cyrilzakka/clinical-trials huggingface dataset:
Immune Response to Respiratory Syncytial Virus (RSV) in Health Care Workers

Respiratory Syncytial Virus (RSV) is a human restricted pathogen and is the single most important cause of severe respiratory illness in infants and young children, a major cause of infantile bronchiolitis and is the most frequent cause of hospitalization of infants and young children in industrialized countries. Severe RSV infection early in life is associated with an increased risk of subsequent recurrent wheezing and asthma. There are few population-based estimates of the incidence of RSV disease from developing countries, but the existing data clearly indicates that the virus accounts for a high proportion of Acute Respiratory Infections (ARI) in children. Studies in Brazil, Colombia and Thailand suggest that RSV causes 20-30% of ARI cases in children from 1-4 years of age, a proportion similar to that in industrialized countries, and WHO has estimated the global RSV disease burden at 64 million cases and 160 000 deaths every year. RSV also causes severe disease in elderly and immune-compromised adults, and the burden of RSV disease in the elderly is comparable to that of seasonal influenza. The economic impact of RSV-related disease in adults estimated to be greater than that of influenza in relation to numbers of days lost from work.

The development of a safe and effective vaccine against RSV would benefit greatly from data on the immune responses in healthy adults naturally exposed to the virus. RSV infection has been shown to increase and induce short-lived circulating antibody secreting cells and produce an increase in the RSV specific antibody titres but very limited data is available on the cellular immune responses induced by RSV during natural infection in healthy adults. The existence of cell mediated immune response against RSV in humans has been described but characterization of this response remains poor and simultaneous analysis of several immunological parameters have not been attempted in an RSV exposed population before.


Eligibility Criteria:
Inclusion Criteria:

* Willing and able to give informed consent for participation in the study and comply with study requirements
* Male or Female, aged from 18 to 60 in healthy status.
* Working on a paediatric ward which admits acute medical paediatric admissions during the RSV season (Group 1 only).

Exclusion Criteria:

* History of any immunodeficiency or immunological disorder which could affect the acquisition of RSV responses.
* Use of immunosuppressive medications such as steroids.
* Working on an NHS ward or in close contact with populations at higher risk of RSV transmission (e.g. nursery workers, care home workers, parents of young children) during the RSV season (Group 2 only).
Beer, Marathon, Genetics, Inflammation and the Cardiovascular System: Be-MaGIC-Trial

The purpose of the study is to determine the myocardial function and vascular adaptation after strenuous exercise in association with consumption of polyphenols. The investigators aim to investigate the effects of extreme endurance exercise on the inflammatory system. Furthermore, the role of the cardiovascular response and adaptive mechanisms of the vasculature are examined. Subclinical injuries to the myocardium and vascular wall are being investigated.

Regular exercise leads to an improvement of cardiovascular risk factors in patients with coronary heart disease, atherosclerosis and metabolic disorders.

Aerobic exercise has anti-inflammatory effects. In contrast, the exertional exercise of marathon running causes an acute pro-inflammatory impulse. This may lead to myocardial injury and, in case of preexisting plaques, may result in plaque rupture and acute myocardial infarction.

We aim to define the critical role of inflammatory markers and cardiovascular risc factors as a predictor of an increased risk for myocardial and endothelial dysfunction in marathon runners.

Diagnostic tools include measurements of microvasculature, the large vessels and echocardiography. Inflammatory markers include high sensitive c-reactive protein (CRP) and interleukins.

All variations are analysed on the basis of consumption of polyphenols as they are found in in hops (Humulus lupus L.) and beer.

Eligibility Criteria:
Inclusion Criteria:

* men aged 20-60 years

Exclusion Criteria:

* manifested heart disease
* insulin dependent diabetes mellitus
* multi drug therapy
* GFR \< 60 ml/min
* smokers
* neoplasia
* (former) alcoholism
* known malabsorption
* known chronic inflammatory disease
Neck Posturing in Surgeons During Microsurgery Procedures Using Upright Go 2 Device

Consultant and senior registrars performing microsurgery will be invited to participate in this Study. The study will take place at single site (Beaumont Hospital). A questionnaire to collect demographic information (age, height, sex, year of training, prior neck trauma or know neck issues) will be given to the consented surgeons. Additionally, surgery characteristics will be recorded (procedure, surgeon role (i.e lead or assisting), table height, frequency of adjustment of table height, and use of sitting or step stool, headlight, and/or loupes for \>50% of the procedure).

A postural training device, Upright Go 2 will be positioned at the spinous process of the cervical vertebrae of each surgeon and used to measure neck positions during microsurgical procedures. The device will be calibrated to an ideal neutral cervical spine position, so that excessive flexion and extension of the neck can be recorded.

The device contains built-in sensors that provide bio-feedback in the form of gentle vibrations if posture has deviated from neutral position.

During the first stage of the study the device will be set to record cervical spine positioning without bio-feedback signals. This will be used to record duration of time surgeons held maladaptation postures.

The second stage will involve real-time feedback through the device. For surgeons who consent, bio-feedback signals will be given once deviated from a neutral posture for \>1 minute. Response of surgeons to bio-feedback signals will also be recorded.

The Neck Disability index score will be used to assess for neck pain and the functional implications in relation to reported neck pain. This will be completed following study completion.


Eligibility Criteria:
Inclusion Criteria:

* Plastic and reconstructive surgeons performing microsurgery
* Consultants, Registrars, and Senior House Officers with no prior cervical spine surgery or cervical degeneration

Exclusion Criteria:

* Surgeons not performing microsurgery on a regular basis (at least once a month)
* Plastic and reconstructive surgery trainees with \<1 years experience in microsurgery.
Mobilizing Early Management of Mental Health Complications After Mild Traumatic Brain Injury

Mental health problems frequently complicate recovery from mild traumatic brain injury (mTBI) but are under-recognized and under-treated. Our research program aims to identify evidence-based strategies for closing this knowledge-practice gap. Building on a successful pilot trial, the reseachers will evaluate the effectiveness of a clinical practice guideline implementation tool designed to support proactive management of mental health complications after mTBI in primary care.

Goal: To determine if a clinical practice guideline implementation tool, designed to support proactive management of mental health complications, can improve clinical outcomes from mild traumatic brain injury (mTBI).

Background: Up to 1 in 4 people who sustain an mTBI develop depression or an anxiety disorder within the first 3 months. Mental health problems triple the risk of long-term disability after mTBI. However, mental health disorders after mTBI are under-detected and under-treated. Canadian clinical practice guidelines for mTBI developed by the Ontario Neurotrauma Foundation (ONF) recommend that family physicians proactively screen and initiate treatment for mental health disorders.

Aims: To evaluate the effectiveness of an implementation intervention designed to facilitate timely detection and treatment of mental health complications in primary care.

Approach: Triple-blinded (treatment provider, patient, assessor) cluster randomized controlled trial with two arms. The intervention involves collecting screening test results from patients and a complex intervention with two components: sharing the screening test results in an actionable format with their family physician and activating patients for the clinical encounter with the family physician by sharing education materials about mental health problems and treatment options after mTBI. The comparison group is usual care.

Hypotheses: The researchers hypothesize that the guideline implementation tool will be associated with lower rates of mental health complications at 26 weeks post-injury, compared to usual care.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-69 years old,
* presentation to emergency department within 72 hours of injury,
* probable mTBI diagnosis per emergency department chart review and interview based on World Health Organization Neurotrauma Task Force diagnostic criteria,
* fluent in English,
* primary residence in British Columbia,
* designate a specific family physician or walk-in clinic where they plan to seek follow-up care

Exclusion Criteria:

* Pre-existing unstable/serious medical condition (e.g., cancer, multiple sclerosis, etc.)
* Pre-existing unstable/severe mental illness (e.g., schizophrenia requiring hospital admission in past year)
Diagnostic Performance of the S100B Protein in the Prognosis of Patients With Mild Head Trauma With Risk of Complications in Patients Over 65 Years Old.

For patients with mild head trauma, a large number of CT scans are performed. The S100B protein allows, when the dosage is below the threshold, to rule out the diagnosis of brain damage with a negative predictive value of 98%.

In patients over 65 years old it was found that the dosage of S100B came back positive more often compared to a younger population.

This study proposes to determine the positivity threshold value for S100B dosage in patients over 65 years old. In patients over 65 years suffering from mild head trauma, a head CT will systematically be performed (in accordance with the recommendations) and the S100B will be measured (taken from an additional tube on the blood test carried out in these patients). The results of the TDM will then be compared with the results of the S100B to determine the values of sensitivity, specificity, negative and positive predictive value of different thresholds.


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 65 or more
* Patients going to the emergency for a mild head trauma with risk of complication and treated within 3 hours of the head injury, according to the following criteria:
* Adult patients with head trauma presenting:
* Retrograde amnesia lasting more than 30 min, Or
* A loss of consciousness or amnesia of the facts Or
* Glasgow score \<15 to 2 hours from traumatism
* Speaking and reading French
* Subject having expressed his non-opposition to the research or non-opposition given by a trusted person / member of his family in cases where the patient is not in a position to express his non-opposition.
* Subject affiliated to a social health insurance protection scheme

Exclusion Criteria:

* Severe head trauma
* Mild head trauma without risk of complication
* Patient under the protection of justice
* Patient under guardianship, curatorship
* Subject in exclusion period (determined by a previous or current study)
Safety and Immunogenicity Study of V710 Lyophilized Formulation (V710-004)

This study is being performed to evaluate a single 60 Mcg dose of lyophilized formulation of Merck Staphylococcus aureus vaccine (V710) in healthy subjects. This study is intended to provide necessary safety and immunogenicity data for the lyophilized formulation of V710 prior to its subsequent evaluation in patients at risk for developing serious S. aureus infections.


Eligibility Criteria:
Inclusion Criteria:

* 18 to 80 years of age
* Good physical health based upon medical history and physical examination
* Willing and able to participate in the entire study duration
* Female subject with a negative urine pregnancy test immediately prior to study vaccination

Exclusion Criteria:

* Chronic skin infections or a chronic skin condition (e.g. psoriasis)
* Serious S. aureus infection in the last 12 months
* Allergy to aluminum-containing substance taken in the body or to any other vaccine component
* Oral temperature equal to or greater than 100.4ºF (38.0ºC), within the past 2 days
* Participation in a prior V710 vaccine clinical study
* Participation in any other clinical study in the past 4 weeks, or during the 3-month study duration
Erwinase Study in Patients With Acute Lymphoblastic Leukemia

The goal of this clinical research study is to allow doctors to use Erwinia L-Asparaginase (Erwinase®) as a replacement for patients who are allergic to E.coli L-asparaginase or Pegylated E.coli L-asparaginase as part of the treatment for acute lymphoblastic leukemia (ALL) or T or B cell lymphoma.

This trial was part of a multi institutional effort by the drug company to make Erwinase available for use.

The Study Drug:

Erwinia L-Asparaginase helps stop the growth of cancer cells by blocking the nutrients that cancer cells needed to survive.

Study Visits:

Erwinia L-Asparaginase will be given either outpatient or inpatient, depending upon your condition.

If you are allergic to E. Coli Asparaginase or Pegylated Asparaginase, you will be given 6 doses every other day.

You will receive Erwinia L-Asparaginase as an injection through a needle in your vein, under the skin, or in your muscle, as directed by your study doctor.

You will be monitored closely by your nurse and your doctor before, during, and after receiving the drug for any side effects. If you develop a severe allergy to Erwinia L-Asparaginase, you may not receive any more asparaginase therapy.

The length of study will be based upon on the ALL treatment you are currently receiving. Your doctor will discuss the details of your treatment schedule with you.

This is an investigational study. Erwinia L-Asparaginase is not FDA approved. The FDA allows patients with acute lymphoblastic leukemia who have an allergic reaction to the U.S.-approved L-asparaginases to receive Erwinia L-Asparaginase. Up to 35 patients will take part in this study at The University of Texas (UT) MD Anderson Cancer Center.

Eligibility Criteria:
Inclusion Criteria:

1. Age: no restrictions
2. Patient must give written informed consent to receive Erwinase® under Investigational New Drug (IND) 290.
3. Patient must be treated for Acute Lymphoblastic Leukemia
4. Patient with either T or B cell lymphoma being treated with Asparaginase.
5. Patient must have either systemic hypersensitivity reactions to native (Elspar®) or pegylated (Oncaspar®) E. coli L-Asparaginase. This includes patients with generalized rash with or without anaphylactic symptoms, but not those with only local pain or redness at the site of injection.
6. Patient with previously documented local or systemic reactions to E. coli derived L-Asparaginase.
7. Patients who are on Elspar® (including those enrolled in a clinical trial randomized to Elspar®) and where Elspar® is not available.

Exclusion Criteria:

1. Previous allergic reaction to Erwinia L-Asparaginase (Erwinase ®)
2. Previous acute pancreatitis
3. Pregnant or lactating woman
Laser Speckle Imaging in Ischaemic Tissue Loss

Peripheral arterial disease is a condition in which the arteries become narrowed due to a build up of cholesterol, as a result, blood cannot flow efficiently through the arteries and this can compromise the parts of the body supplied by these arteries. In its most severe form, peripheral arterial disease can lead to decomposition of tissues in the feet, leading to ulcers or gangrene. Patients with peripheral arterial disease undergo procedures to improve blood flow.

However, there are often multiple arteries to treat and each intervention carries risk. It therefore can be difficult to judge how much treatment is sufficient to promote healing. Laser Speckle Imaging is a technique used to demonstrate blood flow in the skin. It is hoped that changes in skin blood flow, as measured by LSI, immediately after a procedure to improve blood flow, may help in the decision making as to whether further intervention is necessary. An LSI scan will be performed before a procedure for tissue loss and immediately after it is performed. The patient's clinical records will then be checked to see whether the wound has improved and whether the difference in LSI scans correlated with this.


Eligibility Criteria:
Inclusion Criteria:

Patients with diabetes Patients with a foot ulcer or open wound Patients aged over 18 Patients able to given consent Patients undergoing femoropopliteal bypass or superficial femoral / popliteal artery angioplasty

Exclusion Criteria:

nability to consent Planned major limb amputation for the affected limb
The Effects of Gum Chewing on Math Scores in Adolescents

Context: Gum chewing has been shown to increase cognitive functioning. With the rise in standardized testing of school-age children and the concurrent attempts to improve their scores, finding simple and inexpensive methods to bolster performance is needed.

Objective: To examine the effects of gum chewing on standardized test scores and class grades in a group of 8th grade math students.

Design: Math classes were randomized to a gum chewing (GC) condition that provided students with gum during class and testing, or a control condition with no gum (NG) provided during class and testing. This study was conducted during the Spring 2008 school semester.

Setting: A charter school in Houston, TX.

Participants: All students enrolled in eighth grade math at the charter school were approached for recruitment in this study. A total of 108 (94%) students participated. Participants were between the ages of 13 and 16.

Main Outcome Measures: The Texas Assessment of Knowledge and Skills (TAKS), the Woodcock Johnson III Tests of Achievement (WJ-III), and math class grades were used to assess any differences in academic performance between the GC and NGC conditions. For purposes of this study, only the math sections of the WJ-III and TAKS, which are both standardized tests, were assessed.

Our primary hypothesis was that adolescents in a gum chewing (GC) condition would have significantly improved standardized test scores and math grades compared to adolescents in a non-gum chewing (NG) control condition.


Eligibility Criteria:
Inclusion Criteria:

* Enrollment in eight grade math class

Exclusion Criteria:

* Parents did not consent to participation
Perioperative Aspirin Response in Patients Undergoing Vascular Surgery

Reduced antiplatelet activity (low response (LR)/high on-treatment platelet reactivity (HPR)) of aspirin (ALR) or clopidogrel (CLR) is associated with an increased risk of thromboembolic events. The prevalence figures for low-responders reported in the literature vary widely and there have been few investigations in vascular surgery patients to date. The aim of this prospective monocentric study was to increase the evidence base on vascular surgery patients and to detect any changes in the response following vascular surgery procedures.

The activity of aspirin (acetylsalicylic acid, ASA) and clopidogrel is measured by whole blood impedance aggregometry using a multiple electrode aggregometer (Multiplate). The agonists used are arachidonic acid for aspirin and adenosine diphosphate (ADP) for clopidogrel. Vascular patients requiring treatment for peripheral artery disease (PAD) and/or carotid stenosis are included in the study. To identify possible risk factors demographic data, concomitant medication, laboratory parameters, co-morbidities, severity of the condition and the type of procedure performed are documented. In addition, a follow-up aggregometry is performed after completion of the vascular procedure.

Eligibility Criteria:
Inclusion Criteria:

• Vascular patients requiring treatment for peripheral artery disease (PAD) and/or carotid stenosis are included in the study.

Exclusion Criteria:

* non-adherence to the antiplatelet medication
* abnormal platelet count in patients,
* current gastrointestinal disorders,
* current infections,
* serious concomitant medical conditions (such as recent gastrointestinal bleeding, cancer, severe cardiac or liver disorders)
* known bleeding or coagulation disorders,
Hematopoietic Stem Cell Microtransplantation for in AML

The purpose of this study is to evaluate the efficacy of hematopoietic stem cell microtransplantation for in acute myeloid leukemia (AML)patients who can not receive hematopoietic stem cell transplantation (HSCT).

Despite allogeneic HSCT is the only curative therapy for AML, some patients can not receive transplantation due to intolerance of transplant-related toxicity or unwillingness of HSCT. For these patients, microtransplantation seems an optional therapy. However, the efficacy still remain unclear.

Eligibility Criteria:
Inclusion Criteria:

* AML patients who have received induction chemotherapy with moderate-high dose Ara-C and 3 courses consolidate chemotherapy
* Intolerance or unwillingness of allogeneic HSCT
* Subjects (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study

Exclusion Criteria:

* Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure)
* Patients with any conditions not suitable for the trial (investigators' decision)
Study of XL820 Given Orally Daily to Subjects With Solid Tumors

The purpose of this study is to assess the safety and tolerability of the KIT inhibitor XL820 when given orally daily to adults with advanced solid tumors.


Eligibility Criteria:
Inclusion Criteria:

* Subject has a histologically confirmed solid tumor that is metastatic or unresectable for which known effective measures do not exist or are no longer effective, and there are no known therapies to prolong survival
* Subject is at least 18 years old
* Subject has ECOG performance status ≤ 2
* Subject has a life expectancy of \> 3 months
* Subject has adequate organ and marrow function
* In the adrenocorticotropic hormone (ACTH) stimulation test, the subject has a serum cortisol level ≥ 20 ug/dL (552 nmol/L) 30-90 minutes after injection of ACTH
* Subject has given written informed consent
* Sexually active subjects (male and female) must use accepted methods of contraception during the course of the study.
* Female subjects of childbearing potential must have a negative pregnancy test at screening.

Exclusion Criteria:

* Subject has received anticancer treatment within 30 days before the first dose of XL820, or has not recovered to grade ≤ 1 from adverse events due to agents administered more than 30 days earlier
* Subject has received radiation to ≥ 25% of his/her bone marrow within 30 days of XL820 treatment
* Subject has received an investigational agent within 30 days of the first dose of XL820
* Subject has known brain metastases
* Subject has known uncontrolled intercurrent illness
* Subject is pregnant or lactating
* Subject is known to be positive for HIV
* Subject has a known allergy or hypersensitivity to any of the components of the XL820 formulation