cyrilzakka/clinical-trials huggingface dataset:
Cerebral Blood Flow and Metabolism During Hypoxia and Endotoxemia

The objective of the present protocol is to study whether a low level of oxygen in the blood will affect the immune response to as well as cerebral blood flow and metabolism during an infection and, conversely, whether the acute systemic and cerebral physiologic response to hypoxia is modified by an ongoing inflammatory response.

The combination of acute infection and a low level of oxygen in the blood is a common phenomenon. Thus, acute hypoxia may complicate severe infections including severe sepsis. Conversely, healthy persons who ascend to moderately high altitudes, which will be associated with a lowering of the inspired oxygen level, may sustain an infection. Even so, it is unknown whether hypoxia modifies the systemic inflammatory response, or, conversely, whether the reaction to hypoxia is influenced by the presence of systemic inflammation. The present protocol aims to measure global cerebral blood flow, metabolism and net flux as well as the systemic response in healthy volunteers who are subjected to either normobaric hypoxia alone (N=12), low-dose IV endotoxin infusion alone (N=12), or a combination of endotoxin infusion and normobaric hypoxia (N=12).

Eligibility Criteria:
Inclusion Criteria:

* Healthy nonsmoking male
* Age 18-45 yrs

Exclusion Criteria:
Sonography for COVID-19 Vaccines Related Reactive Lymphadenopathy

This study aimed to provide vast clinical information to facilitate breast sonographic examination for participants who underwent recent SARS-CoV-2 vaccination.

Among different SARS-CoV-2 vaccines in the Asian Taiwanese population, reactive axillary lymphadenopathy was investigated through breast sonographic findings and clinical data analysis. The sample included participants with recent vaccinations by different brands approved in Taiwan.

Study Design and Sample The retrospective study included female patients who underwent breast sonography in the radiology department of Chi Mei Medical Center between July 2021 and March 2022. The patients' breast cancer history and COVID-19 vaccination history were collected and analyzed.

Analysis of Breast Sonography Lymphadenopathy is defined as an enlarged lymph node with cortical thickening \>3 mm, either concentric or eccentric, with or without effacement of fatty hilum, or in-creased non-hilar vascularity on color or power Doppler. The positive axillary lymph node findings were correlated by confirming a link to SARS-CoV-2 vaccination history within 90 days in the ipsilateral arm.

Statistical Analysis All statistical analyses were performed using the R Stats package. Descriptive summaries were reported as mean ± standard deviation for continuous variables and percentages for categorical variables. For non-parametric variables, median with interquartile range and Mann-Whitney U test were used. Statistical significance was set at a p-value \<0.05.

Eligibility Criteria:
Inclusion Criteria:

* female patients receiving breast sonography

Exclusion Criteria:

* receive Covid 19 vaccine other than AZ, BNT, Moderna
* Ongoing primary breast malignancy
* History of malignancy other than primary breast malignancy
Single Breath Counting Test for Acute Respiratory Failure in Emergency Department

The purpose of the study is to determine whether SBCT is a useful tool for diagnosing the main form of failure respiratory acute and to define the SBCT limit associated with insufficiency respiratory in this population, the requirement for NIV or invasive ventilation.

Furthermore, the correlation with the most common scores and indices used in the emergency room will be studied, such as: HACOR, MEW, REMS SCORE, ROS, CURB-65, qSOFA, SEVERITY INDEX OF PNEUMONIA, GWTG HF, LUNG ULTRASOUND SCORE, SINGLE BREATH COUNT

Single breath counting test (SBCT) is the measurement of how far an individual can count in a normal speaking voice after a maximal effort inspiration. Previous work has demonstrated that SBCT has good correlation with the gold standard measures of pulmonary function test, peak expiratory flow rate and forced expiratory volume in the first second.

The easy of the SBCT makes this test appealing for rapid assessment of respiratory status overall in patients admitted for acute respiratory failure and we hypothesized that it will be valuable, replicable and fast tools for bedside assessment of respiratory function in Emergency Department.

The purpose of the study is to determine whether SBCT is a useful tool for diagnosis of the major form of acute respiratory failure and to define the cut-off limit of SBCT associated to respiratory failure in this population, requirement of NIV or invasive ventilation. Moreover, it will be studied the correlation with the most common scores and indexes used in emergency department like: HACOR, MEW, REMS SCORE, ROS, CURB-65, qSOFA, PNEUMONIA SEVERITY INDEX, GWTG-HF, LUNG ULTRASOUND SCORE, SINGLE BREATH COUNTING TEST

Eligibility Criteria:
Inclusion Criteria:

* Any Acute Respiratory Failure
* SaO2 \<92% on air room at ED admission

Exclusion Criteria:

* Age \< 18 yo
* Patients already in NIV AND HCFN in ED
* Home-oxygen or Home-NIV therapy
* SpO2 \< 80%
* Severe dyspnea
* unable to speak complete sentences
* Uncooperative patients
* Hemodynamic Instability \< 90 mmHg or vasopressor requirement at admission
* ST Elevation-Miocardial Infarction
* Tracheo -stomized or -tomized patients
* End of life
A Trial of Dexmedetomidine Hydrochloride Nasal Spray in Preoperative Sedation of Children

The study is being conducted to evaluate the efficacy, safety and the population pharmacokinetic characteristics of dexmedetomidine hydrochloride nasal spray for preoperative sedation in children


Eligibility Criteria:
Inclusion Criteria:

1. Able and willing to provide a written informed consent
2. Male or female
3. Subjects requiring elective general anesthesia surgery
4. Conform to the ASA Physical Status Classification
5. Meet the weight standard

Exclusion Criteria:

1. Not suitable for nasal spray
2. Pediatric populations requiring special care or court/social welfare supervision
3. Subjects who had been under general anesthesia were randomized
4. Subjects with mental disorders and cognitive impairment；Subject with a history of epilepsy
5. Subjects with previous abnormal behavior after medication
6. Subjects with cardiovascular disease
7. Clinically significant abnormal clinical laboratory test value
8. Subjects whose hemoglobin is below the lower limit of normal
9. Subjects who have either an adrenergic receptor agonist or an antagonist were randomized
10. Participated in clinical trials of other drugs before screening (accepted experimental drugs)
11. A history or possibility of difficult airway
12. History of hypersensitivity to drug ingredients or components
13. Other circumstances that the investigator judged inappropriate for participation in this clinical trial
Prehospital Resuscitation On Helicopter Study

The Prehospital Resuscitation On Helicopter Study (PROHS) is a pragmatic, multicenter, prospective observational study of air ambulance-based prehospital resuscitation regimens currently utilized at the participating sites. Patients will be enrolled at participating sites that currently have blood products available on air ambulances and other sites that do not. This study will not change the current prehospital standard of care for resuscitation. The primary outcome will be in-hospital mortality and the primary unit of analysis will be the patient. Other outcomes of interest will include time to hemostasis, hospital length-of-stay, number of ventilator-free and ICU-free days, incidence of major surgical procedures, complications (transfusion-related acute lung injury \[TRALI\], acute kidney injury \[AKI\], multiple organ failure \[MOF\], acute respiratory distress syndrome \[ARDS\], sepsis, intra-abdominal complications, thromboembolic complications, compartment syndromes), lifesaving interventions, the amount and type of blood products and concentrates transfused (including prehospital), wastage of prehospital blood products and concentrates, use of external and internal hemostatic devices, and functional status at discharge/discharge destination.

All patients arriving to the participating center's trauma emergency department via helicopter directly from the scene will be screened and initial data collected. Of that group, all patients who meet the "highest risk" category (based on vital signs, type of injury, use of tourniquet, and/or intubation) or received blood during transport will be followed through "direct observation" through the initial resuscitation period and then indirectly through medical chart review until hospital discharge or 30 days after admission (whichever occurs first).

Eligibility Criteria:
Inclusion Criteria:

Criteria for "at risk" population

* Patients with traumatic injuries received directly from the scene via air ambulance service (did not receive a lifesaving intervention at an outside hospital or healthcare facility)
* Estimated age of 15 or older or greater than/equal to a weight of 50 kg, if age unknown Criteria for "highest risk" population
* Meet at least one of the following during prehospital care: HR \>120 bpm, SBP ≤90 mmHg, penetrating truncal injury, tourniquet application, pelvic binder application or intubation.
* Received blood products during transport (for those facilities with blood product availability)

Exclusion Criteria:

* Prisoners (defined as those received directly from a correctional facility.
Neoadjuvant Befotertinib Combined Bevacizumab or Platinum-based Double Chemotherapy for Resectable Locally-advanced EGFR Mutation-positive Non-Small Cell Lung Cancer

This study targeted patients with resectable stage II-IIIA non-small cell lung cancer with EGFR mutation


Eligibility Criteria:
Inclusion Criteria:

* NSCLC patient with EGFR sensitive mutation as confirmed by needle biopsy;
* At stage II-IIIA (TNM Staging, Version 8) as identified by chest CT, PET-CT or/and EBUS;
* No systemic metastasis (confirmed by head MRI, whole body bone scan, PET-CT, liver and adrenal CT, etc.);
* With the feasibility to receive radical surgery ;
* Good lung function that could tolerate surgical treatment;
* Aged 18-75 years;
* At least one measurable tumor foci (the longest diameter measured by CT shall be \> 10 mm);
* Other major organs shall function well (liver, kidney, blood system, etc.):
* ECOG PS score shall be 0-1;
* The child-bearing female must undergo pregnancy test within 7 days before starting the treatment and the result shall be negative. Reliable contraceptive measures, such as intrauterine device, contraceptive pill and condom, shall be adopted during the trial and within 30 days after completion of the trial. The child-bearing male shall use condom for contraception during the trial and within 30 days after completion of the trial;
* The patient shall sign the Informed Consent Form.

Exclusion Criteria:

* The patient has undergone any systemic anti-cancer treatment for NSCLC, including surgical treatment, local radiotherapy, cytotoxic drug treatment, targeted drug treatment and experimental treatment, etc.;
* The patient suffers from any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina pectoris, angina pectoris that starts to attack within the last 3 months, congestive heart failure \[≥ Grade II specified by New York Heart Association (NYHA)\], cardiac infarction (6 months before enrollment), severe arrhythmia and liver, kidney or metabolic diseases that requires drug treatment;
* The patient is a carrier of HIV;
* The patient has had or is currently suffering from interstitial lung disease;
* The patient had undergone other major systemic operations or suffered from severe trauma within 3 months before the trial;
* The patient is allergic to befotertinib or its any excipients;
* The patient is allergic to bevacizumab or its any excipients;
* The patient is allergic to platinum-based double chemotherapy or its any excipients;
* The female patient is in pregnancy or lactation period;
* There are any conditions under which the investigator considers the patient is not suitable to be enrolled.
Assistive Device for Hand Osteoarthritis

Randomized clinical trial , blind for evaluators, to assess the effectiveness of a self-care program using assistive technology for treatment of hand osteoarthritis.

This program aims to:

* Encourage the use of assistive devices on a daily basis as the main form of joint protection.
* Encourage individual motivation, from the group in attendance, behavior change, developing the capacity of self-management of individuals of their health problems.

Will be held for 4 meetings with an average duration of 90 minutes. Meeting 1: Its proposal address the importance of self-care in the treatment of chronic diseases; knowing the OA of the hands and their main characteristics; recognize the importance of hand function for carrying out activities; understand the meaning of self-care and joint protection; motivation adherence to the program and behavior change.

Meeting 2: Present assistive devices as a protection feature; teach joint protection techniques and energy conservation focusing on the assistive device; deliver and demonstrate the use of assistive devices.

Meeting 3:Encouraging the adhesion of the techniques presented; making workshop for daily activities; verify the difficulties with devices use by the volunteers.

Meeting 4: Strengthening guidance given in previous meetings; make closing with the group to in connection with the program; motivated to continue carrying out the activities at home.

Eligibility Criteria:
Inclusion Criteria:

* Hand OA diagnosis according to the criteria of the American College of Rheumatology (ACR )
* Be properly registered in the rheumatology clinic of Hospital das Clínicas

Exclusion Criteria:

* Surgical treatment or infiltration in the hands, in the last 6 months;
* Treatment of occupational therapy and / or physical therapy, or use of any TA feature (assist device or stent) in the last 6 months;
* Diagnosis of another rheumatologic disease or musculoskeletal system that compromise the hands associated.
Metabolic Disorders and Vertigo

The purpose of investigation is to assess the levels of metabolic factors (hydroxyvitamin D, homocysteine) between patients with vestibular dysfunction of peripheral origin (BPPV) and central origin (vestibular migraine). Also we will analyse another factors (such as anxiety and depression) and optimize therapeuthical approach accordingly with the data.

Dizziness causes up to 2 to 15% of primary neurological complaints. In some patients who have undergone acute vertigo, postural instability, persistent postural perceptual vertigo (PPPV) develops, while in other similar cases occurs full recovery. So, it is necessary to search for neurophysiological, metabolic and psychophysiological factors and associated premorbid conditions that affect the outcome of neurovestibular compensation.

The case-control study will include 2 groups of patients suffering from vertigo of central and peripherial etiology. First group is recruited with patients were diagnosed with peripherial vestibular disorders, such as benign paroxysmal positional vertigo (BPPV), Meniere disease, vestibular neuritis. The proposal number of subjects in the first group is about forty. The second group will consist of forty patients with central vestibular disfunction: vestibular migraine, central positional vertigo etc. The inclusion of patient with persistent postural perceptual dizziness is discussed. Patients will be tested for hydroxyvitamin D and homocysteine in serum using an enzyme-linked immunosorbent assay (ELISA). The perception of the severity of disability was assessed using the Dizziness scale Handicap Inventory (DHI). All patients will undergo psychological test, including tas-26 scale, Beck's Depression Inventory, Spielberg-Hanin'sscale. Statistical analysis was carried out with the Statistical Analysis System (SAS) package. The relationships will be assessed using the chi squared test and logistic regression. The level of significance is set at p \< 0.05. The methods for small samples (Mann-Whitney U ) will be used. It is presumed that differences in vitamin D levels beetween two groups will be considerable.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent of participation in the study;
* Age:over 18 years old
* complaints of dizziness and insteadiness

Exclusion Criteria:

* Severe cognitive impairment (dementia)
* Severe depression
* Syncopal paroxysms
* Epileptic seizures
* Orthostatic hypotension
* Severe arrhythmia, unstable angina pectoris, acute myocardial infarction
* Pregnancy 8. Alcoholism, substance abuse and drug addiction
* Organic liver and kidney diseases with the development of functional disorders.
* Anemia (hemoglobin \<10.5 g / dl for women and \<11.5 g / dl for men)
* Active oncological process
* Demyelinating and neurodegenerative diseases.
Students, Parents, and Teachers On Track: Intervention Development for Youth With Emotional Disturbance

The purpose of the On Track intervention is to address a need raised by a day-treatment school in Lane County: Support for students transitioning from the day-treatment school (Lane School) to their district middle schools. Eligible students are currently attending Lane School, in middle school (Grades 6-8), with or at risk for Emotional Disturbance, and are preparing to transition to their district schools.

A significant problem in education is that the transition period between a treatment school and a district school represents a high-risk time for failure. Education service district and school district leadership in Lane County contacted the Oregon Social Learning Center to collaborate on this project stating that during this transition period the students have insufficient strategies, services, and supports for generalizing the gains made at Lane School (the treatment school) back into the district middle school setting. They reported that this is a period of high stress and instability for many students and their families. Additionally, district schools lack the resources and supports to import the strategies that supported students to be successful at Lane School. Lane School works to track students' placement and services following completion of their program and data indicate that in the first year after transition, approximately 82% of middle school students transfer to public schools in their home district and the remaining students transfer directly to alternative or in-patient treatment centers. By the second year after transition, however, the majority of students who attended public schools were placed in self-contained classrooms, alternative placements, treatment centers, or received out-of-school tutoring due to emotional and behavioral problems. In addition, many students have high rates of truancy and low levels of parental support. This project is intended to address the gaps in support to increase placement stability at the district schools following the transition. To date, four students have begun the transition process with support from this project. One student has fully transitioned and results from qualitative interviews with the parent and the teacher indicate that the intervention is well liked and providing the supports needed to promote student success at the district middle school. We will continue to collect data to determine the level impact in this domain. A secondary impact is developing strategies to effectively collaborate with multiple school districts to support the common goal of transitioning students smoothly and sustaining placement stability. It is our goal to disseminate these strategies via publications and presentations with other educational researchers and practitioners.

Eligibility Criteria:
Inclusion Criteria:

* Clinical Diagnosis of Emotional and Behavioral Disturbance
Lanreotide Levels in Acromegaly

Recently lanreotide (a somatostatin analog) has come into the US marketplace as a commercially available medication approved by the FDA for the treatment of acromegaly. Blood levels in patients getting this drug are unknown and it may be critical to know the levels in patients whose symptoms are poorly controlled.

This is a clinical study of a medical device where the following condition is met: This is research on a medical device for which an investigational device exemption application (21 CFR Part 812) is not required.

The study is exempt from IDE requirements under 21 CFR 812.2(c)(3):

The participants will be 10 CSMC patients who are taking Lanreotide for clinical purposes. After receiving an information sheet and providing verbal consent, the participants will go to their routine blood draw. At this time, they will have an additional 10 cc plasma drawn, which will be sent to Intersciences Institute in Inglewood California to have the lanreotide plasma levels measured.

The key points of this study are:

Patients will have blood drawn at the same time as they are having blood drawn for routine care to avoid unnecessary sticks.

No patient identifiers will be sent to the lab or to any investigators- all plasma tubes will be coded by ISI as a kit and these kits will be given to the physicians. In turn the physician will give the kit to the patients who wish to have their levels measured and the patient will take the kit with them to their routine blood draw. Following the drawing and processing of the blood we will request that the lab just drop the coded plasma tube (and the patient's height weight and monthly lanreotide dose) into the mail in the prepaid mailer. The only information that the investigators will receive is the patient's height, weight and monthly lanreotide dose and the plasma lanreotide level.

No more than 10 cc of blood (a couple of tablespoons) will be drawn for lanreotide measurement.

Whenever possible plasma (which would otherwise be discarded) will be used rather than freshly drawn blood.

All plasma will be assayed at ISI.

The patient will not be charged for the lanreotide assay, an investigational assay. The assay is currently investigational and does not have a "maker" at this time.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Receiving lanreotide depot for treatment of acromegaly

Exclusion Criteria:

* Unwilling to provide consent