cyrilzakka/clinical-trials huggingface dataset:
The Effect of Glitazone Treatment on Bone Marrow and Bone Marrow Cells

Osteoporosis is a generalised bone disease leading to an increased risk of fractures. The disease is caused partly by environmental and partly by genetic factors. It is well known that the fat content of the bone marrow is increased in osteoporotic patients. Animal studies suggest that stimulation of bone marrow stem cells through the molecule PPARgamma with the drug rosiglitazone converts the stem cells to fat cells instead of bone cells thereby decreasing bone strength. In a single study healthy volunteers were treated with rosiglitazone for 14 weeks and had a decrease in bone mineral density.

In the present study we wish to investigate the effect of this treatment on bone and fat tissue. 25 women above the age of 60 will be treated with rosiglitazone 8 mg/day for 14 weeks and compared with 25 women receiving placebo.

The effect will be evaluated as follows:

1. The effect on bone marrow density will be examined by a bone scan prior to and after treatment and again after 6 and 9 months.
2. The effect on bone turnover will be measured in blood- and urine samples at the same times.
3. The effect on fat distribution will be evaluated by an MRI scan after treatment.
4. The effect on bone marrow cells will be investigated bone marrow sampling immediately after treatment
5. The direct effect on fat will be examined by a biopsy immediately after treatment The study hypothesis is that rosiglitazone treatment decreases bone mineral density and increases bone marrow fat content. The causal molecular mechanisms will be investigated from the bone marrow and fat samples


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women age 60-75 with no rosiglitazone allergy

Exclusion Criteria:

* Osteoporosis
* Diabetes
* Hyperthyroidism, untreated hypothyroidism, hyperparathyroidism
* Treatment with bone active drugs
* Low impact fracture
* Heart disease
* Kidney failure
* Liver failure
* Anaemia
* Ineligibility for MRI-scan
* Cancer within last 5 years
Cognition in Allogeneic Stem Cell Transplanted Patients and Sports

Studies suggest that patients with hematological malignancies undergoing allogeneic hematopoietic stem cell transplantation (HSCT) are at risk for cognitive decline and long-term cognitive dysfunction. To address this issue, a randomized controlled intervention trial on the effect of physical exercise on cognition is conducted. In addition, the impact on psychological and physical health outcomes is evaluated. Results may benefit patients who suffer from disease- or treatment-associated cognitive change.

Studies suggest that patients with hematological malignancies undergoing allogeneic hematopoietic stem cell transplantation (HSCT) are at risk for cognitive decline and long-term cognitive dysfunction. To address this issue, a randomized controlled intervention trial on the effect of physical exercise on cognition is conducted. In addition, the impact on psychological and physical health outcomes such as depression, fatigue, health-related quality of life and physical fitness is evaluated. A healthy control group matched to the patients on age, gender, and education will be included to both control for practice effects on neuropsychological measures and allow additional comparisons on self-report measures. The healthy control group will undergo neuropsychological testing and questionnaire survey at baseline and 4 months. Demographic data will be collected from all study participants at baseline. Medical data will be collected from patients at all time points. Results may benefit patients who suffer from disease- or treatment-associated cognitive change.

Eligibility Criteria:
Patients:

Inclusion Criteria:

* hematological malignancy (AML, ALL, MDS, OMF, CML, MM, NHL, Hodgkin, AA)
* 3 to 6 months after allogeneic HSCT
* ≥ 18 years of age at time of transplantation
* German as mother tongue
* regular follow-up visits at the transplantation center during the first year after transplantation

Exclusion Criteria:

* \> 75 years of age at time of transplantation
* relapse/progress
* thrombocyte count ≤ 50 G/l
* GvHD with lung involvement
* compromised lung function (patients who need oxygen)
* compromised cardiovascular function (\< 10-m walk)
* florid infection
* immobility
* neurological disease
* severe psychiatric disease
* regular intake of psychoactive drugs or substance abuse
* uncontrolled diabetes
* high fracture risk
* impaired vision and/or hearing

Healthy controls (matched for age, gender, and education):

Inclusion Criteria:

* ≥ 18 years of age at time of enrolment
* German as mother tongue
* residence in the area of the transplantation center or family members/friends accompanying the patients to clinical follow-up visits

Exclusion Criteria:

* \> 75 years of age at time of enrolment
* hematological malignancy
* solid tumour disease
* neurological disease
* severe psychiatric disease
* regular intake of psychoactive drugs or substance abuse
* impaired vision and/or hearing
Diagnosis of Congenital CMV Infection in Neonates Who Failed Newborn Hearing Screening

Universal hearing screening at birth by use of otoacoustic emission (OAE) is now offered in most maternities in France to detect symptomatic hearing impairment at birth but screening of cCMV infection is not coupled with this screening. In this study, the feasibility of achieving before one month of age the diagnosis of congenital CMV diagnosis and as well as the confirmation of hearing loss in newborns who failed newborn hearing screening will be tested.

Congenital cytomegalovirus (cCMV) is the most frequent congenital infection in France. Around 90% of cCMV infected infants are asymptomatic at birth, of whom 7 to 20% develop sensorineural hearing loss (SNHL). cCMV explains at least 10% of all hearing loss cases in young children. Early antiviral treatment (implemented before 1 month of age) with ganciclovir or valganciclovir can improve hearing outcome. In the absence of universal screening, cCMV remains largely undetected because most infected neonates are asymptomatic or have non-specific symptoms. When symptoms become apparent or develop, it may be too late for confirmation that the infection is of congenital origin becausediagnosis of congenital infection is based on the detection of CMV in samples collected within 2 to 3 weeks after birth. The presence of CMV in samples collected after this time may represent postnatal infection which does not carry the risk of hearing loss or neurodevelopmental sequelae. Universal hearing screening at birth by use of otoacoustic emission (OAE) is now offered in most maternities in France to detect symptomatic hearing impairment at birth but screening of cCMV infection is not coupled with this screening. In this study, the feasibility of achieving before one month of age the diagnosis of congenital CMV diagnosis and as well as the confirmation of hearing loss in newborns who failed newborn hearing screening will be tested.

Eligibility Criteria:
Inclusion Criteria:

* All newborns who have failed universal newborn screening

Exclusion Criteria:

* Neonates whose mothers would object to the use of their child's medical data
Effect of Protein Supplementation on Craving in Subjects Hospitalised for Addiction Treatment

Moncentric pilot study conducted in the addictology department of the Pau Hospital, designed to demonstrate the benefit of protein supplementation on craving in patients with a substance use disorder at the start of their treatment for addiction.

This study will be conducted according a crossover design with a one-week phase with protein supplementation (P) and a one-week phase without protein supplementation (SP).

Addiction is a chronic psychiatric disorder characterised by the loss of control over the use of rewarding substances or behaviours, despite the accumulated damage. Craving, defined as an irrepressible, obsessive craving, is a key early symptom of addiction. Protein supplementation could reduce this craving. Nutritional abnormalities aggravate addictions but no study have directly assessed the impact of protein supplementation on craving. Evidence suggests that protein supplementation reduces cravings for sugary and hyperpalatable foods, which could extend to rewarding substances. The hypothesis is that this supplementation reduces the intensity, duration and frequency of craving in withdrawal patients by influencing dopaminergic reward circuits.

Protein supplementation takes the form of a powder sachet mixed with yoghurt or compote. It will be given twice a day, at the same time (8am and 4pm).

Patients will be enrolled at the admission to the addiction unit. They will be assessed psychologically, addictologically and nutritionally for one week and then will be randomised. Patients will be asked to assess their cravings, dietary needs, consumption of addictive substances and palatable foods.

Eligibility Criteria:
Inclusion Criteria:

* Male and female
* Aged 18 and over
* Admitted for complex care in the addictology department
* Person affiliated to or benefiting from a social security scheme
* Free, informed and written consent signed by the participant and the investigator

Exclusion Criteria:

* Allergy to milk protein
* Admitted to hospital for less than 3 weeks
* Severe somatic or psychiatric pathology incompatible with understanding assessment tools
* Difficulty understanding and/or writing French
* Presumed non-compliant in completing the patient diary
* Person participating in another research study with an exclusion period still in progress
* Person under legal protection (guardianship, curatorship)
The Role of P-cresol and Related Protein Fermentation Metabolites in Chronic Kidney Disease Patients

Study on the natural history of uremic retention solutes in patients with mild-to-moderate chronic kidney disease

Protein-bound uremic retention solutes are increasingly recognized to play a role in the pathophysiology of the uremic syndrome. Numerous in vitro findings are indicative for their implication in the biochemical and physiological changes of uremia. Several of these protein-bound retention solutes originate from bacterial protein fermentation in the colon. p-cresyl sulfate, a fermentation metabolite of the amino acid tyrosine, is considered a prototype of this group of uremic solutes. The protein binding of this molecule was shown to be about 90% in end-stage renal disease patients. Several data have suggested that p-cresol plays a role in the immunodeficiency of uremia. Recently, a link between the molecule and endothelial dysfunction has been demonstrated. Also other members of the class of protein-bound solutes have been found to be associated with immune dysfunction, endothelial cell dysfunction and, closely related to the latter, oxidative stress.

Free serum levels of p-cresol were shown to be greater in stage 5 chronic kidney disease (CKD) patients treated with hemodialysis (HD) hospitalized for infectious disease. Furthermore, a positive relationship was found between serum total p-cresol level and a uremic symptom score in patients treated with peritoneal dialysis (PD), whereas a correlation with small water-soluble solutes and the middle molecule β2-microglobulin was absent. A recent prospective observational study in stage 5 CKD patients treated with conventional HD (3 x 4 hours per week) indicated that the accumulation of p-cresol is a risk factor for overall mortality.

Data on the serum concentrations of p-cresol in chronic kidney disease patients are lacking. The investigators hypothesise that the serum concentration of p-cresol is an independent predictor of progression to end stage renal disease and is an independent predictor for cardiovascular disease.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* Chronic kidney disease, stage 1-4 kDOQI

Exclusion criteria

* age below 18
* Kidney transplant recipient
Z-Drugs for Sleep Disorders in Alzheimer's Disease

The purpose of this study is to determine whether Zolpidem and Zoplicone are efective in the treatment of sleep disorders in Alzheimer's disease (AD)

Sleep disorders (SD) affects 35 to 50 percent of patients with AD. These disorders often make caring for patients at home very difficult. Zolpidem and Zoplicone are prescribed drugs for sleep disorder in AD patients.

Eligibility Criteria:
Inclusion Criteria:

* 55 years of age or older
* Diagnosis of probable Alzheimer's disease (AD) by National Institute of Neurological and Communicative Disorders and Stroke / the Alzheimer's Disease and Related Disorders Association Criteria
* Hachinski Ischemia Scale less than 5
* Mini-Mental State Examination score of 0 to 26
* Actigraph evidence of a mean time immobile of less than 7 hours per night based on at least 7 nights of complete actigraph data collected over a single week
* Four-week history of sleep disorder behaviors, occurring at least once weekly, as reported by the caregiver using the Neuropsychiatric Inventory (NPI) Nighttime Behavior scale
* Sleep disturbance observed was not present before the diagnosis of AD
* Other co-morbidities, especially delirium, depression, chronic pain and medication use may be present, but do not cooperate in the primary symptoms
* Computed tomography or magnetic resonance imaging since the onset of memory problems showing no more than 1 lacunar infract in a nonstrategic area and no clinical events suggestive of stroke or other intracranial disease or normal
* Stable medications for 4 weeks prior to the screening visit
* Having a mobile upper extremity to which to attach an actigraph
* Residing with a responsible spouse, family member, or professional caregiver who is present during the night and would agree to assume the role of the principle caregiver for the 3-week protocol
* Ability to ingest oral medication and participate in all scheduled evaluations

Exclusion Criteria:

* Sleep disturbance associated with an acute illness, delirium or psychiatric disease
* Clinically significant movement disorder, such as akinesia, that would affect actigraphic differentiation of sleep and wakefulness
* Severe agitation
* Unstable medical condition
* Discontinuation of psychotropic or sleep medication within 2 weeks of the screening visit
* Patient unwilling to maintain caffeine abstinence after 2:00pm for the duration of the protocol
* Patient unwilling to comply with the maximum limit of 2 alcoholic drinks per day, and only 1 alcoholic drink after 6:00pm for the duration of the protocolo
* Prior use of zolpidem/zoplicone for the treatment os sleep disturbances
* Caregiver deemed to be unreliable to supervise the wearing of the actigraph, to administer study capsules at the proper time, to maintain the sleep diary, or to bring the patient to the scheduled visits
Evaluation of the Predictive Value of 18F-fluorodeoxyglucose Positron Emission Tomography and Brain Perfusion Computed Tomography for the Efficacy of Anti-angiogenic Therapy (Bevacizumab) in Recurrent Glioblastoma

In this pilot study, the study evaluators will evaluate the ability of positron emission tomography (PET) with 18F-fluorodeoxyglucose (FDG PET) and the computed tomography (CT) perfusion scanner, individually and combined, to predict the effectiveness of anti-angiogenic treatment.


Eligibility Criteria:
Inclusion Criteria:

* The patient must have given their free and informed consent and signed the consent form
* The patient must be a member or beneficiary of a health insurance plan
* The patient has an WHO score ≤ 3
* The patient's estimated life expectancy is more than 3 months.
* Patient with histologically proven diagnosis of glioblastoma.
* Patient presenting with tumor progression on morphological MRI confirmed by a multidisciplinary committee.
* Patient with a unilateral supratentorial target lesion upon inclusion to establish a tumor region of interest (ROI) zone and an equivalent ROI zone in contralateral healthy tissue.
* Patient progressing after radiotherapy and at least one line of chemotherapy with TEMODAL
* Patient in whom treatment with Bevacizumab monotherapy has been validated by a multidisciplinary committee.

Exclusion Criteria:

* The subject is participating in an interventional study, or is in a period of exclusion determined by a previous study
* The subject refuses to sign the consent
* It is impossible to give the subject informed information
* The patient is under safeguard of justice or state guardianship
* Pregnant or breast feeding patients
* Hypersensitivity to iodinated contrast media and creatinine clearance less than 60 ml / minute.
Efficacy and Safety of the Use of Venocur Triplex® in Patients With Chronic Venous Insufficiency

The purpose of this study is to assess the therapeutic efficacy and safety of Venocur Triplex®, administered BID for 60 days in patients with Chronic Venous Insufficiency rated between CEAP 2 and 4, in comparison to a Placebo group.


Eligibility Criteria:
Inclusion Criteria:

* The patient has confirmed his/her willingness to participate in the study, after being informed about all the aspects of the study that might be relevant for his/her decision to participate, and has signed and dated the informed consent form, as approved by the Institutional Review Board/ Ethics Committee (IRB/EC)
* Patients of both sexes, aged above 18 years and below 65 years
* Presence of uni- or bilateral varicose veins with CVI, in both sexes
* The patient's CVI is rated between functional classes CEAP 2 and 4
* Present at least one symptom of CVI prior to the study - leg pains, cramps, fatigue, heavy legs sensation.

Exclusion Criteria:

* If female, the patient has circulatory disorders exclusively during the pre-menstrual period
* If the patient is pregnant or breastfeeding
* The patient has received anticoagulants less than 15 days before study start
* The patient has used steroids or anti-inflammatory drugs less than 8 days before study start
* The patient has received radio or chemotherapy less than 7 days before study start
* The patient has used diuretics, phlebotrophic and venoactive drugs over the past 8 days before enrollment in the study
* The patient has used compression stockings less than 8 days before study start
* Trauma or surgical treatment over the past 30 days before study start
* Prior surgical treatment related to CVI (past 12 months for surgery and past 6 months for sclerotherapy)
* Immobilization of lower limbs over the past 6 months
* Known allergy to the product's ingredients
* Presence of chronic inflammatory diseases (rheumatoid arthritis, for instance), severe chronic infectious diseases (AIDS, tuberculosis, hanseniasis, etc.)
* The patient has suffered from phlebitis or deep venous thrombosis in the past 6 months before the study
* Fibrous lymphedema, primary or secondary lymphedema and lipoedema;
* Concomitant erysipelas
* Active fungal infections of the lower limbs
* Peripheral arteries disease, cerebrovascular or coronary disease
* Severe systemic conditions (heart failure, liver, pulmonary or kidney failure, active neoplastic disease, severe arterial hypertension, uncontrolled diabetes, among others), over the past 6 months before study start
* Hematocrit: \< 32.0 mL RBC/dL for women and \< 36.0 mL RBC/dL for men
* Hemoglobin: \< 11.0 mL g/dL for women and \< 12.0 mL g/dL for men;
* Total protein and fractions: Total protein \< 6.4 g/dL, Albumin \< 4.0 g/dL, Globulin \< 1g/dL and Albumin/Globulin \< 0.9%
* Serum creatinine: \> 1.0 mg/dL for women and \> 1.2 mg/dL for men or if patient in dialysis
* Aminotranferases (SGOT/AST and/or SGPT/ALT) more than twice the upper normal limit
* Participation in study with similar objectives over the past 6 months.
Can the Venus 1000 Help Clinicians Treat Patients With Severe Sepsis or Acute Heart Failure? The CVP Trial

The purpose of this study is to evaluate the impact that the Venus 1000 non-invasive CVP system has on the management of emergency department (ED) patients with fluid sensitive conditions.

The ability to non-invasively, accurately, and continuously measure CVP to assess the preload status of ED patients could lead to its inclusion into existing protocols (similar to EGDT), or the development of novel protocols for the treatment of patients with fluid sensitive conditions. The majority of other non-invasive measures of preload, such as ultrasound of the inferior vena cava or the passive leg raise technique are not continuous measures and require some type of effort or skill on the part of the clinician. Continuous methods of assessing preload include CVP measurement through a central venous catheter, esophageal Doppler monitoring, and pulse contour analysis via arterial catheter monitoring, all of which involve invasive procedures.

The Venus CVP device is non-invasive and has continuous monitoring capabilities. The data acquired from this project will allow us to determine whether emergency physicians will, in practice, utilize the information provided by a non-invasive CVP monitoring device to assist in the management of their patients with severe sepsis or acute HF.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years old or greater
* English speaking
* Clinical diagnosis of: 1) Severe Sepsis, or 2) Acute Heart Failure

Exclusion Criteria:

* Traumatic injuries
* Active bleeding
* Pregnancy
* Prisoners
* Central venous catheter placement in the internal jugular or subclavian veins
* Bilateral external jugular vein catheterizations
* Concurrent enrollment into an interventional clinical trial that may affect subject treatment
Safety and Performance of ENDOMATIC SEPIOLA Left Atrial Appendage (LAA) Closure Device

The study is designed to evaluate the safety and performance of the ENDOMATIC SEPIOLA Left Atrial Appendage (LAA) Closure Device in Patients with non-valvular Atrial Fibrillation, who are at increased risk for stroke, and that cannot take, or have a reason to seek an alternative, to long-term anticoagulation therapy.

Potential patients who are candidates for LAA closure will be screened to confirm that all inclusion/exclusion criteria are met, with final eligibility confirmation on day of procedure.

All enrolled subjects who went through the procedure will be followed during the procedure to hospital discharge.

Additional follow up time points are scheduled at 45 days, 6 months and 12 months post procedure.


Eligibility Criteria:
Inclusion Criteria:

* calculated CHA2DS2-VASc score of 2 or greater.
* The subject is non-eligible or have an appropriate rationale to seek a non-pharmacologic alternative to chronic oral anticoagulants.
* documented non-valvular atrial fibrillation
* Subject suitable for vascular/cardiac intervention procedure
* suitable LAA anatomical measurements for study device

Exclusion Criteria:

* Subject who requires anticoagulation for a condition other than AF.
* NYHA classification IV.
* Complex congenital heart disease.
* Presence of circumflex coronary artery stent.
* The subject has a prosthetic valve in any position.
* atrial septal defect closure or has an ASD/PFO device.
* presence of intracardiac thrombus.
* Any cardiac surgery in the past
* LVEF \< 35%.
* intracardiac thrombus
* moderate or severe mitral valve stenosis