADRE and oncopeptide pulsed DC; p53, survivin and telomerase peptides. Each patient is given 6 immunizations with at least 5x106 peptide/lysate pulsed autologous DC. Vaccination 1-4 is given weekly and 4-6 at 2-week intervals. Those patients who exhibit stable disease, partial response or complete response after 6 injections will be given 4 more vaccinations at 2-week interval. The vaccine is applied by either intranodal or intradermal injection near the inguinal region. For adjuvant used IL-2 2 MIU sc. day 2-6. Scans and re-staging tests are performed at scheduled intervals throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven progressive metastatic or locally advanced breast cancer
* No standard treatment indicated
* Age: \> 18
* WHO-Performance Status 0-1
* At least tone measurable tumor lesions according to the RECIST criteria.
* Expression of the HLA-A2 tissue type
* Life expectancy more than 3 months
* Acceptable CBC and blood chemistry results
* Written informed consent

Exclusion Criteria:

* Patients with a history of any other neoplastic disease less than 5 years ago (excepting treated carcinomas in situ of the cervix and basal/squamous cell carcinomas of the skin).
* Patients with metastatic disease in the central nervous system (CNS).
* Patients with other significant illness including severe allergy, asthma, angina pectoris or congestive heart failure.
* Patients with acute or chronic infection including HIV, hepatitis and tuberculosis.
* Patients who are pregnant.
* Patients who have received antineoplastic therapy including chemotherapy or immunotherapy less than 4 weeks before beginning the trial.
* Patients who receive corticosteroids or other immunosuppressive agents.
* Patients with active autoimmune diseases such as lupus erythematosus, rheumatoid arthritis or thyroiditis.
Efficacy and Safety of Aclidinium Bromide 400 µg Compared to Placebo and to Tiotropium Bromide in Patients With Stable Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

The aim of the present study is to evaluate the 24h bronchodilatory efficacy of inhaled aclidinium bromide 400 µg administered twice a day versus placebo and tiotropium bromide, respectively, after 6 weeks of treatment.


Eligibility Criteria:
Inclusion Criteria:

* Adult male and female patients aged ≥40 with stable moderate to severe COPD (GOLD guidelines).
* Post-salbutamol (FEV1) \< 80% and ≥ 30% of predicted normal value and Post-salbutamol FEV1/FVC \< 70%.
* Current or ex-smokers of 10 ≥pack-years.

Exclusion Criteria:

* Patients with no history or current diagnosis of asthma.
* No evidence of an exacerbation within 6 weeks prior to the screening visit.
* No evidence of clinically significant respiratory and/or cardiovascular conditions or laboratory abnormalities.
* No contraindication to use of anticholinergic drugs such as known symptomatic prostatic hypertrophy, bladder neck obstruction or narrow-angle glaucoma.
Effect of Collagen Supplementation on Tendinopathy

Tendon injuries represent a significant problem in elite athletes. Therefore, prevention and effective treatment of tendon overload injury/tendinopathy is important. Among different treatment options, heavy-slow loading based rehabilitation is considered among the most efficient treatments in athletes. In this study, we will investigate if supplementation with hydrolyzed collagen in combination with a heavy-slow loading based 12 weeks rehabilitation regime can improve treatment of tendon overload injury/tendinopathy. The investigators will examine elite athletes with overload injury/tendinopathy with regards to symptoms (pain, function), tendon morphology (ultrasonography), and vascularization (Doppler US). The investigators hypothesize that collagen supplementation can have an improving effect on tendon pain and function. Thus, the investigation will show if a rehabilitation regime of collagen supplementation combined with heavy-slow mechanical loading can improve tendon healing compared to mechanical loading alone.

Randomized placebo-controlled intervention study with follow-up after one month

Eligibility Criteria:
Inclusion Criteria:

* Elite athletes
* 18-40 years old
* Exercise related tendon pain on one or both legs
* Soreness during physical examination of tendon upon palpation
* Uni- or bilateral tendinopathy symptoms \> 3 months

Exclusion Criteria:

* Previous tendon surgery
* Diabetes
* Arthritis
* Corticosteroid injection for tendinopathy within the last 3 months
* Any form of tendon injection within the last 3 months
* Smoking