cyrilzakka/clinical-trials huggingface dataset:
Comparison of Preoperative ABUS and MRI in Newly Diagnosed Breast Cancer Patients

Comparison of Preoperative Automated Breast Ultrasound (ABUS) and magnetic resonance imaging (MRI) in Newly Diagnosed Breast Cancer Patients.

This is a prospective pilot study investigating the use of Automated Breast Ultrasound in the preoperative evaluation of newly diagnosed breast cancer patients. The Investigator intends to demonstrate that preoperative automated breast ultrasound (ABUS) will provide a relatively inexpensive and well-tolerated alternative to MRI for detection of occult breast cancer missed by mammography and hand-held ultrasound in women with newly diagnosed breast cancer. The research will take place at the University of Kansas Medical Center (KUMC). The research study will be open to newly diagnosed breast cancer patients who present to KUMC with a recommendation for preoperative MRI and who fit all inclusion criteria and have none of the exclusion criteria.

Eligibility Criteria:
Inclusion Criteria:

* Women (age 18-100) undergoing preoperative evaluation at the University of Kansas Cancer Center (KUCC) for a new diagnosis of breast cancer
* Patients with a diagnosis of breast cancer by either core needle biopsy or excisional biopsy.
* Bilateral mammography and hand-held ultrasound (if clinically indicated) performed prior to the MRI and ABUS.
* If a breast MRI is advised and there is no contraindication to MRI, a breast MRI and ABUS will performed at KUCC (Study Arm 1).
* If a breast MRI is not performed, an ABUS exam without MRI will be performed (Study Arm 2).
* The MRI and ABUS exam must be obtained within 2 weeks of each other.

Exclusion Criteria:

* Males
* Pregnant women
* Lactating women
* Patients \< 18 and \> 100 years of age
* Patients with breast implants
Evaluation of a Supporting Transition and Resilience to Clinical Nursing Education (STRONG) Study

This study aims to address the following research questions:

1. Evaluate the effectiveness of a Supporting Transition and Resilience to Clinical Nursing Education (STRONG) program on first year nursing students' anxiety, depression, stress, resilience, practice readiness, physical activity and eating behaviours.
2. Explore first year nursing students' experiences and perception of the STRONG program.

Participants will be invited to participate in an asynchronous online STRONG program


Eligibility Criteria:
Inclusion Criteria:

* First year nursing students enrolled in the NUR1107B Nursing Practice Experience and NUR1202C Clinical Experience I module
* Above the ages of 18 years
* Able to comprehend the English language
* Have a device that can connect to the Internet

Exclusion Criteria:

* Students who refused to participate in this study
Prospective Cohort of Patients With Critical Limb Ischemia Undergoing Revascularization

Peripheral Arterial Occlusive Disease is associated with a high risk of cardiovascular events. The critical ischemia stage represents the most severe stage of Peripheral Arterial Occlusive Disease, associated with decubitus pain and / or foot ulceration. The severity of this arterial involvement involves functional prognosis of the lower limb with a high risk of amputation, and the vital prognosis of the patient. In these patients, the rate of amputation and mortality at 1 year can reach 20%. Therefore, the goal of management in a multidisciplinary setting is limb salvage and improvement of the patient's vital prognosis.

In the vascular medicine department, the indication and modalities of the revascularization procedure are discussed in a multidisciplinary consultation meeting. Surgical revascularization by distal bypass requires venous material that can be used, a receiving artery without diffuse lesions, in direct continuity with the arterial network of the foot, and the absence of co-morbidities against general anesthesia. With the modernization and development of endovascular equipment dedicated to the hamstrings, the interventional radiology techniques in the management of critical ischemia allow the treatment of one or more arterial axes as well as a very distal revascularization in the arteries. of the foot with less morbidity-mortality compared to surgery, especially in patients the most fragile patients. Since 2013, the endovascular revascularization procedures performed by the interventional radiology team have been an integral part of the management of patients with peripheral arterial disease of the lower limbs monitored in the vascular medicine department. The hospital is therefore a privileged place to observe the long-term impact of this medical care on the future of patients with different stages of severity of arterial disease.

The objective of this prospective study is to assess the vital prognosis, limb salvage and associated prognostic factors in patients with critical ischemia supported by endovascular revascularization in the vascular medicine service of the GHPSJ. The objective of this cohort study is to build a database on critical ischemia in hospitalized patients, to judge the management, monitoring and prognosis of patients.


Eligibility Criteria:
Inclusion Criteria:

* Man or Woman whose age is ≥ 18 years old
* Patient with critical lower limb ischemia defined by the existence of decubitus pain or a wound (foot ulcer or gangrene) evolving for more than 2 weeks associated with hemodynamic criteria (systolic toe pressure \<30 mm Hg and / or systolic ankle pressure \<50 mm Hg).
* Hospitalized in the vascular medicine department
* Endovascular revascularization gesture discussed and confirmed by multidisciplinary staff

Exclusion Criteria:

* Patients under guardianship or curatorship
* Patients deprived of their liberty
* Patients objecting to the use of their data for this research
Tumor Lysate Pulsed-Dendritic Cell Vaccines After High-Dose Chemotherapy for Non-Hodgkin's Lymphoma

When patients relapse after primary chemotherapy for Non-Hodgkin's lymphoma, they may be eligible to receive high-dose chemotherapy with autologous stem cell support. Unfortunately high-dose chemotherapy is curative in less than half the patients who receive it. This study is being conducted to determine the safety, side effects, and the ability to respond to an investigational vaccine that consists of tumor-pulsed dendritic cells given with an immune stimulating drug called interleukin-2. The patient must have a lymphomatous node accessible for excision to prepare the vaccine. Dendritic cells are immune cells that are obtained from the blood, and are important in the body's immune response to foreign substances. This study will examine the response of the immune system after three vaccinations (composed of dendritic cells, which have been exposed to dead fragments of lymphoma cells) given beginning three months after transplant. Vaccination may result in sensitizing the patient's dendritic cells to his lymphoma cells, potentially resulting in an immune response against the lymphoma. Twelve patients will be treated on study.


Eligibility Criteria:
Inclusion Criteria:

* Histologically documented, aggressive and/or intermediate grade NHL, B-cell and T-cell.
* In relapse after first-line conventional chemotherapy. Primary therapy should include a doxorubicin-based regimen.
* Patients must have disease sensitive to induction chemotherapy, radiation therapy, and/or radioimmunotherapy. Successful treatment of CNS or meningeal disease is allowed.
* Patients must have accessible tumor for biopsy or excision.
* Cumulative total doxorubicin: \<500 mg/m2
* Performance score 0-2
* No prior pelvic RT
* Patients with a prior malignancy are eligible if they were treated for cure and have no evidence of active disease.
* Patients may not be taking immunosuppressive agents.
* Informed Consent; IRB approval
Effects of H1-Antagonist on Cognition

The purpose of this study is to determine whether histamine is involved in memory and specific processes in human cognition.

The neurotransmitter histamine appears to be involved in human cognitive performance. However, the exact role is very unclear. The role it plays in memory performance is highly disputed, as animal studies show decreased performance when the H1-receptor is blocked in the central nervous system while such findings in humans is scarce. To clarify the role of histamine in human memory and different processes in cognition, the effects of an H1-antagonist (dexchlorpheniramine) on memory, alertness and sensory and motor processes are measured. The study will be conducted according to a within subject cross-over design using healthy volunteers.

Eligibility Criteria:
Inclusion Criteria:

* Healthy as determined by a physician

Exclusion Criteria:

* present or history of any neurological of psychiatric disease
* present or history of any substance abuse
Cataract Surgery With Intracameral Triamcinolone in Infants

The aim of the present study is to investigate the outcomes of congenital cataract surgery when injecting intraoperative intracameral triamcinolone versus the postoperative use of oral prednisolone.

This is a prospective, randomized clinical trial. Sixty children will be submitted to congenital cataract surgery younger than 2 years of age. They will be randomly divided in two groups. The study group will receive an intraoperative intracameral triamcinolone acetonide injection. The control group will receive prednisolone syrup postoperatively. The surgical outcomes will be assessed after one year.


Eligibility Criteria:
Inclusion Criteria:

* Patients younger than 2 years of age
* Unilateral or bilateral congenital cataracts compromising the red reflex

Exclusion Criteria:

* Corneal opacity
* Glaucoma
* Aniridia
* Subluxated cataract
* Traumatic cataract
* Complex microphthalmia
* Persistant hyperplastic primary vitreous
* Retinal detachment
* Patients with intraoperative complications, such as IOL implanted in the sulcus
PH III Study of Lenalidomide and Dexamethasone With or Without Elotuzumab to Treat Previously Untreated Multiple Myeloma (ELO 1 Substudy)

The purpose of the study is to look at subjects who receive Lenalidomide, Dexamethasone, and Elotuzumab and determine if they will have lower surface CS1 expression on malignant plasma cells at the time of progression than those who receive Lenalidomide and Dexamethasone without Elotuzumab


Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

Subjects who are newly diagnosed with symptomatic MM and who:

* Have not received any prior systemic anti-myeloma therapy
* Have measurable disease
* And are not candidates for high-dose therapy plus stem-cell transplantation (SCT) because of age (≥65 years) or coexisting conditions. Refusal to undergo high dose therapy with SCT is NOT sufficient for entry onto CA204-006 for a subject \<65 years old. There must be a comorbidity that prevents SCT for a subject \<65 years old

Exclusion Criteria:

* Subjects with non-secretory or oligo-secretory or free light-chain only myeloma
* Smoldering MM, defined as asymptomatic MM with absence of lytic bone lesions
* Monoclonal Gammopathy of Undetermined Significance (MGUS)
* Active plasma cell leukemia
* Known Human Immunodeficiency Virus (HIV) infection or active hepatitis A, B, or C
Liver MRI for Colorectal Cancer Liver Metastasis: Comparative Effectiveness Research for the Choice of Contrast Agents

Magnetic resonance imaging (MRI) has been widely used for problem-solving tool in the evaluation of hepatic lesions, and it has been shown to have better sensitivity than CT for detection of colorectal liver metastases, especially for lesions which are smaller than 1 cm. After introduction of a liver-specific hepatobiliary MR contrast agent, gadoxetic acid, gadoxetic acid-enhanced MRI (Gd-EOB-MRI) has been increasingly used for evaluation of liver lesion including CRLM. However, compared to conventional MRI with extracellular contrast agent (ECA-MRI), Gd-EOB-MRI has different pharmacodynamic characteristics, and is more expensive due to higher cost of gadoxetic acid and needs longer scan time to obtain hepatobiliary phase which is generally acquired 15 to 20 minutes after contrast injection. The purpose of this study was to compare the clinical outcome and diagnostic performance of Gd-EOB-MRI and ECA-MRI for evaluation of focal hepatic lesion in newly diagnosed colorectal cancer.


Eligibility Criteria:
Inclusion Criteria:

1. patients with surgically proven colorectal adenocarcinoma
2. patients who underwent abdominopelvic CT and liver MRI for initial staging before any treatment
3. no past or concurrent malignancy other than colorectal adenocarcinoma.

Exclusion Criteria:

1. precontrast abdominopelvic CT
2. precontrast liver MRI
3. liver MRI using contrast other than extracellular agent or gadoxetic acid
4. the interval between CT and liver MRI was longer than 4 weeks
5. patients who had suspected multiple hepatic metastases (\> 10) on CT
6. distant metastasis other than liver and
7. unavailable reference standard of their hepatic lesions with no pathologic confirmation or follow up imaging.
Is There a Desensitization During Sleep After Exposure to a Violent Verbal Input ?

There is a need for quantify the emotional and neurophysiological perception of verbal violence, in order to understand the impact it might have on a subject. This project aims at assessing the influence of time, sleep, and people interaction on the perception of verbal violence.

There are many processes involved in the perception of verbal violence. There is a need for quantified data to have a better understanding the physiological and neurological perception of verbal violence, in order to understand the impact it might have on a subject. This project aims at assessing the influence of time, sleep, and people interaction on the perception of verbal violence. The "cognitive replay" will also be assessed through dreams. The investigators think that sleep plays a role in desensitization to negative emotions and to memory consolidation. However, the role of sleep in verbal violence remains unknown.

Eligibility Criteria:
Inclusion Criteria:

* Subject fully understands French
* Subject willing to consent to the study and signed the written consent
* Subject is afiliated to the Freanch national health care system (Sécurité Sociale)
* Subject level of education superior to "Brevet des collèges" (an equivalent would be the general certificate of secondary education)

Exclusion Criteria:

* The subject is not able to understand the protocol
* The subject has a language disorder
* The subject has a psychiatric or neurological disorders
* The subject does not use psychotropic drugs
* The subject has watched the advertidement : "stop djihadisme", broadcasted on television by the french government
N-acetylcysteine to Reduce Ischemia/Reperfusion Injury in Liver Resection

Study hypothesis: N-acetylcysteine (NAC) can reduce ischemia/reperfusion injury in liver resection performed under ischemic preconditioning and intermittent portal triad clamping.

One of the most important factors in the pathophysiology of liver dysfunction after hepatic surgery is the cellular damage derived from the interruption of blood flood with reperfusion of the organ. N-acetylcysteine (NAC) has proved beneficial in several conditions involving oxidative damage. This study investigates the effects of NAC to reduce ischemia/reperfusion injury in liver resection performed under ischemic preconditioning and intermittent portal triad clamping.

Methods: 46 ASA II-III patients scheduled to undergo liver resection where randomised to receive NAC (initial dose: 150 mg/Kg; and infusion of 50 mg/kg, from 30 minutes before the ischemia up to 60 minutes later to the reperfusion) or placebo in a phase IV clinical trial. Blood, hepatic and urinary markers were obtained at basal status and 1, 3 and 24 h post final reperfusion.

Eligibility Criteria:
Inclusion Criteria:

* Hepatectomy

Exclusion Criteria:

* ASA 4
* Cirrhosis
* Creatinine \> 1.2 mg/dL
* Associate surgery (pancreatic or splenectomy)
* Intraoperative bleeding \> 2 L.
* Active infection of inflammatory disease
Preventing Youth Soccer Injury

A study is proposed to test whether adding additional referees to youth soccer matches may reduce the risk of injury to the children playing soccer. Publicly-open youth soccer games will be randomly assigned to have either one or three referees and videotaped. The videotaped games will then be watched to record risk-taking behavior by players, referee decisions, and other factors relevant to potential injury.


Eligibility Criteria:
Inclusion Criteria:

* unit of measurement was youth soccer teams playing in Birmingham, Alabama area league

Exclusion Criteria:

* teams serving children under age 9 or over age 11
PET Quantitative Assessments of Solid Tumor Response to Immune Checkpoint Blockade Therapy

This study aims to develop methods for quantitative imaging of solid tumors in patients who are receiving immunotherapies that have a delayed mechanism of action.

PET imaging with \[18F\] 2-deoxy-2-(18F)fluoro-D-glucose (FDG) is a potent diagnostic tool and is able to detect melanomas and other tumors, some of which are undetectable by CT. FDG PET is now used commonly in detecting melanoma in humans as melanomas quite consistently have high glucose metabolism. PET with FDG can image the response of tumors to therapy, but has not been extensively evaluated in melanoma nor in immunotherapy for melanoma. PET has been shown to be highly predictive of outcomes of patients following radioimmunotherapy of lymphoma, and has shown changes in tumor glycolysis as early as 7 days after immunotherapy initiation.

In order to develop PET/CT as a tool to detect early evidence of response in patients with solid tumors receiving immune checkpoint blockade, investigators propose to perform PET/CT imaging prior to therapy, again between days 21 and 28, and finally at 4 months post-treatment initiation. Each scan will be assessed qualitatively and quantitatively. Investigators will use the PERCIST criteria to determine peak and maximum standardized uptake values corrected for lean body mass (SUL) in tumor, tumor volumes, and tumor total glycolytic volumes, and will use CT from PET/CT to measure tumor size by immune RECIST criteria. (See section on Outcome Evaluation below.) Investigators will assess whether early changes in tumor metabolism seen on FDG PET are predictive of progression free and overall survival outcomes. Through these systematic pilot studies, investigators hope to better link FDG PET measurements to individual patient responses to immune checkpoint blockade therapy and better understand and refine this emerging and often effective therapeutic approach.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years
2. Any subject with documented metastatic melanoma, RCC or NSCLC.
3. Subjects must be scheduled to receive therapy, or received only one dose, with an anti-neoplastic agent that works by immune checkpoint blockade such as ipilimumab/Yervoy (anti-CTLA-4), MDX-1106/BMS-936558 (anti-PD-1) or MDX-1105/BMS-936559 (anti-B7-H1) mAbs.
4. Subjects must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension as \>10 mm with spiral CT scan.

Exclusion Criteria:

1. Patient is unable to provide informed consent
2. Patient is pregnant
3. Patient enrollment on research protocol which includes an additional mid-therapy investigational FDG PET/CT at approximately month from start of therapy.
Strategies to Improve Appropriate Referral to Rheumatologists

The aim of this cluster randomized controlled trial is to improve the number of effectively referred patients with IRD to the rheumatology outpatient clinic with either use of validated referral pro formas or triage of IRD by specialists in a primary care setting compared to usual care. In addition, the investigators want to provide tools for the general practitioner to recognise IRD and improve early referral of patients with IRD, and a cost-effectiveness analysis will be performed to evaluate the decreasing effect on health-care cost.

Rationale: Currently, only 22% of all patients referred to the rheumatologist by primary care are diagnosed with an inflammatory rheumatic disease (IRD). Previous research has shown that structured referral sheets and community-based specialist service improve appropriateness of referrals.

Objective: The aim of this study is to improve the number of effectively referred patients with IRD to the rheumatology outpatient clinic with either use of validated referral pro formas or triage of IRD by specialists in a primary care setting compared to usual care. In addition, the investigators want to provide tools for the general practitioner to recognise IRD and improve early referral of patients with IRD, and a cost-effectiveness analysis will be performed to evaluate the decreasing effect on health-care cost.

Study design: Cluster randomized trial with randomization of general practitioner clinics.

Study population: Primary care patients of 18 years or older who are suspected of an IRD and considered by a GP for referral to a rheumatologist.

Intervention: One group of GPs will use a standardized referral strategy for IRD, another group will consist of triage by a rheumatologist in the local primary care clinic, the third group is usual care.

Main study parameters/endpoints: Percentage of patients diagnosed with an IRD by a rheumatologists after 12 months. In addition, cost effectiveness, quality of life, work participation and health care costs at baseline and after 12 months.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: There is no additional risk to participating patients. Patients might benefit from early referral since the referral pro formas point out important aspects of IRD that are frequently overlooked. Patients will be requested to fill in three online questionnaires related to quality of life, work participation and socio-economic costs. There are no additional visits, physical examinations or other tests.

Eligibility Criteria:
Inclusion Criteria:

* A primary care patient who is referred by the GP to the rheumatology outpatient clinic
* Subject must be able to understand and communicate with the rheumatologist
* Participant must give a written signed and dated informed consent before enrolment.

Exclusion Criteria:

* Limited understanding of the Dutch language.
* Legally incapable or vulnerable subject as described in the Medical Research with Human Subjects Act (WMO).
Effect of Memantine on Functional Communication in Patients With Alzheimer's Disease

The objective of this study is to evaluate the effect of memantine versus placebo on functional communication in patients with Alzheimer's Disease


Eligibility Criteria:
Inclusion Criteria:

* Male and female outpatients, 50 years or older, native English speakers, meeting National Institute of Neurological and Communicative Disorders and Stroke--Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria for probable AD with a Mini Mental State Examination (MMSE) score of 10 to 19 at Screening and Baseline

Exclusion Criteria:

* Current Diagnostic and Statistical Manual of Mental Disorders--Fourth Edition (DSM-IV) Axis I disorder other than AD
* Previous imaging results not consistent with the diagnosis of AD
* Modified Hachinski Ischemia Score greater than 4
* Evidence of other neurologic disorders
* Clinically significant systemic disease
* A known or suspected history of alcohol or drug abuse in the past 5 years
* Taking excluded medication
* Previous treatment with commercial memantine