cyrilzakka/clinical-trials huggingface dataset:
Emergence Agitation is a Problem in Pediatric Anesthesia. We Aim to Lower Its Incidence by Using Dexmedetomidine

Emergence agitation is commonly encountered after receiving inhalation anesthesia. This distressing phenomenon carries risks that are harmful to patients, caregivers and medical personnel. Using total intravenous Dexmedetomidine, the investigators seek to reduce agitation and provide gentle emergence from anesthesia.

Surgery for pediatric cleft lip and palate repair often utilizes high dose opioids and inhaled anaesthesia, thereby causing postoperative complications such as desaturation and/or severe agitation after anesthesia. These complications are detrimental to the child, medical personnel and causes tremendous psychologic stress to parents. This study aims to decrease these complications through Dexmedetomidine, an Alpha-2 receptor agonist with anxiolytic, sympatholytic and analgetic properties. Devoid of respiratory depressant effect, it allows patients to maintain effective ventilation and reduce agitation, postoperatively. Its unique anesthetic property may shed light to provide safe anesthesia and gentle emergence to this young, vulnerable population.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with weight ranging 5 kg - 25 kg
2. Patients with American Society of Anesthesiologist (ASA) Physical Status Classification 1 and 2

Exclusion Criteria:

1. Patients with any acquired congenital syndrome
2. Patients who are actively taking anti-seizure medications and/or has been diagnosed with epilepsy
3. Patients with functional and structural abnormalities of the heart, including arrythmias
4. Patients with liver disease
Registry Evaluating AF Ablation Techniques

The purpose of this observational registry is to prospectively collect procedure efficiency, safety and acute and long term outcome data from catheter ablation procedures as treatment of paroxysmal atrial fibrillation, using the following treatment modalities:

* Cryoballoon ablation
* Manual guided RF ablation using Contact Force catheters
* Remote Magnetic Navigation guided RF ablation with e-Contact and high power settings
* Remote Magnetic Navigation guided RF ablation with e-Contact and low power settings


Eligibility Criteria:
Inclusion Criteria:

* Documented Paroxysmal Atrial Fibrillation
* Eligibility for Pulmonary Vein Isolation by catheter ablation based on the respective ACC/AHA/ESC Guideline valid at the date of procedure
* Signed the informed consent to participate in the registry

Exclusion Criteria:

* Younger than 18 years of age
* Prior AF ablation procedure (including MAZE procedure)
* Prior ablation of Non-AF Arrhythmia within 3 months of enrollment
* Presence of cardiac thrombus
* Other AF ablations performed during procedure (e.g. lines, rotor, CFAE's etc)
* Active endocarditis or systemic infection
* Life expectancy \< 1 year
* Pregnancy
Data Collection for Development of a Bladder Sensor During Urodynamics

This is an explorative, single-center, feasibility study using a prototype of a future Bladder Sensor to collect data during urodynamics. Obtained data shall be used for the continuous development of the future Bladder Sensor, which is intended for use for individuals suffering from urinary incontinence.

The purpose of this clinical investigation is to collect raw measurement data of the urinary bladder region of participants (patients who are scheduled for urodynamics and fulfill the in- and exclusion criteria) with the TENA-PROTO2, for the continuous development of an algorithm to determine the bladder filling status with the future Bladder Sensor. Secondarily, safety of the subjects will be continuously documented such as adverse events (AE) and device deficiencies (DD); AEs, Adverse Device Events (ADE), Severe Adverse Events (SAE), Severe Adverse Device effects (SADE), Unanticipated Serious Adverse Device Effects (USADE) and DDs.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects who are scheduled for urodynamics
2. Men and women defined by biological sex at birth
3. Individuals at the age of ≥ 18 years
4. BMI \>18.5 kg/m² and ≤ 39.9 kg/m²
5. Capability to understand the subject information and to provide conscious informed consent
6. Signed informed consent for study participation and data protection regulations
7. Willingness to conduct a urine pregnancy test for all female subjects \<55 years old (Exceptions: the site team determines that the subject is not likely to become pregnant due to e.g., hysterectomy, postmenopausal)
8. Capability and willingness to follow the study protocol and procedure of the urodynamics

Exclusion Criteria:

1. Subjects with breached skin, open wounds, sutures or major scar tissue in the suprapubic region
2. Subjects with suprapubic catheter
3. Subjects with implants that can be affected by electromagnetic interference (e.g. pacemaker)
4. Subjects who are pregnant or breast feeding
5. Known allergies or intolerances to one or several components of the study product
6. Alcohol abuse as reported by subject and/ or suspected by investigator that impacts capability to understand the subject information and to provide conscious informed consent in the discretion of the investigator
7. Drug abuse as reported by subject and/ or suspected by investigator that impacts capability to understand the subject information and to provide conscious informed consent in the discretion of the investigator
8. Objections of the investigator to the subject's participation in the trial due to medical reasons or any other reason for which the subject should not participate in the opinion of the investigator
9. Participation in any clinical investigation with systemic and/or pharmaceutical substances within the last 4 weeks and/or in parallel
10. Sponsors, manufacturers or clinical research organization (CRO) staff
Postmarketing Surveillance Study to Assess Handling and Patient Satisfaction on Berodual® Respimat® Solution for Inhalation in Comparison to a Powder Inhaler in Patients With Chronic Obstructive Pulmonary Disease

New perceptions about handling and patient satisfaction of the everyday use of Berodual® Respimat® compared to a powder inhaler in patients with chronic obstructive lung disease (COLD). Moreover, further knowledge should be attained about the tolerability of Berodual® Respimat®


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients aged at least 18 years
* Patients who are suffering from symptoms of a chronic obstructive lung disease (COLD) can be included in the PMS. To reduce influences caused by the use of a variety of different powder inhaler, only patients who are already regularly using Diskus® powder inhaler should be included, as the Diskus® as well as the Berodual® Respimat® are multiple dose devices
* During the PMS the Diskus® therapy is to be continued

Exclusion Criteria:

* Patients who meet one or more of the general or specific contraindications mentioned in the Summary of Product Characteristics (SmPC) are excluded from the Postmarketing Surveillance (PMS)
The TOGETHER Project - Kidney RNA-seq Validation

The researchers are trying to develop a way to measure the risk of rejection through the validation of a blood test.


Eligibility Criteria:
Inclusion Criteria:

* Adult (\>/=18 years) renal transplant recipient.
* Patients who have given informed consent and are willing to comply with the protocol, including the use of their peripheral blood specimens and data for subsequent research.

Exclusion Criteria:

-Adult (\<18 years) renal transplant recipient.
Effect of Spasticity on Tibial Nerve Entrapment

Stroke is the most common cause of mortality and is one of the most common causes of morbidity in the world. Polyneuropathies and entrapment neuropathies are known as the complications of stroke


Eligibility Criteria:
Inclusion Criteria:

* 1- A hundred patients with hemiplegia /paresis subsequent to a stroke as diagnosed by CT or MRI.

  2- A hundred patients from both sexes, their ages ranged from (55-65) years. 3- Body weight of patients was ranged from(55 -95 kg) ,while their height was from (151-185 cm) and BMI was ranged from (20-30 kg/m2).

  4- Duration of illness (6 - 9 months post stroke). 5- Patients have spasticity ranging from grade 1 to grade 3 according to modified Ashworth scale 6- Patients were medically stable

Exclusion Criteria:

* 1- Patients with lumbosacral sciatica that could mimic TTS or interfere with its evaluation 2- Patients with tibial neuropathy, significant polyneuropathy, or marked orthopedic abnormalities; 3- Patients with contractures 4- Patients with psychological disturbance or seizures 5- Systemic diseases known to cause TTS, such as diabetes mellitus, hypothyroidism, rheumatoid arthritis, or chronic renal failure;
Cell Therapy for Venous Leg Ulcers Pilot Study

Chronic venous leg ulcers (CVU) represent a medical problem associated with significant morbidity, increased work absenteeism and earlier retirement as a consequence of disability. This strongly affects the patient's quality of life and has a significant economic impact on healthcare systems.

Reports of studies with animal models show that treatment with bone marrow-derived stem cells has a beneficial effect in healing chronic skin wounds.

The purpose of this pilot study is to determine the safety and feasibility of cell therapy with bone marrow derived cells (BMDC) as a complementary healing therapy in chronic venous leg ulcers, and in addition to evaluate its effectiveness. The knowledge gained in the pilot study will be used to refine the clinical protocol procedures of a subsequent randomized study.

Patients with venous legs ulcers meeting eligibility criteria and providing appropriate written informed consent will be enrolled for study participation. Enrolled patients will receive Autologous BMDC implantation at de venous ulcer in conjunction with standard of care (SOC) treatment.

During follow up, adverse events will be assessed by ulcer clinical examination. Effectiveness of the experimental treatment will be assessed by evaluating ulcer healing (reduction of the ulcer area) and pain reduction over a six-month period.


Eligibility Criteria:
Inclusion Criteria:

* Age from 40 to 75 years
* Patients with primary venous insufficiency
* Patients with venous ulcers with area larger than 2 cm2, who have received SOC treatment in the previous three months.
* Ulcers with negative bacterial cultures or with polymicrobial flora.

Exclusion Criteria:

* Patients with decompensated heart failure.
* Patients with lower limb edema of nonvenous etiology.
* Patients with diagnosis of diabetes mellitus.
* Patients with body mass index (BMI) ≤ 18.5 or \> 40.
The Effect of Distraction Methods on Children Aged 3-6 Years Receiving Inhaler Therapy

The aim of this study is to observe the effect of distraction methods on children aged 3-6 years who apply to the emergency department due to respiratory complaints and receive inhaler medication.

The research was designed based on voluntary participation in threegroups: the experimental group (doll and musical keyboard or musical book) and the control group. The inhaler drug application process is planned to be 10 minutes.

First, routine explanations are given to the children in the experimental group, and the child is ensured to be in an upright position for the parent to be present and to administer the inhaler medication. The child is explained that a doll will accompany him during the inhaler medication administration, and a nebulization mask is attached to the doll. Before starting the inhaler medication administration, the doll is placed next to the child in a sitting position. The child is asked to sit with the doll for 5 minutes and the child is asked whether he/she will play with a musical book or a musical piano.After the child decides which toy he/she will play with and plays with the toy for 5 minutes, the Child Fear Scale (CCS) and the Children's Emotional Indicators Scale (ÇEGÖ) are evaluated by the child, parent, researcher, nurse and vital signs before starting the procedure. Later, when the researcher decides that the child is ready for the procedure, inhaler medication administration is started. After the drug administration is completed, the child, parent, researcher and nurse evaluate the CQS and CEGRS, and vital signs are evaluated by the researcher, and the parent gives a parental satisfaction score.

In the control group, a routine explanation of the emergency department is given to the child and the parent, the parent is next to the child and the child is ensured to sit upright during the inhaler medication administration. To the children in the control group, the researcher shows how the procedure will be done with a nebula mask on himself. The procedure begins after the necessary explanations are made and the researcher decides that the child is ready for inhaler medication administration. Before starting the procedure, the child, parent, researcher, nurse and vital signs are evaluated by the researcher. After the inhaler intake is completed, ÇÖS and ÇEGÖ child, researcher, nurse, parent; Vital signs are evaluated by the researcher and parental satisfaction score is given by the parent.

Eligibility Criteria:
Inclusion Criteria:

* people who volunteer
* Children between 3 and 6 years old
* children without mental problems Children presenting to the emergency department with respiratory illnesses

Exclusion Criteria:

* children with a mental problem
* non-volunteers
CardiAMP™ Cell Therapy for Heart Failure Trial

This is a prospective, multi-center, randomized, controlled, patient- and evaluator-blinded study comparing treatment with the CardiAMP cell therapy to a sham control treatment. A roll-in phase with a maximum of 10 subjects may occur.

Heart failure is a clinical condition in which the output of blood from the heart is insufficient to meet the metabolic demands of the body. In 2015, the American Heart Association, or AHA, report on heart disease statistics estimated that there are 5.7 million Americans over the age of 20 that have heart failure. Heart failure is increasingly prevalent due to the aging population and the increase in major cardiovascular risk factors, including obesity and diabetes.

The AHA also estimates that one in five adults will develop heart failure after the age of 40. During heart failure progression, the heart steadily loses its ability to respond to increased metabolic demand, and mild exercise soon exceeds the heart's ability to maintain adequate output. Towards the end stage of the disease, the heart cannot pump enough blood to meet the body's needs at rest. At this stage, fluids accumulate in the extremities or in the lungs making the patient bedridden and unable to perform the activities of daily living. The long-term prognosis associated with heart failure is approximately 50% mortality at five years following the initial diagnosis.

CardiAMP cell therapy is a comprehensive therapeutic treatment that comprises (i) a point of care cell processing platform and (ii) a biotherapeutic delivery system. CardiAMP cell therapy is the first comprehensive therapeutic treatment utilizing a patient's own cells for the treatment of ischemic heart failure with reduced ejection fraction. In the screening process, the physician extracts a small sample of the patient's bone marrow in an outpatient procedure performed under local anesthesia. The clinic sends the sample to a central diagnostic lab, which tests the sample. For the study treatment, a clinician collects and then prepares the patient's own bone marrow mononuclear cells, or autologous cells, using the CardiAMP point of care cell processing platform, which a cardiologist then delivers into the heart using the Helix biotherapeutic delivery system.

BioCardia intends to submit data obtained from this clinical trial in a Pre-Market Approval Application to the United States Food and Drug Administration

Eligibility Criteria:
Inclusion Criteria:

* New York Heart Association (NYHA) Class II or III
* A diagnosis of chronic ischemic left ventricular dysfunction secondary to myocardial infarction (MI) as defined by selected criteria.
* On stable evidence-based medical and device therapy for ischemic etiology heart failure, per the ACC/AHA Heart Failure guidelines, for at least three (3) months prior to randomization.
* Left ventricular ejection fraction between 20% and 40%.
* Qualification of a pre-procedure screening of the patient's bone-marrow characteristics

Exclusion Criteria:

• Other cardiac or vascular system or other health-related criteria which may be seen in a patient's history and physical examination.
Itch and Clinacal Caracteristics in Systemic Sclerosis

Systemic sclerosis (SSc) has heterogeneous symptoms and significant medical morbidity. Recently, itch was described as a symptom of SSc (prevalence of 42,6%). To the investigators knowledge, no study yet has examined the clinical features of itch neither had used a specific itch-related quality of life (QoL) scales in patients with SSc. The objectives were to evaluate the prevalence of pruritus, its characteristics and its impact on the QoL in those patients.

In this descriptive study, patients followed for SSc in the departments of dermatology, rheumatology, internal medicine and pulmonology at the University Hospital of Brest were included. Participants received a questionnaire including questions about the clinical features of pruritus and 2 scores (5-D itch scale, ItchyQol).


Eligibility Criteria:
Inclusion Criteria:

* aged more than 18 years
* followed for systemic sclerosis since 2000, in the departments of dermatology, rheumatology, internal médicine or pneumology at the University Hospital of Brest.

Exclusion Criteria:

* lower than 18 years
* refusal to participate
Physical Activity Component of the Greek Interventional Geriatric Study to Prevent Cognitive Impairment and Disability (GINGER)

The Greek Interventional Geriatric Study to Prevent Cognitive Impairment and Disability (GINGER) is a six-month multimodal, multicenter study aimed at people with Subjective Cognitive Impairement (SCI).

One of the GINGER's interventional components is the Physcial Activity (PA) component, coordinated by the University of Patras.

This PA component's scope is to determine whether an enhanced individualized physical exercise intervention programme can improve cognitive changes, physical function, quality of life and wellbeing in people with subjective cognitive decline.


Eligibility Criteria:
Inclusion Criteria include people with:

* Subjective Cognitive Decline confirmed from the Subjctive Cognitive Decline Questionnaire (SCD - Q score \>7)
* Absence of objective cognitive imparement as confirmed from cognitive assessment tests (i.e. MoCA, Trail A \& B, Stroop, RCFT, FAS. )

Exclusion Criteri include people with:

* Mild Cognitive Impairement (MCI) or dementia
* Chronic psychiatric or neurological disorders affecting cognition (i.e. bipolar disorder, schizophrenia, MS, TBI, Parkinson's disease etc.)
* Unstable pathological diseases (i.e. uncontrolled hypothyrodism, athythmias, uncontrolled hypertension, high blood pressure at rest etc.)
* Recent (\<6 month) surgery, which restrics active participation in exercise/physical activity
* inadequate knowledge of Greek
Mindfulness-Associated Brain Changes in Adults With Autism

The purpose of this study to measure brain functioning before and after stress-reduction classes to better understand how symptom improvements relate to brain functioning in adults with ASD (Autism Spectrum Disorder). Participants will be randomly assigned to one of two stress reduction classes that will meet once a week for 8 weeks. One group will complete a structured training program called Mindfulness Based Stress Reduction (MBSR) that involves teaching about increased mindfulness strategies and gentle stretching. The other group will review relaxation techniques and other stress reduction strategies and will include social support. Structural and functional MRI, EEG, and behavioral self-report data will be collected to understand more about how the brain changes in subtle ways when people feel better and are more aware of their emotional state.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 89 years old, with a special focus on adults with ASD who are going to college given the additional stress of this phase in life. We are recruiting participants across a broad age range in order to maximize our ability to inform interventions for adults with ASD. The upper age limit of 89 years was selected so a de-identified dataset can be created with all participant ages included.
* ASD diagnosis via gold-standard diagnostic assessments (Autism Diagnostic Observation Schedule-2).
* Must be able to attend at least 7 of the 8 weekly intervention classes.
* English speaking: Participants must be English-speaking because the screening and behavioral measures are in English (including the intelligence estimate).

Exclusion Criteria:

* Participants with Intelligence Quotient (IQ) scores \<70 will be excluded to minimize variability due to general cognitive functioning.
* Report of any major medical illnesses, histories of seizures, or head trauma with loss of consciousness. These health factors can cause brain changes that would confound findings.
* Concerns that the participant may not be able to complete the MRI neuroimaging requirements for the study, including claustrophobia or metal objects within the participant's body or eyes. Implanted metal objects may create a safety hazard in the powerful magnetic field during MRI imaging.
* Pregnant women. MRI has no known effects on pregnancy or fertility. However, since we are not 100% certain MRI has no effects on a developing fetus, women who are pregnant may not participate in this study.