cyrilzakka/clinical-trials huggingface dataset:
Development of Inflammation and Fibrosis Index, Combining MRI and PET 18F-FDG, in Patient's With Crohn's Disease

Chronic inflammatory bowel disease (IBD) is a disabling, incurable condition that affects 250,000 people in France, and Crohn's disease (CD) is the most common form. CD progresses, in one-quarter of the cases, towards the appearance of intestinal stenosis, most often on the terminal ileum, sometimes with obstructive symptoms and requiring an optimization of medical treatment (biotherapies) and/or surgery The hypothesis of this study is \[18F\]FDG PET /CT, (Positron emission tomography with the tracer fluorine-18 (18F) fluorodeoxyglucose (FDG), called \[18F\]FDG PET coupled to a dedicated CT scanner) could help quantify intestinal inflammation in patients with abnormal entero-MRI, and differentiate inflammation and fibrosis on a joint PET /CT and MRI , in patients with complicated Crohn Disease intestinal stenosis

Intestinal inflammation could be quantified by the PET/CT due to the tropism of a PET tracer, \[18F\]FDG for activated inflammatory cells.

\[18F\]FDG PET/CTperformed on latest digital PET/CT cameras and recordings focused on the abdomen could help quantify intestinal inflammation in patients with abnormal entero-MRI, and differentiate inflammation and fibrosis on a joint PET/CT and MRI , in patients with complicated Crohn Disease intestinal stenosis.

Magnetic resonance imaging (MRI) indices are used to assess the upgradability and activity of CD and try to predict response to treatment, in particular Nancy's MRI score for digestive inflammation.

An inflammation index (FILM-i) and a fibrosis index (FILM-f), based on this MRI/PET analysis, will be developed and validated to develop personalized medicine in patients with stenosing CD. Indeed, these indices will guide the therapeutic choice, in particular for the biotherapies prescription or the need to operate these patients.

Eligibility Criteria:
Inclusion Criteria:

* Major subject having received complete information of the clinical research and having signed their informed consent
* Subject with a stenosing CD (objectified on MRI, CT and / or endoscopy).
* Subject for which surgical resection of one or more stenosis (s) of the terminal ileum is programmed as part of the treatment.
* Subject with a social security scheme

Exclusion Criteria:

* Subject having a contraindication to performing MRI and / or PET / CT at 18F-FDG.
* Subject with an ostomy
* Diabetic subject treated by metformin.
* Subject referred to in articles L. 1121-5, L. 1121-7 and L1121-8 of the public health code.
* Pregnant woman, parturient or nursing mother.
* Subject with a legal protection measure (guardianship, curatorship, safeguard of justice).
* Subject unable to express consent.
* Subject deprived of their liberty by a judicial or administrative decision, persons subject to psychiatric care under articles L. 3212-1 and L.3213-1.
Using Virtual Reality to Improve Job Reentry in Adults With TBI

The purpose of this research is to investigate the effectiveness of virtual reality (VR) to improve job reentry skills in individuals with TBI.

The current study will examine a virtual reality (VR) intervention entitled "Virtual Reality Job Interview Training (VR-JIT)" which targets social competency skills needed for successful job interviewing, and its efficacy when applied to individuals with traumatic brain injury (TBI). Preliminary evidence suggests that the VR-JIT is successful in individuals with autism spectrum disorder and schizophrenia in improving interview abilities. However, the efficacy of VR-JIT has not been evaluated in TBI populations.

Eligibility Criteria:
Inclusion Criteria:

* I am between the ages of 18 and 65.
* I have a diagnosis with moderate to severe TBI.
* I am at least one year post injury.
* I am able to speak and read English fluently.

Exclusion Criteria:

* I have a history of multiple sclerosis, stroke, seizures or another neurological injury or disease in the past (like brain tumor or epilepsy).
* I have a history of significant psychiatric illness (like bipolar disorder, schizophrenia or psychosis).
* I am currently taking steroids and/or benzodiazepines as determined by study staff review of my medications.
Rivastigmine Monotherapy and Combination Therapy With Memantine in Patients With Moderately Severe Alzheimer's Disease Who Failed to Benefit From Previous Cholinesterase Inhibitor Treatment

This is a prospective, multicenter, open-label study. Following screening and baseline assessments, eligible patients will be switched to rivastigmine and will enter the 16 week run-in rivastigmine treatment phase. After completion of assessments at the end of the run-in phase, patients who were not sufficiently stabilized on rivastigmine alone will receive add-on memantine to their rivastigmine treatment; patients who were stabilized on rivastigmine alone will have completed and be discontinued from the study.


Eligibility Criteria:
Inclusion Criteria:

* Outpatients who have probable Alzheimer's disease according to the DSMIV criteria
* Patients treated with donepezil (5-10 mg ) or galantamine (16- 24 mg) for at least 6 months
* Patients, in the investigator's clinical judgment, not stabilized on treatment with donepezil or galantamine

Exclusion Criteria:

* Patients with evidence of severe or unstable physical illness, i.e., acute and severe asthmatic conditions, severe or unstable cardiovascular disorders, active peptic ulcer disease, hypersensitivity to cholinesterase inhibitors or memantine, clinically significant laboratory abnormalities or any patient with a medical condition which would prohibit them from completing the clinical trial
The Effect of Breathing Exercise and Stabilization Exercise With Chronic Low Back Pain

The aim of this study is to compare the effect of sleep hygiene, breathing exercises, and stabilization exercises on pain, sleep quality, and anxiety level in patients with non-specific chronic low back pain.

Addressing sleep problems in patients with chronic non-specific low back pain (LBP) can reduce chronic pain, the risk of developing depressive illness and improve pain-related quality of life.

Sleep is a concept that has physiological, psychological, and social dimensions. Sleep is one of the essential and indispensable daily life activities that affect individuals' quality of life and well-being. Decreasing pain is expected and likely to improve sleep quality. Still, it is unknown what will happen due to improving sleep quality to resolve the pain of unknown origin.

Education about sleep hygiene with physiotherapy has not been assessed before on individuals with nonspecific LBP. Since this training will require a lifestyle change, individuals should be warned not once but several times in a certain time, and this training should be reinforced. This will be an advantage for the patients receiving physiotherapy, and their therapists will support them in applying this training during the physiotherapy sessions.

In our study, individuals with nonspecific chronic low back pain will be divided into three groups using the blinding method as part of a randomized controlled trial.

The first group, as the conventional physical therapy group, will receive a hot pack and TENS only.

The second group, as the stabilization group, will receive lumbar stabilization exercises and the conventional physical therapy program.

The third group, as the breathing exercise group, will receive breathing exercises, including sleep hygiene and stabilization group program.

Eligibility Criteria:
Inclusion Criteria:

* individuals between the ages of 18-65
* Having low back pain for at least the last 3 months
* Pain at 4 out of 10 according to VAS (Visual Analogue Scale)

Exclusion Criteria:

* Radiculopathies
* Body mass index \> 35
* Neurological, orthopedic, or cardiopulmonary diseases that will contraindicate exercise
* Treatment for pain in the last 3 months who have received
* individuals who can't cooperate and those who have problems adapting to exercises
Pharmacokinetics of Polymyxin B in Adult Patients With Cystic Fibrosis

Cystic fibrosis (CF) pulmonary disease is a major cause of morbidity and mortality in CF patients and is punctuated by episodes of acute exacerbation that require antibiotic treatment. Pseudomonas aeruginosa is the predominant bacterial pathogen isolated in patients with acute exacerbations, and practice guidelines recommend combination antibiotics directed against this pathogen as initial therapy. Such therapy traditionally consists of an antipseudomonal beta-lactam with either an antipseudomonal fluoroquinolone or an aminoglycoside. With growing P. aeruginosa multi-drug resistance, more adult patients present with isolates resistant to these traditional options.

The polymyxins are a class of cyclic peptide antibiotics that exert bactericidal activity through binding to the lipopolysaccharide component of gram-negative bacterial membranes and include colistin and polymyxin B (PMB). In recent years, there is growing evidence of increased rates of acute kidney injury associated with colistin in critically ill patients. Additionally, population pharmacokinetic (PK) studies suggest that fixed drug dosing may yield an improved therapeutic index over the traditional weight-based dosing of this agent. Thus there is growing interest in use of PMB as an alternative in CF acute exacerbations but the optimal dosage regimen is not known.

This is a single-center, open-label, non-interventional study to characterize the pharmacokinetics and safety of fixed-dose PMB in adult patients with CF by measuring serum concentrations in patients receiving IV therapy as a part of routine care. This study will help to validate existing population PK models and allow for adjustment of patient specific covariates (i.e. weight, renal function) unique to adult patients with CF. The study will also monitor for nephrotoxicity and neurotoxicity to determine if PMB has an acceptable margin of safety in this patient population. This investigation is the first to prospectively validate the pharmacokinetics and toxicities of fixed-dose PMB in CF and will guide optimal use of this compound in the management of acute pulmonary exacerbations.

This study initially planned to include "Change in forced expiratory volume in one second (FEV1)" and "Non-response to therapy" as secondary outcome measures. These outcome measures were removed, as the small number of participants prohibited collection of significant data beyond what was collected for the baseline measures.

Eligibility Criteria:
Inclusion Criteria:

1. Adults ≥ 18 years of age.
2. Diagnosis of CF.
3. Receiving polymyxin B in the course of routine care.

Exclusion Criteria:

1. Evidence of acute kidney injury during the 48 hours prior to and following initiation of PMB therapy.
2. Extracorporeal organ support (including ECMO, iHD, and CRRT).
3. Pregnant or breastfeeding women.
Optical Biopsy for Thoracic Lymph Nodes.

EUS-FNA is the recommended diagnostic examination of choice when patients present with suspected lower mediastinal lymph nodes on imaging. EUS-FNA is minimal invasive and low in costs, and although it has a good record in detecting diseases (eg confirm a nodal metastasis or granulomas) it has limitations in excluding diseases (missing metastases/ or granulomas) resulting in a false negative rate of 15-20%. Substantial limitations that most likely can be attributed to areas within the node that are not sampled during EUS-FNA tissue acquisition. Improved needle based EBUS/ EUS guided nodal diagnostics might result in improved quality of the fine needle aspirations, reduce in surgical diagnostic procedures , reduced costs and result in a shorter timebefore-treatment interval.

Needle based confocal laser endomicroscopy (nCLE) is a modern imaging technique, compatible with the conventional diagnostic aspiration needle, that uses an excitation laser light to create 'real-time' microscopic images of tissues. Therefore this technique provides additional information regarding the nodal status and could therefore improve the diagnostic yield of EUS-FNA. Specifically, we will describe the nCLE image characteristics of lymph nodes involved in lung cancer and sarcoidosis as well as in healthy lymph nodes. Improved characterization of mediastinal nodes might lead to improved diagnosis.

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years of age
* Suspected or tissue proven sarcoidosis (stage I or II based on CT/PET-CT) and referred for diagnostic endosonographic work up or
* Suspected or tissue proven NSCLC with suspected mediastinal lymph nodes within reach of EUS-FNA

Exclusion Criteria:

* Inability and willingness to provide informed consent
* Inability to comply with the study protocol
* Patients with known allergy for fluorescein
* use of betablokker within 24 hours before procedure
* possible pregnancy or lactating women
Telemedical Risk Assessment and Preoperative Evaluation (TAPE)

The purpose of this study is to assess the feasibility, patient satisfaction and time saving of a telemedical risk assessment and preoperative evaluation for anesthesia.

The preanesthesia evaluation and risk assessment is conducted by an anesthesiologist prior to elective surgery. The physician assesses the patient´s medical records and specifies the individual preoperative procedure in order to minimize the perioperative risks. The on-site meeting is often connected with extended travel time and during the COVID-19 pandemic also with an increased infection risk for the patient. This project was initiated to reduce time efforts on patient site and to reduce possible infection risks. The TAPE-software turns every patients home into a remote facility allowing the physician to conduct the preanesthesia evaluation over distance.

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years
* estimated ASA I/II classification based on the American Society of Anesthesiologists (ASA) classification
* elective surgery
* surgery at least 14 days in the future
* patient access to a Windows-10-based personal computer with webcam

Exclusion Criteria:

* language or cognitive barriers (e.g. dementia, laryngectomy...)
* high risk surgeries with need of postoperative ICU stay
* acute infection with required auscultation
Comparison Between Two Total Knee Prosthesis Medacta GMK Sphere and Medacta GMK PS

The purpose of the study is to compare the clinical outcome after two total knee endoprosthesis designs Medacta GMK Sphere and Medacta GMK PS.

Primary outcome measures KOOS, Forgotten Knee Score and range of motion.

Single-center, randomized trial

The clinical outcome measures were measured preoperativ and postoperativ (1 year, 5 year and 10 year).

Secondary outcome measures: number of reoperations and revisions, survival of the prosthesis

The patient population would consist patients with knee osteoarthritis eligible for total knee replacement

The aim of the study is to evaluate the effect of the knee prosthesis design on the patient outcome

Eligibility Criteria:
Inclusion Criteria:

* patient is eligible for a total knee replacement
* patient is eligible for a Medacta GMK Sphere or Medacta GMK PS knee prosthesis
* patient signed the informed consent

Exclusion Criteria:

* patient is pregnant
Efficacy and Safety of Two Doses of SPD476 (Mesalazine) 2.4g and 4.8g Once Daily, With Reference to Asacol 0.8g Three Times Daily in Subjects With Acute, Mild to Moderate Ulcerative Colitis

The primary objective of the study was to compare the percentage of subjects in remission after 8 weeks of treatment with SPD476, 2.4 g/day once daily vs placebo and SPD476 4.8 g/day once daily versus placebo


Eligibility Criteria:
Inclusion Criteria:

* newly diagnosed or relapsing mild to moderate UC (score of 4-10 (inclusive) on the UC-DAI scale, with a sigmoidoscopy score of =\> 1 and a PGA \<=2) with compatible histology
* females eligible if post--menopausal, surgically sterile or if they had a negative urine pregnancy test at screening and were on adequate contraception

Exclusion Criteria:

* subjects with relapsing UC who were in relapse for \> 6 weeks prior to baseline
* subjects who relapsed on maintenace therapy with doses of mesalazine =\> 2g/day
* subjects who had unsuccessfully treated their current relapse with steroids or a mesalazine dose of \> 2g/day
* subjects with Crohn's disease, proctitis, bleeding disorders, active peptic ulcer disease, previous colonic surgery, or those at an immediate risk of toxic megacolon or a stool culture positive for enteric pathogens
* subjects who had used systemic or rectal steroids within the last 4 weeks, immunosuppressants wihtin the last 6 weeks or anti-inflammatory drugs on a repeat basis within 7 days prior to the baseline visit
* subjects with hypersensitivity to salicylates and subjects with moderate/severe renal impairment
The Cleveland Cardiometabolic Cohort

In this observational study, the investigators will examine the changes in body composition in HIV-infected subjects before and after initiation of HIV treatment, and look at the correlations with changes in cardiometabolic indices such as endothelial function and coronary calcium scoring.

The effects of lifestyle factors on body composition changes after antiretroviral therapy (ART) are unknown, and as such, investigators will use this prospective observational cohort to study relationships between lifestyle factors, including diet, physical activity and illicit drug use, with changes in body composition after ART. In addition, the effect of the body fat changes will be correlated to changes in cardiometabolic indices such as endothelial function and coronary calcium scoring.

Eligibility Criteria:
Inclusion Criteria:

* HIV-1 infection as documented by any licensed ELISA test kit and confirmed by Western blot at any time prior to study entry. HIV-1 culture, HIV-1 antigen, plasma HIV-1 RNA, or a second antibody test by a method other than ELISA is acceptable as an alternative confirmatory test
* Provides written informed consent and is capable of reading and comprehending the informed consent
* Is not currently taking antiretroviral therapy and has never been on such treatments in the past. Exception would be for subjects who had been in the past on ≤30 days cumulative antiretrovirals, as long as these were stopped \>6 months prior to study entry
* Is planning on starting antiretroviral therapy as part of routine clinic care

Exclusion Criteria:

* Pregnancy or lactation
Multi-mode Stroke Rehabilitation System: Development and Validation of Clinical Efficacy

The specific study aims will be:

1. To develop the novel, digital, and interactive MSR system of arm and hand with integrated digital action observation therapy (AOT) and mirror therapy (MT).
2. To pilot usability testing for examining the feasibility of this new MSR system from the users' experiences and feedback.
3. To examine the treatment effects of digital AOT, digital MT and a control intervention in patients with stroke by conducting a randomized controlled trial.
4. To identify who will be the possible good responders to digital AOT and MT based on their baseline motor function and mental imagery abilities.

Phase I: Multi-mode stroke rehabilitation (MSR) System Development \& Usability Testing

Ten patients with stroke and 4 certified occupational therapists were recruited in this phase I study. During the pilot testing, each stroke patient will try to use each training mode of digital AOT and MT by the assistance of the therapist. At the end of the pilot testing, the patients and the therapists will be asked to complete the System Usability Scale and a self-designed questionnaire to assess the user experience and perspective about this new MSR system and their view of its suitability for stroke patients.

Phase II: Validation of Clinical Treatment Efficacy

This three-arm, single-blind, randomized controlled trial will investigate the treatment effects among the 3 groups of digital AOT, digital MT, and dose-matched control intervention. An estimated 60 patients with stroke will be recruited to participate in this phase II study. Each participant will receive a total of 15 training sessions (60 minutes per session) for 3 to 4 weeks. Clinical outcome measures will be conducted at baseline, immediately after treatment (the fourth week), and at 1 month follow-up after treatment.

Eligibility Criteria:
Phase I: Multi-mode stroke rehabilitation (MSR) System Development and Usability Testing

For stroke patients

Inclusion Criteria:

* diagnosed as having a unilateral stroke;
* aged from 20 to 80 years;
* a baseline score of the Fugl-Meyer Assessment in a range of 20 to 60;
* able to follow the instructions and able to provide user feedback verbally;
* without aphasia and neglect

For therapists

Inclusion Criteria:

* holding an occupational therapist license

Phase II: Validation of Clinical Treatment Efficacy

Inclusion Criteria:

* diagnosed as having a unilateral stroke;
* at least 6 months after stroke onset;
* aged from 20 to 80 years;
* a baseline score of FMA in a range of 20 to 60;
* able to follow the study instructions;
* capable of participating in therapy and assessment sessions

Exclusion Criteria:

* global or receptive aphasia,
* severe neglect,
* major medical problems or comorbidities that have influenced upper-limb usage or caused severe pain
Promoting Optimal Treatment for Community-acquired Pneumonia in the Emergency Room (PIONEER)

Pneumonia in children can be caused by different types of germs such as bacteria and viruses. Giving antibiotics to children with bacterial bugs is helpful while giving antibiotics to children with viruses will not help them. Unfortunately, it is difficult for doctors to tell when a child's pneumonia is caused by bacteria or viruses. Most young children are given antibiotics even though it doesn't help them.

Our study wants to test a new way to care for children with pneumonia so that only children who will benefit from antibiotics will receive them. The study will use a combination of the child's symptoms, x-rays results, and lab testing to better determine if a child needs antibiotics. The study team will then review the testing results and follow up with the patient and their family in the following days to ensure that the child is improving. PIONEER will test a novel care pathway for treating non-severe pediatric pneumonia with the goal of decreasing antibiotic prescription while maintaining equal clinical outcomes to standard care.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed primarily with community-acquired pneumonia as per the ED MD and are well enough to be discharged home.
2. They also must have any one of:

   1. tachypnoea;
   2. cough;
   3. increased work of breathing; or
   4. auscultatory findings consistent with pneumonia;

Exclusion Criteria:

Children will be excluded if they have any of the following: cystic fibrosis, anatomic lung disease, bronchiectasis, congenital heart disease (requiring treatment or with exercise restrictions), history of repeated aspiration/velopharyngeal incompetence, malignancy (current or past), immunodeficiency (primary, acquired, or iatrogenic), pneumonia previously (clinically) diagnosed within the past month, or lung abscess diagnosed within the past six months. Children who present with ongoing fever after 4 or more days of beta-lactam therapy active against S. pneumoniae (ie. amoxicillin, amoxicillin-clavulanate, cefprozil, cephalexin, cefadroxil), levofloxacin/moxifloxacin, or doxycycline will not be eligible. Children will not be eligible to participate more than once.