cyrilzakka/clinical-trials huggingface dataset:
Return of Aspiration-Free Swallow After Laryngotracheal Anesthesia

Patients undergo laryngotracheal anesthesia (LTA) for a variety of in-office laryngology procedures. Prior to resolution of laryngeal sensory anesthesia, oral intake may predispose patients to aspiration. The purpose of this study is to objectively characterize a time period for return of aspiration-free swallow after LTA.

Swallowing is a complex process involving coordination of multiple muscle groups. Sensation in the throat is very important for swallowing safely. Laryngotracheal anesthetic (LTA, or topical application of lidocaine anesthetic to larynx and trachea) is needed for a variety of in-office laryngology procedures, including examination of the air passage, or tracheobronchoscopy. This causes a temporary decrease in sensation that can affect swallow function and result in aspiration (passage of swallowed material into lungs instead of into esophagus and stomach). It is not known how long this effect lasts. It would be helpful to know this for counseling patients on when they can resume swallowing after a procedure. In general, most patients are advised to avoid eating/drinking for 90 minutes after their procedure to allow for sensation to return. To date, there has been no study characterizing the time required for return of aspiration-free swallow after LTA.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Ability of patients to speak and understand English
* Ability for patients to consent for themselves
* Undergoing tracheobronchoscopy procedure for the treatment of airway stenosis
* Eating Assessment Tool (EAT-10) score ≤ 3

Exclusion Criteria:

* Age less than 18 years
* Patients unable or unwilling to provide informed consent
* Women who are pregnant
* History of abnormal swallowing evaluation, either videofluroscopic study of swallow or functional endoscopic evaluation of swallowing (FEES)
* History of medical condition affecting swallowing, such as

  * Neurodegenerative disorders: stroke, traumatic brain injury, dementia, motor neuron disease, myasthenia gravis, cerebral palsy, Gullain-Barre syndrome, poliomyelitis, myopathy, Parksonism, Huntingon's disease, progressive supranuclear palsy, Wilson's disease, vocal fold paralysis
  * Connective tissue disorders: polymyositis, dermatomyositis, progressive systemic sclerosis, Sjogren's disease, scleroderma
  * History of gastroesophageal tumor
  * History of gastroesophageal surgery
  * History of recent open central neck surgery (i.e., thyroidectomy, anterior cervical discectomy or fusion)
  * History of head and neck cancer
  * History of head and neck radiation therapy or chemotherapy
Ambulatory Blood Pressure Monitoring in Post-Partum Pre-Eclamptic Patients

Preeclamptic pregnancy is associated with alterations in the left ventricular structure and function and elevation of cardiovascular biomarkers. The alterations are still persistent several months after delivery and are more clearly observed in early-onset and severe Pre-eclampsia


Eligibility Criteria:
Inclusion Criteria:

* All previously healthy women who were diagnosed as preeclampsia.( defined as gestational hypertension ( systolic BP of at least 140 mm Hg and/or a diastolic BP of at least 90 mm Hg on at least two occasions at least 6 hours apart after the 20th week of gestation in women known to be normotensive before pregnancy and before 20 weeks' gestation ) plus proteinuria (300 mg or more per 24-hour period)

Exclusion Criteria:

* Current pregnancy
* Chronic hypertension or any condition requiring the use of antihypertensive medication
* Chronic kidney disease
* Any disease requiring the use of anti-inflammatory medication, diabetes or any other endocrine disease such as hyperthyroidism
Comparison of the Risk of Surgical Site Infections Between Dressings Stopped at Postoperative Day 1 vs Dressings Stopped at Postoperative Day 6+/-1 After Elective Abdominal Surgery

The daily changing of postoperative dressings is a widespread practice, often continuing until the 5th-7th day after surgery. In theory, dressings aim to reduce the risk of superficial surgical site infections (SSIs). However, several studies have suggested that early removal of the dressing does not significantly impact the rate of superficial SSIs, and this approach is now applied in clinical practice by several teams. A Cochrane review indicated that the absence of dressing does not appear to be harmful, though it emphasized the very low level of evidence provided and the need for high-quality randomized controlled trials. In this study, the investigators aim to provide high-level evidence on the effect of stopping dressings from the 1st postoperative day and the lack of impact on the risk of SSIs, to standardize practices and enable recommendations.


Eligibility Criteria:
Inclusion Criteria:

* Patient of legal age (≥18 years)
* Scheduled for elective abdominal surgery requiring a skin incision of at least 4 cm long listed below:

All pancreatectomies, All hepatectomies, All splenectomies, All adrenalectomies, All bariatric surgeries, All gastric surgeries, including gastrectomy and reflux surgery, All parietal surgeries; ventral hernia repairs, inguinal or femoral hernia repairs, with or without mesh placement..

All small bowel resections, Laparotomy cholecystectomies, All duodenal surgeries, Right, transverse or left colectomy, by laparotomy or laparoscopy, provided that there is a skin incision for extraction of the surgical specimen, but without the presence or creation of a stoma Proctectomy but without the presence or creation of a stoma

* Class I or II (clean or clean-contaminated) according to the ALTEMEIER classification
* Affiliated in a Social Security scheme (beneficiary or entitled person, excluding AME)
* Have signed an informed consent form

Exclusion Criteria:

* Presence or completion of a stoma
* Previous abdominal surgery in the month prior to inclusion
* Emergency surgery
* Outpatient surgery
* Trocar holes
* Closure by biological glue
* Active bacterial infection at the time of surgery or recent antibiotic therapy (up to 15 days before surgery)
* Neutrophil count \< 500/mm3 at time of surgery
* Grade B or C cirrhosis (Child-Pugh classification)
* Pregnancy
* Breast-feeding
* Patient under guardianship or curatorship
* Patient deprived of liberty by judicial or administrative decision
* Patient unable to perform perioperative care
Conservative Treatment in Patients With Symptomatic Femoroacetabular Impingement

This is a single-group, prospective, intervention study. A total of 30 participants with unilateral symptomatic femoroacetabular impingement will be included into the study. The intervention consists in neuromuscular training for the lower limb muscles (12 weeks, 2 times/week supervised training, 2 times/week home training). The training includes physical exercises routinely used worldwide in clinical settings. No control intervention group was included into the study because nowadays there is no standard conservative treatment for patients with symptomatic femoroacetabular impingement. Assessments will be performed at (1) baseline, (2) mid-intervention, (3) end-intervention, and (4) follow-up. Clinical, functional, neuromuscular and self-reported parameters will be collected during assessments.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of unilateral symptomatic FAI according to clinical, radiographic and magnetic resonance imaging criteria
* Living place: Canton of Zurich or neighbouring Cantons
* Signed written informed consent to participate into the study

Exclusion Criteria:

* Previous hip surgery
* Any surgery to the lower limbs in the prior 6 months
* Congenital/developmental dysplasia
* Hip osteoarthritis
* Initiation of opioid analgesia and corticosteroid injection for hip pain within the prior 30 days
* BMI \>35 kg/m2
* Significant cardiorespiratory diseases
Prevention Trial: Immune-tolerance With Alum-GAD (Diamyd) and Vitamin D3 to Children With Multiple Islet Autoantibodies

The purpose of this study is to evaluate if immune-tolerance with Alum-formulated GAD (Diamyd), in combination with high dose Vitamin D3, may delay or stop the autoimmune process leading to clinical type 1 diabetes in non-diabetic children with ongoing beta-cell autoimmunity as indicated by positive islet autoantibodies.

The primary objective of this study is to evaluate if immune-tolerance with Alum-formulated GAD (Diamyd), combined with high dose Vitamin D3, may delay or stop the autoimmune process leading to clinical type 1 diabetes (diagnosed according to American Diabetes Association criteria) in non-diabetic 4-17.99 year old children with ongoing beta-cell autoimmunity as indicated by positive islet autoantibodies.

The secondary objective is to demonstrate that treatment with Diamyd is safe in children at risk for type 1 diabetes.

The children will be followed for 5 years in the study. Primary endpoint is proportion of subjects diagnosed with type 1 diabetes in each treatment arm. Secondary endpoints are 1) safety, 2) change in metabolic status from normal to impaired glucose metabolism in the group of children with normal glucose metabolism at baseline screening.

Eligibility Criteria:
Inclusion Criteria:

* Children 4-17.99 years of age with positive autoantibodies to glutamate decarboxylase (GADA) and at least one additional type 1 diabetes associated autoantibody (to insulinoma associated protein 2 (IA-2A), Zinktransporter 8 (ZnT8R/Q/WA) or insulin (IAA)).
* Written informed consent from the child and the childs legal representative(s).

Exclusion Criteria:

1. Ongoing treatment with immunosuppressant therapy.
2. Diabetes.
3. Treatment with any oral or injected anti-diabetic medications
4. Significantly abnormal hematology results at screening.
5. Clinically significant history of acute reaction to vaccines or other drugs
6. Treatment with any vaccine within one month prior to the first dose of the study drug or planned treatment with vaccine up to three months after the last injection with the study drug.
7. A history of epilepsy, serious head trauma or cerebrovascular accident, or Clinical features of continuous motor unit activity in proximal muscles
8. Participation in other Clinical trials with a new chemical entity within the previous 3 months.
9. History of hypercalcemia.
10. Unwilling to abstain from other medication with Vitamin D during the study period.
11. Significant illness within 2 weeks prior to first dosing.
12. Known Human Immuno Deficiency Virus infection or hepatitis.
13. Presence of associated serious disease or condition.
14. Diabetes-protective Human Leucocyte Antigen (HLA) DQ6.
15. Females who are lactating or pregnant.
16. Males or females not willing to use adequate contraception, if sexually active, until 1 year after the last Diamyd administration.
Utility of the Clamping Bean Test (CBT) for Covert Hepatic Encephalopathy Screening

Hepatic encephalopathy is a brain dysfunction caused by liver insufficiency and/or porto-systemic shunt. It manifests as a wide spectrum of neurological or psychiatric abnormalities ranging from subclinical alterations to coma. According to the symptoms, it is classified as covert HE (CHE) and overt HE (OHE). CHE can progress to OHE and is associated with reduced driving ability, increased risk of accidents and hospitalization and weakened health-related quality of life, resulting in poor prognosis and socio-economic status. However, due to the absence of readily identifiable clinical symptoms and signs, CHE is often neglected in clinical practice.

Presently, the diagnosis of CHE depends on psychometric and neurophysiological tests, including the psychometric hepatic encephalopathy score (PHES), critical flicker frequency (CFF) test, continuous reaction time (CRT) test, inhibitory control test, the SCAN test, and electroencephalography. Among them, PHES is most widely used and recommended by several guidelines. However, it is difficult to screen CHE among all cirrhotic patients in the clinic using PHES because of the time required and a dependence on trained experts.

Moving beans from one container to another with tweezers involves dexterity, agility and coordination.The hypothesis was that the utility of the Clamping Bean Test (CBT) will enable early screening patients with CHE.


Eligibility Criteria:
Inclusion Criteria:

* written informed consent;
* Age 18-70 years old;
* Patients with clinical diagnosis of liver cirrhosis and without current OHE.

Exclusion Criteria:

* Presence of other uncontrollable neuro-psychiatric or neurological diseases that affect cognitive function, such as Alzheimer's disease, Parkinson's disease, schizophrenia, etc.;
* Clinically diagnosed as overt hepatic encephalopathy(OHE);
* Consumption of hypnotic or sedative drug and psychotropic drug in the past 4 weeks;
* Alcohol consumption \>50 g/day within the past 3 months;
* Conditions preventing the patient from completing the test independently (for instance, red-green color blindness, difﬁculty in comprehension).
Auricular Acupressure on Improving Pain and Heart Variability in Patients After Cervical Spine Surgery

The primary objective of this study is to investigate the effectiveness of auricular acupressure in improving post-cervical spine surgery pain and heart rate variability in patients.

This study adopts a quasi-experimental research design, where a medical center in northern Taiwan served as the enrollment location. Both the experimental group and the control group received standard ward care. The experimental group commenced auricular acupressure intervention post-surgery. Questionnaire assessments and heart rate variability measurements were conducted in the experimental group on the first, second, third, and fourth days before discharge. The control group did not receive auricular acupressure and underwent only questionnaire assessments and heart rate variability testing. Measurement tools included the McGill Pain Questionnaire and the Heart Master wrist-worn physiological monitor.

Eligibility Criteria:
Inclusion Criteria:

1. Those who are over 20 years old and have undergone cervical spine surgery.
2. Those who have clear consciousness and can communicate in Mandarin or Taiwanese.
3. Patients who have undergone cervical spine surgery and have no complications (such as wound infection or postoperative limb mobility impairment) disability).
4. Those who are willing to cooperate with ear acupuncture and heart rate variability testing.
5. Those who agree to participate in the research and sign the consent form.
6. The skin of the auricle is intact and has no deformation, defects or allergies.-

Exclusion Criteria:

1. Those who use self-controlled pain control (PCA) after surgery.
2. Those diagnosed with mental illness or cognitive impairment.
3. Those who are transferred to the intensive care unit after surgery.
4. Those who use breathing aids.
5. Those with major chronic diseases, such as cardiovascular disease or cancer.
6. Those who develop delirium after surgery.
A Clinical Trial to Assess the Safety and PK of OMN6 in HABP or VABP Caused by Acinetobacter Baumannii Complex

This is a phase 2a, multinational, multicenter, double-blind, randomized, placebo-controlled, dose-ranging safety, tolerability and PK study in patients with HABP (Hospital Acquired Bacterial Pneumonia) or VABP (Ventilator Associated Bacterial Pneumonia) caused by ABC to identify safe and well-tolerated doses and to assess the PK profile of OMN6 in patients.


Eligibility Criteria:
Inclusion Criteria:

1. A signed informed consent form.
2. Male or female patients 18 years or older
3. A diagnosis of either a HABP or a VABP
4. ABC infection of the lower respiratory tract suspected based on a positive rapid testing of respiratory specimens
5. Women of childbearing potential (WOCBP) (i.e., not post-menopausal or surgically sterilized) must have a negative highly sensitive urine or serum pregnancy test before randomization.
6. Acute Physiology and Chronic Health Evaluation II (APACHE II) score between 10 and 24

Exclusion Criteria:

1. Moderate to severe reduction of renal function
2. Liver dysfunction
3. Evidence of septic shock
4. Acute respiratory distress syndrome.
5. Immunosuppressed patients (due to either immunosuppressant drugs or to any medical condition).
6. History of any known hypersensitivity to colistin or to carbapenems
7. Any condition or circumstance that, in the opinion of the investigator, would compromise the safety of the patient or the quality of the study data
Preoperative Prehabilitation for Sarcopenic Patients Prior to Pancreatic Surgery for Cancer

Major digestive surgery is associated with a significant rate of postoperative complications. To improve postoperative outcome, efforts are focused on postoperative course leading to the concept of rehabilitation. However, the rehabilitation concept does not allow to improve muscular and functional reserves at the time of surgery. Sarcopenia is a condition characterized by loss of skeletal muscle mass and function. Also, the prevalence of sarcopenia in patients with cancer is high and has a prevalence of around 25% in patients with pancreatic cancer, with a considerable impact on postoperative and survival outcomes.

The hypothesis is the preoperative management of sarcopenia by a rehabilitation program could improve patients' operative outcomes by reducing the rate of postoperative complications.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing pancreaticoduodenectomy for cancer
* Sarcopenic status

Exclusion Criteria:

* Age younger than 18 years
* Medical contraindications including cardiovascular disease or clinically significant vascular disease
* Physical inability to exercise
* Emergent surgery
Comparison of School-Based Supervised Versus Parental Supervised Asthma Therapy

1. Develop a simple school-based intervention using school-based supervised asthma therapy to increase adherence to asthma medication.
2. Implement a school-based internet monitoring system within both the school-based supervised asthma therapy and parent supervised asthma therapy groups to record asthma symptoms, peak flow meter readings, school absences, and usage of rescue medications at school.
3. Randomly assign 250 children from inner-city school systems to either school-based supervised asthma therapy or parental supervised asthma therapy.
4. Compare children assigned to school-based supervised asthma therapy with children assigned to parent supervised asthma therapy, in regards to time-averaged proportion having at least one exacerbation per month, rescue medication use, peak flow meter readings, asthma symptoms, school absences, and asthma self-management knowledge.

BACKGROUND:

Pediatric asthma is a well-documented public health issue in the United States. The impact of pediatric asthma can be measured by both health care costs and morbidity. Whereas many factors contribute to the high health care costs of asthma, much of the morbidity can be directly attributed to lack of adherence to medical treatments. The consequence of non-adherence for most individuals with ashtma is exacerbations. Greater numbers of exacerbations lead to increased school absenteeism, greater activity limitations, decreased quality of life for both parent and child, increased urgent health care use and costs, and increased parental days missed at work. Therefore, adherence to treatment is essential for proper asthma management and ultimate reductions in morbidity.

Asthma morbidity, as measured by the number of exacerbations, is largely preventable with patient education and optimal treatment. However, it has been demonstrated that patient education alone is insufficient to decrease asthma morbidity. Optimal treatment is essential to control asthma morbidity. Inhaled corticosteroids offer considerable protection against asthma exacerbations. However, only a minority of asthma patients take their inhaled steroids as recommended by the National Asthma Education and Prevention Program (NAEPP) guidelines. Therefore, the Pediatric Asthma Guidelines recommend development and testing of programs (including school-based programs) to increase adherence with therapy.

Because morbidity is higher in inner-city, low-income, minority children, this study will collaborate with several inner-city, low-income, minority school districts to examine the effects of school-based supervised asthma therapy.

DESIGN NARRATIVE:

This study is a longitudinal two-group trial of the effectiveness of a school-based supervised asthma therapy program. Two hundred and fifty children will be randomly assigned to one of two groups: school-based supervised asthma therapy or parental supervised asthma therapy. The children will be followed for 16 months.

Eligibility Criteria:
Inclusion Criteria:

* Persistent asthma requiring daily controller medication
* Enrolled at a participating elementary school
Sevoflurane Sedation as an Alternative for Awake Fiberoptic Intubation in Difficult Airway Patients

The aim of this study is to compare patient satisfaction and intubating conditions with fiber optic intubation under sevoflurane sedation versus airway blocks in difficult airway patients

Awake fiberoptic intubation (AFOI) is a suitable option for anticipated difficult intubation. The ideal condition for AFOI requires a calm, cooperative patient with blunted airway reflexes to facilitate easy intubation, especially if there is difficulty with laryngeal anatomy and/or pathology.

For this purpose, sedative and anxiolytic agents such as benzodiazepines, sevoflurane, remifentanil, ketamine, propofol, and dexmedetomidine are almost always required to relieve the patients from comfort without impairing ventilation. Patient responsiveness and cooperation are almost always required.

Eligibility Criteria:
Inclusion Criteria:

* Age from 18 to 50 years.
* Both sexes.
* American Society of Anesthesiology (ASA) physical status I-II.
* Patients with difficult airway (Mallampati grade 3 and 4 with mouth opening less than 5 cm).

Exclusion Criteria:

* Patient refusal.
* Patients with bleeding disorders and nasal mass.
* Allergy or intolerance to one of the study medications.
* Patients with uncontrolled systemic diseases.
* patients with gastro-esophageal reflex.
* history of nasopharyngeal surgery or drug abuse.
Solid Tumors in RASopathies

RASopathies are a group of syndromes, caused by variants of genes involved in the regulation of the Ras/MAP/ERK pathway. This intracellular transduction pathway profoundly affects embryogenic development, organogenesis, synaptic plasticity and neuronal growth.

RASopathies are characterized by multi-organ involvement, growth delay, premature aging and haemato-oncological manifestations.

Based on evidences provided by literature, cancer screening protocols are applied in some individuals affected by RASopathies, even though detailed information about prevalence and molecular pathogenesis of such tumors is still not clearly elucidate.

To define the prevalence of solid (non-haematological) neoplasms in a monocentric cohort of patients affected by RASopathies To perform Next Generation Sequencing (NGS) analysis on tissue samples to preliminarily characterize the molecular pathogenesis of solid tumors in these patients' categories.

Eligibility Criteria:
Inclusion Criteria:

* Clinical and molecularly confirmed diagnosis of a RASopathy

Exclusion Criteria:

* Clinical diagnosis of RASopathy without molecular characterization