cyrilzakka/clinical-trials huggingface dataset:
Echocardiographic Analysis by Artificial Intelligence in Hypertension

The objective of this study is to develop artificial intelligence (AI) tools to characterize cardiac remodelling in arterial hypertension through the analysis of routine imaging data (echocardiography) coupled with patient data. More precisely, this study will make it possible (i) to represent in a relevant way the spectrum of the cardiac repercussions of a population affected by hypertension to better characterize the progress of the pathology, in particular vis-à-vis the more ambiguous subjects to be characterized ("grey" area); (ii) to develop tools for the automatic quantification of cardiac function (segmentation and robust monitoring of the myocardium during the cardiac cycle, for the dynamic analysis of the shape and global deformation of the heart) and therefore to extract descriptors richer in cardiac function than those currently used in clinical routine.


Eligibility Criteria:
Inclusion Criteria Patients who underwent a comprehensive blood pressure assessment during hospitalization in the Cardiologic Federation at Croix Rousse Hospital and Lyon Sud Hospital between January 2018 and December 2021.

Exclusion Criteria Patients who are minors. Patients under curatorship or guardianship.
Cutaneous Remote Ischemic Preconditioning in Plastic Surgery

Background: In plastic and reconstructive surgery, free flaps are routinely used for treatment of soft tissue defects. Treatment strategies aim at reducing or preventing flap necrosis by conditioning tissue tolerance against ischemia. Although previous studies indicate that remote ischemic preconditioning (RIPC) is a systemic phenomenon, only a few studies have focused on the elucidation of its mechanisms of action. Therefore, the aim of this study is to evaluate the microcirculatory effects of remote ischemic preconditioning on a potential free flap location in a human in-vivo setting for the first time.

Conclusion: Remote ischemic preconditioning improves cutaneous tissue oxygen saturation, arterial capillary blood flow and postcapillary venous flow in a remote free flap donor location. To what extent remote preconditioning might ameliorate the reperfusion injury of free flap transplantation, further clinical trials have to evaluate both in the means of microcirculatory assessment and partial or total flap loss as end points of these studies.


Eligibility Criteria:
Inclusion Criteria:

* healthy male and female subjects aged 18 to 35 years

Exclusion Criteria:

* soft tissue inflammation or osteomyelitis, peripheral arterial occlusive disease, vasculitis, chronic kidney or liver disease, cardiac dysfunction, arterial hypotension and any type of vasoactive medication, i.e. ß-blockers, calcium channel blockers, nitroglycerin
Ambulatory Alcohol Detoxification With Remote Monitoring

This study is designed to examine the feasibility and impact of the use of remote monitoring devices during an outpatient ambulatory alcohol detoxification treatment for patients with alcohol use disorders.

The study will include 30 subjects with a diagnosis of alcohol use disorder. The study uses a breathalyzer device with facial recognition to confirm the patient's identity and sends the information to the study staff using cellular technology. A second device is used which is a wireless blood pressure cuff that connects to the patient's smartphone and sends blood pressure and heart rate measurements directly to the study physician for enhanced monitoring during alcohol withdrawal management. The duration of the study is 8 days, starting with an initial appointment to set up the equipment. Throughout the study, surveys are completed by subjects in regards to their experience with the device. Subjects undergo a brief 30-60 minute appointment on the first day of the study, appointments as needed throughout the study, and an appointment on the last day of the study to check in with the physician for ongoing ambulatory management of alcohol withdrawal, including medication adjustments if indicated.

Eligibility Criteria:
Inclusion Criteria:

* Male or female Subject between the ages of 21-75 years old
* Meeting DSM-V criteria for alcohol use disorder and needing medically supervised detoxification based on medical history and pattern of alcohol use delineated by timeline follow back method.
* Has 24/7 easy access to a hospital. This is to ensure easy admission to a higher level of care if indicated.
* Willing to use the Soberlink Device to provide blood alcohol concentration (BAC)
* Willing to use the blood pressure cuff to provide blood pressure and pulse (BPPT) measurement
* Willing to sign an informed consent

Exclusion Criteria:

* BAC above the legal driving limit at the time of screening
* Developing symptoms or history of symptoms of severe withdrawal syndrome such as fever, disorientation, drenching sweats, severe tachycardia, or severe hypertension
* History of delirium tremens or seizures
* Co-morbid medical or psychiatric history requiring inpatient admission for careful monitoring
* Subject unwilling to respond to redirection when blood pressure and heart rate warning signs are triggered
* Does not have an iPhone, iPod, iPad, or Apple Watch with iOS 7.0 or later, or does not have an Android phone or tablet with Android 4.4 or later
* Unable or unwilling to properly use the monitoring devices, or find the monitoring devices an obstruction to comply with treatment
* Subject that is non-English speaking
* Subject that is a child, adolescent, or cognitively impaired
Nutritional Intervention and DNA Damage of Patients With HBOC

Breast and Ovarian Cancer Syndrome (HBOC) is characterized by mutations in tumor suppressor genes such as BRCA1 and BRCA2, which increase the carrier's risk of developing breast and ovarian cancer, especially before 40. In this pathology the DNA damage is increased because there is a state of chronic inflammation, plus the antineoplastic treatments and changes in body composition result in oxidative stress. The inductions of epigenetic changes by a nutritional intervention with an specific distribution of macronutrients, micronutrients and polyphenols, not only ensures an optimal nutritional status, but also shows a decrease in oxidative stress, and therefore in DNA damage. The aim of this study is to assess if the DNA damage in patients with HBOC decreases after the nutritional intervention.

Breast and Ovarian Cancer Syndrome (HBOC) is a genetic disease characterized by mutations in tumor suppressor genes such as BRCA1 and BRCA2, elevation of Reactive Oxygen Species (ROS), inflammation and DNA damage; all this as a result of the pathology itself. Antineoplastic treatments and changes in body composition such as malnutrition, cachexia and obesity lead to an increase of the inflammatory state. The induction of epigenetic changes by a nutritional intervention suggests that an hypo caloric diet, complex carbohydrates, polyunsaturated fatty acids, some amino acids, and some vitamins, minerals and polyphenols as well, can reduce DNA damage because of the interaction between mechanisms related with DNA stability and reparation, cellular replication, induction of apoptosis, and antioxidant systems. Previous studies report that using polyphenols supplements can reduce de DNA damage, but when the administration is only through food there's no benefit at all. So the aim of this study is to assess if the use of different micronutrients and polyphenols in conjoint can make synergism and reduce de DNA damage without the need of supplements.

Eligibility Criteria:
Inclusion Criteria:

* Female patients diagnosed with HBOC according to the Mexican Consensus of Breast Cancer
* Patients over 18 years who voluntarily agree to participate in the study and sign the informed consent.

Exclusion Criteria:

* Patients with end-stage chronic kidney failure, heart failure, liver failure, rheumatoid arthritis, non-inherited AC or HIV.
* Patients who carry out a structured exercise plan (rehabilitation) at the time of inclusion in the study.
* Patients who carry out a structured eating plan (adherence to diet) or who are consuming a food supplement at the time of inclusion in the study.
* Patients with significant primary clinical disorders: hematological (hemoglobin \<13 in men and \<12 in women), renal (creatinine\> 3), neurological (other than epilepsy).
Role of Perforator Flaps in Back Defects Reconstruction

evaluation of perforator flaps versus perforator plus flaps

One of the neural tube defects, myelomeningocele, is a congenital anomaly developing in the fourth gestational week. It is characterized by insertion of neural elements into a pouch floored by meninx through a vertebral defect.

The aetiology is multifactorial. causes are genetic properties, geographic factors, and deficiency of folic acid.

Meningomyelocele incidence range between 1 and 2/1000 live births. The defect location can reside anywhere between the cervical region and the sacrum.

surgical closure of the defect is performed to prevent cerebrospinal fluid leakage and central nervous system infections. it is a combined work between neurosurgery and plastic surgery. Fascial turnover flaps, muscle flaps, local fasciocutaneous flaps.

With the emerging concepts of perforator flaps in the last three decades, the reconstruction of myelomeningocele defects has completely changed since the anatomy of the dorsal intercostal artery perforators (DIAP) and lumbar artery perforators(LAP) has been fully studied.

Despite utilizing perforator flaps having greatly improved the outcome of myelomeningocele reconstruction, venous compromise remained a major concern associated with complications.

By preserving, the perforator vessels and minimizing the amount of tissue that is removed, the Perforator Plus technique can improve blood flow and decrease the risk of venous congestion.

Preoperative perforator mapping may be executed by a multitude of diagnostic modalities. Hand-held Doppler (HHD), color-coded duplex sonography (CCDS), computed tomography angiography (CTA), magnetic resonance angiography (MRA) and others may be applied.

Systematic reviews of the literature revealed that CCDS has the highest sensitivity and positive predictive value to identify perforators for flaps.

Eligibility Criteria:
Inclusion Criteria:

* infants up to one year,
* dorso-lumbar myelomeningocele.
* moderate to large myelomeningocele defects. (25 - 39 cm2 ) .

Exclusion Criteria:

* cervical myelomeningocele
* very large defects (more than 40 cm2 )
* preterm newborn patients.
* hematological disease
* any problem against prone position of the patient
Performance of MammoAlert™, Point of Care System, for the Screening of Breast Cancer in Women 18 Years of Age or Older

POC Medical Systems has developed a Point of Care system for the screening of breast cancer in the general population. Via a proprietary algorithm, the MammoAlert™ is expected to determine breast cancer's risk level for a subject by identifying the presence in plasma of known biomarkers. The present study aims to determine the Sensitivity and Specificity of the test in plasma samples of subjects of whom the status vis-à-vis breast cancer is known.

2400 subjects will be screened for breast cancer in seven enrolling sites across the country to ensure diverse ethnicity.

"Positive" subjects should be confirmed breast cancer positive by Mammography and/or biopsy. Breast cancer positive samples will be compared to the control group of samples obtained from women attending clinics for non-cancerous related pathology.

Both Positive and Negative Predictive Values will be evaluated to determine accuracy and sensitivity of the screening test.

Subjects whose known cancer positive or negative status do not match the test report will be followed up as appropriate, on case by case basis to identify false positive and false negative results.

Eligibility Criteria:
Inclusion Criteria:

1. Ability to give informed consent. Written informed consent by the patient/patient's legally acceptable representative (LAR) for donating blood sample
2. Documented absence of cancer (other than Breast Cancer)
3. Documented (Mammography and/or Biopsy) diagnosis of Breast Cancer (IDC/ILC/DCIS ), any stage
4. Blood sample taken before any treatment for Breast Cancer was administered to the subject.

Exclusion Criteria:

1. Other malignancy besides breast cancer in the 5 years prior to obtaining the sample.
2. Therapies for breast cancer that have been administered within 1 year of obtaining the sample
3. Any condition (including psychiatric), which in the Investigator's opinion, places the patient at undue risk by participating in the study.
Health and Cardiovascular Risk Factors in Slums.

Cardiovascular risk factors and disease burden has been showed to affect more deeply to poorer populations. People who live in slums are the most vulnerable subgroup in the populations where, paradoxically scarcity of data exists on risk factors and cardiovascular disease burden.

Our study aim to describe the prevalence of cardiovascular risk factors and cardiovascular disease burden in a representative sample of an urban slum of Buenos Aires city, using validated questions from the National Risk Factors Survey (edition 2013). Also, the investigators will measure blood pressure and cardiac rate to all study participants.

Cardiovascular risk factors and disease burden has been showed to affect more deeply to poorer populations. People who live in slums are the most vulnerable subgroup in the populations where, paradoxically scarcity of data exists on risk factors and cardiovascular disease burden.

Hypothesis: the prevalence of modifiable cardiovascular risk factors in an urban slum from Buenos Aires city is higher than the rest of the country and, consequently requires a distinctive management approach.

Objectives:

1. To measure the prevalence of cardiovascular risk factors in a representative sample of the villa 31 (an urban slum from Buenos Aires city).
2. To measure the self-perceived health in a representative sample of the villa 31 (urban slum from Buenos Aires city).

Design: observational study. Survey. Procedures: the survey will be conducted by neighbors from the slum that received specific training as community health workers and were trained on the use of the survey questionnaire and for blood pressure measuring.

Sampling: representative samples of slum population will be obtained using probabilistic, multi-staged sampling methods.

Blood pressure measures: blood pressure will be measured using automatic blood pressure monitoring device with appropriate cuff sizes.

Statistical analyses: categorical variables will be expressed as numbers and percentages, and continuous variable as means and standard deviations or medians and interquartile ranges. Between groups comparisons will be conducted using chi2 test for categorical variables and T test or Mann-Whitney U's test for continuous variables. To compare the prevalence of risk factors with the rest of the country, the database will be jointed with the national risk factor survey (publicly available). All analyses will be weighted to account for the sampling method.

Eligibility Criteria:
Inclusion Criteria: \>= 18 years. Sign the informed consent.

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Exclusion Criteria: Unable to answer the survey. Unwilling to participate.

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Monitoring Your Exercise-related Metrics Over Time Via Wearable Electronic Devices

To test the use of a continuous activity and heart rate tracker (Fitbit) and continuous glucose monitor (CGM) in monitoring daily exercise-related activities.

Primary objective:

To evaluate the feasibility of a CGM-based physical activity intervention that includes the use of CGM and Fitbit®.

Secondary objectives:

To examine changes in physical activity motivation and other related psychosocial variables (e.g., intention, perceived benefits, outcome expectancy) before and after the intervention.

Exploratory objective:

Examine cancer-related biomarkers and their associations with daily glucose pattern.

Eligibility Criteria:
Inclusion Criteria:

* Men and women at least 18 years old
* Body mass index (BMI) 25 kg/m2
* Engage in less than 150 minutes of moderate-intensity PA per week in the past month
* Capable of participating in moderate-vigorous unsupervised exercise (as determined by the Physical Activity Readiness Questionnaire (PARQ) or a medical release from their physician)
* Self-reported ability to walk one block without pain or discomfort
* Have a smart phone with daily internet access that is compatible with the LibreLink app
* Ability to speak, read, and write in English
* For the cancer survivor cohort (participant accession number #21 and beyond), individuals must have been diagnosed with stage I-III breast or colorectal cancer and completed adjuvant therapy (i.e., chemo and/or radiation therapy).

Exclusion Criteria:

* Self-reported current diagnosis or history of type 1 diabetes or type 2 diabetes
* Self-reported use of oral antidiabetic agents (OADs)
* Previous or current treatment with any insulin regimen other than basal insulin, e.g. prandial or pre-mixed insulin (short term treatment due to intercurrent illness including gestational is allowed at the discretion for the investigator)
* Current use of a continuous glucose monitor
* Fasting glucose \> 125 mg/dL
* Pregnancy
* Self-reported health issues that limit physical activity
* On dialysis
* Work overnight shifts
* Unwilling to use CGM
* Current participation in other wellness or weight loss-related program or intervention
* Currently on a low-carb diet
* Unable to receive REDCap survey through their mobile phones
PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - XT Intermediate and High Risk

The purpose of this trial is to determine the safety and effectiveness of the Edwards SAPIEN XT transcatheter heart valve and delivery systems which are intended for use in patients with symptomatic, calcific, severe aortic stenosis.

The PIIA cohort is a prospective multi-center trial undergoing aortic valve replacement for severe aortic stenosis. Patients randomized to the treatment arm will receive an Edwards SAPIEN XT THV with either transfemoral, transapical or transaortic delivery access. Patients in the control arm will receive a surgical bioprosthetic heart valve via aortic valve replacement surgery.

To assure that patients with an STS score ≥ 4% have been selected.

Eligibility Criteria:
Inclusion Criteria

1. Patient has senile degenerative aortic valve stenosis with echocardiographically derived criteria: mean gradient \>40 mmHg or jet velocity greater than 4.0 m/s and an initial aortic valve area (AVA) of ≤0.8 cm2 or indexed EOA \< 0.5 cm2/m2 Qualifying echo must be within 60 days of the date of the procedure.
2. Patient is symptomatic from his/her aortic valve stenosis, as demonstrated by NYHA Functional Class II or greater.
3. The heart team agrees (and verified in the case review process) that valve implantation will likely benefit the patient.
4. The study patient or the study patient's legal representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board (IRB) of the respective clinical site.
5. The study patient agrees to comply with all required post-procedure follow-up visits including annual visits through 5 years and analysis close date visits, which will be conducted as a phone follow-up.
6. Study patient agrees to undergo surgical aortic valve replacement (SAVR) - if randomized to control treatment.

Exclusion Criteria

1. Evidence of an acute myocardial infarction ≤ 1 month (30 days) before the intended treatment \[defined as: Q wave MI, or non-Q wave MI with total CK elevation of CK-MB ≥ twice normal in the presence of MB elevation and/or troponin level elevation (WHO definition)\].
2. Aortic valve is a congenital unicuspid or congenital bicuspid valve, or is non-calcified.
3. Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation \>3+).
4. Preexisting mechanical or bioprosthetic valve in any position (except NR3).
5. Any therapeutic invasive cardiac procedure resulting in a permanent implant that is performed within 30 days of the index procedure (unless part of planned strategy for treatment of concomitant coronary artery disease). Implantation of a permanent pacemaker or ICD (S3 Cohort only) is not excluded.
6. Heart team assessment of inoperability (including examining cardiac surgeon).
Honey Dressing - A Preventive Procedure for Post-Surgical Site Infection.

The goal of this clinical trial is to compare the wound healing in the participants who underwent the clean surgical procedure, by applying honey dressing and common Iodine solution dressing, participants will have no other co-morbidities like Diabetes, Anemia, etc. which can make the results biased. The main questions it aims to answer are:

* Do the iodine solutions are enough to counter the infections caused by resistant strains of bacteria?
* What is the efficacy and efficiency of honey dressing in wound care?

Participants will be tasked to

* Ensure strict follow-up in the hospital dressing room
* Half of the participants will apply common iodine solution dressing and the other half will be applied honey dressing.

Researchers will compare Iodine dressing (Control group) with Honey dressing (Experimental group) to see if Honey dressing is better in the prevention of post-surgery wound infection and if it is cost-efficient and its efficacy.


Eligibility Criteria:
Inclusion Criteria:

Patients with sterile/clean post-surgical wounds are admitted in general surgery, neurosurgery, orthopedic, and gynecology wards and require follow-up dressings.

Exclusion Criteria:

1. Patients with:

   * Anemia
   * BMI\>30
   * Local Infection in wound area.
   * Venous leg ulcers
   * Diabetes
   * Immunocompromised (Oncological patients)
2. Patient under negative pressure therapy
A Randomized, Open-Label Study of Daclatasvir and Sofosbuvir With or Without Ribavirin for 8 Weeks in Treatment-Naïve, Non-cirrhotic Subjects Infected With Chronic Hepatitis C Virus (HCV) Genotype 3

The purpose of this study is to determine if 8 weeks of Daclatasvir plus Sofosbuvir with or without Ribavirin is safe and effective in the treatment of genotype 3 hepatitis C infected patients without advanced fibrosis or liver cirrhosis who have never been treated previously.


Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Genotype 3
* HCV RNA \< 2000000 IU/mL
* Never taken HCV medication
* Absence of advanced fibrosis or cirrhosis
* Body mass index (BMI) 18-40 kg/m\^2

Exclusion Criteria:

* Infection with HCV other than genotype 3 (GT3); Mixed infections of any genotype
* Previously taken HCV medication
* Liver Cirrhosis
* Evidence of decompensated liver disease
* HIV/ hepatitis B virus (HBV) coinfection