cyrilzakka/clinical-trials huggingface dataset:
Dynamic Full-field Optical Coherence Tomography for Structural and Microbiological Characterization of Endotracheal Tube Biofilm in Critically Ill Patients

Biofilm is a microstructure organised into aggregates of microbiological species within a polymeric matrix. As early as the 2000s, the Centers for Disease Control and Prevention (CDC) recognised the possible role of the biofilm lining endotracheal endotracheal tubes in the development of ventilator-associated pneumonia (VAP) , the most common infection in intensive care, with a high morbidity and mortality rate and a significant increase in hospital costs.

Targeting biofilm therefore now appears to be a new area of interest for limiting the risk of VAP, and this rationale has led to the development of an intraluminal for abrading biofilm deposited on the inside of the intubation probe

. Evaluation of this type of strategy nevertheless justifies the introduction of more precise methods for characterisation of the biofilm.

To this end, the investigator carried out an initial clinical study describing the biofilm on intubation probes, BIOPAVIR 1, showing the existence of several biofilm structures, each associated with a specific microbiological signature. Several limitations including a lack of power due to an insufficient number of patients and the use of number of patients, and the use of a confocal microscopy technique with poor axial without the possibility of acquiring metabolic images of the biofilm.

Based on the previous description of biofilm by optical coherence tomography (OCT), and a recent experience with an optimised form of high-resolution OCT, called full-field OCT, the investigator hypothesise that full-field OCT will allow more accurate characterisation of biofilm, due to its high spatial resolution and its potential ability to capture metabolic activity in the biofilm BIOPAVIR 2 proposes to use the performance of full-field OCT to better characterise the biofilm lining endotracheal tubes in patients undergoing mechanical ventilation in intensive care units. This project represents a first step towards understanding the link between the development of biofilm on intubation and the occurrence of VAP


Eligibility Criteria:
Inclusion Criteria:

* Patient or relative informed of the study and having declared their nonobjection
* Patient over 18 years of age
* Patient exposed to mechanical ventilation for at least two calendar days

Exclusion Criteria:

* Patient unable to declare their nonobjection
* Patient whose endotracheal tube collection is impossible
* Patient whose endotracheal tube is collected following self-extubation (sample contamination)
A Study of ABT-652 in Adults With Osteoarthritis Pain of the Knee

To compare the analgesic efficacy and safety of ABT-652 administered twice daily (BID) to placebo in subjects with osteoarthritis (OA) of the knee.


Eligibility Criteria:
Inclusion Criteria

* History of OA of the knee joint and meeting American College of Rheumatology (ACR) Clinical and Radiographic criteria,
* Pain score as required by the protocol at Screening and Baseline
* Willing to washout of analgesics and to follow treatment plan, visit schedules and study procedures.

Exclusion Criteria

* History of sensitivity to histamine medications, acetaminophen (paracetamol), or non-steroidal anti-inflammatory drugs (NSAIDs)
* Active gastrointestinal (GI) disease, GI bleeding or GI ulceration, or history of GI bleeding or GI ulceration in the last 6 months
* History of major psychiatric disorders
* Diagnosis of rheumatoid arthritis, autoimmune disorder, arthritis other than osteoarthritis involving the study joint, or other painful syndrome that could interfere with the assessment of pain at the study joint
* Any cardiac, respiratory, neurological or other medical condition or illness that is not well controlled with treatment
Randomized Clinical Trial of Intensive Computer-based Cognitive Remediation in Recent-onset Schizophrenia

The aim of this study is to investigate the efficacy of neuroscience-guided computerized cognitive training exercises on the remediation of cognitive deficits and symptoms associated with recent-onset schizophrenia and to examine the influence of subject characteristics, brain structure and function, and pharmacotherapy on the response to remediation.

Participation in this study will last approximately 12 months and will involve individuals with recent-onset schizophrenia. All participants will undergo baseline assessments that will include an interview, written tests, blood draws, and electroencephalogram (EEG) and magnetic resonance imaging (MRI) scans. Participants will then be assigned randomly to receive treatment with either computerized neuroadaptive cognitive training or commercially available computer games. Participants will be asked to complete 60-minute sessions of their assigned treatments 5 days per week for 8 weeks. For participants receiving cognitive training, exercises will focus on improving speed and accuracy in the perception of and response to verbal and visuospatial targets. The 8 weeks of treatment will focus on targeted cognitive training (TCT). Participants assigned to practice computer games will play standard commercially available games, with no targeted response.

Participants will repeat baseline assessments after the computer training and Month 6 of follow-up. The EEG and MRI will be repeated only at post training assessment visit. There will be a blood draw at Week 2 of treatment as well. After the Month 6 assessment, participants in the control condition will be offered an opportunity to complete an additional 8 weeks of computer training with different modules.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of schizophrenia, schizophreniform, or schizoaffective disorder
* First psychotic episode within the last 3 years
* Good general physical health
* Age between 12-35
* Is fluent and proficient in the English language
* Achieved clinical stability (e.g., outpatient status for at least 3 months before study entry; on stable doses of medication for at least 1 month before study entry
* Minors must have parental/legal guardian consent to participate

Exclusion Criteria:

* Any neurological disorder
* History of psychoactive substance abuse in the past 6 months
A Prospective Multicenter Study on Patients'Satisfaction With Angeliq® Micro in Real Clinical Practice Conducted in Russia

To evaluate the patients' satisfaction with Angeliq Micro in real clinical practice after 13 cycles of treatment.

This non-interventional study is planned with the aim of obtaining information about the results of the product use in real clinical practice by means of the evaluation of the patients' satisfaction.

The study will be multicenter, non-interventional, prospective, cohort study in patients for whom their physicians have taken a decision about Angeliq Micro treatment, irrespectively of the fact of this study inclusion.

The absence of a control group (patients who receive another menopausal hormonal therapy medication, or do not receive menopausal hormonal therapy at all) is based on high risk of bias (heterogeneity of exposure in case of comparison of low-dosed and ultralow-doses menopausal hormonal therapy regiments, or in case of comparison with a group of patients for whom the menopausal hormonal therapy is not indicated).

Eligibility Criteria:
Inclusion Criteria:

* Female patients aged 50 to 65 years with vasomotor symptoms of menopause (moderate or severe in intensity), who has been prescribed or will be prescribed the menopausal hormonal therapy with Angeliq Micro.
* Patients, who are already receiving continuous combined menopausal hormonal therapy (except Angeliq) for 3-5 years willing to continue MHT, and who will change their therapy for Angeliq Micro.
* Patients who never ever received menopausal hormonal therapy, if at least 3 years have passed after the last menstruation, with the STRAW+10 stage +1c and younger than 60 years at the moment of inclusion.
* Signed informed consent form (written consent for the study participation).

Exclusion Criteria:

* Unwillingness or inability to give the informed consent for the study participation.
* Contraindications for menopausal hormonal therapy (according to the Angeliq Micro SmPC).
* Current use or history of use during 1 month before of dietary supplements containing St John's wort, as they can affect tolerability and safety of hormonal therapy.
* Current participation in any other clinical study
Nasopharyngeal Bacterial Carriage and Antibiotic Resistance in Children With Sickle Cell Disease in Ile-De-France

The objective of this study is to to determine the rate of nasopharyngeal carriage of Streptococcus pneumoniae (Sp) in children with sickle cell disease over 6 months and under 15 years of age over a 9-month period in Ile-De-France.

Sickle cell disease is the most common genetic disease in France, with one affected child for every 1,736 births. Ile-de-France is the region in Europe with the highest prevalence of sickle cell disease.

Children with sickle cell disease have an increased susceptibility to infections related to encapsulated bacteria and are at high risk of invasive infections (particularly Streptococcus pneumoniae), which is the leading cause of mortality in children with sickle cell disease under 5 years of age worldwide.

the patients are subject to intense selection pressure (long-term antibiotic prophylaxis and systematic probabilistic curative antibiotic therapy) and are at high risk of carrying nosocomial bacteria (repeated hospitalizations). Moreover, children with sickle cell disease have reinforced immunization schedules, especially against pneumococcal disease.

However, data concerning the carriage of resistant bacteria (prevalence, risk factors) in children with sickle cell disease in France are scarce.

This study aims to determine the nasopharyngeal bacterial carriage and antibiotic resistance in children with sickle cell disease in Ile-De-France

Eligibility Criteria:
Inclusion Criteria:

* Children aged 6 months to 15 years, regardless of immunization status.
* Child with a major sickle cell syndrome (SS, SC, S+, S°, SE) followed in one of the centers of competence or reference for rare diseases (CRMR) " Major sickle cell syndromes, Thalassemias and other rare pathologies of the Red Blood Cell and Erythropoiesis " in Ile de France.
* Children who are not subject to legal protection measures.
* Child affiliated to a social security system.
* Signed informed consent

Exclusion Criteria:

* Sickle cell child with a febrile syndrome at the time of sampling or hospitalized for any reason.
* Child having received antibiotic therapy other than oracillin in the 7 days preceding the nasopharyngeal swab.
* Child already included in the observation period (only 1 nasopharyngeal swab per patient).
* Other hemoglobinopathies and heterozygous AS or AC patients.
* Patients already involved in a therapeutic protocol or in the exclusion period following a previous research.
* Patients under AME or without social security coverage.
Memory and Fear Study (Fear of Memory Loss Study)

This study is a randomized control study to determine the impact of a tailored, web-based mindfulness program to reduce anxiety and increase the quality of life in older adults experiencing dementia-related fears, relative to a conventional meditation program.

The study will test two different types of online mindfulness programs to see if an online self-paced mindfulness program can help reduce anxiety related to memory loss. Participants will be involved in the study for a total of 10 weeks. Participants will log on to an online mindfulness program 4 days per week for about 10-20 minutes each. The total program will last 3 weeks. Participants will also be asked to complete questionnaires before starting the program, during the program, and after they complete the program.

Eligibility Criteria:
Inclusion Criteria:

* 55 years of age or older
* Elevated dementia-related fear
* Able to read/write in English
* Willingness to be randomized to intervention group
* Willingness to complete three weeks of self-guided intervention, questionnaires, and cognitive tests.
* Access to a reliable internet connection

Exclusion Criteria:

* Diagnosis of mild cognitive impairment, Alzheimer's Disease, or dementia by a healthcare provider.
* Impaired cognitive or neurologic function
* Unstable medical condition
* Severe depression
* Current treatment for anxiety or depression
* Current participation in another psychotherapy
* Current use of psychiatric medication
* Current substance use disorder
* Inadequate vision or hearing to interact with study materials
Enhancing Prospective Thinking in Early Recovery

The goal of this clinical trial is to use a novel virtual reality intervention to test for efficacy in reducing stimulant use and increasing abstinence, with concomitant increases in future self-identification, future time perspective, and delay-of-reward, in early recovering stimulant use disorder (StUD) persons. The main question\[s\] this trial aims to answer are:

* Will the Virtual Reality (VR) intervention decrease the number of stimulant use days?
* Will the VR intervention produce longer abstinence periods during follow-up visits?
* Will the VR intervention increase stimulant drug abstinence rates?
* Will the VR intervention increase future self-identification?
* Will the VR intervention increase self-reported future time perspective?
* Will the VR intervention increase preference for delayed rewards in a laboratory delay discounting task on the study day?
* Will the VR intervention produce gains in the behavioral effects of future self-identification, future time perspective, and delayed rewards at the 30-day and 6-month follow-ups?

Researchers will compare the experimental and control groups to see if there are differences in the results for the questions outlined above.


Eligibility Criteria:
Inclusion Criteria:

* Abstinence between ≥14 days and ≤1 year
* At least 18 years old
* Verbal endorsement of commitment to recovery
* Outpatient
* Psychotropic drugs for SUD-comorbidity
* Drug/alcohol abstinence ≥ 24 hours at the time of the study day visit
* English comprehension

Exclusion Criteria:

* Unstable medical disorders
* Less than 18 years old
* Habitual drug use
* Mu-opioid drugs
* Smell/taste disorders
* Unstable psychiatric conditions
* Extravagant/elaborate face tattoos
iExposure Intervention for Social Anxiety

Social anxiety (SA) is a highly prevalent mental health concern, thought to disproportionately affect youth with recent international estimates of more than 30% of individuals reporting clinically elevated symptoms. Despite the prevalence of SA, as few as one in five individuals receive care, due to limited access to evidence-based treatments. Additionally there has been a notable increase in social anxiety since the start of the COVID-19 pandemic. This proposal will use iExposure to develop a personalized mechanism-focused approach to optimizing treatment response for individuals with social anxiety by testing standard iExposure against two augmentations that incorporate distinct attention mechanisms (attention guidance and attention control).


Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Fluent in English
* Leibowitz Social Anxiety Scale \> 47 and endorses both social anxiety items on the Web Screening Questionnaire for Common Mental Disorders

Exclusion Criteria:

* Currently receiving CBT for Social Anxiety Disorder
* Significant visual impairment precluding engagement in the simulated teleconferencing interactions
* Unstable dose of psychotropic medications within 6 weeks prior to baseline assessment
* Current alcohol or substance use disorder
* Current or past bipolar disorder or psychosis
DFT383 in Pediatric Participants With Nephropathic Cystinosis

An open-label, multi-center, phase I/II study to assess the safety, tolerability and efficacy of DFT383 in pediatric participants with nephropathic cystinosis.

The purpose of this clinical study is to assess safety, tolerability, and efficacy of DFT383 in participants aged 2 to ≤ 5 years with nephropathic cystinosis. DFT383 is a cellular gene therapy.

This study includes an active arm (Cohort 1) of participants treated with study treatment DFT383 and a concurrent reference arm (Cohort 0) treated with Standard of care (SoC). The study is not randomized and Cohort 0 aims to collect prospective and concurrent data in this rare disease.

This study is an open-label, multi-center, phase I/II study to assess the safety, tolerability, and efficacy of DFT383 in participants aged 2 to 5 years with nephropathic cystinosis. The study consists of participants receiving DFT383 in Cohort 1 and Standard of Care (SoC) in Cohort 0. The two cohorts will be run in parallel. Investigational sites may participate in one or both cohorts.

Cohort 1 Approximately 15 participants will receive treatment with DFT383 in 3 cohorts (1A, 1B and 1C) dosed in a staggered approach. The total study duration for a participant in Cohort 1 will be up to 32 months.

Cohort 0 Approximately 15 participants meeting similar inclusion/exclusion criteria and receiving SoC will be enrolled. The Schedule of Activities will be reduced for this Cohort. This cohort 0 is not a direct control but will provide essential context for interpreting the results observed in the participants receiving DFT383. The total study duration for a participant in Cohort 0 will be up to 24 months.

Eligibility Criteria:
Key Inclusion Criteria:

Participants eligible for inclusion in this study must meet all the following criteria:

1. Informed consent in writing from parent(s) or legal guardian(s) must be provided
2. 2 to 5 years of age (including 5 years and 364 days old) at Screening
3. Weight-for-stature is ≥ the third percentile is ≥ 10 kg
4. Oral cysteamine therapy for at least 6 months
5. Historic clinical diagnosis of nephropathic cystinosis
6. Laboratory evidence of of renal fanconi syndrome (RFS)
7. Preserved kidney function (eGFR ≥ 90mL/min/1.73m2)
8. Received all age-appropriate vaccinations

Key exclusion Criteria for Cohort 1 and 0

1. A history of kidney transplantation
2. A prior or planned bone marrow or stem cell transplantation or prior treatment with gene therapy
3. History of malignancy
4. A severe or uncontrolled medical disorder
5. Major surgery within 90 days

Additional Key exclusion criteria for Cohort 1 - The following exclusion criteria only apply to Cohort 1 only as they are important for procedures related to DFT383 treatment:

1. Indomethacin within 2 weeks prior to Screening

Other protocol-defined inclusion/exclusion criteria may apply.
Optimisation of Radiotherapy in Rectal Cancer (ORREC)

This is a retrospective study using images acquired routinely for diagnosis of rectal cancer to see if these could be used to predict responses to radiotherapy treatment and if it can, whether the treatment can be optimised to produce better outcome for patients. Using a clinical database, patients who have had neo-adjuvant chemo-radiotherapy will be recruited, their diagnostic images and radiotherapy planning scan will be obtained. By use of imaging registration and clinical information, the question of why some patients respond well to radiotherapy and some don't could be answered.

The treatment of locally advanced rectal cancer is primarily radiotherapy (+/- chemotherapy) followed by surgery. The reason for radiotherapy is to reduce the risk of recurrence after surgery or to shrink the tumour first so that when surgery is done all the cancer will be successfully removed otherwise some will be left behind to grow. More than 80% of patients require a stoma after their surgery, some get reversed by two years after surgery but a third has it lifelong. About 15% of patients after radiotherapy have no disease left (clinical complete response) and can be monitored closely after radiotherapy and will not need to have surgery or stoma. Surgery carries a risk of death and complications, having a stoma have a lot of complications and have an effect on patient's quality of life, most end up not going out much and withdraws from friends and family due to the risk of accidents in public places. This study is aimed at looking at ways to increase the number of patients that do not require surgery after radiotherapy by looking at the differences between those that responded well to radiotherapy and the ones that did not by comparing their diagnostic and treatment scans. The main question to answer is why some patients have complete response to radiotherapy and others don't. Is there a way to increase the number of these patients through changes in radiotherapy? The study will be looking at the diagnostic images and radiotherapy planning scans to compare these two groups. Is there a way of predicting who will respond to radiotherapy treatment? If there is, modifications could be made to the type of treatment given. This study will be looking to radiomics techniques to develop this. This retrospective study will only make use of scans that patients have already had for their diagnosis and treatment so no patient intervention is required. Patients will be recruited using the clinical and research database of the Christie hospital which is the largest cancer centre in the UK. The study is funded by the charitable fund of the Christie Hospital NHS Foundation Trust.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed rectal adenocarcinoma.
* Received pelvic radiotherapy (+/- chemotherapy) as neo-adjuvant treatment
* Age 18 and above

Exclusion Criteria:

* Other rectal pathologies.
* Patients less than 18yrs at diagnosis.