cyrilzakka/clinical-trials huggingface dataset:
Use of a Medical Food in Adults Undergoing Surgery

Multi-center, prospective, one arm study to evaluate the addition of a medical food to the standard of care in elderly adults undergoing a surgical procedure.


Eligibility Criteria:
Inclusion Criteria:

* Participant is scheduled to have non-melanoma skin cancer on either the head, leg, trunk and arm removed with final wound size of 1.0 to \< 5.0 cm in diameter or with 1.0 \< 5.0 cm long axis if not circular that will be healed by secondary intent
* Participant has an acceptable state of health and nutrition
* Participant agrees not to begin taking any new medications, dietary supplements, or alternative therapies during the study period
* Participant is interested in participating in the study, willing to comply with the study protocol, and willing to consume two servings of drink mix per day according to the protocol
* Participant has voluntarily signed and dated an informed consent form (ICF), approved by an Independent Ethics Committee/Institutional Review Board (IEC/IRB) and provided Health Insurance Portability and Accountability (HIPAA) authorization prior to any study participation

Exclusion Criteria:

* Participant has a disease or condition that could interfere with the assessment of safety and efficacy of the study treatment and compliance of the participant with study visits/procedures
* Participant has type 1 diabetes mellitus or uncontrolled type 2 diabetes mellitus
* Participant has known immunosuppression
* Participant has platelet or coagulation disorders
* Therapy with another investigational agent within 30 days of Visit 1 that has not been approved
* Systemic infection at the time of enrollment in the study
* Currently receiving or have received recombinant human platelet-derived growth factor or similar therapies, or other bioengineered tissue therapy within the previous 4 weeks
* Participant has an allergy or intolerance to any ingredient in the study product
* Participant is taking nutritional supplement(s)/capsules/formulas for wound healing and is unwilling to discontinue therapy for the duration of the study
* Participation in another clinical study
Clinical Outcome of Two-piece Zirconia Implants in Immediate Implant Placement

The purpose of the study is to test whether a two-piece zirconia implant is as reliable in the indication of immediate implant placement as a standard titanium implant.


Eligibility Criteria:
Inclusion Criteria:

Patients giving informed consent to participate in the clinical trial and fulfil the following criteria will be included in the investigation:

1. good oral hygiene standard;
2. good general health;
3. 18 years or older;
4. non-smokers;
5. presence of single-tooth or multiple gaps in the mandible or the maxilla;
6. intact facial bone wall;
7. sufficient bone volume to support an implant of at least 10 mm length.
8. Teeth with removable periapical lesions are included.

Exclusion Criteria:

Primary exclusion criteria are as follows:

1. parafunctional habits;
2. active periodontitis;
3. smoking;
4. pregnancy;
5. acute or chronic medical conditions for which implant therapy has always been considered a contraindication: uncontrolled diabetes (HbA1c \>8.0%), mucosal disease, untreated periodontitis, immunological disorders, active malignancy, alcoholism, condition after radiation therapy to the head and neck area and antiresorptive therapy.

   Secondary exclusion criteria will be applied at surgical procedure:
6. loss of facial bone wall due to extraction procedure;
7. insufficient primary stability (less than 32Ncm insertion torque).
Evaluation of the Safety & Effectiveness of the Bausch & Lomb AKREOS® TL Intraocular Lens

This study is to evaluate the safety and effectiveness of the Bausch \& Lomb Akreos TL (thin lens) intraocular lens (IOL) following implantation in adults requiring cataract surgery.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must have a clinically documented diagnosis of age-related cataract that is considered amenable to treatment with standard phacoemulsification/extracapsular cataract extraction.
* Subjects must be undergoing primary intraocular lens implantation for the correction of aphakia following continuous curvilinear anterior capsulotomy and phacoemulsification cataract extraction.
* Subjects must require a lens power from 15 to 30 diopters.
* Subjects must have a visual potential of 20/40 or better in the study eye.

Exclusion Criteria:

* Subjects with any anterior segment pathology for which extracapsular phacoemulsification cataract surgery would be contraindicated.
* Subjects with any inflammation or edema (swelling) of the cornea.
* Subjects with uncontrolled glaucoma or glaucoma under current treatment in the study eye or with ocular hypertension.
* Subjects with previous retinal detachment.
* Subjects with diabetic retinopathy (proliferative or non-proliferative).
* Subjects with rubella, bilateral congenital, traumatic, or complicated cataract.
* Subjects who have had previous ocular surgery in the planned operative eye, excluding ocular adnexa surgery.
* Subjects who have already received an Akreos TL IOL in the fellow eye.
Study on the Prognostic Prediction Model of Patients With Acute Intracerebral Hemorrhage by Artificial Intelligence

Spontaneous intracerebral hemorrhage(SICH) is the most lethal and disabling stroke. Timely and accurate assessment of patient prognosis could facilitate clinical decision making and stratified management of patients and is important for improving patient clinical prognosis. However, current studies on the prediction of prognosis of patients with SICH are limited and only include a single variable, with less precise results and inconvenient clinical application, which may lead to delays in effective patient treatment. Our group's previous studies on SICH showed that hematoma heterogeneity and the degree of contrast extravasation within the hematoma are closely related to the clinical outcome of patients, but they are difficult to describe quantitatively based on imaging signs. Based on this, we propose to use radiomics to quantitatively extract hematoma features from NCCT and CTA images, combine them with patients' clinical information and laboratory tests, study their relationship with the prognosis of cerebral hemorrhage, and use artificial intelligence to establish a rapid and accurate prognostic prediction model for patients with SICH, which is of great significance to guide clinical individualized treatment.


Eligibility Criteria:
Inclusion Criteria:

* 1. aged 18-80 years; 2. patients diagnosed with acute cerebral hemorrhage by CT examination; 3. complete non-contrast CT and CTA images; 4. the time interval from onset to the first baseline CT and CTA examination is less than 6 hours; 5. follow-up data within 3 months; 6. agree and sign a written document.

Exclusion Criteria:

* 1. Patients with secondary aneurysm hemorrhage; 2. Patients with secondary hemorrhage of cerebrovascular malformation; 3. Patients with dissecting aneurysm hemorrhage; 4. Patients with cerebral infarction hemorrhage transformation; 5. Patients lost to follow-up within 3 months; 6. CT or CTA images have a heavy artefact.
Exercise Intervention for LGBT Cancer Survivors

The purpose of this study is to test preliminary efficacy, as well as acceptability and feasibility, of a dyadic exercise intervention, the current study will randomize LGBT cancer survivors and their non-professional caregivers as dyads to either an individual or a dyadic Exercise for Cancer Patients (EXCAP) intervention. The primary outcome assessed will be psychological distress. Analyses will involve pre-post comparisons of outcomes across the study arms, testing the hypothesis that a 6 week, daily, dyadic exercise intervention will result in greater improvements in psychological distress than an individual intervention.

The proposed randomized controlled trial aims to recruit 70 lesbian, gay, bisexual, and transgender (LGBT) cancer survivors who have completed treatment (surgery, radiation, or chemotherapy) within the past 24 months, so as to have a final, evaluable sample of 60 LGBT survivors after attrition. The proposed RCT will also recruit caregivers (broadly defined) of the above cancer survivors. Each recruited cancer survivor will be asked to name a person who they feel provided care (emotional, informational, tangible, etc.) during their cancer experience, with no further strictures placed on this relationship in terms of type or duration. The caregiver will be approached to participate in the RCT. Thus the sample will consist of 70 LGBT survivors (60 evaluable) and their caregivers (140 individuals total/120 evaluable). Recruitment and primary analyses will specifically target the LGBT cancer survivor.

All data will be gathered from participants 21 years of age or older. Participants are cancer survivors who have completed treatments or caregivers of cancer survivors; both survivors and caregivers are able to read and understand English.

Eligibility Criteria:
Inclusion Criteria:

* (Survivors): To be included in the study, cancer survivors must:
* Have had a diagnosis of cancer (any cancer type excluding squamous and basal cell \[skin cancers\]) and have completed primary surgery, chemotherapy, and/or radiation (those on continued adjuvant treatment are still eligible),
* Identify as lesbian, gay, bisexual, or transgender, or have a same-sex romantic partner,
* Have a caregiver willing to participate in the study (defined as anyone who provided emotional support or tangible assistance during the survivors' cancer experience),
* Be able to read English,
* Be 21 years of age or older, and
* Give written informed consent.
* (Caregivers): Caregivers must:
* Be nominated by a cancer survivor,
* Be able to read English,
* Be 21 years of age or older,
* Give written informed consent.

Exclusion Criteria:

* Have physical limitations (e.g., cardiorespiratory, orthopedic) contraindicating participating in a low- to moderate-intensity home-based walking and progressive resistance program and physical function testing, as assessed by their medical oncologist, their primary care physician, and/or the study medical monitor (or any of these three physicians' designees),
* For caregivers, be currently undergoing active treatment for cancer.
Phenotypic and Molecular Characterisation of Cerebral Amyloid Angiopathy

Cerebral Aβ amyloid angiopathy is a severe disease characterised by amyloid deposits in the cerebral vessels, manifested mainly by recurrent cerebral haematomas and cognitive impairment. Diagnostic criteria are based on brain imaging, but the usefulness of this imaging in predicting the course of the disease remains undetermined. The genetic component is largely understudied. Less than 5% of patients carry mutations or duplications of the APP gene. Susceptibility factors such as APOE genotypes and rare variants recently discovered in Alzheimer's disease within the SORL1, TREM2 or ABCA7, ABCA1 and ATP8B4 genes could play a role in the pathophysiology of cerebral amyloid angiopathy. There is currently no specific treatment available. Based on a national recruitment of patients with cerebral amyloid angiopathy, this project aims to assess the role of genetic variants in the diagnosis and progression of cerebral amyloid angiopathy. A better understanding of the mechanisms, particularly genetic, could help us to develop treatments in the era of gene therapy.

This research is carried out on the same blood sample taken during the treatment and sent to the Rouen University Hospital Genetics Laboratory for research into point mutations or duplication of the APP gene as part of the diagnosis of cerebral amyloid angiopathy (CAA). For each gene, the proportions of variant carriers will be compared between cases and controls using a Fisher exact test with R statistical software. To rule out any population stratification bias, the tests will also be carried out using logistic regression adjusted on the first PCA axes (principal component analysis) using the seqmeta function. A Bonferroni correction will then be used to adjust the significance threshold according to the number of genes tested.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of cerebral amyloid angiopathy (CAA) whose genetic samples are initially sent to the Rouen or Paris-Lariboisière genetics laboratories for molecular diagnosis of a genetic cause, thanks to national recruitment and for whom the patients consent to continuing genetic analyses for research purposes without feedback.
* Diagnosis of cerebral amyloid angiopathy (CAA) certain or probable according to the modified Boston diagnostic criteria (1) (except age)
* Age of onset of symptoms \<66 years
* Absence of APP mutation/duplication (analysis must already have been carried out in the laboratory on receipt of the sample as part of routine care)
* Signed consent for research
* Patient covered by a social security scheme

Exclusion Criteria:

* Age at first neurological symptom \> 66 years
* Minor patients
* Other differential diagnosis that better explains the clinical situation
* Identification of mutations or duplication of the APP gene
* AAC possible but not probable according to the revised Boston criteria
* Patient deprived of liberty by judicial or administrative decision
Pregnancy Ultrasound Satisfaction Scoring System

Sonographic imaging stands as the mainstay of fetal anatomical investigation and the primary screening tool for structural abnormalities early in pregnancy. This study aimed to evaluate the occurrence and effect of a cluster of maternal features on sonographic image quality and operator satisfaction.

This was a cross-sectional, single-center observational study of ultrasound scans performed on singleton pregnant women who underwent ultrasound imaging at 11-14 weeks and 19-21 weeks gestation. From March 2023 to March 2024, a convenience cohort of pregnant women who presented for prenatal care at the Fetal Medicine and Prenatal Diagnosis Unit of "Di Venere" Hospital in Bari (Apulia, Southern Italy) and the Obstetrics and Gynecology Unit of Vito Fazzi Hospital in Lecce (Apulia, Southern Italy) to receive routine gestational ultrasound was recruited for the present study.

The inclusion criteria were singleton pregnancy and the presence of one or more of the risk factors widely described in the literature as limiting features, i.e., excess weight (BMI\>24.9 Kg/m2), retroverted uterus, the presence of myomas, a previous abdominal surgery, and a limited echo absorption. No exclusion criteria related to women's gestational age or ethnicity were applied.

Eligibility Criteria:
Inclusion Criteria:

Pregnant women presenting one or more of the risk factors widely described in the literature as limiting features, i.e., excess weight (BMI\>24.9 Kg/m2), retroverted uterus, the presence of myomas, previous abdominal surgery, and limited echo absorption.

Exclusion Criteria:

* No limiting factors described above
* No pregnant women
Hybrid Construct Versus Pedicle Screw-only System for the Treatment Scoliosis

The placement of pedicular screws in spinal surgery has become the gold standard for scoliosis treatment. However, the use of sublaminar bands (SBs) on the apex of the curvature in idiopathic scoliosis (AIS) lowers the risk of neurological complications related to incorrect implementation of transpedicular screws into dysplastic pedicles without a cancellous channel. The latest research does not define a set of anatomical guidelines for applying SBs, nor does it use a dedicated classification system related to the structure of pedicles. The aim of this study was to assess the safety of the method and the correction attained through hypoplastic/aplastic pedicles when applying a hybrid instrumentation system to patients suffering from AIS Lenke type 1. Methods: Twenty patients were involved in a prospective, single-center, non-randomized case series study. The patients were assigned to the group "SCREWS" or "HYBRID" where SBs were used.

Adolescent idiopathic scoliosis (AIS) is a three-dimensional deformation of the spine. The goal of the treatment is to achieve a reduction in deformity, restoring proper alignment and the best possible function of the spine. Pedicular screw placement in spinal surgery has become the gold standard for scoliosis reduction techniques in the last 30 years \[6\]. The screw-only systems are relatively safe, as various authors have proven. However, if implemented incorrectly, the screws increase the risk of damage to nervous or vascular structures and internal organs. The latest research does not define a set of anatomical guidelines for applying SBs, nor does it use a dedicated classification system related to the structure of pedicles. The aim of this study was to assess the safety of the method and the correction attained through hypoplastic/aplastic pedicles when applying a hybrid instrumentation system to patients suffering from AIS Lenke type 1. Methods: Twenty patients were involved in a prospective, single-center, non-randomized case series study. The patients were assigned to the group "SCREWS" or "HYBRID" where SBs were used. The inclusion criteria were this being the patients' first scoliosis operation due to AIS (Lenke type 1) and age under 18 years. The primary measured outcome involved correction efficacy, defined as the Cobb score baseline to endpoint change.

Eligibility Criteria:
Inclusion Criteria:

* idiopathic scoliosis (AIS)
* Lenke type 1

Exclusion Criteria:

* AIS other than Lenke type 1 (neurogenic, congenial, or syndromic curvatures)
* abnormalities in the structure of the central nervous system in the MRI image
* advanced chronic respiratory or circulatory failure
* emergency surgery
* reoperation
Combined Focused Ultrasound and Calcium Hydroxylapatitie Filler for Skin Laxity and Volume Restoration

Non-invasive treatment options such as focused ultrasound has been used with success for the treatment of skin laxity in various parts of the body including the face, neck, décolletage, arms, buttocks, thighs, and legs. With the increasing demand for greater results, researchers have started combining modalities together such as focused ultrasound and intradermal filler, with promising effects for skin laxity and volume restoration. This study aims to elucidate the efficacy and added benefits of a combination therapy using focused ultrasound (Ulthera) and calcium hydroxylapatite (Radiesse) for the treatment of skin laxity and volume restoration of the lower thighs, specifically the lower anterior third of the thigh.


Eligibility Criteria:
Inclusion Criteria:

1. Exhibit skin aging and laxity that will benefit from treatment as determined by the investigator/physician.
2. Subjects between the ages of 18-85 years old, at the time of consent.
3. Subjects may be male or female.
4. Subjects can be of any Fitzpatrick Skin type (I-VI).
5. Subjects must be able and willing to give written informed consent and to comply with the requirements of this protocol. The consent form has been standardized in English. For those patients who do not read and understand English, a consent form will be standardized and provided in a language that they read and understand.

Exclusion Criteria:

1. Children and adolescents (less than 18 years old).
2. Subjects who are not willing or able to provide written consent.
3. Individuals with any significant medical history including skin disorders and eating disorders as determined by the investigator/physician.
4. Subjects on any substances affecting blood coagulation (including but not limited to aspirin and other non-steroid anti-inflammatory drugs, warfarin, vitamin E, fish oil, heparin, low-molecular weight heparin, novel anti-coagulants).
5. Subjects with known blood coagulopathies.
6. Subjects with a compromise of local blood supply (including but not limited to recent surgery, severe scarring, autoimmune diseases involving the lower thigh such as lupus, morphea, sarcoid or mixed connective tissue disease).
7. Subjects who have received any treatment for skin laxity or liposuction in the last 12 weeks.
8. Subjects who have experienced an increase or decrease in body weight of more than 10% in the past 24 weeks.
9. Subjects who have a known hypersensitivity reaction to calcium hydroxylapatite or the components of the filler product.
10. Subjects with open wounds in the area of ultrasound treatment.
11. Subjects with pacemakers and/or electronic device implants in the area of ultrasound treatment.
12. Female patients who are planning a pregnancy, currently pregnant or nursing.
Effects of Active Gamification on Sleep and Anxiety in Primary School Children

Active gamification, which incorporates game elements with physical interaction, is presented as an innovative strategy to address anxiety problems and sleep quality in children. There is evidence to suggest that physical activity and structured play can positively influence emotional regulation and sleep hygiene, which makes it relevant to explore interventions based on this methodology within the educational field. This study aims to evaluate the impact of an active gamification program on these variables in children in Primary Education. To do so, a randomized controlled trial will be carried out with the participation of 120 children between 8 and 11 years of age. Participants will be randomly assigned to one of two groups: an experimental group, which will participate in a program designed to promote physical activity through game dynamics for 12 weeks, and a control group, which will continue with traditional physical education classes without modifications to their usual methodology. The implementation of the program includes structured sessions with activities designed to encourage interaction, movement and decision-making within a playful environment, in order to enhance children's commitment and adherence to the intervention.


Eligibility Criteria:
Inclusion Criteria:

* Age between 8 and 11 years
* No medical contraindication for physical activity
* No intellectual disability that could interfere with understanding or compliance with the study procedures; and iv) informed consent from parents or legal guardians.

Those students who did not meet the inclusion criteria were able to participate in the intervention with their peers, but were not considered in the analysis.

Exclusion Criteria:

* Diagnosis of neuromotor disorder or severe physical disability that limits participation in the scheduled physical activity
* Presence of severe psychological or behavioral disorders that make integration into group activities difficult.
* Use of medication that significantly affects physical or cognitive performance.
* Failure to attend more than 20% of the intervention program sessions
* Withdrawal of informed consent by parents or legal guardians during the study
The Treatment of Coronary De-novo Lesions With the Elutax Paclitaxel-eluting Balloon Alone, a Pilot Study

A randomised open-label pilot study to assess the safety and efficacy of treatment with a drug eluting balloon alone in coronary de novo lesions). Elective patients requiring PCI to coronary de novo lesions in vessels 2.5 mm - 4.0 mm.


Eligibility Criteria:
Inclusion Criteria:

* Patient ≥ 18years old
* Stable angina symptoms
* Elective treatment to coronary lesion
* Reference vessel diameters of ≥ 2.5mm and ≤ 4.0 mm on visual inspection

Exclusion Criteria:

* Left main stem lesion
* Bifurcation lesions
* Acute coronary syndrome (UAP, NSTEMI, STEMI)
* Cardiogenic shock
* Chronic total occlusion
* Additional lesions requiring PCI
* Platelet count ≤ 50 x 109/mm3
* Left ventricular ejection fraction ≤ 30%
* Patient life expectancy less than 12 months
* Known allergies to aspirin, clopidogrel, prasugrel, heparin, stainless steel, intravenous contrast (severe), or paclitaxel
* Participation in another investigational drug or device study
* Patient unable to give informed consent