cyrilzakka/clinical-trials huggingface dataset:
ICE: Intracardiac Ultrasound Within the Left Atrium During Radiofrequency Ablation of Nonvalvular Atrial Fibrillation

Imaging Real Time within the Left atrial chamber Enhances safety and efficacy of Radiofrequency Ablation of Atrial Fibrillation

Atrial fibrillation is the most common rhythm disturbance affecting the human population.

1. Its prevalence increases with age and can be found in \>8% of humans over the age of eighty;
2. Radiofrequency ablation for drug refractory nonvalvular atrial fibrillation has become a common therapy available to patients. It has been shown to be both efficacious and cost effective;
3. The standard approach to atrial fibrillation involves electrical isolation of the pulmonary veins (PVI) from the rest of the atrium chamber. This involves moving a 3.5mm tip ablation catheter point to point around the PV structures until an encircling ablation line is formed. This can be made difficult by not knowing if the tip is in good contact with the atrial tissue. In addition the esophagus is a posterior lying structure and injury to the esophagus by ablating the overlying tissue has been reported, at times fatal;
4. Currently, intracardiac imaging of the left atrium has FDA approval in the right atrial chamber. This leads to difficulty in visualizing tip tissue interface, and important left sided structures such as carina, ligaments, and esophagus. By placing the tip of the ICE catheter in the left atrium, enhanced visualization of the tip tissue interface may lead to more effective ablation points, fewer needed ablation points, and enhanced safety by avoiding placement over adjacent noncardiac structures.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 80 years
* Recommended for radiofrequency ablation of nonvalvular atrial fibrillation

Exclusion Criteria:

* none
Evaluation of the Peripheral Nerve Ultrasound as a Diagnostic Tool in CANVAS Neuropathies

Cerebellar ataxia with neuropathy and bilateral areflexia syndrome (CANVAS) is a late onset neurodegenerative disorder with a slowly progressive ataxia. It's genetic causative etiology with an autosomal recessive inheritance has a recent discovery.

It is clinically characterized by impaired visually enhanced vestibulo-ocular reflex, although patients commonly present with imbalance as a main concern, associated with sensory complaints. It has been demonstrated that sensory impairment in CANVAS patients is due to degeneration of dorsal root with abnormal sensory nerve conduction.

Previously defined diagnostic criteria included cerebellar atrophy on brain MRI, neuronopathy on electrophysiological studies and negative genetic testing for other inherited ataxia syndromes like Friedriech ataxia and spinal cerebellar ataxia (SCA).

Peripheral nerve ultrasound is a noninvasive technique, able to identify abnormal peripheral nerves with underlying injuries and specific sonographic characteristics. Pelosi et al established that patients with CANVAS have a smaller nerve cross sectional area (CSA) compared to healthy individuals and/ or axonal neuropathies.

The main objective of this study was to obtaine a detailed description of peripheral nerves in consecutive patients with CANVAS syndrome followed in theneurology department of the Universitary Hospital of Nimes (France), using conventional electrophysiology and peripheral nerve ultrasound.


Eligibility Criteria:
CANVAS Patients :

Inclusion Criteria:

* Patients followed at the University Hospital of Nîmes between 2018-2021
* Age \> 18 years
* Diagnosis of CANVAS with genetic evidence (RFC1+)
* Diagnosis of neuronopathy

Exclusion Criteria:

* Age \<18 years
* Chronic polyradiculoneuritis or other demyelinating neuropathy

Control group, inclusion criteria :

Patient with axonal sensory-motor or pure sensory neuropathy confirmed by electro neuromyography, and concordant with the clinic.
ImmuneSense COVID-19 Variant Study

This study will assess the clinical performance of the T-Detect™ COVID test to identify an immune response to SARS-CoV-2 infection in the setting of multiple circulating variants of the SARS-CoV-2 virus. Performance may vary depending on the variants circulating at the time of testing, including newly emerging strains of SARS-CoV-2 and their prevalence, which changes over time.


Eligibility Criteria:
General Inclusion Criteria

Inclusion Criteria:

Participants must satisfy the following criteria to be enrolled in the study:

i. Individuals who have tested positive for SARS-CoV-2 via EUA RT-PCR testing. ii. Male and female participants of any race and ethnicity between 18 to 89 years of age (inclusive) at the time of enrollment in the study. iii. Must be able to communicate with the investigator, understand, and comply with the requirements of the study. iv. Must be able to provide estimated date of symptom onset. v. Must be available for specimen collection greater than 14 days (i.e., 15 days inclusive onward) and less than 107 days (i.e., 106 days inclusive or less) after first exhibiting symptoms of confirmed SARS-CoV-2 infection.

Exclusion Criteria:

The presence of any of the following will exclude a participant from enrollment:

* Individuals who did not test positive for SARS-CoV-2 on EUA RT-PCR.
* Protected populations including pregnant women, prisoners, mentally disabled persons, and wards-of-the state.
* Any significant condition, laboratory abnormality, or psychiatric illness that would prevent the participant from safely participating in the study.
* Exposure to a SARS-CoV-2 investigational drug (new chemical entity) within 60 days prior to enrollment at the discretion of the Sponsor.
* Receipt of immunosuppressive medications, such as, but not limited to, recent moderate- or high-dose systemic steroids or immunomodulators within 1 month prior to enrollment at the discretion of the Sponsor.
* Treatment with immunosuppressants/ immunomodulators that do not impact T cells or B cells may be allowed at the discretion of the Sponsor.
* Steroid formulations including low-dose oral steroids (≤ 10 mg prednisone equivalents per day), inhaled steroids, or topical steroids are not considered exclusionary. Doses \>10 and \<20 mg prednisone equivalents per day, must receive Sponsor approval.
Animal-assisted Therapy for Children and Adolescents With Chronic Pain

Chronic pain is highly prevalent in children and adolescents, up to one in four children will develop pain that persists or recurs for three or more months. Chronic pain is not only linked to significant psychological, physical, and social concerns for affected children and their families, but also places an enormous burden on healthcare systems - in the United States, chronic pain costs around $19.5 billion dollars each year and ranks among the most expensive pediatric health problems. Chronic pain significantly decreases quality of life and is associated with numerous missing days at school or at work.

Several interventions exist, however, for some, the risk-benefit profile is not favorable, or the effect sizes are small and the clinical effect can be questioned. In general, a multidisciplinary approach that includes medical, psychological, and physiological aspects has been shown to be most promising in the treatment of chronic pain in children and adolescents.

Clinical impressions suggest that an Animal-assisted Therapy (AAT) intervention could be promising, but to the best of our knowledge, this is the first study to investigate the effectiveness of an AAT intervention for children and adolescents with chronic pain. With this pragmatic trials investigators aim to investigate the pre- and post-intervention differences in pain levels, levels of emotional distress, and quality of life within participants with chronic pain.


Eligibility Criteria:
Inclusion Criteria:

* Children and adolescents aged 8-15 years
* Suffering from chronic pain (i.e., persistent or recurrent pain for 3 or more months, associated with significant emotional distress or functional limitations)
* Willing to work with therapy animals
* Fluent in German
* Willingness to participate

Exclusion Criteria:

* children younger than 7 years or adolescents older than 16 years of age
* Acute pain
* Allergy to animals Aversion against animals
For Patients With Ischemic Stroke, Clinically Study the Effectiveness and Safety of Butylphthalide.

This is a prospective, open, single-arm, the real world of clinical trials. The researchers plan to recruit 300 eligible patients. The main purpose of this study is to evaluate the effectiveness and safety of butylphthalide in the treatment of ischemic stroke, and to establish a population pharmacokinetic model of butylphthalide in elderly patients to explore its blood drug concentration. Correlation with its efficacy and adverse reactions.

Ischemic stroke is one of the diseases that seriously threaten human health, with the characteristics of high incidence, high disability and high recurrence rate. Patients will not only suffer from impaired physical function, but also mental symptoms, social function and other obstacles, which seriously affect the quality of life.

Butylphthalide can improve the damage of central nervous system in patients with acute ischemic stroke, and can promote the improvement of patients with neurological deficits. Regarding the treatment of ischemic stroke with butylphthalide, there is still a lack of big data research based on real-world efficacy and safety; there is a lack of data on the pharmacokinetics of elderly patients and their correlation with adverse reactions.

Thus, it is estimated that 300 patients will be enrolled and given intravenous butylphthalide sodium chloride injection 25mg twice a day for 7-14 days, and then oral butylphthalide soft capsule 0.2g three times a day for 76-83 days. The patients will be collected for experiment before and after treatment. Laboratory data, electrocardiogram, NIHSS, mRS, combined medication and adverse events, etc., to evaluate the effectiveness and safety of butylphthalide in the treatment of ischemic stroke. In addition, a population pharmacokinetic model of butylphthalide in elderly patients was established for 50 of them.

Eligibility Criteria:
Inclusion Criteria:

* 1. Female or male aged ≥ 18 years.
* 2. Acute ischemic stroke within 48 hours of onset
* 3. Examination to exclude intracranial hemorrhage
* 4. Provision of informed consent.

Exclusion Criteria:

* 1.Head CT or MRI suggests the presence of intracranial hemorrhagic disease
* 2.Patients with cerebral embolism or suspected cerebral embolism with severe atrioventricular block disease, atrial fibrillation, myocardial infarction, heart valve disease, infective endocarditis, heart rate less than 50 beats per minute
* 3.Abnormal liver function (transaminase ALT or AST exceeding the upper limit of normal), abnormal renal function (creatinine exceeding the upper limit of normal), or suffering from other serious systemic diseases, etc
* 4.Allergy to Butylphthalide
3-dimensional Sensor Technology to Quantify Leg-edema

The purpose of the study is two-fold:

1. to test 3-dimensional reconstruction of leg-edema in patients hospitalized for acute heart failure with leg-edema.
2. to measure changes in QRS-morphology in a simulation of conventional blood-pressure measurement in patients hospitalized for acute heart failure.

Leg-edema are common in patients with worsening heart failure. Apart from using a measuring tape there is no standardized tool to quantify leg-edema. Consequently, in patents with heart failure early detection of leg-edema is quite difficult.

From earlier pacemaker-studies it has been shown that an increase of afterload changes ECG-signals. Currently it is unknown how simple diagnostic procedures such as measuring blood-pressure affect QRS-morphology in patients with heart failure.

Eligibility Criteria:
Inclusion Criteria:

* hospitalization for worsening heart failure
* age greater than 18 years
* ability to stand without help from others
* informed consent

Exclusion Criteria:

* leg-edema of non-cardiac origin (venous, lymphatic)
* dialysis shunt
Ridge Preservation In Mandibular Molars Using Mixture Of ABB And Autogenous Particulate VS Sticky Bone

Histological Measurement Comparing the density of the new bone formed during socket preservation technique using a Mixture of Anorganic Bovine Bone(ABB) And Autogenous Particulate vs a Mixture of Injectable Platelets Rich Fibers, ABB And Autogenous Particulates (sticky bone). radiographical measurements of the amount of bone dimensions changes in socket preservation technique in 6-month period using a Mixture Of Anorganic Bovine Bone(ABB) And Autogenous Particulate vs a Mixture Of Injectable Platelets Rich Fibers, ABB And Autogenous Particulates (sticky bone)


Eligibility Criteria:
Inclusion Criteria:

* Adult patients with hopeless mandibular molars indicated for extraction and implant placement in two stages that indicate socket preservation.
* Both sexes.
* No intraoral soft and hard tissue pathology.
* No systemic condition that contraindicate implant placement.

Exclusion Criteria:

* Presence of fenestrations or dehiscence of the residual bony Walls after extraction.
* Heavy smokers more than 20 cigarettes per day .(24)
* Patients with systemic disease that may affect normal healing.
* Psychiatric problems
* Disorders to implant are related to history of radiation therapy to the head and neck neoplasia, or bone augmentation to implant site.
* Patients that refuse to be called back for implant placement post extraction.
* Patients that have exceeded bone resorption surrounding the tooth prior to extraction and require guided bone regeneration.
Descriptive Study of Pathogens Involved in Summer Diarrhea in Children Leading to Pediatric Emergency Room Visits (PE-DIA)

Acute diarrhea in children is a public health problem. It is estimated that children under 3 years are subject to 1 or 2 episodes of diarrhea per year in Europe. These diarrheal episodes are frequent, expensive and responsible for many consultations and hospitalizations in developed countries. The origin of diarrhea in children is viral in about 70% of cases. The diagnosis of a viral infection is often considered without microbiological evidence. However, microbiological evidence is recommended for certain categories of patients.

The involvement of bacteria or parasites in the child's diarrhea does not seem negligible.

The main objective of this study is to estimate the prevalence of infectious diarrhea among summer diarrhea in children leading to pediatric emergency room visits.

Secondarily, we will describe the pathogens responsible for childhood diarrhea during the summer period, describe common factors that can serve as guidance on the etiology of diarrhea, and describe common factors that can be used as tools. preventive to the transmission of these pathogens.

After obtaining consent from the holders of parental authority, a stool collection will be requested from all pediatric emergency patients presenting as a reason for "diarrhea" consultations between June 1 and September 30, 2020. It will be given by the nurse organizing the reception, a medical information questionnaire and a stool collection container for those accompanying a child with diarrhea.

If the child presents stool during the waiting period or during the medical consultation, these will be collected and sent to the medical biology laboratory of the University Hospital for a broad analysis (virological, bacteriological and parasitological).

The doctor in charge of the patient will complete a pre-established clinical information sheet.

In the laboratory, the stool will be taken care of and a DNA extract will be made and preserved. The search for pathogens will be carried out by molecular biology, by series, non-prospectively. The results will only be transmitted at a distance and will not be communicated to families.

Therapeutic management of children included in the study will be identical to the usual practice. Microbiological analysis will not delay, prolong or disrupt the treatment of the acute episod of diarrhea.

Eligibility Criteria:
Inclusion Criteria:

* Children aged from 0 to 16 years with diarrhea
* pediatric emergency at the University Hospital of Clermont-Ferrand consultation
* between june and september 2020

Exclusion Criteria:

* consent not felt by the child or the person with parental authority
* no stool removal
Explorative Clinical Study on the Performance and Acceptance of New Intermittent Catheters in Healthy Volunteers

Performance and acceptance of new intermittent catheters tested in healthy volunteers

This study is a single blinded, randomised, crossover study. The study period consists of an information visit, an inclusion visit, three test visits and a termination visit.

Two prototypes of intermittent catheters (Test product 2 and 3) compared to the standard catheter SpeediCath® Flex (Comparator).

In the investigation ten subjects will be included. The subjects will be catheterised once per visit. The subjects will be catheterised with the two test catheters and comparator in a randomised order. The order of the catheterisations will be randomised to prevent bias.

During the test visits the primary, secondary and explorative endpoints will be registered.

Subjects will be asked to participate in an interview in continuation of their last visit (Test Visit 3). The interviews will be performed by a Coloplast representative asking questions related to their experience with the catheter.

The subjects must sign a separate consent form for this purpose and can participate in the investigation without participating in the interview. In addition, subjects will be asked for consent to tape recording and filming during the interviews, but can participate in interviews without this.

In addition, a Coloplast representative will interview the Investigator and her representatives after LPO with questions related to their experience with the catheters.

The investigation is planned to be conducted in August 2018-Januar 2019. The visit window will be minimum five days between the visits (catheterisations), to ensure time for healing of any potential urethral trauma. However, the maximum time between visits should be adjusted to ensure the subject is terminated before LPO.

No biobank will be established for this investigation. All urine samples in the clinical investigation (for evaluating in- and exclusion criteria and for evaluating end points) will be destructed immediately after analysis.

Eligibility Criteria:
Inclusion Criteria:

Has given written informed consent and signed letter of authority Is at least 18 years of age and has full legal capacity Is a male Willing to comply without using analgetica up to 24 hours prior to catheterisation visits

Exclusion Criteria:

Has a previous history of genitourinary disease including congenital abnormalities and surgical procedures performed in the urinary tract Has symptoms of urinary tract infections (frequent urination, stinging and pain at urination) Are participating in any other clinical investigation related to urinary tract system during this investigation (inclusion to termination) Known hypersensitivity toward any of the test products
Frailty Status and Quality of Life in Elderly

Frailty is a dynamic process from fit (robust) and pre-frail elderly. There is no previous study that determine the risk factors from fit to pre-frailty and pre-frailty to frailty in Indonesian elderly.

This study was aimed to define the risk factors of frailty transitional status and its correlation with quality of life in Indonesian elderly outpatients.

Frailty is an age-associated, biological syndrome characterized by decreased biological reserves, due to dysregulation of several physiological systems, which puts an individual at risk when facing minor stressors, and is associated with poor outcomes (ie, disability, death, and hospitalization).

Frailty identifies a high-risk subgroup and off ers characteristics of great clinical importance: a higher reversibility at early stages than disability, and a higher predictive value than chronic disease for adverse outcomes at older ages. It is also the most common condition leading to death in community-dwelling older people.

However, there is current consensus that physical frailty is potentially reversible. It is hence useful to objectively detect frailty among frail elderly persons, as frailty indices serve a useful purpose for risk stratification, predicting need for institutional care and planning of services needed.

To date, there is no study or information about frailty status in Indonesia elderly. This study was aimed to define the risk factors of frailty transitional status and its correlation with quality of life in Indonesian elderly.

Eligibility Criteria:
Inclusion Criteria:

1. Elderly aged \>= 60 years old
2. Fit (robust) or pre-frailty;
3. Capable to understand and carry-out the instruction.

Exclusion Criteria:

1. Unwilling to join the study;
2. Abbreviated Mental Test (AMT) score \< 8;
3. Geriatric Depression Scale (GDS) score \>= 10;
4. Body mass index (BMI) \<18,5 Kg/m2;
5. Malnutrition (according to Mini Nutritional Assessment/MNA);
6. Liver cirrhosis, severe liver dysfunction, or serum ALT levels \>3 times upper normal limit;
7. Acute illness during inclusion period, eg. pneumonia, pain due to acute arthritis (visual analog scale \>6/10), stroke attack, crisis hypertension;
8. Severe cardiac dysfunction: acute decompensated heart failure and/or chronic heart failure functional class III or IV (New York Heart Association classification);
9. Severe pulmonary dysfunction: acute exacerbation of chronic obstructive lung disease stage III or IV (GOLD classification), and/or PaO2 levels \< 60 mmHg.
Safety, Tolerability, and Pharmacokinetics of Anti-Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Chicken Egg Antibody (IgY) (COVID-19)

The primary objective of Part 1 (Single Ascending Dose) is to assess the safety and tolerability of anti-SARS-CoV-2 IgY when given as single-ascending doses administered intranasally to healthy participants.

The primary objective of Part 2 (Multiple Dose) is to assess the safety and tolerability of anti-SARS-CoV-2 IgY when given as multiple doses administered intranasally to healthy participants. A secondary objective is to assess the pharmacokinetics of anti-SARS-CoV-2 IgY when given as multiple doses administered intranasally to healthy participants.

Safety will be evaluated using adverse event (AE), physical examination (including vital signs), electrocardiogram, and clinical laboratory data. Pharmacokinetics will be evaluated by serum anti-SARS-CoV-2 IgY concentration.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males or non-pregnant, non-lactating females
* Body weight of at least 50 kg
* Good state of health (mentally and physically)
* Must agree to use of highly effective method of contraception

Exclusion Criteria:

* Received other investigational drug within the last 30 days prior to screening
* History of drug or alcohol abuse in the past 2 years (\>21 units of alcohol per week for males and \>14 units of alcohol per week for females)
* Current smoker / e-smoker
* Abnormal kidney function
* Abnormal liver function
* Positive for hepatitis B or C infection
* Positive for HIV infection
* Positive for SARS-CoV-2 infection
* History of egg allergy
* Abnormal cardiac function