cyrilzakka/clinical-trials huggingface dataset:
Resilient Together for Dementia (RT-D)

This study will evaluate the feasibility and preliminary efficacy of the novel Resilient Together for Dementia (RT-D) intervention for couples following dementia diagnoses. The primary target is emotional distress, and the program aims to prevent chronic distress in at-risk couples.

Both persons living with dementia and their spousal care-partners experience high levels of clinically elevated emotional distress, which can become chronic without treatment and negatively impact the health, quality of life, communication, and care-planning of both partners. A tailored dyadic intervention, such as the proposed Resilient Together for Dementia, delivered over live video to this at risk population has the potential to prevent chronic emotional distress and preserve quality of life for PWDs and their loved ones.

A pilot feasibility randomized control trial (RCT; Aim 3; NIA Stage 1B; N=50 dyads) will be conducted of the refined RT-D versus a minimally enhanced educational control (MEUC, educational pamphlet). Primary outcomes will be feasibility, credibility, and acceptability markers to inform a hybrid efficacy effectiveness R01 (year 4) of RT-D vs. MEUC (NIA Stage II). In this subsequent R01, the researcher will examine RT-D's impact on emotional distress and quality of life outcomes and test mechanisms of change (individual and interpersonal resiliency skills) through mediation and moderation. The researcher will revise the approach if feasibility benchmarks are not met.

Eligibility Criteria:
Inclusion Criteria:

* Recent (\~3 month) chart documented ADRD diagnosis,
* ADRD symptom onset after age 65
* Cognitive assessment scores and symptoms consistent with early stage dementia, as determined by the Clinical Dementia Rating Scale scores of .5 or 1.0
* Cognitive awareness of their problems (as determined by the treating neurologist), and ability to understand study and research protocol, as determined by a standardized teach-back method assessment

Additional inclusion criteria for dyads are:

* English speaking adults (18 years or older)
* Dyad lives together
* At least one partner endorses clinically significant emotional distress during screening (\>7 on Hospital Anxiety and Depression scale subscales or \<5 on the Geriatric Depression Scale)

Exclusion Criteria:

* Patient is deemed inappropriate by the neurology team
* Either partner has a co-occurring terminal illness
* Patient was diagnosed with forms of dementia with clinical profiles that would preclude participation (e.g., Frontotemporal Dementia- behavioral variant), as determined by treatment team.
Molecular-Based Selection of Patients with Head and Neck Squamous Cell Carcinoma: Biomarker Analysis

This is an observational, prospective study enrolling patients who meet the inclusion criteria and provide consent for the use of biopsy samples collected as part of standard clinical practice. The analysis will focus on the following biomarkers: TP53, P16, Cyclin D1, EGFR, Akt, PDL-1, and ERCC1.

These biomarkers will be examined in both observation groups.

The primary objective of this project is to evaluate the prognostic role of the biomarker P53, as numerous studies suggest its association with poor prognosis. This analysis will be particularly relevant for p16-positive (HPV-related) patients, who are currently considered a good prognosis category. The study aims to determine whether cases with overexpression of both p16 and P53 deviate from this assumption.

A secondary objective is to validate a molecular signature in clinical practice, composed of multiple biomarkers, to assess whether specific combinations can predict treatment response.

The biomarkers TP53, P16, Cyclin D1, EGFR, Akt, PDL-1, and ERCC1 will be analyzed on biopsy samples from patients with newly diagnosed, locally advanced squamous cell carcinoma of the head and neck.

The study population consists of patients with locally advanced Head and Neck Squamous Cell Carcinoma who have an available biopsy sample collected as part of standard clinical practice. The groups will be classified based on the treatment received:

* Group A: Patients undergoing surgery followed by chemoradiotherapy.
* Group B: Patients receiving exclusive chemoradiotherapy with CDDP, CBDCA, or Cetuximab.

Eligibility Criteria:
Inclusion Criteria:

1. Patients aged \> 18 years
2. Written informed consent approved by the competent Independent Ethics Committee
3. Histopathological diagnosis of squamous cell carcinoma of the head and neck region originating from one of the following organs or structures: Oral cavity, oropharynx, larynx, hypopharynx
4. Locally advanced stage: from T1N1M0 to T4N3M0
5. Availability of a tissue sample from a biopsy performed according to clinical practice guidelines.

Exclusion Criteria:

1. Recurrent/metastatic disease
2. Presence of a synchronous second tumor
Epidemiology of Incidents and Accidents in Sport. Influence of Moisture.

sports accidents and incidents are relatively frequent. We hypothesize that the pursuit of good hydration, including days without training or competition could prevent their occurrence

Main objective: to show, among practicing sports club that regular hydration, including days without competition may prevent the occurrence of an incident or accident during sport.

Primary endpoint: number of accidents and sport incidents, - Adverse events and complications at 3 months and 6 months.

EXPERIMENTAL PLAN: randomized clinical trial of two groups of athletes:

* dismissed the first group consume water from Aix-les-Bains in quantity defined during the 6 months of the study.
* Licensees 2nd group (control group) will have a free hydration, at their convenience and habits during the 6 months of the study. They will be able, if they wish to receive water from Aix within 3 months of the study.

NATURE OF TREATMENT: daily intake of Aix 1.5l water baths according to European recommendations (1 liter for children under 16 years) POPULATION STUDIED

Features licensees:

* Licensee aged 10 to 80 years;
* Practitioners sport regularly at a health club Number of members: as this is a pilot study will enroll a maximum of volunteers in each of the two clubs, a staff of 50 athletes per group is expected.

STATISTICAL ANALYSIS The variables are described (number and frequency for categorical variables, mean, standard deviation, median and confidence interval for continuous quantitative variables). The initial comparability of the two groups will be tested.

The primary endpoint will be analyzed using a Chi-square test without continuity correction if the validity conditions are true or if otherwise by Fisher's exact test. The usual additional criteria (relative risk and 95) will be presented.

For the analysis of quantitative secondary endpoints, the Student t-test will be used. If distribution does not meet the normal distribution, the nonparametric Mann-Whitney will be used. The percentage change in the activity score between baseline and 6 months 3 months will be calculated.

The qualitative evaluation criteria will be analyzed by Chi-square test without continuity correction if the conditions of validity is checked or if otherwise by Fisher's exact test.

An analysis of variance with repeated measures (comparison Inclusion- 3 months - 6 months) will be made on the physical activity score taking into account the treatment factor and interaction repetitions X treatment.

Eligibility Criteria:
Inclusion Criteria:

* Sports practitioners aged 12 to 80 years;
* Enrolled in one of two clubs participating in the study

Exclusion Criteria:

* Pregnant or breastfeeding.
* Major Licensee protected by law or deprived of liberty by administrative and judicial decisions;
* Licensee with an contra-indication for drinking water of Aix (anuric renal failure for example)
* Having dismissed contra-indication for sport practice (unlikely event, regulation of clubs requiring a medical certificate)
CINSARC Genomic Signature as Predictor of Resectability of Ovarian Adenocarcinoma

The majority of primary cancers of the ovary or peritoneum are represented by high-grade serous adenocarcinomas. These are rare pathologies, the incidence of which is estimated at 7.1 per 100,000, representing approximately 4,500 new cases per year in France (INCA 2017). In the absence of effective screening, nearly 85% of patients have an advanced disease at diagnosis (corresponding to the FIGO III or IVA stage, characterized by diffuse peritoneal involvement). Despite multidisciplinary care, the majority of patients (80%) will recur within a median of 18 to 24 months.

It is therefore necessary to develop new tools, in particular molecular, in order to allow :

* to better select patients accessible to full interval surgery
* to exclude patients who would not benefit from this surgery in terms of survival

In 2010, Chibon et al. identified, from a cohort of patients with soft tissue sarcoma (STM), a molecular signature (called CINSARC), based on the expression profile of 67 genes involved in mitotic control and chromosomal integrity. The team showed that this transcriptomic signature is an independent prognostic factor in different types of STM, but also a prognostic factor more discriminating than the histological grade (FNCLCC), historical and major prognostic factor of STM.

Being initially made from frozen material and on a DNA biochip (Affymetrix), this signature was unusable outside the field of fundamental research. This is why CINSARC has been gradually optimized, first by the RNA sequencing technique on frozen tissue fixed in formalin (FFPE), and recently on FFPE tissue by the NanoString® technique. This very sensitive and inexpensive technique requires only small amounts of total RNA, making it compatible with use on "routine" diagnostic samples, microbiopsy or surgical biopsy, opening the door to real clinical application. Several clinical studies using this latest CINSARC optimization (called NanoCind®) to determine the treatment of patients with STM will also begin soon.

As a result of this work, necessary in order to more precisely support the potential of CINSARC in this pathology, the investigators hope to be able to assess from the diagnosis the evolutionary potential of the patients, which could make it possible to evaluate therapeutic strategies adapted to the profiles of each subpopulation: the investigators can for example imagine in theory a therapeutic de-escalation for low-risk patients, or else, for very high-risk patients, an intensified strategy.

RNA extraction from 150 patients archival tumor, fragments of 50 to 300 nucleotides size.

RNA preparation, hybridation, detection, scanning according to Nanostring manufacturer recommandations: obtention of CINSARC molecular signature Sensibility, specificity, prognostic value of the signature will be analyzed

Eligibility Criteria:
Inclusion Criteria:

* Patients with ovarian adenocarcinoma treated in IUCTO Toulouse by primary chemotherapy and for whom diagnosis tumoral sample is available

Exclusion Criteria:

* None
Single-blind, Dose-ranging Study of Novel Swine Influenza Virus Vaccine in Japanese Pediatric Subjects

This study is to identify the preferred vaccine dosage (of antigen and adjuvant) and schedule (one or two administrations) of the cell-derived H1N1sw monovalent vaccine in healthy children/adolescents based on European Medicines Agency's Committee for Medicinal Products for Human Use (EMEA/CHMP) criteria, and safety and tolerability.

This is a multi-center, randomized, single-blind, dose-ranging study. Subjects were randomized at a 1:1 ratio to receive either 3.75μg of cell-derived H1N1sw vaccine formulated in half (i.e., half the content of the European-licensed adjuvanted seasonal influenza vaccine) MF59 adjuvant (3.75_halfMF59) or 7.5μg of cell-derived H1N1sw vaccine formulated with full MF59 (7.5_fullMF59). Subjects were not informed of their allocated doses. Two vaccinations were administered IM three weeks apart. Subjects in both the vaccine groups were stratified into three age strata: 6 to 35 months, 3 to 8 years and 9 to 19 years. Blood samples were collected at day 1 (baseline), three weeks after the first vaccination (day 22) and three weeks after the second vaccination (day 43). Sera were tested by Hemagglutination Inhibition (HI) and Microneutralization (MN) assays. Local and systemic reactions were collected for the first week following each injection using Diary Card (i.e., day 1 to day 7 and day 22 to day 28). All adverse events (AE), serious adverse events (SAE), and AEs that led to withdrawal from the study and related prescription medications were collected for the entire study period.

Eligibility Criteria:
Inclusion Criteria:

* Healthy Japanese aged 6 months to 19 years

Exclusion Criteria:

* History of anaphylaxis, serious vaccine reactions, hypersensitivity to vaccine viral proteins or excipients
* Administration of adjuvanted influenza vaccine or suspected influenza disease within 3 month prior to study start
* Administration of any other vaccines within 4 weeks prior to enrollment expect for seasonal influenza vaccines within 1 week
* History of progressive or severe neurological disorders
Self-Compassion for Children and Caregivers

The Self-Compassion for Children and Caregivers Study aims to understand if an online course designed to help kids and their caregivers learn self-compassion is feasible, enjoyable, and helpful for well-being and relationships in families from diverse backgrounds. Children ages 8-11 who have a caregiver willing to participate with them will:

* Attend 2 in-person study visits (about 1-1.5 hour each) that includes

  * A survey for caregiver and child
  * A brief computer puzzle challengetask while heart rate and sweat is recorded (child)
  * A brief discussion about how the challenge went
* Participate in a 6-session, online self-compassion course with other families (see back)
* Provide feedback about how the course went

This pilot study examines the feasibility, acceptability, and preliminary outcomes of the Self-Compassion for Children and Caregivers (SCCC) program. Twenty-four children ages 8-11 and a primary caregiver will be recruited from a racially diverse school community to participate in 6 1-hour group intervention sessions over 6 weeks. Feasibility and acceptability data will guide program refinements; pre and post assessments will explore dimensional changes in anxiety/depression symptoms as well as potential physiological, relational/behavioral changes associated with SCCC participation.

Eligibility Criteria:
Inclusion Criteria - English speaking:

* Youth between the ages of 8 and 11 years old
* Youth are currently attending an elementary school in the Madison Metropolitan School District (MMSD).
* Accompanied by a willing and able caregiver (e.g., parent, grandparent, legal guardian)
* Access to an internet-enabled device
* Both parent and youth participants must be able to read/write in English
* Meet threshold (T greater than 59) for clinically significant anxiety and/or depression from either parent- or youth-report of symptoms

Inclusion Criteria - Spanish speaking:

* Youth between the ages of 8 and 11 years old
* Accompanied by an eligible caregiver participant
* Safe access to a computer or mobile device that can connect to the internet
* Visual acuity adequate to read text on a computer or mobile device
* Able to provide assent and complete surveys in Spanish

Exclusion Criteria - English speaking:

* Are unable to provide adequate informed consent and/or assent
* Parent or youth that is currently impaired by any medical condition that would prevent study participation
* Active self-reported psychotic disorder
* Current use of psychotropic medication is not exclusionary. However, certain medications that may impact physiology recordings may be excluded (e.g. those with direct impacts on the sympathetic nervous system). Exclusionary medications will be decided on a case-by-case basis, per discretion of the PI, a pediatric psychiatrist

Exclusion Criteria - Spanish speaking:

* Previous completion of a Mindfulness and Self-Compassion for children and Caregivers (MSC-CC) program
Comparing the Effect of Toe-in Gait Modification Along With Conventional Physiotherapy in People With Medial KO

Medial knee osteoarthritis (OA) remains a prevalent and debilitating condition, despite conventional physiotherapy interventions aimed at reducing pain and improving function. This study investigates the additional benefits of toe-in gait modification when combined with conventional physiotherapy in individuals with medial knee OA. Rooted in biomechanical theories suggesting that altering gait patterns can reduce medial knee load, this research employs a randomized controlled trial methodology.

Participants are divided into two groups: one receiving conventional physiotherapy alone, and the other receiving a combination of conventional physiotherapy and toe-in gait modification. Outcomes are assessed over a 8-week period, focusing on pain levels and physical function. The significance of this study lies in its potential to enhance current treatment protocols, offering a more effective, non-invasive intervention to alleviate symptoms and improve the quality of life for those suffering from medial knee OA. The findings could inform clinical practices and pave the way for personalized rehabilitation strategies that incorporate gait modifications, ultimately reducing the healthcare burden associated with knee osteoarthritis.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of MKOA having Grade 1-3 (radiographic evidence of MKOA)
* Knee pain on most days of previous month. (The most symptomatic side will consider the study limb for participants with bilaterally eligible knees)
* Age \> 45
* Ability to walk unaided for at least 25 min
* Gender eligibility both male and female

Exclusion Criteria:

* Severe MKOA (Grade 4)
* Lateral OA
* Patella femoral OA
* Previous or planned hip or knee surgery
* Hip or ankle arthritis
* Rheumatoid arthritis
* Severe valgus and varus alignment requiring the use of an assistive device and the inability to walk independently
* Neurological dysfunction
Postoperative Pain Following Restoration With Composite Resin Versus Sonic Fill

The aim of this study is to assess the postoperative pain following restoration with composite resin versus sonic fill in children with deep carious first permanent molar.

For many years, composite resin restorations have been considered an acceptable treatment choice for anterior applications. Recent advances in composite resin mechanical properties and improved adhesive systems have broadened the application of these materials to include the restoration of posterior teeth. However, it is still generally accepted that posterior composite resin restorations have limitations and that there is no ideal material available. A volumetric shrinkage occurs when a composite resin material is cured. The shrinkage is the result of conversion of monomer molecules into a more dense polymer network, which leads to bulk contraction. A new nanohybrid composite activated by sonic energy has been recently introduced as a single-step, bulk-fill restorative material. This system utilizes the patented sonic-activation technology enabling a rapid flow of composite into the cavity for effortless placement and superior adaptation in one single layer, thereby, emphasizes its practical and efficient technique for placing posterior composites. The hand piece, designed by KaVo (Germany), delivers sonic energy at varying intensities, which is adjusted on the shank from low to high (1 to 5) to control rate of composite extrusion.

Eligibility Criteria:
Inclusion Criteria:

* Asymptomatic First Permanent Molar
* Age of the patient ranging from 6-9 years
* Normal periodontal status
* Teeth with no previous restorative treatment
* Good oral health
* Absences of pathological mobility

Exclusion Criteria:

* Adverse medical history
* Potential behavioral problems
* Parents refusing participation of their children
Dural Graft Equivalent Comparison Trial

This research study is to find out which types of dural grafts used during surgery for Chiari Malformations are superior. We believe that autologous dural grafts are superior to non-autologous grafts.

The study compares autologous grafts vs. non-autologous grafts. Non-autologous grafts include synthetics and grafts from animals. Autologous grafts have a better side-effect profile than non-autologous grafts. We believe this improved side-effect profile will result in a decreased incidence of reoperation for post-operative infections and post-operative fluid collections (pseudomeningoceles and seromas). Study is open to all non-pregnant minor and adult subjects. Subjects must have symptomatic Chiari Malformation described as \> or equal to 6mm descent of the cerebellar tonsils below the foramen magnum with accompanying headaches and/or neurologic findings (arm pain/weakness, myelopathy, etc.). After the 12-month follow-up is completed on the first 100 subjects there will be an interim analysis of the results in order to determine whether one of the treatments has a statistically superior outcome. If a statistically superior outcome is noted, the trial will stop after being reviewed by a data monitoring committee. If no statistically significant difference is seen at one year, the study will continue until the 12-month follow-up is completed on the 200th patient.

Eligibility Criteria:
Inclusion Criteria:

* Minor or adult males and females
* Symptomatic Chiari Malformation
* Greater or equal to 6mm descent of the cerebellar tonsils below the foramen magnum
* Headaches and/or neurologic findings (e.g., arm pain/weakness, myelopathy, etc.)

Exclusion Criteria:

* Pregnancy
The Effect of Subsartorial Saphenous Block on Postoperative Pain Following Major Ankle and Hind Foot Surgery

The study investigates the effect of a ultrasound-guided subsartorial saphenous block on postoperative pain following major ankle and hind foot surgery.

Major ankle and hind foot surgery causes intense postoperative pain. Implementation of continuous sciatic catheters has been a great success in reducing postoperative pain following these operations, but despite an effective sciatic catheter patients still report moderate to severe pain from the anteromedial side of the ankle. According to cadaver dissection studies the saphenous nerve innervates the anterior and medial parts of the ankle and talonavicular joint, and even though a saphenous block is standard procedure in many departments of anesthesiology worldwide, scientific evidence regarding the effect of the saphenous block on postoperative pain is lacking.

This study investigates the effect of a selective, ultrasound-guided subsartorial saphenous block on postoperative pain following major ankle and hind foot surgery.

Eligibility Criteria:
Inclusion Criteria:

* Elective ankle or hind foot surgery either: (1) total ankle arthroplasty, (2) ankle arthrodesis (3) subtalar arthrodesis or (4) triple arthrodesis
* Age ≥ 18
* American Society of Anaesthesiology Classification I-III
* Informed consent both orally and in writing after the patient has fully understood the protocol and its limitations.

Exclusion Criteria:

* Communication problems or dementia
* Allergies to any medical product used in the study
* Neuropathy of the sciatic or femoral nerve prior to the operation
* Morbus Charcot-Marie-Tooth disease, diabetic neuropathy, peripheral vascular disease
* Daily use of opioids
* Coagulation disorders
* Infection at the site of injection or systemic infection