cyrilzakka/clinical-trials huggingface dataset:
International Multicenter Mycotic Aneurysm Aorto-iliac Study

The term mycotic aneurysm (MA) is commonly used to describe all infected aneurysms. Although MAs are believed to occur uncommonly, the true incidence is difficult to determine and is probably underestimated since MAs can be asymptomatic and are diagnosed only at autopsy. In an autoptic study, mycotic aortic aneurysms (MAAs) were reported in 3.3% of all detected aneurysms. The incidence of infected aneurysms of the aorta and iliac arteries ranges from 0.6% to 1.3%.

A recent literature review of the management of MAAs showed that therapeutic strategies are multiple, including open surgical repair (OSR) in the majority of cases, endovascular aortic repair (EVAR), which increased over the last decade, and medical treatment alone for patients unfit for any aortic repair in a very limited part. Following the unfavorable prognosis towards rupture and since the medical treatment alone in mycotic aneurysms has shown mortality of almost 100%, surgical treatment is generally the preferred option.

Surgical treatment includes both open and endovascular surgery. The latter is less invasive than conventional surgery but does not involve resection of the infected tissue and is therefore associated with an increased risk of sepsis and prosthesis infection. The gold standard is still open surgery, including extra-anatomic reconstruction and in situ repair, with different type of vascular graft.

This is a multicenter retrospective observational study. It will examine all patients undergoing surgical treatment of mycotic aortic-iliac aneurysms and in situ reconstruction at the participating centers.


Eligibility Criteria:
Inclusion Criteria:

* primary mycotic aorto-iliac aneurysm who underwent in situ repair

Exclusion Criteria:

* patient with vascular graft infections;
* patient with secondary aorto-enteric fistula.
Preventing Neck & Back Pain in Teleworking Office Workers: a Randomized Controlled Trial

The purpose of this study is to assess the effect of a general training program and educational session to prevent neck and/or low back pain in desktop workers

After being informed about the study and potential risks, all subjects that met the preset inclusion criteria and gave written informed consent to participate will be randomized into an intervention or control group in a 1:1 ratio. Next, subjects of both groups will undergo baseline testing (online survey). The subjects of the intervention group receive a single educational video (online) and are motivated to follow 2 training sessions of 60 minutes each, during 12 consecutive weeks. Instructions for the specific exercises are provided via an online platform. The subjects of the control group are instructed to maintain their normal working activities and activities of daily life and receive no further intervention. Subjects of both groups are prompted to fill out a weekly online logbook to gather information on their physical activity and neck and/or back complaints. All subjects undergo post-intervention testing at 12 weeks (short term effects), 6 months, and 12 months (long term effects).

Eligibility Criteria:
Inclusion Criteria

* age between 18-69 years
* perform regular desktop work (at least 20 hours/week)
* perform desktop work for at least 1 year (employee or student)

Exclusion Criteria:

* documented structural neck- and/or back pathology (confirmed by medical imaging)
* known shoulder or vestibular pathology
* whiplash-associated disorders
* history of surgery in the neck, shoulder, hip, and/or back area
* (history of) chronic pain condition
* serious headache
* serious cardiovascular/metabolic/systemic/neurological conditions
* chronic fatigue syndrome
* fibromyalgia
* psychiatric conditions or history of serious depression
* serious catastrophizing thoughts
* pregnancy or delivery in the past year
Ai Chi Versus Stretching in Fibromyalgia Management

The purpose of the study is to compare the efficacy and tolerability of Ai Chi, an adaptation of Tai Chi exercise to water, with stretching on fibromyalgia symtomatology.

Physical therapies have shown to be effective in the treatment of fibromyalgia and It is generally assumed that a multidisciplinary approach, combining both pharmacologic and non-pharmacologic measures, is probably the optimal treatment approach for most fibromyalgia patients. As these patients are usually physically deconditioned, low-intensity exercise has been recommended at least as initial treatment. At this respect, exercise in warm water is considered a good option as both temperature and water buoyancy minimize body weight's stress and help patients to minimize pain. In a previous study comparing short term physiotherapy with stretching and Ai Chi we found that Ai Chi was at least as effective as stretching and induced a significant reduction in fibromyalgia core symptomatology and in sleep parameters. The objective of the present randomized controlled study is to compare both physiotherapy techniques in a long term basis.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of fibromyalgia according to the ACR criteria
* 18 years or older
* written informed consent to participate

Exclusion Criteria:

* unable to tolerate warm chlorinated water
* associated medical condition contraindicating exercise in warm water
Validity and Inter-Rater Reliability of a Novel Bedside Referral Tool for Spasticity

The purpose of this study is to improve spasticity diagnosis through development of a simple physical examination guide for primary care providers to identify patients who would benefit from being referred to a movement disorders neurologist for a spasticity evaluation.

The aim of this study is to improve spasticity (a form of muscle rigidity) diagnosis through development of a simple physical examination guide for primary care providers/clinicians. This guide will assist in the identification of patients who would benefit from being referred to a movement disorders neurologist for spasticity evaluation and subsequent treatment. The examination tool will be tested for bedside implementation in all consenting participants residing in Tennessee State Veteran's Home, which is a long-term care facility in Murfreesboro, TN. Each of the 140 residents will receive one neurological examination and two physical examinations guided by the referral tool. A medical record review will also be performed.

Eligibility Criteria:
Inclusion Criteria:

* Males or female subjects of any race, aged 18 and above
* Resident of the selected long-term care facility
* The subject, or if appropriate their medical decision maker, is willing and able to provide written informed consent.

Exclusion Criteria:

* Subjects for whom participation in the study may cause medical harm
ACT-DE for Diabetes Distress in Adults With Type 2 Diabetes: A Pilot RCT

This study is a pilot RCT to examine the feasibility, acceptability and preliminary effectiveness of a 6-week acceptance-based diabetes education programme (ACT-DE) on diabetes distress, self-care efficacy and behaviours of adults with type 2 diabetes in Hong Kong.

It is hypothesise that the ACT-DE programme will:

* Be acceptable, feasible and beneficial for adults with type 2 diabetes to improve their psychological distress and self-care.
* Significantly reduce participants' diabetes distress (primary outcomes), when compared with the usual care (control) group immediately post-intervention;
* Significantly improve self-care efficacy, self-care behaviour and psychological flexibility (secondary outcomes) than the control group immediately post-intervention.

Diabetes distress is an aversive feeling and emotional disturbance specific to diabetes, including the burden of daily self-care, worry and guilty feelings, and low satisfaction level with health care professionals. Around 36% of people with type 2 diabetes worldwide suffered from diabetes distress, which is associated with poor self-care performance, low self-efficacy in diabetes management and higher blood glucose levels. Acceptance and Commitment Therapy, one of the mindfulness and acceptance-based interventions, integrated with diabetes education are found to be potentially effective interventions for reducing diabetes distress.

Participants who agreed to participate in the study were randomly allocated into the intervention (N=24) and the control group (N=24). Participants in the intervention group received a 6-week group-based acceptance and commitment therapy integrated with diabetes education (ACT-DE). There were five sessions in 6 weeks with 120 minutes per session. The group size were 6. While participants in the control group received one session of diabetes education without any information on acceptance and commitment therapy.

Eligibility Criteria:
Inclusion Criteria:

* community-dwelling adults Hong Kong Chinese residents,
* aged 18-64,
* diagnosed with type 2 diabetes for over one year;
* at least moderate level of diabetes distress as measured with the Chinese Diabetes Distress Scale (CDDS-15; mean score \>2 per item);
* having suboptimal blood glucose control as shown by HbA1c level of ≥ 7% in the laboratory results within the past six months;
* able to communicate in Cantonese and give written content.

Exclusion Criteria:

* history of a clinically diagnosed mental illness such as depression and anxiety disorder, and/or an acute/severe medical disease;
* noticeable cognitive impairment(s) as indicated by the total score (\<6 of 10) of the Abbreviated Mental Test;
* recently received/receiving any psychological therapy such as mindfulness or acceptance-based therapy.
Cardiovascular Risk Assessment For Kidney Transplantation - Utility of Computed Tomography Coronary Angiography in the Assessment of Patients Awaiting Kidney Transplantation

Cardiovascular disease (for example, heart attack, stroke, heart failure) is the commonest complication of kidney failure. Kidney transplantation reduces cardiovascular risk but cardiovascular disease remains the commonest cause of death in patients following transplantation.

Current strategies to assess patient's cardiovascular risk prior to kidney transplantation do not identify those at highest risk and do not improve outcomes.

This study will use a heart scan known as computed tomography coronary angiography (CTCA) to see whether this scan can identify patients at highest risk of future cardiovascular disease prior to transplantation. Studies have shown it is able to do this in patients with normal kidney function.

The aim of this study is to develop CTCA as an effective tool to risk stratify patients prior to kidney transplantation.


Eligibility Criteria:
Inclusion Criteria:

* Has kidney failure and is on the waitlist for a kidney transplant
* Age 16 years and over
* Able to give informed consent

Exclusion Criteria:

* Contraindication to CT scanning, including contrast allergy
* Patients being considered for a simultaneous kidney-pancreas, kidney-liver and/or kidney-islet transplantation
* Inability to give informed consent
Survival and Dialysis Independency in Highly Sensitized Patients After Desensitization With Imlifidase and Tx of Kidneys

The goal of this follow-up study is to learn about long-term patient survival and graft function in highly sensitized patients who have received desensitization treatment with imlifidase or standard of care (SoC) in order to enable kidney transplantation in clinical study ConfIdeS (20-HMedIdeS-17, NCT04935177).

This is an observational follow-up study subsequent to the ConfIdeS study (20-HMedIdeS-17, NCT04935177) in highly sensitized patients who were randomized to imlifidase or SoC desensitization prior to kidney transplantation with a deceased donor graft, or, if SoC perioperative treatment has been deemed not appropriate, wait for a more immunologically compatible organ offer.

After the patients have given written informed consent to participate in the follow-up they will be included in the study and followed until 5 years after randomization in the ConfIdeS study.

Most of the assessments in this study are already part of the follow up within SoC for these patients. During the local clinic routine follow-up visits at year 2, 3 and 5 after randomization in the ConfIdeS study, information about patient survival, wait-list status, graft survival, kidney function, and health related quality of life will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

1. Signed Informed Consent obtained before any trial-related procedures.
2. Previous participation in the clinical trial ConfIdeS.

Exclusion Criteria:

1. Inability by the judgement of the investigator to participate in the trial for any reason.
Autologous Transplantation of Mesenchymal Stem Cells (MSCs) and Scaffold in Full-thickness Articular Cartilage

The purpose of this study is to investigate the efficacy and safety of autologous transplantation of Bone Marrow Mesenchymal stem cells (MSCs) mixed with collagen I scaffold in patient with Knee cartilage defects and osteoarthritis

Articular cartilage defects have a weak potential for self-repair because of the reduced mitotic capacity of chondrocytes in vivo. Because some patients with articular cartilage defects may progress to osteoarthritis, such defects need to be repaired even though their exact natural course remains obscure. Traditional methods for repair, such as micro fracture, perforations, abrasion arthroplasty, have not produced consistent satisfactory long term clinical results. Transplantation of autologous bone marrow MSCs expanded in culture would be a promising approach in the repair of articular cartilage defects in human osteoarthritic knees. This method is clinically straightforward to perform because autologous cells can be readily harvested and expanded in culture without losing their capacity to differentiate into chondrocytes. The purpose of this study was to evaluate the clinical results obtained with autologous MSCs expanded in culture for the treatment of full-thickness chondral defects in human knee.

Eligibility Criteria:
Inclusion Criteria:

* Age 45 to 60, inclusive
* Normal axial alignment
* Stable knee-previous ligament reconstruction, if stable
* Intact articular cartilage in posterior meniscal weight-bearing zone
* Ability to understand and willingness tosign consent from
* O.C.D or OA calgran classification II,III

Exclusion Criteria:

* Pregnant or lactating
* Inflammatory arthritis
* Oral steriod, methotrexate
* Unable to follow post-operative exercise regimen or return for evaluations
A Study of Lebrikizumab (LY3650150) Administered by Two Different Devices in Healthy Participants

The main purpose of this study is to look at the amount of the study drug, lebrikizumab, that gets into the blood stream and how long it takes the body to get rid of lebrikizumab (LY3650150) when given using either a pre-filled autoinjector (AI) or a pre-filled syringe with needle safety device (PFS-NSD). The safety and tolerability of lebrikizumab will also be evaluated. The study will last up to 102 days.


Eligibility Criteria:
Inclusion Criteria:

* Are Overtly healthy males or nonpregnant females of childbearing or non-childbearing potential as determined through medical evaluation.
* Agree not to donate blood or plasma until after the end of their participation in the study
* Have a body mass index (BMI) within the range 18.0 to 32.0 kilograms per meter squared (kg/m²)

Exclusion Criteria:

* Are females who are pregnant or lactating.
* Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs
* Have a history or presence of psychiatric disorders
* Show evidence of human immunodeficiency virus infection.
* Show evidence of hepatitis C and/or hepatitis B
* Medical history of allergic reaction to humanized monoclonal antibodies
* Have had lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years.
* Are currently enrolled in any other clinical study involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study.
* Smoke more than 10 cigarettes per day or the equivalent including electronic cigarettes or are unable to abide by CRU smoking restrictions
Impact of Regional Anesthesia on Blood Pressure in Lower Limb Traumatism

This study aims to compare the hemodynamic impact of two anaesthetic strategies 'Regional anesthesia' versus 'General anesthesia' in leg and ankle fractures surgery.

Leg and/or ankle surgery is frequently performed under General Anesthesia (GA). GA is frequently associated with a high risk of hypotension with significant consequences.

Regional anesthesia could be an interesting alternative to GA in order to limit hemodynamic consequences, especially in elderly patients.

Furthermore, in the current state of Covid 19 crisis, regional anesthesia could provide solutions in preserving drugs for GA and exposing less medical staff on patient's airway.

Currently, unlike neuraxial anesthesia, few data deal with impact of peripheral RA and hemodynamic consequences.

The investigators hypothesize that the use of Regional anesthesia reduces the use of intraoperative vasopressor.

After ethical committee approval, a retrospective cohort of patients with lower limb traumatism, in Montpellier's University Hospital, was analyzed from 2016 to 2020. An informational note was given to all patients participating to the study.

Eligibility Criteria:
Inclusion criteria

* ASA I - IV
* Ankle and/or leg fracture
* Operated between january 2016 and december 2020 at Montpellier

Exclusion criteria

- age \< 18 years
Creating a Comfortable Cafeteria: Staff and Student Feedback - Outcome Study (Cafeteria Prog)

A mixed methods design was used to explore the outcomes of a 6-week, occupational therapy-led Comfortable Cafeteria program designed to build capacity of cafeteria supervisors to create a positive mealtime environment so that all students can successfully participate in and enjoy their meal and socialization with peers.

A mixed methods design was used to explore the outcomes of a 6-week, occupational therapy-led Comfortable Cafeteria program designed to build capacity of cafeteria supervisors to create a positive mealtime environment so that all students can successfully participate in and enjoy their meal and socialization with peers. Statistically significant improvements in pretest posttest visual analogue scale ratings of participation in and enjoyment for students with low and mid-range scores at the outset was found. Cafeteria supervisors demonstrated statistically significant improvements in perceptions of having the knowledge and skills to supervise and to encourage healthy eating based on pretest posttest ratings. Qualitative findings add further insight about the program suggesting that students learned prosocial values (e.g. being kind, helping others), supervisors actively encouraged positive social interaction, and occupational therapy practitioners enjoyed implementing the Comfortable Cafeteria program and recognized positive supervisor and student changes as a result of integrating services in the cafeteria.

Eligibility Criteria:
Inclusion Criteria:

* Students participating in lunch from a particular grade
* Cafeteria supervisors of those children
* Students with parental consent

Exclusion Criteria:

* Students who did not have parental consent
Peer-Led Dissonance Eating Disorder Prevention: Virtual Delivery

This proposed pilot study will evaluate whether this body acceptance class produces greater reductions in eating disorder risk factor symptoms (pursuit of the thin ideal, body dissatisfaction, dieting, dietary restraint and negative affect), eating disorder symptoms, and future onset of eating disorders over 6-month follow-up in this population.

Dozens of eating disorder prevention programs have been evaluated, but only the 4-hr Body Project has reduced eating disorder symptoms and future eating disorder onset over 3-4 year follow-up, produced larger reductions in outcomes than credible alternative interventions, been shown to engage the intervention target (valuation of the thin beauty ideal), and produced effects in trials from several independent teams. Although undergraduate peer-educator-led Body Project groups have produced larger reductions in outcomes than an eating disorder education video, an unmoderated Internet-based prevention program, and even clinician-led Body Project groups, it can be logistically difficult to schedule in-person Body Project groups with high school and college students. One solution to this key implementation barrier is to have peer educators deliver Body Project groups virtually over the Internet. A pilot trial in Sweden provided initial evidence that virtually-delivered peer-led Body Project groups produced greater reductions in eating disorder symptoms and future onset of eating disorders than an active expressive-writing intervention. The proposed pilot study will evaluate whether Body Project produces greater reductions in risk factor symptoms, eating disorder symptoms, and future onset of eating disorders in this population.

Participation in the intervention will last four weeks. Participants will be randomly assigned to the intervention condition or waitlist-control condition. Assessments will take place at pre-intervention, post-intervention, and 6 month follow up. Waitlist control participants will receive the intervention after they complete their post-test assessment.

Eligibility Criteria:
Inclusion Criteria:

* Body image concerns

Exclusion Criteria:

* N/A
Investigational TMS Treatment for Depression

This study is aimed to help us learn about the effects of Transcranial Magnetic Stimulation at the forehead versus the left side of the head for treatment of Treatment Resistant Depression.

While transcranial magnetic stimulation (TMS) to the left dorsolateral prefrontal cortex (DLPFC) is an FDA approved treatment for depression, a growing and converging database suggests the medial prefrontal cortex (MPFC) may be even more critical to the neurobiology of depression and antidepressant treatment response. This study will compare the efficacy of high frequency transcranial madntic stimulation on these two sections of the brain.

Eligibility Criteria:
Inclusion Criteria:

* 21-70 years old
* inadequate response to one current antidepressant medication
* currently depressed

Exclusion Criteria:

* psychiatric comorbidities