cyrilzakka/clinical-trials huggingface dataset:
Prediction of Stroke Risk in Patients with Atrial Fibrillation Based on Chest CT Images

This study aims to create and assess a deep learning framework for extracting left atrial appendage features in atrial fibrillation patients and combining them with clinical data to predict ischemic stroke risk. Clinical data and chest CT images from patients diagnosed with non-valvular atrial fibrillation will be collected. Patients will be categorized into stroke and non-stroke groups to build a data repository. The dataset will be divided into training and validation sets, with missing data handled and pulmonary vein CTV and virtual non-contrast images annotated. A deep learning model will be used for image segmentation and feature extraction to develop a prediction system.

This study aims to develop and evaluate a deep learning framework that can automatically extract imaging features of the left atrial appendage in patients with atrial fibrillation and combine them with clinical features to predict the risk of ischemic stroke in these patients. The study intends to retrospectively collect clinical data (including patients\&#39; general information, medical history, laboratory tests, etc.) and chest CT images, as well as pulmonary vein CTV images (if available), from patients diagnosed with non-valvular atrial fibrillation between January 2018 and June 2024. The patients will be divided into stroke and non-stroke groups based on whether they have experienced an ischemic stroke, and a data analysis repository will be established. The dataset will be split into training and validation sets. Missing data will be handled, and data labeling will be performed on the pulmonary vein CTV sequence images and virtual non-contrast (VNC) sequence images. The left atrial morphology will be delineated, and a deep learning-based image segmentation network model will be developed to extract and select radiomic features for the prediction system.

Eligibility Criteria:
Inclusion Criteria:

Diagnosed with atrial fibrillation by ECG, 24-hour Holter monitor, or recordable ECG monitor; atrial fibrillation confirmed by an implanted pacemaker or defibrillator, lasting at least 30 seconds Available chest CT images and complete clinical data.

Exclusion Criteria:

Incomplete clinical data or diagnosis of valvular atrial fibrillation (e.g., rheumatic heart valve disease, post-valve replacement) Poor-quality CT images that prevent complete assessment of left atrial appendage morphology Patients who have undergone left atrial appendage closure Patients who have had radiofrequency ablation or cardioversion with no evidence of recurrence post-procedure
Validation of a Tear-based Screening Assay for Breast Cancer

This study will explore and better understand the value, usage, and benefits of a tear-based screening test for breast cancer as a supplemental tool for screening mammograms. This tear-based screening test was developed and validated by Namida Lab, Inc., a high complexity Clinical Laboratory Improvement Amendments (CLIA) certified lab.

The primary objective of this study is to determine if a tear-based biological test is an effective option in breast cancer screening. This will be assessed by comparing the score and classification produced from the assay to the current gold standard, screening Mammograms.

The primary endpoint will be assessed by calculating the sensitivity, specificity, PPV, and NPV for the biological assay compared to the results of imaging.

The secondary objective of this study is to obtain provider insight and recommendation as to the potential clinical utility of a tear-based biological test as a breast cancer screening option.

The secondary endpoint will be achieved through a provider roundtable discussion. After completion of enrollment and evaluation of tear samples and time will be arranged, either in person or virtual, to review the test scores determined for the sites patient population. Providers will be allowed to verbally review the process and give their thoughts on the utility of a tear-based biological test within their clinic and how they feel it should be used. A member of the Namida Lab clinical team will be present to take notes. After the discussion a report will be generated and the site providers will be allowed to review it for accuracy. Sites will be given a copy of their participants' scores as well as a summary of the provider roundtable discussion. Sites may request to have the participants' results blinded if prior to review if preferred.

Eligibility Criteria:
Inclusion Criteria:

Female over the age of 18 Able to undergo the informed consent process Willingness to comply with all study procedures

Exclusion Criteria:

Currently diagnosed or are receiving treatment for breast cancer Have an active eye infection under 18 years of age
Music Therapy for Cancer Patients(Meraki_PC)

The overall aim of the study is to analyse the impact of a music therapy-based treatment on the emotional well-being and quality of life of cancer patients in palliative care (PC). To this end, the effectiveness and efficiency of a music therapy-based treatment to improve adaptation to illness and psychological well-being in this population will be validated and implemented.

Specifically, the implementation of an individualised treatment programme for palliative care patients will be carried out.


Eligibility Criteria:
Inclusion Criteria:

* The patient is receiving palliative care for an oncological diagnosis and was admitted to the hospital a week ago. They do not have moderate to severe cognitive impairment. This treatment is for oncological patients in an advanced stage who are receiving palliative anti-tumour treatment such as chemotherapy and/or radiotherapy. These patients require support treatment that cannot be provided at home due to their complexity. The patient is in an advanced or terminal phase of the disease according to WHO criteria.
* Be over 18 years of age.
* Have preserved cognitive ability (SPMSQ, Pfeiffer). More than 2 errors (3 in illiterate persons) would suggest the presence of cognitive impairment.
* Have signed the informed consent form
* Have completed at least 2 of the 3 treatment sessions and have completed the pre-test and post-test assessment.

Exclusion Criteria:

-Estimated survival time. Patients with a life expectancy of two weeks or less shall not be operated on.
The Caffeine, Postoperative Delirium, and Change in Outcomes After Surgery (CAPACHINOS-2) Study

The objective of this study is to test the effects of caffeine on neurocognitive and clinical recovery after major surgery. Specifically, this trial tests the primary hypothesis that caffeine will reduce the incidence of postoperative delirium.

Delirium is a syndrome characterized by failure of basic cognitive functions that affects approximately 20-50% of older surgical patients. Delirium during surgical recovery is associated with increased mortality, cognitive and functional decline, and prolonged hospitalization. In fact, 3-year survival rates for acutely hospitalized patients with delirium, and subsyndromal delirium, are both less than 50%. Older age is predictive of delirium after surgery, and with aging surgical populations, the incidence of postoperative delirium and related complications are likely to increase in the coming years.

Caffeine represents a novel, neurobiologically informed candidate intervention for reducing risk of early postoperative delirium. Caffeine promotes arousal via adenosine receptor antagonism and improves cognitive function concurrent with increased cortical cholinergic tone. Our preliminary data suggest that caffeine reduces risk of postanesthesia care unit (PACU) delirium in adult non-cardiac surgery patients by optimizing cortical dynamics for cognition. Caffeine also optimizes key neurocognitive processes that support information processing and may improve other, related aspects of clinical recovery, such as rebound headache in habitual caffeine users. The objective of this trial is to thus test the effects of caffeine on neurocognitive and clinical recovery after major surgery. Specifically, the primary hypothesis is that caffeine will reduce the incidence of postoperative delirium. The secondary objectives are to (1) test whether caffeine positively impacts the quality of postoperative recovery via validated patient-reported measures and (2) identify neural correlates of delirium and Mild Cognitive Impairment via advanced electroencephalographic (EEG) analysis.

Eligibility Criteria:
Inclusion Criteria:

1. Adult (\>/= 70 years old) undergoing non-cardiac, non-intracranial neurologic, non-major vascular surgery requiring general anesthesia with a planned admission for at least 48 hours.
2. Stated willingness to comply with all study procedures and availability for the duration of the study.
3. Provision of signed and dated informed consent form.

Exclusion Criteria:

1. Emergency surgery
2. Outpatient surgery
3. Severe cognitive impairment precluding the capacity for informed consent
4. Seizure disorder history
5. Intolerance or allergy to caffeine (based on subjective reporting or objective documentation)
6. Weight \>130 kg (as a 3 mg/kg dose would approach the upper limit of daily intake recommended by the FDA)
7. Enrollment in conflicting research study
8. Patients in acute liver failure
9. Acute kidney injury preoperatively
10. Diagnosis of pheochromocytoma
11. Severe audiovisual impairment
12. Non-English speaking
Effect of QVA149 (Indacaterol Maleate/Glycopyrronium Bromide) on Cardiac Function in COPD Patients

This mechanistic study is a single-center, randomized, double-blind, placebo-controlled, cross-over study to evaluate the effect of dual bronchodilation with QVA149 on cardiac and lung function parameters in hyperinflated COPD patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients with airflow limitation indicated by a post-bronchodilator FEV1 \<80% of the predicted normal value and a post-bronchodilator FEV1/FVC\<0.7
* Current or ex-smokers who have a smoking history of at least 10 pack years.
* Able and willing to give written informed consent
* Hyperinflated patients with RVol\>135% predicted

Exclusion Criteria:

* Patients on LABA or LAMA treatment at Visit 1.
* History of one COPD exacerbation that required treatment with antibiotics, systemic steroids (oral or intravenous) or hospitalization 3 months prior to Visit 2.
* More than one COPD exacerbation that required treatment with antibiotics, systemic steroids (oral or intravenous) or hospitalization within 6 months prior to Visit 2.
* Patients who have clinically significant cardiovascular abnormalities, which could interfere with the assessment of the study treatment (such as but not limited to cardiac arrhythmias, heart failure with left ventricular ejection fraction \<40% as determined by MRI scan, unstable ischemic heart disease, NYHA Class III/IV left ventricular failure, history of myocardial infarction 6 months prior to Visit 2)
* Patients with a known history or current atrial fibrillation to be confirmed by ECG.
* Patients with pacemaker, bypass or stent.
* Patients whose QTcF measured at Visit 3 is \>450 ms for males and \>470 ms for females

Additional study-specific inclusion and exclusion criteria may apply
Salvage Therapy With Chemotherapy and Natural Killer Cells in Relapsed/Refractory Paediatric T Cell Lymphoblastic Leukaemia and Lymphoma

To determine safety profile of immunotherapy with natural killer cells and activated expanded (NKAEs) after salvage chemotherapy in relapsed/refractory paediatric T cell lymphoblastic leukaemia and lymphoma.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged between 0 and 21 years with relapsed or refractary acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma.
* Lansky Index \> 60%.
* Left ventricular ejection fraction \> 39%.
* Negative HIV serology.
* Provide informed consent in accordance with current legislation.

Exclusion Criteria:

* Patients with a history of poor compliance.
* Patients not valid after psycho-social evaluation
* Severe (4) functional organ disorders (hepatic, renal, respiratory) according to NCI CTCAE v3 criteria
Study of MK0476 (Montelukast Sodium) and Effects on Asthma and Nasal Symptoms Upon Exposure to Cats (0476-256)

The purpose of this study is to determine the protective effect of an approved medication on asthma and allergic rhinitis (inflammation of the mucous membrane of the nose) upon exposure to cats.

The duration of treatment is 2 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Increased sensitivity to cat allergen proven by positive allergy testing, and by decreased lung function and increased symptoms of allergic rhinitis (runny nose) upon exposure to cats.

Exclusion Criteria:

* Medical history of a lung disorder (other than asthma) or a recent upper respiratory tract infection.
Tundra Gifts: Harvesting Local And Regional Resources To Prevent Obesity Among Alaska Native Children In Remote, Underserved Communities

The long-term goal of this community based participatory research project is to prevent obesity in 3-5 year old Alaska Native children in remote communities.

Investigators will design and evaluate a culturally responsive, home-focused intervention, Tundra Gifts, that links early childhood education programming (i.e. Head Start) and federal food assistance programs (i.e. WIC and SNAP) with primary caregivers to support healthy eating and an active lifestyle using a cluster-randomized design. The intervention integrates behavior change theory with Indigenous traditional knowledge. Primary caregivers will attend monthly interactive education session, receive a monthly gift basket that includes resources and supplies to support behavior change at home and receive ongoing social support through a Facebook site. Investigators will also evaluate key process indicators of Tundra Gifts to understand the impact on outcomes of variations in persons and settings and to enhance the generalizability of findings.


Eligibility Criteria:
Inclusion Criteria:

* 3-5 year old children enrolled in Head Start and their primary caregiver in Yup'ik Alaska Native communities
Evaluation of Interventions to Prevent Suicide of Medical Students Through the School-Based Social Support System

The purpose of this study is to determine whether school-based social support systems are effective in preventing suicide in medical students.


Eligibility Criteria:
Inclusion Criteria:

* Medical university students Grades 1 through 2

Exclusion Criteria:

* Psychopath
Comparing Asthma Action Plans for Pediatric Asthma

The purpose of this study is to evaluate and compare the relative effectiveness of two asthma action plans (pictorial versus written) in terms of asthma action plan knowledge, medication use, and family satisfaction with asthma education.

Asthma medical regimens are complex for families, requiring changes in the types and amounts of medication based on the frequency and intensity of symptoms. Written asthma action plans (AAP's) are commonly used to provide a set of instructions to help parents and children implement these complicated regimens. However, written AAP's require substantial literacy levels, so for younger children, low-literacy families, or non-English speaking families, a pictorial version of the AAP may be more understandable and useful. The study aims to validate a newly developed, fully pictorial AAP in terms of its relative impact on parent- and child-reported knowledge of the action plan, medication use, and parent- and child-reported satisfaction, when compared to a standard-care written AAP.

Eligibility Criteria:
Inclusion Criteria:

* Children who are new patients
* Receive a diagnosis of persistent asthma
* Are in need of an asthma action plan

Exclusion Criteria:

* Diagnosed with intermittent asthma
* An established patient who already has an asthma action plan
* Not English or Spanish speaking
Trial of 2nd Generation Anti-CEA Designer T Cells in Metastatic Breast Cancer

The purpose of this study is to collect data on the safety and effectiveness of 2nd generation designer T cells in patients with breast cancer. Designer T cells are prepared by collecting white blood cells from the participant, and then modifying these cells in the laboratory so that they recognize the tumor antigen (CEA). These modified cells are then given back to the participant so that they can attack and kill tumor cells.

T cells can penetrate virtually every biologic space and have the power to dispose of normal or malignant cells as seen in viral and autoimmune diseases and in the rare spontaneous remissions of cancer. However, T cells are easily tolerized to self or tumor antigens and "immune surveillance" has manifestly failed in every cancer that is clinically apparent. It is the goal of this study to supply the specificities and affinities to patient T cells without regard for their "endogenous" T cell receptor repertoire, directed by antibody-defined recognition to kill malignant cells based on their expression of antigen. We will achieve this by preparing chimeric IgCD28TCR genes in mammalian expression vectors to yield "designer T cells" from normal patient cells. Prior studies in model systems demonstrated that recombinant IgCD28TCR could direct modified T cells to respond to antigen targets with IL2 secretion, cellular proliferation, and cytotoxicity, the hallmarks of an effective, self-sustaining immune response.

It therefore becomes of paramount interest to extend these studies to a human system of widespread clinical relevance to explore the clinical potential of this new technology. The target antigen for these studies is carcinoembryonic antigen (CEA), which is prominently expressed on tumors of the stomach, colon and rectum, breast, pancreas and other sites.

For the Phase Ia component, patients receive a single dose of gene-modified autologous T cells on this dose-escalation trial. Doses are 10\^9 and 10\^10 modified T cells. Patients are monitored for safety and response. Patients are on-study for one month after dosing.

For the Phase Ib component, patients receive a fixed dose of gene-modified T cells (10\^11 cells), randomized to receive T cell growth factor interleukin 2 (+IL2) \[Experimental\] or not (-IL2) \[Control\]. The IL2 is administered outpatient by continuous infusion for a two-week period. On Day +2 and Day +10, the patient's tumor is biopsied to assess the designer T cell presence in the tumor as a means of judging the benefit of added IL2. Patients will also be followed for tumor response.

Eligibility Criteria:
Inclusion Criteria:

* Must have cancer of the breast
* Must have metastatic or unresectable locally advanced disease
* Tumor must express CEA by tumor staining or by elevated serum CEA (\>10 ng/ml)
* Must have measurable disease radiologically or by physical exam
* Must have failed potentially curative standard therapy
* Must be 18 years of age or older
* Good performance status (PS 0-1)

Exclusion Criteria:

* Requiring systemic steroids
* Serious medical conditions
* Concurrent malignancies
Effects of Beclometasone Dipropionate/Formoterol Fumarate Via NEXT(Haler) in a Real-world Study on Asthma Control

The goal of asthma management is to achieve and maintain optimal asthma control. The NEWTON study assesses the evolution over time of patient reported outcomes (PROs) in asthmatic patients, not adequately controlled with ongoing treatments and initiating therapy with extrafine beclometasone dipropionate/formoterol fumarate (BDP/FF) via NEXThaler.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients aged ≥18 years;
2. Patients enrolled on the same day as the first prescription with BDP/FF NEXThaler® 100/6 micrograms, or having ongoing treatment with BDP/FF NEXThaler® 100/6 micrograms started within the previous 14 days (maximum), as per local standard clinical practice.
3. Not adequately controlled asthmatic patients (according to clinician's judgement) when BDP/FF NEXThaler® 100/6 micrograms was prescribed;
4. Patients not treated with extrafine formulations during the 6 months before starting the treatment with BDP/FF NEXThaler®;
5. Written informed consent to participate in the study and for the processing of personal data.

Exclusion Criteria:

1. Recent (i.e. within the last 6 months) history of life-threatening asthma exacerbations;
2. Diagnosis of chronic obstructive pulmonary disease (COPD);
3. Asthmatic patients on treatment with biologic agents (e.g. monoclonal antibodies) and/or extemporary or fixed triple combinations (e.g. long-acting β2 agonist (LABA)/long-acting muscarinic antagonist (LAMA)/inhaled corticosteroid (ICS) at any dose regimen;
4. Patients with uncontrolled/clinically significant diseases (according to clinician's judgement) or inability to understand and fill in study questionnaires;
5. Concomitant participation in experimental clinical studies/investigations or participation in experimental clinical studies/investigations within 3 months prior to enrolment into the present study.
Total Infectome Characterization of Eye Infections

Multiple pathogens can cause eye infection. In recent years, emerging and resurging viral infections represent an important public health problem. Many emerging viruses cause infectious diseases involving ophthalmic manifestations, including Mpox virus, Zika, Ebola, and SARS-CoV-2. Broad and unbiased pathogen surveillance is essential, so we design this unbiased metagenomic sequencing based study to investigate the total infectome of eye infections. The study is historical and prospective in design.

This is an investigator-initiated observational study to describe the total infectome of eye infections using metagenomic sequencing. The eye infections, including acute conjunctivitis, keratitis, uveitis, and endophthalmitis, are diagnosed by experienced ophthalmologists according to routine clinical exams.

For the collection of additional biological samples apart from the diagnosis and treatment process, written informed consent is required from the eligible subjects or their legal guardians at the recruitment time is required. The application for exemption of informed consent has been made for using clinical surplus samples. After completing informed consent, subjects will be sampled, and their clinical information will be collected.

Biospecimens, including conjunctival sac swabs (1 swab for each involving eye), or intraocular fluid (more than 100μl), will be collected for metagenomic sequencing using the Illumina NovaSeq X Plus platform.

The clinical information of participants will be collated from electronic medical record information system, including (1) demographic characteristics: age, sex, comorbidities; (2) laboratory examination: blood routine test, immune inflammatory factors, clinical microbiology examination (PCR, serological examination, culture, etc.); (3) imaging examination: anterior segment photograph, corneal endothelial cell examination, corneal confocal microscopy, fundus photograph.

Meta-transcriptomic analysis of the ocular samples will be conducted to identify viruses, bacteria, fungi and parasites. The abundance of pathogens is indicated as the RPKM (i.e. Reads Per Million divided by the length of the reference genome, measured in kilobases).

Eligible participants will be recruited consecutively between August, 2024 and December, 2026 in Department of Ophthalmology, Shanghai General Hospital. The total study duration is expected to be two years from the first subject enrolled to the final analysis.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with a clinical diagnosis of one or more types of eye infections (including acute conjunctivitis, keratitis, uveitis, and endophthalmitis).
2. Biological samples has been collected for clinical microbiological examination, or consented to participate in this study.

Exclusion Criteria:

1. Patients who have no historically clinical surplus specimens.