cyrilzakka/clinical-trials huggingface dataset:
Tumor-Targeted-NIR-II Fluorescent Molecular Probes for the Identification of Breast Cancer Tissue and SLN Metastatic Status

Accurate evaluation of tumor boundaries in breast-conserving surgery is closely associated with reducing the second operation of patients. Meanwhile, accurately assessing sentinel lymph node (SLN) metastasis is crucial for determining the extent of axillary lymph node dissection (ALND) and minimizing complications. Near-infrared-II (NIR-II) fluorescence imaging using molecular agents has shown promise for in situ imaging during resection. However, very effective probes can be applied to clinical trials up to now, which limits the clinical application of fluorescence imaging. Here we developed a new technology that can quickly differentiation between cancer and para-cancer tissue as well as metastatic and normal sentinel lymph nodes(SLN). In brief, the fresh tissues were incubated with the probe immediately after intraoperative resection and imaged to identify the tumor area and distinguish the metastatic status of SLN. The accuracy of fluorescence imaging was confirmed by pathological diagnosis.

After enrollment, the patients received surgical treatment according to clinical diagnosis and treatment.During the operation, the excised breast tissue and SLN was incubated, and the specific procedure was as follows.

1. Preparation of the incubation solution: The probe was dissolved in phosphate buffer saline(PBS) buffer as the incubation solution at room temperature in the dark,with varying concentrations (12.5, 25, 50,100 ug/mL).
2. In vitro incubation of fresh breast cancer or SLN tissues: The fresh excision breast cancer and SLN tissues were completely soaked in the incubation solution for about 1,3, 5, 7 or 10 minutes, followed by 5 minutes rinse with PBST buffer (PBS with Tween 20) and drying with the use of absorbent paper.
3. Analysis of the images in the "Digital Precision Medicine(DPM)" NIR-II system. The DPM parameter was set up before scaling. Then fluorescence imaging was performed with the DPM NIR-II system. And the result was analyzed to identify the tumor area and distinguish the metastatic status of SLN.
4. Confirmed the diagnosis by pathological examination.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients between 18-75 years of age
* Female
* Patients presenting with a breast nodule or mass presumed to be resectable on pre-operative assessment
* Good operative candidate
* Subject capable of giving informed consent and participating in the process of consent

Exclusion Criteria:

* Patients unable to participate in the consent process
* Patients had contraindications to surgery, such as serious cardiopulmonary disease, coagulation dysfunction, etc
* Other conditions that the researcher considers inappropriate to participate in the study
Tamoxifen in Treating Women With Breast Cancer

RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using tamoxifen may fight breast cancer by blocking the uptake of estrogen by the tumor cells.

PURPOSE: Randomized phase III trial to compare the effectiveness of at least 2 years of tamoxifen with that of 5 additional years of tamoxifen in treating women who have breast cancer that has been surgically removed.

OBJECTIVES:

* Compare the disease-free and overall survival of women with early breast cancer who are randomized to discontinue adjuvant tamoxifen vs those randomized to continue for at least 5 additional years.

OUTLINE: This is a randomized study. Patients are stratified for analysis according to duration of tamoxifen given before randomization (2-3 years vs 4-5 years vs 6-7 years vs 8-9 years vs 10 years and over), age (less than 49 vs over 50), and important prognostic factors, including tumor type and grade and nodal and estrogen receptor status. Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients discontinue tamoxifen after at least 2 years of prior treatment.
* Arm II: Patients continue treatment with tamoxifen for at least 5 additional years in the absence of unacceptable toxicity or disease progression.

Patients are followed annually.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

PROJECTED ACCRUAL: A total of 8,000-20,000 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed breast carcinoma that has been completely excised

  * Clinically relapse free
* Must have completed at least two years of adjuvant therapy with tamoxifen for early breast cancer AND have no clear indication for or against receiving further tamoxifen
* No significant endometrial hyperplasia
* No patients with negligibly low risk of breast cancer death
* Hormone receptor status:

  * Any status allowed

PATIENT CHARACTERISTICS:

Age:

* Not specified

Sex:

* Female

Menopausal status:

* Any status allowed

Performance status:

* Not specified

Life expectancy:

* Not specified

Hematopoietic:

* Not specified

Hepatic:

* Not specified

Renal:

* Not specified

Other:

* No other life threatening disease
* No retinopathy
* No psychiatric disorder or other condition that would preclude study compliance
* No serious toxicity (e.g., depression) thought to be due to tamoxifen
* Not pregnant or nursing
* Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* Not specified

Endocrine therapy:

* See Disease Characteristics

Radiotherapy:

* Not specified

Surgery:

* See Disease Characteristics

Other:

* Any primary treatment allowed
School-Based Intervention to Increase Physical Activity Among Adolescent Females

Physical inactivity is a major public health problem in the United States. Research has shown that physical activity levels decline during adolescence, and the decline is greater in females than males. The purpose of this study is to evaluate a life-skills oriented physical activity intervention at increasing activity levels and decreasing cardiovascular risk factors in adolescent females.

Physical activity levels decline dramatically during adolescence, particularly among females, with the decline most apparent among African Americans. The health benefits of regular physical activity are well-known; individuals who are active have lower rates of obesity and less incidence of cardiovascular disease. Because physical activity behaviors often develop during childhood, it is important to develop programs specifically for adolescents to encourage them to adopt and maintain a physically active lifestyle. Unfortunately, few programs have been developed that specifically focus on adolescents, and the long-term effectiveness of these programs is unknown. This study will evaluate the effectiveness of a life-skills oriented Comprehensive Physical Activity Program (CAP) at increasing activity levels in adolescents. Participants in the CAP program will develop new behavioral skills, which will assist them to continue a physically active lifestyle once the program ends. The purpose of this study is to compare CAP versus a standard physical education (PE) class at increasing physical activity levels and decreasing cardiovascular risk factors in adolescent African American and Caucasian females.

This study will enroll 9th grade female students who attend a high school in Baltimore, Maryland. They will be randomly assigned to participate in either a standard PE class or CAP. Participants in the CAP program will also receive support from a family member to ensure that they receive encouragement for engaging in exercise. Baseline assessments will include physical activity level; cardiorespiratory fitness; cardiovascular risk factors, including blood pressure, lipoproteins, and body mass index (BMI); and psychosocial factors. Participants will attend follow-up visits at the end of each school year in the 9th, 10th, and 11th grades.

Eligibility Criteria:
Inclusion Criteria:

* Enrolled in 9th grade at the participating high school in Baltimore, Maryland

Exclusion Criteria:

* Has a chronic medical disorder
* Currently taking medications that affect the cardiovascular or metabolic systems (e.g., beta adrenergic blockers)
* Excused from the State of Maryland's PE requirement
* Planning on leaving the area prior to the end of the study
* Has a sibling enrolled in the study
* Pregnant or breast-feeding
Effect of Enteral Immunonutrition on Immune, Inflammatory Markers and Nutritional Status in Patients Undergoing Gastrectomy for Gastric Cancer

Enteral immunonutrition (EIN) has been gaining increasing attention, but data of its immune and anti-inflammatory function in patients undergoing gastrectomy for gastric cancer are poorly investigated. The aim of this study was to assess the effect of EIN on immune function, inflammation response and nutrition status when compared to standard enteral nutrition (SEN).

The investigators believe that the proportion of cluster of differentiation 4 T-cells(CD4＋T-cells), cluster of differentiation 3 T-cells(CD3＋T-cells) and the counts of CD4＋ / cluster of differentiation 8 T-cells (CD8＋), immunoglobulin G(IgG), immunoglobulin M(IgM), and immunoglobulin A (IgA) were larger in EIN group, while the level of WBC, CRP and TNF-α were lower and nutritional status was similar.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 to 80 years
* with histologically diagnosed cancer of stomach
* candidates for elective subtotal or total gastrectomy

Exclusion Criteria:

* pregnant or lactating woman,
* diagnoses of mental diseases
* resent severe concomitant diseases (chronic cardiopulmonary disease, chronic renal failure, etc.)
* known allergies to nutrition formula or component
* drug intolerance
* known immunodeficiency or autoimmune diseases
Hormonal Contraception in Healthy Young Men (P42306)(COMPLETED)(P06057)

Male volunteers receive a new hormonal contraceptive consisting of an implant releasing a hormone and hormone injections in order to investigate the suppressive effect on sperm production and reversibility of sperm production after end of treatment.


Eligibility Criteria:
Inclusion Criteria:

* Male
* Mentally and physically healthy
* BMI between 18 and 32 kg/m\^2
* Two pre-treatment semen samples \> 20 million/ml with normal morphology and motility

Exclusion Criteria:

* History or presence of psychiatric disease, liver disease, renal disease, diabetes, cardiovascular disease, any malignancy, prostatic disease, or genitourinary infection
* PSA \> 2.5 ng/ml
* Use of drugs known to interfere with pharmacokinetics of steroids
* Use of lipid-lowering drugs
Evaluation of a Computer-Based, Self-Management Tool for People With Type 2 Diabetes

NEW Brief Summary: Managing diet and physical activity are vital aspects of diabetes self-care; however, people with diabetes often find it difficult to make changes to their usual diet and physical activity patterns. There is some evidence that computer based education may help some people develop the skills they need to better manage their diabetes. The investigators have developed an external hard drive (a USB stick), focusing on knowledge, self-monitoring, goal setting and skill-development in relation to diet and physical activity for people with Type 2 diabetes. A major emphasis was placed on eliciting the views of people with Type 2 diabetes throughout the development of the computer based program. This study will examine whether this computer based program can improve knowledge, skills and self-care behaviour in people with diabetes. One hundred participants who have been diagnosed with Type 2 diabetes in the past 2 years will be assigned by chance to one of two groups: they will either be assigned to continue with their normal care routine consulting with their doctor as normal, or they will be assigned to use the USB stick at least once a week for 12 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Medical diagnosis of Type 2 diabetes in the past 2 years
* Have access to a computer on a regular basis

Exclusion Criteria:

* Pregnant or lactating
* Other medical conditions where changes in diet or physical activity would be contraindicated
A.Fib Emergency Department Study Atrial Fibrillation

Patients with a history of atrial fibrillation (AF) who frequently attend the emergency department (ED) with symptoms may not require emergency treatment, and may be more appropriately managed in an alternative outpatient setting. This may be the result of inappropriate or inadequate advice or a lack of patient understanding. The main research objective pertains to the reason for seeking medical attention for AF in the ED, ED management of the patient, outcomes of ED care and alternative strategies.

This study is a multi-centre, multi-provincial, patient survey using mixed methods. 778 patients will be enrolled from 9 centres in 3 provinces from academic, urban, and rural centres to achieve geographical and health system heterogeneity. The planned duration of the entire study (enrollment through follow-up) is approximately 12 months. Patients presenting to the ED with a primary diagnosis of AF and with a prior diagnosis of established AF will be approached to participate. Each centre will be responsible for obtaining local consent. Data will be stored confidentially and securely at the coordinating centre (Queens University, Kingston, Ontario).

Patients who meet the inclusion criteria will be invited to take part at the time of presentation to the ED or after their ED visit. For all enrolled patients, one follow up telephone call will be made within one to four weeks of the ED visit by a social scientist with specialised training in questionnaires based in Queens University, Kingston, Ontario.

Eligibility Criteria:
Inclusion Criteria:

* Male or female ≥ 18 years of age
* Atrial fibrillation is the primary reason for ED visit (documented by 12-lead ECG or Holter rhythm strip by a member of the healthcare team providing care to the patient).
* Patients with an established history of AF (prior diagnosis with ECG / rhythm strip evidence of AF)
* Patient must be literate in English
* Patient must provide informed consent

Exclusion Criteria:

* Male or female \< 18 years of age
* Non-English speaking
* unable and/or unwilling to consent
* Acute coronary syndrome (ischemic chest pain, ST changes, + troponin \[mild troponin elevation alone does not exclude the patient\])
* Cardiogenic shock or class IV congestive heart failure at the time of visit
* Enrolled in a cardiovascular drug or device research study
* New onset atrial fibrillation
Technology Interventions for Youth Alcohol Use

The purpose of this study is to evaluate the effects of two programs to prevent/reduce alcohol misuse among youth primary care patients. Depending on their study condition, youth will receive a brief web-based computer program or the web program + 8 weeks of supportive text messages. Parents/caregivers of youth are encouraged to use a freely available app to guide conversations with their child about drinking. This study will have significant impact by evaluating response to these scalable interventions which can be deployed widely in clinical care settings.


Eligibility Criteria:
Inclusion Criteria:

* patients age 12-17 within the Michigan medicine pediatric care system who had an appointment date within the past 2 years; and
* past 12-month alcohol use; and
* patient has a phone that can receive text messages

Exclusion Criteria:

* patients who do not understand English; or
* patients deemed unable to provide informed consent due to conditions that preclude understanding of assessment or intervention content; or
* parent/guardian consent is not obtained; or
* another child in household already enrolled in the study; or
* ongoing participation in another behavioral health research study
D Tc 99m Dimercaptosuccinic Acid SPECT Versus Planar

Knowing what will DMSA spect add to the DMSA planar in detection in renal cortical defects


Eligibility Criteria:
Inclusion Criteria:

* patient with history of peylo nephritis.

Exclusion Criteria:

* pregnant women
Family-centred E-health in Pediatric Weight Management: A Pilot Study

This is a pilot study to examine the feasibility of implementing an objective physical activity and sleep monitoring tool into a pediatric weight management program in conjunction with a personal health record (PHR) for children and their families. This feasibility study is intended to provide proof of concept in the incorporation of monitoring devices within the PHR for pediatric patients and their families. Additionally, the investigators will examine whether the PHR helps to empower pediatric patients, their families and the health care team to more effectively monitor the patient's behavior change. Participants will be randomized to receive, or not receive, augmented communication with the health care team between clinical in person visits.

Lifestyle behaviour changes represent the foundation of pediatric weight management and are usually promoted through individual and/or group-based counseling to encourage the adoption and maintenance of health lifestyle behaviours including nutritional intake, sleep and physical activity. Consensus on the need for comprehensive, behavioural interventions exists, but the nature of these interventions vary considerably. The intensity of the intervention (i.e. number of contact hours) may be a key determinant of efficacy, but little detail on the characteristic of these contact hours for optimal delivery is currently available.

In this proof of concept study, we will evaluate the enhancement of behavioural change strategies utilizing technology that provides direct feedback on behaviour change. These devices will be incorporated into a PHR and supplemented with a related e-learning module.

This study will examine the feasibility and perceived usefulness of incorporation of a personal electronic device to encourage behaviour change in children and youth enrolled in a weight management program. We intend to incorporate this device within an established PHR and supplement with evidence-based e-learning.

This is a prospective, randomized pilot study of children and youth (ages 5-17 years) enrolled in a multidisciplinary pediatric weight management program (at McMaster Children's Hospital) for 4 months. This pilot study will include 10 children/youth and parent dyads from each of 3 age groups: 5-9 years, 10-13 years and 14-17 years. All families will utilize a personal electronic device that they can utilize with the individualized PHR. Participants will be randomized to receive, or not receive, regular communication with and access to the clinical team outside of their routine clinical visits, this will occur through a secure portal in the PHR.

Eligibility Criteria:
Inclusion Criteria:

* children/youth between the ages of 5-17 years
* enrolled in pediatric weight management program at McMaster Children's Hospital
* provide informed written assent (child/youth)
* provision of informed written consent (parent/caregiver)

Exclusion Criteria:

* no access to internet/home computer
POSTconditioning During Coronary Angioplasty in Acute Myocardial Infarction Study

The POST-conditioning during coronary angioplasty in Acute Myocardial Infarction (POST-AMI) trial will evaluate the usefulness of postconditioning in limiting infarct size and microvascular damage during the early and late phases after AMI.

POST-AMI is a single-center, prospective, randomized trial, with a planned inclusion of 78 patients with ST-elevation Acute Myocardial Infarction (AMI). Patients will be randomly assigned to postconditioning arm (primary angioplasty (PA) and stenting followed by brief episodes of ischemia-reperfusion performed during the first minutes of reperfusion) or non-postconditioning arm (PA and stenting without additional intervention). All patients will be treated medically according to current international guidelines, including glycoprotein IIb/IIIa inhibitors before PCI. The primary end point is to evaluate whether postconditioning, compared to PA without additional intervention, reduces infarct size estimated by magnetic resonance at 30±10 days after the AMI. Secondary end points are microvascular obstruction observed at magnetic resonance, ST-segment elevation resolution, persistent ST-segment elevation, angiographic myocardial blush grade \<2 and non sustained/sustained ventricular tachycardia in the 48 hours following PA. Further secondary end points are enzymatic infarct size, left ventricular remodeling and left ventricular function at magnetic resonance performed at 6±1 months, and the reduction of major adverse cardiac events at 30 days and 6 months.

Eligibility Criteria:
Inclusion Criteria:

* clinical evidence of myocardial infarction defined by the presence of ischemic chest pain lasting more than 30 minutes, with a time interval from the onset of symptoms less than 6 hours before hospital admission, associated with typical ST-segment elevation on the 12-lead ECG
* angiographic-detected culprit lesion with stenosis diameter \>70% and TIMI flow grade \<=1

Exclusion Criteria:

* previous acute myocardial infarction
* previous myocardial revascularization (angioplasty or coronary bypass)
* previous heart valve replacement
* previous heart transplant
* clinical instability precluding the suitability of the study
* cardiogenic shock or persistent hypotension (systolic blood pressure \<100 mmHg)
* rescue angioplasty after thrombolytic therapy
* evidence of coronary collaterals (Rentrop grade\>0) in the risk area
* advanced atrioventricular block
* significant bradycardia
* absence of sinus rhythm
* inability to lay flat (due to severe cardiac heart failure/respiratory insufficiency)
* history or clinical evidence of bronchospastic lung disease
* pregnancy
* known existence of a life-threatening disease with a life expectancy \<6 months
* inability to give informed consent
* any contraindication to undergo cardiac-MRI, such as implanted metallic objects (cardiac pacemakers and/or implantable cardioverter defibrillator, implanted insulin pumps or any other type of electronic devices, cerebral clips, aneurysm clips) or any other contraindication to cardiac-MRI (such as claustrophobia)
Effect of Green Tea on Treatment of Lupus

This randomized double blind clinical trial performed on 68 patients (32 in intervention and 36 in control group) diagnosed with SLE. The patients in intervention group were given daily dose of 1000mg of aqueous green tea extract (of 6 gram of dried green tea leaf) in form of two capsules ( 500 mg). Also in control group, the patients were given daily dose of 1000mg of cellulose in form of two capsules ( 500 mg) Variables include SLE disease activity, some biomarkers of inflammation and oxidative stress and anthropometric indicators at baseline and end of the study.

The investigators used SLEDAI (systemic lupus erythematous disease activity index ) questionnaire for evaluating the clinical signs of the disease. The questionnaires filled out at baseline and after 3 month.

noting

Eligibility Criteria:
Inclusion Criteria:

The patients older than 15 years,diagnosed with systemic lupus erythematous (SLE) according to ACR(American College of Rheumatology) criteria.

Exclusion Criteria:

* Patients with other autoimmune diseases (diabetes, ...)
* Cardiovascular disease
* Patients with infectious or liver disease;
* severe infection
* Pregnancy
* Breastfeeding
* Smoking
* Alcohol consumption
* Use of any dietary supplements
* Changing of medication during the study period
The Effect of Progesterone on Human Endometrium

This study evaluates the relationship between progesterone levels and endometrial gene expression


Eligibility Criteria:
Inclusion Criteria:

* Ages 18-35, regular menstrual cycles, the cycle length between 25 and 35 days, body mass index (BMI) between 18 - 25

Exclusion Criteria:

* History of infertility, history of pelvic pain or/and endometriosis, history of pelvic mass, history of hormonal therapy in the last 3 months