cyrilzakka/clinical-trials huggingface dataset:
Effects of Standard Treatment of Acute Coronary Syndromes on Macrophage Activity as Measured by Serum Neopterin

This is a prospective observational study focused on monitoring the effects of various treatment options for acute coronary syndrome (ACS) patients by measuring serum neopterin levels. Serum neopterin is a marker for measuring macrophage activation. Prior studies have illustrated that there are elevated serum neopterin levels in ACS. Patients enrolled are those with ACS. Blood samples are drawn at presentation, and at 72 hours after admission, or at office visits and at 72 hours later. Neopterin levels are measured via a commercially available assay..

The study is a prospective observational study focused on monitoring the effects of various treatment options for acute coronary syndrome (ACS) patients by measuring serum neopterin levels. Serum neopterin is a marker for measuring macrophage activation. Prior studies have illustrated that there are elevated serum neopterin levels in ACS. The investigators' study focused on comparing different treatment arms with regard to their neopterin levels and correlating neopterin levels to the Thrombolysis in Myocardial Infarction (TIMI) risk score. Patients enrolled are those with ACS. Blood samples are drawn at presentation, and at 72 hours after admission, or at office visits and at 72 hours later. Neopterin levels are measured via a commercially available assay.

Eligibility Criteria:
Inclusion Criteria:

* Chest pain and either ST segment elevation or depression \> 0.1 mV in at least 2 contiguous electrocardiographic leads as well as elevation in troponin levels.

Exclusion Criteria:

* History of medical conditions known to alter neopterin concentrations in blood. The exclusion criteria includes:

  * renal failure,
  * history of HIV,
  * transplant patients,
  * active infections,
  * history of autoimmune disease,
  * malignancy,
  * phenylketonuria,
  * immune mediated liver disease, and
  * patients taking immunomodulating therapy.
Relationship Between Circulating Tumor Cell Cultures' Treatment Response and Clinical Outcomes

The purpose of this prospective, non-randomized, single-center pilot exploratory study is to investigate whether established circulating tumor cell (CTC) cultures have a similar response to targeted therapy treatment as the in vivo (patients') disease.

This study will isolate circulating tumor cells (CTCs) from blood samples taken from patients with liver and/or lung metastases who will receive systemic treatments. The CTCs will be cultured and given the same treatment as the patient received. The main goals of this project are 1) to assess CTC cultures' treatment response and compare the in vitro response to the clinical response, and 2) determine the sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of CTC cultures' response in predicting clinical response including complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD).

Eligibility Criteria:
Inclusion Criteria:

* Patients with a metastatic solid tumor malignancy with either liver and/or lung metastasis. Patients with newly diagnosed metastatic disease who have not had systemic therapy or are progressing on systemic therapy fitting one of the following cohorts:

  * Patients had a tumor or liquid biopsy with molecular analysis (genomic analysis or other type of molecular characterization) resulting in a therapeutic target with planned targeted therapy by the patient's treating physician.
  * Gastric cancer patients who have failed the first and second line chemotherapy.
  * Bladder cancer patients (with liver and/or lung metastasis) who will receive systemic treatment.
* Scheduled to initiate systemic treatment for management of their disease. The systemic treatment will be either cytotoxic chemotherapy or targeted therapy but not checkpoint inhibitor immunotherapy.
* ≥18 years of age
* Written informed consent obtained and signed
* Able to have blood collection without excessive difficulty

Exclusion Criteria:

* Patient unwilling or unable to complete informed consent
* Currently pregnant or lactating women
* Physical or psychological inability to complete sample collection for any reason including but not limited to: inability to tolerate any study procedures, any physical limitation that would undermine the safety of the subject in the study, or any psychiatric or neurological condition that inhibits full comprehension of study requirements and inability to complete informed consent, as determined by treating physician
MRI T1 Relaxation Time in Rectal Cancer

The goal of this observational study is to learn about the T1 relaxation time and T1 relaxation time properties of the disease in people with locally advanced rectal cancer. The main question it aims to answer is:

Does MRI T1 relaxation time have a high diagnostic performance in recognizing fibrosis as a complete response to neoadjuvant treatment of rectal cancer?

Participants will receive standard neoadjuvant treatment and be part of the standard examination programme regarding rectal cancer.


Eligibility Criteria:
Inclusion Criteria:

* rectal cancer, age \>18 years

Exclusion Criteria:

* contraindications for MRI (pacemaker, claustrophobia, implanted medical injectors and nerve stimulators),
* previous radiochemotherapy or another disease which investigator judges inappropriate for the persons continued participation.
An Internet-Based Education Program for Care Partners of People Living With Dementia

With the aging population, the prevalence of dementia is increasing dramatically. People living with dementia are highly dependent on family care partners, who may have little knowledge of the disorder. National and provincial guidelines have all highlighted the importance of online resources to improve care partner education; however, very few have been widely implemented or rigorously studied.

The investigators have developed the award-winning dementia education platform to complement traditional patient and family educational approaches. It allows free access to multimedia e-learning lessons, live expert webinars, and email-based content that care partners can access any time, anywhere.

In a pilot randomized controlled trial (RCT), the investigators propose to study 1) the feasibility and care partner acceptance of the intervention and some of the study methods, and 2) the impact of the intervention on care partner self-efficacy, knowledge, and sense of burden.

This initiative has the potential to improve the quality, cost effectiveness, and efficiency of dementia care. The intervention could be easily scaled and spread both provincially and nationally to complement other dementia education methods, at a time when the prevalence of dementia is increasing and access to high quality internet-based interventions is essential.


Eligibility Criteria:
Inclusion Criteria:

1. they are a family and/or friend care partner of a person living with dementia,
2. they reside in Canada,
3. they are 18 years of age and over,
4. they have a good command of the English language,
5. they have access to email and internet,
6. they are comfortable using email and internet,
7. they have the ability to grant online informed consent, and
8. they complete online baseline assessments.

Exclusion Criteria:

1. they are a not family and/or friend care partner of a person living with dementia,
2. they do not reside in Canada,
3. they are not 18 years of age and over,
4. they do not have a good command of the English language,
5. they do not have access to email and internet,
6. they are not comfortable using email and internet,
7. they do not have the ability to grant online informed consent, and
8. they do not complete online baseline assessments.
The Effect of Percutaneous Superior Venae Cava Cannulation Clamping on Cerebral Near Infrared Spectroscopy in MICS

The use of minimally invasive cardiac surgery has progressed over the last 5-10 years to allow access to the heart through a small incision in the right chest. This avoids the use of a sternotomy incision through the bone in the front of the chest. The benefits of such an approach are cosmetic (smaller incision not easily visible) and faster recovery. The minimally invasive approach also eliminates the risk of sternal wound infection. Minimally invasive cardiac surgery however poses additional challenges; one of the biggest is access to the large blood vessels which need to be cannulated to allow the heart lung machine to function. In conventional surgery, these vessels are easily accessed as they are entering or leaving the heart. In minimally invasive surgery, the cannula are placed into easily accessible arteries and veins, traditionally the femoral vessels. These vessels are smaller than those by the heart and so require smaller cannula, which provide challenges to the heart lung machine. One way around this is to use more cannulae and so cannulation of a vein in the neck is also performed. This cannula however, has been associated with neck hematoma, tearing of the vein and blood loss. While placement of the cannula in the neck is routine at LHSC now, when this surgery was first performed here 10 years ago, it was done so without the neck cannula and with no injury to patients. The purpose of this study therefore, is to more rigorously study the effect of the neck cannula on heart lung bypass, and more specifically to see if oxygen delivery to the organs, and the brain in particular is sufficient to avoid hypoxia.


Eligibility Criteria:
Inclusion Criteria:

* 18-80 years of age
* Elective mitral valve repair or replacement.
* Scheduled to have minimally invasive approach (right thoracotomy)
* No contraindication to SVC line placement

Exclusion Criteria:

* Emergency surgery
Effect of Rhythmic Auditory Stimulation on Balance in Children With Cerebral Palsy.

To evaluate the effect of Rhythmic Auditory Stimulation (RAS) on balance in children with cerebral palsy.


Eligibility Criteria:
Inclusion Criteria:

* Patients with cerebral palsy at 7-15 years old with Gross motor function classification system 1-3.
* Patients can understand and follow to command.

Exclusion Criteria:

* Patients who received surgery/chemo-denervation injection/injury at spine/pelvic/lower extremities in last 6 months.
* Patients with intrathecal baclofen pump implantation.
* Patients with other signs and/or symptoms of neurological deficit that effect ability to ambulation.
Improving Quality of Life and Function for Older Cancer Patients Receiving Radiotherapy

This study is a first part of a larger project aiming at improving the following outcomes in older cancer patients receiving external beam radiation therapy (EBRT): quality of life, functioning and need for professional help (dependency). To achieve this, the investigators will develop and test a geriatric assessment (GA) with management (GAM) intervention targeting patients at risk of negative outcomes as defined. The problems and needs that older patients experience before, during and after EBRT are poorly described. Furthermore, although GA is the recommended approach to assess older cancer patients' vulnerability, very few studies have investigated its benefit and feasibility in a radiotherapy setting and there is no universal recipe for how an efficient GAM intervention should be applied in this setting. Before defining and testing an intervention, the investigators will therefore conduct an observational study addressing older patients \>= 65 years referred for either palliative or curative EBRT. The main objectives are to identify patients at risk for negative outcomes, and to test the feasibility of GA in the community service and at a radiotherapy department.

GA includes a systematic assessment of area where older people often have problems, i.e. assessment of comorbidity, medication, functional status and physical functioning, cognitive function, nutritional status, and depression. In this observational study, the assessment will be performed using well-established instruments and tests before start and after completion of radiotherapy. The patient will be followed-up by repeated assessments at week 2, 8 and 16 post treatment. Quality of life (QoL) questionnaires will be filled in by self-report at the same points in time. Follow-up data will also include information on the patients' use of health services (home-, nursing home and hospital care). Additionally available diagnostic CT scans will also be used for analyses of nutritional status and body composition. Eligible patients will be included at the Radiotherapy Unit, Innlandet Hospital Trust after having given written informed consent. A project nurse (cancer nurse) will perform the assessments at the Radiotherapy Unit, whereas follow-up assessments will be performed by community cancer nurses. All municipalities in the hospital catchment area are invited to participate in the study. The study will be conducted in co-operation with several national and international partners, including partners from the local municipalities

Eligibility Criteria:
Inclusion Criteria:

* Patients \>= 65 years of age
* histologically confirmed cancer diagnoses
* referred for palliative or curative EBRT
* living in the hospital catchment area, able to understand and fill in self-report questionnaires
* fluent in Norwegian (orally and in writing), provide written, informed consent

Exclusion Criteria:
Evaluation of the DIABEO System in Poorly Controlled DM1 or DM2 Patients Treated With a Basal-bolus Insulin Regimen

The aim of the TELESAGE study is to demonstrate

1. the superiority of follow up with the DIABEO system (software alone) versus usual follow up in terms of improvement in HbA1c after 1 year in DM1 or DM2 patients treated with a basal-bolus insulin regimen.
2. the superiority of follow up with the DIABEO system (software + telemonitoring) compared to usual follow up in terms of improvement in HbA1c after 1 year in DM1 or DM2 patients treated with a basal-bolus insulin regimen.

The DIABEO software alone is an electronic diary system incorporating an immediate automatic aid to calculating the insulin dose according to the prescription given by the doctor, and a data processing, automated analysis message and secure internet data transfer system.

The DIABEO software added by paramedical telemonitoring is the electronic diary combined with remote paramedical monitoring of data (telemeonitoring)


Eligibility Criteria:
Inclusion Criteria:

* Type 1 or type 2 diabetic patients
* Performing auto-glycaemic control (at least 2 glycemias a day)
* Treated with insulin by a basal-bolus regimen for at least 1 year and using the same method of administration for at least 3 months (insulin pen or pump)
* Who have an Apple® or Androïde® Smartphone compatible, or intend to acquire one before their participation in the study
* Whose HbA1c dating of less 1 month and more than 3 months is ≥ 8%
* Who are able to understand and follow the study protocol
* Who have given their signed consent to take part in the study
* Subject affiliated to the French National Health Insurance funds or benefiting from such insurance

Exclusion Criteria:

* Age \< 18 years old
* Patients who have used the DIABEO system within 6 months before inclusion
* Participation in a clinical study within 6 months, except for the Meos (or télédiab 3) study after a participation period of 6 months
* Patients who are pregnant or who wish to become pregnant during the study.
* Patients treated with human insulin A patient pre-screening register will be set up in each centre to establish the reasons for DM1/DM2 patients treated with a basal-bolus insulin regimen who are not taking part in the study.
The Pediatric Eating Assessment Tool

There is no dysphagia spesific and patient/parent centered outcome instrument in the pediatric population. The purpose of this investigation is to develop the Pediatric version of the Eating Assessment Tool (PEDI-EAT-10) and investigate its validity and reliability.

The evaluation of pediatric swallowing disorders includes clinical and instrumental techniques. The clinical evaluation is important for clinical decision-making and to assess the need for an instrumental evaluation of swallowing. A recent systematic review suggested that the currently available non-instrumental assessments for clinicians to evaluate swallowing and feeding function in the pediatric population have wide variations in design, assessment domains, and target groups. It was concluded that there is a significant need for standardized assessment tools with good psychometric properties in the pediatric population. The existing instruments measure the presence or absence and frequency of challenges related to eating/feeding problems in pediatrics, they do not comprehensively measure oropharyngeal phase swallowing problems or do not reflect the severity of oropharyngeal dysphagia symptoms. The 10-item Eating Assessment Tool (EAT-10), which was designed for adult patients, is a good model for this current research. It has proven highly successful in quantifying initial dysphagia symptom severity and in monitoring treatment efficacy in a vast array of dysphagia etiologies. Although the EAT-10 is a symptom survey, it has been able to predict objective evidence of swallowing dysfunction. There is no dysphagia spesific and patient/parent centered outcome instrument in the pediatric population such as the EAT-10. The purpose of this investigation is to develop the Pediatric version of the Eating Assessment Tool (PEDI-EAT-10) and investigate its validity and reliability.

Eligibility Criteria:
The inclusion criteria are:

* Age above 18 months,
* Fed orally,
* Referred due to parent complaints about their child's swallowing function,
* Not admitted a swallowing center before.

The exclusion criteria are:

* Age below 18 months,
* Fed nonorally,
* No parent complaints about their child's swallowing function,
* Admitted a swallowing center before.
Application of Hyperspectral Imaging Analysis Technology in the Diagnosis of Colorectal Cancer Based on Colonoscopic Biopsy

The purpose of this study is to develop and validate a deep learning algorithm for the diagnosis of colorectal cancer other colorectal disease by marking and analyzing the characteristics of hyperspectral images based on the pathological results of colonoscopic biopsy, so as to improve the objectiveness and intelligence of early colorectal cancer diagnosis.

Prospectively collect the hyperspectral image information of ordinary colonoscopic biopsy tissue. The colonoscopic biopsy tissue is from the Endoscopy Center of Qilu Hospital of Shandong University. The hyperspectral images are marked based on the biopsy pathological results, and the deep convolutional neural network (DCNN) model is used. With training and verification, develop the Hyperspectral Imaging Artificial Intelligence Diagnostic System (HSIAIDS) .A portion of colonoscopic biopsy tissue will be collected as a prospective test set to prospectively test the diagnostic performance of the HSIAIDS algorithm.

Eligibility Criteria:
Inclusion Criteria:

* patients aged 18-75 years who undergo the colonoscopy examination and biopsy

Exclusion Criteria:

* patients with severe cardiac, cerebral, pulmonary or renal dysfunction or psychiatric disorders who cannot participate in colonoscopy
* patients with previous surgical procedures on the gastrointestinal tract.
* patients with contraindications to biopsy
* patients who refuse to sign the informed consent form
Biomarker Directed Treatment in Metastatic Colorectal Cancer

This pilot study is being mounted to assess whether treatment assignment by ERCC-1 gene expression status suggests better clinical results from historical experience in metastatic colorectal cancer (mCRC). In wild type KRAS mCRC patients treated with either FOLFOX or FOLFIRI in combination with cetuximab the median response rate is approximately 60-65%. Biomarker directed treatment in this study may demonstrate that patients with low ERCC-1 treated with FOLFOX and cetuximab, and those with high ERCC-1 treated with FOLFIRI and cetuximab, will improve response rate to 70-75%. KRAS wild type patients will be treated with 6 cycles of one of the following regimens chosen for optimization based on patient characteristics (primary treatment phase). Patients with ERCC-1 \< 1.7 relative gene expression of ERCC-1 over ß-actin (ERCC-1 low) will be assigned to treatment with mFOLFOX6 in combination with Cetuximab. Patients with ERCC-1 gene expression \> 1.7 relative gene expression of ERCC-1 over over ß-actin (ERCC-1 high) will be assigned to treatment with FOLFIRI in combination with Cetuximab.


Eligibility Criteria:
Inclusion Criteria:

1.1 Inclusion criteria for pre-screening phase:

* Untreated advanced metastatic colorectal cancer patients
* Adequate tissue to evaluate for genotyping (10 x 10µm thick formalin fixed paraffin embedded tissue sections and one corresponding HE stained slide or a FFPE tumor block)

1.2 Inclusion criteria for treatment phase:

Patients must fulfill all criteria listed below prior to enrolment in the study:

* Untreated wild-type KRAS metastatic colorectal cancer
* Previous adjuvant therapy must have been completed \> 6 months before therapy initiation on this study
* Age \>18 years
* Measureable disease with CT or MRI
* ECOG performance status of 0-2
* Adequate organ function

  * Hematologic:

    * Absolute neutrophil count \> 1,500/µL
    * Hemoglobin \>9 mg/dl
    * Platelet count \>100,000 /µl
  * Renal:

    * Serum creatinine \<1.5 x Upper limit of normal (UPN) or estimated clearance \> 30 ml/min
  * Hepatic:

    * Serum bilirubin \< 1.5 mg/dl

Exclusion Criteria:

* Creatinine clearance below 30 ml/min
* Patients with a history of other malignancies within 2 years prior to study entry, except for adequately treated carcinoma in situ of the cervix; basal or squamous cell skin cancer; low grade, early stage localized prostate cancer treated surgically with curative intent; good prognosis DCIS of the breast treated with lumpectomy alone with curative intent.
* Patients with a history of severe cardiac disease; e.g. NYHA Functional Class III or IV heart failure, myocardial infarction within 6 months, ventricular tachyarrhythmias requiring ongoing treatment, or unstable angina.
* Other known co-morbidity with the potential to dominate survival
* Hypersensitivity with anaphylactic reaction to humanized monoclonal antibodies or any of the applied drugs
* Pregnant or breast feeding women
* Any co-existing medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent.