cyrilzakka/clinical-trials huggingface dataset:
Computer-assisted Fetal Monitoring - Cardiology

In the context of fetal heart monitoring (prenatal and during childbirth), the SurFAO project offers an alternative to current clinical routines. The challenge is to extract, from non-invasive sensors on the maternal abdomen, a fetal electrocardiogram (ECGf) of great quality allowing a clinical diagnosis (follow-up of the FHR (Fetal Heart Rate)) and extraction of ECG waveforms).

The approach proposes a technological breakthrough shared by a consortium of researchers and clinicians. The originality is driven by innovative methodological choices: the use of a multimodal system (ECG coupling with PCG (phonocardiography)) for the signal acquisition in order to increase the robustness of information extraction, by taking into account clinical uses and the need to support the monitoring process, and by setting up a multimodal database.

The objective is to feed a database that will be used in the future to develop ECGf extraction methods.

To monitor the well-being of a fetus or for clinical diagnosis, the challenge is to extract a high-quality fetal electrocardiogram (fECG) signal from non-invasive sensors on the maternal abdomen.

As early as the 20th week of amenorrhea, heart rhythm disorders (tachycardia, bradycardia) can be detected in the fetus, most often by fortuitous circumstance, during routine obstetrical ultrasound examinations. It is then necessary to analyze these rhythmic anomalies, understand their origin and, if necessary, initiate pharmacotherapy. The effectiveness of the treatments is then monitored by ultrasound in the high-risk pregnancy department.

The analysis of a fetal electrocardiogram (fECG) provides information that allows to determine the nature of the rhythm disorder, its origin and therefore its potential severity.

The innovative methodological approach considered for the extraction of non-invasive ECGf is to combine 2 complementary modalities of the same cardiac phenomenon. This is achieved by combining the use of ECG sensors with sound sensors giving access to phonocardiographic signals (PCG).

Eligibility Criteria:
Inclusion Criteria:

* single pregnancy
* between 20 and 26 weeks of amenorrhea
* with a BMI between 18.5 and 30 at the beginning of pregnancy
* fetal heart considered normal after expert ultrasound
* examination conditions deemed correct by the expert
* registered in a social security scheme
* having signed the study consent form

Exclusion Criteria:

* subject to a legal protection measure or unable to express consent (guardianship, guardianship) (article L1121-8)
* deprived of liberty by judicial or administrative decision (article L1121-6)
* in a period of exclusion from another study
* with toxic consumption (i.e. tobacco, alcohol, cannabis)
* Intrauterine growth retardation (estimated fetal weight less than the 10th percentile)
* fetal heart rhythm disorders
* with unclear pregnancy term
* with pregnancy denial
Cardiac Function as Measured by Non-invasive Electrical Velocimetry Cardiac Monitor in Hospitalized Children

To assess whether a non-invasive cardiac output monitor can follow heart function in children during treatments in the hospital. To establish a normal reference for children who are well and awake.

The aim of the study is to evaluate the ability of a new FDA-approved non-invasive Electrical Velocimetry (EV) cardiac monitor called AESCULON (Cardiotronic Inc, La Jolla CA) to detect and trend hemodynamic changes in hospitalized ambulatory pediatric patients during recovery from acute illness. We postulate that if the cardiac monitor can trend hemodynamic changes in hypertensive patients whose mean arterial pressure (MAP) decreases to normal levels, or hypotensive patients whose MAP increases to normal levels over several days, it may improve our understanding of different disease processes and allow us to improve care. We also seek to establish normative data for different measures provided by the AESCULON monitor - specifically cardiac output (CO) and systemic vascular resistance (SVR), which are the prime determinants of MAP.

Eligibility Criteria:
Inclusion Criteria:

* Medical patients without complex medical history with expected hospital stay for less than 10 days
* Uncomplicated Medical Patients as define as (1) Previously healthy children or (2) Children with diagnosis of a single chronic medical disorder that is not associated with cardiac dysfunction

Exclusion Criteria:

* Congenital heart disease with and without repair (includes PFO, ASD and PDA, cardiac valve disease or pulmonary hypertension
* Chronic lung disease (except asthma)
* Abnormal Hemoglobin (SSD)
The Effects of Exercise on Dietary Intake

The purpose of this study is to determine whether or not energy and macronutrient intake changes when comparing habitually active and habitually sedentary college-aged males in two different sessions of one resting and one exercise.

Obesity is a consequence of positive energy balance, in which more energy is consumed than expended. It is hypothesized that regular amounts of physical activity may be important in helping individuals more accurately regulate energy balance. More research is needed to understand the impact of a physically active lifestyle on energy regulation capabilities Therefore, this study looks at sedentary college aged males compared to active college aged males when looking at two different sessions of energy expenditure, one exercise session and one resting session, and their energy and macronutrient intake after these sessions. The sessions will take place in the morning where each participant will exercise or rest and then be allowed to eat from a buffet ad libitum, where acute energy and macronutrient intake will be assessed.

The following hypotheses are proposed:

* Individuals who regularly engage in physical activity will more accurately respond to an energy deficit caused by an acute period of physical activity by increasing intake at a subsequent meal.
* Individuals who do not regularly engage in physical activity (sedentary individuals) will be less sensitive to accurately regulate energy balance and will not respond to an energy deficit caused by a period of acute physical activity.

Eligibility Criteria:
Inclusion Criteria:

* BMI of 20-25
* Percent body fat of 10-18%
* Exercises greater than or equal to 5 days/wk at 30 min/day or less than or equal to 1 day/week at 1 hour/day consistently for the past month
* Likes study foods

Exclusion Criteria:

* Does not fit in exercise criteria
* Allergies or unwillingness eat study food, falls
* From survey qualifies as a "conscious eater"
Different Doses of Dexmedetomidine Added to Bupivacaine in Transversus Abdominis Plane Block in Caesarean Delivery

Cesarean birth is a common surgical procedure. After cesarean birth, postsurgical pain may delay recovery, interfere with maternal-newborn bonding, and reduce the breastfeeding if not adequately controlled. Postpartum analgesia has become a common concern.

Many adjuvant drugs used for peripheral nerve blocks as( N-methyl-d-aspartate (NMDA) receptor antagonists , Magnesium , Ephedrine , Dexamesathone , Fentanyl , Midazolam and Neostigmine) Dexmedetomidine is a potent and highly selective α2 adrenergic receptor agonist, exerts its sympatholytic effect by inhibiting the release of noradrenaline from central and peripheral sympathetic nerve endings. It is considered to be a useful agent with a wide safety margin, excellent sedative capacity and moderate analgesic properties

This prospective double-blinded randomized controlled study will be done on parturients that are scheduled for elective cesarean delivery under spinal anesthesia to assess the efficacy of two different doses (0.5 mcg/kg and 1mcg/kg) of dexmedetomidine as an adjuvant to isobaric bupivacaine in TAPB compared to a control group on the postoperative analgesia in cesarean section under spinal anaesthesia

Eligibility Criteria:
Inclusion Criteria:

* Age from 19 to 40 years old
* American Society of Anesthesiologists (ASA) physical status II patients
* Singleton pregnancies with a gestational age of at least 37 weeks.
* Patients undergoing spinal anesthesia for cesarean delivery via a Pfannenstiel incision with exteriorization of the uterus.

Exclusion Criteria:

* Age \< 19 or \> 40 years.
* Height\<150 cm, weight \< 60 kg, body mass index (BMI) ≥40 kg/m2.
* Inability to comprehend or participate in the pain scoring system.
* Contraindications to spinal anesthesia (Coagulopathy, increased intracranial pressure, or local skin infection).
* Hypersensitivity to any drug used in the study.
* Any hypertensive disorders of pregnancy.
* Renal impairment or other contraindications to non-steroidal anti-infilamatory drugs (NSAIDS).
* Significant cardiovascular, renal or hepatic abnormalities.
* Patients with history of opioid intake, drug abusers or psychiatric patients
Injection Rate and Erector Spinae Plane Block

To evaluate the effect of injection rate on the block sensory level in the ESP block.

Many women experience severe acute postoperative pain after breast cancer surgery. Regional techniques are frequently used as a part of multimodal analgesia in breast surgery. Ultrasound-guided erector spinae plane (ESP) block is a preferred method to reduce the postoperative opioid requirement for postoperative pain management. In this study, we aimed to evaluate the effect of injection rate on the block sensory level in the ESP block.

Eligibility Criteria:
Inclusion Criteria:

* aged between eighteen and sixty-five
* ASA I-III
* undergo elective breast cancer surgery

Exclusion Criteria:

* under 18 years of age or over 65 years of age
* ASA IV and above
* declined to give written informed consent
* contraindications of peripheral blocks or local anesthetic infiltration
* history of allergy against local anesthetics
* chronic pain history
* history of hepatic, neuromuscular, cardiac and/or renal failure
* infection at the injection site
Optimization of Thoracic Aortic MRI Acquisition Sequences for the Quantification of Diagnostic-assisting Biomarkers

The main objective is to optimize MRI acquisition and image post-processing protocols in order to define the best compromise between short scan time and image quality (contrast between different tissues, spatial and temporal resolutions) high enough to accurately measure morphologic, hemodynamic and structural aortic biomarkers.

This Magnetic Resonance imaging study of the thoracic aorta aims to: 1- enhance patient comfort during the examination, shorten appointment waiting times and overall reduce MRI cost, and 2- provide a reliable diagnosis and risk assessment of aorta-related diseases occurring in hypertension, obesity or diabetes but also throughout normal aging.

The impact of MRI acquisition innovations on the measurement of biomarkers that are extracted from image post-processing software and therein on disease characterization (normal values, severity thresholds, etc.) must be systematically reevaluated. More specifically, the investigators design image acquisition and automated image processing methods to reduce operator variability. This study will optimize thoracic aortic MRI acquisition sequences for the quantification of diagnostic-assisting biomarkers in a healthy population.

Eligibility Criteria:
Inclusion Criteria:

* Subject aged between 20 and 35 or between 50 and 70 (limits included)
* BMI \< 30 kg/m²
* Asymptomatic subject
* Having given informed, free and written consent
* Affiliated to a French social security scheme or entitled

Exclusion Criteria:

* Contraindication to MRI (claustrophobia, presence of a metallic foreign body)
* Pregnant or breastfeeding woman
* Known cardiac pathology
* Personal cardiovascular history
* Person deprived of liberty by court decision or benefiting from legal protection (under guardianship or curatorship)
* Abuse of alcohol or narcotics
* Subject under AME
* Participation in another interventional research involving the human person or being in the exclusion period at the end of a previous research involving the human person
Predicting Cognitive and Emotional Health From Neurocircuitry Following TBI

Abnormalities in structural and functional connectivity between brain regions have been suggested as putative biomarkers of mild traumatic brain injury (TBI) and significant contributors to neuropsychological functioning and injury outcome. The purpose of this study is to use two advanced magnetic resonance imaging (MRI) techniques called diffusion-weighted imaging (DWI) and resting state functional MRI to compare structural and functional connectivity between individuals with documented mild TBI and healthy controls. To evaluate the significance of structural and functional connectivity for behavior, the brain imaging data will then be related to measures of cognition and emotion. Over a 4-year period, 150 adults with documented mild TBI and 30 healthy controls will participate in the study.

The study will investigate the following questions and hypotheses:

1. Evaluate the DWI metric fractional anisotropy (FA) as a measure of white matter integrity across multiple stages of recovery following mild TBI relative to healthy controls. It is hypothesized that mild TBI will be associated with greater white matter abnormalities than healthy controls.
2. It is hypothesized that there will be a relationship between FA, cognition and emotion as a function of the injury.
3. It is hypothesized that functional connectivity will be related to FA.


Eligibility Criteria:
Inclusion Criteria:

* English as first language
* Ability to provide informed consent
* For TBI group: documented TBI experienced within 12 months prior to testing.

Exclusion Criteria:

* Metal within the body, claustrophobia or other contraindications for MRI
* Complicating medical conditions that may influence the outcome of neuropsychological assessment or neuroimaging (e.g., HIV, brain tumor, etc.)
* Less than 9th grade education
* History of alcoholism or substance use disorder
* Excess current alcohol use or illicit substance use
* for Healthy Controls (HC): life-time history of TBI or Axis I disorder
* Pregnancy (ruled out by urine β-HCG)
* Colorblindness
* for HC: Having participated in a sport with a high risk of concussive/subconcussive blows for a period of at least 1 month including but not limited to: football, rugby, boxing, ice hockey, wrestling, soccer, martial arts
The Effect of Telerehabilitation of Patients With Duchenne Muscular Dystrophy

The aim of this study is to investigate the effect of a telerehabilitation approach to patients with Duchenne Muscular Dystrophy and evaluate patients' motor function, parents' anxiety and depression levels before and after the intervention


Eligibility Criteria:
Inclusion Criteria:

* Patients with Duchenne muscular dystrophy

Exclusion Criteria:

* Patients without the ability of independent ambulation
Study of SANGUINATE™ Versus Hydroxyurea in Sickle Cell Disease (SCD) Patients

The purpose of this study is to compare the safety of SANGUINATE™ versus Hydroxyurea in patients suffering from Sickle Cell Disease.


Eligibility Criteria:
Inclusion Criteria:

* Patients with Homozygous (HbSS) Sickle Cell Anemia;
* Hb levels: \>6g/dL - \<10g/dL;
* Age : \>18 years old;
* Frequency of ER hospitalizations \< 6x/yr for SCD pain events documented "medical history".

Exclusion Criteria:

* Patients, who are on chronic transfusion program, defined as regular transfusions every 2-8 weeks;
* Allergic to Hydroxyurea;
* History of clinical significant disease, as determined by the Investigator;
* History of allergy or major allergic reaction considered to be clinically significant by the Investigator;
* Screening assessments considered to be abnormal by the Investigator;
* Patient has sever pulmonary hypertension (index \>3 meters per sec);
* Donated blood within 60 days of screening or otherwise experienced blood loss of \>250 mL within the same period;
* Intending to begin new concomitant drug therapy or over-the-counter medication anytime from scree4nin to the time of administration of study drug;
Opioid-free Analgesia in Intensive Care Unit

ICU patients experience moderate to severe pain. Studies and guidelines point out the benefits of multimodal analgesia on pain control, opioid spare and on lowering its adverse effects. However, no recommendation about drugs or protocol has been formulated. In our study, investigators studied the feasibility and the impact on Remifentanil spare of a standardized protocol using multimodal analgesia (Paracetamol, Nefopam, Tramadol, Ketamine, Remifentanil) compared to the standard-of-care strategy using Paracetamol and Remifentanil. The investigators conducted a prospective, ''proof of concept'', randomized, double-blind, parallel group, placebo-controlled trial. The investigators studied multimodal analgesia versus standard-of-care in ICU patients requiring sedation-analgesia for invasive mechanical ventilation.The investigators hypothesized that Remifentanil consumption decrease by 15% with the use of a standardized multimodal analgesia strategy

ICU patients requiring sedation-analgesia for mechanical ventilation for at least 48 hours are randomized in 2 parallel groups : control arm using ''standard of care'' analgesia (Paracetamol and Remifentanil), and interventional arm using multimodal analgesia at different level according to pain accessed by BPS (Step 1 : Paracetamol, Nefopam, Tramadol, Step 2 : Ketamine, Step 3 : Remifentanil). Sedation drugs are standard of care (Propofol and Midazolam if Propofol isn't enough) to obtain prescribed sedation accessed by RASS. Double-bling is kept for 72 hours until the primary outcome is obtained.

The investigators hypothesize a 15% reduction of Remifentanil consumption in the interventional group.

Eligibility Criteria:
Inclusion Criteria:

* Patient hospitalized in ICU and requiring sedation-analgesia for mechanical ventilation.
* Patient undergoing mechanical ventilation for more than 2 hours and less than 24 hours.
* Informed consent signed by the patient or his trusted person, legal representative, family member, curator or tutor, or emergency consent procedure.
* Patient affiliated to the French Government Public Health Insurance.
* Patient over 18 years old.

Exclusion Criteria:

* Patient already involved in a trial that might influence our primary endpoint.
* Patient in exclusion-period determined by another trial or study.
* Patient who is likely to be requiring less than 48 hours of mechanical ventilation.
* Patient with contraindication or allergies to at least one of the following medication : paracetamol, nefopam, tramadol, ketamine, remifentanil.
* Patient with hepatic insufficiency (defined as PT \< 50%).
* Parturient or breast-feeding patient.
* Patient suffering from moderate to severe Acute Respiratory Distress Syndrome (ARDS), with decreased PaO2/FiO2 ratio under 150mmHg after respiratory optimization (courant volume 6mL/kg and PEEP \> 5mbar).
* Patient requiring curare treatment.
* Patients with an indication for locoregional analgesia prior to extubation (perineural sealing, epidural analgesia).
Study to Evaluate the Effect of Eleclazine on QT, Safety, and Tolerability in Participants With Long QT2 Syndrome

The primary objective of the study is to evaluate the effect of oral eleclazine (formerly GS-6615) on corrected QT (QTc) interval in participants with long QT2 syndrome.


Eligibility Criteria:
Key Inclusion Criteria:

* Participants with an established diagnosis of LQT2 (by genotype testing)
* Mean (of triplicate) QTc interval ≥ 480 msec for at least four out of seven time points, determined by standard 12-lead electrocardiogram (ECG), at screening

Key Exclusion Criteria:

* Known mutations associated with long QT syndrome type 1 or long QT syndrome type 3
* Known or suspected history of seizures or epilepsy
* History of heart failure defined as New York Heart Association (NYHA) Class IV and/or known left ventricular ejection fraction (EF) ≤ 45%
* Body mass index (BMI) ≥ 36 kg/m\^2 at screening
* Severe renal impairment at screening (defined as an estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73m\^2, using the 4 variable modification of diet in renal disease (MDRD) equation), as determined by the study center
* Abnormal liver function tests at screening, defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 2 x upper limit of normal (ULN), or total bilirubin \> 1.5 x ULN
* An aborted cardiac arrest (ACA), implantable cardioverter-defibrillator (ICD) implantation, syncopal episode, or appropriate ICD therapy within 3 months prior to screening
* Any other condition or circumstance that in the opinion of the investigator would preclude compliance with the study protocol.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Evaluate Efficacy, Tolerability & Safety of Combination of Clindamycin and Ketoconazole for the Treatment of Mixed-Type Vaginosis, Bacterial Vaginosis and Candidiasis

The purpose of this study is to determine the Efficacy, Tolerability \& Safety of Combination of Clindamycin 100mg and Ketoconazole 400mg in Vaginal Capsules, used for 7 consecutive days in patients with Mixed-Type Vaginosis compared to Combination of Tetracycline 100mg and Amphotericin B 50mg in Vaginal Cream.


Eligibility Criteria:
Inclusion Criteria:

* Mixed-type vaginosis
* Bacterial vaginosis
* Candidiasis

Exclusion Criteria:

* Pregnancy
* Vaginal bleeding
* History of recurrent vaginosis