cyrilzakka/clinical-trials huggingface dataset:
PhaseⅠ/Ⅱ Study of URLC10-177 and TTK-567 Peptide Vaccine Combined With CpG7909 in Patients With Esophageal Cancer

This is a single institution phase I / II trial to evaluate the safety and efficacy of URLC10-177 and TTK-567 emulsified with Montanide ISA 51 in combination with different doses of CpG7909 in patients with advanced or recurrent esophageal cancer.

phase I: Patients will be vaccinated on day 1,8,15 and 22 of each 28-day treatment cycles. On each vaccination day, the URLC10-117 peptide(1mg) and TTK-567 peptide(1mg) mixed with CpG 7909 (escalating doses: 0, 0.02, 0.1mg/kg) emulsified with Montanide ISA 51 will be administered by subcutaneous injection. Repeated cycles of vaccine will be administered until patients develop progressive disease or unacceptable toxicity, or for maximum 2 cycles, whichever occurs first. In this phase I study, we evaluate the safety and tolerability of URLC10-177, TTK-567 and different doses of CpG7909 to determine the recommended phase II dose of CpG7909.

phase II: Patients will be vaccinated on day 1,8,15 and 22 of each 28-day treatment cycles. On each vaccination day, the URLC10-117 peptide(1mg) and TTK-567 peptide(1mg) mixed with CpG 7909 (recommended dose determined in phase I study) emulsified with Montanide ISA 51 will be administered by subcutaneous injection. Repeated cycles of vaccine will be administered for 2 cycles. In this phase II study, we evaluate the efficacy of this vaccine therapy.

Eligibility Criteria:
Inclusion Criteria:

DISEASE CHARACTERISTICS

1. locally advanced or metastatic esophageal cancer precluding curative surgical resection and recurrent esophageal cancer
2. measurable disease by CT scan

PATIENT CHARACTERISTICS

1. ECOG performance status 0-1
2. Life expectancy \> 3 months
3. Laboratory values as follows

   * 2000/mm3 \< WBC \< 15000/mm3
   * Platelet count \> 75000/mm3
   * Aspartate transaminase \< 150 IU/L
   * Alanine transaminase \< 150 IU/L
   * Creatinine \< 2.0 mg/dl
4. HLA-A\*2402
5. Able and willing to give valid written informed consent

Exclusion Criteria:

1. Pregnancy(woman of childbearing potential:Refusal or inability to use effective means of contraception)
2. Breastfeeding
3. Active or uncontrolled infection
4. Concurrent treatment with steroids or immunosuppressing agent
5. Prior chemotherapy,radiation therapy, or immunotherapy within 4 weeks
6. Clinically significant heart disease
7. Decision of unsuitableness by principal investigator or physician-in-charge
Advanced Radiotherapy (ART) in Gynecological Cancer Patients (GYN-ART)

This is an observational mono-institutional study. Patients with gynecologic tumors treated with advanced radiotherapy- Image Guided Radiotherapy (IGRT), Intensity Modulated Radiotherapy (IMRT), Stereotactic Body Radiotherapy (SBRT)- will be included and toxicity and outcomes analyzed.

The patients with gynecological cancer treated with Advanced Radiotherapy (ART)- Image Guided Radiotherapy (IGRT), Intensity Modulated Radiotherapy (IMRT), Stereotactic Body Radiotherapy (SBRT)- at the Department of Radiotherapy of "IRCCS San Raffaele Scientific Institute" (IRCCSSRaffaele) from January 2005 to January 2024 will be identified and their clinical and dosimetric data retrieved and analyzed.

The study objectives are the analysis of acute and late toxicity, and clinical outcomes, such as local, regional and distant control,disease free survival, cancer-specific survival, and overall survival. Secondary objective is the identification of prognostic factors for toxicity, disease progression, survival, including radiomic characteristics.

Eligibility Criteria:
Inclusion Criteria:

* gynecologic cancer patients
* \>18 years old
* treated with advanced radiotherapy techniques (IGRT, IMRT, SBRT)

Exclusion Criteria:

* other tumors
* \> 90 years old
Bridging Brain Structure and Function by Correlating Structural Connectivity, Cortico-Cortical Transmission and Direct Electro-Stimulation

Elucidating the structure-function relationship of the brain is one of the main open questions in neuroscience. The capabilities of diffusion MRI-based (dMRI) techniques to quantify the connectivity strength between brain areas, namely structural connectivity (SC), in combination with modalities such as electroencephalography (EEG) to quantify brain function have enabled advances in this field. However, so far the actual relationship between SC measures and measures of information transport between neuronal patches has not been determined. In this project, we aim to establish a relationship between dMRI SC measures, direct measures of electrical properties of the human brain cortex obtained with electrocorticography (ECoG), and response elicited by direct electrostimulation of the brain (DES). Ten patients operated on awake surgery for brain tumor removal will be included. First, a dMRI will be acquired prior to the surgery, in order to extract SC indices through probabilistic tractography. Then, intrasurgical cortico-cortical electrical measures will be obtained by ECoG electrodes positioned on the predefined cortical terminations of the designated bundles. These measures will be correlated to functional responses obtained during the cortical cartography, following the common DES procedure. The results of this multi-modal approach combining structure and function explorations of the brain should help to elucidate the relationship between non-invasive (dMRI) SC measures and cortico-cortical transmission properties (delays, transfer functions), and should boost the understanding of cognitive function as well as neurosurgical planning for the treatment of pathologies such as brain tumor resection and drug-resistant epilepsy.


Eligibility Criteria:
Inclusion Criteria:

* Patient eligible at an awake surgery for a brain tumor resection
* Informed consent of the patient

Exclusion Criteria:

* Contraindication to MRI
* Withdrawal of the patient's consent
Clinical Significance of Computer Aided Image Analysis in Treatment Response Evaluation of Lung Cancer

The investigators will evaluate the utility of computer aided image analysis in lung cancer with the aim of predicting treatment response and prognosis.

Tumor biological behavior is the fundamental cause of heterogeneous prognosis. The features found on medical images are also reflections of the tumor biological behavior. However, the limitations in spatial and intensity resolution of the naked eye are two inevitable shortcomings of image interpretation by naked eyes, resulting in subjective and limited analyses of images. Computer aided image analyses such as radiomic analysis and machine learning methods are emerging as promising image interpretation methods. The natural advantage of the unlimited spatial and intensity resolution of computers can overcome the shortcomings of visual inspection with the naked eye. Moreover, the massive computing power of computer is also far greater than that of humans. This study will focus on the application of computer aided analysis in predicting treatment response and prognosis in lung cancer.

Eligibility Criteria:
Inclusion Criteria:

1. Patients \>= 18 years old
2. Pathological diagnosis of NSCLC between 2012 and 2019;
3. PET/CT or CT examination before any cancer-specific treatment;

Exclusion Criteria:

1. A time interval between treatment and image examination greater than 1 month;
2. A history of other malignancies
Topo-pachimetric Accelerated Epi-On Cross-linking Compared to Dresden Protocol Using Riboflavin With Vitamin E TPGS

In the present study the investigators compare the clinical outcome corneal cross linking with either the stand-ard Dresden (sCXL) or the accelerated custom-fast (aCFXL) ultraviolet A irradiation protocol using riboflavin-D-α-Tocopheryl polyethyleneglycol1000 succinate for progressive keratoconus.


Eligibility Criteria:
Inclusion Criteria:

* documented progressive keratoconus
* changes in uncorrected distance visual acuity (UDVA) above 1.00 D
* Corrected distance visual acuity (BCVA) above 1.00 D
* spherical equivalent greater than 0.50 D

Exclusion Criteria:

* Corneal pachymetry of less than 400 µm
* less than 2000 cells/cm2,
* corneal scarring,
* nystagmus or any motility disorder that prevented a fixed gaze during the examination
* Current contact lens use
The Development of an Eating Laboratory for Overweight Adolescents

The purpose of the study is to develop methods to evaluate the eating behavior of adolescents, including overweight, normal weight, and candidates for adolescent bariatric surgery.

The purpose of this study is to examine the eating behavior, meal-related perceptions and meal-related hormones in overweight adolescents, normal weight adolescents and overweight adolescents who are undergoing bariatric surgery. Subjects will be asked to consume a single-item breakfast meal of a fixed amount (Ensure) and a multiple-item meal from a luncheon buffet. During the single-item meal, subjects will fill out questionnaires assessing subjective responses to the meal (e.g. hunger, fullness, pleasantness) and blood samples will be taken before, during, and after the meal to assess hormonal responses to the meal. The multiple-item meal will permit an assessment of total caloric consumption, food and macronutrient choice and rate of eating. Overweight adolescents undergoing bariatric surgery will be asked to do the meal studies 1 to 3 months before and 3 to 6 months after their surgery. Some bariatric surgery patients will only be studied after their after their surgery.

The data gathered from these pilot subjects will be used to further develop and refine our future studies on assessing eating behavior in overweight adolescents.

Eligibility Criteria:
Inclusion Criteria:

* BMI Index Enrollment in bariatric surgery program Ages 12-18

Exclusion Criteria:

* Pervasive developmental or psychological disorder Current use of weight loss medication Clinically significant medical condition Pregnancy Food allergy to single-item meal
Epidemiology of Sleep Disordered Breathing in Children

To collect fundamental data regarding the distribution of measures of sleep disordered breathing (SDB) in a pediatric population, prevalence of clinically significant SDB in children, risk factors, and associated co-morbidity.

BACKGROUND:

Developing strategies for recognizing and treating children with Sleep Disordered Breathing (SDB) was not possible in the absence of essential epidemiological data that addressed the distribution of measures of SDB in pediatric populations. The potential public health importance of this was underscored by preliminary data that suggested that risk of SDB was increased in susceptible populations, in particular in African Americans and in children born prematurely.

DESIGN NARRATIVE:

The design was that of a cohort study with a nested case control arm. Sleep disordered breathing was evaluated in 850 children with in-home state-of-the art respiratory monitoring techniques. A number of risk factors were evaluated: sociodemographic characteristics; anthropometry; upper and lower airway size and function (questionnaire, spirometry, and reflectometry); perinatal exposures (from neonatal records); family history; and home environment (passive smoking; sleep patterns, maternal-child stress indices). Behavior, cognitive skills, attention, and health-related quality of life were assessed with standardized instruments to assess co-morbidities (potential SDB outcomes). Analysis of the longitudinal data provided cognitive-developmental trajectories that were evaluated in relationship to SDB. The case-control arm confirmed and extended the findings of the in-home assessments with comprehensive laboratory polysomnography, cephalometry, and objective measures of sleepiness (Multiple Sleep Latency Tests) in three groups of children: definite SDB by home assessment; equivocal SDB; and no SDB. Collection of comprehensive polysomnographic data helped to identify which measures best discriminated symptomatic (e.g., snoring, sleepy) from asymptomatic children.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Retrospective Real-Life Study From One Brazilian Reference Center Assessing Long-Term Experience In The Treatment Of Adult Spasticity With AbobotulinumtoxinA

The aim of the study is to describe the long-term use of abobotulinumtoxinA (Dysport®) in adult subjects affected with upper limb spasticity (ULS) +/- lower limb spasticity (LLS) who received treatment with Dysport® for a minimum of three injections cycles at the Instituto de Medicina Física e Reabilitação do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (IMREA HC FMUSP) in Brazil.


Eligibility Criteria:
Inclusion Criteria:

* Adult aged ≥18 years old at the time of the first Dysport® injection
* Diagnosed with spasticity
* Treated with a minimum of three Dysport® injection cycles for ULS +/- LLS in the observational period
* Follow up effectiveness data are available in the subject's medical record

Exclusion Criteria:

* Patients have received previous treatment with another BoNT-A less than 12 weeks prior to the patient data collection in the study
* Adults with cerebral palsy
* Patients treated with BoNT-A in a clinical trial setting
Professional Quality of Life in German Mental Health Nursing

The purpose of this study is to assess professional quality of life in German nurses working with patients with mental disorders.

The purpose of this study is to assess professional quality of life, which includes compassion satisfaction, burnout and secondary traumatization in nurses, working with patients with mental disorders, in Germany.

Eligibility Criteria:
Inclusion Criteria:

* Nurse
* Currently working with patients with mental disorders
* At least 18 years old
* Sufficient German skills for answering the questionnaire

Exclusion Criteria:

None
Trial of Cognitive Behavioral Therapy to Reduce Antiretroviral Therapy Side Effects

The hypothesis is that participants in the intervention group will experience fewer/less intense side effects from anti-HIV medications, if they receive training sessions on the use of guided imagery, relaxation, and reframing of the medication-taking experience. Such training is not part of the usual care of HIV patients.

HIV patients on antiretroviral medications, who are suffering from pain, nausea, anxiety, or fatigue will be randomly assigned to either the usual care for an HIV patient, which is an educational program about the medications, or an intervention program, which includes both the educational program and three sessions with a psychologist. The sessions will help participants understand their concerns about the medications and will teach relaxation techniques and guided imagery to help participants reduce discomforts associated with the medications. All patients will continue to receive the usual care from their medical providers. The main measures are the measured frequency and intensity of the symptoms under study; secondary measures examine medication adherence, CD4 counts, and virus levels. Control measures include the number of doses of side effect medications taken in each group, and the number of relaxation/imagery sessions practiced privately by participants in the intervention group.

Eligibility Criteria:
Inclusion Criteria:

* Participants currently taking antiretroviral medications for HIV
* Participants suffer from one or more: nausea, pain, fatigue, anxiety

Exclusion Criteria:

* Non-English speaking/reading
* Pregnant or planning to become pregnant within 3 months
* Any severe health problem that would prevent participation (e.g., opportunistic infection requiring hospitalization)
* Substance abuse preventing active participation in care
AZD7325 Single Ascending Dose Study in Healthy Male Japanese Subjects

This is a Phase I randomized double-blind, placebo-controlled, single centre study to assess the safety, tolerability and pharmacokinetics of AZD7325 following single ascending dose administration to healthy male Japanese volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) : 18 to 27 kg/m 2

Exclusion Criteria:

* Clinically relevant disease and/or abnormalities (past or present)
* Clinically relevant abnormalities in physical examinations,vital signs,clinical chemistry, hematology or urinalysis at screening as judged by the investigator
* Use of any medication or herbal preparation within 14 days of Study day 1 through the Follow-up Visit other than paracetamol (up to 3 g/day)
* Smoking in excess of 5 cigarettes per day or the equivalent within 28 days prior to the first study day or inability to refrain from smoking during the study confinement period
Collect Clinical Data in Chinese Patients Received CUBICIN Treatment for Actual Usage in Clinical Practice

This is a Multicenter, observational, non-interventional registry designed to collect clinical data in Chinese patients who have received CUBICIN treatment under condition of actual usage in clinical practice.

MC MD

Eligibility Criteria:
Inclusion Criteria:

* Patient has received CUBICIN treatment, decided by treating physician
* A patient who is considered as ethnic Chinese
* Provision of subject informed consent

Exclusion Criteria:

* A patient record will not be eligible for the registry database if the patient received CUBICIN as part of a controlled clinical study for the current infection episode.
Wheelchair Positioning and Pain in Neuromuscular Patients

A retrospective study with the patients having a positioning consultation at hospital, between 2009 and 2014. In every neuromuscular disorder, the investigators describe the population seen in consultation, the aim of consultation, the postural problem observed in wheelchair, pain when sitting in wheelchair, and pressure ulcer.

Postural problem is described with MCPAA (Measure of Postural Control in Sitting Position, created by B. GAGNON, physiotherapist in Quebec) : we look at pelvic obliquity, pelvic rotation, pelvic anteversion or retroversion, trunk slope and rotation, kyphotic or scoliotic posture, neck posture and legs posture. We evaluate if these deformities are soft, moderate or severe, and if they are relievable

Eligibility Criteria:
Inclusion Criteria:

* Adult patient with neuromuscular disorder
* using wheelchair
* Patient having a positioning consultation in GARCHES Hospital

Exclusion Criteria:

* refusal to participate to the protocol
* pregnancy
Quantifying Effects of Treatment of Pediatric Dysphonia

The diagnosis and management of childhood dysphonia is a significant clinical problem; however, there have been few studies aimed at defining standard assessment methods for pediatric dysphonia. Accordingly, pediatric dysphonia is difficult to diagnose and it is difficult to quantify change following treatment. The long-term goal of this research program is to develop valid, responsive, reliable, and age-appropriate methods for assessing vocal pathology in children. In the present small grant, our objective is to define assessment methods that are appropriate for use in determining response to treatment. Our main focus, therefore, is the issue of assessment responsivity. The first specific aim is to develop a set of responsive measures of vocal pathology in school-aged children by inducing short-term change in vocal status via behavioral and medical management of extraesophageal reflux disease (EERD). Because we are treating children suspected of EERD, this study also presents the opportunity for examining the benefits of combined vocal hygiene and medical management in the treatment of pediatric EERD. Accordingly, our second specific aim is to determine predictive criteria for improvement in vocal status in dysphonic children suspected of EERD. Our hypothesis is that a particular set of measurements will emerge as particularly responsive to change in vocal pathology in this population, and will allow for informed prediction of degree of improvement with treatment. The proposed research is significant in filling a gap in knowledge in childhood dysphonia assessment and treatment, which are important clinical issues consistent with the mission and intent of the NIDCD. Because phonatory disorders in children may have lasting negative effects, studies geared toward accurate assessment and treatment are very important.


Eligibility Criteria:
Inclusion Criteria:

* chronic dysphonia with suspected extraesophageal reflux

Exclusion Criteria:

* previous reflux treatment.
* laryngeal disorder treated primarily with surgery
Study on Disease Characteristics and Treatment in Locally Advanced or Recurrent / Metastatic Cervical Cancer in Italy

Multicenter, Observational, Retrospective charts review. Observational study with descriptive purpose only. Retrospective data capture in consecutive patients diagnosed with CC who attended the Oncologic Clinics from Jan 2018 to Dec 2021 (using medical records, either electronic or not), inserted in eCRF and analyzed.

This is a multicenter, observational, retrospective study. The primary aim of this trial is to describe patients and disease characteristics, as well as treatment pattern of locally advanced and recurrent/metastatic cervical cancer (R/M and LACC) in Italy, through a retrospective data capture, from January 2018 to December 2021.

Eligible cervical cancer patients will be identified by reviewing medical records and physician notes (paper or electronic).

Disease will be defined as follow:

* Locally advanced cervical cancer: a large tumour within the cervix (more than 4cm) or it has grown into the tissues around the cervix, but the cancer has not spread to other organs; usually includes stage 2B, 3 and 4A (FIGO staging)
* Recurrent cervical cancer: local tumour regrowth or development of distant metastasis discovered 6 months or more after complete regression of the treatment (26)
* Metastatic cervical cancer: cancer spreads beyond the pelvis to other parts of the body; usually defined as stage 4B (FIGO staging) Moreover, the patients' characteristics will be stratified as low risk and high risk for locally advanced cervical cancer and differences between their treatment partners will be reported.

Eligibility Criteria:
Inclusion Criteria:

* Patient (or their legally acceptable representatives) must have signed and dated the Informed Consent \& Privacy Form (ICF)
* Age ≥18 years
* Diagnosis of a cervical cancer
* Locally advanced stage (not suitable for curative surgery) or recurrent or metastatic disease
* Any treatment received between January 2018 and December 2021 for advanced disease

Exclusion Criteria:

* Patients participating in a pharmacological clinical trial for the treatment of advanced disease
* Patients who participated in a clinical trial
* Patients who were administered with Pembrolizumab, Olaparib or Levantinib or medications from these class of drugs