cyrilzakka/clinical-trials huggingface dataset:
The Effect of Listening to Stories and Watching Cartoon Film on Pain in the Aspiration Process in Children Receiving Palliative Care

The aim of this study is to determine the effect of listening to fairy tales and watching cartoons on pain in the aspiration process in play-age children receiving palliative care.

15 voluntary children with receiving palliative care, aged between 1-3 years will be randomly divided into two groups: fairy tale group and cartoon group. Interventions will be applied for 3 weeks, 1 times a day (16 sessions). No intervention will be applied to both groups besides fairy tale or cartoon intervention. The children will be assessed before, during and after. PAIN DUE TO ASPIRATION PROCEDURE will be evaluated using the FLACC Pain Scale. In addition, the heart rate, respiration, blood pressure, tidal volume and fever values of the children will be measured with the help of a bedside monitor.

Eligibility Criteria:
Inclusion Criteria:

* Being in the 1-3 age group
* Being in the palliative care service for at least 3 months
* Receiving inpatient treatment in the pediatric palliative care service
* Absence of visual and hearing anomalies
* No other chronic disease
* Having a tracheostomy

Exclusion Criteria:

* The family's desire to leave research.
* Deterioration of the child's condition
* The child's diagnosis of an additional chronic disease
OPUS School Meal Study

The aim of this randomized crossover study, is to investigate the effect of school meals based on a sustainable New Nordic Diet on growth, learning abilities, well-being, sleep quality, physical activity and risk markers of cardiovascular disease (CVD), type II diabetes and osteoporosis in 8-11 year old Danish school children.

The participating 3rd and 4th grades on 9 selected primary schools will be randomized to either start receiving New Nordic Diet school meals for 3 month(mo) or to eat their habitual school lunch for 3 mo and then crossover for additional 3 mo. All participants will be examined three times; at baseline, after 3 mo and after 6 mo.


Eligibility Criteria:
Inclusion Criteria:

* Pupils in 3rd and 4th grades
* Primary Schools in the Zealand Region and Capital Region of Denmark
* Schools with an available school kitchen, that can be approved by the food authorities
* Schools where at least 60 % of the pupils in three or more classes signs up to participate in the Study

Exclusion Criteria:

* The children should not participate in a scientific study or have participated in a scientific study within the last 4 weeks. This, however depends on the character of the other study.
* The children must not suffer from serious food allergies or food intolerance.
* The children must not suffer from diseases or conditions that makes them ill-suited for participation in the study, eg. malabsorptive conditions or serious mental disorders
* The Schools must not offer an well-established common meal plan, that provides most of the pupils with healthy food on a daily basis
MRI Scan and Intra-labyrinthine Schwannoma

Evaluate the interest of gadolinium for the positive and topographic diagnosis of intra-labyrinthine schwannoma, comparing T1 sequence acquired after gadolinium injection to a sequence of fast imaging type employing steady state acquisition (FIESTA-C)


Eligibility Criteria:
Inclusion Criteria:

* Age 18-80 years
* Have intra-labyrinthine schwannoma
* Have benefited from an MRI with gadolinium injection on the MRI 3T with interpretable sequences of good quality
* Subject giving their consent for their participation
* Subjects who benefited, between 2009 and 2016, from an MRI of the external auditory canals, with gadolinous product injection and on the 3 Tesla MRI, in which a diagnosis of intra labyrinthine schwannoma was made

Exclusion Criteria:

- Refusal to participate in the study
MRI Assessment of Leukemia Response to Therapy

The purpose of this study is to investigate if a type of magnetic resonance imaging (MRI) scan of the bone marrow before the start of standard chemotherapy can predict complete remission of leukemia patients after the therapy. This type of MRI scan, called dynamic contrast-enhanced MRI (DCE-MRI), measures bone marrow blood flow. For those patients who do not achieve complete remission status after initial therapy and will be treated with additional therapy, the investigators are also interested in determining if the second MRI exam before the additional therapy can predict complete remission. If successfully tested, the MRI exam may be used in the future to help with early identification of patients who are unlikely to respond to standard chemotherapy. This will allow for a personalized therapeutic plan to be developed for these patients at an early stage and prevent them from being exposed to toxic and ineffective therapies.


Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed or relapsed AML patients, who are scheduled to receive standard induction therapy.
* Age \> 8 years and requiring no sedation.
* Patients must not be pregnant
* Women of childbearing potential must have negative serum pregnancy test performed within 7-days prior to start of study
* The subject or subject's legal guardian has the ability to understand and the willingness to sign a written informed consent and/or assent document. A signed study-specific informed consent and/or assent must be obtained prior to any study specific procedures.

Exclusion Criteria:

* Patients who would be normally excluded from undergoing an MRI examination - patients with a pacemaker, aneurysm clip or any other condition that would warrant avoidance of a strong magnetic field.
* Patients who have known or suspected allergy to gadolinium-based contrast agent.
* Severe claustrophobia precluding subject from undergoing a MRI
* Patients with acute or chronic kidney dysfunction (estimated Glomerular Filtration Rate (eGFR) \< 30ml/min/1.73 m2 as calculated using the Modification of Diet in Renal Disease (MDRD) Equation)
* Pregnant women are excluded from this study because of possible risk to the fetus.
Nitroglycerin Infusion During Cardiac Surgery

Hypothermic cardiopulmonary bypass results in peripheral vasoconstriction and heparin trapping. Hypoperfusion and ischemic-reperfusion injury are associated with systemic inflammatory response, while insufficient and delayed neutralization of heparin by protamine may contribute to more blood loss during rewarming stage.

Nitroglycerin infusion, an NO-related vasodilator, is an established and effective treatment for unstable angina, myocardial infarction, congestive heart failure, and perioperative hemodynamic management for cardiac surgery. Therefore, we hypothesize that nitroglycerin infusion during rewarming corrects systemic ischemic stress and facilitates heparin neutralization in cardiac surgery.

A randomized clinical trial in a tertiary academic center in patients with cardiac surgery, to receive either nitroglycerin infusion dose of 0-0.1 mcg/kg/min, or 1-5 mcg/kg/min during rewarming in cardiopulmonary bypass.

Eligibility Criteria:
Inclusion Criteria:

* elective cardiac surgery

Exclusion Criteria:

* heart failure, respiratory failure, asthma attack, uremia, normothermic bypass.
Low Intensity Shock Wave Therapy (LI-ESWT) for Erectile Dysfunction in Post Radical Prostatectomy Patients Not Responding to PDE5 Inhibitors (LI-ESWT)

Low intensity shock waves (LISW) have been proven in animal studies to induce local growth of new blood vessels. The investigators hypothesized that LISW therapy could improve the symptoms of patients with erectile dysfunction resulting from a problem of blood supply (damage that can occur after radical prostatectomy in addition to neural damage or solely) that do not respond to oral therapy (PDE-5 inhibitors).


Eligibility Criteria:
Inclusion Criteria:

* Prior prostatectomy surgery
* ED of more than 6 months
* Rigidity score \< 3 during PDE5i therapy
* Non- hormonal, neurological or psychological pathology Stable heterosexual relationship for more than 3 months

Exclusion Criteria:

* Any unstable medical, psychiatric, spinal cord injury and penile anatomical abnormalities
* Clinically significant chronic hematological disease
* Anti-androgens, oral or injectable androgens
* Radiotherapy in pelvic region
Effects of a Pre-Workout on Performance, Perceptual Responses, Energy Feelings and Muscular Properties, After a Training Microcycle in Adults.

The investigation will be conducted as a double blinded, randomized, crossover within-participant comparison design with two 1-week intervention periods separated by 2-weeks for wash out, recovery, period.

Following inclusion, familiarization and baseline assessments, the participants will be randomly allocated to receive either a multi-ingredient, pre-workout supplement (PREW) or maltodextrin (CHO). Thereafter, the participants will take a 5-day microcycle, involving three resistance training sessions (Monday, Wednesday and Friday) intercalated with two endurance training sessions (Tuesday and Thursday). After the first interventional microcycle, and the 2-week washout period, the participants will switch to the other nutritional condition for continuation with the second 5-day identical microcycle. Assessments of muscle contractile properties via Tensiomyography on Vastus Medialis, Biceps Femoris Long Head and Anterior Deltoids will be taken before and after each resistance training session. Measurements of strength (Isometric Mid Thigh Pull) upper and lower body muscular power (Medicine Ball Throw and Vertical Jump) will be performed immediately after each resistance training workout. The supplements will be ingested 15 min before each training session, just before completing an energy feeling questionnaire. In addition, the perceptual response to training will be assessed during and 20 min after the completion of all workouts. The contribution of carbohydrate and fat metabolism will be estimated using a gas analyzer via the calculation of respiratory exchange ratio the (RER) during each endurance training session.

Eligibility Criteria:
Inclusion Criteria:

* Healthy (no current injuries).
* Between 45 and 70 years old.
* Active.

Exclusion Criteria:

* Injuries.
* Never trained before.
* Under 45 or over 70 years old.
Impact of a Booklet-Question List on Cancer Patients or Their Families Seeking Prognostic Information During a Palliative Care Consultation

Prospective, randomized, multicentre phase III study to evaluate the level and type of information requested by patients or families during a palliative care consultation after they have been given the Booklet-Question List (BQL).


Eligibility Criteria:
Inclusion criteria:

* Patient over the age of 18 years,
* Patient who has signed the informed consent form after being given a written information sheet
* Patient followed for metastatic cancer with or without specific treatment, with a limited life expectancy
* Patient referred to the palliative care team.
* French-speaking Patient

Exclusion criteria:

* Cognitive disorders
* Documented psychiatric disorders or marked psychological fragility
Default Options to Reduce Unnecessary Daily Imaging During Palliative Radiation

The goal of this study is to reduce preference sensitive, unnecessary daily imaging during radiation treatment in which a pre-planned quality improvement default option for radiation treatment prescriptions will be introduced throughout the network of Penn Radiation Oncology.

The goal of this study is to reduce preference sensitive, unnecessary daily imaging during radiation treatment in which a pre-planned quality improvement default option for radiation treatment prescriptions will be introduced throughout the network of Penn Radiation Oncology. This study is a prospectively designed, observational trial with two comparison groups: (1) a usual practice group (control group) and (2) a default radiation treatment prescription group (intervention group), in which the usual practice group will subsequently rollover from control to intervention so that all sites and physicians in the practice network of Penn Radiation Oncology are exposed to intervention. The purpose of this study is to reduce preference sensitive, unnecessary daily imaging during radiation treatment with the implementation of a quality improvement initiative within 5 sites of Penn Radiation Oncology. We aim to leverage the introduction of a default prescription option to reduce the use of daily imaging in palliative intent cases where it has limited clinical benefit and adds to cost burden. Our objective is to encourage more patient-centric clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* Radiation treatment courses with palliative intent
* Palliative treatment of bone, soft tissue, and intracranial metastases
* Photon radiation with 3D conformal therapy (3DCRT) only

Exclusion Criteria:

* Use of intensity modulated radiation (IMRT) or stereotactic body radiation (SBRT) as radiation treatment modality
* Retreatment to same site
* Proton radiation
Written Exposure Therapy for PTSD in a Virtual, Group-based Format

The purpose of this study is to examine whether Written Exposure Therapy (WET) can be effectively delivered virtually and in a group format for the treatment of Post-Traumatic Stress Disorder in a military and police population. The objective of this study is to assess treatment feasibility and acceptability, drop out rates, changes in severity of trauma-related symptoms and symptoms of depression, quality of life, and the need for further trauma-focused treatment (TFT) for the the delivery of WET as a virtual, group based intervention.

This study will assess the efficacy and acceptability of WET being delivered virtually and in a group format for the treatment of PTSD through the Operational Stress Injury Clinic (OSIC) at Deer Lodge Centre.

WET is offered in small groups of 10 patients. This study will follow 8 iterations of the group for a potential total of 80 participants in this study. Each WET group session will be facilitated by two OSIC clinicians, at least one of whom will be a clinical psychologist. Each session, administered via the Zoom app for healthcare, will start with a brief check in, then instructions will be provided to the whole group. Each group will receive a total of 5 therapy sessions, each of which will last approximately 1.5hrs.

Prior to the first WET session, participants will be asked to complete three clinical measures: Patient Health Questionnaire- 9 (PHQ-9), PTSD Checklist for DSM-5 (PCL-5, weekly version), and Outcome Questionnaire-45 (OQ-45). Participants will be asked to complete the PCL-5 prior to each session. Participants will also complete a Treatment Acceptability/Adherence Scale prior to the start of the second session.

Following the final session of therapy, participants will be asked to complete the three clinical assessment questionnaires (PHQ-9, PCL-5, and OQ-45) at 1 week, 1 month, and 3 months post-treatment. A research assistant will also follow-up with each participant at the 3-month mark to ask whether they have sought or attended further psychological treatment since the end of the WET sessions.

Eligibility Criteria:
Inclusion Criteria:

* Referred for Written Exposure Therapy at the Occupational Stress Injury Clinic (OSIC) in Winnipeg
* Able to speak, read, and write in English
* Medication held at a stable dose for four weeks prior to beginning treatment and throughout the duration of treatment (if on a prescribed medication)

Exclusion Criteria:

* Current psychosis
* Presence of another psychiatric disorder that requires prioritization over treating PTSD
* Any cognitive, visual, or motor impairment that would prevent writing for 30 minutes
Pharmacokinetics and Dynamics of Dexmedetomidine as Adjuvant in TAP Block

TAP-block has been shown to be a safe and effective postoperative analgesia method in a variety of general. Dexmedetomidine is a selective α2 agonist with 8 times more affinity for α2 adrenergic receptors compared to clonidine and possesses all the properties of α2 agonist without respiratory depression. Dexmedetomidine has been focus of interest for its broad spectrum (sedative, analgesic and anesthetic sparing) properties, making it a useful and safe adjunct in many clinical applications.


Eligibility Criteria:
Inclusion Criteria:

* 24 ASA I-II
* patients (age 18-60 years
* weight 50-89 kg

Exclusion Criteria:

* a known allergy to the study drugs
* significant cardiac
* respiratory, renal or hepatic diseases
* bleeding diathesis
Descriptive Study of Mental Activity

Provide a description of patients admitted in the psychaitric department of the Mayotte Hospital

This feature and the proximity of Mayotte with developing countries give this department different specificities, both culturally and medically. Indeed, the local population of lifestyle and specific beliefs, combining Islam and animism. Thus, a person with mental suffering is traditionally treated by a wizard who will come into contact with the spirits that inhabit the person, the community that supports the patient remains at home.

Mayotte is far behind compared to the metropolis where the supply of psychiatric care with a fragile population, a care network being created, and few downstream solutions To handle crisis situations, emergency unit and psychiatric liaison, speaking to general emergencies was established in 2010. It is currently the only access to emergency psychiatric care on the island.

The situations covered by this unit are for patients of all ages and all social and geographical origins, reflecting the demographics of the population.

Investigator has only quantitative data (number of patients / year) and has no qualitative analysis tool. No epidemiological research has been done to date in this direction.

The aim of our study was to analyze the impact of various psychiatric disorders represented Mayotte of the emergency hospital to get a statistical picture of its business.

This description will present to the scientific community the specifics of this department

Eligibility Criteria:
Inclusion Criteria:

Patient in need of psychiatric care in the emergency department

Exclusion Criteria:

* Patient leaves the emergency department against medical advice or fugue
* Patient leaves the service without the medical diagnosis is made
* Patient in exclusion period determined by a previous search
* Patients for whom it is impossible give clear information
* Patient who manifested their opposition to participate in research
* Patient minor whose parental agreement has been reached
* Patient on safeguarding justice whose guardian will not be contacted
Pharmacokinetics and Safety of RV521 Formulations

The main aims of the study are to assess the pharmacokinetics and safety of single doses of RV521 administered as two different formulations


Eligibility Criteria:
Inclusion Criteria:

* Willing to comply with protocol defined contraception requirements
* In good health with no history of major medical conditions
* A body mass index (BMI) of 18-25 kg/m\^2, inclusive

Exclusion Criteria:

* Evidence of any clinically significant or currently active major medical condition
* Positive test for Hepatitis B surface antigen (HBsAg), Hepatitis C antibody (HCV Ab), or human immunodeficiency virus antibody (HIV Ab) at screening
* Not willing to comply with protocol defined restrictions for intake of drugs of abuse, alcohol, nicotine-containing products, medication (prescription, OTC, herbal, vitamins/minerals etc) and specified food and drink products
Effects of Blood Flow of Venoarterial Extracorporeal Membrane Oxygenation Life Support on Microcirculation

Extra-corporeal membrane oxygenation (ECMO) life support system can provide both cardiac and respiratory support to patients with heart and respiratory failure. It can save time for these patients to regain organ function or to receive transplantation. Both the investigators' team and Ince et al. from the Netherland found that the microcirculatory dysfunction is more severe in ECMO non-survivors. The next step of research is to find out the key factors that affect microcirculation in ECMO patients. Because the blood flow supplied by the venoarterial ECMO (VA-ECMO) is directly related to macrocirculation, this study aims to investigate the effect of adjustment of VA-ECMO blood flow on microcirculation. The investigators hope that the results of this study can help the medical team to improve the quality of ECMO care.

After evaluation, explanation, and acquisition of agreement, the sublingual microcirculation will be examined within 24 h and at 48 h after placement of VA-ECMO. The VA-ECMO blood flow will be recorded, and the baseline microcirculation will be examined. After the ECMO technician adjusting the ECMO flow, sublingual microcirculation will be examined 2 minutes after each adjustment, and the change of ECMO blood flow will be recorded. When the ECMO team plans to weaning off the ECMO within 72 h, the sublingual microcirculation will be examined. The VA-ECMO blood flow will be reduced by ECMO technician, and sublingual microcirculation will be examined 2 minutes after each adjustment of the blood flow. The ECMO parameters, medications, and clinical data will be recorded, and the prognosis will be followed up on the 28th day.

Eligibility Criteria:
Inclusion Criteria:

* Patients who require venoarterial extra-corporeal membrane oxygenation (ECMO) life support

Exclusion Criteria:

* who can not take an examination of sublingual microcirculation within 24 hours after placement of venoarterial ECMO support
* Non-native speakers
The Role of Paracetamol-caffeine and Laser Irradiation on Controlling Pain and Discomfort During Orthodontic Treatment

Patients with class I malocclusion who have mild to moderate crowding will be treated in this study. The efficacy of low level laser therapy and Panadol-extra® in relieving pain due to orthodontic treatment will be assessed. The effect of these two interventions on oral-health related quality of life during all stages of orthodontic treatment will be explored, i.e. at the following stages: (1) separation between teeth, (2) archwire changing, (3) bonding of brackets, (4) removal of the fixed appliances.

There are three groups :

1. a group of patient being irradiated with low-level laser therapy (LLLT) at specific time points to relieve pain and discomfort.
2. a group of patient in which pain control will be accomplished by prescribing Panadol Extra tablets in a regular manner.
3. a group of patients in which nothing will be given to them during the course of treatment.

The assessment of oral-health-related quality of life during the different stages of orthodontic treatment is probably unique in the literature.

The study will cover the different stages of orthodontic treatment from A to Z. In other words, patients will be followed up till the end of treatment at which fixed appliances are removed. Pain control will be accomplished in one arm using LLLT and in another arm by prescribing Panadol Extra®. A third group will be left without any medication or laser irradiation to serve as a control group.

Eligibility Criteria:
Inclusion Criteria:

* Class I malocclusion with mild to moderate crowding (2-5 mm of tooth-size-arch-length-discrepancy)..
* Good oral hygiene and periodontal health
* No need for any preparation for fixed orthodontic appliance.
* No severe skeletal discrepancy (i.e. Class I skeletal relationship).

Exclusion Criteria:

* Previous orthodontic treatment
* Patients with psychological abnormalities.
* Patients with systematic diseases or being treated from chronic pain or headache.