cyrilzakka/clinical-trials huggingface dataset:
Registration Trial of the Intracranial Visualized Stent for the Wide-necked Intracranial Aneurysms

A registration trial of the Intracranial Visualized stent in the treatment of wide-necked intracranial aneurysms


Eligibility Criteria:
Inclusion Criteria:

* At the time of signing the informed consent form(ICF), the applicant shall be male or non-pregnant female, aged 18 to 80 years;
* Target aneurysms was diagnosed as intracranial wide-necked saccular aneurysms(neck ≥4mm, or body-neck ratio \<2) by DSA/CTA/MRA；
* The diameter of the parent vessel should be 2.0 to 4.5mm;
* The target aneurysm should be suitable for stent-assisted coiling surgery and could be treated through one operation;
* Subject or its legal representative should be able to understand the purpose of this study, also agree to comply with protocol and sign the informed consent form voluntarily.

Exclusion Criteria:

* Subject whose mRS score was greater or equal to 3 during the clinical evaluation before enrollment;
* Subject with recurrent aneurysm which was already embolized through stent-assisted coiling surgery;
* Subject with multiple aneurysms that cannot be treated by single stent;
* Subject with aneurysm ruptured within 30 days;
* Subject who is not suitable for anesthesia or endovascular surgery;
* Subject with significant stenosis of the parent arterty(\>50%)
* Subject who underwent major sugical procedure (such as internal fixation for limb fractures, tumor resection, surgery for vital organs, etc.) within 30 days before signing the ICF or would underwent major sugical procedure 60 days after signing the ICF;
* Subject who is currently participating in a clinical trial of another drug or device which has not met the primary endpoint, or who are expexted to participate in a clinical trial of another durg or device;
* Subject with conditions or pathological changes which may interfere with the use of instrument, including but not limited to: carotid artery dissection, vasculitis, aortic dissection, etc;
* Subject who is contraindicated with stent-assisted coiling:

Subject with allergy to required anti-platelet and/or heparin medications required for treatment; Subject with allergy to radiographic contrast; Subject with allergy to Nitinol, platinum-tungsten, platinum-iridium alloy.

* Women who is pregnant or now breastfeeding;
* Subject with a life expectancy less than 12 months.
Porto-Venous Radiomics in Pancreatic Cancer

Multi-centre Retrospective Observational Cohort study of patients who underwent pancreaticoduodenectomy from 01/01/2005 to 01/02/2022 with histologically confirmed pancreatic head malignancy

Pancreatic cancers are often inoperable at diagnosis, with only 13-22% of patients being suitable for surgical resection.1 Surgery is the only curative therapeutic option for pancreatic cancer and higher rates of long-term patient survival following surgery are seen in patients where the tumour is completely removed (termed R0 resection). However a majority of those patients who undergo surgery will develop tumour recurrence at the primary surgical site or a distant location. The likelihood of cancer recurrence following surgery increases when there is involvement of major blood vessels that lie adjacent to the pancreas. This involvement is often microscopic in nature and only detected after surgery when the surgical specimen is examined microscopically (termed R1 resection). Pre-operative cross-sectional imaging (usually Computed Tomography (CT) is the standard tool used to assess the risk of R1 resection prior to pancreatic cancer. However this approach significantly overestimates the number of patients with a resectable tumour as a significant proportion ultimately have an R1 resection after surgery. If there is felt to be an increased risk of R1 resection prior to surgery the patient can be offered oncological treatment prior to surgery to improve the rates of R0 resection that in turn improve long-term patient survival.

The emerging field of Radiomics offers the opportunity to stratify patients undergoing pancreatic cancer surgery into those at risk of R1 resection prior to surgery. Radiomics has emerged as a valuable adjunct to medical decision making over the past 10 years. The basic premise is to extract and analyse large amounts of information not usually visible to the human eye from medical images, and it is increasingly being used in the field of cancer diagnostics. The aim of this study is to employ 3D radiomic analyses to pre-operative CT scan images for cases of pancreatic head cancer that underwent surgical resection, to determine whether this information could be used to predict R0 and R1 resection margins pre-operatively.

Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent pancreaticoduodenectomy/Whipple's surgery for pancreatic head malignancy between 01/01/2005 and 01/02/2022.
* Pre-operative Computed Tomographic images within 90 days prior to surgical resection.
* Post-operative histological confirmation of pancreatic ductal adenocarcinoma (PDAC), ampullary adenocarcinoma (AA), distal bile duct carcinoma (DBC), pancreatic neuroendocrine tumours (NET/NEC), duodenal adenocarcinoma (DA) or duodenal gastro-intestinal stromal tumours (GIST).

Exclusion Criteria:

* Postoperative surgical histology confirming benign pathology, metastatic disease or invasive malignancy arising from sites other than duodenum, pancreatic head or distal common bile duct.
* Patients who underwent distal pancreatectomy or total pancreatectomy as their primary surgical procedure.
Visualization of the Intubation Pathway With the "IRRIS"-Device

A prospective, open label, non-randomized, single centre safety and feasibility study. Patients with no expected airway difficulties scheduled for elective surgery including tracheal intubation and general anesthesia procedures will be enrolled into the study. Following standard induction of anesthesia, the IRRIS will be attached to the patient's neck skin just beneath the laryngeal prominence (Adam's apple) and the intubation will be performed by using a video-laryngoscope in a standardized fashion. The IRRIS device emits a light that penetrates through the skin into the airway and that is visible on the video-laryngoscope display. This light highlights the right pathway for the tracheal tube and facilitates the visual recognition and identification of the laryngeal inlet. In case of problems identified during the induction period such as an unexpected difficult intubation situation and the IRRIS does not provide the expected facilitation of intubation, the local "unexpected difficult airway" protocol goes into effect.

The IRRIS (InfraRed - Red Intubation System) is an external disposable light source in a patch that is intended for single use while it is placed externally on the patient's neck before tracheal intubation for the duration of tracheal intubation. The device transmits near-infrared light through the skin towards the trachea. During laryngoscopy, the emitted light becomes visible only from the trachea and not from the oesophagus. Video assisted devices which already are in the market known as video-laryngoscopes and fiberoptic bronchoscopes are capable of detecting and visualizing the emitted light so that the anaesthesiologist who is performing the intubation is aided to direct and insert the endotracheal tube into the trachea by following the light on the screen of his video-assisted endoscope. The objective of this study is to assess the safety, and performance of IRRIS in patients who undergo tracheal intubation in terms of skin integrity, duration of intubation, number of attempts, success of intubation and usability aspects in terms of subjective physician grading of the IRRIS.

Eligibility Criteria:
Inclusion Criteria:

1. Male and female patients scheduled for elective surgery requiring general anesthesia and tracheal intubation.
2. Patient age: adult (\>18 years old)
3. Mallampati scores 1 to 3.
4. ASA Physical Status Classification System 1-3
5. Ability to understand the requirements of the study, willingness to comply with its instructions and schedules, and agreement to the informed consent

Exclusion Criteria:

1. Emergency cases
2. Expected airway difficulties as defined during the pre-anaesthesia visit
3. Necessity for an alternative airway management approach other than by using a video-laryngoscope
4. Rapid sequence induction
5. Skin disorders and skin light sensitivity (SLE, lupus, Porphyria, Dermatomyositis, Pemphigus, Pellagra etc.)
6. Known history of any significant medical disorder, which in the investigator's judgment contraindicates the patient's participation
7. Impaired head and neck mobility
8. Scars or skin injuries at the neck
Open-label Extension Study of Evolocumab (AMG 145) in Adults With Hyperlipidemia and Mixed Dyslipidemia

This study will contribute to the evaluation of long-term safety, tolerability and efficacy of evolocumab (AMG 145) in adults with hyperlipidemia and adults with mixed dyslipidemia.


Eligibility Criteria:
Inclusion Criteria:

- Complete a qualifying evolocumab (AMG 145) parent study (ie, Study 20110114 \[NCT01763827\], 20110115 \[NCT01763866\], 20110116 \[NCT01763905\], 20110117 \[NCT01763918\], 20110109 \[NCT01516879\], 20120122 \[NCT01953328\], 20120332 \[NCT01984424\], 20120348 \[NCT01849497\], or 20120356 \[NCT01879319\]).

Exclusion Criteria:

* Experienced a treatment-related serious adverse event that led to study drug discontinuation in the parent study
* Have an unstable medical condition, in the judgment of the investigator
* Known sensitivity to any of the products to be administered during dosing
* Currently enrolled in another investigational device or drug study (excluding evolocumab (AMG 145) parent study), or less than 30 days since ending another investigational device or drug study(s),or receiving other investigational agent(s)
EUS Examination Using EndoSound Vision System vs. Standard Echoendoscope

This is a randomized trial to compare the standard echoendoscope with the newly developed EndoSound Visual System in the evaluation of lesions in the gastrointestinal tract.

Endoscopic ultrasound (EUS) is the gold standard for evaluation and biopsy of lesions in the pancreaticobiliary tract, subepithelial lesions in the gastrointestinal tract and luminal cancer staging due to its high sensitivity and specificity. Endoscopic ultrasound examination is performed by echoendoscopes, which are endoscopes with an ultrasound probe at the distal end to allow endoscopic ultrasound evaluation. A new endoscopic ultrasound system - the EndoSound Visual System has now been developed for endoscopic ultrasound examination. The EndoSound Visual System is a device that can be attached externally to upper gastrointestinal endoscopes, thereby converting a standard endoscope into an echoendoscope which can then be used to perform an EUS examination.

The aim of this randomized trial is to compare the standard echoendoscope with the newly developed EndoSound Visual System in the evaluation of lesions in the gastrointestinal tract.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Any patient undergoing EUS examination for evaluation of the pancreas, bile duct, mediastinal or intraabdominal lymph nodes, or luminal lesions in the esophagus, stomach, duodenum or colon.

Exclusion Criteria:

* Age \< 18 years.
* Unable to obtain consent for the procedure from either the patient or LAR.
* Intrauterine pregnancy.
Efficacy of Helium/Oxygen Compared to Air/Oxygen in Severe Exacerbation of Chronic Obstructive Pulmonary Disease (COPD)

The primary objective of the study is to evaluate the efficacy of Helium/Oxygen (He/O2) 78%/22% compared to a conventional Air/O2 mixture in reducing endotracheal intubation rate and mortality in patients with severe hypercapnic exacerbations of Chronic Obstructive Pulmonary Disease (COPD) during their index Intensive/Intermediate Care Unit (ICU) stay.

Patients eligible for this study are critically ill patients with COPD admitted in Intensive Care Unit for an exacerbation of their chronic disease with hypercapnic acute respiratory failure. The patients will receive an Helium/Oxygen mixture or an Air/Oxygen mixture for a maximum of 72 hours during Non-Invasive Ventilation (NIV) and NIV-free sessions.

During NIV sessions, gas mixtures will be administered using a ventilator suitable for NIV with either He/O2 or Air/O2 and a NIV facemask.

Patients will be followed until hospital discharge and then contacted by phone up to the 6th month after randomization.

Eligibility Criteria:
Inclusion Criteria:

* Patient with known or suspected COPD
* Patient presenting current exacerbation of COPD with hypercapnic acute respiratory failure
* Patient eligible for Non-Invasive Ventilation (NIV)
* Patient admitted in an ICU

Exclusion Criteria:

* Patient who had lung transplant
* Patient having a contraindication to NIV
* Patient with tracheostomy
* Patient requiring Oxygen flow rate \> 6 L/min or Inspired Oxygen Fraction (FIO2) \> 0.50
* Patient admitted in the ICU for more than 24 hours and/or having received NIV in ICU for more than 6 hours (in total) for the current exacerbation of COPD
Support Groups - a Model for Social Inclusion and Reduction of Bullying in School

Study Title: Support Groups - a model for social inclusion and reduction of bullying in school Study Design: Cluster Randomized Controlled trial (CRCT) Objective: To investigate the effectiveness of a support group intervention using a solution-focused approach among school children in 5th-7th grade in southeastern Norway Intervention: Peer support groups with a solution-focused approach Study Population: School Children

The primary objective of this study is to investigate the effectiveness of a support group intervention using a solution-focused approach in reducing bullying, enhancing mental health, improving quality of life, and increasing general self-efficacy among school children in 5th-7th grade. Investigators hypothesize that the awareness of bullying created by the intervention, and the empowerment of children as contributors to the solution, will generate positive ripple effects benefiting all children in the intervention schools. Furthermore, investigators hypothesize that children with a peer support group will exhibit lower levels of bullying, improved mental health, better quality of life, and increased general self-efficacy after the intervention compared to their baseline levels. Investigators expect these effects to persist even after 3 and 6 months. Aligned with the cluster RCT, the investigators will undertake a parallel process evaluation to assess the extent of the intervention coverage, whether the intervention was implemented according to the protocol, and identify factors that hinder or aid the implementation of a support group intervention. For the process evaluation, investigators will use the framework presented by the Medical Research Council guidelines focusing on the implementation (what is implemented and how), the mechanisms of impact (how the delivered intervention produces change), and the context (how the context affects implementation and outcomes).

Eligibility Criteria:
Inclusion Criteria:

* Primary Schools with more than 200 students
* Public Health Nurse employed in a 50% position or more

Exclusion Criteria:

* Primary Schools with less than 200 students
Music Breathing Therapy for Children With Attention-deficit Hyperactivity Disorder and Their Caregivers

This pilot randomized controlled trial aims to evaluate the feasibility (in terms of rates of recruitment, retention, and attendance), acceptability, and potential effects of the dyadic video-assisted gamified music breathing therapy on dyads' resilience, children's emotional and behavioral symptoms, parents' parenting stress, and psychological distress.

Attention-deficit hyperactivity disorder (ADHD) is a prevalent neurodevelopmental disorder characterized by persistent inattention, hyperactivity, and impulsivity that impact various aspects of both the child's and the caregiver's functioning. Evidence shows that cultivating resilience helps children with ADHD manage emotional dysregulation and improve caregivers' psychological well-being. Music breathing therapy - an adaptation of the Bonny Method of Guided Imagery and Music (GIM) - has shown beneficial effects in enhancing resilience and alleviating psychological distress among different populations. However, it remains unclear whether it is a feasible and effective intervention to enhance the resilience of Chinese school-aged children with ADHD and their caregivers.

Aims:

* To determine the feasibility (in terms of rates of recruitment, retention, and attendance), and acceptability of the intervention
* To examine the effects of the dyadic video-assisted gamified music breathing therapy on dyads' resilience, children's emotional and behavioral symptoms, parents' parenting stress, and psychological distress.

Hypotheses:

It is hypothesized that compared with dyads in the control group, those who receive the dyadic video-assisted gamified music breathing therapy will report the following outcomes: higher levels of dyads' resilience, reduced children's emotional and behavioral symptoms, lower levels of parents' parenting stress and psychological distress at immediately post-intervention (i.e., the 6-week follow-up).

Eligibility Criteria:
Inclusion Criteria:

Children

* have a clinically documented diagnosis/suspected ADHD diagnosis according to DSM-5 criteria
* aged 7 to 12 years (school age)
* can read and communicate in Chinese

Parents

* aged 21 years or above
* are the primary caregivers and living together with the child
* can read and communicate in Chinese

Exclusion Criteria:

Children

* have other disabling diseases (physical disability, mental disability, autism) that might limit their full participation in the study.
* have been engaged in any music intervention in the past 6 months

Parents

* are caring for more than one child with a chronic or critical illness or caring for another family member with a chronic illness
* has a diagnosed mental illness, cognitive impairment, or learning problem, and/or is taking regular psychotropic medications that might limit their full participation in the study
* have been engaged in any music intervention in the past 6 months
Cryobiopsy or Forceps Biopsy During Semirigid Thoracoscopy: a Comparative Study

The purpose of this study is to compare cryobiopsies with forceps biopsies during semirigid thoracoscopy.

The investigators are going to compare diagnostic yield and size, morphological features, immunohistochemistry as measures of the quality of the samples. The secondary aim is to evaluate safety with focus on bleeding intensity.

Eligibility Criteria:
Inclusion Criteria:

* 18 or more years old
* unilateral pleural effusion of unknown origin
* pleural irregularities suspicious for pleural malignancy
* referral for thoracoscopy after less invasive means of diagnosis had failed

Exclusion Criteria:

* uncontrolled bleeding tendency
* unstable cardiovascular status
* severe heart failure
* ECOG performance status 4
* persistent hypoxemia after evacuation of pleural fluid
* pleural symphisis, fibrothorax
Influence of Tightly Glucose Control on Hyperglycemic Toxicity and Protein Catabolism in Critically Ill Patients

To compare the differences of urinary nitrogen excretion, nitrogen balance and clinical outcomes between tightly insulin therapy and conventional insulin therapy in the ICU.

Critical illness is associated with increased circulating concentrations of proinflammatory cytokines, such as tumor necrosis factor (TNF-α), interleukin (IL)-1, and IL-6 which may be important mediators of insulin resistance and results in hyperglycemia. Altered glucose metabolism was caused by release of counter regulatory hormones such as glucagons; epinephrine and cortisol oppose the normal action of insulin, leading to an increase in skeletal muscle proteolysis. It did not know whether tightly glucose control had beneficial effect in urinary nitrogen excretion and nitrogen balance.

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to the adult ICU who had baseline blood glucose \> 180 mg/dl
* expected to require treatment in the ICU on 3 or more consecutive days.

Exclusion Criteria:

* pregnant patients
* patients with chronic renal loss (Chronic renal loss was defined as persistent acute renal failure, complete loss of kidney function \> 4 weeks)
Efficacy and Safety Trial of Transcranial Laser Therapy Within 24 Hours From Stroke Onset (NEST-3)

The purpose of this pivotal study is to demonstrate safety and efficacy of transcranial laser therapy (TLT) with the NeuroThera® Laser System in the treatment of subjects diagnosed with acute ischemic stroke. The initiation of the TLT procedure must be feasible for each subject between 4.5 and 24 hours of stroke onset.


Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of acute ischemic stroke
2. Subject is not a candidate for treatment with neurothrombectomy
3. Initiation of the TLT procedure begins between 4.5 and 24 hours
4. Baseline NIHSS score range: 7-17
5. Full functional independence just prior to the present stroke episode
6. Negative pregnancy test in females of childbearing potential
7. Subject Informed Consent obtained prior to enrollment into this study

Exclusion Criteria:

1. Evidence of an intracranial, subdural, or subarachnoid hemorrhage
2. Acute ischemic strokes located exclusively in the brainstem, or cerebellum, or small deep infarctions, or massive hemispheric strokes
3. Seizure at stroke onset or within the 7 days prior to stroke onset
4. Sustained blood glucose \>300 or \<60 mg/dl
5. Sustained hypertension (SBP \>220 mmHg or DBP \>140 mmHg)
6. Sustained hypotension (SBP \<80 mmHg or DBP \<50 mmHg)
7. A presumed and/or confirmed septic embolus
8. History of CNS vascular disease (e.g. aneurysm, AVM) or history of CNS disease or damage (e.g. neoplasm or dementia) which may influence the subject's outcome assessment.
9. Head implant of any kind
10. Significant skin condition of the scalp (eg. psoriasis)
11. Use of any intravenous or intra-arterial thrombolytic medication
12. Use of any diagnostic or therapeutic interventional neurovascular procedure
13. Female who is pregnant or lactating or who is of childbearing potential and not using a medically acceptable method of birth control.
Safety and Immunogenicity of a Inactivated Influenza Vaccine When Administered to Non Elderly Adults and Elderly Subjects.

The purpose of this study is to evaluate safety and immunogenicity of a single intramuscular (IM) injection of a Surface Antigen, Inactivated, Influenza Vaccine, Formulation 2005-2006, when Administered to Non-Elderly Adults and Elderly Subjects


Eligibility Criteria:
Inclusion Criteria:

* subjects 18 years of age or older

Exclusion Criteria:

* Any serious disease such as: cancer, autoimmune disease, advanced arteriosclerotic disease or complicated diabetes mellitus, chronic obstructive pulmonary disease (COPD) that requires oxygen therapy, acute or progressive hepatic disease, acute or progressive renal disease, congestive heart failure
* hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or polymyxin or any other component of the vaccine
* history of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine
* known or suspected (or high risk of developing) impairment/alteration of immune function