cyrilzakka/clinical-trials huggingface dataset:
Immunogenicity，Safety and Cross - Immune Response With Mutant Strains of a Third Dose of an Inactivated COVID-19 Vaccine

This is a phase Ⅳ follow-up clinical trial based on the previous Phase Ⅳ clinical trial of an inactivated COVID-19 vaccine (CoronaVac) manufactured by Sinovac Life Sciences Co., Ltd.The purpose of this study is to evaluate the immunogenicity,safety and cross-immune response of booster immunization using COVID-19 vaccine,to compare the similarities and differences of immune responses between primary immunization and booster immunization and to detect antibody against hepatitis A and evaluate the immune persistence of the one dose immunization schedule of hepatitis A vaccine in healthy population aged 18 years and older.

This study is a phase 4 clinical trial to evaluate the immunogenicity,safety and cross-immune response of booster immunization using COVID-19 vaccine，to compare the similarities and differences of immune responses between primary immunization and booster immunization and to detect antibody against hepatitis A and evaluate the immune persistence of the one dose immunization schedule of hepatitis A vaccine in healthy population aged 18 years and older. The experimental vaccine is manufactured by Sinovac Life Sciences Co., Ltd.. A total of 180 healthy subjects received two dose of inactivated COVID-19 vaccine (CoronaVac) based on primary immunization in previous Phase Ⅳ clinical trial will be enrolled, including 90 adults aged 18-59 years and 90 elderly elderly aged 60 years and older.Subjects in each age group will receive the booster immunization of CoronaVac(the third dose) and will be collected blood sample before booster immunization and 14 days after booster immunization.

Eligibility Criteria:
Inclusion Criteria:

* Participated in the clinical studies on the safety and immunogenicity of Inactivated COVID-19 Vaccine combined immunization with 23-valent pneumococcal polysaccharide vaccine in Rushan city, Shandong Province from July to October 2021;
* The interval between complete immunization with two doses of COVID-19 vaccine is 6-8 months;
* Subjects will be willing to participate in the study and follow the study procedure to collect venous blood;
* Proven legal identity;

Exclusion Criteria:

* History of asthma, history of allergy to the vaccine or vaccine components,or serious adverse reactions to the vaccine, such as urticaria, dyspnea,and angioedema;
* Severe neurological disease (epilepsy, convulsions or convulsions) or mental illness;
* Fever at the time of vaccination, or acute onset of chronic disease, or uncontrolled severe chronic disease, or acute disease;
* Pregnancy or lactation;
* Receipt of attenuated live vaccines in the past 14 days;
* Receipt of inactivated or subunit vaccines in the past 7 days
* According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial.
The Role of Muscular Ultrasound in Predicting Weaning Success

When attempting to wean a patient from the ventilator, even if he/she passes the spontaneous breathing test, 10-20% of the time extubation failure occurs and the patient is reintubated. When the patient is reintubated the mortality rate increases and the length of intensive care unit stay is also increased. It is vital to intensively assess the patient before extubation and correctly predict extubation success. Muscular ultrasound may be helpful in these situations.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients undergoing weaning from mechanical ventilation
* Patients who have been mechanically ventilated for more than 72 hrs

Exclusion Criteria:

* Pregnant patients
* Patients with previous neuromuscular diseases
* Difficulties in muscular ultrasound (Dressing, operation, etc)
Learning and Encouragement Effect on 6 Minute Walking Test in Children Between 6 and 12 Years

Evaluation of the learning and encouragement effect on six minutes walking test in children under 12 years


Eligibility Criteria:
Inclusion Criteria:

* healthy subjects

Exclusion Criteria:

* acute or chronic lung, cardiac or neuromuscular disease
* at risk of- or overweight (BMI higher than 85th percentile for children of the same age and sex)
* a motor disability
Fiberoptic Intubation in Lateral Versus Supine Position in Pediatrics Undergoing Non-head-and-neck Surgery

Fiberoptic intubation was first described in the late 1960s and has since become an effective and well-established technique for airway management in awake, sedated, and anesthetized patients. This technique is especially useful in patients with known or suspected difficult airways such as those with limited mouth opening, reduced neck mobility, cervical spine injury, obesity, or an elevated risk for aspiration. The benefits of fiberoptic intubation also include fewer complications such as tooth injury and oropharyngeal bleeding; and the opportunity for optimal positioning of double-lumen tubes in patients undergoing thoracic surgery.

Anesthesiologists may be confronted with situations in which patients in a lateral position during surgery experience an accidental loss of airway patency. Intubation with direct laryngoscopy is more challenging and time-consuming in patients in the lateral position than in the supine position, particularly when there is an abrupt loss of airway patency, as demonstrated by prior research. These observations suggest that there is an unmet need for a reliable method of airway management for patients in the lateral position. Although the airway is of a larger caliber and ventilation renders less peak and better oxygenation when patients are in the lateral position, glottic view was unfavorable for intubation when Macintosh direct laryngoscope was used in this position. This could be the reason why such a procedure is unfamiliar in anesthesia even when it is the most needed in special situations. Flexible fiberoptic intubation in lateral position would be convenient in emergency situations like accidental extubation during surgery or inadequate regional anesthesia requiring general anesthesia. Flexible fiberoptic intubation in lateral position would be of significant assistance in neurosurgical patients especially those with occipital lesions and patients with difficult airway scores with limited mouth opening or neck extension.

After thorough literature review, we found that studies comparing flexible video-assisted fiberoptic intubation in the lateral versus supine position in pediatrics are lacking.


Eligibility Criteria:
Inclusion Criteria:

* Children aged 2-10 years old.
* Both genders.
* ASA physical status I and II.
* Elective non-head-and-neck surgeries.

Exclusion Criteria:

* Refusal of patients.
* Head and neck surgeries or with history of previous ones.
* Head, neck and lung congenital deformities or pathologies.
* Patients with expected difficult intubation (based on examination).
* Patients with neuromuscular disorders.
* Hypoxia: defined as low oxygen saturation (SpO2) ≤ 95% on room air.
* Trauma patients or patients requiring emergency procedures.
Nutritional Risk and Nutritional Care Practices in the Hospitalized Elderly

The purpose of this study is to estimate the prevalence of nutritional risk and examine nutritional care practices in the hospitalized elderly at one large university hospital in Norway.

A cross-sectional study was designed and carried out at a university hospital in Norway. The study was developed by a collegium at a nursing bachelor education program in a multidisciplinary collaboration with representatives from the university hospital and other experts. Data on nutritional risk and nutritional care practices of elderly patients were collected by 173 second year nursing students at the university college in question who were undergoing their acute and clinical care practice studies on 20 wards at the university hospital. Nine nutritional screening days were conducted in the academic years 2011/2012 and 2012/2013. On the screening days the students filled in the questionnaire for each patient, including questions about age, gender, length of hospital stay, normal weight in recent months, weight, height, BMI, nutritional risk and nutritional care practices. The students measured weight and height whenever possible, and screened the patients for nutritional risk. Data were collected by using a stratified sampling technique along with adequate power calculations to improve the representativeness of the sample. The researchers received anonymously completed questionnaires and screening forms from the students and never met the patients.

Eligibility Criteria:
Inclusion Criteria:

* All elderly (≥70 yrs) patients admitted on the included wards at 08.00 am on the screening days were asked to participate.

Exclusion Criteria:

* Terminal patients (assumed short-lived, \<1 month), patients diagnosed with dementia and patients whom the ward staff found unfit to participate were excluded.
Monitoring of Nocturnal Hypoglycemia Using EarlySense Monitoring Device

This study observes the continuous measurement of breathing patterns, heart rate, restlessness, and tremor in sleep using the EarlySense ES 16 device as a tool in the management of hypoglycemia in pediatric type I diabetes patients.

The study patients are children, 12-18 years old, suffering from type I diabetes. Each patient will participate in the trial for 30 days.

During this period of time the patients' breathing patterns, heart rate, restlessness and tremor in sleep will be measured by the EarlySense device which is put in the patient's bed. These measured values will be compared to:

1. glucose values measured by a "Guardian RT" device - an approved device for CBGM - Continuous Blood Glucose Measurement;
2. glucose levels tested by SBGM -Self Blood Glucose Measurement.

These comparisons will show whether the EarlySense device is applicable in predicting hypoglycemia events in type I diabetes patients.

Eligibility Criteria:
Inclusion Criteria:

* Age between 12-18 years
* Diagnosis of type I diabetes for at least a year
* Home close to participating center
* Guardian able and willing to cooperate with the trial for at least 1 month and prepared to sign the Informed Consent Form.

Exclusion Criteria:

* Recent (within 3 months) admission to emergency room or intensive care unit (ICU) due to any condition unrelated directly to diabetes.
* Any other pre-existing medical pathology unrelated to diabetes.
* Inability of the patient or his guardian to use the Guardian RT.
SUPPLEMENTARY EFFECTS OF RESISTANCE TRAINING IN ADDITION TO JOINT MOBILIZATION IN PERSONS WITH KNEE OSTEOARTHRITIS

Joint mobilization and resistance exercise training are effective conservative treatment options for the management of osteoarthritis. However, currently no study has highlighted the supplementary effects of resistance training in addition to joint mobilization in people suffering from knee osteoarthritis. The current study is aimed at bridging the gap in literature and providing evidence regarding the additive impact of resistance training to joint mobilization in knee osteoarthritis.


Eligibility Criteria:
Inclusion Criteria:

* Knee OA grade I-III
* Individuals of either gender aged 40-70 years
* Knee OA history of no less than 3 months
* Knee pain no more than 8/10 cm on the visual analogue scale (VAS)
* Radiological evidence of grade III or less on Kellgren classification.

Exclusion Criteria:

* Those with signs of serious pathology such as malignancy, inflammatory disorder or infection.
* History of trauma or fractures in lower extremity
* Signs of lumbar radiculopathy or myelopathy
* History of knee surgery or replacement and/or receiving intra-articular steroid therapy in the preceding two months
CPAP to Reduce Arterial Stiffness in Non Sleepy, Moderate to Severe Obstructive Sleep Apnea (STIFFSLEEP)

This study intends to determine whether continuous positive airway pressure (CPAP) can reduce arterial stiffness (measured by pulse wave velocity) in nonsleepy as well as in sleepy patients with obstructive sleep apnea .

Obstructive sleep apnea (OSA) is associated with increased cardiovascular morbidity and mortality. Arterial stiffness, evaluated by pulse wave velocity, is related to atherosclerosis and cardiovascular risk. It has been reported that arterial stiffness is higher in patients with OSA than in healthy control groups, and it is assumed that it decreases after treatment with CPAP.

In patients with OSA without daytime hypersomnolence it is not clear if CPAP has some benefits on cardiovascular events and hypertension.

This study aims to evaluate the effect of CPAP therapy in an interventional cohort of patients with moderate to severe OSA, in which each patient will be is own control, for ethical reasons; the effect of CPAP therapy on the subcohorts of sleepy and of nonsleepy patients will be compared. The effect of a three months trial of CPAP will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* moderate to severe obstructive sleep apnea, defined as apnea/hypopnea index superior to 15

Exclusion Criteria:

* Epworth sleep scale superior to 16
* other sleep diseases
* moderate or severe lung disease
* cardiac disease other than hypertension
* cerebrovascular diseases
* other vascular diseases
* other chronic diseases except metabolic syndrome
Optical Coherence Tomography in Patients With Acute Myocardial Infarction and Nonobstructive Coronary Artery Disease

The purpose of this study is to evaluate the prevalence and morphological features of coronary plaques by means of OCT in patients with acute myocardial infarction but without any significant coronary stenosis at coronary angiography. In addition, cardiac magnetic resonance imaging (CMR) will be performed to assess the prevalence, location, and pattern of myocardial injury as well as other concomitant findings. As a secondary analysis, the association between the distribution and characteristics of coronary plaques detected on OCT and myocardial injury shown by CMR will be evaluated. In addition, a post-hoc survey regarding the potential modification of the interventional treatment approach based on OCT analysis will be conducted.

The mechanism of myocardial infarction in patients with nonobstructive coronary artery disease remains unknown. The SOFT-MI study has been designed as a single-center, prospective observational trial to investigate the prevalence of vulnerable and disrupted plaques in patients with acute MI but without any significant coronary stenosis (defined as stenosis of \>50%) at coronary angiography. All patients will undergo coronary OCT immediately after coronary angiography. In addition, CMR will be performed within 1 week of coronary angiography to evaluate associated myocardial abnormalities as well as extracardiac findings. The study will provide insight into the mechanism of MI without obstructive coronary artery disease at coronary angiography, and may be useful in order to establish an appropriate therapeutic strategy for the secondary prevention of ischemic events.

Eligibility Criteria:
Inclusion Criteria:

* Evidence of myocardial infarction: elevation of troponin to above the laboratory upper limit of normal (ULN) or new ST segment elevation of ≥1mm on 2 contiguous ECG leads or new left bundle branch block
* Symptoms of ischaemia (chest pain or anginal equivalent symptoms at rest or new onset exertional anginal equivalent symptoms with concomitant ST-segment depression, T wave inversion or transient ST-segment elevation)
* Delivery of an informed consent and compliance with study protocol
* Age ≥ 18 years

Exclusion Criteria:

* Prior diagnosis of obstructive CAD (including history of percutaneous coronary intervention or coronary artery bypass grafting)
* Stenosis \>50% of any coronary vessel on invasive angiography
* Contraindication to OCT in the opinion of the treating physician
* Use of vasospastic agents
* Alternate causes of myocardial injury/ischaemia (severe anaemia, hypertensive crisis, acute heart failure, cardiac trauma, pulmonary embolism, etc.)
* Severe renal failure (eGFR\<30)
* Pregnancy
Robotic Telerehabilitation of the Upper Limb in Stroke

The goal of the study is to investigate the feasibility and the effects of a home-based upper-limb rehabilitation treatment (based on teleconsulting, telemonitoring, and robotic telerehabilitation using the robot Icone and integrated sensors) in patients with stroke.

Stroke is the second leading cause of death, the third leading cause of disability in the world and the leading cause of disability in the elderly. Rehabilitation treatment is a long and costly process, the effectiveness of which is supported by strong scientific evidence. In recent years, technology has spread to the rehabilitation field and, to date, the use of rehabilitation robotics, in addition to conventional treatment, is recommended by some stroke guidelines. The coronavirus pandemic has required a reorganization of rehabilitation services, but also an enhancement of technology as a tool in the rehabilitation field that can allow treatment in compliance with social distancing. Many scientific works have in fact confirmed the usefulness of these approaches to overcome the limits imposed by the pandemic, in particular for the treatment of disabilities in stroke patients.

The rehabilitation robot Icone (CE marked medical device, Class II-A, produced by Heaxel), is a device with certification for home use and therefore suitable for telerehabilitation. The proposed study aims to test the feasibility of rehabilitation treatment in a home setting based on a system of telecounseling, telemonitoring and robotic telerehabilitation using the robot Icone and integrated sensors for patients with stroke, to overcome the limits imposed by the COVID-19 pandemic.

Patients undergo robotic telerehabilitation treatment, carried out at home. The patient is supervised by a caregiver and, remotely, by a multidisciplinary team thanks to the use of webcams and sensors embedded in the robot. The evaluations, through clinical scales and instrumental evaluations, are carried out both in presence (at the enrollment and the end of the study) and remotely (before the first telerobotic rehabilitation session, in the middle and after the last telerobotic rehabilitation session). The study is included in the Regional Smart Specialization Strategy (S3 - Biorobotics for rehabilitation) for business \& life continuity and co-financed by the European Union through LazioInnova

Eligibility Criteria:
Inclusion Criteria:

* ischemic or hemorrhagic stroke (verified by MRI or CT);
* time since stroke onset \> 3 months
* cognitive abilities adequate to understand the experiments and the follow instructions
* upper limb impairment (Fugl-Meyer Assessment - upper extremity score ≤58);
* presence of a caregiver to supervise the treatment

Exclusion Criteria:

* fixed contractions in the affected limb (ankylosis, Modified Ashworth Scale equal to 4);
* inability to understand the instructions required for the study;
* behavioral disorders that may influence therapeutic activity;
* other orthopedic or neurological diseases
* inability or unwillingness to provide informed consent.
A Clinical Trial of PRAX-562 in Subjects With Developmental and Epileptic Encephalopathies (DEE)

This is a Phase 2, double-blind, randomized clinical trial to explore the safety, tolerability, efficacy, and pharmacokinetics of PRAX-562 in pediatric participants who have seizures associated with early-onset SCN2A-DEE and SCN8A-DEE.


Eligibility Criteria:
Inclusion Criteria:

* Has a documented rare missense variant in SCN2A with onset of seizures occurring in the first three months of life or has a documented de novo (not observed in either parent) missense variant in SCN8A with onset of seizures occurring in the first six months of life.
* Has a seizure frequency as follows:

  * At least 8 countable motor seizures in the 4 weeks immediately prior to Screening as reported by the parent/legal guardian or in the opinion of the investigator AND
  * At least 8 countable motor seizures during the 28 day Baseline Observation Period (during which seizure frequency is recorded in a daily seizure diary).
* Additional inclusion criteria apply and will be assessed by the study team.

Exclusion Criteria:

* Has any clinically significant or known pathogenic or likely pathogenic genetic variant other than in SCN2A and SCN8A or a genetic variant that may explain or contribute to the participant's epilepsy and/or developmental disorder.
* Has a documented, functionally characterized loss-of-function (LoF) missense variant or a presumed LoF variant (nonsense or frameshift variant) based on genetic testing and/or clinical evidence that prior exposure to a sodium channel blocker (SCB) medication worsened seizures.
* Has 2 or more episodes of convulsive status epilepticus requiring hospitalization and intubation in the 6 months prior to Screening.
* Additional exclusion criteria apply and will be assessed by the study team.
Depression Medication Choice Decision Aid

The quality of care for patients facing depression, one of the most prevalent chronic diseases, needs improvement. Despite its high incidence, depression remains sub-optimally managed, particularly in primary care, where most patients suffering from depression receive care. Successfully treated depressive patients can potentially improve their burden of disease and significantly improve their quality of life, but not without the best treatment adapted to their contexts, preferences, and expectations. Clinical research provides essential knowledge for the delivery of quality care which is unfortunately seldom applied in daily practice.

One of the preferred methods for overcoming this lack of quality of care is shared decision making: a collaborative process between a clinician and patient that relies on the consideration of scientific evidence, in addition to the values and preferences of the patient. The use of decision aids supports this process by presenting scientific information in an accessible manner while focusing on patient-centered discussion. We developed and rigorously evaluated, in the United States, a decision aid regarding pharmaceutical treatment options for depression, Depression Medication Choice, to be used by health professionals and patients during clinical encounters. The integration and impact of Depression Medication Choice, in primary care practices in a Canadian context is unknown.

The specific objectives of this study are threefold: (i) Evaluate the potential impact of the use of Depression Medication Choice by health professionals and patients during clinical encounters on measures of the quality of the decisional process and on health issues important to the patient and health professional; (ii) Document the processes and optimal measures to take to successfully realize projects on a larger scale; and (iii) Evaluate the feasibility of performing patient-centered studies in a realistic context, minimally disturbing to the study environment, in the primary care context in Quebec, Canada.

Once completed, the estimated potential impact of this decision aid and shared decision making in primary care in a Canadian context will have been measured, progressing toward high-quality patient-centered care. Moreover, it will be possible to optimally perform future studies in realistic contexts while minimizing the burden on the clinics, their health professionals, and their patients.


Eligibility Criteria:
Inclusion Criteria:

* Already have or receive a depression diagnosis (according to the treating clinician)
* Speak English of French
* Have no major obstacles providing clear written consent
* Discuss the possibility of taking antidepressants during the clinical encounter