cyrilzakka/clinical-trials huggingface dataset:
Functional Digestive Disorders Observatory

Functional digestive pathologies are defined by symptoms such as functional dyspepsia, gastroesophageal reflux, irritable bowel syndrome, gastroesophageal reflux, functional constipation, functional diarrhea, functional bloating, the opioid-induced constipation and fecal incontinence, without organic substratum. These diseases are very common in the general population (20%) and represent the first cause of consultation in city gastroenterology. The objective of this study is to collect prospective clinical and tests data and a biological collection from biological samples collected as part of the standard care. This collection could identify diagnostic or prognostic markers of the therapeutic response.

Functional digestive pathologies are defined by symptoms such as functional dyspepsia, gastroesophageal reflux, irritable bowel syndrome, gastroesophageal reflux, functional constipation, functional diarrhea, functional bloating, the opioid-induced constipation and fecal incontinence, without organic substratum. These diseases are very common in the general population (20%) and represent the first cause of consultation in city gastroenterology. The objective of this study is to collect prospective clinical and tests data and a biological collection from biological samples collected as part of the standard care. This collection could identify diagnostic or prognostic markers of the therapeutic response. The investigators hope that a better knowledge of the pathophysiology of digestive functional diseases will improve the therapeutic management by making a therapeutic choice based on the observed pathophysiological abnormalities.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years of age;
* Patients with functional digestive disorder for more of 3 months;
* Patients assessed as part of routine care;
* Patients affiliated to the Social Security ;
* Patients not opposed to participation in the Centre

Exclusion Criteria:

* Person deprived of liberty by administrative or judicial decision or major protected subject (under guardianship or curatorship);
* Patients unable for any reason to read, understand, respond questionnaires (visual, psychiatric, cognitive, etc.)
Safety and Feasibility of Atrial Deganglionation as Adjunctive Therapy for AF

A prospective, single arm, multi-center exploratory study of safety and feasibility in the treatment of patients undergoing cardiothoracic surgery.

To assess the safety and feasibility of electroporation/Pulsed Electric Field (PEF) as a technology to achieve selective GP ablation. This treatment will be performed on 30 patients undergoing cardiothoracic surgery. Primary feasibility endpoint will be demonstration of ability to access and deliver Pulsed Electric Field energy to all of the targeted ablation sites.

Eligibility Criteria:
Inclusion Criteria:

* Age is between 18 and 70 years.
* Scheduled for open-chest cardiothoracic surgery, for coronary artery bypass grafting.
* Legally competent and willing to sign the informed consent.
* Life expectancy of at least 2 years.

Exclusion Criteria:

* • Previous cardiac surgery.

  * Prior pericardial interventions.
  * Prior pulmonary vein isolation (PVI).
  * Previous or existing pericarditis.
  * Persistent or long-standing persistent atrial fibrillation.
  * Indication for surgical ablation or PVI for atrial fibrillation.
  * Indication for concomitant surgical valve repair or replacement.
  * Indication for concomitant left atrial appendage (LAA) ligation or excision.
  * History of previous radiation therapy on the thorax.
  * History of previous thoracotomy.
  * Prior electrical or mechanical isolation of the Left Atrial Appendage (LAA).
  * The presence of LAA occlusion devices, coronary stents, prosthetic heart valves, pacemakers or implantable cardioverter defibrillators (ICDs).
  * Myocardial infarction within the previous 2 months.
  * NYHA (New York Heart Association) Class IV heart failure symptoms.
  * Left ventricular ejection fraction (LVEF) \< 40%, measured by transthoracic echocardiography (TTE).
  * Left atrial (LA) diameter \> 5.0 cm, measured by transthoracic echocardiography (TTE).
  * The presence of left atrial thrombus when examined by transoesophageal echocardiography (TEE).
  * The presence of AF attributable to non-cardiovascular causes such as thyroid disease, electrolyte imbalance/dehydration or other reversible causes.
  * Active infection or sepsis as evidenced by increased white blood cell count, elevated CRP (C-Reactive Protein) or temperature \> 38.5°C.
  * Known or documented carotid stenosis \> 80%
  * Stroke or transient ischemic attack within the previous 6 months.
  * Known or documented epilepsy.
  * Pregnancy or child-bearing potential without adequate contraception.
  * Circumstances that prevent follow-ups.
  * Drug abuse.
  * Patients cannot be enrolled in another clinical study
Evaluation of High Speed Laser Doppler Imaging Technology

Skin prick tests (SPT) are commonly used in daily allergological practice to assess skin reactivity to allergens. Multiple factors can contribute to non-optimal results of conventional wheal and flare measurement (CWFM) of SPT such as inaccurate measurements, observer-dependency and absence of traceability.

This study aims to evaluate the quantification of SPT by a novel High Speed Laser Doppler Imaging (HSL-DI) and to compare it with CWFM. First, SPT with birch and/or grass pollen extracts as well as positive and negative controls will be performed in 20 volunteers (11 atopics, 9 non-atopics) to establish the characteristics (cut-off, optimal reading time and allergen concentration) of HSL-DI analysis based on two parameters ("area" and "flow" measurement). In a second step, fifty patients will be tested with birch and grass pollen extracts at optimal allergen concentration and time window. Analysis of SPT by HSL-DI and CWFM will be compared.


Eligibility Criteria:
Inclusion Criteria:

* age 18 to 65 years
* history of allergic rhinitis to birch pollen and/or grass pollen.

Exclusion Criteria:

* any medical condition (including pregnancy) that could influence the study (viral or bacterial airway infection, active allergic rhinitis)
* uncontrolled asthma (peak expiratory "flow" \<80% of volunteer's best personal value)
* treatment with antihistamine medication less than two weeks before enrolment or during the trial.
A Registry Based Collaborative to Measure Efficiency, Effectiveness, and Safety of Farapulse PFA Technology for AF

The DISRUPT-AF Registry is an observational, prospective, multi-center, non-randomized, real-world registry designed to obtain clinical experience with the Farapulse Pulsed Field Ablation System for the treatment of atrial fibrillation (AF).

The DISRUPT-AF Registry is an observational, prospective, multi-center, non-randomized, real-world registry designed to obtain clinical experience with the Farapulse Pulsed Field Ablation System for the treatment of atrial fibrillation (AF). All types of AF including paroxysmal, persistent and long standing persistent may be included.

The registry has three cohorts: 1) Acute Arm, 2) Symptomatic Monitoring Only Arm, and 3) Full Monitoring Arm. In the Acute Arm, patient assessments will occur at pre- procedure and procedure visits. In both the Symptomatic Monitoring Only Arm and the Full Monitoring Arm, patient assessments will occur at pre- procedure, procedure, 3 months, and 1 year post ablation. Additionally, the Full Monitoring Arm will assess for asymptomatic recurrence at 6- and 12-months post-ablation.

Sites will be assigned to an arm in which they will enroll under based on their practices current Standard of Care. Sites can only participate in one arm.

The primary purpose of the registry is to assess clinical outcomes, including procedural efficiency, safety, and long-term effectiveness of pulsed field ablation (PFA) in the treatment of patients with AF. Also, to assess the effect of PFA technology implementation on practice patterns, operational workflow and operator experience.

The registry will utilize real world clinical data obtained from the use of commercially available technologies under the authority of a health care practitioner within a legitimate practitioner-patient relationship.

Eligibility Criteria:
Inclusion Criteria:

* Patients who, in the opinion of the Investigator, are candidates for ablation for AF
* Plans to undergo an ablation procedure using the Farapulse Pulsed Field Ablation System manufactured by Boston Scientific
* De Novo ablation unless it is a repeat procedure for a subject whose index procedure is also included in the registry
* 18 years of age or older
* Able and willing to participate in baseline and follow up evaluations for the full length of the registry

Exclusion Criteria:

* Enrolled in an investigational drug or device trial, or any trial that dictates the treatment plan without prior approval from Sponsor
* Prior left atrial ablation (catheter or surgical)
* Currently receiving inotropic or mechanical support
* In the opinion of the Investigator, any known contraindication to an ablation procedure or to any device or drug required for use during an ablation procedure as assessed by the Investigator
Cryo-Touch III Refinement Study Investigational Plan

This is a prospective, non-randomized study to evaluate the performance of the MyoScience Cryo-Touch III device for the treatment of glabellar and/or forehead wrinkles.


Eligibility Criteria:
Inclusion Criteria:

* Age 30-70 years
* Subject has a glabellar and/or forehead wrinkle rating by investigator of at least 2 in animation on the 5-point Wrinkle Scale (5WS)\*
* Subject has signed institutional review board (IRB)-approved informed consent form

Exclusion Criteria:

* Subject takes any medication or dietary supplement regularly that affects blood clotting (e.g., Coumadin, aspirin, clopidogrel) or increases the risk of bleeding/bruising
* Subject has had prior surgery that alters the subcutaneous anatomy of the target treatment sites
* The investigator is unable to substantially lessen facial lines by physical separation
* Subject has undergone another facial cosmetic procedures at or above the level of the cheekbones within the past 6 months
* Subject is participating in another facial cosmetic research study

Patient has any of following conditions:

* History of facial nerve palsy
* Marked facial asymmetry
* Ptosis
* Excessive dermatochalasis
* Deep dermal scarring
* Thick sebaceous skin
* History of neuromuscular disorder
* Chronic dry eye symptoms
* Allergy or intolerance to lidocaine
* Other local skin condition (eg, skin infection) at target treatment site
* Any physical or psychiatric condition that in the investigator's opinion would prevent adequate study participation
Interest of Real Time Measurement of Autonomous Nervous System for the Detection of Brain Death

Context: A major lack of organ donors is a serious public health problem. It determines a prolonged delay before a transplant can be performed and thus a significant number of deaths of patients waiting for transplantation. The aim of this project is to reduce the delay of the diagnosis of brain death, and also to improve its diagnosis in the Intensive Care Unit.

The diagnosis of brain death is strictly defined by the law and relies either on two consecutive flat electroencephalograms recorded at an interval of four hours, or on the lack of cerebral circulation during a brain angiography performed after suspecting brain death on the clinical exam. However, in usual practice, it is difficult to have all the needed clinical arguments, and their interpretation can be difficult in the pathological context. This may participate in the delay and the lack of patients potentially donors.

Pre-study: In a pilot study, fifty subjects with severe cerebral lesions, had a continuous ECG recording. The investigators could find that a decrease in autonomic nervous system activity, as measured through the ECG, was correlated to the transition to brain death assessed by cerebral angiography. The loss of cardiac variability was always observed between two cerebral angiographies, one before and the second after brain death. This study allowed the investigators to calculate the threshold values of sympathetic and parasympathetic activities to confirm brain death.

Aim: The aim of this second study is to validate prospectively the interest of the analysis in real-time of autonomic nervous system activity to detect brain death.

Benefits expected: Increase the number of organ donors and the number of organs removal available for transplantation.

Eligibility Criteria:
Inclusion Criteria:

* severe cerebral lesions
* admitted in intensive care units

Exclusion Criteria:

* neoplastic pathology
* prior myocardiac infarction
* hearth failure
* atrial fibrillation
* insulin-treated diabetes mellitus
* cardiac pacemaker
Body Image in Youth With HIV

This is an observational study that seeks to gather information about perceptions of body image through the use of a one-time questionnaire completed by participants at the time of study enrollment.

Effective management of Human Acquired Immune Deficiency Syndrome (AIDS) caused by the Human Immunodeficiency Virus (HIV) has become possible through the use of Highly Active Antiretroviral Treatment (HAART). As a result of more successful treatment options, HIV/AIDS has transitioned from a terminal illness to one which is treated as a chronic condition. One particular group that has been impacted tremendously by HIV in the United States is the adolescent population. As youth are living longer with HIV/AIDS, clinicians and researchers are beginning to examine ways in which the disease can affect one's physical health, mental health, and other psychosocial factors. Research emerging involving adults with HIV/AIDS has suggested that increased attention to and negative views of one's body image may be found at a higher rate in this group. To our knowledge, very few studies have examined this relationship in adolescents with HIV.

The purpose of this exploratory study is to characterize body image perceptions among youth with perinatally and behaviorally acquired HIV. In a cross-sectional design, adolescents will be asked to complete an ACASI questionnaire that will assess body image, medication adherence, depressive symptoms, medical, and other sociodemographic variables which may relate to adolescents with HIV. Information regarding the adolescents' medical history, medications, and physical functioning also will be abstracted from his or her medical record. Guided by the Intervention Mapping (IM) approach, findings from this study will inform future intervention studies designed to enhance HIV disease management among adolescents.

PRIMARY OBJECTIVE:

To characterize body image perceptions among youth with HIV.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of HIV infection as documented in adolescent's medical record
* Adolescent is aware of his/her HIV diagnosis
* The adolescent/caregiver's primary language in English
* Adolescent is ≥ 16 and \< 24 years old
* Adolescent is willing and able to provide consent per institutional guidelines

Exclusion Criteria:

* Adolescent has documented diagnosis of mental retardation or a significant motor or sensory impairment that would preclude participation in the study survey.
* Adolescent has known acute psychiatric illness, including suicidal ideation, homicidal ideation or active psychosis.
* Adolescent is a pregnant female.
Retrospective Data Collection for a Correlation Study Between Gastric Cancer and Clinical and Laboratory Variables

This is an observational, retrospective, case-control, single-center, national study that involves the collection of anamnestic, clinical and therapeutic data of patients diagnosed with gastric cancer by histological examination at the Pathological Anatomy Unit (Prof. D'Errico) in the period 2016-2020.

The corresponding medical records will be analyzed to derive information on the socio-demographic characteristics and risk factors of the included subjects. Each case will be paired with two controls chosen from patients who have performed a gastric biopsy with relative histological examination during an endoscopic examination carried out at the IRCCS Azienda Ospedaliero-Universitaria of Bologna.

Eligibility Criteria:
Inclusion Criteria cases:

* Età \> 18 anni.
* Diagnosi istologica di carcinoma gastrico
* Ottenimento del consenso informato.

Inclusion criteria controls:

* Età \> 18 anni.
* Esecuzione di indagine endoscopica gastrica con relativo esame istologico (mucosa sana, gastrite acuta, gastrite cronica con o senza infezione da Helicobacter pylori, metaplasia intestinale)
* Ottenimento del consenso informato.

Exclusion Criteria:

* none
Efficacy and Safety Study of PEG-rIL-29 Plus Ribavirin to Treat Chronic Hepatitis C Virus Infection

Interleukin 29 (IL-29) is a substance that is produced in the body to help fight viral infections. The purpose of this study is to evaluate the safety and antiviral effects of several different doses of PEG-rIL-29 (a man-made form of IL-29) when it is given in combination with daily oral doses of ribavirin (an antiviral drug) to subjects with hepatitis C infection who have received no prior treatment for this disease.

PEG-rIL-29 (also known as PEG-interferon lambda) is a unique Type III interferon molecule that has demonstrated antiviral activity when administered weekly for 4 weeks to treatment-relapsed and treatment-naive subjects with genotype 1 hepatitis C virus (HCV) infection. Because PEG-rIL-29 binds to a unique receptor with a more limited distribution than the receptor for interferon (IFN)-α, it may have the potential to treat HCV without some of the treatment-limiting side effects associated with IFN-α-based therapies. The purpose of this Phase 2a/b randomized, controlled, multicenter study is to compare the safety and efficacy of PEG-rIL-29 and peginterferon alfa-2a, both administered subcutaneously weekly for up to 48 weeks in combination with daily oral ribavirin, in treatment-naive subjects with chronic genotype 1, 2, 3, or 4 HCV infection. The initial part of the study (Phase 2a) will be conducted as an open-label study; the second part of the study (Phase 2b) will be conducted as a blinded study. The above information provided in this listing is specific to the Phase 2b portion of the study. In addition, two small open-label substudies will be conducted to evaluate the efficacy of 24-week treatment with PEG-rIL-29 and ribavirin in subjects with HCV genotype 1 who have a particular genetic polymorphism associated with favorable response (n=60) and to evaluate the efficacy of 16-week treatment with PEG-rIL-29 and ribavirin in subjects with HCV genotype 2 or 3 (n=30).

Eligibility Criteria:
Inclusion Criteria:

* No prior therapy for chronic HCV, other than up to 2 weeks of single-agent therapy with a direct-acting antiviral agent, including but not limited to, a protease or polymerase inhibitor
* HCV genotype 1, 2, 3, or 4
* HCV RNA ≥100,000 IU/mL
* ALT and AST ≤5.0 × ULN
* Documented absence of cirrhosis
* Able to comprehend the investigational nature of this study and sign an informed consent form

Exclusion Criteria:

* Mixed genotype HCV infection
* Current or prior history of decompensated liver disease
* Received any investigational drug, including a direct-acting antiviral agent, within 60 days prior to receiving study drug
* Positive test for hepatitis B surface antigen, human immunodeficiency virus (HIV)-1, or HIV2 antibody at screening
* Active substance abuse, such as alcohol, or inhaled or injected drugs, within 6 months

Additional inclusion and exclusion criteria are specified in the protocol.
Improving the Quality of Care in Nursing Homes

The overall goal of this project is to increase the number of high quality nursing homes in Massachusetts. The study will evaluate an intervention involving two active treatment arms: one implementing a CQI program and a second implementing the CQI program and specific protocol programming. The intervention will be implemented in 24 nursing homes identified as performing, over multiple quality indicator domains, at a poor or average level across multiple outcome domains.

Nursing facilities as well as CMS and state governments are under pressure to find cost-effective methods to improve quality, particularly in poor and average facilities. In our prior work, we found that better performing facilities make more extensive use of CQI mechanisms, have more protocol driven problem advanced resolution mechanisms and systematically address multiple areas Both arms of the study apply the same standardized approach to CQI, while one arm will include specific best-practice care strategies targeted at identified problems. The study will evaluate whether the CQI program improves quality indicator scores in multiple domains, relative to control facilities, and whether improvement is greater in facilities that also utilize the study's best-practice protocols.

The study consent form describes the MDS assessment (used to evaluate the reliability of the facility's assessment), including items to be reviewed and how information will be obtained. The subject is informed that there is no known risk for participating in research, the purpose of which is to determine if the intervention improves nursing home care in Massachusetts

The outcomes will be reviewed by means of a change in twelve quality indicator scores: ADL decline, ADL decline following improvement, Mobility change, walking improvement, cognitive change, communication change, bowel continence change, bladder continence change, depressed mood change, new insertion of an indwelling urinary catheter, infection prevalence, worsening pain.

Eligibility Criteria:
Inclusion Criteria:

* Men and Women
* Residents of long-term care facilities in Massachusetts who have had
* a Minimum Data Set assessment completed by the facility in the last 90 days.

Exclusion Criteria:

* None
Evaluation of a Simulation Training Tool to Identify Lesions Requiring Further Screening for Melanoma

The investigators will design a curriculum for visual screening for melanoma and skin biopsy procedure, based on the mastery learning model, using simulators and web-based didactic instruction for medical students and internal medicine residents. This requires having a skin simulation model that presents a range of lesions from benign nevus to atypical nevus to melanoma in a distribution and density that mimics the clinical findings of those with 2 skin tones: fair-skin non- Hispanic white and Hispanic.


Eligibility Criteria:
Inclusion Criteria:

* Medical student in his primary care clerkship at Northwestern University

Exclusion Criteria:

* Not a medical student in his primary care clerkship at Northwestern University