cyrilzakka/clinical-trials huggingface dataset:
Influence of Natural Images on Patients' Anxiety in the Waiting Rooms of Imaging Ward

VERTIM study aims to evaluate the influence of different environments of imaging waiting rooms on the anxiety felt by patients before MRI or CT scans. For this, four environments (neutral/standard; and nature "green", "sea", and "zen") will be set up in MRI and CT waiting rooms.

Each year, the Medical Imaging Unit of the University Hospital of Bordeaux (CHU Bordeaux) receives 80,500 patients for CT or MRI scans in usual care. The length of waiting, the environment of the waiting room, the reasons for the examination are factors that increase the levels of anxiety during waiting and but also during early examination.

Previous studies have shown that the integration of nature (real as well as artificial) is likely to decrease the level of anxiety. Before implementing a multicentre and randomised trial, a pilot study is necessary to assess the feasibility of the procedure, to test the relevance of the tools, to identify the influence of socio-cultural and socio-demographic characteristics on anxiety's level.

For this, the present study will be conducted over the same period of the year in order to avoid seasonality biases. The study will take place over 8 weeks, during which MRI or scanner patients will be exposed either to the neutral environment (standard environment of the waiting room) or to one of the 3 environments (wall posters representing the nature ("green", "sea", "zen")).

There is no specific intervention assigned to the study participants, i.e. the patients will receive one of the four environments as part of routine medical care, and a researcher studies the effect of this environment on anxiety's level. Every week, one environment will be set up in the MRI or scanner waiting room and the study will be proposed to all eligible patients present in this room. Fifty patients are expected each week so that 100 patients per environment and equally distributed between the MRI and scanner waiting rooms are expected.

Eligibility Criteria:
Inclusion Criteria:

* patient 18 yrs and older;
* patients in MRI or scanner's waiting room awaiting one of these 2 exams;
* patients not objecting to answer questionnaires;
* patient covered under social security

Exclusion Criteria:

* patient \<18yrs old;
* patients with hearing and visual impairments;
* patients unable to answer questionnaires;
* patients awaiting for other exams than MRI or scanner;
* legally protected patient
Dynamic ctDNA Detection for Colorectal Cancer Liver Metastases

Evaluating the value of dynamic monitoring of a colorectal cancer liver metastasis cohort underwent curative resection after receiving multipoint ctDNA detecting in predicting recurrence prognosis and guiding adjuvant chemotherapy treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Before implementing any trial-related procedures, written informed consent should be signed;
2. \>=20 and \<= 85 years old, male or female;
3. Patients with liver metastases pathologically confirmed as colorectal adenocarcinoma;
4. According to the Response Evaluation Criteria for Solid Tumors (RECIST version 1.1), there is at least one lesion that can be measured by imaging;
5. The multidisciplinary team (MDT) confirmed that the liver metastases were initially resectable ,without locally treatable extrahepatic metastases;
6. The general physical condition is good (ECOG score 0-1);
7. Life expectancy of more than 3 months;
8. There is no obvious symptoms of primary bleeding, obstruction and other indications for emergency surgery;
9. adequate organ function;
10. samples meet NGS quality control requirements;
11. The subjects are able and willing to comply with the visits, treatment plans, laboratory tests and other research-related procedures stipulated in the research protocol.

Exclusion Criteria:

1. Patients who are intolerant to systemic chemotherapy or surgery;
2. Patients with multiple primary lesions;
3. Blood samples and/or baseline tissue samples that do not meet the requirements for testing (hemolysis, low tumor cell content, insufficient DNA extraction yield, etc.);
4. Excessive tissue necrosis after conversion therapy, making it impossible to sample according to testing requirements
5. Patients who have not undergone surgery after conversion therapy, only receiving radiofrequency ablation or chemotherapy follow-up
6. Not all metastatic lesions were resected after conversion therapy, or liver metastatic lesions did not achieve R0 resection
7. No definite mutations detected in the tissue, or mutations detected in tumor tissue were not covered by the designed small panel.
STarting incrEmental Prescription of Peritoneal Dialysis

Kidney failure is fatal without dialysis. Peritoneal dialysis (PD) completed at home offers greater flexibility and autonomy for patients . However, PD is often prescribed for 24 hours/day, 7 days/week for every patient starting dialysis. This practice is not evidence-informed, may be unnecessary and potentially harmful. The STEP-PD trial aims to determine the optimal approach to commencing patients on PD through starting at low dose PD and incrementing over time.

The STEP-PD study is an investigator-initiated, pragmatic, international, multicentre, prospective, adaptive, randomised, open-label, parallel group, non-inferiority trial led by an international multi-disciplinary team of clinician scientists, nephrologists, consumers, social scientists, trialists, health economists, dialysis nurses, statisticians, and registry experts. The STEP-PD trial is co-designed with consumers with lived experience of peritoneal dialysis (PD) to determine the optimal approach to starting patients with kidney failure on PD. Specifically, this trial will test the hypothesis that, compared with full dose PD, starting patients on incremental start PD preserves symptom burden related quality of life (QOL), reduces dialysis burden, is safe, is more environmentally sustainable and costs less for patients, the community and the healthcare system. The STEP-PD trial has the potential to transform and personalise the treatment of kidney failure globally by providing definitive evidence on the patient-prioritised question regarding the effectiveness and safety of incremental start PD, particularly in relation to the patient-critical outcome of symptom burden-related QOL. Favourable results would lead to a paradigm shift in how patients are started on PD, thereby mitigating unnecessarily burdensome, expensive, and possibly harmful treatment.

Eligibility Criteria:
Inclusion Criteria:

* adults (≥18 years) commencing PD as their first dialysis therapy (and been on dialysis for \<1 month)
* able to give informed consent

Exclusion Criteria:

* urine output \<0.5L/day
* previous kidney transplant
* unlikely to be on dialysis for ≥1 year.
* known or planned pregnancy during the trial
BAMI. The Effect of Intracoronary Reinfusion of Bone Marrow-derived Mononuclear Cells(BM-MNC) on All Cause Mortality in Acute Myocardial Infarction

This is a multinational, multicentre, randomised open-label, controlled, parallel-group phase III study. Its aim is to demonstrate that a single intracoronary infusion of autologous bone marrow-derived mononuclear cells is safe and reduces all-cause mortality in patients with reduced left ventricular ejection fraction(\</=45%) after successful reperfusion for acute myocardial infarction when compared to a control group of patients undergoing best medical care.


Eligibility Criteria:
Inclusion Criteria:

* signed and dated informed consent form
* men and women of any ethnic origin aged≥18years
* patients with acute ST-elevation myocardial infarction as defined by the universal definition of AMI (including new LBBB)
* Patients with acute ST-elevation myocardial infarction as defined by the universal definition of AMI.
* Successful acute reperfusion therapy (residual stenosis visually \<50% and TIMI flow ≥2) within 24 hours of symptom onset or thrombolysis within 12 hours of symptom onset followed by successful percutaneous coronary intervention (PCI) within 24 hours after thrombolysis
* Left ventricular ejection fraction ≤ 45% with significant regional wall motion abnormality assessed by quantitative echocardiography (central, independent core lab analysis) 2 to 6 days after reperfusion therapy
* Open coronary artery suitable for cell infusion supplying the target area of abnormal wall motion

Exclusion Criteria:

* Participation in another clinical trial within 30 days prior randomisation unless non interventional trials or trials where patients are randomised to only standard care and this has been discussed and agreed with the CI/sponsor prior to consenting
* Previously received stem/progenitor cell therapy
* Pregnant or nursing women
* Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study or to follow the protocol
* Necessity to revascularise additional vessels, outside the target coronary artery at the time of progenitor cell infusion (additional revascularisations after primary PCI and before BM-MNC cell infusion are allowed), unless clinically indicated and according to latest guidelines. This decision should be made at the time of the index procedure and explicitly stated at that time.
* Cardiogenic shock requiring mechanical support
* Platelet count \<100.000/µl, or hemoglobin \<8.5 g/dl
* Impaired renal function, i.e. creatinine \>2.5 mg/dl
* Fever or diarrhoea not responsive to treatment within 4 weeks prior screening
* Cliinically significant bleeding disorder within 3 months prior screening
* Uncontrolled hypertension (systolic \>180 mmHg and diastolic \>120 mmHg)
* Life expectancy of less than two years from any non-cardiac cause or uncontrolled neoplastic disease
Role of Hypertonic Saline Versus Mannitol in the Management of Raised Intracranial Pressure in Patients With ALF

Patients with ALF (Acute liver Failure) would undergo a detailed clinical evaluation. Information would be collected regarding the onset and duration of symptoms, etiology, and severity of disease, other baseline clinical features, demographic characteristics, routine biochemical and hematological investigations. Patients would also be screened for the assessment of raised intracranial hypertension by either clinical or neuroimaging or by ONSD (optic nerve sheath diameter) and TCD (Transcranial doppler ultrasonography). Patient found to be having risen ICP (Intra Cranial Pressure) would be randomized in the two groups of the study. The group A would receive intravenous mannitol 20 to 30 minutes every 4 hourly where as those in the group B would be given 3% hypertonic saline as continuous infusion at a rate of 25ml /hr and titrated q4 hrs per sliding scale to achieve a target serum sodium level of 144-155 mmol/L .Both the groups would receive other supportive measures such as head end elevation, oxygen supplementation, dextrose infusion to maintain normoglycemia standard medical treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patients with Acute Liver Failure with age \>18 yrs
* Grade III or grade IV HE with raised ICP
* Patient's next-of-kin consenting for the study protocol.

Exclusion Criteria:

* Patients with ocular trauma.
* K/c/o DCM, congestive heart failure, cerebral aneurysm, intracranial pathology
* Serum Na\>160 and s creat\>1.5 mg% with oligurea
A Study to Collect Pre-existing Data on the Administration of Cabozantinib in Participants With Advanced Renal Cell Carcinoma (aRCC) Who Initiated Cabozantinib in 2nd Line in a Real-life Clinical Setting in France.

Cabozantinib is an orally bioavailable tyrosine kinase inhibitor (TKI) approved in patients with aRCC previously treated with a Vascular Endothelial Growth Factor (VEGF)-targeted therapy. Cabozantinib has been increasingly used in routine care in second line and more in advanced or metastatic RCC in France.

Cabozantinib effectiveness and safety notably in a real-word setting are now well known, but too many questions that arise during the routine care of patients with aRCC remain unanswered by the current literature.

Obtaining data on cabozantinib effectiveness and treatment pattern in those participants subpopulations will allow physicians to improve patients care.

The aims of this study are to describe the effectiveness - in terms of Duration of Treatment (DOT), Best Overall Response (BOR) and Progression-Free Survival (PFS) - and the safety of second line cabozantinib a real-life setting in France and to address the unanswered questions that arise during the routine care of patients with aRCC treated with cabozantinib in order to improve the care of these participants.

Since 2018, cabozantinib has been increasingly used in routine care in second line and more in advanced or metastatic RCC in France.

Cabozantinib effectiveness and safety notably in a real-word setting are now well known, but too many questions that arise during the routine care of patients with aRCC remain unanswered by the current literature.

As an example, there is currently no real-world data on cabozantinib in elderly patients (≥ 75 years old); in patients with a systemic therapy after progression under cabozantinib (only one published monocentric retrospective study on 56 participants); or in long responder patients (with a disease controlled after \> 12 months of cabozantinib). Obtaining data on cabozantinib effectiveness and treatment pattern in those patient subpopulations will allow physicians to improve patients care.

Eligibility Criteria:
Inclusion Criteria:

* Male or female ≥ 18 age at the time of cabozantinib initiation.
* Pathologically confirmed diagnosis of Renal Cell Carcinoma (RCC) considered as advanced at the time of cabozantinib initiation.
* Cabozantinib initiated from 1st March 2018 to 1st March 2021 for an advanced RCC.
* Cabozantinib initiated in 2nd line according to local Summary of Product Characteristics (SmPC).

Exclusion Criteria:

* Participant medical file without documented follow-up visits (post-cabozantinib initiation).
* Participant alive at study initiation who is opposed to data collection.
* Participant who died before study initiation and who was opposed to data collection for research purposes when alive.
Study of Antibody Responses After a Dose of Tetravalent Meningococcal Diphtheria Conjugate Vaccine in Children

The study investigated safety profile and the antibody responses to an experimental tetravalent meningococcal diphtheria conjugate vaccine (Menactra®) in children who have received a monovalent meningococcal C conjugate vaccine at least one year previously.

Primary objective:

To describe and compare the Serum Bactericidal Assay (SBA) antibody response for serogroup C in participants receiving Menactra® to the serogroup C antibody response in a control group of participants receiving a licensed Haemophilus Influenzae Type b (Hib) conjugate vaccine 28 days following vaccination.


Eligibility Criteria:
Inclusion Criteria :

* Participant is healthy, as determined by medical history and physical examination.
* Participant is 2 years to \< 5 years of age at the time of vaccination.
* At least one year from primary vaccination with a monovalent meningococcal C conjugate vaccine has elapsed.
* Parent/Guardian has signed an Ethics Committee-approved informed consent form. A culturally appropriate translation will be used for non-English speaking participants where required.

Exclusion Criteria :

* Serious chronic disease (i.e. cardiac, renal, neurologic, metabolic, rheumatologic, etc.)
* Known or suspected impairment of immunologic function
* Acute medical illness with or without fever within the last 72 hours or an axillary temperature ≥ 37.5ºC at the time of inclusion
* History of documented invasive meningococcal disease
* Administration of immune globulin, other blood products within the last three months, injected or oral corticosteroids or other immunomodulatory therapy within six weeks of the study vaccine. Individuals on a tapering dose schedule of oral steroids lasting \< 7 days may be included in the trial as long as they have not received more than one course within the last two weeks prior to enrolment
* Antibiotic therapy within the 72 hours prior to vaccination or 72 hours prior to drawing any blood sample
* Received any vaccine in the 28-day period prior to enrolment, or scheduled to receive any vaccine during enrolment in the trial
* Received a meningococcal C conjugate vaccine within one year prior to enrolment
* Suspected or known hypersensitivity to any of the vaccine components
* Unavailable for the entire study period or unable to attend the scheduled visits or to comply with the study procedures
* Enrolled in another clinical trial
* Any condition, which, in the opinion of the investigator, would pose a health risk to the participant or interfere with the evaluation of the vaccine.
TeleRehabilitation for Patients With Chronic Respiratory Failure.

It is widely described in the literature that exercise training improves patients' exercise tolerance, quality of life, symptoms, anxiety and depression, regardless of the location. Despite overwhelming evidence of the benefits of exercise training, only a very small percentage of eligible people have ever completed a program. Alternative modes of exercise training are needed to improve equity of access for patients with chronic respiratory disease. So TeleRehabilitation, using information and communication technologies to provide distance exercise training services, may be an answer.


Eligibility Criteria:
Inclusion Criteria:

* chronic respiratory disease patients
* Patients with dyspnea or exercise intolerance.
* Stable patients at home.
* Patients who can use a computer (after explanations) and have adequate hearing and vision.
* Collection of the patient's non-objection

Exclusion Criteria:

* Life expectancy \<3 months.
* Absolute contraindication to performing physical activity
* Hospitalization for exacerbation in the two months prior to inclusion.
Microbial and Human Determinants of the Onset of IBD Flares

This is a longitudinal, observational study that aims to identify the microbial and human molecular triggers of IBD flares via stool, saliva, and blood metatranscriptomes, whole blood proteome, and collected clinical metadata. This study is direct to participant and will not utilize clinical sites.

This is a longitudinal, observational study that aims to identify the microbial and human molecular triggers of IBD flares via stool, saliva, and blood metatranscriptomes, whole blood proteome, and collected clinical metadata. This study will last approximately 3 years and will recruit up to 1000 Crohn's Disease participants and up to 1000 Ulcerative Colitis participants that will participant in the study for approximately 12 months. Participants will be sent at home sample collection kits and a study survey each month. If the survey responses indicate a participant is in a flare, they will be sent a sample collection kit and survey on a weekly basis until the flare is over and the monthly schedule resumes. The objective of the data analysis is to identify microbial functions that are predictive of the onset of a flare.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Able to provide written informed consent prior to screening
* Established diagnosis of small bowel or colonic Crohn's Disease (CD) or Ulcerative Colitis (UC)

Exclusion Criteria:

* Pregnant or breastfeeding
* Use of antibiotics within the last 3 months
* Bowel surgery in the past 3 months or planned bowel surgery during the 12-month study period
Natural History of Medullary Thyroid Cancer to Inform Advanced Disease Management

This study utilizes a multi-institutional registry to describe the natural history of medullary thyroid cancer that has spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) in understanding disease management. The goal of this study is to learn about how medullary thyroid cancer develops and progresses.

PRIMARY OBJECTIVES:

I. To describe the natural history of medullary thyroid cancer (MTC) using a comprehensive battery of demographic, clinical, pathologic, and genotypic variables collected in our existing multi-institutional patient registry.

Ia. To describe the demographic, clinical, pathologic, and genotypic variables associated with each phase of disease.

Ib. To identify those variables which are predictors of progression to the most advanced phases of disease that require small molecule therapy, including commercially approved and experimental agents.

II. To characterize patients' experience with the different phases of MTC through a systematic evaluation of patient-reported outcomes (PROs).

IIa. To describe clinical, psychosocial, economic, and physical well-being variables and the subsequent impact on quality of life associated with each phase of disease.

IIb. To evaluate longitudinal changes in clinical, psychosocial, economic, and physical well-being variables between and within all phases of MTC, and the subsequent impact they have on quality of life.

III. To evaluate the association of selected biometric and patient-reported outcomes on adherence, change, and discontinuation of approved targeted therapies and drugs being tested within clinical trial.

OUTLINE:

AIM I \& II: Patients complete questionnaires over 10-40 minutes 2-4 times per year about health and how finances and quality of life effect experience with disease.

AIM III: Patients complete a questionnaire over 2 minutes and undergo blood pressure measurements every day for up to 12 weeks.

The questionnaire data gets paired with the collected medical record history that is maintained in the Registry.

Eligibility Criteria:
Inclusion Criteria:

* Aims 1 and 2: A diagnosis of MTC
* Aims 1 and 2: A registrant in the Medullary Thyroid Cancer Registry (MTCR). Patients of all disease phases will be eligible for enrollment
* Aim 3: A diagnosis of advanced phase (red or gray) MTC as determined by clinical team
* Aim 3: A current registrant in the MTCR