cyrilzakka/clinical-trials huggingface dataset:
Role of Airtraq Mobile to Improve Intubation Conditions With Airtraq

Airtraq sp has been proven effective for intubating patients presenting with difficult airway.

The Airtraq sp allows visualisation of the tracheal inlet only for the intubator.

By adding a smartphone with a dedicated app (Airtraq Mobile) to the Airtraq sp, the visualisation of the tracheal inlet is possible for all the airway providers.

The investigators aim to demonstrate that the addition of the Airtraq Mobile app improves success rate of intubation (primary endpoint), as well as confort of the airway provider, shortens time for intubation and reduces injury to the patients.

Airtraq sp has been proven effective for intubating patients presenting with difficult airway.

The Airtraq sp allows visualisation of the tracheal inlet only for the intubator.

By adding a smartphone with a dedicated app (Airtraq Mobile) to the Airtraq sp, the visualisation of the tracheal inlet is possible for all the airway providers.

The investigators aim to demonstrate that the addition of the Airtraq Mobile app improves success rate of intubation (primary endpoint), as well as confort of the airway provider, shortens time for intubation and reduces injury to the patients while their neck is imobilized by a cervical collar, creating a simulated difficult airway.

Patients will be included if they necessitate an elective general anesthesia and orotracheal intubation.

Exclusion criteria are related to difficult airway, ASA IV and patient refusal.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesia classification 1-3, elective surgey necessitating general anesthesia and intubation, patient consent

Exclusion Criteria:

* American Society of Anesthesia classification 4, patient refusal, history of difficult airway
Culture-sensitive Emotion Regulation Group Therapy for Traumatized Refugees

There is a lack of studies on treatment effect in traumatised refugees. Recent findings indicate that emotion regulation deficits play a key role in PTSD also among traumatized refugees and highlight the importance and potential directions for the development of an emotion regulation training for refugees. In this study, the investigators therefore want to examine the effectiveness of a new, transdiagnostic, cultural-sensitive group therapy, which systematically teaches specific emotion regulation strategies. Participants will be randomly assigned to either the emotion regulation training, delivered in group format or a wait list control condition. The study takes place in cooperation with REFUGIO Munich, which is a treatment centre specialised in the treatment of traumatised refugees. Clinicians will deliver the treatment to traumatized asylum seekers and refugees that report difficulties in emotion regulation. The investigators will examine if refugees and asylum seekers in the intervention group will show improvements in psychological symptoms, social functioning as well as in emotion regulation in comparison to a wait list control group which will receive the treatment after the intervention group has completed. The group therapy covers 14 sessions and has a cognitive-behavioural background. It focuses on conveying strategies to cope with intense feelings and the patients should gain a sense of self-efficacy and control over their trauma-relevant feelings and symptoms. Qualified interpreters will be used in the assessments as well as group therapies.


Eligibility Criteria:
Inclusion Criteria:

* Refugee or asylum seeker from Afghanistan, speaking Dari
* reporting at least one traumatic event on a trauma list
* reporting difficulties in emotion regulation
* between the age of 15 and 21 years

Exclusion Criteria:

* Psychosis
* Serious suicidal ideations
* Currently receiving psychotherapy elsewhere
* Serious dissociation
Cortico-cortical Connectivity During Midazolam Sedation in Humans; a TMS/EEG Study

The aim of the proposed research is to measure the effect of drug-induced sedation on the functional connectivity between brain regions as indicated by EEG signal transmission within the human brain. The results of this study will help to identify the neurophysiological correlates of changes in conscious experience that occur during drug-induced sedation.

In the proposed experiments cortical areas will be stimulated using low frequency, low-amplitude transcranial magnetic stimulation (TMS) in healthy human subjects during wakefulness and during drug-induced responsive sedation and unresponsive sedation. Simultaneously, high-density electroencephalography (Hd-EEG) will be recorded to evaluate the temporal and spatial characteristics of evoked responses and induced rhythms over the cortex.

Eligibility Criteria:
Inclusion Criteria:

* Healthy right-handed men
* Aged 18-35
* Non-smokers
* No metallic implants

Exclusion Criteria:

* Younger than 18 or over the age of 35.
Efficacy and Safety of Nitazoxanide in Preventing Recurrence of Hepatic Encephalopathy

Efficacy and Safety of Nitazoxanide in preventing recurrence of Hepatic Encephalopathy.

Clinical Study Evaluating the Efficacy and Safety of Nitazoxanide in preventing recurrence of Hepatic Encephalopathy.

Eligibility Criteria:
Inclusion Criteria:

* Cirrhotic patient with at least one previous episode of hepatic encephalopathy.
* Adult Patients aging from 20 to 65 years old

Exclusion Criteria:

* Active GIT bleeding.
* Major psychiatric illness (psychosis \& epilepsy).
* Renal insufficiency (S.Cr 2mg/dl).
Study of Efficacy & Safety of Oral YM087 in Subjects With Euvolemic or Hypervolemic Hyponatremia

Study of efficacy \& safety of oral YM087 in subjects with euvolemic or hypervolemic hyponatremia


Eligibility Criteria:
Inclusion Criteria:

* Serum Sodium 115 to \<130mEq/L
* Plasma Osmolarity \<290 mOsmol/kg H2O

Exclusion Criteria:

* Significant renal insufficiency
* Serum sodium increase of ≥8 mEq/L over the baseline day ( Hours 0 to 12)
Study to Identify if Saie Beauty's Under Eye Concealer Works to Improve Under-Eye Skin Appearance and Reduce Imperfections

Saie Beauty has developed 'Hydrabeam Sheer Brightening Under Eye Concealer' that is specifically designed for improving under-eye skin health. The concealer is aimed at improving under-eye skin features including hydration, firmness/elasticity, smoothness, and brightness. At the same time, it is aimed at reducing imperfections such as dark circles, skin redness, fine lines, wrinkles, and crow's feet. The aim is to understand and assess the efficacy of treatment from the participants' perspective and to see if the participants reported changes in skin features, dark circles, brightness, fine lines, wrinkles, crow's feet, and other skin imperfections.


Eligibility Criteria:
Inclusion Criteria:

* Female between 18 and 45 years old
* Must be in good general health
* Want to improve under-eye skin health by improving skin hydration, firmness/elasticity, smoothness, and brightness
* May have dark circles, fine lines, wrinkles, and crow's feet
* Must be willing to comply with the study protocol
* Must be willing to add the concealer to their daily routine for the duration of the study
* Must maintain a basic skincare routine, e.g., must use moisturizer and sunscreen daily
* Able to communicate in English
* Must provide a written Informed Consent Form (ICF)
* Willing to share feedback via the given online portal

Exclusion Criteria:

* Unwilling to follow the routine of the study
* Unwilling to provide informed consent
* Currently participating in another research study
* Severe chronic conditions including ontological and psychiatric conditions
* Use of prescription medication relevant for the skin
* Have any known allergies to the ingredients of the test product
* Known to have any severe allergic reactions in the past
* Undergoing any cosmetic procedures such as laser treatments, Botox, or chemical peels for the duration of the study.
* Have diagnosed or self-identified sensitive skin
* Have any learning and/or cognitive difficulties that prevent them from reading and understanding questionnaires and surveys (e.g. dementia)
* Currently pregnant or breastfeeding, or want to become pregnant for the duration of the study
* Use of prescription drugs (topical or oral) that are targeted at any sort of skin condition (for example retinoids)
Contribution of 18FDG PET-Scan in Tumour Volume Determination in Patients Operated of Breast Cancer

Use of positron emission tomography (PET) in determination of functional tumour volume can provide usable information for radiotherapy to define the irradiated volume.

To determine the best tumour volume measure method, the investigators have chosen as model the breast cancer which allows us to study a stationary or moving organ by the patient position and belonging to a primary surgery.

The used methodology is based on lesion volume measure in preoperative time, obtained with PET, and on the measure of specimen volume by the anatomic laboratory after surgery.

This study's main objective is to compare this two measure of tumour size and secondarily to compare TEP with or without respiratory gating.

The PET-scan is achieved with FDG, under his French permission marketing, and acquire in 3 times:

A whole body acquisition in supine position, follow by a centered tumour acquisition with respiratory gating, then an acquisition in prone position to immobilise the lesion.

This study is monocentric and descriptive. It provides to include 30 patients in 1 year.

The use of positron emission tomography (PET) in determination of functional tumour volume may pose two major problems especially for the exact delineation of tumour contours:

* Respiratory movements, when the tumour is thoracic, may induce an overestimation
* The PET's low spatial resolution, linked to the emission of photons

The usual method to define tumour contours result of three types of delineation usually used: the visual contouring, the segmentation based on an activity threshold fixed, and the segmentation with adaptive thresholding.

Eligibility Criteria:
Inclusion Criteria:

* Invasive non-lobular breast cancer, histologically proven by biopsy
* Tumour T2 - T3 regardless of nodal status, stemming from a primary surgery, in whom FDG-PET is performed for staging
* Age greater than or equal to 18 years
* Good condition: WHO lower 2.
* Women receiving effective contraception throughout the duration of treatment and 3 months after cessation of treatment,
* Patient has signed informed consent

Exclusion Criteria:

* Carcinoma other than breast ductal carcinoma.
* Patients for whom no target tumor is assessable.
* Patients for whom surgery first of their breast cancer is not indicated (tumor spread, metastasis, general health, co-morbidities).
* Pregnant women, or likely to be during breastfeeding.
* Major protected (under supervision and under guardianship)
* Failure to submit to medical supervision of the study for reasons of geography, social or psychological
* Incomplete tumor resection
Evaluation of the Emotional Burden of the Nurse

Asses the emotional burden on nursing staff and how much they are at risk for burnout.

The study involves the administration of a questionnaire paper questionnaire (maslach burnout scale) in the presence.

Eligibility Criteria:
Inclusion Criteria:

* Nursing personnel afferent to the OU of hematology and stem cell transplantation hematopoietic and the uoc geriatric hematology and rare hemapathies with more than 2 years of experience in the above departments.
* Signature of informed consent.
* Ability to understand and complete.

Exclusion Criteria:

* Nursing staff not belonging to the departments of hematology
* Failure to sign informed consent
PET Perfusion Imaging Techniques and Comparing Them to CT Perfusion Imaging in Stroke

Adult patients who are diagnosed with an acute supratentorial ischemic stroke within 48 hrs of onset will be enrolled into the study. Participants will undergo both a CT Scan and PET scan within 7 days of onset. Participants will have the option to undergo a second PET scan with fluorodeoxyglucose (FDG).

Patients older than 18 years of age diagnosed with an acute supratentorial ischemic stroke within 48 hrs of symptom onset will be prospectively enrolled. Research imaging will be obtained before 7 days after symptom onset. The patient will receive the standardized treatment protocol at the hospital. Informed consent will be obtained from each patient or a substitute decision maker for each individual imaging study (CTP, Rb PET, and FDG PET). The patient will be given the option of undergoing the CTP imaging with the Rb PET only or both the Rb PET and FDG PET components.

Eligibility Criteria:
Inclusion Criteria:

* Age: \>18 yo
* Gender: male or female
* Acute (within 7 days from symptom onset) Supratentorial Ischemic Stroke

Exclusion Criteria:

* 1) Planned surgical intervention
* 2) Severely abnormal blood glucose level (will be excluded from FDG PET imaging)
* 3) Unable to undergo CTP or PET imaging (i.e. claustrophobia)
* 4) Pregnancy
The Impact of Docosahexaenoic Acid on the Prevention of Necrotizing Enterocolitis in Preterm Neonates

The study will assess the efficacy of Docosahexaenoic Acid in reducing the incidence of necrotizing enterocolitis in premature infants.

The efficacy of Docosahexaenoic Acid in reducing the incidence of necrotizing enterocolitis in preterm neonates will be evalutaed through measuring its immune-modulatory effect on proinflammatory cytokines.

Eligibility Criteria:
Inclusion Criteria:

* Preterm neonates having a gestational age equal or less than 34 weeks at birth.
* Weight (less than or equal 1.500 KG)
* Clinically stable to begin enteral feeding

Exclusion Criteria:

* Persistent bleeding at any level.
* Receiving medication to avoid coagulation.
* Persistent vomiting.
* Gastrointestinal malformations.
* Mother taking Omega-3 supplements and planning to breastfeed.
Analysis of Breath Sound During Thoracic Surgery

In modern thoracic surgery, double-lumen endobronchial tube (DLET) is the first choice for intubation. One lung ventilation can be perfectly performed by DLET, with the benefit of maintaining adequate gas exchange and establishing great surgical field. Traditionally, we use stethoscope and fiberscope for DLET site evaluation. However, there are some concerns over traditional methods. Stethoscope evaluation can be subjective from person to person; fiberscope, on the other hand, can cause additional bronchial injury as it is an invasive procedure. We hope to utilize patches, also known as electronic stethoscope, which provide non-invasive and visualized spectrum information, to assist anesthesiologists evaluate DLET insertion site more precisely in patients undergo thoracic surgery.

This is an observational study. We use electronic stethoscope, which stick on patient's anterior chest, to record breath sound after intubation. The soundtrack will then be transformed to visualized waveform, enabling us to analyze and compare with actual result confirmed by fiberscope.

Eligibility Criteria:
Inclusion Criteria:

* patients undergo thoracic surgery and general anesthesia using DLET

Exclusion Criteria:

* patients have no will to participate
* vulnerable groups, including physically disabled and mental diseased patients
* patients with abnormal breath sound, pulmonary disease or history of cardiothoracic surgery
Muscle Oxygenation, Functional Capacity and Frailty in Kidney Transplant Recipients with and Without Inspiratory Muscle Weakness

The aim of this study was to compare respiratory function, muscle oxygenation, functional capacity, peripheral muscle strength, body composition, and frailty in kidney transplant recipients with and without inspiratory muscle weakness.


Eligibility Criteria:
Inclusion Criteria:

* Patients with kidney transplantation
* At least 6 months after the kidney transplant
* Not having regular exercise habits
* Voluntary participation in the study

Exclusion Criteria:

* Having a musculoskeletal problem that may interfere with the tests
* Having neurological impairment
* Having chronic lung disease
* Having had any cardiovascular event in the last 6 months
Pain in Breast Surgery Intervention

This study will be a randomized control trial providing an educational component to study participants and a pre-operative and post-operative survey with a goal to show an improvement in pain control, decrease in narcotic use, and increase in patient knowledge in the study group.

The use of opioid pain medications in surgical patients is contributing to an epidemic of opioid pain medication use. It is known that the quality of pain control after surgery is a large factor of the patient's perception of their experience. However, little research has been done to improve pain control in plastic surgery patients. To the investigators knowledge, no study has yet looked at education of breast surgery patients to improve pain experience. The study goal is to survey breast surgery patients in the Plastic Surgery department before and after surgery to evaluate the participants experience with pain and pain medications. Half of the participants in the study will be randomized to receive an information sheet about pain control at the participants pre-operative appointment.

Eligibility Criteria:
Inclusion Criteria:

* Female patients presenting for the first stage of breast reconstruction using tissue expanders
* Patients 18 years of age and older

Exclusion Criteria:

* Male patients
* Patients under age 18
* Patients who have had previous breast reconstruction or tissue expansion
* Patients who are not able to read English will be excluded from this study as the study materials will be in written English
Salvage Cryotherapy for Recurrent Prostate Cancer After Radiation Therapy

The main objective of this project is to establish a shared comprehensive and systematic protocol for a multicenter prospective registry of patients undergoing salvage cryoablation of the prostate (SCAP).

Our study hypothesis is that SCAP constitutes an effective and safe approach to treat local prostate cancer recurrence after brachytherapy or external beam radiation therapy (EBRT).

Salvage cryoablation of the prostate has been proposed as an alternative to salvage radical prostatectomy, as it has a potentially lower risk of morbidity and equal efficacy. A recent systematic review assessed a total of 32 studies of SCAP (5.513 patients). The overwhelming majority of patients (93%) received whole-gland SCAP. The adjusted pooled analysis for 2-year BCR-free survival for SCAP was 67.49% (95% CI: 61.68-72.81%), and for 5-year BCR-free survival was 50.25% (95% CI: 44.10-56.40%).

Nevertheless, the evidence base relating to the use of SCAP is poor, with significant uncertainties relating to long-term oncological outcomes. One of the main limitations when these studies are analyzed is the lack of information about the histopathology both before starting treatment and at the time of recurrence after cryotherapy. The vast majority only refer to biochemical-free survival as end point, thus limiting interpretation of real oncological performance of this technique. Furthermore, side effects vary widely from study to study and there are uncertainties about the real morbidity associated to cryotherapy in the salvage setting.

Due to this lack of evidence, the EAU 2021 Guidelines recommend that SCAP should only be performed in selected patients in experienced centres as part of a clinical trial or well-designed prospective cohort study.

Eligibility Criteria:
Inclusion Criteria:

* Patients with local recurrence (with histological confirmation) after treatment with radiotherapy or brachytherapy without evidence of distant involvement evaluated with PET/PSMA (if not available then Fluciclovine PET/CT or choline PET/CT must be performed).
* Life expectancy \>10 years
* Prostate volume \< 100cc
* PSA\<10 ng/mL
* mpMRI + fusion/systematic biopsy ≤cT3a without affecting the bladder neck or the membranous urethra

Exclusion Criteria:

* Patients with clinically confirmed distant metastasis
* Any previous major rectal surgery
* Clinically significant lower urinary tract or rectal anomalies
* Existing urethral, rectal, or bladder fistulae
Comparison of Conspicuity of Masses and Architectural Distortions Between Wide- and Narrow-angle Digital Breast Tomosynthesis Systems

To compare narrow-angle digital breast tomosynthesis (DBT) and wide-angle DBT.

Primary Objectives

- The primary objective of this proposed study is to show that bWBT (B.brilliant wide-angle breast tomosynthesis) images provide better lesion conspicuity for masses and architectural distortions than NBT images based on the standard screening tomosynthesis imaging.

Secondary Objectives

* The secondary objective of this proposed study is to show that WBT images provide better lesion conspicuity for masses and architectural distortions based on the standard screening tomosynthesis imaging.
* Additional secondary objectives include radiologist feedback on the B.brilliant images, technologist experience with B.brilliant, and a participant comfort survey.

Eligibility Criteria:
Inclusion Criteria:

* Women undergoing standard screening mammography.
* Ability to understand and sign consent.

Exclusion Criteria:

* Pregnant women.
* Women unable to consent.
* Male patients.
Severe Acute Respiratory Syndrome Coronavirus Type 2 (SARS-CoV-2)-Related Multiple Sclerosis (MS) Vaccination Study

The primary objective of this study is to document immunization status of MS participants after SARS-CoV-2-vaccinations and to evaluate possible effects of disease modifying therapy (DMTs) on the immune status. The secondary objectives of the study are to document longevity of immunization status of MS participants after SARS-Cov-2-vaccinations and to evaluate possible effects of DMTs on the immune status, to assess anti SARS-CoV-2 antibody titers regarding amount and persistence, to document immunization status of MS participants after repeated SARS-Cov-2-vaccinations and to evaluate possible effects of DMTs on the immune status, to document vaccine types used in MS population in Germany and to describe tolerability of SARS-CoV-2 vaccines according to participant's assessment.


Eligibility Criteria:
Key Inclusion Criteria:

* Diagnosis of MS according to McDonald criteria (2018)
* SARS-CoV-2 vaccination is planned (within the upcoming 90 days), underway (only one of two vaccinations received) or only recently completed (in the last 6 weeks) or SARS-CoV-2 vaccination has been completed \>6 weeks but an additional vaccination is planned within the upcoming 30 days

Key Exclusion Criteria:

* Participant cannot be regularly followed up for organizational or geographic reasons
* Participant is unwilling to get vaccinated against SARS CoV-2 virus

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.