cyrilzakka/clinical-trials huggingface dataset:
Impact of Intraventricular Electrical Activation in Resynchronization Therapy

Impact of intraventricular electrical activation in resynchronization therapy. We seek to evaluate the impact of Cardiac Resynchronization Therapy (CRT) on electrical activation of the Left Ventricle (LV). The first goal of the study is to evaluate if CRT is able to decrease the heterogeneity of LV activation in heart failure patients. A second goal is to evaluate the electrical determinant of clinical response to CRT using invasive and non-invasive mapping technology.

Comprehensive study, prospective, monocentric and cohort study.

Biventricular pacing is an effective therapy to improve end stage heart failure patients, however up to 30% of patients are unresponsive to this therapy. Among others, optimization of Left Ventricle (LV) pacing site location is critical to optimize response to Cardiac Resynchronization Therapy (CRT). Whether a better comprehension of baseline LV electrical activation can help to determine optimal LV lead location remains to be investigated.

After informed consent patients are included in the sudy. Day 1: CRT device is implanted under general anesthesia in a conventional fashion. The coronary sinus leads will be implanted guided by the acute hemodynamic response (+(dP/dt)max) using a RADI guide wire. After device implantation, a steerable mapping catheter will be inserted in the LV cavity to build a tridimensional activation map of the LV. This map will be obtained with and without CRT. From these maps different parameters describing LV activation will be measured and compared between patients with and without CRT. Quantitative parameters: Global LV activation time (LVATG) (primary outcome); septal activation time (LVTAS); Global intra-LV dispersion time and Qualitative parameters: presence of intraLV line of block, area of late activation. Day 5±2: A non-invasive map of the LV will be recorded with the CardioInsight ® system with and without CRT. The same parameters will be measured and compared with those obtained with invasive mapping. A 3 and 6 months follow-up visit including clinical, biological evaluation (NYHA status, 6-min walking test, BNP) of the patients will be performed with an additional transthoracic echocardiography at 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Adult (aged 18 or above)
* Sinus rhythm
* Patient must have signed informed consent
* Cardiac insufficiency of whatever cause (ischemic or non-ischemic)
* Patient eligible for implantation of a ventricular resynchronization device or patient with a ventricular resynchronization device having a procedure of ventricular tachycardia ablation
* Left ventricular ejection fraction \<35%
* NYHA Class II to IV with optimal medical treatment
* Patient covered by national healthcare insurance

Exclusion Criteria:

* Pregnant woman
* Sequel of transmural myocardial infarction
Fecal Metabolome and the Intestinal Microbiota in Irritable Bowel Syndrome

The purpose of this study is to find out the relationship between the bile acids, fatty acids (fatty acids are part of the diet) and bacteria that are present in the intestines.

There is emerging evidence that alterations in bile acids and SCFA associated with IBS could be associated with changes in the gut microbiota. In addition to modulating levels of intraluminal organic acids, it has been hypothesized that gut microbiota may alter local immune responses, modulate visceral pain responses, and impair gut barrier function.

Our overall goal is to investigate the relationship between fecal bile acids, SCFA and the gut microbiota in IBS. Results of this pilot study could reveal insights into the interplay of the gut microbiota and small molecule mediators of IBS to suggest targeted clinical strategies for improved diagnosis and management of this important syndrome.

AIM 1: Test the hypothesis that fecal organic acids (SFCA and bile acids) and fecal microbiota play an important role in IBS.

AIM 2: Test the hypothesis that there is association between colonic transit and fecal microbiota in IBS

Eligibility Criteria:
Inclusion Criteria:

* Patients with IBS, ages 18-65 fulfilling Rome IV criteria and asymptomatic controls with no prior history of GI disease or symptoms.
* Participants should be on a stable and consistent diet regimen and should not be following an extreme diet intervention such as gluten-free or a low FODMAP diet at the time of study participation.

Exclusion Criteria:

* Participants with microscopic/lymphocytic/collagenous colitis, inflammatory bowel disease, celiac disease, visceral cancer, chronic infectious disease, immunodeficiency, uncontrolled thyroid disease, history of liver disease or history of elevated AST/ALT \> 2.0x the upper limit of normal
* Prior radiation therapy of the abdomen or abdominal surgeries with the exception of appendectomy or cholecystectomy \> 6 months prior to study initiation
* Ingestion of any prescription, over the counter, or herbal medications which can affect GI transit or study interpretation (e.g. opioids, narcotics, anticholinergics, norepinephrine reuptake inhibitors, nonsteroidal anti-inflammatory drugs, COX-2 inhibitors, bile acid sequestrants) within 6 months of study initiation for asymptomatic volunteers or within 2 days before study initiation for IBS patients
* Any females who are pregnant or trying to become pregnant or breast-feeding
* Antibiotic usage within 3 months prior to study participation
* Prebiotic or probiotic usage within the 2 weeks prior to study initiation
* Use of tobacco products within the past 6 months.
Biomarkers in Patients With Head and Neck Cancer

RATIONALE: DNA analysis of tumor tissue may help doctors predict how well patients will respond to treatment.

PURPOSE: This research study is studying biomarkers in patients with head and neck cancer.

OBJECTIVES:

* To determine the mutation rates of HRAS and PIK3CA in patients with head and neck squamous cell carcinoma (HNSCC) who were treated with cisplatin/placebo and cisplatin/cetuximab on protocol ECOG-E5397.
* To determine the association between HRAS or PIK3CA mutation status and clinical benefits (i.e., response, progression-free survival, and overall survival) in patients treated with cisplatin/cetuximab compared with those receiving cisplatin/placebo on protocol ECOG-E5397.

OUTLINE: DNA is isolated from one unstained slide per patient. The mutations in HRAS and PIK3CA are determined using BEAMING technology.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Treated on protocol ECOG-E5397

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
CAR T Cell Therapy Related Cardiovascular Outcomes

This will be a cohort study of all patients receiving Cluster of Differentiation 19 (CD19)-specific CAR T cell therapy for relapsed/refractory B cell haematological malignancies. Patients will receive cardiac assessment and have serum cardiac biomarkers, ECG, transthoracic echocardiogram and cardiac magnetic resonance imaging performed at baseline prior to CAR T cell therapy, 7 days post CAR T cell infusion, and 3 months post CAR T cell infusion. Abnormalities in these cardiac investigations will be used to demonstrate cardiac injury and identify which patients are most at risk of developing cardiac injury related to CAR T cell therapy.

CD19-specific chimeric antigen receptor (CAR) T cells are a novel therapy for relapsing or refractory blood cancers, which have delivered a significant improvement in the rates of complete and partial remission. However, they are associated with toxicities, with some of early evidence suggestive of cardiovascular involvement. Despite this, the full extent of cardiovascular toxicity is poorly understood.

This research study seeks to understand the cardiac safety of CAR T cells in patients who receive this therapy as part of standard care for relapsed/refractory B-cell blood cancer. They will be assessed for cardiovascular risk factors via history, blood biomarkers, and cardiac imaging tests. These parameters will be repeated at 7 days following administration of the CAR T cells or if there are signs of cardiovascular deterioration, and again at 3 months follow up.

The aim is to predict the cohort most at risk of cardiovascular toxicity, and demonstrate evidence of cardiac injury on the cardiac imaging scans.

Eligibility Criteria:
Inclusion Criteria:

* Patients with capacity, (aged 16 and older)
* Undergoing CAR T cells for treatment for relapsing or refractory haematological malignancies

Exclusion Criteria:

* Patients under 16 years
Effect of Frontal Transcranial Direct Current Stimulation on BDNF in Stroke Patients With Cognitive Impairment

The purpose of the clinical trial is to find a treatment for stroke patients with cognitive impairment, and the main questions it aims to answer are:

* \[Search for effective treatments of cognitive impairment after stroke\]
* \[explore the relationship between BDNF level and cognitive function\] Participants will receive conventional treatment, tDCS treatment, .And then compare cognitive function and BDNF level

1. To study the therapeutic effect of transcranial direct current stimulation (tDCS) on post-stroke cognitive impairment (PSCI) by evaluating cognitive function and detecting plasma brain-derived neurotrophic factor (BDNF).
2. To explore the correlation between plasma BDNF level and cognitive function in patients with PSCI.

Eligibility Criteria:
Inclusion Criteria:

* (1)Stroke patients with CT or MRI imaging evidence, among which ischemic stroke met the diagnostic criteria of Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2018, and cerebral hemorrhage diseases met the diagnostic criteria of Chinese Guidelines for the Diagnosis and Treatment of Cerebral hemorrhage 2019; (2) There are symptoms related to cognitive dysfunction; Cognitive dysfunction was assessed by rehabilitation physicians. According to the MoCA evaluation standard,MoCA score ≤26 points; according to the MMSE evaluation standard, illiteracy score ≤17 points; primary school education level ≤20 points; secondary school education (including secondary school) level ≤22 points; college education (including junior college) level ≤23 points; (3)Age range 40-80 years old; (4) no obvious aphasia, speech expression and attention can cooperate with the completion of evaluation and treatment; (5)The patient or the patient's family members read and agree to sign the informed consent.

Exclusion Criteria:

* (1) Patients with severe diseases, such as malignant arrhythmia, acute myocardial infarction and acute heart failure, who cannot tolerate rehabilitation treatment; (2) Patients with untreated intracranial aneurysms, severe epilepsy, and intracranial metals who cannot receive tDCS treatment; (3) Non-PSCI patients with cognitive impairment, including patients with cognitive impairment left over from previous stroke and other organ disorders.
Stress Reduction Using Video Googles on Patients Undergoing Vascular Surgery

One treatment option of internal carotid artery stenosis is open surgical endarterectomy. The operation is frequently carried out under regional plexus anesthesia, allowing the patient to remain awake during the procedure. This approach offers the advantage of monitoring for neurological changes during carotid artery clamping, allowing the surgical team to immediately respond by placing a shunt to ensure cerebral perfusion. As a result, performing surgery under regional anesthesia provides therefor a benefit. However, for patients, the procedure, which can last up to two hours or longer in some cases, may pose a significant burden. The fixed position, inability to move, sterile drapes over the face, manipulation by the surgical team, and anxiety about potential complications are just a few of the factors that may distress patients during the operation. Increased sweating and reports of substantial subjective distress are not uncommon if the procedure is performed under local anesthesia.

In many medical fields, devices and therapies are now being utilized to reduce patient stress in the perioperative setting. In procedures performed under local or regional anesthesia, such as in orthopedics or dentistry, efforts are being made to make operations more tolerable and less stressful for patients. For example, music and video goggles are employed to entertain and distract patients during the intervention. Newer approaches using video googles appear in more and more fields to reduce distress. Especially in vascular surgery and particularly in carotid surgery, the use of audiovisual distraction during the procedure has not been implemented to our knowledge, and its benefits remain undocumented. Because of the special setting and burden for the patients it is highly necessary to test these devices in carotid surgery and explore potential benefits for these patients.


Eligibility Criteria:
Inclusion Criteria:

* Planed carotid endarterectomy in local anesthesia

Exclusion Criteria:

* patients which are not able to communicate because of stroke or language barrier,
* Dementia or neurological damage which impairs answering questionnaires or the understanding of the situation during surgery
* medication with steroids
Clinical Evaluation of the NeuMoDx SARS-CoV-2 Assay (COVID-19)

A multicenter study, using prospectively collected, fresh (Category I) and frozen (Category II), residual/leftover nasopharyngeal (NP) swab in UTM/UVT specimens obtained from symptomatic individuals suspected of COVID-19 infection. This study will evaluate the NeuMoDx SARS-CoV-2 Assay's clinical performance on the NeuMoDx 288 and NeuMoDx 96 Molecular Systems.


Eligibility Criteria:
Inclusion Criteria:

1. Any de-identified NP swab specimen in transport medium from a symptomatic individual suspected of COVID-19 at the time of collection.
2. NP swab specimens obtained using a flexible mini-tip flocked swab and collected into 3mL Copan UTM \[Cat. No. 305C\] or BD UVT \[Cat. No. 220531\].
3. Prospective specimens, fresh (Category I) shall be tested within:

   1. (4) hours when held at room temperature, or
   2. (3) days when held at (2 to 8°C), with cold storage starting within (4) hours of collection.
4. Minimum volume of ≥ 2mL.

Exclusion Criteria:

1. Required information unable to be obtained from the associated medical chart.
2. Specimens that remained on-board the NeuMoDx System for \> (8) hours prior to processing.
Pediatric Metabolism and Microbiome Repository

The aim of this project is to establish a bio-repository of diverse specimen types to provide investigators access to specimens in order to further research related to metabolism and the microbiome in the pediatric population.

Human microbial cell lines, stool and/or DNA and RNA will be collected from participants 10-18 years with a BMI greater than 95th percentile and their healthy siblings.

Specimens will be collected at 3 time points over a seven month period. Healthy siblings will provide just one blood and stool sample. Samples will be maintained at the Duke Medical Science Research Laboratory.

Eligibility Criteria:
Inclusion Criteria:

* Patients of the Healthy Lifestyles Program at Duke for the care of children with obesity, a sibling of a patient in the Healthy Lifestyles Program, or is a patient at Duke Children's Primary Care.

Exclusion Criteria:

* Pregnant females.
Clinical Observational Study Investigating the Role of Diastolic Dysfunction in Determining Abnormal Cardiorespiratory Exercise Testing Parameters in Patients Undergoing Major Surgery

REASON FOR STUDY

Major non-cardiac surgery has a high degree of morbidity and mortality. Recently, suitable measurements of a patient's preoperative cardiorespiratory reserve, performed non-invasively by cardiopulmonary exercise testing, have been shown to be predictive of outcome following non-cardiac surgery. Although the exact mechanisms behind poor reserve in this population are unknown, poor cardiac function and particularly diastolic dysfunction are likely to be important.

AIMS

The aim of the present study is to investigate the role of diastolic dysfunction in determining poor cardiorespiratory reserve in elderly patients undergoing major non-cardiac surgery. This will provide suitable information to inform a further therapeutic preoperative interventional study.

OBJECTIVES AND METHODS

1. To determine the presence and severity of diastolic dysfunction, measured by preoperative transthoracic echocardiogram, in a series of elderly surgical patients undergoing major elective non-cardiac surgery
2. To investigate the relationship between diastolic dysfunction and poor cardiorespiratory function during and following exercise measured by non-invasive testing including cardiopulmonary exercise testing, non-invasive blood pressure measurements and biochemical analysis
3. To determine whether patients with poor diastolic dysfunction are likely to have worse outcomes following major surgery compared with those who show no evidence of diastolic dysfunction. Outcomes will be measured in terms of length of hospital stay and early postoperative morbidity (validated scoring system) and mortality.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing major surgery
* Low functional capacity

Exclusion Criteria:

* Unable to give consent
Decompression of Odontogenic Cysts

The aim of this case-control study is to evaluate the effects of decompression of cystic jaw lesions by means of comparing pre- and post-decompression histologic findings.

The main question it aims to answer is:

Does decompression of cystic jaw lesions alter the histologic diagnosis?

A retrospective analysis was performed based on the comparison of initial and final histologic diagnoses of patients with an odontogenic cystic lesion, that was surgically treated with decompression followed by a definitive surgery.

The study included patients with a histologic diagnosis of an odontogenic cystic lesion, that was surgically treated with decompression followed by a definitive surgery. The study was carried out retrospectively by means of evaluating records, surgical and histologic reports of patients. Pre- and post-decompression histologic findings were compared in effort to understand if decompression leads to alteration in histologic character and change in diagnoses of lesions.

Eligibility Criteria:
Inclusion Criteria:

* To have an initial diagnosis of an odontogenic cystic jaw lesion confirmed with an incisional biopsy.
* The patients must have undergone decompression and, enucleation or enucleation and peripheral ostectomy after decompression period.

Exclusion Criteria:

* Previously treated patients
* The patients with missing information in medical and/or dental records
* The patients who did not adhere to follow-up protocol
Long-Term Efficacy and Safety of Growth Hormone Replacement Therapy in Chronic Heart Failure

After the encouraging results of 6 months of Growth Hormone Replacement Therapy in Patients With Chronic Heart Failure and Coexisting Growth Hormone Deficiency (NCT00591760) the investigators wanted to collect data about the long-term efficacy and safety of this kind of therapy.


Eligibility Criteria:
Inclusion Criteria:

* Chronic Heart Failure New York Heart Association functional class II to IV, secondary to ischemic or idiopathic cardiomyopathy
* Age range 18-80 years
* Stable medication for at least one month including beta-blockers that had to be started at least 5 months before entering the study
* Left Ventricular ejection fraction 40% or less
* Growth Hormone Deficiency (defined as a peak GH response to intravenous stimulation with GHRH + Arginine \< 9 ng/ml)
* Written Informed consent

Exclusion Criteria:

* Acute proliferative or severe non-proliferative diabetic retinopathy
* Active malignancy
* Evidence of progression or recurrence of an underlying intracranial tumor
* Unstable Angina or recent myocardial infarction
* Serum Creatinine levels \> 2.5 mg/dl
* Severe liver disease (Child-Pugh B-C)
Assessment of CRYOBEAUTY MAINS ET DECOLLETE Versus Liquid Nitrogen Cryotherapy, in the Treatment of Solar Lentigines

This study evaluates the performance of new technology "CRYOTHERAPY MAINS ET DECOLLETE" against a classic cryotherapy "Nitrogen Liquid " to treat solar lentigines.

The hands and the neckline will be randomised, either left or right side and treated by two cryotherapy devices:

1. CRYOTHERAPY MAINS ET DECOLLETE is the device under evaluation.
2. Liquid nitrogen is a comparator device.


Eligibility Criteria:
Inclusion Criteria:

* Phototype II to IV
* Presenting solar lentigos on both hands and neck, diameter ≤ 6mm
* Accepting not to expose the body to sunlight or artificial UV rays during the study
* Affiliate to a health insurance plan
* Having undergone a general clinical examination attesting to his / her ability to participate in the study
* Having given written consent

Exclusion Criteria:

* Having carried out aesthetic care (exfoliants, scrubs or self-tanning, manicure, hand care, UV ...) in the month before the start of the study, at the level of the hands and/or neckline.
* Having applied a depigmenting product in the month preceding the start of the study, at the level of the hands and/or neckline.
* Having carried out aesthetic care at a dermatologist (laser, IPL, peeling, depigmenting creams, cryotherapy ...), at the level of the hands and/or neckline, during the last six months
* Dermatosis, autoimmune disease (vitiligo), systemic, chronic or acute disease, or any other disease that may interfere with the treatment or influence the results of the study (people with diabetes, circulatory problems, cold allergies, With Raynaud's syndrome ...)
* Receiving general or local treatment (corticosteroids ...) likely to interfere with the evaluation of the studied parameters.
* Participating in another study or being in an exclusion period from a previous study
* Being incapable of following the requirements of the protocol
* Person protected by law
* Unable to read and write French
* Pregnant woman or woman wishing to be pregnant during the study, or during breastfeeding period
* Women of childbearing age who do not have contraception