cyrilzakka/clinical-trials huggingface dataset:
Study Comparing Arthrodesis Technique of Thoracic and/or Lumbar Spine by Posterior Approach Performed by Robot-assisted Surgery (Robot Mazor X Stealth ™) Versus Conventional Surgery

Osteosynthesis by pedicle screwing is the reference technique since the 1980s, due to the quality of the mechanical grip of the screw in the pedicle, despite difficulties of placing the implant in this narrow tunnel.

This precision was improved by fluoroscopy, then by navigation, which made it possible to reduce the extra-pedicular placement of the screws and consequently the complications.

Since the 2000s, robotic has been developed in all areas, including medicine and surgery, (Da Vinci robot in urology) and several robots are currently marketed for spinal surgery, Medtronic's Mazor X Stealth ™ robot being the most successful.

The aim of this study is to evaluate on a prospective randomized comparative study the quality of the placement of the screws as well as the occurrence of complications, the clinical results and the medico-economic interest that robotic surgery can bring.


Eligibility Criteria:
Inclusion Criteria:

* Male, female, over 18 years old,
* Any patient operated for thoracic and/or lumbar spine arthrodesis (spondylolisthesis, asymmetric disc disease, spinal instability, spinal deformities, advanced disc disease),
* Patient having given his free, informed and written consent to participate in the study,
* Patient able to answer questionnaires, able to communicate in the language of the country of the study,
* Negative pregnancy test,
* Patient affiliated to a social security scheme or beneficiary of such a scheme.

Exclusion Criteria:

* Minor,
* Psychological disorders,
* Addiction to analgesics,
* Chronic infection,
* History of instrumented lumbar surgery,
* BMI greater than or equal to 40kg/m²,
* Pregnant or breastfeeding woman,
* Patient participating in another clinical study,
* Protected patient: adult under guardianship, curatorship or other legal protection, deprived of freedom by judicial or administrative decision.
Validation of Instruments Used for Assessment of Dysphagia in Patients With Esophageal Cancer

This study validates 3 well known dysphagia scores for dysphagia due to malignancies of the oesophagus and gastro-oesophageal junction and to the Swedish language.

In the present study, our aim was to firstly, validate 3 commonly used scales for use in patients with dysphagia due to malignancy, and secondly, to validate them in the Swedish language. The 3 scales were: The Watson dysphagia scale, which was developed in studies on surgical treatment of reflux disease. It consists of questions about food with 9 different viscosity and solidity and the patient answer if they have problems with a specific food: never, sometimes or always when ingesting this. The scores are added and provides a range of 0-45 where 45 is the worst possible dysphagia. The Ogilvie score is a 5-graded scale 0-4 where 4 is total inability to swallow. The Goldschmid score is graded from 0-5 where 0 is inability to swallow and 5 is normal function. QoL was measured with validated instruments originating from the European Organization for Research and Treatment of Cancer (EORTC), which has a generic instrument that measures global QoL in patients with cancer (QLQ-C30) and a more symptom-specific instrument that is developed for cancer in the oesophagus and stomach (QLQ-OG25). These are well known, validated instruments that also have normal reference values for the healthy population. The symptom specific instrument QLQ-OG25 includes a dysphagia module consisting of 3 questions which is validated to malignant disease and food intake with the help of expert groups and deep interviews with patients.

Eligibility Criteria:
Inclusion Criteria:

* Cancer in the gastro-esophageal junction or in the esophagus
* Dysphagia
* Ability to fill in the questionnaires
* Written acceptance of the informed consent

Exclusion Criteria:

* Not for-filling inclusion criteria
* No consent
Suicide Prevention Program for Veterans Discharged From Community Care Settings

The goal of this pilot randomized controlled trial is to test an adapted suicide prevention program (the Building VA Engagement, Self-efficacy, and Social Support To Prevent Suicide or BESST) in rural Veterans discharged from community care mental health treatment settings. The main question it aims to answer is:

* Does BESST combined with standard care improve suicide-related outcomes among this population compared to standard care alone?

Participants will be assigned by change to a treatment group. Some will receive the BESST intervention combined with standard care, and some will receive standard care alone. All participants will be in this research study for up to three months.

Those receiving the BESST intervention will have:

* 1 one-hour brief educational session;
* Seven follow-up check-ins (\~30 minutes each)

All participants will have three assessment interviews where they will be asked about their mental health and treatment received outside of the VA.

The investigators will compare participants assigned to the BESST intervention combined with standard care vs participants assigned to standard care alone to see if the BESST intervention improves suicide-related outcomes.


Eligibility Criteria:
Inclusion Criteria:

* The patient was recently discharged from a VA community care mental health treatment setting
* The patient is at risk for self-harm
* Be a patient connected to the White River Junction VA Medical Center (VAMC), the Togus VA Medical Center (VAMC), or the Manchester VA Medical Center (VAMC);
* Be a Veteran;
* Be 18 years or older;
* Be able to speak English;

Exclusion Criteria:

* Unable to provide informed consent;
* The investigators do not plan to enroll any potentially vulnerable populations including prisoners, institutionalized patients, or involuntarily committed patients;
* Study physician deems the patient not clinically appropriate
Impact of Exenatide on Sleep in Type 2 Diabetes

The investigators propose a pilot study to test the novel hypothesis that Exenatide treatment in patients with type 2 diabetes results in improved sleep duration and quality and to explore the relationship between improvements in sleep and measures of metabolic and circadian function. This project would be the first to probe the relationship between incretin hormone regulation, duration and intensity of sleep, glucose tolerance and circadian dysfunction in diabetic patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of T2DM based on physician documentation according to established guidelines will be eligible.

Exclusion Criteria:

* Patients with unstable cardiac, neurological or psychiatric disease
* Women who are pregnant or report trying to get pregnant will be excluded.
* Patients treated for obstructive sleep apnea (OSA) will be excluded.
* Patients with established OSA will be included only if they have declined treatment of OSA.
* Patients with morbid obesity (BMI ≥ 40 gk/m2)
* Patients on insulin
* Patients already taking an incretin-based drug will not be included
* Patients with renal disease (creatinine clearance \<30 ml/min), gastroparesis and history of pancreatitis will also be excluded based on known possible adverse medication side effects.
* Patients taking an insulin secretagogue will be excluded.
* Patients with Hemoglobin A1c values greater than or equal to 10 will be excluded.
Fostering Healthy Futures for Teens: An RCT

This study will implement and evaluate a mentoring program designed to promote positive youth development and reduce adverse outcomes among maltreated adolescents with open child welfare cases. Teenagers who have been maltreated are at heightened risk for involvement in delinquency, substance use, and educational failure as a result of disrupted attachments with caregivers and exposure to violence within their homes and communities. Although youth mentoring is a widely used prevention approach nationally, it has not been rigorously studied for its effects in preventing these adverse outcomes among maltreated youth involved in the child welfare system. This randomized controlled trial will permit us to implement and evaluate the Fostering Healthy Futures for Teens (FHF-T) program, which will use mentoring and skills training within an innovative positive youth development (PYD) framework to promote adaptive functioning and prevent adverse outcomes. Graduate student mentors will deliver 9 months of prevention programming in teenagers' homes and communities. Mentors will focus on helping youth set and reach goals that will improve their functioning in five targeted "REACH" domains: Relationships, Education, Activities, Career, and Health. In reaching those goals, mentors will help youth build social-emotional skills associated with preventing adverse outcomes (e.g., emotion regulation, communication, problem solving). The randomized controlled trial will enroll 234 racially and ethnically diverse 8th and 9th grade youth (117 intervention, 117 control), who will provide data at baseline prior to randomization, immediately post-program and 15 months post program follow-up. The aims of the study include testing the efficacy of FHF-T for high-risk 8th and 9th graders in preventing adverse outcomes and examining whether better functioning in positive youth development domains mediates intervention effects. It is hypothesized that youth randomly assigned to the FHF-T prevention condition, relative to youth assigned to the control condition, will evidence better functioning on indices of positive youth development in the REACH domains leading to better long-term outcomes, including adaptive functioning, high school graduation, career attainment/employment, healthy relationships, and quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Teens with open child welfare cases placed in foster care, kinship care or living at home
* Starting 8th or 9th grade
* History of child maltreatment according to child welfare and court records
* Live within 35 minutes of the University of Denver (for mentoring feasibility)

Exclusion Criteria:

* Youth with a known history of severe violent behavior and/or sexual perpetration
* Youth who are deemed unsafe or unable to participate in a community-based mentoring program by their caseworker
* Incarcerated at baseline
* Moderate or severe developmental delay or physical disability
* Youth who are/will be parenting during the prevention program
Fast Tracking Impact on Fentanyl Consumption and Parents Satisfaction

The investigators are measuring fentanyl consumption in micrograms used during anesthesia for patients on fast track congenital cardiac surgeries

The investigators are measuring fentanyl consumed for both fast track and conventional corrective cardiac surgeries and also parents Parental Perceptions satisfaction with early child communication in ICU and impact of caudal anesthesia on extubation time our 2ry outcomes are the hospital and ICU length of stay

Eligibility Criteria:
Inclusion Criteria:

* patients diagnosed with congenital cardiac anomaly for surgical correction.
* age limit: child 3months of age to 18 years

Exclusion Criteria:

patients with any o the following:

* emergency surgeries
* redo surgeries
* complex surgeries
* patients weight less than 3kg
Plating Versus Nailing in Pediatric BB Forearm Fractures

A randomized controlled trial to compare between dual intramedullary nailing and dual plating trying to synthesis a high quality evidence study that can solve the conflict between the decisions.


Eligibility Criteria:
Inclusion criteria:

1. Both-bone Forearm Diaphyseal Fracture.
2. age more than or equal nine years old with open distal radius physis.
3. Simple transverse or short oblique fractures (2R2-A2,2R2-A3,2U2-A2,2U2-A3) according to OTA/ AO classification.

Exclusion criteria:

1. Neurovascular injury.
2. Open fractures
3. Comminuted fractures
4. Pathological fractures
Supreme LMA and Proseal LMA in Prone Anesthetized Patient

There is no significant difference about success rate of two devices.

There is no significant difference about success rate of two device: efficacy and safety

Eligibility Criteria:
Inclusion Criteria:

* American Society Anesthesiologists physical status I-III
* Patient undergo elective orthopedics surgery in prone position under general anaesthesia

Exclusion Criteria:

* Age \<15year
* Non-fast
* Morbid obesity (BMI \> 35kg/m2)
* Pregnancy
* Known or predicted difficult airway
* GERD
* History of laryngeal problem (injury,subglottic stenosis)
* Local pharyngeal problem (abscess,tumor)
* Poor dentation
* Pulmonary disease
Single-Cell Insights Into Diabetic Retinopathy Mechanisms

This study aims to uncover the cellular and molecular mechanisms of diabetic retinopathy through single-cell sequencing to identify new therapeutic targets.

The study will collect retinal tissue samples from 3 patients with advanced proliferative diabetic retinopathy who underwent prosthetic eye implantation and 3 normal cadaver donors. Additionally, aqueous humor, vitreous fluid, and plasma samples from patients with severe diabetic retinopathy requiring surgery and macular hole surgery patients without diabetic retinopathy will be analyzed using ELISA, qPCR, and Western Blot. These experiments will validate sequencing results and explore the pathogenesis of diabetic retinopathy to identify potential treatment targets.

Diabetic retinopathy is the leading cause of blindness among the working population worldwide. However, its pathogenesis is not fully understood, and effective prevention and treatment methods are limited. This study, initiated by Shanghai First People's Hospital, aims to explore the cellular and molecular mechanisms underlying its occurrence through methods such as single-cell sequencing, to identify new intervention targets. This study plans to collect retinal tissue samples from 3 patients each who underwent prosthetic eye implantation due to late-stage proliferative diabetic retinopathy blindness and from 3 normal cadaver donors at the Ophthalmology Department of Shanghai First People's Hospital for single-cell sequencing and bioinformatics analysis. Additionally, samples of aqueous humor, vitreous fluid, and plasma will be collected from 30 patients with severe diabetic retinopathy requiring surgery and from 30 macular hole surgery patients without diabetic retinopathy. These samples will be subjected to experiments such as ELISA, qPCR, and Western Blot to validate sequencing results, investigate the pathogenesis of diabetic retinopathy, and identify potential therapeutic targets.

Eligibility Criteria:
Inclusion Criteria :

* For the single-cell sequencing group: Patients with advanced proliferative diabetic retinopathy (PDR) resulting in blindness or ocular atrophy, who voluntarily opt for enucleation and ocular prosthesis implantation surgery, and have no systemic or local contraindications to surgery. For the validation group: patients with severe PDR lesions requiring vitrectomy, and who also have no systemic or local contraindications to surgery.
* Patients who voluntarily agree to participate in this clinical trial and sign the informed consent form.

Exclusion Criteria:

* Patients with severe systemic diseases such as autoimmune diseases or cancer
Positive Node Traced Before Neoadjuvant Chemotherapy (NAC)

To investigate this regression model by injecting and tracing carbon nanoparticles (CNs) into the fusion node prior to NAC in patients with breast cancer.

Guided by ultrasound, 0.3 mL of CNs suspension was injected in a fusion node prior to NAC in 110 patients with local advanced breast cancer. Patients underwent breast surgery and total axillary lymph node dissection following 2-6 cycles of NAC. The distribution by intercostobrachial nerves (ICBN) of positive nodes, black-stained nodes and lymphovascular invasion was investigated by response to NAC.

Eligibility Criteria:
Inclusion Criteria:

* invasive ductal carcinoma diagnosed by biopsy;
* clinically positive node diagnosed by contrast enhance computer tomography (CECT), the number of strengthened nodes at Level I ≥ 1 with the longest diameter of the strengthened node ≥ 2cm;
* NAC regimen followed the NCCN guideline;
* no prior history of breast cancer or other malignancies.

Exclusion Criteria:

* the cycle number of neo-adjuvant chemotherapy is equal to or less than 2
Patients' Opinions and Responses to the National Cancer Institute's Colorectal Cancer Risk Assessment Tool

Little is known about the impact of risk assessment tools on decision-making by patients and clinicians. In particular, even though the NCI Colorectal Cancer Risk Assessment Tool is one of the most prominent risk assessment tools available, no study has quantified its usability or impact on decision-making or uptake of screening. In this study, we will measure patients' satisfaction with the NCI CRC RAT, their perception of its usability and helpfulness, and its impact on their decision-making and behavior. In addition, we will assess the impact of adding information about their chance of having an advanced adenoma.


Eligibility Criteria:
Inclusion Criteria:

* Age 50-75 years old
* No colonoscopy performed in last 10 years, sigmoidoscopy in last 5 years, or fecal occult blood testing (including FIT) in last 1 year.
* Appointment with healthcare practitioner in upcoming month or within the past six months at one of five Indiana University Health primary care sites.

Exclusion Criteria:

* Undergoing workup for signs or symptoms consistent with colon cancer, such as weight loss, iron-deficiency anemia, change in bowel habits, or rectal bleeding.
* Enrolled in "Trial of a Computer-Based Presentation of Quantitative Information about Colorectal Cancer Screening"; Dr. Schwartz's study that recently completed enrollment.
* Diagnosis with any of the following conditions: Ulcerative colitis, Crohn disease, Familial adenomatous polyposis (FAP), Hereditary Nonpolyposis Colorectal Cancer (HNPCC), Personal history of colorectal cancer or adenomatous polyp
* Inability to speak and read English
PET-CT-based Study of Central Mechanisms of Cortical Metabolism in 18F-FDG and 18F-AV1451 Age-related Deafness

The participants were recruited from elderly subjects in the age range of 60-85 years and audiological assessments, cognitive function assessments, non-invasive brain imaging, behavioral assessments were collected from the normal control group, the elderly deaf non-hearing group and the elderly deaf hearing group according to the inclusion and exclusion criteria. The project aims to investigate the differences in auditory speech and cognitive function in age-related deafness at the behavioural level, and to investigate the central cortical metabolic mechanisms in age-related deafness at the brain imaging level.

The participants were recruited from elderly subjects in the age range of 60-85 years and audiological assessments (pure tone audiometry, speech audiometry), cognitive function assessments (Simple Mental State Examination MMSE scale, Montreal Cognitive Assessment Scale MoCA scale), non-invasive brain imaging (functional near-infrared spectroscopy fNIRS, EEG/ERP), behavioral assessments (functional near-infrared spectroscopy fNIRS, EEG/ERP, PET/CT, etc.) were collected from the normal control group, the elderly deaf non-hearing group and the elderly deaf hearing group according to the inclusion and exclusion criteria. The project aims to investigate the differences in auditory speech and cognitive function in age-related deafness at the behavioural level, and to investigate the central cortical metabolic mechanisms in age-related deafness at the brain imaging level.

Eligibility Criteria:
Inclusion Criteria:

* age\>50yrs，≤85yrs；
* Normal control group: normal hearing, no MCI, i.e. mean air conduction hearing threshold (0.5, 1, 2, 4 kHz) \< 25 dB HL, no air-bone conduction difference, MMSE score of 27-30; MoCA (corrected for educational attainment) score of 26-30;
* Elderly deafness without hearing aid group: patients diagnosed with elderly deafness, i.e. as a symmetrical, slowly progressive, binaural occurrence with age. hearing loss and reduced speech recognition with predominantly high frequency hearing involvement in the first place, with reference to the Expert Consensus on the Diagnosis and Intervention of Hearing Loss in the Elderly 2019 edition, mean air conduction threshold (PTA) \> 25 dB HL, mean air conduction hearing threshold at high frequency (HF-PTA) \> 25 dB HL, no poor air bone conduction, and no previous hearing aid use.
* No major neurological disorders, serious systemic diseases, family history of genetic predisposition, major psychological disorders.

Exclusion Criteria:

* Pure tone audiometric cues with an average pure tone hearing threshold (500Hz, 1kHz, 2kHz, 4kHz) \> 91dB HL.
* Excluding diseases such as noise deafness and drug-induced deafness.
* Basic information is incomplete.
Early Case Management on Recovery From a Cardiac Event in Women

Outpatient cardiac rehabilitation (CR) is an exercise-based lifestyle program for patients who have experienced a myocardial infarction, systolic heart failure, percutaneous revascularization or cardiac surgery. CR plays a key role in secondary prevention, which is the prevention of subsequent cardiac events. CR has been shown to reduce both cardiovascular mortality and one year hospital readmissions as well as improve quality of life, exercise capacity, and physical function. Although the benefits have been clearly established for cardiac patients, women are much less likely to attend CR than men. Based upon our own preliminary data (and the medical literature), attendance at CR is determined by factors that vary in their importance between men and women. These findings demonstrate that older age and poor social support are particular barriers to CR participation in women. This information can guide efforts to increase CR participation and adherence in women, areas which have received little study.

Case management (CM) has been effective at reducing cardiovascular risk and reducing hospitalizations amongst cardiac patients. Further, CM has been effective at promoting attendance in a variety of health related programs (for example, diabetes treatment or cocaine dependence treatment). The primary aim in this randomized controlled trial is to examine the efficacy of early CM to promote participation and adherence in CR. The CM model can identify individualized determinants of health and social needs to identify potential barriers which may hinder CR enrollment. Additionally, the case manager will conduct a home visit and provide individual counseling to address lifestyle changes including physical activity. Thus, a component of CR and physical activity can be still be delivered for those unable to attend CR. The concept of CM to improve CR participation and adherence has not been specifically tested in women, a vulnerable patient population. This intervention, therefore, has the potential to increase utilization of CR and significantly improve health outcomes in female cardiac patients.


Eligibility Criteria:
Inclusion Criteria:

-

Inclusion Criteria:

1. A cardiac rehabilitation qualifying condition including: A recent myocardial infarction or coronary revascularization or heart valve replacement or repair, stable angina, or congestive heart failure (ejection fraction \<35%)
2. Lives in and plans to remain in the greater Burlington, Vermont area for the next year.

Exclusion Criteria:

1. Severe dementia
2. Advanced cancer, advanced frailty, or other longevity-limiting systemic disease
3. Severe life threatening ventricular arrhythmias unless adequately controlled (e.g. intracardiac defibrillator)
4. Exercise-limiting non-cardiac disease such as severe arthritis, past stroke leading to paralysis
5. Participation in cardiac rehab within the past year