cyrilzakka/clinical-trials huggingface dataset:
Surveillance for Adverse Events Following Influenza Immunization

Influenza vaccines are continuously modified to adjust to the virus antigenic shifts or drifts, and its safety profile may vary. While generally considered safe, influenza vaccines have been associated in the past with increases in cases of Guillain-Barré syndrome (1976) and with oculorespiratory syndrome in 2001. Last year, with the vaccination against the pH1N1, an increase of allergic-like reactions was observed.

Passive surveillance is collecting notifications of adverse events (AE) on the whole population but the sensitivity of this system is not high and its timeliness is not necessarily optimal. Last year, with the new pandemic Influenza vaccine the investigators piloted a web-based active surveillance of a large number of health care workers (HCW) vaccinated with the new adjuvanted monovalent pH1N1 influenza vaccine (Arepanrix® GSK, Canada). Because healthcare workers (HCW) constituted a well-defined group with general good health and received the Influenza vaccine in priority, this group of people was well suited for monitoring the safety of the influenza vaccine. For this study, 6242 HCW were recruited in three different sites (5183 were from Quebec). A total of 468 events (local reactions, fever, systemic reactions, gastrointestinal and respiratory problems) were reported by 430 HCW. 80% of the HCW recruited completed at least one of the three surveys and 52% responded to all questionnaires. During this surveillance, the investigators didn't have unexpected findings but this active surveillance of adverse events among healthcare workers would have been effective enough to rapidly detect adverse events occurring at a rate ≥ 1 per 200 vaccinees. For this year the investigators want to expand the surveillance to more sites and more participants to be able to detect AE occurring at rates ≥ 1 per 500 vaccinees, and to increase the response rate to all three surveys in participants.

The main objective of this project is to estimate in HCW vaccinated against influenza the frequency of adverse events of sufficient severity to cause work absenteeism or medical consultation.

This year the network will include 5 Canadian hospitals (Quebec City, Vancouver, Toronto, Halifax, + another one ) with a total enrollment of \>10 000 HCW. This should allow us to detect AE occurring at a rate of ≥ 1 per 500 vaccinees.


Eligibility Criteria:
Inclusion Criteria:

* To be a healthcare worker from one of the seven Canadian Hospitals participating in the Public Health Agency of Canada/Canadian Institutes for Health Research-Influenza Research Network (PCIRN): Quebec City, Toronto, Halifax, Vancouver, Ottawa and Sherbrooke.
* To have been immunized with the influenza vaccine 2010
* To have an email address
* To be 18 years old and older
* To have sign the consent form

Exclusion Criteria:

* Pregnant women
Medtronic RESOLUTE ONYX Core (2.25 mm - 4.0 mm) Clinical Study

The purpose of this trial is to assess the safety and efficacy of the Resolute Onyx Zotarolimus-Eluting Coronary Stent System for the treatment of de novo lesions in native coronary arteries with a reference vessel diameter of 2.25 mm to 4.2 mm.


Eligibility Criteria:
Inclusion Criteria:

* Must be an acceptable candidate for percutaneous coronary intervention (PCI), stenting, and emergent coronary artery bypass graft (CABG) surgery
* Must have clinical evidence of ischemic heart disease, stable or unstable angina, and/or a positive functional study
* Must require treatment of either a) a single target lesion amenable to treatment OR b) two target lesions located in separate target vessels
* Target lesion(s) must be de novo lesion(s) in native coronary artery(ies)

Exclusion Criteria:

* Known hypersensitivity or contraindication to aspirin, heparin and bivalirudin, thienopyridines, cobalt, nickel, platinum, iridium, chromium, molybdenum, polymer coatings (e.g. BioLinx) or a sensitivity to contrast media, which cannot be adequately pre-medicated
* History of an allergic reaction or significant sensitivity to drugs such as zotarolimus, rapamycin, tacrolimus, everolimus, or any other analogue or derivative
* History of a stroke or transient ischemic attack (TIA) within the prior 6 months
* Active peptic ulcer or upper gastrointestinal (GI) bleeding within the prior 6 months
* History of bleeding diathesis or coagulopathy or will refuse blood transfusions
* Concurrent medical condition with a life expectancy of less than 12 months
* Currently participating in an investigational drug or another device trial that has not completed the primary endpoint
* Documented left ventricular ejection fraction (LVEF) \< 30% at the most recent evaluation
Non-Invasive Imaging of the Human Eye

Evaluate the clinical information obtained from the use of the machines.

Evaluate the clinical information provided by these devices and determine their clinical utility and efficacy and safety.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients from 18 to 80 years old who have full legal capacity to volunteer on the date the informed consent is signed.
2. Subjects who can follow the instructions by the clinical staff at the clinical site and can attend examinations on the scheduled examination date.

Exclusion Criteria:

1. History of ocular pathology.
2. History of cataract of ocular surgical procedures that render the cornea opaque or otherwise impact its ability to be imaged using the investigational device.
3. History of systemic disease
4. fixation problems which may prevent obtaining good quality images in the eye.
The Effect of Sodium Alginate on Appetite Sensation

The aim of the study is to investigate the effects of a low-calorie alginate containing fruit flavored beverage on appetite and body weight development.

The project consists of two different studies:

Study I: A randomised controled meal test study aimed at studying the acute effect of the alginate-containing beverage on appetite sensation and spontaneous calorie intake (and safety i.e. nausea, well-being etc) in normal to overweight healthy subjects. Here, a placebo beverage or the alginate-containing beverage will be administered as a pre-load before a standardised breakfast meal. Subjective appetite sensation will be measured with Visual Analogue Scale (VAS) every 30 minutes four up to 5 hours. An additional beverage will be administered prior to an ad libitum lunch meal, where spontaneous water and energy intake will be registered.

Study II: Secondly the aim is to study the effects of a daily intake of a placebo or alginate-containing beverage on body weight and composition in a randomised parallel intervention study of 12 weeks duration. A total of app. 50 obese healthy adults will receive a hypocaloric diet and be randomised to consume either placebo or alginate-containing beverage before each of the three main meals every day. The development in body weight and composition and blood pressure will be monitored and blood samples will be analysed for markers related to the risk of CVD and type 2 diabetes.

Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women
* Normal to slight overweight (BMI: 22-28 kg/m2)
* 20-45 years of age

Exclusion Criteria:

* Smoking
* Daily medicine use (oral contraceptives excluded)
* Use of dietary supplements
* Blood donation 3 months prior to the study
* Hb\<7.5 mmol/l
* Chronic illnesses such as hyperlipidemia, diabetes and inflammatory diseases
* Pregnancy or breastfeeding
* Elite athletes (\>10 hours hard exercise/week)
* Vegetarians
Benefit of Cone-beam CT and Robotic-assisted Bronchoscopy During Bronchoscopy

This randomized controlled trial evaluates the integration of cone-beam computed tomography (CBCT) and robotic-assisted bronchoscopy (RAB) for diagnosing pulmonary lesions, hypothesizing improved diagnostic yield compared to traditional methods. The trial involves 2 study arms (2x46 lesions) over 24 months with 12 months of follow-up and the diagnostic yield (ATS 2024 criteria) as the primary endpoint.

This randomized-controlled-trial, classified as Category A under Art 6 ClinO-MD, investigates the potential benefits of integrating cone-beam computed tomography (CBCT) and robotic-assisted bronchoscopy (RAB) into clinical practice for diagnosing pulmonary lesions. The study aims to enhance biopsy accuracy and safety by utilizing 3-dimensional reconstructions and increased flexibility of the bronchoscope tip. It targets two main clinical scenarios: peripheral lung lesions (PPLs) and other lung diseases requiring tissue biopsies. The hypothesis is that CBCT and RAB will significantly improve diagnostic yield compared to traditional 2D fluoroscopy techniques and endobronchial ultrasound.

The trial will involve 300 participants in the overall observational study, with a nested randomized controlled trial (RCT) for specific lesion types, targeting 2x46 lesions for 2 study arms i) usual care, ii) CBCT and RAB .

Primary endpoints include procedure time for the overall trial and diagnostic yield (ATS 2024 criteria) for the nested RCTs, analyzed via Pearson's Chi-squared test and multivariable logistic regression. Inclusion criteria encompass patients aged 18 or older, scheduled for bronchoscopy, with necessary pre-interventional exams and informed consent. Exclusion criteria include inability to tolerate the procedure, pregnancy, previous trial randomization, and specific lung conditions. The study's recruitment phase spans 24 months, with a 12-month follow-up, running from July 2024 to July 2027.

Eligibility Criteria:
Inclusion Criteria:

* Aged \>18 years
* Scheduled for bronchoscopy in order to obtain at least 1 specimen(s) of the lung via transbronchial biopsy
* Necessary periinterventional laboratory examinations and other examinations needed for the bronchoscopy
* Informed consent

Exclusion Criteria:

* Not able to tolerate procedure (bronchoscopy or apnea for CBCT)
* Previous randomization to an arm of the present trial
* Endobronchial lesion causing lobar atelectasis
* Inability or contraindications to undergo bronchoscopy (e.g. severe cardiopulmonary diseases, coagulation disorders, intolerance to anesthesia or endoscopic operation, psychiatric disorders, or severe neurosis)
* Pregnant or lactating women

For nested RCTs (Trial A + B):

* A: At least 1 peripheral lung lesion suspicious for lung cancer, beyond the visual range of the bronchoscope, rounded or irregular opacity, may be well or poorly defined, measuring ≤3 cm in diameter of the short axis (in CT scan)
* B:At least 1 peripheral target lung lesion of any kind beyond the visual range of the bronchoscope (measuring \>3 cm in diameter of the short axis and/or with an interstitial pattern)
Pain Management With Virtual Reality Hypnosis

The latency phase corresponds to the first phase of the first stage of labour, during which the parturient feels regular, rhythmic uterine contractions that are often painful, with or without changes of the cervix. This phase lasts an average of 8 hours for primiparous women, compared with 5 hours for multiparous women, and can last up to twenty hours in total.

Cervical ripening corresponds to the medical induction of regular, painful uterine contractions in order to obtain a favourable cervix for the induction of labour. Cervical ripening is carried out either medically (oral or local prostaglandins) or mechanically (double balloon dilatation) and accounts for 69.2% of labour inductions, which in turn account for 25.8% of births.

At Amiens-Picardie University Hospital, this maturation stage can last from a few hours to 2 days, depending on the service protocol.

What these two stages of childbirth have in common is that they are both painful, with very few analgesic drugs available that can be used without side-effects on the foetus during pregnancy.

In recent years, there has also been a growing demand from parturients for the use of non-medicinal therapies.

It therefore seems essential to provide parturients with as many effective non-drug methods as possible to manage their pain properly.

If virtual reality hypnosis sessions prove to be effective, they will provide better pain management for women in labour, reduce the use of morphine derivatives (with their attendant side-effects, particularly on the foetus), and above all meet the growing demand from women in labour for the most physiological possible support during childbirth.


Eligibility Criteria:
Inclusion Criteria:

* Parturient over 18
* Parturient who speaks and understands French
* Parturient hospitalised prior to labour
* Membranes intact or ruptured
* Spontaneous or induced labour
* Parturient in latency phase
* Term ≥ 37SA
* END \> 3
* Parturient requiring active pain management (medicinal or non-medicinal)
* Low-risk pregnancy

Exclusion Criteria:

* Parturient under legal protection
* Parturient with a hearing impairment
* Parturient with visual impairment
* Parturient with epilepsy
* Parturient with psychiatric problems
* Pathological pregnancy
* Parturient with chronic pain
* Parturient with addiction-related disorders
* Parturient allergic to paracetamol
* Parturient allergic to phloroglucinol
* Parturient allergic to codeine
* Parturient allergic to nalbuphine
* Parturient allergic to orozamudol
Wheelchair Basketball and Attention Training

The goal of this interventional study is to evaluate the effect of attention training on performance in wheelchair basketball players. The main question it aims to answer is:

Does attention training have an effect on the performance of wheelchair basketball players? Participants will participate attention training from an occupational therapy perspective.

The attention skills of the athletes will be evaluated with a competition-like designed assessment session. Then, the planned 10-week intervention program will be carried out as one session per week. After the intervention program, the evaluation session will be repeated and the results will be recorded. Then, it will be evaluated whether there is improvement in the attention skills of the athletes. The results obtained will be important for athletes, coaches and professionals working in this field.

Eligibility Criteria:
Inclusion Criteria:

* Actively active in a regional wheelchair basketball team for at least 6 months.
* Volunteering to participate in the research.
* Being literate.

Exclusion Criteria:

* Having a neurological or cognitive disorder other than a physical disability.
* Being colorblind.
Biomarkers in Blood Samples From Patients With Acute Myeloid Leukemia

RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors identify and lean more about biomarkers related to cancer.

PURPOSE: This research study is studying biomarkers in blood samples from patients with acute myeloid leukemia.

OBJECTIVES:

Primary

* To determine if serum 2-hydroxyglutarate (2HG) is only detected in acute myeloid leukemia (AML) patients with isocitrate dehydrogenase (IDH) mutations.

Secondary

* To determine if the level of serum 2HG impacts leukemia-free survival (LFS).
* To determine if the level of serum 2HG impacts overall survival (OS).
* To determine if serum 2HG is undetectable at the time of documented clinical remission (CR) in IDH-mutated patients.

OUTLINE: Archived serum samples are analyzed for 2-hydroxyglutarate expression by reverse-phase liquid chromatography coupled to mass spectrometry. Results are then compared with presence or absence of an IDH mutation, patients' clinical outcome, as well as age, sex, white blood cell count at diagnosis, platelet count, bone marrow blast percentage at diagnosis, circulating (serum) percentage at diagnosis, cytogenetic risk group, presence of FLT3, NPMN1, and/or TET2 mutations, specific IDH mutation, and randomization treatment group allocation.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Morphologically confirmed acute myeloid leukemia (AML)

  * Newly diagnosed with AML
  * Serum samples from patients enrolled on the ECOG-1900 clinical trial between 2002 and 2008
  * Patients with or without isocitrate dehydrogenase (IDH) mutations

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Received 2 different doses of standard induction chemotherapy on ECOG-1900
Micro-mobile Foot Compression and Diabetic Foot

Diabetic foot ulceration (DFU) is a common and largely preventable complication. While most of these ulcers can be treated successfully, some will persist and become infected. Ultimately, nearly one fifth of patients with infected lower-extremity diabetic ulcers will require amputation of the affected limb.Prevention by identifying people at higher risk is the key for better clinical management of such patients. It is not uncommon for patients suffering from diabetes to have concomitant lower extremity edema or even venous insufficiency and they subsequently may benefit from graduated compression. However, because of the common association of peripheral arterial disease (PAD) in patients with diabetes, most clinicians are reluctant to apply compressive dressings in fear of exacerbating the symptoms of PAD and the possible resulting gangrene.

A novel micro-mobile foot compression device named Footbeat (AVEX, Inc.) offers alternative means providing lower extremity compression. This device is portable and can be used in a standard diabetic shoes on daily basis, which in turn may improve venous blood and relief from concomitant lower extremity edema. In addition, potential improvement in lower extremity blood flow in response to regular foot compression, could improve balance, gait, skin perfusion, plantar sensation, and overall daily physical activities (e.g. number of taken steps per day, duration of standing, etc).

The purpose of this study is to conduct an observational study with N=30 ambulatory patients with diabetes and loss of protective sensation to assess whether this micro-mobile foot compression device can help improving motor function, lower extremity perfusion, and vascular health.


Eligibility Criteria:
Inclusion Criteria:

* Male or female , age 18 or older with the ability and willingness to provide Informed consent
* Patient is willing to participate in all procedures and follow up evaluations necessary to complete the study
* History of type 2 diabetes confirmed by patient's physician.
* History of peripheral neurpathy .

Exclusion Criteria:

* Patients with severe peripheral vascular disease (ankle-brachial systolic pressure index (ABI) \<0.5 or ABI\>1.30)
* Patients with active wound infection, or untreated osteomyelitis
* Patients with major foot deformities (e.g. Charcot Foot) or major amputation (e.g. above ankle)
* Unamulatory of those who are unable to independently walk with or without walking assistance, a distance of 40 feet.
* Patients who are unable or unwilling to participate in all procedures and follow up evaluations
* Patients currently on immunosuppressive drugs.
* Pregnant or breast feeding ladies.
Comparative Clinical Study Between Virtual Reality Hypnosis and Nitrous Oxide Inhalation for Dental Anxie

The vicious circle of dental anxiety impacts major aspects of a child's quality of life. Hypnosis using distraction is one of the most common non-pharmalogical techniques in behavior and pain management in pediatric dentistry. Its value over traditional pharmalogical sedation is undeniable. This clinical study examines the application of hypnosis delivered through immersive virtual reality (VR) for anxious children ongoing dental procedures. The investigators will explore whether VR is as effective on pain and anxiety relief as a pharmacological sedation with inhalation of nitrous oxide.

The working hypothesis of this study is that hypnosis through virtual reality can reduce children's anxiety as well as their pain level during dental care with an efficiency and tolerance at least similar to nitrous oxide inhalation. Specifically, the statistical analyses will be based on an assumption of non-inferiority of VR compared to the pharmacological technique of nitrous oxide sedation.

Each patient (aged from 6 to 10) attended for two visits in order to benefit of 2 similar conservative dental treatments on primary molars.

Everyone was randomly allocated to receive hypnosis through virtual reality or nitrous oxide/oxygen titrated to 50%/50% at the first visit, the alternative being used at the second visit. This randomization helps avoid any experimental bias related to a first positive or negative experience, each patient being its own control.

Vital signs and a video of the child's behavior are recorded for an external examinator. The video shows the child's body response as an indicator for his anxiety level through the procedures. The child's face doesn't appear on the video in order to reduce risks of bias.

Eligibility Criteria:
Inclusion criteria:

* Patients aged between 7 and 10 years
* With an indication for conservative and/or endodontic care of at least 2 temporary molars belonging to the same dental arch, unilateral or bilateral, and equivalent in terms of caries and symptoms
* With dental anxiety
* ASA I patients

Exclusion criteria:

* Patient with a history of MEOPA or virtual reality sedation for dental treatment
* Patient refusing to do preoperative intra-oral x-rays
* Patient with one of the MEOPA contraindications
* Patient with a history of post-operative nausea vomiting or motion sickness
* Patient with visual or hearing disorders
* Patient presenting with a psychiatric pathology or having taken psychotropic drugs in the 8 weeks preceding the 1st visit and during the duration of the study
* Patient with claustrophobia
* Patient without French Social Security coverage
* Lack of consent from the holders of parental authority to participate in the study
Effectiveness and Safety of BIO-11006 Inhalation Solution to Treat the Overproduction of Mucus and Inflammation in COPD

The symptoms associated with COPD include overproduction of mucus and inflammation in the lungs. Overproduction of mucus results in impaired lung function and it encourages bacterial growth and associated COPD exacerbations. Therefore, a treatment that inhibits mucus overproduction or blocks inflammation could benefit COPD patients. The drug under evaluation in this study, BIO-11006 Inhalation Solution, is a new drug that may inhibit overproduction of mucus and may have important anti-inflammatory properties.

COPD encompasses a number of chronic lung disorders that obstruct the airways and may be accompanied by airway hyperactivity. The most common form of COPD is a combination of chronic bronchitis and emphysema. Many of the signs and symptoms associated with chronic bronchitis are a result of airway mucus hypersecretion induced by chronic inflammation of the airways. Clinically, mucus hypersecretion results in impaired gas exchange and compromised mucociliary clearance, encouraging bacterial colonization and associated exacerbations. A treatment that inhibits mucus hypersecretion or blocks inflammation could benefit COPD patients with chronic bronchitis. The drug under evaluation in this study, BIO 11006, is a new therapeutic agent that may inhibit mucus secretion and may have important anti inflammatory properties. In this study, BIO-11006 will be administered to COPD patients with chronic bronchitis, and the effects lung function will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Clinically stable male or female outpatients, 45 years of age or older
* Active COPD with chronic bronchitis indicated by: (1) FEV1 = 40% to 70%, (2) FEV1/FVC ≤70%, (3)Chronic productive cough for 3 months in each of 2 successive years, and (4) Sputum (phlegm) production at least several days a week over the past 4 weeks
* Current or previous smoker with a 20-pack year history

Exclusion Criteria:

* Treatment with oral prednisone during the 6 weeks before enrollment
* Changed inhaled corticosteroid dose or long acting bronchodilator dose during the 6 weeks before enrollment
* Treatment with oxygen (with the exception of night time oxygen) during the 6 weeks before enrollment
* Current asthma as determined by the investigator
* Change in smoking status during the previous 6 months