cyrilzakka/clinical-trials huggingface dataset:
Surveillance Imaging Modalities for Breast Cancer Assessment

The purpose of this study is to determine the effectiveness of surveillance breast MRI compared to mammography alone in women with a personal history of breast cancer

Our overall aim is to find out how well MRI works compared with mammography for surveillance in women who have previously had breast cancer. Specifically, our goals are to:

1. Understand doctors' and patients' experiences with surveillance mammography and MRI
2. Provide evidence on which outcomes are more or less likely to occur
3. Develop patient decision aids to help women and their doctors choose the surveillance method that is right for them

How we will conduct the study: We will work with patients, doctors, policy makers, advocacy groups, and researchers to improve surveillance for women who have a personal history of breast cancer. Through focus groups with patients and interviews with doctors, we will gain insights into women's experience with surveillance mammography and MRI. We will also compare mammography to MRI using data from the Breast Cancer Surveillance Consortium-the largest collection of breast cancer surveillance data in the nation. We will use data from more than 13,000 women diagnosed with breast cancer between 2005 and 2012 to determine how well each test works. We will measure the tests' effectiveness at finding second cancers, and estimate the likelihood of different outcomes. We will also determine whether one test appears to work better than the other to detect second breast cancers among different groups of women. We will then develop patient decision aids to help women and their doctors make more-informed choices about surveillance.

What we hope to achieve: We hope this study will improve medical decision making and care for the 3 million women in the United States who have a history of breast cancer. Specifically, our results will help women and their doctors make clearer, better choices about the surveillance method that is right for them.

Eligibility Criteria:
Inclusion Criteria: Surveillance imaging exams in women included in the Breast Cancer Surveillance Consortium who are 18+ years of age at the the of a Stage 0-III incident breast cancer diagnosis between January 1, 2005 and December 31, 2012.

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Exclusion Criteria:

* Women with a diagnosis of lobular carcinoma in situ
* Women with missing cancer staging data from Surveillance, Epidemiology and End Results (SEER) Program records
* Women with Stage 4 breast cancer at time of diagnosis
* Women with a diagnosis of a second breast cancer event within six months of the primary diagnosis
* Women who die within six months of primary diagnosis
* Women who have had a double mastectomy
Comparison of the Clinical Efficacy of 2 Paravertebral Block Strategies in Thoracic Surgery by Thoracotomy: by the Anesthetist (Paravertebral Block Guided by Ultrasound) and by the Thoracic Surgeon (Paravertebral Block Visual)

Post-thoracotomy pain is one of the most severe. The local analgesia allows its effective control and a reduction of postoperative morbidity and mortality.

The gold standard for local analgesia is the thoracic epidural. However, this technique can be dangerous with severe complications.

The paravertebral block showed comparable efficacy to the thoracic epidural for local analgesia . In addition, it has a better safety profile. There are several installation techniques. The difference in efficiency of these laying techniques is unknown.

Compare the clinical effectiveness of two strategies of realization of paravertebral block: by the anesthetist before incision (paravertebral block guided by ultrasound) and by the thoracic surgeon at chest closure (paravertebral block visual).

Eligibility Criteria:
Inclusion Criteria:

* patient with thoracotomy indication for segmentectomy (s), lobectomy (s) lung or pulmonary wedge resection
* patient consenting to participate to the study
* patient enrolled in the national healthcare insurance program
* patient older than 18 years

Exclusion Criteria:

* patient with neuropathy
* patient with body mass index superior to 35 kg/m2
* patient with contraindication for paravertebral block or local analgesia
Neurofibromatosis Type 1 (NF1) and Tibial Dysplasia

The study is a multicenter four-year outcome study of the natural history of tibial dysplasia in patients with NF1 and selected patients without NF1. We will obtain information on the natural history, burden, functional and health status, health-related quality of life, and surgical interventions/outcomes of tibial dysplasia. The project will also establish a Core Facility (NOCF) for tissue samples for future studies.

The three specific aims of this study are:

* Specific Aim 1 - To assess health status and health - related quality of life (HRQL) in 50 children and adolescents with NF1 and tibial dysplasia and in NF1 controls. We hypothesize that children and adolescents with NF1 and tibial dysplasia will experience an additional burden of morbidity due to tibial dysplasia and a downward trajectory of health status and HRQL over time.
* Specific Aim 2 - To assess the long term outcome of current treatment in 100 adult patients diagnosed with NF1 and tibial dysplasia in childhood. We hypothesize that better quality of life and function, in adults with NF1 and tibial dysplasia, are associated with amputation in childhood compared to multiple surgical procedures, the lack of fibular involvement, and fracture later in childhood. We also hypothesize that individuals with NF1 and tibial dysplasia have a higher risk of other bony dysplasias but are at no higher risk of fracture in other bones.
* Specific Aim 3 - To assess the natural history and short-term response to therapy in a cohort of at least 60 children with NF1 and tibial dysplasia and at least 60 children with tibial dysplasia presumably without NF1 prospectively diagnosed during the course of the four-year study period. We hypothesize that NF1 patients with earlier presentation, Crawford Class II A-C, male gender, and the lack of bracing prior to age two are more likely to fracture. We also postulate that individuals with and without NF1 have a similar outcome and response to treatment.

The results of this project will provide a rational basis for future clinical and therapeutic trials.

Eligibility Criteria:
Inclusion Criteria:

* Aim 1:

  * Group 1, NF1 with Tibial Dysplasia, Ages: 3-18
  * Group 2 (control), NF1 without Tibial Dysplasia, Ages 3-18
* Aim 2: NF1 with Tibial Dysplasia, 19+
* Aim 3: Tibial Dysplasia with or without NF1, Ages: birth to 18
* Tissue procurement, any participant undergoing surgery at the tibial site for routine standard of care

Exclusion Criteria:

* Patients without a diagnosis of NF1 or Tibial Dysplasia
Comparative Evaluation of Handling Characteristics of Two Adrenaline Autoinjectors,EpiPen in Comparison With Jext

The purpose of the study is to demonstrate non-inferiority of Jext compared with EpiPen for the proportion of subjects with a successful self-injection. And to evaluate and compare the handling characteristics of two auto-injectors (Jext and EpiPen).


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent obtained before entering the study 1
* Prescription of EpiPen or AnaPen for at least 2 months
* Age ≥16 years
* Body weight \>50 kg
* Subject willing and able to comply with study protocol

Exclusion Criteria:

* Any of the following concomitant diseases: cardiovascular disease, e.g. arrhythmias or signs of coronary atherosclerosis, heart failure, uncontrolled hypertension, uncontrolled diabetes mellitus, cancer, hyperthyroidism, severe renal impairment
* Known blood-born infection, e.g. hepatitis and/or HIV
* Concomitant treatment with medication which may potentiate the effect of adrenaline, e.g. catechol-O-methyl transferase (COMT) inhibitors, monoamine oxidase (MAO) inhibitors and tricyclic antidepressants
* Pregnancy
* Being immediate family of the investigator or study staff, defined as the investigator's/staff's spouse, parent, child, grandparent or grandchild
Is Mitral Velocity Time-integral a Marker of Preload-responsiveness in Patients With Acute Circulatory Failure?

The aim of this is to assess the reliability of the variability of the mitral velocity time-integral with passive leg raising to predict the fluid responsiveness in patients with acute circulatory failure in intensive care.

Adult patients with acute circulatory failure will be included in the study. An initial echocardiography is performed in patients placed in a semi-recumbent position. On the apical views (4 and 5-chamber views), the left ventricular outflow tract velocity time integral (LVOT-VTI) and mitral valve (MV-VTI) velocity time integral are measured (baseline values). Then a passive leg raise test is performed and the parameters (LVOT-VTI and MV-VTI) are measured again. Preload-responsiveness is defined by an increase in LVOT-VTI of at least 10%. In preload-responsive patients, a fluid loading with 500 ml of 0.9% saline administered over 15 minutes is performed. Immediately after fluid therapy, the same parameters are recorded during a third echocardiography. An increase of 10% or more of LVOT-VTI , compared with baseline, defines fluid responsiveness. Patients are monitored using the standard of care practices. Hemodynamic assessment includes repetitive echocardiographic examinations if needed. In patients with shock, invasive blood pressure is monitored with an arterial catheter.

Eligibility Criteria:
Inclusion Criteria: Acute circulatory failure.

Exclusion Criteria:

* Recent surgery (\<5 days)
* Suspected or confirmed intra-abdominal hypertension.
* Intracranial hypertension.
* Severe mitral valve disease: Severe mitral insufficiency or severe mitral stenosis
* Acute cor pulmonale
* Atrial fibrillation
* Low echogenicity
Virtual Reality Exercise on COPD Patient

The program allows the patient to interact with the simulated VR technology using motion sensors, focusing on patients' fitness through various tests providing them a clinically stable environment; to counter moderate level of diseases according to GOLD criteria and to monitor the effects of exercise program on dyspnea. The purpose of this study is to facilitate the patients so that they get acquainted with the digital technology with significant contribution towards pulmonary rehabilitation program for COPD patients. It also analysis the satisfaction of the patients and encourages the use of emerging technology integrated with clinical trials.

Chronic obstructive lung disease (COPD) is a reversible lung disease which is a principal cause of morbidity and mortality worldwide. It is the third leading cause of death worldwide according to the reports of American Thoracic Society (ATS) and European- Respiratory Society. According to World Health Organization (WHO), every year death and in 2030 it will become the third most common cause of death. COPD risk factors includes smoking tobacco, exposure to dusts, hereditary predisposition, and fumes, indoor and outdoor air pollutants, ageing, and asthma. Out of all these risk factors, the main reason that develops COPD fastest is smoking which is further linked with depression

Eligibility Criteria:
Inclusion Criteria:

* Age:50-70 years
* Both genders
* Clinical Signs and Symptoms of Moderate COPD (GOLD Criteria)
* Clinically Stable
* Ratio of FEV1/ FVC is \<0.7
* Reported Smoking History

Exclusion Criteria:

* Pneumonia, tuberculosis, and other respiratory
* inflammatory disease
* Heart Failure
* Advanced Uncontrolled Hypertension
* Post Cardiac or Thoracic Surgery (\< 6 Months)
* Neuromuscular Disorders
* Metal Implant in Lower Limb
* Cardiac Pacemaker
* Cognitive Dysfunction or Mini-Mental Scale Scores \<24
* Long- term Non-Invasive Ventilation
* Comorbidity that could Limit Exercise Testing and Training i.e., Arthritis, Osteoporosis, Fracture, Diabetic Neuropathy etc.
Tdap Vaccine Safety for Plasma Donors

This is a prospective, open label, single-arm, multi-center, Phase 1 study measuring the safety and tetanus antibody responses to Tdap vaccine administered to plasma donors every 3 months ±1 week for 12 months (5 vaccinations) with a 6 month follow-up after the last vaccination. After obtaining informed consent and screening for eligibility including plasmapheresis donor eligibility, subjects will have other baseline assessments performed and if eligible, will receive the scheduled vaccinations, will be assessed for adverse events (AEs) and have plasma samples collected for antibody titers each month thereafter for 11 months, and then at 1 and 6 months after the last vaccination. As these subjects are participating in a standard donor plasmapheresis donor program, assessments for donor eligibility and routine plasmapheresis will be performed; however, only the data specifically required to meet the objectives of this study will be collected.


Eligibility Criteria:
Inclusion Criteria:

* Male or female ages 18 to 63 years
* Females of childbearing potential who agree to employ adequate birth control measures during the study
* Signed the informed consent form (ICF)
* Met all of the criteria required by GCAM to be a Normal Source Plasma donor
* Subject is not participating in any other immunization program

Exclusion Criteria:

* Subject is pregnant
* Subject has a condition or abnormality that in the opinion of the Investigator would compromise the safety of the subject or the quality of the data
* Subject has repeated reactions or hypersensitivity to components in the vaccine (e.g., thimerosal, latex, etc.)
* Subject has history of a severe reaction to any immunization
* Subject has a history of Guillain-Barré Syndrome
* The Investigator concludes that the anticipated vaccination site (deltoid area) is not suitable for AE assessment
Femorofemoral Bypass in Redo Cardiac Surgery

Redo cardiac surgery are becoming more common with a patient population at greater risk. Sternal re-entry poses the hazard of probable injury to vital structures. To minimize the risk associated with sternal re-entry, the investigators adopted the method of establishing femoral artery-femoral vein cardiopulmonary bypass (CPB).

Redo cardiac surgery are more frequent with a patient population at greater risk. Repeat sternal entry poses the risk of possible injury to vital structures. These include laceration of the myocardium, especially the right ventricle, injury of great vessels or crossing coronary bypass grafts as the internal mammary grafts in particular, or dislodgement of emboli from patent vein grafts. To minimize the risk associated with sternal re-entry, the investigators adopted the method of establishing femoral artery-femoral vein cardiopulmonary bypass (CPB) in order to achieve cardiac drain prior to sternotomy. Also, femorofemoral bypass support the hemodynamics in cases of redo emergency cardiac surgery.

Eligibility Criteria:
Inclusion Criteria:

* 25-65 years old
* Patients scheduled for repeat open heart surgery with sternotomy
* informed consent has been obtained

Exclusion Criteria:

* Planned off-pump cardiac surgery
* Vascular disease
* previous operation on femoral artery
* under 25 years of age
Use of a Collagen Membrane for Soft Tissue Grafting

Is PriMatrix wound dressing capable of regenerating gum tissue inside the mouth?

PriMatrix is an acellular fetal bovine dermal matrix that has a wide array of FDA approved uses. These uses include partial- and full-thickness wounds, pressure, diabetic, and venous ulcers, surgical wounds, trauma wounds, tunneled wounds, and draining wounds. It is a sheet-like matrix made up primarily of type I and type III collagen. An increased proportion of type III collagen appears to play a key role in healing and regeneration.

The use of extracellular dermal matrices is a relatively young field, and the exact mechanism by which PriMatrix promotes skin regeneration is still unknown. Despite this, PriMatrix has demonstrated differences in manufacturing and molecular composition that make it conducive to the harsh environments in which it has already been tested. Intraorally, where there is a rich vascular bed, this material holds exceeding promise.

Utilizing this vascularity, autogenous free gingival grafts from the palate have already had their efficacy proven as a method of augmenting the keratinized tissue.The need to increase the keratinized tissue is based upon the postulation that less mobile, keratinized epithelium is more resilient than the non-keratinized oral mucosa. This is especially important in areas where recession and attachment loss has already occurred. Without having keratinized gingiva apical to the recession area, it has been suggested that there is a greater risk for more attachment loss to occur, thus reducing the support for the tooth. In addition, autogenous free gingival grafts have demonstrated the phenomenon of "creeping attachment" where a portion of the recession actually becomes covered as a result of grafting.

While autogenous grafting is the gold standard in soft tissue augmentation, the amount of tissue that can be taken from the palate is limited, making it difficult to treat patients with generalized recession. Furthermore, a secondary surgical site increases the morbidity associated with the procedure. The hypothesis of this study is that PriMatrix will be able to provide similar results to an autogenous free gingival graft.

Eligibility Criteria:
Inclusion Criteria:

* Must have one to three consecutive teeth with recession and less than 1 mm of keratinized gingiva

Exclusion Criteria:

* Asthma
* Pregnancy
* Uncontrolled diabetes
* Use of continuous positive airway pressure (CPAP) machine for sleep apnea
* Oral appliances (removable partial dentures, braces, mandibular advancement, bruxism splints, etc.)
* Tobacco use
* Immunocompromised individual
Fruit and Vegetable Intake Promotion. "The UVa Community Eats Healthy" Study Protocol (University of Valladolid)

The goal of this randomized controlled trial is to increase the consumption of fruit and vegetables of the University of Valladolid (UVa) community employing three different online methodologies: facebook (FB), virtual campus (VC) and, instagram (IG).

In order to use different methodologies, the sample was randomly divided in four groups, three took the nutrition educational program and the other one was a control group.

All four groups had access to the virtual campus of the UVa which uses the teaching platform Moodle Learning Management System (LMS). In this platform, a course entitled "The UVa community eats healthy" was created with four sections. Each of the sections corresponded to one of the four groups, the names of the sections were: I-campus (VC group), C-campus (control group), F-campus (FB group), and G-campus (IG group).

To make the intervention more effective, this program was theory-based designed, based on the theory of planned behaviour (TPB).

In order to assess the effectivity of social media use for nutrition education compared to more traditional interventions, the program was adapted to three platforms: virtual campus, private account of IG and private group of FB. The topics of the intervention groups were the same but with adapted activities.

Eligibility Criteria:
Inclusion Criteria:

* being part of the UVa community at the time of recruitment
* having IG and/or FB account
* having made the self-registration to the Moodle virtual campus of each group during the enrolment period

Exclusion Criteria:

* not meeting inclusion criteria
Study of Two-step Anesthesia in Posterior Vitrectomy

A prospective, randomised, single-masked comparison of local anaesthetic approaches including topical anesthesia combined sub-conjunctival anesthesia(two-step anesthesia) for minimally invasive vitrectomy（TAMIV）vs peribulbar block vs retrobulbar block

Purpose: topical anesthesia combined sub-conjunctival anesthesia(two-step anesthesia) for minimally invasive vitrectomy Methods: This prospective, randomized, single-blinded clinical trail is conducted at Shanghai Aier Eye Hospital. Selected group of 60 patients with retinal-vitreous diseases will be randomized divided into 3 groups and underwent 25-gauge vitrectomy. Group1 uses two-step anesthesia , whereas Group 2 uses retrobulbar anesthesia, group 3 uses peribulbar anesthesia. A 5-point Visual Analogue Pain Scale is used to assess patients' pain score and surgeon's ease while operating. Any complications therefore will be made note of.

Eligibility Criteria:
Inclusion Criteria:

* Proliferative diabetic retinopathy (PDR);
* Vitreous haemorrhage (VH);
* Retinal detachment (RD);
* Retinal vein occlusion(RVO);
* Other diseases (idiopathic macular hole, macular pucker and high myopic maculopathy);
* Silicone oil-filled eye.

Exclusion Criteria:

* Communication problems;
* Allergy to amide-type local anaesthetic agents;
* History of vitreoretinal surgery or orbital surgery;
* Orbital deformity;
* With episcleral adjunct surgery;
* Trauma;
* Keratitis;
* Conjunctivitis and active uveitis.
VYxeoS Liposomal Italian Observational Study iN the Real Practice

The study is a prospective, single-arm, non-experimental, observational study in patients in Italy with Acute Myeloid Leukaemia (AML) with myelodysplastic-related changes or therapy related AML initiating treatment with JZP351 (Vyxeos liposomal) in their normal clinical practice.


Eligibility Criteria:
Inclusion criteria:

* Patients newly diagnosed with AML-MRC (Acute myeloid leukemia with myelodysplasia-related changes) or t-related AML (Therapy related Acute myeloid leukemia) following 2016 World Health Organization (WHO) classification.
* Age ≥ 18 years old.
* Patients considered eligible for intensive chemotherapy in the opinion of the treating physician.
* Patients who will initiate the treatment with commercially JZP351 treatment after the Informed Consent Form (ICF) signature. The decision to prescribe JZP351 treatment must have been made prior and regardless of the enrollment of the patient in the study.
* Cardiac ejection fraction ≥ 50% by echocardiography or MUGA (Multi-Gated Acquisition).

Exclusion criteria:

* Prior treatment intended for induction therapy of AML (Acute Myeloid Leukemia).
* Patients with prior cumulative anthracycline exposure of greater than 368 mg/m2 daunorubicin (or equivalent)
* Clinical evidence of active CNS (Central Nervous System) leukemia.
* Patients with active (uncontrolled, metastatic) second malignancies.