cyrilzakka/clinical-trials huggingface dataset:
Registry for Study of Coils in Intracranial Aneurysms

The current proposal describes a post-market, clinical registry of HydroSoft, aimed at gaining robust clinical data in a large set of patients to better define the advantages, and potentially, the disadvantages of the HydroSoft, and to inform future randomized trials.

Aim 1. (Primary Outcome) To test the hypothesis that HydroSoft coils lead to diminished rates of aneurysm recurrence relative to bare platinum coils. In order to test this hypothesis, we will compare recanalization or recurrence rates observed in this prospective registry of HydroSoft coils used as finishing coils to historical series of aneurysms treated with bare platinum coils. This registry is designed to achieve 80% power to detect a minimally clinically relevant difference in rates of recurrence between HydroSoft-treated aneurysms compared with bare platinum coils. Based on recent, prospective, randomized trials assessing both bare platinum coils and hydrogel-bearing coils with 25% and 15% recurrence rates, respectively, we predict a recurrence rate of 18% for HydroSoft treated aneurysms. Typically, a "minimally clinically relevant difference" is on the order of a 30% diminution in a given undesirable outcome. As such, the registry is well powered to detect this minimally clinically relevant difference (18% expected recurrence rate for HydroSoft treated coils versus 25% for the historical control group).

Aim 2. (Secondary Outcome 1) To test the hypothesis that the HydroSoft embolic coil can be placed reliably in intracranial, saccular aneurysms, even late in the embolization procedure. Success of this aim is defined as ease of placement of the HydroSoft device, without need for coil removal and subsequent "finishing" with a bare platinum coil.

Aim 3. (Secondary Outcome 2) To test the hypothesis that use of the HydroSoft embolic coil is associated with risks of thromboembolism similar to that with other coil types, on the order of 3-5% or less.

Eligibility Criteria:
Inclusion Criteria:

1. Patient presenting with a ruptured or un-ruptured cerebral aneurysm appropriate for endovascular treatment as determined by the neurovascular team (neurosurgeon/neurointerventionist)
2. Patient age: patients aged between 21 and 90 years will be eligible.
3. Patient HUNT AND HESS Grade 0-3.
4. Patient has given fully informed consent to endovascular coiling procedure or if patient cannot consent for themselves, appropriate written consent has been sought from their next of kin, or from appropriate power of attorney.
5. Aneurysm 3-15mm in maximum diameter.
6. Patient is willing and able to return for follow up angiography or MRA between 6-18 months.
7. The patient has not been previously entered into this registry
8. The aneurysm has not previously been treated (by coiling or clipping).

Exclusion Criteria:

1. Inability to obtain informed consent.
2. Medical or surgical comorbidity such that the patient's life expectancy is less than 1 year.
Booster Study of SpikoGen COVID-19 Vaccine

The purpose of the study is to assess the effectiveness of Spikogen vaccine when used as a 3rd or 4th dose booster in adults who have been previously vaccinated with any Covid-19 vaccine types, including mRNA vaccine, adenoviral vector vaccines, recombinant protein vaccines, or inactivated virus vaccines.

Currently in Australia, mRNA, adenoviral vector and recombinant protein vaccines have provisional approval for use as 3rd or 4th booster doses. This study will provide important data on the use of Spikogen as an alternative recombinant protein booster vaccine. The study will provide data in ambulatory adults on the safety and effectiveness of Spikogen vaccine when administered as a single intramuscular booster dose in those who previously vaccinated with mRNA vaccine in comparison to those immunised with other Covid-19 vaccine platforms.

Eligibility Criteria:
Inclusion Criteria:

* Able to provide written informed consent
* Males or females 18 years of age or older
* Have previously had a primary course of Covid-19 vaccine with the most recent dose no less than 3 months previously.
* Understand and are likely to comply with planned study procedures and be available for all study visits.

Exclusion Criteria

* Allergy to Spikogen vaccine or one of its components, e.g. polysorbate 80.
* Have received an experimental agent within 30 days prior to the study vaccination or expect to receive another experimental agent during the trial reporting period.
* Any serious medical, social or mental condition which, in the opinion of the investigator, would be detrimental to the subjects or the study.
Immune Infiltrate Analysis of Psoriasis Skin During Therapy With Anti-interleukin 23 (IL-23)

Psoriasis is an immune-mediated inflammatory skin disease characterized by the presence of erythematous and itchy plaques.

Psoriasis has a multifactorial pathogenesis, environmental and genetic factors contribute to its development.

Although interleukin-23 blockade has been shown to be highly effective in the treatment of psoriasis, relapses have occurred during therapy.

Our study aims to identify the cellular source of key cytokines involved in disease recurrence or persistence of at least one psoriatic lesion in patients affected by moderate- severe psoriasis treated with an anti-IL-23 biologic drug. The immune infiltrate of resistant or relapsed plaques during anti-IL-23 therapy will be analysed from skin biopsies.


Eligibility Criteria:
Inclusion Criteria:

* moderate-severe psoriasis PASI\>10
* anti IL 23 biologic therapy for at least 6 months (for the group under treatment)
* during therapy at least one area resistant to treatment or at least one flare of disease (for the group under treatment)
* patients able to express informed consent

Exclusion Criteria:

* patients unable to express informed consent
* patients with complete response to anti IL23, without resistant plaques or disease flare-ups
Analysis of Volatile Organic Compounds by Electronic Noses in Hospitalised Patients for an Infection by SARS-COV-2 (COVID-19)

The study of volatile organic compounds (VOCs) detected in exhaled air is an innovative research area for respiratory diseases. This analysis can be done by the technique of electronic nose, simpler and faster, which provides an idea of the general profile of the VOCs without identifying them. The VOCs in exhaled air in patients hospitalized for COVID-19 infection are analysed in this study, using electronic noses.


Eligibility Criteria:
Inclusion Criteria:

* Patients infected by SARS-CoV-2 whose medical condition warrants hospitalisation (out of intensive care) for oxygen therapy less or equal to 4 l/min
* Patients must be 18 years of age or older
* Fluent in the French language
* Have signed a consent form
* Being affiliated with healthcare insurance

Exclusion Criteria:

* Pregnant woman
* Patient deprived of liberty by judicial or administrative decision
Patient Educational Materials for Prostate Cancer Screening

Although the harms of screening for prostate cancer with the prostate-specific antigen (PSA) test outweigh the benefits, 560,000 Ontario men undergo PSA screening each year. Guideline developers, such as the Canadian Task Force on Preventive Health Care (CTFPHC), have disseminated patient educational materials (PEMs) on PSA screening widely in Ontario, yet men remain confused about screening harms and benefits. One potential contributing factor may be that PEMs are typically developed by researchers and clinicians and may not address patient barriers to change. The investigators will assess whether a PSA screening PEM that is co-created with patients provides added value over PEMs developed using the traditional approach (i.e., researchers and clinicians develop a PEM with patient involvement in usability testing only. The investigators will also assess satisfaction with the engagement process and calculate the costs and resources required for each method (i.e. co-creation, usability, and recommendations only). This study will generate a PSA screening PEM to help patients make evidence-based screening decisions. It will also help Ontario organizations, including Cancer Care Ontario, identify optimal methods for developing PEMs for PSA screening and other areas of preventive health care, such as breast and colorectal cancer screening.


Eligibility Criteria:
Inclusion Criteria:

* English-speaking men aged 40+ years will be eligible to take part in the project if they have never been diagnosed with prostate cancer and do not have any signs or symptoms of prostate cancer.

Exclusion Criteria:

* Individuals will not be eligible for the project if they indicate that they are a health care professional or have any conflicts of interest relevant to the guideline topic (e.g., owning shares in a company related to prostate cancer treatment).
A Study With RO4917523 in Patients With Fragile X Syndrome

This randomized, double-blind multiple ascending dose study will evaluate the safety and tolerability, pharmacokinetics and efficacy of RO4917523 in patients with Fragile X Syndrome. The patients will be randomized to receive either active drug or placebo. The anticipated time on study treatment is 6 weeks. The target sample size is \<100 patients.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, 18 to 50 years of age
* Fragile X Syndrome
* IQ less than 75
* Reliable caregiver

Exclusion Criteria:

* Current psychosis or presumption of psychosis
* History of suicidal behavior or considered a high suicidal risk
* Severe self-injurious behavior
* Any unstable medical condition other than Fragile X Syndrome (e.g. hypertension, diabetes)
* Current seizure disorder
Exercises Directed To Dynamic Stiffness Of The Thoracolumbar Region And Performance Of Amateur Runners

Introduction: Worldwide, the number of amateurs runners is growing exponentially, with consequent increase in musculoskeletal injuries. Although prevention and treatment by myofascial release has shown some evidence over the years, many issues remain. However, this evidence is based on studies that are not randomized controlled trials. Thus, issues associated with prevention and treatment strategies and their effects have not yet been fully explored by researchers. Objective: Contribute to the formation of basic knowledge and understanding of the impact of exercises aimed at the fascial system (fascial fitness®) on the dynamic stiffness of the thoracolumbar region and on the performance of amateur runners. Methods: This project tests a randomized, double-blind (evaluator and patient), parallel clinical trial in three groups comparing the effects of fascial fitness®, kinesiotherapy and placebo for a dynamic stiffness of the thoracolumbar thoracolumbar region and for the performance of amateur runners. Participants will be randomly allocated to receive a 6-week fascial fitness® program, either kinesiotherapy or placebo (detuned ultrasound). Outcome measures will be used before interventions, 3 and 6 weeks after randomization. Interventions will be cared out twice a week for six weeks. Primary outcomes will be the dynamic stiffness of the thoracolumbar region and the time to complete the 5 km run. As secondary outcomes form the ability to maintain static posture in three different postures, the pressure pain threshold, the electromyographic activity of the latissimus dorsi muscle, the quality of movement patterns and heart rate variability in the 5 km run. To analyze whether fascial fitness® or kinesiotherapy or placebo will mediate changes in outcome variables, multivariate analysis of variation will be used.


Eligibility Criteria:
Inclusion Criteria:

Eligible runners must meet the following criteria:

* 5km amateur runners;
* 18 to 45 years old;
* the both sexes;
* be performing running activity for at least 1 year;
* training rate of at least twice a week.

Exclusion Criteria:

* Difficulty in understanding the Portuguese language to answer the questionnaires;
* self-report of carrying neuromusculoskeletal diseases;
* trauma or surgeries in the last 90 days in the lower limbs;
* vestibular system in the last 30 days;
* controlled medicine;
* previous physiotherapeutic treatment in the last 30 days.
Evaluation of a Combined Ridge Expansion Technique With Simultaneous Dental Implant Placement

Patients with long span, narrow edentulous ridge in the posterior mandible underwent piezotomed ridge splitting and osseodensification with simultaneous implant placement.

This study is a single arm clinical trial. Patients of both genders, who are indicated for ridge splitting, were recruited from the outpatient clinic, Faculty of dentistry, Alexandria University.

The PICO question: "What is the effect of piezotomed ridge splitting and osseodensification on implant placement in narrow posterior mandibular ridges?"

Ethical approval for the study was obtained from the regional Ethical Review Board of the Faculty of Dentistry. All patients were informed about the procedure details, and each participant signed a written consent.

Ridge expansion was accomplished by piezotomed ridge splitting and osseodensification. Simultaneous implant placement was done in the same procedure.

Implant stability was assessed. Also, bone width gained and bone density were measured around the dental implants using cone beam computed tomography.

Eligibility Criteria:
Inclusion Criteria:

* Patients with good oral hygiene
* Patients with long-span, narrow posterior edentulous mandibular area
* Age limit range \[25 - 66 years\]
* Patients who accept to participate in the study
* Minimum height 10mm from the crest of the ridge till the upper border of inferior alveolar canal
* Minimum ridge thickness = 3mm at the crestal region
* If the patient is diabetic, should be controlled.

Exclusion Criteria:

* Immunosuppressive/ autoimmune disease patients
* Patients with osteoporosis
* Lack of sufficient amount of keratinizing mucosa at the crest of the edentulous saddle
* Patients with bleeding disorder disease
* Ridge width less than 3 mm
* Smokers
* Patients having periodontal disease
* The presence of a pathological lesion in the area of ridge splitting
Effects and Safety of Budesonide Inhalation Suspension Via Transnasal Nebulization in Nasal Polyps

This randomized, double-blind, placebo-controlled clinical trial enrolled subjects with eosinophilic CRSwNP. Subjects were randomized to receive either budesonide inhalation suspension or placebo for 14 days. Visual analogue scales (VAS）of nasal symptoms, endoscopic polyp scores and morning serum cortical levels were assessed pre- and post-treatment. Polyp samples were evaluated for inflammatory cytokines, matrix metalloproteinases (MMPs) and tissue inhibitors of metalloproteinases (TIMPs) by immunoassay; collagen by histochemistry; and frequencies of different inflammatory T cell infiltration by flow cytometry. this study is undertaken to evaluate the efficacy of short-term prescription of budesonide inhalation suspension via transnasal nebulization by clinical and immunologic assessments. As outcome parameters for remodeling, differences in the expression of collagen and albumin were investigated before and after budesonide treatment. Meanwhile, TGF-β, MMPs and TIMPs expression differences in nasal polyps were investigated to explore underlying mechanisms of tissue reconstitution.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of chronic rhinosinusitis was made on the basis of symptoms of rhinosinusitis for at least 12 weeks, confirmed by abnormalities in all sinuses on computed tomography scan.
* Bilateral nasal polyps were present.
* CRSwNP was defined as eosinophilic when percent of tissue eosinophils exceeded 10% of total infiltrating cells.
* All patients had taken no steroids or antibiotics for at least 4 weeks before sample collection.

Exclusion Criteria:

* cystic fibrosis
* pregnancy
* serious or unstable concurrent disease
* psychological disorder.
Development and Evaluation of Web-Based Fertility-Related Decision Support for Young Female Cancer Patients

This study aims to develop a patient-centered, user-center, interactive web-based decision aid to support the young women with cancer in making an informed fertility-related decision and further evaluate its efficacy.

This study uses mixed-method and involves 2 stages. As following the IPDAS recommendation for developing decision aids, the first sample of 25 young woman survivors with breast, hematology or ovarian cancer, and oncologist, fertility specialists or nurses will be interviewed to assess the fertility-related decision needs from and. The decision aid is then developed further process of evidence synthesis and multidisciplinary external review. After the draft being evaluated for its validity via Think-aloud cognitive interview method, field testing via one-group quasi-experimental design on 90 young women with newly diagnosed breast, hematology or ovarian cancer will be applied to test its outcomes of decision quality, emotional health and fertility concerns.

Eligibility Criteria:
Inclusion Criteria:

* Age between 20 to 44
* Have been diagnosed with breast, hematology or ovarian cancer, and will conduct cancer treatment, such as chemotherapy, hormonal or radiation.
* Willing to take questionnaire via computer and tablet.
* Ability to answer the questionnaire with functional emotion and cognition.
* Ability to read newspaper.
* Had been consulted and advised by Doctor on the ability of fertility, but have not decided to give birth to a baby.

Exclusion Criteria:

* Age below 20 or above 45.
* Had been diagnosed with stage 4 cancer.
* Do not require chemotherapy, hormonal or radiation therapy.
* Not able to read newspaper or do not access the internet.
National Survey Concerning Vaccination Against COVID-19 in Nursing Homes and Long-Term Care Units

The COVID-19 pandemic is a challenge for the French healthcare system, particularly among the elderly due to their particular vulnerability to the serious consequences of the disease, with an estimated mortality rate of around 30-35% among the frail elderly. The management of the health crisis could take a new turn in 2021 with the arrival in France of vaccines against the SARS-CoV-2 virus.

The objectives of this vaccination campaign are to reduce the morbi-mortality attributable to COVID-19 on the one hand, and to maintain essential activities related to the functioning of the country on the other hand and in particular the health system.

However, the distrust of vaccination, traditionally strong in France, could have a negative impact on this strategy. While the President of the Republic announced on November 24, 2020 that vaccination against SARS-CoV-2 would not be made compulsory, almost one French person in two declared in several surveys that they did not want to be vaccinated; the main criterion for acceptance of vaccination being advanced age (the older they are, the more French people declare accepting to be vaccinated).

In view of the gradual vaccine supply schedule for the year 2021, the French National Authority for Health established at the end of 2020 a prioritization by vaccine availability phases. The critical initial supply phase,which is currently taking place, is the one during which residents of retirement home and long-term care units are prioritized because of their particular vulnerability (age and co-morbidities) and their increased exposure to SARS-CoV-2.

For these reasons, and in order to carry out the current vaccination campaign in the most optimal way possible, this national survey is launching to evaluate the acceptance rate of the SARS-CoV-2 vaccine among people living in retirement homes and long-term care units, to understand the mechanisms of acceptance or rejection, and to draw up an initial large-scale inventory of the symptoms observed following vaccination.


Eligibility Criteria:
Inclusion Criteria:

* People aged 75 years and older in retirement homes or long-term care units who have accepted the SARS CoV-2 vaccine
* People aged 75 years and older in retirement homes or long-term care units who have refused the SARS CoV-2 vaccine
* National survey in france

Exclusion Criteria:

* Opposition of the elderly person and/or his or her relatives
Evaluation of Different Teaching- and Learningmethods

Due to the corona pandemia and the consecutive reduction of teaching students face to face the imparting of medical skills is limited. Video sequences may be an adequate alternative to educate selected practical skills. The investigators explored this aspect in spring 2021 concerning the humeral intraosseous access. This study was registered under ClinicalTrials: NCT04842357. Data is still under statistical analysis and not published yet. As a secondary endpoint we found participant having done self-study first and watched a teaching-video one week later performed better than participant in the vice versa sequence. This may have important curricular implications. So, we launch the present study to investigate, if the sequence: Self-Study, then Teaching-Video is more efficient than vice versa.

The investigators will recruit last year medical students and randomise them into two groups: Group A and Group B. Group A will watch a standardised video about the skill, then directly do self-study. Group B will do self-study and then directly watch a standardised video. Right after this, both groups will be video recorded during the performance of the skill: humeral intraosseous access on a simulator. The performance will be quantified by a scale by two investigators

Eligibility Criteria:
Inclusion Criteria:

* voluteer medical students in their last year of medical school (i.e. after 2nd state board in Germany)
* writen informed consert

Exclusion Criteria:

* denial of participation
SAR231893-LPS15497- "Dupilumab Effect on Sleep in AD Patients"

Primary Objective:

To evaluate the effect of dupilumab on sleep quality in adult participants with moderate to severe atopic dermatitis (AD).

Secondary Objectives:

To evaluate the effect of dupilumab on objective and subjective quantitative sleep parameters, AD related outcomes, and daytime consequences of sleep deprivation.

To continue to assess the safety and tolerability throughout the study.

Duration per participant was up to 28 weeks.

Eligibility Criteria:
Inclusion criteria:

Participants, male or female 18 years or older,

* with diagnosed chronic AD, demonstrated 1) inadequate response to topical medications, 2) expected severity of AD and 3) sleep disturbance.
* had applied skin emollients (moisturizers) at least 7 days before screening.
* had applied medium potency topical corticosteroids (TCS) on all active AD lesions at least 7 days before screening.
* willed and able to comply with all clinic visits and study-related procedures.
* provided signed informed consent.

Exclusion criteria:

Participants excluded from the study:

* with known hypersensitivity to Dupixent, clinical depression, drug abuse history, sleep problems not related to AD, irregular sleep pattern, active/acute infections, severe medical conditions, laboratory abnormalities, any condition that might present unreasonable risk to participants or interfered with study assessment, or any severe concomitant illness(es) that would adversely affect the participant's participation in the study, and contraindications of topical corticosteroids.
* at Baseline, presence of any conditions listed as criteria for study drug discontinuation.

The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.