cyrilzakka/clinical-trials huggingface dataset:
A Study About the Natural History in Adults With BAG3 Dilated Cardiomyopathy (a Type of Heart Disease) (BAG3 DCM)

The purpose of this study is to learn about the natural progression of DCM (dilated cardiomyopathy) caused by BAG3 gene mutations. DCM is a condition as the heart muscle is weakened and the heart becomes enlarged. This makes it hard for the heart to pump enough blood for the body.

The study is seeking up to about 35 participants who have:

* BAG3 mutation (change in the gene) that causes or is likely to cause dilated cardiomyopathy
* NYHA (New York Heart Association) Class I-IV at screening (Stage B-D)
* Left Ventricular Ejection Fraction less than or equal to 50% (meaning reduced heart function)

All participants in this study will receive their usual treatment. The investigators will observe the natural progression of people who have BAG3 DCM. This will help the investigators better understand the disease and aid in future research.

Participants will take part in this study for one year. During this time, participants will visit the site at least 4 times (about every 3 months). Participants will undergo study procedures and give information about their health. These procedures will include a physical exam, cardiac magnetic resonance imaging, echocardiography, ECG monitoring, activity monitoring, cardiopulmonary exercise testing, and blood tests. Participants will answer questions about health and quality of life. The study team will also call participants about 1 time over the phone.


Eligibility Criteria:
Inclusion Criteria:

* Documented BAG3 mutation that causes or is likely to cause dilated cardiomyopathy
* New York Heart Association (NYHA) Class I-IV at screening (Stage B-D)
* Left Ventricular Ejection Fraction ≤50% (i.e., Reduced Heart Function)

Exclusion Criteria:

* Acute decompensated heart failure within 1 month prior to enrollment.(such as hospitalization)
* Any of the following within 3 months prior to screening: myocardial infarction (MI), cardiac surgical procedures (other than for pacemaker/ICD/CRT-defibrillator \[CRT-D\] implantation), acute coronary syndrome, or hospitalization for cardiac arrhythmia.
* History of heart transplantation
* eGFR \<30 mL/min/1.73 m2 (significantly impaired kidney function)
* Noncardiac condition that limits lifespan to \<1 year.
* Presence of other form(s) of cardiomyopathy contributing to heart failure
* Previous administration with an investigational drug within 30 days (or as determined by the local requirement).
* No more than 3 first-degree members of the same family who are already participating in the study
Oral Tranexamic Acid and Topical Hydroquinone in the Treatment of Melasma

This study assess the effectiveness of oral tranexamic acid in combination with hydroquinone cream in the treatment of melasma.

Hydroquinone (HQ) is considered the gold standard depigmenting agent for melasma, nevertheless, many patients are recalcitrant to this treatment.

Recent studies have shown that tranexamic acid, a plasmin inhibitor, can prevent UV-induced pigmentation.

Eligibility Criteria:
Inclusion Criteria:

* moderate melasma (subject with mMASI score of 5 to 7.9),
* severe melasma (subject with mMASI score ≥ 8),
* willing to follow up for 6 months.

Exclusion Criteria:

* pregnant women,
* nursing women,
* women on exogenous hormones
* current treatment with blood thinners,
* had a history of thrombosis,
* had an abnormal kidney function,
* use of topical hydroquinone within 3 months of study enrollment,
* use of topical steroids, vitamin A analogs, chemical peels within 1 month of study
Study of the Life Stories of Patients Making a Request for Euthanasia, in the Context of Advanced Cancer.

This study wishes to focus on the life course of patients, beyond the moments of suffering experienced at the time of the request for euthanasia. It is based on the perspective that the patient's account of his or her life course can be a source of information for better understanding and accompanying patients requesting euthanasia.


Eligibility Criteria:
Inclusion Criteria:

* Major patients
* With cancer in the palliative phase, i.e. with an incurable disease according to current knowledge.
* Expressing a request for euthanasia in terms evoking a request for death with the intervention of an outside person.
* Non-opposition to the study after full written information.

Exclusion Criteria:

* Severe decompensated psychiatric pathology
* Vulnerable persons defined here as pregnant women, parturients and persons under legal protection or unable to express their consent
* Inability to conduct an interview
Mepilex Border Flex Utilization Pilot Spain

The aim of this study is to assess and describe the utilization of Mepilex® Border Flex and other foam dressings available in routine clinical practice in the management of patients with chronic wounds, in order to understand the pattern of use and the frequency of dressing changes in wound management. The study will also allow to gain information about the opinion of the HCPs and the patient's experience concerning wound management with foam dressings. This information may help to understand patient's health care optimization in terms of quality and efficiency.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years or older.
* The patient has been deemed by the HCP to change dressing to Mepilex® Border Flex.
* Patients with chronic wounds (wounds that have not reduced in size by more than 40% to 50% or healed within a month) treated with foam dressings, other that Mepilex® Border Flex, according to its intended use at baseline visit for minimum 4 weeks.
* Patients with an expectation of wound follow-up of at least 4 weeks.
* Patients agree only to have the dressing changed by the HCP.
* Patients capable of signing the Informed Consent Form and answer the questions being asked.

Exclusion Criteria:

* Patients with any applicable contraindication or sensibilization to any of the dressing compounds
* Patients with pressure ulcers (PU) stage I, deep tissue injuries or terminal wounds (e.g., fungating wounds)
* Patients with wounds whose location and/or aetiology requires a dressing change for reasons that are unrelated to the dressing characteristics such as wounds in the sacral area.
* Hospice patients
* Patients participating in other studies interfering with this study.
COVIDISC: Rapid Diagnostic Tests on Nasopharyngeal Swabs for the Detection of COVID-19

The Covid-19 pandemic requires a reliable diagnosis of patients in order to take care of them in the best conditions and in the appropriate services. Moreover, the current diagnostic reference is reverse transcription by polymerase chain reaction (RT-PCR) on a nasopharyngeal sample taken by swab. This technique is expensive (54€) and its production time is several hours.

Alternative methods are in progress, including, rapid diagnostic tests. The MEMS microfluids and nanostructures (MMN) laboratory, in partnership with the Institut Chimie Biologie Innovation (CBI) (Paris, 75005), have developed a portable test "COVIDISC", low-cost (10 €), fast (1 hour), including extraction, elution and amplification in solid medium isothermal, reverse amplification loop mediated transcription (RT-LAMP).

The "lab" version has received an analytical validation on human nasopharyngeal samples with performance comparable to classic RT-PCR (sensitivity of 7 copies per μl, specificity 100%).

The objective of this study is to validate the in vitro diagnostic medical device, COVIDISC, with the standard nasopharyngeal RT-PCR test.

All outpatients and hospitalized patients (intensive care unit, internal medicine service and emergency service) will be proposed to participate to the study after assessment of eligibility criteria by the investigator. The investigator will collect a written consent of the patient or from the support person or a familiar if, the patient is not in condition to consent. Patient's participation will be notified in his medical record.

After inclusion of patient, the nurse will collect general and clinical data and 2 nasopharyngeal swabs will be taken. One sample to test the prototype of the RT-LAMP and the second one to carry out the classic RT-PCR. The results will be collected and compared in a second step.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing nasopharyngeal SARS CoV2 RT-PCR testing

Exclusion Criteria:

* \< 18 years old
* Having signed a written informed consent form,
* Affiliation to the social security system.
Metabolic Activation of Brain Areas With Emotional Stimuli Compared With Score in Psychological Test

Quantitative assessment of the activation of brain areas by functional magnetic resonance imaging (fRMI) in the face of positive and negative emotional stimuli using audiovisual materials validated for the local population and its correlation with degrees of emotional disorder based on a score obtained by a validated questionnaire for the local population, in 16 volunteers from the city of La Rioja in Argentina.

The technology applied in fMRI allows us to visualize on a color scale the changes in blood flow in those sectors of the brain that increase their metabolic activity during a given action. This is achieved by mapping the cerebral blood volume, which increases or decreases according to the metabolic activity in a certain region of the brain. This indirect method of measuring the metabolic activity of brain areas is very useful for anatomically identifying motor areas and critical functions in individual patients prior to neurosurgery, to allow better surgical planning. Currently this is its main application in healthcare practice. In the field of research it is applied in clinical neurology, psychiatry and psychology. Studies have been conducted on the activations of brain regions in basic emotions. There is less data on the quantitative differences of these activations in the Argentine population according to the degree of emotional disorder, this being the object of study of this project. Emotional disorders are transversal to different pathologies, with or without a psychotic component.

Eligibility Criteria:
Inclusion Criteria:

- Must be able to understand the instructions and collaborate during the data adquisition.

Exclusion Criteria:

* Any contraindication to enter an MRI (for example, a pacemaker)
* Claustrophobia.
Efficacy and Safety of Fentanyl ETHYPHARM for Breakthrough Pain in Opioid-treated Patients With Cancer

The purpose of the study is to assess the clinical effectiveness of Fentanyl ETHYPHARM when used to relieve breakthrough pain (BTP) in opioid-treated cancer patients.


Eligibility Criteria:
Inclusion criteria:

1. Written informed consent
2. Malignant solid tumor or a hematological malignancy causing cancer-related pain
3. Background opioid treatment at a stable dose for at least a week
4. One to four episodes of breakthrough pain per day

Main exclusion criteria:

1. Hypersensitivity to fentanyl or to any of the excipients
2. Intrathecal opioids
3. Recent history of substance abuse
4. Recent or planned therapy that would alter pain
5. Moderate or severe hepatic or renal disease
Database of Monochorionic Pregnancies

The purpose of this study is to collect and analyze data regarding natural history, indications for fetal interventions, and maternal and fetal/neonatal outcomes associated with complicated monochorionic twin pregnancy.


Eligibility Criteria:
Inclusion Criteria:

* The study population will consist of MC pregnancies (maternal, fetal, and neonatal data) that have undergone evaluation and/or treatment for complications attributable to monochorionic twin pregnancy at the University of Miami.
* Maternal age 18 years and older.

Exclusion Criteria:

* Participation declined or consent not granted in prospective arm
* Loss to follow-up
Remifentanil for General Anesthesia in Preeclamptics

The purpose of this study is to determine whether remifentanil use in preeclamptic patients may blunt hemodynamic response to intubation during general anesthesia for cesarean section.

General anesthesia for cesarean section involves rapid sequence induction with a muscle relaxant and barbiturate followed by endotracheal intubation. Although the use of opioids may blunt haemodynamic responses to endotracheal intubation, they are avoided in pregnant patients due to possible respiratory depressants effects on neonates.Preeclamptic patients response with exaggerated sympathoadrenal reflex to anesthesia induction and intubation. The resulting hypertension and tachycardia may result in cerebrovascular accident, pulmonary edema, arrhythmias, increased myocardial oxygen consumption and fetal hypoxia by uterine vasoconstriction. Several drugs have been used to blunt the hemodynamic disturbances to intubation, but none of them have been implicated for routine use for general anesthesia in preeclamptic patients.

Recently remifentanil has started to be used in general anesthesia of high risk obstetric patients. Remifentanil is a μ-opioid receptor agonist that is metabolized by nonspecific blood and tissue esterase hydrolysis. It has a low distribution volume with a context sensitive half life of 3 minutes. Its elimination half life is 12 minutes even after repeated boli. Previously remifentanil use in pregnant patients with cardiac pathology has been reported with minimal neonatal side effects. A randomized controlled study in normal parturient has shown that remifentanil is transferred through placenta and may cause mild neonatal depression that is easily managed. Umbilical artery and vein remifentanil concentrations has shown that remifentanil is quickly redistributed or metabolized in fetus. Thus, remifentanil may be an appropriate drug for induction and maintenance of general anesthesia in severe preeclamptic patients.

Eligibility Criteria:
Inclusion Criteria:

* Severe preeclamptic parturients with single fetus pregnancy with contraindication to regional anesthesia

Exclusion Criteria:

* Known allergy to study drugs
* Known fetal anomaly and /or gestation week and /or estimated to be nonviable (fetal weight \<400 gr, gestational week\<24 weeks)
* Known cardiac disease diagnosed prior to pregnancy
* Known drug abuse in the parturient
* Multifetal gestation
* Anticipated difficult airway management (mask ventilation and/or endotracheal intubation).
VIOLA Post Market Surveillance Clinical Protocol

The goal of this post marketing surveillance clinical trial is to learn about VIOLA as a proximal seal device in patients undergoing coronary artery grafting (CABG) surgery. The main objective is to evaluate the clinical safety and performance of the VIOLA. Participants will be treated with routine CABG with use of VIOLA for maintaining hemostasis when suturing the proximal anastomosis. Patients will be followed for any clinical events at 6 weeks and 9 months post surgery.

The goal of this post marketing surveillance clinical trial is to collect post market data on the safety and performance of VIOLA as a proximal seal device in patients undergoing coronary artery grafting (CABG) surgery. The main objective is to evaluate the clinical safety and performance of the VIOLA. Participants will be treated with routine CABG with use of VIOLA for maintaining hemostasis when suturing the proximal anastomosis. Data will be collected intraoperatively, at discharge, at 6 weeks, and at 9 months post CABG.

Eligibility Criteria:
Inclusion Criteria:

1. Patient scheduled for isolated CABG on clinical grounds
2. One or more bypass grafts originating from the aorta
3. Ability to give their informed written consent
4. Ability and willingness to comply with study follow up requirements
5. Patient is ≥ 18 years of age

Exclusion Criteria:

1. Emergency CABG surgery (cardiogenic shock, inotropic pressure support, IABP)
2. Prior clinical stroke less than one year before surgery
3. Pre-operative neurological deficits
4. Chronic atrial fibrillation
5. Aortic external diameter less than 25 mm measured intraoperatively
6. No proximal aortic anastomosis eligible for VIOLA use, assessed intraoperatively according to surgeon's discretion (E.G inadequate punch size, thin-walled aorta).
7. Symptomatic carotid disease
8. Acute MI within 24 hours of planned surgery
9. EuroScore II ≥ 4
10. Known allergy to nickel
11. Women of child bearing age
12. Participating in any other investigational study for either drug or device which can influence collection of valid data under this study.
Safety and Efficacy Study of an Iontophoretic Patch Containing Lidocaine and Epinephrine for Venipuncture in Healthy Adult Volunteers

The purpose of this study is to evaluate the effectiveness of administering Lidocaine and Epinephrine using an iontophoretic device treatment to provide local anesthesia to healthy adult volunteer subjects undergoing venipuncture.


Eligibility Criteria:
Inclusion Criteria:

* Subjects may be of any race, either sex, and must be \>18 years of age
* Healthy subjects as per medical screening
* Subjects must have intact, healthy skin (no tattoos, surgical scars, skin infections, etc.) where the iontophoresis treatment will be performed
* Subjects must be alert, oriented, mentally competent, and able to understand and comply with the requirements of the study
* Subjects must have signed and dated a written informed consent
* Female subjects of childbearing potential must have a negative pregnancy test result prior to the iontophoresis treatment

Exclusion Criteria:

* Subjects with a known allergy or sensitivity to lidocaine, epinephrine or other local anesthetics of the amide or ester type
* Subjects with a know sensitivity to any components (e.g. adhesives) of the IDDSSubjects who have undergone venipuncture in the treatment area within the prior 2 weeks or longer if bruising or hematoma is apparent
* Subjects who have taken an analgesic pain medication during the 24-hour period prior to the venipuncture in the posterior surface of the hand
* Subjects with skin allergies or have skin diseases (e.g. psoriasis, eczema
* Subjects with an open skin lesion at the treatment site
* Subjects who are pregnant or breastfeeding
* Subjects exposed to an investigational drug or device within the past 30 days or are involved concurrently in other treatment clinical trials
* Subjects who participated in previous DTI/Transcu clinical studies related to this product
* Subjects with known concurrent illness
* Subjects with "current" known/admitted substance abuse (alcohol/drug)
* Subjects with pacemakers and/or externally mounted electronic devices
* Current or history of conditions that contraindicate use of iontophoretic treatment or venipuncture
Personalize My Treatment (PMT) Registry

The 'Personalize My treatment' (PMT) platform is a novel form of biobanking in which cancer patients willingly consent to provide residual, clinical samples (surplus after diagnostic testing) of their tumors for cancer research, to give access to their medical record for data collection and then followed prospectively throughout the trajectory of their illness. They further willingly consent to be recontacted for being informed of other research projects, including clinical trials.


Eligibility Criteria:
Age of majority in the province of recruitment.
Comparison of Vessel-FFR Versus FFR in Intermediate Coronary Stenoses

This is a prospective, randomized, controlled, multicenter, open-label study designed to assess whether vFFR is non-inferior to FFR in assessment of intermediate coronary stenosis in terms of the occurrence of MACE during 12 months after randomization.

Coronary angiography is insensitive to assess the physiologic significance of a coronary stenosis. Therefore, clinical guidelines support the use of pressure-derived fractional flow reserve (FFR) to assess the hemodynamic significance of coronary stenosis. Nevertheless, the penetration of FFR in clinical routine continues to be limited by its requirement for pharmacological vasodilation, prolonged procedure time and adverse systemic effects from adenosine.

Vessel-FFR (vFFR) is a novel method for evaluating the functional significance of coronary stenosis by calculation of the pressure drop in the vessel based on computation of two angiographic projections. The vFFR values at each point along the vessel are color-coded and superimposed on the 3D epicardial model and cut-off values of ≤0.80 identical to standard invasive FFR apply.

These developments may translate towards more physiology guided intervention bearing the potential to improve clinical outcomes in patients with stable CAD. The ability to derive FFR values from routinely performed coronary angiograms, without the practical drawbacks that limit invasive techniques, could have an important impact on daily clinical practice.

To date no randomized outcome-based clinical trial has compared an image-based FFR methodology with standard invasive FFR in terms of subsequent clinical outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Willing to participate and able to understand, read and sign the informed consent document before the planned procedure
* Eligible for coronary angiography and/or PCI
* Coronary artery disease in one or more native major epicardial vessels or their branches by coronary angiogram with visually assessed de novo coronary stenosis in which the physiological severity of the lesion is in question (typically 40-80% diameter stenosis).
* Stable angina or acute coronary syndrome (non-culprit vessels only and outside of primary intervention during acute STEMI or NSTE-ACS)
* Participation in another interventional study

Exclusion Criteria:

* Previous CABG with patent grafts to the interrogated vessel
* Tandem stenoses separated by more than 10 mm that require separate pressure guide wire interrogation or PCI (not to be interrogated or treated as a single stenosis)
* Total coronary occlusions
* Hemodynamic instability (Killip class III-IV)
* Heavily calcified or tortuous vessels
* Terminal disease with life expectancy of less than 12 months
* STEMI within 48 hours of procedure
* Severe valvular heart disease
* ACS patients with difficulty in assessing which the culprit lesion is
* Significant contraindication to adenosine administration (e.g. Asthma bronchiale)
* Pregnancy
Brain Mechanisms of Reducing Polysubstance Use Following a Novel Body-mind Intervention

The proposed study will examine brain mechanisms of a brief mindfulness intervention - integrative body-mind training (IBMT) on alcohol, tobacco, and cannabis (ATC) reduction.

The R61 phase of the proposed study will examine brain mechanisms of a brief mindfulness intervention - integrative body-mind training (IBMT) that targets at self-control networks in the brain, and test IBMT effects on alcohol, tobacco, and cannabis (ATC) reduction.

Eligibility Criteria:
Inclusion Criteria:

* (1) at least 18 years old;
* (2) free of any psychiatric diagnoses or medication (besides a substance use disorder to alcohol, tobacco, or cannabis);
* (3) in the past month, at least 4 episode of heavy episodic drinking; at least 3 occasion of cannabis use; and daily cigarette use for at least the past month;
* (4) normal or corrected-to-normal vision;
* (5) written informed consent;
* (6) no previous meditation or neurofeedback (NF) experiences.

Exclusion Criteria:

* (1) any psychiatric diagnoses other than a substance use disorder;
* (2) medical disorder(s) that may affect the central nervous system; medications that affect the central and autonomic nervous system; or a positive pregnancy test result (females);
* (3) excluding cannabis, evidence of recent (past month) illicit drug use.