cyrilzakka/clinical-trials huggingface dataset:
Management of Infection Risk in Non-comparative Trial (MINT)

The URGO2875 dressing is an innovative antimicrobial dressing made of exclusive technologies of TLC-Ag healing matrix and fibres. The dressing has been developed for the local treatment of chronic (leg ulcers, pressure ulcers, diabetic foot ulcers) and acute (burns, traumatic wounds, surgical wounds) moderately to highly exudative wounds at risk or with signs of local infection.

The purpose of this non-comparative clinical trial was to evaluate the performance (efficacy and safety) of the URGO2875 dressing, on the healing process of chronic wounds presenting a high-risk of infection.

The URGO2875 dressing is indicated for the local treatment of chronic (leg ulcers, pressure ulcers, diabetic foot ulcers) and acute (burns, traumatic wounds, surgical wounds) moderately to highly exudative wounds at risk or with signs of local infection.

Eligibility Criteria:
Inclusion Criteria:

* Adult patient, aged ≥ 18 years, who signed and dated informed consent form,
* Patients affected by VLU or mixed ulcer of predominantly venous origin (ankle brachial pressure index (ABPI) ≥ 0.7 and ≤ 1.3),
* Patient willing and able to wear an effective venous compression system every day during the study period,
* Patient with at least three of the five inflammatory clinical signs : pain between dressing changes, periwound erythema, local oedema, malodour and presence of heavy exudate.

Exclusion Criteria:

* Patients under guardianship or protection of vulnerable adult
* Pregnancy or breastfeeding women,
* Childbearing potential women with no medically-acceptable method of birth control,
* Patients included in another clinical study,
* Patients with known allergy with hydrocolloid (carboxymethylcellulose CMC), silicone or silver,
* Patients with wound covered partially or totally with necrotic tissue,
* Patients who had within the 3 months prior the inclusion, deep vein thrombosis
* Patients with a serious general disease that deemed to interfere with the treatment period and evaluation
* Patients with progressive neoplastic lesions treated by radiotherapy, chemotherapy or hormone therapy
* Patients with non-controlled systemic infection by an suitable antibiotic therapy
* Patients with clinically infected wound
* Patients with wound requiring surgical treatment or for which surgery is scheduled during the study period
* Patients with known cancerous lesions
Evaluation of Stendo Pulsating Suit on Microcirculation and Endothelial Function in Diabetic Patients

The action of one Stendo pulsating suit session will be evaluated on 16 type 2 diabetic patients referred on the diabetic consultations. The effects of one Stendo pulsating suit session system will be assessed on the peripheral cutaneous microcirculation and on endothelial functions

The role of the endothelium in micro-vascular system is mediated by synthesis and release of numerous substances that act on the smooth muscle fibers. The release of these products is modulated, in turn, by various circulating molecules, by autonomic nervous system and by local mechanical factors such as shear stress.

The type 2 diabetes leads to early vascular redesign with the onset of endothelial dysfunction and the worsening of the arterial stiffness.

These anomalies, well correlated with the cardiovascular risks, are currently investigated in the department of Endocrinology, Diabetes, and Nutrition at the Jean Verdier Hospital. The analysis methods allow identifying early modifications in response to various drugs, nutritional or physical stimuli.

The aim of this study is therefore to evidence a peripheral microcirculation and endothelial function improvement in type 2 diabetic patient in comparison to a cross-over control session.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetic patient
* Diagnosis of diabetes \> 1 year
* HBA1c between 6 and 8,5
* Treated with oral anti-diabetic, insulin and/or incretins which can be stayed unchanged during the 2-week study

Exclusion Criteria:

* Type 1 diabetic Patient
* Antecedent of cardiomyopathy, cardiac ischemia or valvulopathy
* Severe kidney failure
* Non controlled hypertension (\> 160/100mm Hg)
* Cardiac arrhythmia
* Severe respiratory failure
* Patient with an advanced obstructive arterial disease
* Patient with a recent and progressive deep venous thrombosis
Cognitive-motor Dual Task Training in Patients With Multiple Sclerosis

Clinical features of Multiple Sclerosis (MS) vary widely from patient to other. About the 60% of patients with MS presents cognitive deficits associated with motor disability. The principal consequences of the motor disabilities concern difficult in gait and balance. The principal cognitive deficits concern the speed in elaborating information, the complex attention and the memory. During walking in daily life, it is often required to turn the head for looking something happening in the surrounding environment, for example when a sudden noise is heard, while crossing the street, when there's something interesting around or when is required to verbally answer to someone without stopping walking. All these examples are referred to a common daily life mechanism that has been defined as dual task (DT). Considering that the attention is a limited function, divide it in two different and simultaneous tasks (motor and cognitive), cause a cognitive-motor interference (CMI) that lead to a loss of efficacy in one or in both the tasks. The main aim of the study is to verify the impact of a brief rehabilitation training that combining motor and cognitive therapy using a dual-task paradigm, on balance and gait in MS patients, compared with the traditional therapies that provide a specific postural stability rehabilitation approach. Recruited patients will be randomized in two different groups which perform two different training. Each group perform the allocated training 3 times a week for 4 weeks. All the patients will be evaluated at the baseline (T0), at the end of the training (T1) and 60 days after the end of the training (T2).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of MS according with revisited McDonalds criteria;
* Expanded Disability Status Scale (EDSS) ranging between 0 and 6;
* Ability to walk independently or with aid for at least 50 meters.

Exclusion Criteria:

* Associated psychiatric and/or neurological disorders (different from the MS);
* Clinical relapse within the three months prior to enrollment;
* Steroid therapy within 30 days before the enrollment;
* Peripheric diseases as visual and/or auditory impairments that could interfere with motor and cognitive tasks execution;
* Fracture of lower limb within three months before the enrollment.
Remote Ischemic Conditioning to Attenuate Myocardial Death and Improve Operative Outcome.

This study evaluates the addition of remote ischemic preconditioning and postconditioning to standard myocardial protection protocol in patients submitted to off - pump coronary artery bypass grafting in a prospective, 1:1 randomized, double blind fashion. An interventional group will receive remote ischemic preconditioning 24-hours before OP-CABG, immediately before surgery and within 60 minutes following surgery by means of lower limb ischemia achieved by pressure cuff inflation, whereas control group will receive sham procedure perioperatively.

In a prospective, 1:1 randomized and double blind fashion, the study will evaluate the impact of remote ischemic preconditioning, both immediate and second window of protection (24 hours and immediately before surgery) with remote ischemic postconditiong on operative outcomes in patients submitted to coronary artery bypass grafting without use of extracorporeal circulation.

Remote ischemic conditioning was found to provide protection against necrosis and apoptosis due to ischemia and reperfusion injury, a phenomenon observed during coronary artery bypass grafting. That in turn was associated with poor postoperative outcomes, predominantly poor survival.

Remote ischemic preconditioning will be provided by repeated lower leg ischemia and reperfusion with pressure cuff inflation for five minutes and deflation for five minutes in three consecutive cycles. Remote ischemic preconditioning will be performed 24 hours before CABG and immediately before surgery. Remote ischemic postconditioning will be performed within 60 minutes following the last coronary artery bypass graft completion and the restoration of coronary blood flow.

The study will assess clinical endpoints such as postoperative acute myocardial infarction (type 5 MI), postoperative mortality, postoperative renal failure and laboratory outcomes such as postoperative serial measurements of troponin T release or glomerular filtration rate as secondary outcomes.

Eligibility Criteria:
Inclusion Criteria:

Patients qualified to coronary artery bypass grafting according to ESC/EACTS Guidelines of myocardial revascularization, suffering from:

* Multivessel coronary artery disease amenable for surgical treatment
* Negative history of previous cardiac or vascular surgery in childhood and afterwards.
* Negative history of active neoplastic disease, neither past medical history of oncological treatment
* Patients with non insulin dependent diabetes mellitus treated chronically with oral derivatives of sulfonylourea such as but not limited to: glibenclamide.

Exclusion Criteria:

Patients suffering from acute insuficiency of any organ/ system and those suffering from end stage organ failure such as:

* Chronic renal disease - KDOQI stage ≥ 3;
* Chronic renal failure class A by Child - Pugh'a;
* Chronic respiratory failure (type I and II according to Campbell et al. and type I according to Wood et al.);
* Chronic intermittent claudication class 2A according to Fontaine;
A Bioavailability Study Comparing 3 Different AZD1981 Tablets

The purpose of this study is to study the relative bioavailability of AZD1981 when using a new tablet compared to the current tablet.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and postmenopausal or surgically sterile female volunteers aged 18-55, inclusive
* Have a body mass index between 19-30 kg/m2 and weigh at least 50 kg and no more than 100 kg, inclusive
* Be a non-smoker or ex-smoker who has stopped smoking for \>6 months prior to screening
* Volunteers must be willing to use barrier methods of contraceptive, unless their partners are post-menopausal, surgically sterile or using accepted contraceptive methods.

Exclusion Criteria:

* Any clinically significant disease or disorder
* Any clinically relevant abnormal findings in the physical examination, clinical chemistry, haematology, urinalysis, vital signs (including body temperature), or ECG assessments at Visit 1, or in vital signs (including body temperature) at Visit 2
* Prolonged QTcF \>450 ms or shortened QTcF\<340 ms at Visit 1 or family history of long QT syndrome
* History of, or current alcohol or drug abuse
Improving Health Literacy in African-American Prostate Cancer Patients

Investigators propose an observational interview study to explore how patients understand treatment conversations with their physicians within the framework of health literacy. The study team will test whether patients' understanding of treatment options and side effects can be improved when patients receive a low literacy educational supplement after meeting with their urologist. Investigators will interview a group of newly diagnosed, early stage, African American prostate cancer patients.

Investigators propose an observational interview study to explore how patients understand treatment conversations with their physicians within the framework of health literacy. The study team will test whether patients' understanding of treatment options and side effects can be improved when patients receive a low literacy educational supplement after meeting with their urologist. Investigators will interview a group of newly diagnosed, early stage, African American prostate cancer patients.

Investigators hypothesize that the delivery of a scripted, tailored, low literacy educational supplement will result in a statistically significant decrease in decisional conflict, and a statistically significant improvement in comprehension of cancer treatment and its side effects compared to standard practice.

The study team will measure patients' comprehension of treatment options and side effects, as well as decisional conflict; after standard practice, and again after exposure to the educational supplement. Investigators will compare the urologists' assessment of patients' 1) health literacy 2) preferences for side effects 3) stage of decision making, 4) treatment choice or predisposition toward treatment choice. 5) preference for role in decision making (active, passive, or shared with physician); to measures obtained from patients. These comparisons will allow investigators to quantify the potential benefit to the physician of information obtained through the interview and low literacy educational supplement.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have undergone pathology review of their prostate biopsy at Emory University, Grady Memorial Hospital, Saint Joseph's Hospital, and Atlanta VA Medical Center with AJCC clinical stage T1-T2 prostate cancer by physical exam

Exclusion Criteria:

* RN or MD degree
* History of head injury or dementia
* History of cognitive impairment
* Unable to undergo the informed consent process and the study interview in English per the judgment of the primary urologist or urological provider
Tumor-induced Osteomalacia Disease Monitoring Program

The objectives of this observational study are to assess the long-term safety and long-term effectiveness of burosumab in patients with TIO who are being treated with burosumab as prescribed by their physician and to monitor the course of the underlying phosphaturic mesenchymal tumor (PMT) overtime in patients with TIO irrespective of their treatment status.

Enrolled patients may or may not be treated with commercially available burosumab during the TIO DMP at the discretion of their treating physician. Given the observational nature of the TIO DMP, specific treatments or supportive management will not be provided as part of the study.

Eligibility Criteria:
Inclusion Criteria:

* Have a clinical diagnosis of TIO based on the presence of an underlying PMT (confirmed by imaging) AND/OR historical documentation. Note: For adult patients with TIO in whom the causative PMT has never been located, and all pediatric patients, documented evidence of negative genetic testing for other hereditary hypophosphatemic disorders is necessary
* For patient safety, all participating female patients of child-bearing potential must be willing to have pregnancy tests prior to certain assessments performed as part of the DMP
* Be willing to provide access to prior medical records including tumor pathology reports and biopsy slides, imaging, biochemical, and diagnostic, medical, and surgical history data, if available
* Be willing and able to provide informed consent after the nature of the study has been explained, and prior to any research-related procedures
* Be willing and able to comply with the study visit schedule and study procedures

Exclusion Criteria:

* Have a clinical diagnosis of TIO deemed to be caused by a tumor other than a PMT
* Serious medical or psychiatric comorbidity that, in the opinion of the Investigator, would present a concern for patient safety or compromise the ability to provide consent or comply with the study visit schedule and study procedures
* Less than 1 year of life expectancy (for any cause) in the opinion of the Investigator
* Concurrent enrollment in a clinical trial without prior approval from the TIO DMP Sponsor
* Undergoing treatment with burosumab for an unapproved indication
The Surgical Education Culture Optimization Through Targeted Interventions Based on National Comparative Data - "The SECOND Trial"

Due to a number of factors, residents are susceptible to mistreatment (i.e., discrimination, harassment, and abuse) and toxic outcomes (i.e., burnout, attrition, and suicidality). Our work following the FIRST Trial identified considerable variation in program-level rates of resident-reported burnout, gender discrimination, racial discrimination, sexual harassment, and verbal abuse. To investigate these issues, the SECOND Trial will include a national mixed-methods analysis of and a pragmatic cluster-randomized controlled trial to improve the resident learning environment and trainee wellness.

The prospective, pragmatic cluster-randomized controlled trial will include approximately 320 surgical training programs across the United States. Participating programs will be randomized to the intervention or control arm. The intervention arm (vs. control) will receive program-specific reports about their learning environment and residents' well-being, as well as access to a Wellness Toolkit of ready-to-implement interventions. We will provide implementation support help facilitate and support intervention uptake throughout the trial period.

To assess the individual efficacy of the reports in regards to decreasing rates of mistreatment and toxic outcomes, the reports will be given to programs approximately 2 months to 6 months prior to Toolkit dissemination. Prior to Toolkit dissemination, programs will have the opportunity to fully review the report, form internal teams to address the issues, and mobilize necessary resources in preparation for receiving the Toolkit. A comprehensive list of all activities performed after report dissemination will be kept at a program-level. Toolkit dissemination to intervention programs will occur within 6 months of report dissemination. Coaching webinars and in-person/virtual conferences will be held at a variety of time points during the trial. The control arm will continue to perform their normal educational (including potential wellness) activities.

The investigators will compare multiple outcomes between the two study arms using data collected from an annual resident survey.

Extension of this work is anticipated to surgical subspecialty training programs (e.g., vascular surgery, cardiothoracic surgery). Eligible subspecialty programs will be assigned as per the randomization scheme of corresponding general surgery programs at their institution. Similar protocols will be in place for surgical subspecialties, with modifications to investigate specialty-specific survey items and interventions.

Eligibility Criteria:
Inclusion Criteria:

* Surgery training programs in the United States

Exclusion Criteria:

* None
Risk Factors of Complications After Ileocolic Resection for Crohn Disease According to the Comprehensive Complication Index

Aim: The aim of this study was to investigate the risks factors of complications after ileocolic resection for Crohn disease according to the comprenhensive complication index.

Methods: Data collected between January 2010 and March 2020 will be analyzed. Informations about preoperative, peroperative and post operative will be collected. The outcome after surgery will be analysed according to the comprehensive complication index.

There are several risk factors reported for postoperative complication after ileocolic resection for Crohn disease. With recent new therapeutics (anti TNF, monoclonal antibodies), these criteria are questioned.

According to the ECCO 2010 Consensus Conference, five post-operative risk factors for recurrence of Crohn disease were described: smoking, extensive small bowel resection (\> 50cm), repeat bowel resection, presence of ano-perineal lesions, and penetrating disease (type B3). However, postoperative complication risk factors after ileocolic resection remain debated. Currently the place of a pre-operative treatment with anti-TNF seems to be a post-operative complication risk factor according to the last ECCO 2017 consensus conference, as well as preoperative parenteral nutrition and emergency versus planned surgery. In addition, a recent GETAID study seems to challenge the penetrating phenotype as a risk factor of postoperative complication. A current study could provide new data on the various known or suspected complication risk factors in the anti-TNF/monoclonal antibodies era.

The classification of Clavien Dindo does not necessarily take into account the respective severities of each complication in a patients. The new classification (Comprehensive Complication Index (CCI)) could be usefull to take into account all the complications and their importance, without focusing only on the most important. To our knowledge, there is no study specifically evaluating CCI after ileocolic resection for Crohn disease. We believe that the CCI can provide a more refined analysis of risk factors for postoperative complications after this procedure.

The aim of this study is to analyze the different complication risk factors after ileocecal resection according to the recent Comprehensive Complication Index, tools potentially more sensitive than Clavien Dindo classification to highlight differences in postoperative morbidity.

Eligibility Criteria:
Inclusion criteria:

* Patients who underwent an ileocolic resection for Crohn disease
* Patient ≥18 years old

Exclusion Criteria:

- Patient who reject the study protocol
HOPE-Genomics Intervention for the Improvement of Cancer Patient Knowledge of Genomics

This clinical trial studies the effectiveness of a web-based cancer education tool called Helping Oncology Patients Explore Genomics (HOPE-Genomics) in improving patient knowledge of personal genomic testing results and cancer and genomics in general. HOPE-Genomics is a web-based education tool that teaches cancer/leukemia patients, and patients who may be at high-risk for developing cancer, about genomic testing and provide patients with information about their own genomic test results. The HOPE-Genomics tool may improve patient's genomic knowledge and quality of patient-centered care. In addition, it may also improve education and care quality for future patients.

PRIMARY OBJECTIVES:

I. Test the efficacy of the HOPE-Genomics intervention in improving patient knowledge of genomics.

II. Test the efficacy of the HOPE-Genomics intervention in improving patient receipt of guideline-concordant care.

OUTLINE: Patients are randomized to 1 of 3 arms.

ARM I (USUAL CARE): Patients receive education pamphlet about whole-genome sequencing (WES) and have their genomics test results returned by their clinician in a typical manner.

ARM II (RETURN OF RESULTS ONLY): Patients receive their genomics test results both from their clinician and from the HOPE-Genomics tool. Patients then view HOPE-Genomics tool over 15-20 minutes after their results are available.

ARM III (RETURN OF RESULTS PLUS PRE-TEST EDUCATION): Patients view HOPE-Genomics tool (containing educational content) over 15-20 minutes before their sequencing results are available. Patients also receive their genomics test results both from their clinician and from the HOPE-Genomics tool.

After completion of study intervention, patients are followed up at 2 weeks, 3 and 9 months after receiving genomic test results.

Eligibility Criteria:
Inclusion Criteria:

* Are enrolled in City of Hope (COH) Institutional Review Board (IRB) 07047
* Have a diagnosis of lung, breast, colorectal, pancreatic, ovarian or prostate cancer
* Having somatic, germline or paired somatic/germline sequencing
* Are fluent in English
* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
* Are \>= 18 years old

Exclusion Criteria:

* Are unable to provide informed consent
QDOT Based PVI for Atrial Fibrillation Treatment - The peQasus Study

PeQasus is a worldwide, retrospective, multicenter analysis focusing on QDOT based PVI. Data of at least 300 patients with QDOT based PVI will be collected. All data will be evaluated after anonymization. Primary endoints are efficacy and safety.


Eligibility Criteria:
Inclusion Criteria:

* Suitable for PVI

Exclusion Criteria:

* Non suitable for PVI