cyrilzakka/clinical-trials huggingface dataset:
Lymph Drainage Mapping for Tailoring Elective Nodal Irradiation in Head and Neck Cancer

This study aims to explore the safety and outcome of lymph drainage mapping(LDM) to individually tailor the elective nodal irradiation (ENI) to the ipsilateral neck only. The goal is to exclude the contralateral negative neck from the irradiation fields when there is no contralateral draining sentinel node. In case contralateral lymph drainage is found on SPECT/CT, a contralateral sentinel node procedure (SNP) is performed to remove the draining node. The patient will only receive contralateral ENI if (micro/macro)metastasis are found in this contralateral sentinel node.

The SUSPECT2 study is a modified concept from the first SUSPECT study (N14SUS). The first study investigated whether lymph drainage mapping (LDM) using SPECT/CT was a safe and feasible method to exclude the contralateral neck from irradiation, or, in case of contralateral lymph drainage, to tailor the contralateral ENI field to the level containing the tracer accumulation. In this study, large dose reductions to most organs at risk were realized, as well as significant reductions of both short term (mucositis, dysphagia) and long term (xerostomia, dysphagia) toxicities.

Firstly, the SUSPECT2 study aims to expand the inclusion criteria of the original SUSPECT study. Secondly, it aims to further reduce the proportion of patients that undergoes bilateral ENI, by performing a contralateral sentinel node procedure (SNP) in case of contralateral lymph drainage. The patient will only receive contralateral ENI if (micro/macro)metastasis are found in this contralateral sentinel node.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed and histopathologically proven primary HNSCC
* T1-4N0-2b
* Tumor does not cross midline
* WHO performance status 0 or 1
* Signed written informed consent

Exclusion Criteria:

* Distant metastatic spread at the time of inclusion
* Chemotherapy or surgery (for the present tumor), prior to inclusion
* Previous radiation treatment in the head and neck region, for any reason
* Previous neck dissection
* Recurrent or second primary tumor in the head and neck region
* Head and neck malignancies arising from skin, lip, nose, sinuses, nasopharynx, salivary glands, thyroid gland or esophagus
* Pregnancy or no active contraception for pre-menopausal women
* Known hypersensitivity to iodine or nanocolloid injection
* Having any condition (physical, mental, sociological) that interferes with the informed consent procedure and follow-up schedules
Trail Evaluating Carbon Ion Radiotherapy (3 GyE Per Fraction) for Locally Recurrent Nasopharyngeal Carcinoma

The purpose of this study is to determine the maximal tolerated dose (MTD) of re-irradiation using carbon ion radiotherapy (CIRT) with the fraction size of 3 gray equivalent (GyE) in the treatment of locally recurrent nasopharyngeal cancer (NPC) and to evaluate the efficacy of such treatment at the MTD. Participants will be treated with CIRT with escalating dose regimens to evaluate the MTD in terms of acute and subacute toxicity observed during and within 4 months after the completion of CIRT. Once the MTD for locally recurrent NPC is determined, the MTD will be used as the recommended dose to patients fulfilling the inclusion criteria in the Phase II part of the trial.

The purpose of this study is to determine the maximal tolerated dose (MTD) of re-irradiation using carbon ion radiotherapy (CIRT) with the fraction size of 3 GyE in the treatment of locally recurrent nasopharyngeal cancer (NPC) and to evaluate the efficacy of such treatment at the MTD. Participants will be treated with CIRT with escalating dose starting from 54GyE (3GyE/daily fraction) to potentially 63GyE (3GyE/daily fraction) to evaluate the maximal tolerated dose (MTD) in terms of acute and subacute toxicity observed during and within 4 months after the completion of CIRT. The classic 3+3 method is used for the phase I dose escalating part of the trial and approximately 4-18 patients will be accrued. Once the MTD for locally recurrent NPC is determined, the MTD will be used as the recommended dose to patients fulfilling the inclusion criteria in the Phase II part of the trial. The Phase II part of the trial will be a single phase single arm study.

Eligibility Criteria:
Inclusion Criteria:

* Completed a definitive course of intensity-modulated photon radiation therapy (IMXT) to a total dose of ≥ 66 Gy
* Recurrence diagnosed more than 12 months after the initial course of IMXT
* Age ≥ 18 and \< 70 years of age
* Karnofsky Performance Score ≥70
* Willing to accept adequate contraception for women with childbearing potential
* Ability to understand character and individual consequences of the clinical trial
* Willing to sign the written informed consent; Informed consent must be signed before the enrollment in the trial

Exclusion Criteria:

* Local recurrence of NPC diagnosed within 12 months from the completion of previous course of radiation therapy
* Presence of distant metastasis
* Technology used other than IMXT (including brachytherapy following IMXT) for the treatment of initial diagnosis of NPC
* Pregnant or lactating women
* Patients who have not yet recovered from acute toxicities of prior therapies
* A diagnosis of malignancy other than carcinoma in situ of the cervix, basal cell carcinoma and squamous cell carcinoma of the skin within the past 5 years
* Refusal of the patient to participate into the study
Virtual Reality for Parkinson's Disease

Parkinson's Disease (PD) is one of the most common neurodegenerative disease. Bradykinesia, tremor, resting tremor and postural instability are the main motor characteristics of this disease. As the disease progresses, mobility, walking, balance are reducing, the risk of falls is increasing and patients become functionally dependent. Along with these symptoms, cognitive functions are also disturbed. The most commonly distorted cognitive functions are executive functions such as planning and reasoning, working memory, episodic memory, attention and visual-spatial skills. Pharmacological and surgical treatments are used in Parkinson's disease. Pharmacologic treatment has a proven effect on motor symptoms, but since there is no approved pharmacologic treatment which has a direct effect on cognitive functions, recent studies suggest non-pharmacological treatments to improve cognitive function. Physiotherapy is also accepted among non-pharmacological treatments. Conventional physiotherapy focuses on optimizing patient independence and safety, focusing on hinting strategies, cognitive movement strategies and exercises utilizing transfers, posture, upper extremity function, balance (and falls), gait, physical capacity and (in)activity. Virtual Reality (VR) technology, a promising commonly used new rehabilitation tool, is a treatment method that can be used as one of the non-pharmacological treatment methods in Parkinson's Disease. In order to understand how neuronal network dysfunction in the Parkinson's Disease leads to clinical symptoms, both the component elements and the interconnections within these networks need to be examined in greater detail. Studies of resting state-fMRI (rs-fMRI) use correlation of activation of brain regions and time series fluctuations between brain regions to give information about connectivity in brain.

The purpose of this study is to investigate the therapeutic effects of virtual reality on motor and cognitive symptoms of PD. Furthermore, the investigation of possible effects of this effect on neuroplasticity through functional brain networks is our other objective. This study will be the first study to evaluate the plasticity effect of virtual reality application with rs-fMRI in Parkinson's disease.


Eligibility Criteria:
Inclusion Criteria:

* To be 50 years old and older
* Clinical diagnosis of PD within the -framework of Brain Bank criteria
* Getting a stable antiparkinsonian medication at least for the last 1 month (or the treatment has not changed)

Exclusion Criteria:

* Having a story of unstable medical condition
* History of head trauma, stroke, or exposure to toxic substances
* Implying Parkinson plus syndromes in neurological examinations; pyramidal, cerebellar examination findings, gaze paresis, autonomic dysfunction
* Being diagnosed with Dementia
The Effects of Frailty on Chronic Kidney Disease

Frailty is a syndrome characterized by decreased reserve and diminished resistance to stressors. The proposed research will evaluate the association of frailty with chronic kidney disease (CKD). The prevalence of frailty increases with age and with CKD, but studies are needed to determine whether frailty is associated with worsening of CKD and whether intervention to treat frailty can improve physical functioning and health-related quality of life (HRQOL) as well as slow progression of CKD.

The intervention is a 6-month prospective interventional pilot study targeted to each domain of frailty. Subjects will be screened into the study by testing each domain; only those who meet criteria for frailty will be included in the study. The clinical intervention, which all subjects will receive, will begin immediately upon enrollment and completion of baseline measurements. Upon enrollment the 3 most recent previous outpatient serum creatinine measurements (up to 1 year) will be used to determine baseline slope of estimated glomerular filtration rate (eGFR). The main objectives of the pilot study will be to gain knowledge in the successful implementation and completion of an intervention targeted toward frailty. Ultimately information ascertained from this pilot will serve as a springboard for planning of a randomized trial aimed at addressing all the domains of frailty, which is key given that previous studies have only implemented interventions aimed at a single domain or in pairs, but no studies have evaluated the extent to which frailty can be reversed through a cohesive intervention addressing all domains together. The intervention outlined in this proposal is comprehensive and focused while maintaining feasibility.

Eligibility Criteria:
Inclusion Criteria:

* Chronic Kidney Disease Stage III to IV
* Receiving care at the San Francisco Veterans Affairs Medical Center
* Able to consent in English

Exclusion Criteria:

* Early chronic kidney disease
* individuals with acute kidney injury
* non-ambulatory
Prevention of Ventilator-Associated Pneumonia by Automatic Control of the Tracheal Tube Cuff Pressure

Background: The aspiration of contaminated secretions pooled above the endotracheal tube cuff secondary to inadvertent falls of cuff pressure is the main pathogenic mechanism of ventilator-associated pneumonia (VAP). Aim of the study: To assess the efficacy of an automatic device for the continuous regulation of tracheal tube cuff pressure in decreasing the incidence of VAP.

Design: Prospective, randomized, controlled trial, with 2 groups: study (automated control of cuff pressure) and control (standard control of cuff pressure). Setting: Respiratory Intensive Care Unit (RICU). Subjects: Patients \>18 yr, intubated and ventilated. Interventions and measurements: Study group (cuff pressure will be kept constant at 25 cmH2O with the automatic device) and control group (cuff pressure control every 8 h. at the same level using a manual pressure controller, according with standard routine); recording of clinical variables at admission and during RICU stay, and end-point variables (incidence of VAP, etiologic microorganisms, RICU and hospital stay, RICU and 60-d mortality. Expected results: Lower incidence of VAP in study group, compared with control group.

Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years,
* Orotracheal intubation for less than 24 hours
* Expectancy to remain on mechanical ventilation for more than 48 hours

Exclusion Criteria:

* Pneumonia
* Witnessed macroscopic aspiration
Evaluation of a New Design of Crowns in the Posterior Teeth

Background: no randomized controlled trial has tried to compare treatment outcomes between the IPS.emmax endocrowns and the IPS.emmax conventional crowns .

Objective: to investigate the clinical performance of the IPS.emmax endocrowns and the IPS.emmax conventional crowns Design and setting: Parallel-groups randomized controlled trial on patients with one or more intensive damaged molars requiring crowning and being treated at the University of Damascus, Dental School in Damascus, Syria .All molars will be examined at the baseline assessment using a modified US Public Health Service (USPHS) criteria.

Participants: Incoming patients to the Fixed Prosthetic and Endodontic Departments will be examined to find any excessively damaged molars requiring crowning. Forty patients will be recruited according to specific inclusion criteria. Randomization will be performed using computer-generated tables; allocation will be concealed using sequentially numbered opaque and sealed envelopes.The included 40 patients will be analyzed (age range between 20-60 years). They will be randomly distributed into two groups with 20 patients in each group (1:1 allocation ratio).

Intervention: Excessively damaged and endodontically treated molars will be restored with IPS.emmax endocrowns or IPS.emmax crowns supported with composite core.

Main outcome measure: marginal adaptation and anatomic form will be investigated clinically and by apical radiographs at the baseline assessment using the modified (USPHS) at six assessment times during an 18-month observation period.

Assessor blinding will be employed.


Eligibility Criteria:
Inclusion Criteria:

* Patients between 20 to 60 years old
* Good oral hygiene
* Gingival index (GI) equal 0
* Plaque index (PI) equal 0 or 1
* Primary acceptation and commitment to the trail

Inclusion criteria of molars:

* Two remaining axial walls at least.
* 0.5 mm above the gingival line at least for damaged axial walls.
* Good endodontic treatment and apical seal
* First and second upper and lower molars only.
* Against teeth could be natural or crowned.

Exclusion Criteria:

* Patients with an open bite or cross bite.
* Bruxism
* Periodontitis
* Gingival hyperplasia
Connective Tissue Growth Factor in Patients With Neovascular Age Related Macular Degeneration

Age-related macular degeneration (AMD) remains a leading cause of blindness in United States and can be broadly divided into two forms: non-neovascular AMD (NNVAMD) and neovascular AMD (NVAMD) AMD. Among the several mechanisms underlying AMD, hypoxia and oxidative stress have been implicated and cause upregulation of several signaling proteins. About 20% of patients with NNVAMD develop choroidal neovascularization and hence convert to NVAMD. Upregulation of vascular endothelial growth factor (VEGF) plays a critical role in conversion from NNVAMD to NVAMD.

Connective tissue growth factor (CTGF) is a polypeptide that has been shown to be overexpressed in various fibrotic disorders, suggesting its involvement in scarring. After the development of choroidal neovascularization, subretinal fibrosis may occur and result in permanent reduction of vision. An important question is, does CTGF contribute to subretinal fibrosis. An important first step in addressing this question is to determine if CTGF levels are increased in the eyes of patients with NVAMD and this is the objective of this study.

The investigators plan to measure levels of connective tissue growth factor (CTGF) in the aqueous humor of patients with neovascular age-related macular degeneration and compare to controls. Levels of VEGF will be measured as a positive control.


Eligibility Criteria:
Inclusion Criteria:

* Age \>/= 18 years
* Willing to sign informed consent and authorization of use and disclosure of protected health information
* For study group: patients must have a clinical diagnosis of NVAMD
* For control group: patients undergoing vitrectomy for macular hole, macular pucker, or vitreomacular traction, vitreous floaters or another condition unrelated to scarring.

Exclusion Criteria:

* Subjects with a retinal condition other than NVAMD in which scarring may occur such as proliferative vitreoretinopathy or retinal detachment.
TORNADO-Omics Techniques and Neural Networks for the Development of Predictive Risk Models

The goal of this observational study is to define a personalized risk model in the super healthy and homogeneous population of Italian Air Force high-performance pilots. This peculiar cohort conducts dynamic activities in an extreme environment, compared to a population of military people not involved in flight activity. The study integrates the analyses of biological samples (urine, blood, and saliva), clinical records, and occupational data collected at different time points and analyzed by omic-based approaches supported by Artificial Intelligence. Data resulting from the study will clarify many etiopathological mechanisms of diseases, allowing the creation of a model of analyses that can be extended to the civilian population and patient cohorts for the potentiation of precision and preventive medicine.

The high-performance pilots of the Italian Air Force are "super healthy" individuals subjected to particular working conditions, as changes in temperature, pressure, gravity, acceleration, exposure to cosmic rays and radiation, which determine psycho-physical adaptation mechanisms to maintain homeostasis. However, this environmental exposure may potentially affect human health, well-being and performance.

The study aims to collect exposure data, clinical, physiological data through biosensors and molecular parameters (at different time point), to be integrated by an Artificial Intelligence algorithm expressly trained to create reliable risk models.

The final outcome will consist of the identification of significant biomarkers of pathological risk, in order to better understand the etiopathological mechanisms of many human diseases and apply early and personalized countermeasures to maintain and empower workers' health status and performance, avoiding clinical symptom presentation.

Eligibility Criteria:
Inclusion Criteria:

* Being part of the Italian Air Force, as in active flight service or ground staff
* Age between 26 and 38 years
* Consent to collect biological samples and use the wearable device to monitor exposure parameters

Exclusion Criteria:

* Age \< 25 years and \> 39 years
* no signature on informed consent
Comparison of Function and Fit of Standard and Gender-Specific CR High-Flex Total Knee Prostheses

The purpose of this prospective, randomized study was to compare functional outcome, radiographic results, range of motion, patients satisfaction, and fit of the femoral component in patients receiving either a standard posterior cruciate-retaining high-flexion (CR-flex) and gender-specific CR-flex total knee prostheses.

The design features of the gender-specific knee prostheses have been claimed to improve fit and function of total knee arthroplasty in women. The purpose of this prospective, randomized study was to compare functional outcome, radiographic results, range of motion, patients satisfaction, and fit of the femoral component in patients receiving either a standard posterior cruciate-retaining high-flexion (CR-flex) and gender-specific CR-flex total knee prostheses.

Eligibility Criteria:
Inclusion Criteria:

* End stage osteoarthritis of the knee joint who require total knee arthroplasty with bilateral lesions.

Exclusion Criteria:

* Inflammatory arthritis
* Osteoarthritis effecting hip joint
* Traumatic arthritis
* Neurologic disorders affecting motor function of lower extremity
* foot and ankle disorders limiting ambulation of the patient
Low-level Light Therapy for Overactive Bladder and Urinary Incontinence

This study aims to evaluate the effectiveness of a self-therapeutic approach of skin adhesive low-level light therapy (LLLT) in females with Overactive Bladder (OAB) and Urinary Incontinence (UI)

Study design: This was a prospective, randomized, double-blind, placebo-controlled, multi-centered trial carried out at two university hospitals. This clinical trial was approved by the Korea Food and Drug Administration and the Institutional Review Boards of the two hospitals.

Study process:

All patients gave informed written consent after being informed of the details of the study. Participants were randomized into either the LLLT or placebo control groups at the third visit. All participants underwent demographic and history taking, a physical examination, bladder examination and laboratory tests. All participants were educated on how to use the device by demonstration and a picture-guided user manual.

During the second visit, the participants conducted a self-evaluation of frequency of urgency urinary incontinence episode using the OABSS scale and underwent urine examination (pre-treatment measurement). The third visit occurred 7 days from the date of the second visit, and a clinical primary nurse described how to use the medical equipment and devices when they were at home. All subjects filled out self-reported diary and filled out UDI-6 and IIQ-7 questionnaires in each visit. Subjects carried out the self-treatment in the same way at home 3 times a day for 12 weeks and then visited the hospital at week 4 and 12 to undergo examination and filled out OABSS, UDI-6 and IIQ-7 questionnaires (post-treatment measurement).

Statistical analysis:

All data are summarized as means ± standard deviation or as numbers with proportions. A p \< 0.05 was considered to indicate significance. The investigator decided that the therapeutic effect would be a \> 20% reduction in the frequency of urgency urinary incontinence episodes after treatment. The statistical analysis was conducted using the self-reported micturition diary after the 12 week visit as the primary endpoint. The investigator used an independent t-test or Wilcoxon rank sum test depending on the normality of the data to evaluate differences in each group between frequency of urgency urinary incontinence episodes measured after the 12 week visit and baseline values. To test for normality, the investigator performed Shapiro-Wilk's test. The examination of the ratio difference in nominal variable was carried out using chi-square test or Fisher's exact test. A per-protocol (PP) and intent to treat (ITT) analyses were used in our clinical trial to assess efficacy and safety. A Last observation carried forward (LOCF) method was used for ITT analysis missing data.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of overactive bladder or urinary incontinence

Exclusion Criteria:

* History of taking medication for urgency urinary incontinence,