cyrilzakka/clinical-trials huggingface dataset:
A Nation-wide Multicenter Clinical Epidemiologic Study of Chinese Females With Advanced Breast

To study the epidemiological trends and characteristics for advanced breast cancer patients, to analyze these trends and report the results

In this study, the investigators conducted a hospital-based retrospective clinical study, recruiting female advanced breast cancer patients from 14 tertiary hospitals at 7 classic geographic regions, to study the clinical epidemiologic characteristics of advanced breast cancer and the current standard of clinical diagnosis and treatment in order to provide references for standardized treatment therapy, and to improve the quality of life and prolong survival time.

To study the epidemiological trends and characteristics for advanced BC patients, to analyze these trends and report the results. To learn about the current treatment therapy for advanced BC patients in different areas in China.To provide references for standardized treatment therapy, to improve the quality of patients' life and to prolong the survival time for the advanced BC patients.To assess the different treatment therapies for advanced BC with consideration of economic cost-effectiveness

Eligibility Criteria:
Inclusion Criteria:

* diagnosed as advanced breast cancer during Jan1st,2012-Dec31st,2014
* complete with surgical pathology data, auxiliary treatment, there is a clear recurrence, transfer time, place, transfer of recurrence after treatment, and curative effect evaluation details.In any age, ethnic group cases.

Exclusion Criteria:

* no available medical record
Novel MRI Techniques for the Characterization and Treatment Assessment of High Grade Brain Lesions

This trial studies different magnetic resonance imaging (MRI) techniques and their ability to provide clearer pictures of lesions in patients with high grade brain lesions. An MRI is a type of imaging scan. Using different MRI techniques to produce clearer images of the brain may help researchers learn about the features of brain lesions and the effects of chemotherapy and/or radiation therapy.

PRIMARY OBJECTIVES:

I. To use 3-dimensional (3D) quantitative mapping to determine whether differences in T2 spin parameters exist between the peritumoral area and normal brain in the contralateral hemisphere at baseline.

II. To use 3D quantitative mapping to examine how differences between peritumoral and normal brain in the contralateral hemisphere change before and after treatment.

SECONDARY OBJECTIVES:

I. Determine whether T2 values might be useful in distinguishing non-enhancing components of the tumor as well as predicting response to treatment.

II. Quantify T1 and proton density (PD) spin parameters of the peritumoral area and their differences before and after treatment.

III. Examine post-contrast T1 spin parameters with perfusion characteristics as measured by an established dynamic susceptibility contrast (DSC) technique.

IV. Examine differences in measured perfusion parameters (blood volume and mean transit time of each tumor) before and after treatment.

OUTLINE:

Within 21 days before standard of care chemotherapy and/or radiation therapy, patients undergo an MRI scan for the first set of images. Patients then receive either gadobutrol or gadobenate dimeglumine intravenously (IV) and undergo an MRI for the second set of images. All MRI scans take a total of 60 minutes to complete. Patients then repeat the MRI scans 120 days after standard of care chemotherapy and/or radiation therapy.

Eligibility Criteria:
Inclusion Criteria:

* At least one enhancing lesion, aggregate of enhancing foci, and nonenhancing lesion measuring at least 1 cm in size and is suspected to be a high grade brain neoplasm
* Patient is dispositioned to surgery, chemotherapy and/or radiation therapy
* Patient is able to understand and give own consent to participate in the study

Exclusion Criteria:

* Contraindication to magnetic resonance imaging (MRI) as assessed by our standard of care magnetic resonance (MR) screening procedure, which includes implants or devices that are unsafe in the magnetic environment
* Contraindication or history of allergy to Gadolinium-based (gadobutrol \[Gadovist\], gadobenate dimeglumine (Multihance\]) intravenous contrast
* Verbal confirmation of pregnancy or a positive pregnancy test result in patient record
* Prior partial (greater than 50%) or gross total resection of primary tumor
* Prior chemotherapy or radiation treatment to brain
Rituximab in Hairy Cell Leukemia: a Multicenter Retrospective Study

Hairy-cell leukemia is a rare and indolent lymphoid disorder, representing 2% of all cases of lymphoid leukemias. Treatment of hairy-cell leukemia relies mainly on the purine analogs, cladribine and pentostatin, which have shown similar efficacy and constitute the gold standard of care either as front-line therapy or for relapsed patients.

However, despite the remarkable response rates obtained with purine analogs therapy, some patients will eventually relapse and the efficacy of these agents seems to decrease at each line of treatment. The addition of new molecules to purine analogs may improve the response rates and prevent relapse.

Rituximab is a chimeric IgG1 kappa-type monoclonal antibody directed against the CD20 molecule. It was first used in relapsed patients with hairy-cell leukemia more than 10 years ago and several series of patients treated with rituximab as monotherapy were published in the following decade, reporting response rates ranging from 25% to 80%.

Aims of the study were :

* to assess the overall efficacy of rituximab in a cohort of unselected patients with hairy-cell leukemia
* to identify factors associated to treatment response, to duration of treatment response and to patient survival in a cohort of unselected patients with hairy-cell leukemia

Eligibility Criteria:
Inclusion Criteria:

* patients with hairy-cell leukemia diagnosed between July 2002 and September 2012
* patients had received at least 3 subsequent injections of rituximab
* aged \> 18 years
Infusion of Cell Populations From Unlicensed Umbilical Cord Blood Units

For the next 5-10 years or possibly longer, a high proportion of the Cord Blood Banks (CBB) inventory worldwide will be composed of unlicensed umbilical cord blood (UCB) units. While Food and Drug Administration (FDA)-licensed units will be prioritized, it will always be possible that an unlicensed unit will have known attributes, making it a better source of cells for the given indication. Because of the wide variety of current and potential indications as a source of cells for hematopoietic reconstitution or other form of cellular therapy, it is critical that the investigators have access to unlicensed UCB units.

Patients will receive intravenous hydration, acetaminophen and diphenhydramine hydrochloride (or appropriate alternative regimen) approximately 30 minutes prior to UCB infusion with doses adjusted for subject age and weight unless otherwise specified in the specific treatment protocol. Additional treatments will vary with the specific use of the UCB cells as specified in institutional review board (IRB)-approved disease-specific protocols at the University of Minnesota.

Eligibility Criteria:
Inclusion Criteria:

To be eligible for an unlicensed umbilical cord blood (UCB) unit, the subject must meet each of the eligibility criteria listed below:

* Subjects with any diagnosis for which there is an institutional review board (IRB) approved treatment protocol that requires UCB as a source of hematopoietic stem cells for lympho-hematopoietic reconstitution after myeloablative or non myeloablative conditioning.
* Subject (or parent/guardian) must provide written informed consent for the use of unlicensed UCB units with co-enrollment onto a University of Minnesota IRB-approved clinical trial that details the disease specific treatment plan that prescribes the use of UCB as source of cells
* Subject has an unlicensed UCB unit that meets required cell dose and HLA matching criteria (as defined in the primary treatment protocol) that is considered negative for tested blood-borne pathogens and also lack an 'equivalent', licensed UCB unit from a University of Minnesota approved Cord Blood Bank

Exclusion Criteria:

* Exclusion criteria are specified in the treatment protocol according to indication.
A Prospective RegistrY of Cardiac Echographic Loops

CARDIAWAVE, a French start-up founded in 2014, aims to develop a new non-invasive therapy to treat patients suffering from Aortic Valve Stenosis (AS) who are not candidates to validated treatment of AS, i.e. TAVI (Transcatheter Aortic Valve Implantation) or SAVR (Surgical Aortic Valve Replacement). This therapy consists in focusing ultrasound on aortic valve transthoracically and use high energy to soften calcification from the target valve. In order to do so, we develop a device able to deliver high energy ultrasounds to a targeted valve thanks to the synchronization of patient hearts live imaging and therapy in real time.

Live imaging will use an algorithm to realize 'valve tracking': an automatic detection of aortic valve position and shape as fast as image acquisition time. In order to develop and validate this 'valve tracking' algorithm, CARDIAWAVE requires cardiac echographic loops of patients with aortic valve calcification, with 30 seconds or 60 seconds recording.

The objective of the present study is to develop and validate the 'valve tracking' processing algorithm of CARDIAWAVE.

ARYEL is a prospective, multicenter, non-interventional study.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged ≥ 18 y.o
* Patients with a confirmed diagnosis of Aortic valve calcification on native valve or bioprosthesis
* Patients with planned cardiac transthoracic echography for 'Aortic valve calcification' follow-up
* Patients who have signed Informed Consent Form
* Patients affiliated to French social security or equivalent

Exclusion Criteria:

* Patients allergic to echographic gel
* Patients with "hostile thorax": serious cutaneous irradiation injury or major thoracic deformity.
* Low echogenicity
* Patients with mild or high abundance pericardic effusion
Prevalence and Outcome of SARS-CoV-2 Infection & COVID-19 in Transplant Recipients: The COVITRA Study

This project will provide novel data using a large cohort of more than 3000 transplanted patients. Risk and protective factors for SARS-CoV-2 infection and COVID-19 disease severity will be identified. The proportion of patients who develop antibodies after infection will be revealed. In this way the presence of these antibodies can be evaluated as a test for prior infection. Our study additionally will demonstrate how long these antibodies remain present and whether they are protective against a new infection.


Eligibility Criteria:
Inclusion Criteria:

* all patients who underwent solid organ or hematopoietic cell transplantation at UZ Leuven and who give informed consent

Exclusion Criteria:

* age under 18 years
The Secondary Prevention Trial for Ischemic Stroke With DengzhanShengmai Capsule

In order to observe the secondary preventive effect of the Dengzhanshengmai capsule on ischemic stroke, the investigators hold the large randomized control trial (RCT). 3143 subjects are included in 83 clinical research centers all over China. The subjects are randomly grouped into two groups. The basic therapy included antiplatelet aggregation, stroke health education, management of blood pressure, blood lipid and blood glucose, etc. The treating group will take the compound Chinese Medicine Deng Zhan Sheng Mai capsule and the contrast group will take the placebo for twelve months. Then all of the subjects are visited on the 30th, 90th, 180th, 360th day after inclusion. The recurrence of stroke, cardiovascular events, and peripheral arterial events are observed.

Objective:To observe the secondary clinical effect of the Deng Zhan Sheng Mai capsule on ischemic stroke patients.

Methods:3143 subjects suffering from acute ischemic stroke are included in 83 clinical research centers all over China. The subjects are randomly divided into two groups:The treating group and the placebo group.Both groups accept the basic therapy and test drug.The basic therapy included antiplatelet aggregation,stroke health education,management of blood pressure,blood lipid and blood glucose,etc.The patients in Dengzhan Shengmaigroup take Deng Zhan Sheng Mai capsule and the placebo group take the placebo drug for twelve months.Then all of the subjects are visited on the 30th,90th,180th,360th day after inclusion. Primary endpoints(cerebral infarction,intracerebral hemorrhage,subarachnoid hemorrhage) and secondary endpoints(cardiovascular events,peripheral arterial disease),functional disability are observed at each follow up.

Eligibility Criteria:
Inclusion Criteria:

* 40-75 years old
* Ischemic stroke diagnosed by CT/MRI scan
* Patient presenting from 14 days to 6 months of first onset of ischemic stroke
* Presence of at least one risk factor of stroke (such as hypertension, diabetes mellitus, coronary heart disease, hyperlipidemia, and smoking, etc.) that can be interfered in
* Informed consent

Exclusion Criteria:

* Silent cerebral infarction
* Cerebral infarction due to other causes except artery scleroses (i.e. cardiogenic embolism, hypercoagulable state, endangium stripping, vasculitis)
* Presence of serious heart disease, heart, liver, lung, and kidney functional failure; malignancy; alimentary tract hemorrhage mental disorder and noncooperation with physician
* Females during pregnancy or lactation
* Already attend other clinical trial
COVID-19 Pandemic and Female Sexual Behavior

World Health Organization declared new SARS-CoV-2 infection a pandemic, and many states enacted strict, rules such as border closures, transportation restrictions and quarantine.Many studies in the literature have described the relationship between mass disasters and female sexual behavior, but none have investigated the effect of SARS-CoV-2 pandemic on women's sexual attitude. The aim of this study is therefore to evaluate the effect of SARS-CoV-2 pandemic on female sexual behavior.

Coronaviruses are a group of RNA viruses that affect mainly the respiratory system and cause the common cold, fever, and coughs in mammals and birds. However, in some cases, coronaviruses are associated with more serious and lethal conditions, such as pneumonia, bronchitis, and severe acute respiratory syndrome. A novel coronavirus (SARS-CoV-2) originating from Wuhan, China led to a global health crisis. At the time of writing, SARS-CoV-2 infected more than two million, resulting in almost 180.000 deaths. World Health Organization declared new SARS-CoV-2 infection a pandemic, and many states enacted strict, rules such as border closures, transportation restrictions, and quarantine.

The term 'sexual behavior' encompasses a large spectrum of actions in which humans present their sexuality. Previous reports have analyzed the effect of mass disasters on female sexual behavior.

Many studies in the literature have described the relationship between mass disasters and female sexual behavior, but none have investigated the effect of the SARS-CoV-2 pandemic on women's sexual attitude. The aim of this study is therefore to evaluate the effect of the SARS-CoV-2 pandemic on female sexual behavior.

Eligibility Criteria:
Inclusion Criteria:

* married
* above 18 yo
* premenopausal status

Exclusion Criteria:

* urinary incontinence
* history of gynecologic operation
* malignancy
* psychiatric or neurologic disease diagnosis
* being infected by HBV HCV or HIV
Be-Prox. An Effectiveness Study of Bullying Intervention in Norwegian Kindergartens.

With an overall aim to ensure a safe and sound kindergarten environment for all Norwegian children in accordance with the Kindergarten Act §§41-43, the objectives of the current project are:

To evaluate the effectiveness of Be-Prox Norway to prevent and handle negative behavior and bullying among peers in Norwegian kindergartens.

To examine implementation factors that promote and inhibit the effectiveness of Be-Prox Norway in Norwegian kindergartens.

To describe the cost-effectiveness of the Be-Prox Norway intervention in Norwegian kindergartens.

To generate knowledge on how the Be-Prox Norway intervention can be aligned and implemented in Norwegian kindergartens.

January 1st, 2021, new additions to the Kindergarten Act came into force in Norway introducing the right for all children to a safe and sound kindergarten environment. According to this act, Norwegian kindergartens shall systematically work to preventing bullying and social exclusion, including adopting a zero-tolerance for violations such as exclusion, bullying, violence, discrimination, and harassment. While relatively little is known about bullying at this age, a growing body of research suggests that bullying occurs also between kindergarten peers and that experiencing bullying at early age is associated with negative consequences.

Currently there are few evidence-based interventions directly targeting bullying among kindergarten peers. Be-Prox, developed for Swiss kindergartens to prevent, uncover and handle negative behavior and bullying in kindergartens have been translated and adjusted to a Norwegian context in a previous pilot study.

The current project is a close collaboration between two Norwegian municipalities, regional centres for child and youth mental health and welfare, and research and educational institutions.

The project aims to evaluate the effectiveness of the Be-Prox Norway in a cluster randomized controlled trial, including process and implementation evaluation and cost-effectiveness analyses. Hence the project complies with the current call through introducing research on tools, systems and models that promote evidence-based practices in Norwegian kindergartens in general, and to prevent negative acts and bullying between kindergarten peers in particular.

If proven effective, Be-Prox Norway can be offered to kindergartens nationwide as evidence-based practice to prevent, uncover and handle negative behavior and bullying among Norwegian kindergarten peers.

Eligibility Criteria:
Inclusion Criteria:

* Children born 2018-2020 in kindergartens enrolled to the Be-Prox project and with parental consent to participate.
* Personnel i Norwegian kindergartens enrolled in the Be-Prox project and who consent to participate.
* Parents of children in kindergartens enrolled to the Be-prox project

Exclusion Criteria:

* children born 2021-2023
* children with no parental consent to participate
Burosumab and 1-25 (OH) Vitamin D on Human Osteoblasts

FGF23 is the cornerstone of phosphate / calcium / vitamin D metabolism: it is synthesized mainly by osteocytes and acts as a phosphaturizing agent, inhibitor of dihydroxyvitamin D, and inhibitor of synthesis and secretion of PTH in most tissues.

The specific role of FGF23 on bone has yet to be demonstrated. In osteoblasts, overexpression of FGF23 in vitro suppresses not only osteoblastic differentiation but also the synthesis of the mineralized matrix independently of its systemic action on phosphate metabolism. In osteoblasts, FGF23 also regulates the secretion of osteopontin by directly suppressing transcription of alkaline phosphatase.

In some diseases such as hypophosphatemic rickets (HR), the direct role of FGF23 on bone has not yet been studied to our knowledge, whereas these genetic hypophosphatemias are secondary to overexpression of FGF23, whether an activating mutation of FGF23 or inhibitory mutations of its inhibitors (DMP1 and PHEX). However, patients with X-linked hypophosphatemic rickets (XLH) have higher circulating FGF23 levels than healthy controls and these levels are higher in treated patients.

Management of XLH consists primarily of correcting the native vitamin D defect by prescribing active vitamin D analogs as well as phosphate supplementation to improve bone mineralization and decrease dental complications, growth, and bone deformities. Recently, a new therapeutic option has been developed for XLH, burosumab, a human monoclonal antibody that binds and inhibits FGF23 activity. The use of burosumab is currently authorized in France in some pediatric patients with severe forms of XLH.

Independently of the indirect bone effects of phosphate correction and vitamin D levels, the direct role of burosumab on bone cells has never been studied. The objective of this project is to study the osteoblastic biology of patients with RH compared to control patients, and to evaluate the direct impact of the treatments used in this pathology on human osteoblasts.


Eligibility Criteria:
Inclusion Criteria:

* Children from 4 months-old to 18 years-old
* Patients requiring craniosynostosis surgery followed by reference centers for rare diseases of calcium and phosphate metabolism / craniofacial malformations
* Patients and parent / holder of parental authority who have been informed of the study and do not object to participate

Exclusion Criteria:

* Patient being treated with oral corticosteroid or having received more than 3 months of corticosteroid treatment before surgery.
Train and EMPOWER a Community Health Workforce to Achieve Equity and Reduce Disparities in Mental Health

The investigators suggest a multi-step approach to improve access to mental health care for minority groups. The plan focuses on three goals: increasing diversity in the mental health workforce, bringing more expertise into the community, and strengthening the community's ability to address the factors that impact mental health.

To do this, the TEACH study team will work with students from underrepresented racial and ethnic groups at a minority-serving school. Students will be provided the opportunity to obtain their CHW Certification while receiving course credit for their degree. Students will then be eligible to participate in an internship to utilize their skills. The TEACH study team will help these students with their training, supervision, and ongoing support. These students will then be able to work with their communities to tackle common mental health issues and the social factors that contribute to those problems.


Eligibility Criteria:
Inclusion Criteria:

* Must be enrolled as a UTA undergraduate student with unmet internship hours
* Must be aged 18 and over
* Must be able to provide informed consent.
* Must have successful completion of the UTA CHW/EMPOWER course (Phase 2) and/or State of Texas CHW certification (for non-EMPOWER-trained CHWs) at the start of internship

Exclusion Criteria:

* Under 18 years
* Not enrolled as an undergraduate student at UTA
* Unable to provide informed consent
* Non-successful completion of EMPOWER course and/or State of Texas CHW certification at the start of internship
Endosonographic Shear Wave Elastography for Liver Stiffness

This is a single-center, prospective, non-randomized, comparative study which will compare the diagnostic accuracy and safety of endosonographic real-time Elastography and shear wave Elastography with the current standards of care, i.e. liver biopsy and Vibration-controlled transient elastography (Fibroscan). Subjects who are referred for an endoscopic ultrasound (EUS) guided liver biopsy will be prospectively enrolled to undergo liver biopsy, Elastography and/or Vibration-controlled transient elastography.


Eligibility Criteria:
Inclusion Criteria:

* Patients referred for EUS guided liver biopsy
* Elevated liver enzymes without obvious etiology, thus necessitating liver biopsy or clinical concern for cirrhosis or NASH requiring histological confirmation
* Ability to provide informed consent and willing to participate

Exclusion Criteria:

* Clinical evidence of cirrhosis which obviates need for liver biopsy
* Noninvasive lab testing which confirms presence of cirrhosis
* Surgically altered foregut anatomy which precludes safe endoscopic liver biopsy
* Coagulopathy with INR greater than 1.6 in patients on anticoagulant therapy
* Thrombocytopenia with platelet count less than 50,000/mL
* Pregnancy (positive urine pregnancy test in females of childbearing age)
* Lack of consent