cyrilzakka/clinical-trials huggingface dataset:
New Breath Actuated MDI Symbicort Compared to Symbicort pMDI and Budesonide pMDI for 12 Weeks Twice a Day

This is a comparison of the efficacy of the Symbicort breath actuated dose inhaler to the Symbicort pressured meter dose inhaler after 12 weeks of a twice a day dose.


Eligibility Criteria:
Inclusion Criteria:

* Male or female 12 years and above
* Clinical diagnosis of asthma according to the American Thoracic Society definition at least 6 months
* Pre-bronchodilator FEV1 ≥ 45% and ≤ 85% of predicted normal
* Patients with reversible airway obstruction
* Documented daily use of inhaled corticosteroids for ≥ 3 months

Exclusion Criteria:

* History of life-threatening asthma, defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnea, respiratory arrest or hypoxic seizures during the 2 years prior to Visit 2
* Hospitalized during previous 6 months for asthma
* Required emergency treatment more than once during previous 6 months for an asthma-related condition
* Intake of oral, rectal or parenteral glucocorticosteroid within 30 days of enrolment
* Respiratory infection affecting the asthma within 30 days
Prediction of Stroke-associated Pneumonia

Stroke-associated pneumonia (SAP) constitutes a clinically relevant complication of stroke, because it increases the mortality and has a negative impact on the neurological prognosis of the patient.

An early identification of patients at risk for SAP allowing an early initiation of antiinfective therapy may improve the prognosis. To date, no reliable prediction models or clinical scores for stroke-associated pneumonia exist. Recently, it was shown that parameters indicating an impaired immune function are associated with the subsequent occurrence of SAP and could therefore be used as predictors for SAP.

This study will develop and prospectively validate a prognostic score to predict SAP based on clinical parameters. Furthermore, the study examines the prognostic properties of selected immune and infectious parameters for the prediction and diagnosis of SAP. The study will further address the question whether these infectious and immune parameters predict the 3-month-outcome. In a subgroup of patients, MRI parameters on stroke size and localization will be assessed to investigate whether these parameters might allow prediction of SAP or the 3-month-outcome.


Eligibility Criteria:
Inclusion Criteria:

* ischemic stroke in the anterior (ACA, MCA) and posterior cerebral circulation (PCA, BA) of any severity
* stroke onset within the last 36h
* age ≥ 18
* consent by the patient or the legal representative

Exclusion Criteria:

* intracranial hemorrhage
* signs of infection at admission (clinical / paraclinical)
* pre-existing dysphagia
* mechanical ventilation at admission
* participation in an interventional trial
Evaluating the Effect of Mucinex 1200mg on Mucociliary and Cough Clearance During an Acute Respiratory Infection

The purpose of this research study is to explore the mechanism of action of Mucinex, an oral, over-the-counter, FDA approved expectorant in patients with acute respiratory tract infections.


Eligibility Criteria:
Inclusion Criteria:

* Symptoms of cough, thickened mucus and chest congestion
* Able to produce sputum
* Non Smoker

Exclusion Criteria:

* Pregnant
* Smokers
* Fever above 101°F
* Any chronic illness
Administration of Virus Specific CTLs for the Prophylaxis and Treatment of EBV/CMV Infections After HSCT in China

Cytomegalovirus (CMV) and Epstein Barr Virus (EBV) cause significant morbidity and mortality in hematopoietic stem cell transplantation (HSCT) patients in China. Antiviral drugs given either prophylactically or as early therapy for patients with detectable viral loads appear to be an effective strategy for reducing viral infections. However, long-term treatment with these drugs is associated with significant toxicity, expense and the appearance of drug resistant virus isolates ultimately resulting in treatment failure. CMV and EBV specific T cells infusion to immunocompromised patients following HSCT is able to induce a successful anti-viral response. The primary purpose of this study is to determine the safety and efficacy of the infusion of CMV and EBV specific cytotoxic T cells (CTLs) for patients with CMV and EBV reactivation or infection.

To generate CMV/EBV specific CTLs, G-CSF mobilized hemopoietic progenitor cell (G-HPC) products or nonmobilized peripheral blood apheresis collectings were stimulated with CMV/EBV specific peptides covering most HLA alleles among Chinese populations. Once the investigators made sufficient numbers of T cells, they tested their ex vivo properties.Then a fraction of CTLs were separated for immediate infusion and the others were frozen for further infusion.

If the donor was available, the donor derived CTLs were started to produce when CMV reactivation was detected by qPCR in recipients peripheral blood. Otherwise, autologous CTLs were used. For patients at high risk of developing CMV/EBV infections after stem cell transplantation, a small part of G-HPC products was extracted for CTLs generation.

Eligibility Criteria:
Inclusion Criteria:

* Patients with any type of allogeneic HSCT
* CMV, adenovirus or EBV activation or infection which is defined as below. EBV/CMV reactivation is defined as CMV/EBV DNA levels \> 1000 IU/ml for a single test or \> 500 IU/ml for two consecutive tests. EBV/CMV related disease were defined as the demonstration of CMV/EBV biopsy specimen or clinical diagnosis through symptoms, signs or radiography.
* Written informed consent and/or signed assent line from patient, parent or guardian
* Positive CMV or EBV serology of the donor
* Absence of severe renal disease (Creatinine \> 3x upper limit normal)
* Absence of severe hepatic disease (Bilirubin \> 3x upper limit normal, AST \> 3x upper limit normal)
* Life expectancy \> 30 days

Exclusion Criteria:

* Active acute GVHD grades II-IV
* Received donor lymphocytes infusion(DLI) within 30 days
* Received ATG or other immunosuppressive monoclonal antibodies within 30 days
* Uncontrolled acute infections
* Active and relapse of malignancy
* Received steroids treatment more than 0.5 mg/kg/day prednisone
Automatic Adjustment for Asynchronies During Mechanical Ventilation

Asynchronies between the patient and the artificial ventilator are a frequent problem. They may cause altered sleep, ventilator-induced lung injury, prolong length of ICU stay, cause neuro-psycologic complications and increase mortality. Although reducing their incidence through ventilator setting adjustments is possible, they frequently go undetected and it also requires that attendings remain at the bedside to repeatedly modify ventilator parameters. Ventilator systems may detect and automatically adjust parameters of mechanical ventilation. This would avoid delays in detection and adjustment if the intensivist is not immediately available. The investigators intend to study an automatic detection and adjustment tool which is incorporated in the ventilator software.

The prevalence and time course of asynchronies will be evaluated in subjects under invasive (n=40) or non-invasive (n=40) mechanical ventilation. Intensivist-optimized ventilator settings will be compared to a software tool (Hamilton ventilators, Intellisync+) in its capacity to control and adjust the triggering and cycling by analysis of the ventilator curves.

The outcome variable is the percentage of the duration of asynchronies during the two 2-hour study periods.

This pilot study has a prospective, randomized cross-over design. The order of the 2 study periods will be randomized to either start with "control" with manual adjustment or "automated adjustment" with Intellisync+.

The total sample size is 80 subjects, 40 receiving invasive mechanical ventilation and 40 on non-invasive mechanical ventilation.

Eligibility Criteria:
Inclusion Criteria:

* Age \>17 years
* Partial ventilatory support ("SPONT" mode) connected to Hamilton C1 model, irrespective of chronic restrictive or obstructive lung disease, categorized by RCexp (Expiratory time constant): restrictive (RCExp \<0.6); obstructive (RCExp \>0.9); normal (RCExp 0.6 - 0.9).
* Software version SW3.0.0 or superior and the IntelliSync+ software tool available in invasive and non-invasive ventilation.
* Presence of asyncronies in pressure and volume curves tracings of the ventilator.
* Signed informed content.

Exclusion Criteria:

* Pregnant
* On extracorporeal respiratory support (ECMO or ECCO2R)
Safety and Performance of REGENERA Breast Implant in Women Affected by Malignant Breast Lesion Treated by Lumpectomy

The goals of this clinical trial are:

* demonstrate the safety of REGENERA breast implant in patients undergoing lumpectomy of malignant breast lesions
* demonstrate the safety and performance of REGENERA in terms of investigator's satisfaction, potential interference with current standard-of-care imaging techniques and occurrence of device-related serious adverse events.

Participants will perform 13 study visits, and at each visit, all necessary study procedures will be performed according to the clinical investigation plan:

* Screening
* Pre-surgery treatment
* Surgery and study device implant
* Post-surgery follow-up up to 5 years

Eligibility Criteria:
Inclusion Criteria:

* Female adult subject aged 40-70 years.
* Subject diagnosed with malignant breast lesion:
* monolateral nodular infiltrative carcinoma,
* without microcalcification,
* single or multifocal,
* included in an area with a maximum diameter of 4 cm,
* non-metastatic (M0).
* Subject with clinically negative axilla.
* Subject considered eligible for conservative breast surgery - BCS (Breast-Conserving Surgery, lumpectomy or quadrantectomy), leaving a volume deficit compatible with a REGENERA implant (available in two dried sizes) volume of 70 ml or 100 ml.
* Confirmation of malignant lesion (pT1, pT2, pN0, pN1) with no discordance between biopsy and radiological imaging.
* Adequate hematopoietic functions.
* Good general health and mentally sound.
* Subject able and willing to give written informed consent form.

Exclusion Criteria:

* Subject with actual concomitant benign breast lesion (B2 and B3), unless present in the same mammary quadrant or in the contralateral breast.
* Subject with actual concomitant malignancies, lobular neoplasm, metastatic breast carcinoma, sarcoma, malignant phyllodes lesions, or Paget's disease.
* Axillary dissection planned as part of the breast lesion surgery.
* History of surgery, chemotherapy, neoadjuvant chemotherapy, or irradiation of the breast parenchyma object of the study.
* Skin retraction at the breast to be operated.
* Infection of the surgical site confirmed pre-operatively by clinical examination.
* Abnormal blood sugar and glycosylated hemoglobin.
* Hard smoker (more than 10 cigarettes a day).
* Acute or chronic severe renal insufficiency (creatinine values \>180 μmol/l).
* History of severe asthma or allergies (including allergy to anesthetics or contrast media).
* Autoimmune disease.
* Subjects who are known to be carriers of BCRA mutation.
* Inability to undergo MRI or allergy to contrast media.
* Systemic infections in an active phase.
* Immunocompromised patients (HIV).
* Pregnant or breastfeeding woman or woman who has nursed a child within 3 months prior to enrolment in the study.
* Subject who has participated in another interventional study within the past 3 months.
* Subject who received immunosuppressant therapy in the last 3 months.
* History of substance abuse (drug or alcohol).
* Non-collaborative patients (severe physical disabilities or psychiatric disorders, as per specialist opinion).
MRI in Assessing Hypoxia in Patients With Localized Prostate Cancer Undergoing Stereotactic Body Radiation Therapy

RATIONALE: Diagnostic procedures, such as MRI, may help measure oxygen levels in tumor cells. It may also help doctors predict a patient's response to treatment and help plan the best treatment.

PURPOSE: This clinical trial is studying how well MRI works in assessing hypoxia in patients with localized prostate cancer undergoing stereotactic body radiation therapy.

OBJECTIVES:

* To characterize the status of global hypoxia within the prostate before stereotactic body radiotherapy (SBRT) as assessed by blood-oxygen-level-dependent and tissue-oxygen-level-dependent MRI.
* To characterize tumor vasculature and metabolism within the prostate before SBRT as assessed by dynamic contrast-enhanced MRI and magnetic resonance spectroscopic imaging, respectively.
* Correlate prostate and normal tissue hypoxia before SBRT with clinical outcomes (toxicity and biochemical \[PSA\] control) after SBRT.

OUTLINE: Within 1-3 weeks before beginning stereotactic body radiotherapy, patients undergo T2-weighted anatomic MRI, magnetic resonance spectroscopic imaging, blood-oxygen-level-dependent and tissue-oxygen-level-dependent MRI, and dynamic contrast-enhanced MRI.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Biopsy proven adenocarcinoma of the prostate

  * Localized disease
* Scheduled to undergo treatment with stereotactic body radiotherapy (SBRT) on a phase II clinical trial

  * Has not yet started SBRT

PATIENT CHARACTERISTICS:

* Serum creatinine ≤ 1.2 mg/dL
* No claustrophobia
* No other contraindication to MRI (e.g., implanted pacemaker device)
* No known allergy to MRI contrast

PRIOR CONCURRENT THERAPY:

* No prior treatment for prostate cancer (e.g., hormonal therapy or chemotherapy)
QuantiFERON-CMV Test in a Prediction for Colic Cytomegalovirus Reactivation During Ulcerative Colitis

CytoMegaloVirus (CMV) infection impairs evolution of Ulcerative Colitis (UC) leading to more severe and resistant to immunosuppressive therapies flare-up. CytoMegaloVirus (CMV) reactivation is assessed by the quantification of the CytoMegaloVirus (CMV) DeoxyriboNucleic Acid (DNA) load by real-time PCR (qPCR) in colonic biopsies; this assay is invasive and costly. The QuantiFERON-CytoMegaloVirus (QF-CMV) assay measures the immune response against CytoMegaloVirus (CMV) in a blood specimen.

This study aim to evaluate the performances of this new assay to predict the risk of CytoMegaloVirus (CMV) reactivation in the colon of UC patients. A new algorithm for the care of Ulcerative Colitis (UC) patients that could be used in all centers, even those without molecular biology lab, could be proposed: in case of a positive QuantiFERON-CytoMegaloVirus (QF-CMV) assay, the immune response protects the patient against Cytomegalovirus (CMV) reactivation and intensification of immunosuppressive therapies should be proposed; at the opposite, a negative QuantiFERON-CytoMegaloVirus (QF-CMV) assay will invite to biopsy in order to detect CytoMegaloVirus (CMV) replication and to treat with ganciclovir when appropriate. This algorithm will preserve invasive biopsies in absence of CytoMegaloVirus (CMV) tissue reactivation.

Eligibility Criteria:
Inclusion Criteria:

* Patient with seropositive for CytoMegaloVirus (CMV) (IgG+)
* Patient requiring hospitalization for flare of Ulcerative Colitis (UC) with Mayo score \> 5 and an endoscopic subscore ≥ 2
* Social security affiliation
* Signed informed consent

Exclusion Criteria:

* Wardship patient and curatorial patient
* Patient unable to understand or sign the protocol
* Colectomy total or partial
Using Tissue-based Spatial Data to Understand How Obesity-related Tumor Metabolites Fuel Prostate Cancer Progression

Evaluate the protein expression of lactate dehydrogenase enzyme (LDHA) and MCT-1/-4 transporters, involved in lactate synthesis and transport, in prostate carcinoma tissues from severely overweight/obese (BMI \> 27.5) and non-severely overweight/normoweight (BMI \< 27.5) patients affected by prostate carcinoma.

ii. Characterize the immune infiltrate in the prostate carcinoma of the aforementioned patients.

iii. Assess the association between intra-tumoral lactate accumulation (using LDHA and MCT-4 protein expression levels as readouts) and alterations in the tumor immune microenvironment and/or deregulation of relevant oncogenic pathways.


Eligibility Criteria:
Inclusion Criteria:

* affected by prostate cancer

Exclusion Criteria:

-
Efficacy of the CMI Magnetocardiograph in Diagnosing Acute Coronary Syndromes in Patients Presenting With High Risk Unstable Angina.

A magnetocardiograph (MCG) is a device capable of recording of magnetic fields arising from the electrical activity of the heart with traces similar to an electrocardiogram (ECG). This system was developed as a noninvasive, non-contact diagnostics of obstructive coronary artery disease (CAD), and especially of lack of oxygen in the heart as in a heart attack. The overall objective of this study is to demonstrate the efficacy of this MCG device for the detection and diagnosis of lack of oxygen of the heart in patients with chest pain.

Coronary Artery Disease is the leading cause of death in the United States. The non invasive detection of Acute Coronary Syndromes (ACS's) remains a clinical challenge. Electrocardiogram (ECG) may only diagnose myocardial infarction in 50 % of the cases. Magnetocardiography is a new and noninvasive method capable of measuring and mapping the magnetic field that is generated during the cardiac cycle. The electric current is affected by ischemic damage, which in turn alters the magnetic field. The magnetic field is not affected by body tissues, unlike the surface current measurements in ECG.

Comparisons: The diagnostic accuracy of the CMI-Magnetocardiograph will be compared to that of the ECG in diagnosing High Risk Unstable Angina.

Eligibility Criteria:
Inclusion criteria:

* Patients classified as having High Risk Unstable Angina according to the ACCIAHA guidelines.
* Age ≥ 18 years.

Exclusion criteria:

* Hemodynamically unstable patients.
* Patients who just prior to or just after admission exhibit tachycardia with heart rates exceeding 150 bpm.
* Patients with third degree AV Block.
* Patients with pacemakers or internal cardiac defibrillators.
* Patients who cannot lie in a supine position for the MCG examination.
* Patients who refuse entry into the registry
Health and Faith (Salud y Fe): Community-Based Diabetes Pilot Intervention

Main objective: To improve diabetes outcomes among Mexican-Americans with diabetes through church-based, culturally tailored, diabetes self-management interventions linked to the local healthcare system.

Specific Aim: To pilot test a church-based, culturally tailored diabetes self-management intervention to improve diabetes outcomes among low-income Mexican-American with diabetes

H1 A church-based diabetes self-care management curriculum partnered with the local healthcare system will improve glycosylated hemoglobin.

H2 A church-based diabetes self-care management curriculum partnered with the local healthcare system will improve systolic blood pressure and low-density lipids.

H3 A church-based diabetes self-care management curriculum partnered with the local healthcare system will improve diabetes related self-efficacy, self-empowerment and self-care management.

Diabetes is a very prevalent and morbid condition affecting Latinos, especially Mexican-Americans in the United States. South Lawndale, a predominately-Mexican neighborhood of Chicago, has a disproportionately high diabetes related mortality rate in comparison to the rest of Chicago and the U.S. Many church-based interventions have shown promise improving health outcomes among minority populations; but data on church-based interventions for Latino populations is scarce. Mobilizing community resources to develop church-based, diabetes self-management interventions may lead to sustainable, culturally tailored interventions, and improve outcomes in Latinos with diabetes. Considering the growth of the Hispanic population and their disproportionate burden of chronic diseases, developing programming aimed at decreasing the health disparities in this population is crucial. Our study proposes to fill this gap.

Eligibility Criteria:
Inclusion Criteria:

* over the age of 18
* able to speak either English or Spanish
* self-report of diagnosis of diabetes by a doctor

Exclusion Criteria:

* cannot give informed consent (e.g. due to intoxication or dementia)
* do not speak English or Spanish
* younger than 18 years old.
* pregnant women
* undergoing hemodialysis or treatment for cancer
* unable to attend 3- and 6-month follow up appointments
A Long Term Study to Assess the Safety of Fostamatinib in Patients in Asia With Rheumatoid Arthritis

The purpose of this study is to evaluate the long term safety and tolerability of fostamatinib in patients in Asia with rheumatoid arthritis (RA).

(OSKIRA-Asia-1X): A Long-term Study to Assess the Safety of Fostamatinib in the Treatment of Rheumatoid Arthritis in Asia

Eligibility Criteria:
Inclusion Criteria:

* Provision of informed consent prior to any study-specific procedures.
* Patients who have successfully completed study D4300C00008 and whose disease is adequately controlled, in the opinion of the Investigator.

Exclusion Criteria:

* Premature withdrawal from study D4300C00008 or in the opinion of the Investigator the patient's disease is not adequately controlled on current treatment.
* Development of any of the withdrawal criteria from study D4300C00008
* Females who are pregnant or breast feeding
* Any other clinically significant disease or disorder, which in the opinion of the Investigator might put the patient at risk due to participation in the study, or may influence the results of the study
Combination of Cryosurgey and NK Immunotherapy for Recurrent Tongue Cancer

The aim of this study is the safety and efficacy of cryosurgery plus NK immunotherapy to recurrent tongue cancer.

By enrolling patients with recurrent tongue cancer adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of the combined therapy using cryosurgery and natural killer (NK) cells.

The safety will be evaluated by statistics of adverse reactions. The efficacy will be evaluated according to local relief degree, progress free survival (PFS) and overall survival (OS).

Eligibility Criteria:
Inclusion Criteria:

* All standard therapies have failed according to NCCN guidelines or the patient refuses standard therapies after cancer recurrence
* Body tumor 1-6, the maximum tumor length \< 5 cm
* KPS ≥ 70, lifespan \> 6 months
* Platelet count ≥ 80×109/L，white blood cell count ≥ 3×109/L, neutrophil count ≥ 2×109/L, hemoglobin ≥ 80 g/L

Exclusion Criteria:

* Patients with cardiac pacemaker
* Patients with brain metastasis
* Patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction