cyrilzakka/clinical-trials huggingface dataset:
The PACO Study ("Personnalité Alzheimer COmportement")

Alzheimer's disease is characterised by a loss of cognitive functions and behavioural problems as set out under the term "Behavioural and psychological symptoms of dementia (BPSD)". The impact of BPSD in everyday life has heavy consequences for the patient and their family. The precocity of incidence, the frequency and the intensity of the BPSD are associated with a rapid decline in cognitive functions, an alteration in the activities of daily living, and a decrease in the quality of life for both the patient and the helper, an increased risk of hospitalisation and of institutionalisation as well as an increase in the cost to the health system. A greater understanding of the risk factors for the occurence of the BPSD would better allow the detection of patients who are particularly at risk for BPSD, to anticipate the crisis situations by proposing early and adapted care, and to better target the medicinal therapies. Certain observational arguments or results of retrospective studies speak in favour of the role of the basic personality in the occurence of BPSD in Alzheimer's disease. The investigators propose to clarify this role through a prospective study.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subject aged over 50 years ;
* In-patient or out-patient at one of the centres participating in the study ;
* Meeting all the diagnostic criteria for dementia due to AD (NINCDS ADRDA, CDR 1 or 2) or pre-dementia with a CDR of 0.5 (Berr et al., 2006, Dubois et al, 2007) ;
* Covered by the state's Social Security system ;
* With sufficient visual, auditory and oral and written French language skills to complete the clinical and neuropsychological evaluations ;
* Accompanied by a caregiver in sufficient contact with the subject to be able to assess their personality and note the onset of changes in behaviour.

Exclusion Criteria:

* Patients with a progressive and/or poorly managed psychiatric pathology (patients with stabilised depression could be included in the study) ;
* Patients taking any neuroleptic psychotropic medication ;
* Patients taking other psychotropic medication, with the exception of any antidepressant, hypnotic, anxiolytic, acetylcholinesterase inhibitors or Memantine which has been prescribed and stabilised for more than 3 months
* Patients with forms of dementia with an aetiology other than that of Alzheimer's disease (frontotemporal dementia, vascular dementia, Lewy Body dementia, and types of dementia that arise as a result of an underlying untreated disease, such as dysthyroidism, vitamin B12 or folic acid deficiency, syphilis, anaemia or hydroelectrolytic disorders) ;
* Patients with serious, progressive or unstable pathologies which could interfere with the variables under consideration ;
* Deafness or blindness which could compromise evaluation of the patient ;
* Pregnancy ;
* Patients under any type of guardianship or belonging to a restricted category as laid out in the Public Health Code ;
* Patients without a suitable caregiver willing to participate.
Iron Absorption From Fortified Extruded Rice Using Different Extruding Temperatures.

Food fortification is regarded as a safe and cost-effective approach to counteract and prevent iron deficiency. Rice is a staple food for millions of people living in regions where iron-deficiency anaemia is a significant public health problem. Therefore, rice may be a promising fortification vehicle.

Hot and cold extrusion, have been identified as the major methods for rice fortification. Extruded rice has the advantage of incorporating vitamins and minerals into the food matrix.

Cold, warm and hot extrusion differ in the processing temperature and the physical structure of fortified rice kernel matrix. A recent human study in young women showed fractional iron absorption was higher in cold extruded rice compared to hot extruded Rice and this was associated with changes in the starch microstructure. These changes cannot be detected in warm extruded rice, thus, our aim is to test the iron bioavailability in difference extrusion methods; hot and warm and cold with and without the solubilizing agent CA/TSC. This will provide information on optimized rice formulations for optimal iron delivery.


Eligibility Criteria:
Inclusion Criteria:

* Female, 18 to 40 years old
* Normal body Mass Index (18.5 - 25 kg/m2)
* Body weight ≤ 65 kg
* Signed informed consent

Exclusion Criteria:

* Pregnancy (assessed by self-declaration)
* Lactating up to 6 weeks before study initiation
* Anaemia (Hb \< 12.0 g/dL)
* Elevate CRP (\>5.0 mg/L)
* Any metabolic, gastrointestinal kidney or chronic disease such as diabetes, hepatitis, hypertension, cancer or cardiovascular diseases (according to the participants own statement)
* Continuous/long-term use of medication during the whole study (except for contraceptives)
* Consumption of mineral and vitamin supplements within 2 weeks prior to 1st meal administration
* Blood transfusion, blood donation or significant blood loss (accident, surgery) over the past 4 months
* Earlier participation in a study using Fe stable isotopes or participation in any clinical study within the last 30 days
* Participant who cannot be expected to comply with study protocol (e.g. not available on certain study appointments)
* Smokers (\> 1 cigarette per week)
* Difficulties with blood sampling
* Male gender
* Do not understand English
Ultrasonographic Appearance of the Endometrium After Ulipristalacetate Use and Endometrial Changes

If endometrial thickening is visualised (\>10mm) after the use of ulipristalacetate in case of medical treatment for uterine fibroids a saline infusion and sonographic examination will be performed to evaluate the endometrium and exclude intra-uterine pathology.

When ultrasonographic examination during follow up of a treatment with ulipristalacetate shows a thickening of the endometrium of 10mm or more ( thickening described in 10% of ulipristalacetate users and is completely benign), a saline infusion can help to exclude pathology in the uterine cavity. Saline infusion helps to better delineate the uterine cavity and endometrium. If fibroids or polyps are present in the uterine cavity they will clearly be seen.

This study was set up to describe how the endometrial changes after Esmya use appear on saline infusion sonography. This study can help to recognize ultrasonographic images in women presenting with thickened endometrium after Ulipristalacetate use.

Eligibility Criteria:
Inclusion Criteria:

* Women with thickened endometrium on ultrasound (defined as double endometrium thickness of ≥10mm) at the end of their treatment with ulipristalacetate.
* Normal double endometrium thickness before the use of ESMYA (\<10mm)
* BMI \>18 - \< 30

Exclusion Criteria:

* Known type 0 or 1 fibroids
* Known intrauterine pathology
A Study to Evaluate The Effects of Two Different Meal Types, Omeprazole And Ranitidine On Danoprevir Pharmacokinetics When Coadministered With Ritonavir in Healthy Volunteers

This randomized, open-label study will evaluate the effect of food, and the effect of omeprazole and ranitidine on danoprevir co-administered with ritonavir. Volunteers will be assigned to one of two treatment groups. Volunteers in both groups will receive oral doses of danoprevir and ritonavir. In addition, volunteers in group 2 will receive oral doses of omeprazole and ranitidine. The anticipated time of the study is approximately 6 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Adult healthy volunteers, aged 18 to 45 years, inclusive
* Weight \>/= 50.0 kg
* Body Mass Index (BMI) 18.0 to 32.0 kg/m2, inclusive

Exclusion Criteria:

* Presence of any active or chronic disease
* Abnormal blood pressure
* Abnormal resting heart rate
* Abnormal ECG values
* History of any clinically significant cardiovascular or cerebrovascular disease
* Current smokers or subjects that have discontinued smoking \< 6 months prior to first dose of study drug
* Positive for hepatitis B, hepatitis C or HIV
* Positive test for drugs of abuse or alcohol
* Positive result for H. pylori
* Regular use of antacids, H-2 blockers, proton pump inhibitors, or any investigational drug within 30 days of first dose of study medication
* History of clinically significant gastrointestinal disease
A Study of Duvelisib Versus Gemcitabine or Bendamustine in Participants With Relapsed/Refractory Nodal T Cell Lymphoma With T Follicular Helper (TFH) Phenotype

The study will evaluate the progression-free survival benefit of duvelisib monotherapy as compared to investigator's choice of gemcitabine or bendamustine in participants with relapsed/refractory nodal T cell lymphoma with TFH phenotype.


Eligibility Criteria:
Key Inclusion Criteria:

* Pathologically confirmed nodal T cell lymphoma with TFH phenotype according to the criteria of the World Health Organization classification (Swerdlow 2017, Alaggio 2022) including any one of Angioimmunoblastic T cell lymphoma (AITL), follicular T cell lymphoma, and other nodal peripheral T cell lymphoma (PTCL) with a TFH phenotype.
* Relapsed or refractory to at least 1 prior systemic, cytotoxic therapy for T cell lymphoma.
* Measurable disease as defined by Lugano 2014 criteria (Cheson 2014) for T cell lymphoma.

Key Exclusion Criteria:

* Cutaneous-only disease.
* Received prior allogeneic transplant any time in the past or received autologous transplant within 60 days prior to the first dose of study drug.
* Received prior treatment with a phosphoinositide-3-kinase (PI3K) inhibitor.
* Prior exposure to planned study treatment investigator's choice therapy (gemcitabine or bendamustine) within 60 days prior to the first dose of study drug.

Other protocol-defined criteria apply.
Staphylococcal Acute Post-Operative PJI Treated With 'DAIR' And Impact Of Rifampin

S. aureus and coagulase-negative staphylococci are the most frequent bacteria responsible for PJI (prosthetic joint infection). The aim of this study is to describe the use of rifampicin.


Eligibility Criteria:
Inclusion Criteria:

patients having had acute PJI (i.e. \<1 month following the implantation), DAIR with exchange of removal components) due to S. aureus and coagulase-negative staphylococci (2011-2016)

Exclusion Criteria:

None
AHSCT With Fludarabine and Cyclophosphamide Based Conditioning Regimes in Patients With Multiple Sclerosis

One of the possible options for the treatment of MS at present is a high-dose immunosuppressive therapy followed by autologous hematopoietic stem cell transplantation (HIST-AHSCT), which is a highly effective treatment for patients with relapsing-remitting MS.

This method of MS treatment was introduced in 1997. Significant complications and mortality associated with HIST-ATHSC is an obstacle to broad use of this method. The risk is even greater in patients with advanced disease, long duration of previous treatment and aggressive forms of MS.

Despite toxicity certain progressive cases of MS are still an indication for HIST-autoHSCT.

Most commonly used conditioning regimens for multiple sclerosis include high-dose cyclophosphamide. One of the options to reduce cyclophosphamide-related toxicity and dose is addition of fludarabine. Fludarabine is a cytostatic drug, an antimetabolite from the group of purine antagonists. It has a pronounced immunosuppressive activity and no overlapping toxicity with cyclophosphamide. The study will evaluate the safety and efficacy of this combination.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-65;
* 1.0-6.5 points on the EDSS scale (for MS);
* Length of illness - any;
* Disease progression during the last 6 months while taking drugs of 1st and 2nd lines;
* An established and confirmed diagnosis of an autoimmune disease in the previous stages of treatment;
* Ineffectiveness, inaccessibility or intolerance of Disease-Modifying Therapies;
* Relapse after AHSCT.
* Absence of severe concomitant somatic pathology;
* Left ventricular injection fraction \> 50%;
* Karnofsky Performance Score (KPS) \> 30%;
* The ability to take oral medications;
* Life expectancy is more than 1 month;
* Signed informed consent of the patient or legal representatives.

Exclusion Criteria:

* Moderate or severe cardiac dysfunction, left ventricular ejection fraction \<50%
* Moderate or severe decrease in pulmonary function, FEV1 \<70% or DLCO\<70% of predicted
* Respiratory distress \>grade I
* Severe organ dysfunction: AST or ALT \>5 upper normal limits, bilirubin \>1.5 upper normal limits, creatinine \>2 upper normal limits
* Creatinine clearance \< 60 mL/min
* Uncontrolled bacterial or fungal infection at the time of enrollment
* Requirement for vasopressor support at the time of enrollment
* Karnofsky performans status \<30%
* Pregnancy
* Somatic or psychiatric disorder making the patient unable to sign informed consent
Cardiac Rehabilitation and Metabolomics in Heart Failure

This is a randomized controlled trial of participants with heart failure randomized into usual care plus integrated cardiac rehabilitation or usual care only. The rehabilitation protocol will comprise one month of thrice weekly sessions including supervised aerobic exercises and counseling, followed by two months of monitored home based exercises prescribed weekly.

Cardiopulmonary performance status, depression and quality of life will be assessed at enrollment and upon completion of the protocol using the 6-minute walk time distance test. Plasma samples will be collected and bio-banked for metabolomic profiling and comparative outcome analysis.

Integrated cardiac rehabilitation will comprise one month of thrice weekly sessions of supervised aerobic exercises and counseling, followed by two months of monitored home based exercises prescribed weekly.

Aerobic threshold (AT) will be determined based on perceived rates of exertion as measured using a Borg scale and target heart rate based on Karvonen's formula. Exercise intensity will be prescribed to achieve the earlier of moderate perceived exertion and 50-60% of their maximal target heart rate on a treadmill. Intensity will be increased over the course of the 12 sessions to attain 70-80% of maximal target heart rate. Duration of exercise will also be increased gradually over the 12 sessions in keeping with the study participants perceived rate of exertion.

Participants will be given pedometers and instructed to use these daily for the period of the study. At the end of the first four weeks, the participant's weekly steps will be averaged to establish a baseline weekly step target. Starting in the 4th week,subjects will be instructed to continue exercises at home whilst maintaining a comparable activity level as will be measured by their weekly step counts. Participants will be contacted weekly for the remaining 8 weeks and step targets will be prescribed based on 10% weekly increments.Prior to the start of each exercise session, participants will receive a brief counseling module reflecting the primary goals of cardiac rehabilitation.

Eligibility Criteria:
Inclusion Criteria:

1. NYHA Class II or III heart failure
2. Owns a mobile telephone
3. Can participate in supervised exercise three times a week
4. Can read/ primary care giver can read in English or Kiswahili

Exclusion Criteria:

1. Recent acute illness requiring hospitalization in the preceding 4 weeks.
2. Limitation of activity because of factors other than fatigue or exertional dyspnea, such as arthritis, claudication in the legs, angina, advanced co morbidities.
3. Known uncontrolled arrhythmia.
4. Heart failure due to congenital heart disease.
5. Pregnant patients as may be confirmed by patient report or urine pregnancy tests
6. Heart failure due to obstructive cardiomyopathy including mitral stenosis and aortic stenosis.
7. Use of pacemakers.
The Effects of Yoga in Mental Health Professional Helpers

This study will investigate if yoga exercises decrease work-related stress and improve stress adaptation in professional health helpers.

Mental health professional helpers including psychiatrists, nurses, psychologists, social workers and occupational therapists often call upon to maintain a good working attitude and enthusiasm, especially in the face of the evaluators of credential systems as well as supervisors' authorities. The symptoms of work-related stress of professional helpers developed day by days and affected their physical and mental health. Gradually, the professional helpers burned out. Philip Burnard (1991) mentioned professional helpers might self-neglect while helping others. These would lead to over work related stress that directly affects the physical and mental health of the professional helpers, and indirectly affects the organization to take care of the patients and their families.

According to researchers and personal experience, colleagues of mental health care developed work-related stress symptoms, such as insomnia or sleep disorder, the physiological disorders, weight fluctuations, irritable or depressed while taking care of psychiatric patients. They might take tranquilizers in order to maintain the quality of work. On the other hand, in April 2012, the researchers engaged in yoga teaching, assisting mental health care to help others of engaging in yoga practice showed that members perceived positive feelings after the yoga practice: "the mood is more relaxed," "tight body become more relaxed and soft resulting in awareness of tension and unease. This helps to modify long-term adverse stances and reduce body aches and/or sitting." For this reason, researchers began to apply yoga to the release work-related stress and enhance stress adaptation. Professional health helpers look forward to practice yoga exercises to relax work-related stress and improve stress adaptation.

It is a parallel-arm randomized control trial compare the outcome of participants assign to the experimental treatment group (yoga, with 30 participants) with those assign to a control group for 3 months (12 weeks). Experimental group receive regular 60-minutes yoga classes twice a week. We confer the difference of work-related stress relief and stress adaptation and biofeedback improvement after yoga.

Eligibility Criteria:
Inclusion Criteria:

* Mental Health Professional Helpers.
* Without sport training.
* Age 20\~60.

Exclusion Criteria:

* Musculoskeletal injury.
Access to Single-Fraction Palliative Radiation Therapy in Cancer Patients Enrolled in Hospice

Feasibility study to report on the impact of ACCESS of single-fraction radiation therapy on cancer patients with bone metastases enrolled in hospice care.

Hospice care for terminally ill patients with metastatic cancer improves quality of life, pain control, and potentially also survival when patients are enrolled early.1-3 However, hospice programs are often seen by patients and their caregivers as the last resort after exhaustion of all effective treatment options. The need to revoke active treatment (for all hospice patients with cancer outside of the VA system) discourages hospice enrollment.

This study aims to understand and analyze barriers to access specifically for short course palliative radiation therapy in cancer patients enrolled in hospice.

Eligibility Criteria:
Inclusion Criteria:

* Solid Tumor Malignancies and Multiple Myeloma with Bone Metastases and Associated Bone Pain Enrolled in Hospice

Exclusion Criteria:

* Decisionally-Impaired Subjects, Pregnant Women
Accuracy of Dexcom G6® and FreeStyle Libre® Sensors in Standardized Hypoxemia Conditions

The major aim is to evaluate accuracy of 2 Continuous Glucose Monitoring Systems (CGMS) : Dexcom G6® and FreeStyle Libre® in standardized hypoxemia conditions (artificial normobaric hypoxia).

Our purpose is to demonstrate the good performance and calibration of these CGM sensors in hypoxemia conditions.


Eligibility Criteria:
Inclusion Criteria: all population

* No history of respiratory diseases (childhood asthma, respiratory allergies, exercise-induced asthma or dyspnea)
* Willing to participate and able to sign an informed consent form (ICF)
* Being affiliated with the French Social Security

Inclusion Criteria:Patients with diabetes

* type 1 diabetes mellitus or type 2 diabetes mellitus (ADA definition)
* Age : 18 to 75 years
* stable diabetes treatment for more than 3 months
* no diabetic retinopathy
* no diabetic neuropathy
* no cardiovascular diseases
* no contra-indication for coronary computed tomography angiography or myocardial perfusion scintigraphy.

Inclusion Criteria: Healthy volunteers

* Age : 18 ; 40 years
* No diabetes
* No persistant drug use \> 3 months except contraception
* Body mass index : \[18,5 - 29,9\] kg/m2

Non-inclusion criteria : all population

* Active smokers
* Pregnant or breastfeeding women, women of childbearing age without effective contraception
* Known allergies to the patch.
* Skin lesions at the sensor site that may interfere with sensor placement or accuracy
* Major cardiovascular complications within the past 3 months
* Decompensated congestive heart failure
* Chronic respiratory failure
* Chronic renal failure
* Resting ambient air O2 saturation ≤95%.
* Treatment with systemic corticosteroids
* Severe hypertension (≥180 mmHg systolic pressure or ≥ 100 mmHg diastolic pressure)
* Any concomitant disease or condition that the investigator believes may compromise patient safety or affect the conduct of the study
* Anemia (Hb\<12g/dl)
* History of severe mountain sickness
* Concurrent participation in another clinical research study,
* Persons benefiting from enhanced protection

Non-inclusion criteria: Patients with diabetes

* Absolute contraindications to physical activity (HAS definitin) :
* Pulmonary arterial hypertension (\> 60 mm Hg)
* Presence of intra-cardiac thrombus
* Acute pericardial effusion
* Severe obstructive cardiomyopathy
* Symptomatic aortic stenosis
* Recent thrombophlebitis with or without pulmonary embolism