cyrilzakka/clinical-trials huggingface dataset:
Magnetic Resonance Imaging of Aortic Aneurysm Instability

Abdominal aortic aneurysm (AAA) is a progressive enlargement of the aorta, the largest blood vessel in the body. It is at risk of bursting when it is usually fatal. Currently the risk of the AAA bursting is estimated from its diameter. In this study, the investigators hope to develop a new type of aneurysm scan involving Magnetic Resonance Imaging (MRI). It is hoped that this scan will be better at determining which AAAs are at risk of bursting and therefore require an operation to prevent this.

Abdominal aortic aneurysms (AAA) have a prevalence of \~5% and when ruptured carry a mortality rate of \~90%. The pathophysiology of AAA encompasses a range of poorly understood biomechanical and biological processes. Currently the diameter of the aneurysm is used as a surrogate for the risk of rupture and patients with an aneurysm diameter greater than 55 mm are considered for elective surgical repair. However, this reliance on a single surrogate measure is too simplistic and does not take into account other physical and biological aspects of the AAA. We propose to evaluate the role of inflammation, proteolysis and neovascularisation in patients with AAA disease. We will compare novel magnetic resonance imaging techniques with blood and tissue measures of inflammation (c-reactive protein, cytokines, macrophage and leucocyte density), proteolytic activity (matrix metalloproteinases, tissue inhibitors of metalloproteinases) and neovascularisation (vessel density, endothelial progenitor cells). By comparing findings between patients with symptomatic and asymptomatic disease, this study will inform our understanding of the disease process as well as potentially identify risk markers of AAA instability that could be used to follow-up patients with asymptomatic disease.

Eligibility Criteria:
Inclusion Criteria:

* AAA measuring \>40mm in AP diameter on ultrasound scanning
* Age \>40 years (patients younger than this with AAA may have a connective tissue disorder and a different aetiology to their disease)
* Considered to be suitable for standard infra-renal open surgical repair

Exclusion Criteria:

* Patients who are not deemed to be fit for open surgical repair
* Patients who are deemed to be suitable for a stent graft performed by the radiologists rather than the standard operation
* Contraindication to MRI scanning identified from MRI Safety Questionnaire (see attached)or claustrophobia
* Age \<40 years
* Patients requiring emergent repair such that there is insufficient time available to complete the protocol
* Patients refusing to give consent
* Patients unable to give consent
* Pregnant women (contrast is teratogenic in animals)
* Intercurrent illness (may confound the results)
* Patients with a systemic inflammatory disorder or underlying malignancy
* Patients who require an emergency operation such that there is insufficient time to complete the study protocol
* Renal dysfunction (Creat \>250 or eGFR\<25)
* Hepatic dysfunction (Child's grade B or C)
Peer-mentor Support for Older Vulnerable Myocardial Infarction Patients

BACKGROUND: Advanced treatment regimens have reduced cardiovascular mortality resulting in an increasingly older myocardial infarction (MI) population in need of cardiac rehabilitation (CR) , the majority (74%) is above 60 years. The positive effect of CR is well established; CR reduces cardiovascular mortality, lowers hospital admissions, and improves quality of life among patients with ischemic heart disease. These positive effects of CR has also been established among older patients. The inherent problem lies in the low attendance rate, often below 50%. Several studies, including studies from Denmark, have shown that low participation in CR is most prevalent among older, vulnerable female patients. The notion vulnerable covers patients with low socioeconomic position (SEP), patients with non-western background and patients living alone, as these groups have particularly low CR attendance. Effective interventions aiming at increasing CR attendance among these low attending groups are thus warranted and the current study will seek to address this.

AIM: To test feasibility and acceptability of methods used in a peer-mentor intervention among older female and vulnerable post MI patients.

DESIGN AND METHODS: The study is designed as a one arm feasibility study. Patients (n=20) are recruited by a dedicated research nurse before discharge from the cardiology department at Nordsjællands Hospital. Data is collected at three timepoints, baseline, 12 weeks and 24 weeks. The patients (mentees) are matched with peer-mentors. Peer-mentoring (i.e. mentoring by a person with a similar life situation or health problem as one self) is a low-cost intervention that holds the potential to improve CR attendance and improve physical and psychological outcomes among older patients. Peer-mentors are role models who can guide and support patients overcoming barriers of CR attendance. Peer-mentoring is unexplored in a CR setting among older, female and vulnerable MI patients; establishing the novelty of the current study.


Eligibility Criteria:
Inclusion Criteria:

* ≥65 years and diagnosed with MI and referred to CR and female or low SEP or single living or non-western background.

Exclusion Criteria:

* Patients unable to provide written consent.
Efficiency of Early Intervention for Autism Spectrum Disorder

Intervention for autism spectrum disorder (ASD) in European French-speaking countries is often heterogeneous and poorly evaluated. Six French-speaking early intervention units for children with ASD following the Early Start Denver Model (ESDM) have been created since 2011 with the common aim to evaluate effectiveness and cost-efficiency of the ESDM applied to the European French-speaking public health system. In those units, Children receive ESDM at minimum 12H per week by trained therapist. Therapist work in collaboration with parents (at home) and preschool or nursery.

The first aim of the investigators study is to evaluate the effectiveness of ESDM intervention 12 hours per week during 2 years on the global development of children with ASD compared to the interventions commonly available in the community.

This is a multicenter (4 centers in France, 1 center in Switzerland and 1 center in Belgium), randomized, controlled, single blind trial using a modified Zelen design .It concerns children with ASD aged 18 to 36 months without severe neurological or physical disorder and living in the proximity of one the early intervention units. After diagnostic, Children will be included in a longitudinal cohort with the consent of the parents. Sixty children will be drawn lots among 180 children of the cohort and will be included in a ESDM intervention with the consent of the parents. Two groups will be compared: an experimental group of 60 children receiving 12 hours a week of ESDM intervention delivered by trained therapists during 2 years and a control group of 120 children receiving typical heterogeneous 'as-usual' intervention proposed by professionals and public services over the same period. Global developmental profiles of all the children will be measured at different time points over the two years through standardized tests such as the Mullen Scale of Early Learning (MSEL), the ADOS-2 and the Vineland Adaptive Behavior Scale. Cost of each intervention will be calculated.

The primary outcome is global development of the child, measured by the developmental quotient with the Mullen after 24 months of intervention.

Eligibility Criteria:
Inclusion Criteria:

* Children 15 months to 36 months
* Children with autism spectrum disorder (according to international criteria and standardized tests)
* Children at a DQ of 30 at least at the MSEL
* Family domiciled within 40 minutes of a early intervention unit (investigator center for the study)

Exclusion Criteria:

* Severe neurological or physical disorder identified not allowing intensive care
* Unavailability of the family for regular monitoring of the child by the investigator center
* Rett Syndrom
Health Status Prior and Post Infection With Influenza or COVID 19: a Population Based Retrospective Analysis of 2016-2021

The overall project aim is to study outcomes after COVID-19 and influenza hospitalisation from 2016 - 2021 by retrieving data from the main social security carriers in Austria for the years 2010-2018


Eligibility Criteria:
Inclusion Criteria:

* Patients with SARS
* Patients with Covid-19
* Patients after Covid-19
* Patients with influenza

Exclusion Criteria:

* none
The Impact of Oral Glutathione on Oxidative Damage and Glycated Hemoglobin (HbA1c) Levels in Type 2 Diabetes Patients

This trial aims to assess the effectiveness of L-glutathione, supplemented with bioavailability boosters (tannin, low molecular weight chitosan, and polyethylene glycol), on improving antioxidant levels and glycemic control in patients with type 2 diabetes (T2D). The study is designed as a randomized, double-blind, placebo-controlled trial intending to enroll 240 T2D patients. The primary objective is to measure changes from baseline to 180 days in several key biomarkers, including endogenous reduced glutathione (GSH), oxidized glutathione (GSSG), 8-hydroxydeoxyguanosine (8-OHdG), and glycated hemoglobin (HbA1c), along with other metabolic parameters.

Hypothesis: The anticipated outcome is a significant increase in GSH levels and a decrease in markers of oxidative damage among participants receiving L-glutathione compared to those in the placebo group, potentially indicating improved antioxidant defenses and some effects on glycemic regulation in T2D patients. This trial aims to fill gaps in current research regarding the role of L-glutathione supplementation in managing oxidative stress and metabolic control in diabetes.


Eligibility Criteria:
Inclusion Criteria:

* subjects with diabetes mellitus type 2 with confirmed levels of glycated hemoglobin (HbA1c) ≥ 6.5%

Exclusion Criteria:

* pregnancy and breastfeeding
* heavy smoking: Individuals consuming more than 20 cigarettes per day;
* excessive alcohol consumption: Participants who consume alcohol in excess of established limits, defined as more than 14 standart doses for men and 7 for woman;
* active clinical infections
* recent cardiovascular events: Individuals who suffered from cardiovascular event in the last 6 months;
* subjects receiving antioxidant drugs or dietary supplements;
Effect of Preoperative Exercise on Postoperative Outcome in AAA Patients: Pilot Study

Basic animal research has demonstrated that exercise training can protect the myocardium from ischemia-reperfusion injury through several biological mechanisms . This effect of exercise training may be beneficial in the perioperative period when cardiac complications may arise. However, exercise induced cardioprotection is lost completely within 18 days of stopping the training program. This finding from animal research will be used to test the hypothesis that 3 days of consecutive exercise with the last bout conducted within the last 24/48 hours prior to surgery, will have a cardioprotective effect . Specifically, exercise has been shown to protect cardiac myocytes against reperfusion induced oxidative stress and mitochondria against reperfusion induced damage. This exercise mediated cardioprotection is observed in short moderate duration ischemia (i.e. 5-20 min) and moderate to severe (i.e.20-60 min) ischemic insults. The effects of exercise induced cardioprotection have only been investigated at cell level and it has not been shown whether this will translate into a reduction in postsurgical reperfusion injury and associated complications. To study this potential cardioprotective effect the investigators will aim to recruit patients who have a high risk of receiving reperfusion injury during surgery. Specifically, the investigators will recruit abdominal aortic aneurysm patients where the risk of heart complications is high. There is also currently no evidence in the published literature with regard to the effect of preoperative supervised exercise.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged \>18 years of age.
* Patients able to give informed consent.
* Able to comply with the study protocol
* Patients undergoing open repair for an asymptomatic perirenal and infrarenal abdominal aortic aneurysm

Exclusion Criteria:

* Patients with severe disabling disorders limiting mobility, e.g. severe osteoarthritis
* Patients undergoing thoracoabdominal aneurysm surgery
* Patients physically unable or unwilling to undertake maximal cardiopulmonary exercise testing and the other fitness tests
* Patients younger than 18 years of age.
Group CBT for Depression and AOD Disorders

The investigators will adapt and test an existing treatment (group CBT for depression) for use in outpatient substance use treatment settings as delivered by trained substance use counselors. The investigators expect that treatment will lead to improved depression and substance use outcomes.

Aim 1. To adapt an existing group therapy (CBT for depression), creating a manualized treatment and accompanying implementation measures and tools for use with clients with persistent depressive symptoms and AOD disorders and to obtain preliminary assessments of the treatment from patient and provider perspectives.

Aim 2. To conduct a pilot test of the revised treatment in which we (a) demonstrate that when the therapy is implemented with fidelity, clinically significant reductions in depressive symptoms and AOD use occur; (b) estimate the likely effect size; and (c) investigate the underlying mechanisms of change, including both cognitive-behavioral and group processes and their relationship to depression and AOD treatment outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Enrolled in outpatient substance abuse program
* BDI II score \>13
* Probable alcohol or substance use problem

Exclusion Criteria:

* Cognitive impairment (Short Blessed \> 10)
* Probably bipolar or schizophrenic disorder
The Diagnostic and Prognostic Value of Presepsin in Sepsis

Intra-abdominal infections are a common cause of sepsis and frequently occur in intensive care unit (ICU) patient. Various markers such as procalcitonin, presepsin and endotoxin are used to identify patients at risk of sepsis or to guide proper treatment.

No studies compared presepsin to procalcitonin and endotoxin in patients treated with by extracorporeal hemoperfusion with a polymyxin-B-adsorbing cartridge (PMX-HA).

Intra-abdominal infections are a common cause of sepsis and frequently occur in intensive care unit (ICU) patient. Various markers such as procalcitonin, presepsin and endotoxin are used to identify patients at risk of sepsis or to guide proper treatment. Particularly, endotoxin can be removed from the blood by extracorporeal hemoperfusion with a polymyxin-B-adsorbing cartridge (PMX-HA).

No studies compared presepsin to procalcitonin and endotoxin in patients treated with PMX-HA. The investigators aim to evaluate the trend and prognostic value of presepsin versus procalcitonin and endotoxin in ICU patients with septic shock from complicated major abdominal surgery, treated with PMX-HA.

Eligibility Criteria:
Inclusion Criteria:

* caucasian patients
* patients undergoing laparoscopic major abdominal surgery

Exclusion Criteria:

* pregnancy,
* organ transplantation,
* palliative care
* metastatic cancer
* head trauma and polytrauma
* coagulopathies
* use of anticoagulants
* neurological disease
* autoimmune disease
* thyroid disease.
Laparoscopic Rectopexy for Rectal Prolapse

The aim of the present prospective, double-blind, randomized study is to study whether laparoscopic anterior mesh rectopexy is as good as laparoscopic posterior rectopexy with respect to obstructive defecation afterwards.

Full-thickness rectal prolapse is defined as a "falling down" of the rectum so that it is outside the body. Rectal prolapse can only be treated by surgery.

The choice of procedure depends on the patient's general condition and is based on a clinical judgment. Usually, elderly, high-risk patients are treated by perineal procedures. All other patients are offered an abdominal rectopexy using open or laparoscopic techniques. The general principle for all abdominal procedures is to induce adhesions between the mobilised, elevated rectum and the presacral fascia.

At least 30%-60% develop long-term complications: Obstructive defecation, which may be related to peroperative trauma to rectums innervation. Sparing of the lateral stalks during the rectal mobilisation results in lower frequency of obstructive defecation afterwards, but also higher recurrence rate.

A nerve-sparing laparoscopic technique for rectal prolapse has been developed in Belgium: Laparoscopic anterior mesh rectopexy.

After this procedure, the rate of obstructed defecations afterwards has been reported to less than 10%, that is, much lower than observed after other procedures.

The functional results after this nerve-sparing laparoscopic technique should be compared to those after laparoscopic posterior rectopexy, i.e. the conventional laparoscopic method.

Eligibility Criteria:
Inclusion Criteria:

* Patients with full-thickness rectal prolapse for whom the department otherwise would offer abdominal rectopexy according to the department's recommendation. That is, patient being fit for an abdominal rectopexy procedure.

Exclusion Criteria:

* Age below 18 years.
* Pregnancy or breast-feeding.
* Patients who do not speak or read Danish.
* Dementia or other psychiatric disease, i.e., inability to give informed consent.
* Recurrence of rectal prolapse.
Thermal Imaging to Identify Distinct Temperature Patterns in Various Stages of Pressure Ulcers

40 patients total with pressure ulcers with a decubitus pressure ulcer will be included in this study. Ten patients with a Stage I, II, III, and IV decubitus pressure ulcer will be included to be analyzed with a thermal imaging camera. Thermal imaging of the various stages of pressure ulcer will be analyzed to determine if a recognizable pattern of thermal distribution can be identified which can then be applied to identify patients at risk of developing pressure ulcers at an earlier stage in their hospital course.

This study will be a single-center prospective Phase I study in which the use of a thermal imaging camera will be used to obtain imaging data on decubitus ulcers of various stages. The data collected during this study will be used to determine if stage-specific thermal distribution patterns can be identified. This information will then be used to design future studies in which patients are risk for the development of pressure ulcers are screened for the presence of pressure ulcers not detectable upon physical examination so that preventative measures and treatments can be instituted.

A total of 40 patients with pressure decubitus ulcers will be recruited for inclusion in this study. The investigators plan to enroll ten patients with each stage of pressure ulcer (i.e. Stage I-IV), which will provide the investigators with a set of thermal imaging data from which the investigators will determine if thermal distribution patterns unique to each stage of pressure ulcer can be identified. It is anticipated that 40 patients who meet the inclusion criteria and distribution of pressure ulcer staging will be enrolled within one year of the start date of this study.

The investigators are planning a study of a continuous response variable from independent control and experimental subjects with 1 control(s) per experimental subject. It is estimated that the response within each subject group will be normally distributed with standard deviation 25. If the true difference in the experimental and control means is 35, the investigators will need to study 9 experimental subjects and 9 control subjects to be able to reject the null hypothesis that the population means of the experimental and control groups are equal with probability (power) 0.8. The Type I error probability associated with this test of this null hypothesis is 0.05.

Eligibility Criteria:
Inclusion Criteria:

* Patients with sacral/heel pressure ulcers, admitted to University of Arkansas for Medical Sciences (UAMS) inpatient services.
* Patients 18-years old or older.
* Patients have an expected survival of \> 48 hours

Exclusion Criteria:

* Patients not compliant with obtaining thermal imaging.
* Patients not expected to survive for 48 hours.
A Study of the Efficacy and Safety of Albiglutide in Subjects With Type 2 Diabetes With Renal Impairment.

This randomized, double-blind, active-controlled study evaluates the efficacy and safety of a weekly dose of albiglutide as compared with sitagliptin. Subjects who are renally impaired with a historical diagnosis of type 2 diabetes mellitus and whose glycemia is inadequately controlled on their current regimen of diet and exercise or their antidiabetic therapy of metformin, thiazolidinedione, sulfonylurea, or any combination of these oral antidiabetic medications will be recruited into the study.

This randomized, double-blind, active-controlled, 2 parallel-group, multicenter study evaluates the efficacy and safety of a weekly subcutaneously injected dose of albiglutide as compared with sitagliptin. Subjects who are renally impaired with a historical diagnosis of type 2 diabetes mellitus and whose glycemia is inadequately controlled on their current regimen of diet and exercise or their antidiabetic therapy of metformin, thiazolidinedione, sulfonylurea, or any combination of these oral antidiabetic medications will be recruited into the study.

Eligibility Criteria:
Inclusion Criteria:

* Renally impaired with a historical diagnosis of type 2 diabetes mellitus and is experiencing inadequate glycemic control on their current regime of diet and exercise or their antidiabetic therapy of metformin, TZD, SU, or any combination of these oral antidiabetic medications
* BMI \>/=20 kg/m2 and \</=45 kg/m2
* Fasting C-peptide \>/=0.8 ng/mL (\>/=0.26 nmol/L)
* HbA1c between 7.0% and 10.0%, inclusive.

Exclusion Criteria:

* History of cancer
* History of treated diabetic gastroparesis
* Current biliary disease or history of pancreatitis
* History of significant gastrointestinal surgery
* Recent clinically significant cardiovascular and/or cerebrovascular disease
* History of human immunodeficiency virus infection
* Abnormal liver function or acute symptomatic infection with hepatitis B or hepatitis C
* Female subject is pregnant (confirmed by laboratory testing), lactating, or \<6 weeks postpartum
* Known allergy to any GLP 1 analogue, sitagliptin, other study medications' excipients, excipients of albiglutide, or Baker's yeast
* Receipt of any investigational drug or sitagliptin within the 30 days or 5 half lives, whichever is longer, before Screening or a history of receipt of an investigational antidiabetic drug within the 3 months before randomization or receipt of albiglutide in previous studies