cyrilzakka/clinical-trials huggingface dataset:
The ULTRA Study: Cross-Comparison of Ultrasound Systems

The purpose of this study is to develop computational methods for cross-comparison of muscle composition measurements in three laboratory ultrasound systems.

The purpose of this study is to develop computational methods for cross-comparison of muscle composition measurements in three laboratory ultrasound systems. We propose a cross-sectional study to obtain ultrasound images of selected muscles in Veteran participants. These data will be used to develop conversion models for each system. Evaluation of neuromuscular symptoms such as muscle weakness and fatigue is crucial to improving quality of life among Veterans. These symptoms may be related to progressive changes in muscle tissue composition, including increased intramuscular fat and atrophy. Quantitative musculoskeletal ultrasound is a diagnostic imaging application used to characterize muscle tissue composition. Despite its non-invasiveness and relative low cost, quantitative musculoskeletal ultrasound has not been widely adopted by the medical community due in part to technical barriers that impede generalization of measurements across ultrasound systems. Unfortunately, few techniques have been proposed to reliably compare system measurements. Development of new cross-comparison methods could expand quantitative musculoskeletal ultrasound applications and improve neuromuscular symptoms diagnosis.

Eligibility Criteria:
Inclusion Criteria:

* Male or female Veteran who receives medical care at the Washington DC VA Medical Center
* Ages 20-85

Exclusion Criteria:

* Limb amputation (upper or lower extremity)
* Lower extremity joint replacement
* Severe cognitive impairment
* Edema
* Inability to read, speak, or understand English
Prospective Validation of Adaptive Radiotherapy (ART) in Patients With Head and Neck Tumors

Adaptive radiotherapy (ART) includes image-guided radiotherapy (IGRT) and also offers further possibilities for plan adaptation. A particularly high benefit can be expected for patients in whom the clinical target volume (CTV) can show a significant change in shape from fraction to fraction due to anatomical deviations. The shape and position constancy of the CTV during the course of the series is examined in this trial. Dosimetric disadvantages of this type have not been reported so far. The aim of this study is to identify patients who benefit from ART at an early stage and to select them for this method, and then to continue to offer ART to this patient group. If a relevant reduction in the minimum planning target volume (PTV) margins with ART compared to IGRT is demonstrated in this study, patients could be treated with ART.

The aim here is to prospectively evaluate modern technical standards. In the last 25 years, radiotherapy has developed rapidly away from two-dimensional procedures towards volume-modulated, three-dimensional techniques. But here, too, there is a broad radiotherapeutic spectrum due to the high technical diversity in radiotherapy and ever newer technical innovations. (1) Definitive radiochemotherapy is standard of care for locally advanced head and neck tumors. The aim of this study is to monitor the influence of the new technical therapy standards (therapy options in application: volume-modulated rapid-arc technique (VMAT) / online onboard image-guidance (IGRT) and adaptive re-planning, using the linear accelerator ETHOS currently established and installed at the Department of Radiotherapy in December 2021) as a function of dose parameters for quality assurance of feasibility.

Therapy with ETHOS represents a comprehensive new treatment option that is tailored and individualized from the initial planning and adjustment on the treatment table to radiation monitoring of the whole therapy.

Online-adaptive radiotherapy (ART) allows the dose distribution to be adapted to the anatomical changes online and immediately before each radiation fraction. Adaptive radiotherapy is a further development of image-guided radiotherapy (IGRT), which is now standard of care in radiotherapy. In contrast to ART, with IGRT the radiation plan cannot be adapted to deformations of the body from radiation fraction to radiation fraction, e.g. through different positioning of the tongue or jaw.

This trial creates the basis for standardizing treatment parameters as far as possible, but also for introducing improvements in the treatment of future patients in a personalized and individualized form.

Standard therapy can be further optimized using modern equipment and high-precision linear accelerators.

Eligibility Criteria:
Inclusion Criteria:

1. ECOG 0-1
2. Histopathology confirmation
3. Compliance
4. Tumor in the head and neck region
5. Indication for radiotherapy

Exclusion Criteria:

1. Pregnancy
Anti-angiogenesis Agent AG-013736 in Patients With Metastatic Renal Cell Carcinoma

The primary purpose of this protocol is to determine the activity of AG 013736 in patients with metastatic renal cell cancer who have received 1 prior cytokine-based therapy.


Eligibility Criteria:
Inclusion Criteria:

* Histologically documented RCC with metastases.
* Failure of 1 prior cytokine-based therapy (interleukin-2 and/or interferon) due to disease progression or unacceptable treatment-related toxicity

Exclusion Criteria:

* Any prior systemic treatment for Renal Cell Carcinoma \[RCC\] other than 1 prior cytokine-based treatment regimen. Cytokine-based regimens containing thalidomide or an anti-angiogenesis agent are not allowed.
* Inability to take oral medication
SAR3419 Administered Weekly in Patients With Relapsed/Refractory CD19-positive B-cell Non-Hodgkin's Lymphoma

The primary objective is to determine the maximum tolerated dose (MTD) of SAR3419 according to the dose limiting toxicities (DLTs) observed when administered as a single agent once weekly.

Secondary objectives are:

* to characterize the global safety profile
* to evaluate the pharmacokinetic (PK) profile of SAR3419 in the proposed dosing schedule
* to assess preliminary evidence of anti-lymphoma activity.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of B-cell non Hodgkin's lymphoma
* Relapsed or refractory after standard treatments and with no curative option with conventional therapy (Patients having undergone stem cell transplantation may be included)
* CD19 positive disease by flow cytometry or immunohistochemistry

Exclusion Criteria:

* Burkitt's lymphoma, Lymphoblastic lymphoma, Chronic lymphocytic leukemia (Small lymphocytic lymphoma may be included)
* Evidence of cerebral or meningeal involvement by lymphoma
* Patients without bi-dimensionally measurable disease
* ECOG performance status \> 2
* Life expectancy less than 3 months
* Chemotherapy or radiation therapy or other investigational agents within 4 weeks prior to entering the study
* Previous radioimmunotherapy within 12 weeks
* Known anaphylaxis to infused proteins
* HIV, HBV and HCV positivity
* Poor kidney, liver and bone marrow functions
* Any serious active disease or co-morbid condition, which, in the opinion of the principle investigator, will interfere with the safety or the compliance with the study
* Pregnant or breast-feeding women
* Patients with reproductive potential without effective birth control methods

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
DOM-INNATE: Study of SGX942 for the Treatment of Oral Mucositis in Patients With Concomitant Chemoradiation Therapy for Head and Neck Cancer

To assess the efficacy of SGX942 compared to placebo in decreasing the duration of severe oral mucositis in patients receiving chemoradiation treatment for the treatment of head and neck cancer


Eligibility Criteria:
Inclusion Criteria:

* Biopsy-proven squamous cell carcinoma of the oral cavity or oropharynx without distant organ metastases
* Scheduled to receive cisplatin chemotherapy of 80-100 mg/m²
* Scheduled to receive a continuous course of fractionated, conventional external beam with a cumulative radiation dose between 55 and 72 Gy at each site

Exclusion Criteria:

* Current mucositis
* Current, clinically significant, active infection that in the opinion of the Investigator would make them an unfit participant in the trial
* Planned to receive Erbitux™ (Cetuximab) or similar targeted therapy between Baseline and 6 weeks post-RT
* Prior radiation to the head and neck
* Chemotherapy treatment within the previous 12 months
* Tumors of the lips, sinuses, salivary glands, nasopharynx, hypopharynx, or larynx
* Evidence of significant renal, hepatic, hematologic, or immunologic disease determined by any one of the following: Estimated creatinine clearance \<30 mL/min; ALT or AST level greater than 10-fold the upper limit of normal or total bilirubin greater than 3-fold the upper limit of normal; Manifestations of end-stage liver disease, such as ascites or hepatic encephalopathy; Thrombocytopenia; or CD4+ T cell count below 200 cells per μL
* Evidence of immediate life-threatening disease or a life expectancy of less than 3 months
* Women who are pregnant or breast-feeding
* Participation in any study involving administration of an investigational agent within 30 days of randomization into this study
The Effects of Light Therapy to Treat Cancer-related Side Effects

Severe fatigue, depression, sleep problems and cognitive impairment are the most commonly reported side effects of cancer treatment. These aversive side effects are hypothesized to be related to the disruption of circadian rhythms associated with cancer and its treatment. Exposure to Bright White Light (BWL) has been found to synchronize the circadian activity rhythms but research with cancer patients has been scarce. Therefore, the proposed randomized control trial (RCT) will test if systematic light exposure (sLE) will minimize overall levels of cancer-related fatigue (CRF), depression, sleep problems and cognitive impairment among breast cancer patients undergoing breast cancer treatment (i.e., surgery, chemotherapy). SLE incorporates the delivery of harmless UV-protected BWL or Dim White Light (DWL - standard comparison in light studies) delivered to patients by using special glasses for 30 minutes each morning, during their treatment. The proposed study, including a delineated comparison condition, will investigate the effects of BWL on CRF, sleep, depression, cognition, circadian rhythms, and inflammation markers among patients undergoing breast cancer treatment. The proposed RCT could have major public health relevance as it will determine if an easy-to-deliver, inexpensive, and low patient burden intervention reduces common side effects (e.g., CRF, depression, cognitive impairment) of cancer treatment (i.e., surgery, chemotherapy).

Aim 1 - Assess whether Bright White Light (BWL) compared with Dim White Light (DWL) among breast cancer patients undergoing breast cancer treatment will minimize overall levels of CRF, depression, sleep problems, and cognitive impairment during and after breast cancer treatment, compared to healthy controls.

Aim 2 - Determine whether the BWL intervention affects cortisol rhythms, circadian activity rhythms, melatonin rhythms, and inflammation markers that have been identified as correlates/causes of cancer-related side effects (e.g., CRF, depression, sleep problems).

Aim 3 - Exploratory: Explore whether the effects of BWL compared to DWL on the cancer-related side effects (e.g., CRF, cognitive impairment) are mediated by the beneficial effects of the BWL in synchronizing circadian rhythms.

Aim 4 - Exploratory: Explore potential moderators of the intervention including seasonality, chronobiology, personality, and social factors.


Eligibility Criteria:
Inclusion Criteria:

1. Breast cancer Patients: Newly diagnosed patients with stages 1 to 3 breast cancer scheduled to undergo surgery (without chemotherapy) and newly diagnosed patients with stages 1 to 3 breast cancer scheduled to undergo both surgery and chemotherapy.
2. Healthy controls: never received a cancer diagnosis

Exclusion Criteria:

* Stage 3B breast cancer, inflammatory or stage 4 breast cancer; under age 18; pregnancy; pre-existing anemia (Hb \<10gm/dl); history of bipolar disorder or mania (which are contra-indications for BWL treatment); and any other physical or psychological impairments (e.g., sleep disorder diagnosis) which could limit participation.
Rheological Functions of Erythrocyte in ESRD

End-stage renal disease (ESRD) disrupts erythrocyte deformability due to osmotic imbalances, oxidative stress, and uremic toxins, leading to impaired microcirculation and oxygen transport. Dysregulation of ion channels, particularly the Gardos channel, exacerbates dehydration and eryptosis, further compromising vascular integrity. Given the critical role of erythrocyte flexibility in oxygen delivery, this study investigates its relationship with aerobic capacity in ESRD patients, highlighting potential mechanisms of microvascular dysfunction

End-stage renal disease (ESRD) profoundly alters osmotic homeostasis, disrupting erythrocyte deformability and impairing microcirculatory dynamics, ultimately compromising oxygen delivery to tissues. Persistent oxidative stress, hyperosmotic fluctuations, and accumulation of uremic toxins collectively modulate ion channel activity, particularly by stimulating cation influx and perturbing calcium regulation. These disruptions accelerate erythrocyte aging and promote eryptosis, a programmed form of red blood cell death. Furthermore, dysregulation of the Gardos channel exacerbates potassium efflux, leading to excessive cell dehydration, increased blood viscosity, and further deterioration of vascular integrity. Given the pivotal role of erythrocyte flexibility in oxygen transport efficiency, impairments in osmotic deformability may contribute to the reduced aerobic capacity frequently observed in ESRD patients. This study aims to elucidate the interplay between erythrocyte biomechanical properties and cardiopulmonary fitness in this population, shedding light on potential therapeutic targets to mitigate microvascular dysfunction.

Eligibility Criteria:
Inclusion Criteria:

* Receiving hemodialysis and medication at least for 6 weeks
* Kt/V score \> 1.2

Exclusion Criteria:

* Under 20 years-old
* Hyperkalemia occurs within 3 month
* Having orthopedic or muscular diseases
* Other concerned medical, psychological or physiological diseases
* Pregnancy
* Other exercise contraindications
Investigating Consumers Perception and Acceptance of Whey Beverages

Brief Summary: This study aims to investigate whether protein fortification of beverages causes mouthdrying and mucoadhesion and whether this is influenced by saliva flow.

To investigate whether whey protein beverages causes mouthdrying and reduces acceptability compared with a control beverage (whey permeate beverage) and to determine whether manipulating salivary flow rates influences mouthdrying.

To determine whether mucoadhesion is a probable cause of mouthdrying.

Eligibility Criteria:
Inclusion Criteria:

* Healthy
* No food allergies or intolerances
* Non smokers

Exclusion Criteria:

* Taking prescribed medication that could influence study outcomes (such as saliva flow)
* Relevant food allergies or intolerances
* Outside age criteria
* Cancer
* Had oral surgery or a stroke
* Smoker
* Diabetic
* Anyone who currently has COVID-19 symptoms or who has had COVID-19 within the last 4 weeks
Study on OsseoSpeed™ Implants Replacing 2-5 Teeth in the Posterior Upper Jaw, Restored With Provisional Teeth Attached 6-7 Weeks Later

The purpose of the study is to evaluate Astra Tech Dental Implant System, Fixture Osseospeed™, in patients with tooth loss in the posterior maxilla in an early loading protocol. Primary objectives are implant stability, marginal bone adaptation and survival rate.


Eligibility Criteria:
Inclusion Criteria:

* Provision of written informed consent
* 18 years of age and over
* Edentulous in the posterior maxilla, Kennedy classes I or II. Last natural tooth, or previously restored implant in function is canine or first bicuspid.
* Deemed by the investigator as likely to present an initially stabile implant situation suitable for early loading

Exclusion Criteria:

* Untreated caries and/or periodontal disease of residual dentition
* History of edentulism in the area of implant placement of less than two months
* Current need for pre-surgical bone or soft tissue augmentation in the planned implant area.
* History of pre-surgical bone or soft tissue augmentation, within12 months, in the planned implant area.
* Sinus floor thickness of less than 5 mm, verified by periapical radiographs.
* Any systemic or local disease or condition that would compromise post-operative healing and/or osseointegration
* Need for systemic corticosteroids or any other medication that would compromise post-operative healing and/or osseointegration
* Present alcohol or drug abuse
* Unable or unwilling to return for follow-up visits for a period of 5 years
* Current use of smoking tobacco
* Pregnancy or lactation at the time of enrollment
Prospective Evaluation of Lymphoedema Among Patients With Gynaecological Cancer

This project will conduct a prospective, longitudinal, observational cohort study to assess the onset and incidence of lymphoedema, as well as investigate factors associated with its development among women newly diagnosed with gynaecological cancers in 2008 to 2011.

Pathological swelling of the lower limbs (lymphoedema) is widely accepted to be a common consequence of treatment for gynaecological cancer. It is both a serious and debilitating complication, associated with significant morbidity, which impacts physically and emotionally on otherwise healthy women. Lymphoedema can also affect patients' ability to earn an income, especially if their work requires prolonged periods of standing or walking.

The causes of lymphoedema are largely unknown with clinical data scarce regarding its onset time and incidence after gynaecological cancer treatment.

The following hypotheses will be tested to address the aims of the project:

1. At least 20% of patients will develop lower-limb lymphoedema following gynaecological cancer treatment.
2. Patient's age, as well as their body mass index (BMI), area of residence, degree of physical exercise, type of disease (uterine, cervical, ovarian, vulval/vaginal cancer; benign disease), mode of treatment (extent of lymph node dissection, radiotherapy, chemoradiation) and delay in wound healing are independent risk factors for lower-limb lymphoedema.
3. Patients who develop lymphoedema after gynaecological cancer treatment, will experience increased pain, lower quality of life (including worse body-image), and decreased sexual \& financial well-being, compared to those who do not develop lymphoedema.
4. There will be at least 10% difference in the incidence of lower-limb lymphoedema between patients treated for gynaecological cancer compared to benign diseases.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for surgery of benign or malignant gynaecological diseases as determined jointly by the surgeon and the patient.
* Non-pregnant female patients.
* Over 18 years of age at time of surgery.
* Patients who understand the conditions of the study and are willing to participate for the length of the prescribed term of follow-up.
* Patients who are capable of, and have given, informed consent to their participation in the study.

Exclusion Criteria:

* Patients with a pacemaker.
* Allergies against adhesive electrodes and extensive internal metal plates are ineligible for BIS measurement.
2D-speckle Tracking in Pediatric Renal Chronic Disease

The SPECKLE- KIDNEY-PED is a multicentre observational controlled trial aiming to evaluate the 2D-Speckle tracking in a population of 85 patients aged from 6 to 17 years old with a chronic renal disease and to compare the results to those of 85 age and gender-matched healthy subjects. The secondary objective is to assess the conventional echocardiographic parameters and the level of exercice capacity.

Kidney disease and chronic kidney failure are one of the most common causes of chronic childhood disease. They are often complicated by cardiovascular disease, which can, in the long run, affect patients' prognosis. Thus, mortality in children undergoing hemodialysis for end-stage kidney failure is related in more than 30% of cases to a cardiovascular complication. An annual cardiac assessment is recommended as part of the follow-up of these patients to assess the cardiac impact of kidney disease (high blood pressure, hyper-uremia, etc.). The use of conventional cardiological assessment parameters does not predict the cardiovascular prognosis of patients because the alteration of these parameters is greatly delayed in the course of the disease. 2D strain or "speckle tracking echocardiography" is a non-invasive ultrasound technique that allows for a more sensitive assessment of myocardial tissue damage and its early impairment has been shown as a factor of poor prognosis in other pediatric chronic pathology (neuromuscular disease, cardiotoxic exposure, etc.) as well as in adult chronic kidney failure.

The SPECKLE- KIDNEY-PED trial is a multicentre observationnal controlled study. The main objective of this work is to asses the 2D strain ventricular function in children with kidney failure, to compare it with that of healthy children of 6 to 17 years old, and to correlate it with the cardio-renal severity of the disease in terms of level of kidney failure and aerobic physical fitness.

The secondary objective is to assess, in this population, the level of exercice capacity and to compare it to the general population of children of the same age.

A total of 180 children are recquired to observe a significant difference of 2,5% of the global strain value with a power of 90% and an alpha risk of 5%.

The SPECKLE- KIDNEY-PED trial intends to improve the level of evidence for future guidelines on cardiologic survey and promotion of physical activity in this population

Eligibility Criteria:
Inclusion criteria:

* Patient aged 6 to 17 years old
* Patient with chronic renal disease (\>3 months)
* Patient with renal insufficiency (glomerular filtration rate \< 80ml/min/1,73m2)

Exclusion criteria:

* Patient with associated congenital heart disease
* Patient with uncontrolled arrythmia