cyrilzakka/clinical-trials huggingface dataset:
Gingival Displacement With RACESTYPTINE Solution and RACEGEL: a Prospective, Comparative Randomized Clinical Trial.

The study design is a prospective, multi-center randomized, controlled, open label, 3-arm parallel group, post market clinical follow-up (PMCF) Clinical Trial.

The aim of the study is to collect clinical performance and safety data from RACEGEL and RACESTYPTINE Solution. Three gingival retraction techniques are being studied: RACESTYPTINE Solution with cord, RACEGEL with cord and RACEGEL without cord.

The study will demonstrate the expected performance of these 3 techniques in terms of sulcus opening, i.e. a lateral gingival displacement of at least 200 µm (state of the art) allowing the realization of pre-prosthetic impression with subgingivally margins. 90 subjects (teeth) requiring a dental restoration with subgingival margins for placement of a fixed prosthesis will be enrolled in 3 groups (30 in each group). For each participant, two dental impressions are performed: one impression before the gingival retraction and one impression immediately after the gingival retraction. Both impressions are scanned with 3D dental scanner and images are superimposed before analysis of tissue displacement.


Eligibility Criteria:
Inclusion Criteria:

* Adult male or female (age ≥18 years),
* Patient requiring a dental restoration with subgingival margins on one or more teeth with placement of a single or multiple fixed prosthesis. Partially edentulous patients can be enrolled.
* Good oral hygiene
* Healthy periodontium and gingiva: probing depth ≤3 mm, no evidence of gingival inflammation (gingival index ≤ 1), attachment loss (attached gingival \>2 mm), bleeding on probing, or plaque accumulation (plaque index \< 3)
* Patient who received information and gave written consent.
* Patient affiliated with a social security/protection plan.

Exclusion Criteria:

* Contraindication to taking impression evidenced at the latest on the day of inclusion visit (gingival index ≥2, sign of attachment loss or tooth mobility, probing depth \>3 mm).
* Known allergy to aluminum, aluminum salts or to one of the compounds of the formula of the gingival retraction material, or to one of the compounds of the impression material.
* Patient with an unbalanced systemic disease (diabetes, thyroid disorders, history of oropharyngeal cancer),
* Simultaneous participation in another interventional clinical investigation or trial,
* Vulnerable Subjects
A Trial of Grazax in Subjects With Hayfever

The trial is performed to evaluate the efficacy and safety of specific immunotherapy with Grazax for treatment of grass pollen induced allergy.


Eligibility Criteria:
Inclusion Criteria:

* History of grass pollen allergy
* Positive skin prick test to grass
* Positive specific IgE to grass

Exclusion Criteria

* FEV1 \<70% of predicted value
Video Messages and Vaccination Intention

This study uses an online panel survey to test the impact of video messages on stated likelihood of COVID-19 vaccination. Participants, who have self-identified as unvaccinated against COVID-19, are randomly assigned to either no video message or 1 of 3 video messages to encourage vaccine take-up. The key endpoint is a question about the likelihood of getting vaccinated in the next 30 days.

This study uses an online panel survey to test the impact of video messages on stated likelihood of COVID-19 vaccination. Participants are recruited from the Prolific.co platform. Those who have indicated to Prolific that they have not been vaccinated will be randomly assigned to either no video message or 1 of 3 video messages created by the Vaccinate LA/USC collaborative. The key endpoint is a question about the likelihood of getting vaccinated in the next 30 days.

Eligibility Criteria:
Inclusion Criteria:

* adults in the Prolific.co panel
* unvaccinated against COVID-19

Exclusion Criteria:

* indicated to Prolific.co that they have received a COVID-19 vaccination
Functional and Ultrasound Guided Resection of Glioblastoma

Functional and ultrasound-guided resection of glioblastoma: assessing the use of additional imaging during surgery to improve outcomes for patients with glioblastoma brain tumours

Stage 1 (IDEAL IIB study) of the trial is observational only and all participants will receive all technologies during surgery.

Stage 2 will be randomised. Randomisation will be via the web-based service provided by the Oxford Clinical Trials Research Unit (OCTRU), using the method of minimisation. Participants will be randomised 1:1 to either:

1. Standard care surgery (neuronavigation based on preoperative imaging and intraoperative use of 5-ALA)(Control arm)
2. Standard care surgery (neuronavigation based on preoperative imaging and intraoperative use of 5-ALA) AND of DTI neuronavigation and NiUS (Intervention arm)

At baseline all participants will undergo a routine preoperative neuronavigation MRI scan. Those participants randomised to the experimental arm, will also have a DTI scan (additional 5 minutes in the MRI). All participants will then undergo the planned resection of their tumour, with the additional technologies if they are in the experimental arm. Following surgery, participants in both arms have the same follow up schedule and undergo standard clinical care for a total of 24 months.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-70 years
* Neuro-oncology Multi-Disciplinary Team (MDT) decision that the imaging shows a primary GB tumour which is maximally resectable (attempted gross total resection of all enhancing tumour)
* Patient is suitable for concomitant adjuvant radiotherapy and Temozolomide (TMZ) chemotherapy or adjuvant TMZ at the time of MDT decision
* Able to receive 5-ALA
* Willing and able to give informed consent
* Able to complete trial questionnaires, this may be with support where English is not their first language. (Stage 2 only)
* Able to provide a proxy who is willing to complete questionnaires as requested (Stage 2 only).

Exclusion Criteria:

* Midline/basal ganglia/cerebellum/brainstem GB
* Multifocal GB
* Recurrent GB
* Suspected secondary GB
* Contraindication to MRI
HEAD-US SCORING SYSTEM: Assessment of the Real-world Impact of Ultrasound

Ultrasound represents a promising technique for the assessment of joint health in persons with haemophilia (PWH) by non-imaging specialists. The Haemophilia Early Arthropathy Detection with Ultrasound (HEAD-US) programme has been developed with the aim of integrating joint ultrasound in the routine assessment of PWH through the use of a simplified scoring system. The inter-operator reliability of the technique among European haemophilia treaters has been validated and described elsewhere. Further work is needed to assess the real-world impact of ultrasound on disease management and treatment decision-making.

Patients are seen routinely in clinic by specialist haemophilia physiotherapists who assess the patients using the Haemophilia Joint Health Score tool (HJHS). Trial participants will be seen during their routine clinic visits and will be seen by a clinician and the physiotherapist who will carry out the routine assessment along with the HEAD-US scan.

Patients will be seen a maximum of 4 times throughout the year from registration of the first patient, according to their visit schedule, but will only be scanned at the first visit.

Results will be analysed to determine if the treatment decision-making is influenced by the results of the scan

Eligibility Criteria:
Inclusion Criteria:

* Moderate (FVIII/FIX:C 1-5%) and severe (FVIII/FIX: C \<1%) patients with haemophilia A or B aged ≥ 6 years
* On demand or prophylaxis treatment regimen

Exclusion Criteria:

* Joints with a previous history of surgery
* Joints with damage as a result of causes other than haemophilia-related bleeding
The Use of a Minimally Invasive Internal Fixation Device for Treatment of Unstable Pelvic Ring Fractures

Pelvic fractures are common presentations to major trauma centers and are associated with significant morbidity in polytrauma patients. Traditional open reduction and internal fixation is associated with a high incidence of surgical morbidity, while external fixators, used for both temporary stabilisation and as definitive management, have a complication rate of up to 62% \[4\], with poor patient tolerance, pin site infection and aseptic loosening the more commonly documented complications in the literature.

Minimally invasive techniques have become more popular recently in the management of pelvic injuries due to their lower incidence of surgical morbidity. The application of a pelvic internal fixator (INFIX) has been presented as a comparable alternative to external fixation of anterior pelvic ring injuries.


Eligibility Criteria:
Inclusion Criteria:

* Patients who had APC-II
* Patients who had APC-III
* Patients who had LC - II
* Patients who had LC -III

Exclusion Criteria:

* Patients who had immature skeletons or medical contraindications such as combined neurovascular injuries and uncontrolled medical diseases.
* Open fractures.
* Stable pelvic ring fractures.
* Patients who had combined acetabular fractures
* Patients who had a hernia or previous lower abdominal surgery.
* Pregnancy.
HIV and Sexually Transmitted Infection Prevention Intervention in the Northwest Territories

Indigenous youth are disproportionately represented in new HIV infection rates in Canada. Limited studies have evaluated longitudinal effects of arts-based approaches to HIV prevention with youth. The authors present a rationale and study protocol for an arts-based HIV and sexually transmitted infections (STI) prevention intervention with Northern and Indigenous youth in the Northwest Territories (NWT), Canada. This is a multi-centre non-randomised cohort pilot study using a pre-test/post-test design with a 12-month follow-up. The target population is Northern and Indigenous youth in eighteen communities in the NWT. The aim is to recruit 150 youth using venue-based sampling at secondary schools. Participants will be involved in an arts-based intervention, Fostering Open eXpression among Youth (FOXY). Participants will complete a pre-test, post-test survey directly following the intervention, and a 12-month follow up.

Introduction: Indigenous youth are disproportionately represented in new HIV infection rates in Canada. Current and historical contexts of colonization and racism, disconnection from culture and land, as well as intergenerational trauma resulting from the legacy of residential schools are social drivers that elevate exposure to HIV among Indigenous peoples. Peer-education and arts-based interventions are increasingly used for HIV prevention with youth. Yet limited studies have evaluated longitudinal effects of arts-based approaches to HIV prevention with youth. The authors present a rationale and study protocol for an arts-based HIV prevention intervention with Northern and Indigenous youth in the Northwest Territories (NWT), Canada.

Methods \& Analysis: This is a multi-centre non-randomised cohort pilot study using a pre-test/post-test design with a 12-month follow-up. The target population is Northern and Indigenous youth in eighteen communities in the NWT. The aim is to recruit 150 youth using venue-based sampling at secondary schools. Participants will be involved in an arts-based intervention, Fostering Open eXpression among Youth (FOXY). Participants will complete a pre-test, post-test survey directly following the intervention, and a 12-month follow up. The primary outcome is new or enhanced HIV knowledge, and secondary outcomes to include: new or enhanced STI knowledge, and increased self-esteem, resilience, empowerment, safer sex self-efficacy, and cultural connectedness. Mixed effects regression analyses will be conducted to evaluate pre- and post-test differences in outcome measurement scores.

Ethics and Dissemination: This study has received approval from the HIV Research Ethics Board at the University of Toronto (REB: 31602).

Eligibility Criteria:
Inclusion Criteria:

* participating in FOXY
* self-identify as a woman
* live in the Northwest Territories
* between the ages of 13 and 16 years of age
* capable of providing informed consent

Exclusion Criteria:

* did not participate in FOXY
* not between 13-16 years old
* don't live in the Northwest Territories
* not capable of providing informed consent
PET/MR Assessment of Sipuleucel T Treatment for Metastatic Castration Resistant Prostate Cancer

This study intents to provide an initial evaluation of the utility of positron emission tomography and magnetic resonance (PET/MR) imaging measures for the prediction of immunological response to Sipuleucel T (SipT) therapy.

Recent studies of treatments of prostate cancer through stimulation of adaptive immune response have indicated the linear measurements by computed tomography (CT) and nuclear scans used to assess tumor response by Response Evaluation Criteria in Solid Tumors (RECIST) were inadequate and the value of progression-free survival (PFS) as a predictive surrogate endpoint of survival was lost.

The objective of this study is to provide an initial evaluation of the utility of PET/MR imaging measures for the prediction of immunological response to SipT therapy. Investigators expect to identify an"imaging-signature" of response to SipT based on changes in metabolism, perfusion, oxygenation and cellularity of metastasis and its correlation with immunological and clinical response. This approach will help elucidate the mechanism of activity and dynamics of immune antitumor responses to SipT in vivo and to identify new parameters of tumor response and predictive value than current RECIST and PFS standards.

Eligibility Criteria:
Inclusion Criteria:

* Men ≥ 18 years of age
* History of prostate cancer treated with androgen deprivation
* Serum Testosterone levels \<50 ng/mL
* Established asymptomatic or minimally symptomatic metastasis
* Eastern Cooperative Oncology Group (ECOG) performance status≤2
* Accept the terms of the imaging modalities and performance at pre-established time points as described in the protocol and consent
* Accept the terms for immune-monitoring blood drawing and performance at pre-established time points as described in the protocol and consent
* Patients that are on steroids (prednisone up to 10mg daily or hydrocortisone 20 mg daily) alone or in combination with Zytega or ketoconazole prior to enrollment are eligible
* Patients that are on steroids for an underlying chronic condition are eligible. (prednisone up to 10 mg daily, dexamethasone \<2 mg daily or fludrocortisone 0.1 mg daily orally)

Exclusion Criteria:

* Chemotherapy or radiation therapy treatment within 21 days of Sipuleucel-T
* ECOG performance status \>2
* Prior treatment with Sipuleucel-T
* Patients with a history of another primary malignancy within the last 2 years that was not curatively treated, excluding basal or squamous cell carcinoma of the skin
* Patients with known positivity for human immunodeficiency virus (HIV) or hepatitis C; baseline testing for HIV and hepatitis C is not required
* Patients with any significant history of non-compliance to medical regimens or with inability to grant a reliable informed consent
* Active spinal cord compression.
Family Engagement in Intensive Care Unit

We hypothesized that engaging families in the care of critically ill patients could improve outcome both at the family and at the patient levels. Thus, the aim of this project is to assess the effects of a family engagement program on family members' satisfaction and on patients' well-being and quality of life.

Despite the health care professionals should consider the active involvement of families in Intensive Care Unit (ICU), little research investigating family member's contributions to care, including its outcomes on family itself and on patient care, has been rendered available. To assess the effects of a family engagement program on family members' satisfaction and on patients' well-being and quality of life. A quasi-experimental study with two non-randomized groups (94 per each group) will be performed in two general ICUs of an Academic Italian Hospital. The intervention will be carried out in a single ICU and consists of family members' involvement in the care of their beloved one with bed physical exercises and simple care tasks. Participants will be assessed for outcomes including the family satisfaction, assessed with the FS-ICU tool within 48 hours after the patient's discharge from ICU, the patient's sense of well-being, measured with a visual analogue scale within 30 minutes after the time period of a visit, and the quality of life, investigated with the SF-12 questionnaire within the first 48 hours after admission in ICU, at three and six months after ICU discharge by telephone. First, this study constitutes a significant step in a research agenda aimed at deepening the nursing sensitive outcomes in ICUs and the quality of hospital care. Secondly, result from this study may have the potential to better understand how families may modify patients' outcomes and whether the family members would benefit from an engagement program.

Eligibility Criteria:
Inclusion Criteria:

PATIENT

* 18 years of age and older;
* expected to stay in-ICU at least three days;
* with high or low acuity conditions.

FAMILY MEMBER

* being the patient's spouse, or in a blood relation, or next of kin, and/or with whom the patient spends most of the time;
* 18 of age or above;
* willing to visit the patient on a daily basis;
* willing to participate in the study.

Exclusion Criteria:

PATIENT Patients' discharge from ICU, transfer to another hospital, or death.

FAMILY MEMBER The unexpected suspension of visiting their loved ones in ICU daily
Peribulbar Block: Lidocaine-bupivacaine vs Lidocaine-bupivacaine-fentanyl

Ophthalmological procedures such as cataract extraction can be carried out with a peribulbar block (PBB). The advantages of this anesthetic technique include a lower incidence of coughing, unwanted movements and emesis during awakening, in addition to providing adequate postoperative analgesia. The researchers want to investigate whether the use of fentanyl citrate by peribulbar route, when administered with a local anesthetic, shortens the anesthetic latency, interfere with the degree of akinesia and if provides greater postoperative analgesia.

Article Type. Clinical trial study

Eligibility Criteria:
Inclusion Criteria:

* All patients scheduled for cataract surgery (Cataract Extracapsular Extraction)
* With indication of regional anesthesia with peribulbar block
* Physical status ASA I or II
* Patients between 45 and 90 years of age

Exclusion Criteria:

* Allergic to amide-type anesthetics and fentanyl citrate
* Patients with a history of woody thorax
* Patients with uncompensated systemic diseases
* Patients in whom it was necessary to change the anesthetic technique due to insufficient analgesia or those in which the administration of intravenous analgesics was required during the operative period.
Using PrEP, Doing It for Ourselves

The aim of this study is to test the effectiveness of the Using PrEP, Doing it for Ourselves (UPDOs) intervention is to improve pre-exposure prophylaxis (PrEP) uptake for Black women using the Motivational PrEP Cascade framework within a community engaged cluster-randomized controlled trial of intervention and control salon clusters. It is expected that compared to control, women in the UPDOs intervention will have higher PrEP uptake. Additionally, this study aims to examine the barriers and facilitators underlining PrEP decision-making among a subsample of Black women in both intervention and control groups using quantitative surveys and qualitative individual interviews. Lastly, the study aims to understand the facilitators influencing implementation of UPDOs for future scalability using quantitative surveys and qualitative interviews grounded in the CFIR (Consolidated Framework for Implementation Research) framework.


Eligibility Criteria:
Inclusion Criteria:

* Black
* Cisgender female
* Ages 18+

Exclusion Criteria:

* Under 18 years of age
* Does not identify as Black
* Not a cisgender female
Effects of Deep Cervical Flexors Training On Forward Head Posture, Neck Pain and Functional Status

Using computer for long hours is related to higher risk of computer related muscular disorders like forward head posture and neck pain. Deep cervical flexor muscles are important head-on-neck posture stabilizers thus their training may lead to improvement in forward head posture (FHP) and neck pain (NP).

In contemporary societies, computer use by children is a necessity and thus highly prevalent. Using computer for long hours is related to higher risk of computer-related muscular disorders like forward head posture and neck pain. Deep cervical flexor muscles are important head-on-neck posture stabilizers thus their training may lead to improvement in forward head posture (FHP) and neck pain (NP). Aim of study was to determine if 4 weeks of deep cervical flexors training is effective in alleviating neck pain and improving forward head posture in adolescent children using computer regularly. A pretest-posttest experimental group design was used. Subjects were randomly assigned into control group (receiving postural advice only) and experimental group (receiving deep cervical flexor training and postural advice). Dependent variables were measured on day 0 (at baseline) and after 4weeks of training. The photographic analysis was used for measuring forward head posture, visual analog scale (VAS) for neck pain intensity and Neck Disability Index (NDI) for functional disability. Experimental group received craniocervical flexion training for 4 weeks and postural advice. Control group received only postural advice.

Eligibility Criteria:
Inclusion Criteria:

* Neck pain with or without headache, of duration more than 3 months and less than 1 year and 6 months, as identified by body discomfort chart and
* Neck disability index value less than 24 (mild to moderate disability scores on NDI)
* Forward head posture as identified by straight line down from external meatus falling anterior to shoulder and mid thorax.
* Using computer for at least 3 hours a day for at least 4 days a week or more.

Exclusion Criteria:

* Ongoing or previous history of spinal fracture
* Ongoing or previous history of neurological signs
* Ongoing or previous history of inflammatory disease
* Ongoing or previous history of spinal tumor
* Ongoing or previous history of spinal infection
* Ongoing or previous history of spinal cord compression
* Ongoing or previous history of congenital, or acquired postural deformity
* Ongoing or previous history of cervical spinal surgery
* Ongoing or previous history of spinal instability