cyrilzakka/clinical-trials huggingface dataset:
Dating of Child Fractures : Chronological Repers From the Radiological Evolution of a Series of Femur Fractures

Although several studies have studied the predictive nature of non-accidental trauma of the different types of fractures and in particular on the femur, the physiological and radiological particularities of the child make it difficult to estimate the age of a fracture and require defining a chronology specific to the specificities of the pediatric population. Some authors have carried out work for the dating of fractures, however the number of cases or the average age of the subjects does not allow a precise estimation of the chronology of evolution of the fractures.


Eligibility Criteria:
Inclusion criteria:

* Child aged 18, cared for in the pediatric orthopedic department of the Strasbourg University Hospitals between January 2007 and December 2020
* Fracture of the femur resulting from orthopedic treatment instituted during a period of hospitalization
* Holders of parental authority who have been informed of the use of their child's data for the purposes of this research and who have not expressed any opposition

Exclusion criteria:

* Patient or legal representative who expressed their opposition to participating in the study
* Fracture of the femur having benefited from a surgical intervention
* Weakening metabolic or bone pathology
* Fracture on pathological focal lesion
* Fractures of the epiphysis or affecting the growth cartilage
* Impossibility of giving informed information to the subject
SOLFA Study to Explore the Thrombogenicity of a Dialyzer

Prospective, multicenter, randomized, crossover, non-masked study to evaluate the impact on the thrombogenicity of the haemodialysis circuit by comparing synthetic haemodialysers against the ATA membrane of the Solacea™.

This is a prospective, multicenter, randomized, crossover, non-masked study that included 32 patients from 4 Spanish hospitals.

The objective of the present work is to evaluate the impact on the thrombogenicity of the haemodialysis circuit by comparing synthetic haemodialysers against the ATA membrane of the Solacea™.

Study population. Patients over 18 years of age in a chronic haemodialysis program who had been on dialysis for more than three months were included. All patients provided informed consent. The study was approved by the local Ethics Committee and was conducted according to the principles of the Declaration of Helsinki. The exclusion criteria were allergies to synthetic membranes and allergies to heparin, patients receiving anticoagulant treatment, women Pregnant, breastfeeding or patients with cognitive impairment.

In each of the two phases of six consecutive two-week HD sessions, patients were dialyzed according to their usual schedule with the haemodialyser assigned after randomization (synthetic vs ATA membrane). During the six sessions of both phases, the dose of heparin was progressively reduced, 100% usual heparin dose in the first session until sixth session without heparin.

After each session, carried out a visual inspection of the venous chamber and the haemodialyser and assigned a coagulation score previously published. Dialyser score from 0 (completly clean, 0% coagulated fibers) to 4 (100% coagulated fibers). Venous chamber score from 0 (clean, without clotting) to 3 (complete oclusión, dialysis is not possible).

Demographic data and dialysis parameters were also collected. The dialyzers from 8 patients were collected at the beginning and end of each study arm and scanned with a reference non-invasive micro-CT (Computed Tomography) scanning technique.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years of age.
* Patients in a chronic haemodialysis program who had been on dialysis for more than three months were included.
* Patients provided informed consent.

Exclusion Criteria:

* allergies to synthetic membranes
* allergies to heparin
* patients receiving anticoagulant treatment
* women Pregnant
* breastfeeding
* patients with cognitive impairment
Medication in Early Diabetes (MED) Study

This study compares metformin (current first-line medication) to pioglitazone (a newer diabetic medication currently approved for combination use). Whilst there is good evidence for the benefits of pioglitazone use in other populations, in light of the known weight gain effects of pioglitazone we believe further assessment is required in Indigenous Australians (in whom there is a strong predisposition for central fat deposition). This study will provide evidence regarding the medication appropriate for first line medication in Type 2 diabetes in this high risk population. This study will assist clinicians to make evidenced-based decisions regarding initial medical management of those with Type 2 diabetes (where there is currently a gap in evidence).


Eligibility Criteria:
Inclusion Criteria:

* Drug naïve Indigenous Australians with Type 2 Diabetes
* Permanent resident of Darwin for at least 1 year immediately before and expected to be for at least 1 year after study commences
* Participants must be able to give informed voluntary consent
* Both males and females (females of child bearing potential excluded if not on reliable means of contraception)
Effect of Letermovir Prophylaxis on CMV-specific Immune Reconstitution Post UCBT

To explore the effect of letermovir prophylaxis on cytomegalovirus-specific immune reconstitution post unrelated cord blood transplantation

To explore the effect of letermovir prophylaxis on cytomegalovirus-specific and other lymphocyte subsets immune reconstitution post unrelated cord blood transplantation, and to analyze the potential mechanism and risk factors of late CMV reactivation after letermovir discontinuation.

Eligibility Criteria:
Inclusion Criteria:

* Patients are receiving a first unrelated cord blood transplantation (UCBT).
* Patients start letemovir prophylaxis within 0-28 days post UCBT.

Exclusion Criteria:

* Patients having active CMV DNAemia at the time of letermovir initiation.
* Patients recruited in a clinical study on an anti-CMV trial.
Using NI-ES to Treat Spinal Cord Injury (SCI)

NI-ES therapy is a treatment that is being studied to potentially treat pain associated with SCI and may help movement below the injury site.

The overall goal of this study is to assess the use of externally applied micro-current electrical stimulation in a subject with SCI to reduce pain and patient perceived improvement of quality of life first, and second, movement below the SCI injury. The Hypothesis is that NI-ES is beneficial in reducing pain following SCI injury, patient perceived quality of life measures, and functional outcomes. We plan to achieve this goal by conducting a Pain Questionnaire and assessment of movement below the injury site prior to external micro-current electrical stimulation with the Spinal Stim (Alpha-Stim M with the Ocular Interface and the Spinal Interface) and again six weeks following the first treatment. These results will be used to characterize the extent and duration of any improvement in pain and movement as a result of treatment with the Spinal Stim.

Eligibility Criteria:
Inclusion Criteria:

* Male or female
* The presence of SCI
* Pain associated with the SCI
* Difficulty with body movement below the SCI

Exclusion Criteria:

* Absence of SCI
* Poor health
* Deemed unsuitable for participation by the Investigator.
[S,S]-Reboxetine Long Term Safety Study In Post-Shingles Pain.

The purpose of this study is to assess the long term (up to 2 years) safety and tolerability of \[S,S\]-Reboxetine in patients with pain after shingles.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have pain present for more than 3 months after healing of the shingles skin rash.
* Patients at screening must have a score of \>/=40mm on the pain visual analogue scale.

Exclusion Criteria:

* Patients with significant hepatic impairment.
* Patients with other severe pain, that may impair the self-assessment of pain due to postherpetic neuralgia (pain after shingles).
SAFE or SORRY? Patient Safety Study of the Prevention of Adverse Patient Outcomes

The aim of SAFE or SORRY? is to develop and test an evidence based inpatient safety program for the prevention of three frequently occuring adverse events: pressure ulcers, urinary tract infections and falls.

Background Patients in hospitals and nursing homes are at risk for the development of, often preventable, somatic complications. However, preventive care is not always optimal. Although guidelines are available for many complications, compliance with the guidelines appears to be lacking. Besides general barriers that inhibit implementation, this non-compliance is also associated with the large number of guidelines competing for attention. As implementation of a guideline is time-consuming, organisations can never implement all available guidelines. Another problem is lack of feedback about performance using clear quality indicators and lack of a recognizable, unambiguous system for implementation.

Aim The aim of SAFE or SORRY? is to develop and test an evidence based inpatient safety program for the prevention of three frequently occuring adverse events: pressure ulcers, urinary tract infections and falls.

Participants Patients and nurses will be recruited from ten hospital wards and ten nursing home wards in the Netherlands. All nurses and all adult patients who are admitted for more than three days, will be asked for informed consent.

Method This study consists of two phases. In the first phase the program will be developed. The content of the program is based on the evidence based guidelines on pressure ulcers, urinary tract infections and falls. The program consists of a computerized registration and feedback system, an educational program for nurses and caregivers, and educational material for the patients.

In the second phase the program will be tested in a cluster randomised clinical trial. The program will be implemented on ten wards (5 hospital wards and 5 nursing home wards), i.e. the intervention group. The control group will continue to give care as usual.

Outcome measures Primary outcome measure: incidence of pressure ulcers, urinary tract infections and falls Secondary outcome measures: Utilization of preventive interventions and knowledge of nurses and caregivers regarding the complications and their prevention.

Eligibility Criteria:
Inclusion Criteria:

* patients on participating wards admitted for more than three days
* all nurses on participating wards

Exclusion Criteria:

* students on participating wards
Brain Imaging of rTMS Treatment for Depression

The overarching goal of this research program is to elucidate causal and directional neural network- level abnormalities in depression, and how they are modulated by an individually-tailored, circuit-directed intervention. By using concurrent TMS and fMRI, the investigators can overcome a major limitation of neuroimaging - the inability to demonstrate causality. The investigators' findings will serve as a platform for future studies wherein TMS treatment can be directly guided by the investigators' ability to image and causally manipulate specific neural networks.

Aim 1: To examine causal interactions between two major brain networks in depression.

Aim 2: To examine the impact of antidepressant TMS on causal network abnormalities in depression.

Hypothesis 1: Depressed subjects will show blunted responses, compared to healthy controls, in two targeted and interacting networks, using concurrent transcranial magnetic stimulation (TMS) and functional magnetic resonance imaging (fMRI).

Hypothesis 2: Treatment of patients with high-frequency repetitive TMS (rTMS) will result in normalization of baseline network-level deficits, and be predicted by degree of baseline network abnormalities.

This study has a single primary outcome measure and other measures are exploratory. Previous versions of this study record incorrectly listed some exploratory outcome measures as secondary.

Eligibility Criteria:
Inclusion Criteria:

* Men and women, ages 18 to 50
* Depression assessed through phone screen
* Must comprehend English well to ensure adequate comprehension of the fMRI and TMS instructions, and of clinical scales
* Has failed \>1 previous adequate antidepressant medication trials
* Right-handed
* No current or history of neurological disorders
* No seizure disorder or risk of seizures

Exclusion Criteria:

* Any contraindication to being scanned in the 3T scanners at the Lucas Center or CNI such as having a pacemaker or implanted device that has not been cleared for scanning at the Lucas Center or CNI
* Any unstable medical condition, any significant CNS neurological condition such as stroke, seizure, tumor, hemorrhage, multiple sclerosis, etc
* Current rTMS treatment or prior treatment failure with rTMS
* Current electroconvulsive therapy (ECT) or prior treatment failure with ECT
* Currently pregnant or breastfeeding
Model-Based Image Reconstruction for X-Ray CT in Lung Imaging

To develop a computer program that will improve CT image quality and decrease the amount of x-ray radiation that future patients may be exposed to when they have a CT examination.

We will be asking patients for their permission to save and use the sinogram from their CT scan. The sinogram will be de-identified and sent to an archive system for storage. It will be exported to a computer for processing using MBIR (model based iterative reconstruction). MBIR (model based iterative reconstruction) is a new method being developed to process CT sinograms. The newly reconstructed images will be reviewed by experts to determine if they are as readable and accurate as CT images created with the software that is currently being used. Sinogram data and the reconstructed images will be shared with collaborating researchers at General Electric Global Research.

Eligibility Criteria:
Inclusion Criteria:

1. 18 years of age and older 2. No medical or psychiatric condition precluding informed consent

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Exclusion Criteria:

1. Inability to lie flat on the back with arms raised over the head for 30min.
2. Metallic implants or metallic devices in the chest or back.
3. Participation in other research trials involving ionizing radiation
Obesity Prevention After Smoking Cessation in Menopause

This study addresses the high risk of weight gain associated with smoking cessation in women. The obesity prevention pilot study is designed for the primary prevention of weight gain that can lead to overweight in normal-weight women, that can progress to obesity in women who are already overweight, and for the prevention of additional weight gain in obese women with BMI greater than or equal to 30.0. Fat and other macronutrient intake, specifically, sugar, complex carbohydrates, and protein, are analyzed as a target for individually tailored, weight control intervention following smoking cessation in Caucasian and African American women.

Middle-aged women, especially African Americans, who quit smoking are at high risk for weight gain, overweight, and obesity. Postcessation weight gain has been attributed to increased food intake, which in turn, has been ascribed to a selective increase in high-sugar and other high-carbohydrate foods with a high-fat content. This study compares the relative effectiveness, for postmenopausal Caucasian and African American women, of following an empirically validated smoking cessation program with either 1) a group cessation maintenance program with standard exercise advice and food pyramid instructions for healthy eating or 2) an individually tailored, dietary-control, exercise, weight-management and cessation-maintenance program. Effectiveness is assessed by weight change from baseline to postcessation months 6, 12, and 20.

The second aim is to assess overall fat and other specific macronutrient intake (sugar, complex carbohydrates, and protein) and total caloric intake with the use of a novel macronutrient self-selection paradigm in Caucasian and African-American postmenopausal women at baseline prior to smoking cessation, after being abstinent for one week, and again at 6, 12, and 20 months postcessation.

The third aim is to assess whether there is differential responsiveness on the above measures in postmenopausal Caucasian vs. African-American women.

Eligibility Criteria:
Inclusion Criteria:

* Female aged 45 - 59 at time of enrollment
* African-American or Caucasian; able to confirm racial heritage of past two generations in family
* Postmenopausal
* Smokers (more than 10 cigarettes per day for 1 year or more)
* Written physician approval to participate in program and medical clearance that use of over-the-counter nicotine replacement is not contraindicated based on patient's medical status

Exclusion Criteria

* Men
* Age below 45 or above 59
* Nonsmokers
* Currently in a standardized weight-reduction program or taking medications for weight loss
* History or presence of significant psychiatric illness (e.g., eating disorders, psychosis, psychoactive substance abuse, major depression)
* History of presence of severe physical illness (e.g., renal failure, hepatic failure, cancer, immunological disease)
* Unable to complete long-term study commitment, including anticipating moving out of study area prior to completion of the study
* Unable to confirm racial heritage of past two generations in family.
Effect of Eye Movement Desensitization and Reprocessing Therapy 2.0 Online Group Protocol

In this study, it will be investigated the efficacy of Eye Movement Desensitization and Reprocessing Therapy 2.0 Online Group Protocol on post-traumatic symptoms compared to control group. Therefore, the randomized control trial is based on Eye Movement Desensitization and Reprocessing Therapy 2.0 group as an intervention.

Eye Movement Desensitization and Reprocessing Therapy is an evidence-based psychotherapy approach, and it is proven as efficient in primarily post-traumatic symptom disorder. EMDR 2.0 is a new approach which is used for the cases that are not answering the standard EMDR protocols. According to the recent studies, both EMDR and EMDR 2.0 show a greater decrease in emotionality and vividness in similar time based on session numbers (Matthijssen, 2021). Also, it is found that EMDR 2.0 requires lower set numbers (shorter sessions) compared to EMDR.

In this study, it will be investigated the efficacy of EMDR 2.0 Online Group Protocol on post-traumatic symptoms compared to control group. Therefore, the randomized control trial is based on EMDR 2.0 group as an intervention. Compared to previous EMDR 2.0 individual settings, this study is based on a group protocol made by our team. This group protocol has been tested in a pilot study on volunteer mental health professionals. The results of this pilot study showed that EMDR 2.0 group protocol was successful, and investigators decided to begin the randomized control trial research.

Eligibility Criteria:
Inclusion Criteria:

* Being older than 18
* Having a traffic accident between 6 months and 10 years
* Having necessary knowledge on using relevant technological devices

Exclusion Criteria:

* Having mental deterioration after the accident
* Having a lower score of 7 on Adverse Childhood Experiences (ACEs)
* Having pre-existing psychotic disorder
The Theranostic Value of STARD3 in Colorectal Cancer: The STAR Study

This study aims at verifying the overexpression of STARD3 in both early and advanced CRC patients derived tissues, to identify the pathways underpinning tumorigenesis and cancer progression in which STARD3 is involved. Moreover its role as a dynamic biomarker of treatment response and its part in treatment sensitivity will be explored.

Colorectal cancer (CRC) is one of the most prevalent and deadly tumours in both men and women worldwide. An RNAi screening on 214 potential oncogenes described by the TCGA was performed and STARD3 was identified as potential theranostic target in mCRC. Considering the effects on cell viability and the druggability, STARD3 represents a strong candidate as a valid diagnostic and therapeutic target for mCRC patients.

In recent years, organoids have become a research hotspot, showing a significant potential in the biological analysis of tumours. Patient derived organoids could be a viable platform to test clinically available drugs and/or promising new molecules to explore tumour sensitivity in an ex-vivo model.

This is a longitudinal observational study on CRC patients derived tissues to verify the overexpression of STARD3 in both early and advanced CRC patients, to identify the pathways underpinning tumorigenesis and cancer progression in which STARD3 is involved through the development of cancer derived organoids, to explore its role as a dynamic biomarker of treatment response and to demonstrate its part in treatment sensitivity measured in tumour derived organoids compared to drug sensitivity observed in real-world patients.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed diagnosis of colorectal cancer, independently from diagnosis stage.
* Age ≥18 years.
* Signed informed consent form.
* Availability of tissue and blood samples stored at the Institutional Biobank for research purposes.

Exclusion Criteria:

* Patients for which the tumour biobanking process could compromise the diagnostic assessments.
* Pregnancy or breast-feeding.
* History of concomitant or previous malignancy in the previous 5 years, except for adequately treated cutaneous squamous cell carcinoma or surgically removed in situ cervical carcinoma.
Comparison of the Efficacy of Oral Oxycodone and Oral Codeine in the Treatment of Postcraniotomy Pain

The efficacy of codeine is dependent on its demethylation to morphine. This extent of demethylation has wide inter-individual variability, making codeine's efficacy as a analgesic variable. Oxycodone is a semi-synthetic opioid and is a weak agonist on mu opioid receptors.

Codeine has been the mainstay of analgesia for patients after craniotomy for many years. Traditionally, craniotomies were not thought to be very painful procedures, hence the use of codeine, a moderately potent opioid (when compared to morphine).

However, in recent years, it has been found that up to 70% of post-craniotomy patients have moderate to severe pain and codeine did not provide adequate analgesic relief. Many studies have compared codeine to other drugs such as PCA morphine, fentanyl and tramadol, and patients on these stronger opioids generally had lower pain scores and better satisfaction.

No study has been conducted to determine the efficacy of analgesia of oral oxycodone to oral codeine.

Hence, the hypothesis is that oxycodone is more effective than codeine in providing pain relief in post-craniotomy patients.


Eligibility Criteria:
Inclusion Criteria:

* Ages 21-70 years of age
* Planned elective craniotomy
* ASA 1-3
* GCS 15 pre and post-op
* Able to understand and use the visual analogue scale

Exclusion Criteria:

* Patients with GCS \< 15 pre and/or post-op.
* Patients who are unable to quantify pain according to VAS scale.
* Patients who will be left intubated post-op.
* Contraindications and/or allergies to any of the trial drugs.
* Patients with renal and/or hepatic impairment.
* Patients with decreased respiratory reserves.
* Patients with post-op cognitive dysfunction.