cyrilzakka/clinical-trials huggingface dataset:
PREselection of Patients at Risk for COgnitive DEcline After Radiotherapy Using Advanced MRI

Meningioma are slow growing and frequently occurring intracranial tumors, responsible for 33% of all asymptomatic intracranial tumors and 13-26% of all symptomatic primary brain tumors. The 10-year survival rate is 72%. A variety of treatment options is available for symptomatic meningioma including surgical removal with or without radiotherapy or radiotherapy alone. These therapies can have negative impact on cerebral functioning.

After high dose radiotherapy for primary or metastatic brain tumors 50-90% of \> 6 months' survivors develop irreversible disabling cognitive decline leading to premature loss of independence, reduced Quality of Life (QOL) as well as significant economic burden both at the individual as societal level. Especially for patients with a good prognosis like benign meningioma, maintaining neurocognitive function is crucial. Understanding the mechanisms underlying radiation induced cognitive decline is complex and which brain areas to spare are an important subject of research.

Evaluation methods to assess cognitive function and predict cognitive decline are urgently needed, this will allow the development of optimized treatment strategies with the aim to preserve or even improve cognitive function in meningioma patients. Improvements in the field of neuroimaging techniques (i.e. advanced MRI techniques) have the possibility to identify areas susceptible to cognitive impairment. This allows in the future a more personalized radiation treatment by identifying patients at risk, by optimizing the radiotherapy dose to specific brain regions, that could eventually reduce or prevent, cognitive decline. Improvements in the field of radiotherapy for example by higher precision treatment such proton therapy have potential in obtaining these more individualized strategies.


Eligibility Criteria:
Inclusion Criteria:

* Meningioma WHO I, grading based on pathology or radiological features
* Age ≥ 18 years.
* Karnofsky Performance Score 70 or above.
* Ability to comply with the protocol, including neuropsychological testing and imaging.
* Ability to understand the requirements of the study and to give written informed consent, as determined by the treating physician.
* Written informed consent.

Exclusion Criteria:

* Resection meningioma \< 3mnd
* Age \< 18 years
* Pregnancy
* Any prior cranial radiotherapy
* Any prior chemotherapy in the last 5 years
* Contra-indication for MR imaging (i.e. metal implants, claustrophobia)
* Any other serious medical condition that could interfere with follow-up.
* Severe aphasia or language barrier interfering with assessing endpoints (i.e. completion of questionnaires or neurocognitive performance)
Low-dose VS High-dose IV Cyclophosphamide for Proliferative LN in Children

Proliferative lupus nephritis (LN)is the predominant cause of morbidity and mortality in juvenile Systemic Lupus Erythematosus (SLE). Induction therapy with high-dose intravenous cyclophosphamide can improve renal outcomes, but considerably associated with infection. Although severe infection is the significant complication related to poorer prognosis for juvenile SLE patients in Asia, cyclophosphamide is still commonly used as the drug of choice for severe lupus nephritis. Euro-Lupus Nephritis Trial demonstrated low-dose intravenous cyclophosphamide regimen followed by azathioprine achieved good clinical results comparable with obtained high-dose regimen. There was lower number of severe infection episodes, but no significant difference. Recent studies applied low dose of cyclophosphamide (500 mg/m2/dose or 500 mg/dose)in young patients and showed good renal response. Low-dose intravenous cyclophosphamide regimen might promote non-inferior renal remission whereas decrease risk of serious infection and improve overall patient outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Child up to 15 years of age who fulfilled the 1997 updating the American College of Rheumatology revised criteria for the classification of SLE and his or her renal biopsy reveals lupus nephritis class III or IV regarding to International Society of Nephrology/Renal Pathology Society revision on the classification of the lupus nephritis.

Exclusion Criteria:

* patient who has prior renal insufficiency due to chronic kidney disease other than lupus nephritis
* patient who has the history of cyclophosphamide hypersensitivity
* patient who has prior cyclophosphamide or mycophenolate mofetil administration within 6 months
* patient who is pregnant
Safety and Efficacy of ARQ-252 Cream in Subjects With Chronic Hand Eczema

This study will assess the safety and efficacy of ARQ-252 cream in subjects with chronic hand eczema

This is a Phase 1/2b multiple dose, parallel group, double blind, vehicle-controlled study of the safety and efficacy of ARQ-252 cream in subjects with chronic hand eczema

Eligibility Criteria:
Inclusion Criteria

* Participants legally competent to sign and give informed consent.
* Males and females 18 years of age and older (inclusive) at the time of consent.
* Clinical diagnosis of chronic hand eczema, defined as hand eczema persistent for more than 3 months, or returned twice or more within the last 12 months. Generally stable disease for 6 weeks.
* Chronic hand eczema involving at least 0.3% body surface area total (i.e., approximately a third of one handprint) lesions on both hands added together
* Female subjects of childbearing potential (FOCBP) must have a negative serum pregnancy test at Screening and negative urine pregnancy test at Baseline. For FOCBP involved in any sexual intercourse that could lead to pregnancy: the subject must agree to use a highly effective contraceptive method for at least 4 weeks prior to Day 1. Additionally, from Day 1 until at least 4 weeks after the last investigational product administration, these subjects must agree to use at least 1 highly effective contraceptive method in addition to 1 barrier method according to the Contraception Requirements Section of the protocol.
* Females of non-childbearing potential must either be post-menopausal with spontaneous amenorrhea for at least 12 months or have undergone surgical sterilization.
* Males, if engaging in sexual intercourse with a female who is pregnant or a female of childbearing potential, must agree to use a condom every time during the study and every and every time subsequently until 4 weeks after the last dose of investigational product.
* Subjects in good health as judged by the Investigator, based on medical history, physical examination, 12-lead electrocardiogram (ECG), serum chemistry labs, hematology values, and urinalysis.

Exclusion Criteria

* Concurrent skin diseases on the hands which, in the opinion of the Investigator, could confound the study (e.g., tinnea manuum).
* Subjects with any presence or history of psoriasis.
* History of a positive patch test with continued exposure to allergen. Subjects must have undergone diagnostic patch testing within 3 years prior to Baseline (Visit 2).
* Subjects who cannot discontinue systemic and/or topical therapies for the treatment of chronic hand eczema prior to Baseline and during the study
* Subjects with a history of chronic alcohol or drug abuse within 6 months prior to Baseline
* Pregnant or lactating women or women planning to become pregnant during the study and / or within 28 days following the last dose of investigational product.
* Subjects with any serious medical condition or clinically significant laboratory, ECG, vital signs or physical examination abnormality that would prevent study participation or place the subject at significant risk, as judged by the Investigator.
StandUPTV Habits: Feasibility Trial for Maintaining Reductions in Sedentary Screen Time

Our goal in this study is to further refine StandUPTV, an application designed to reduce SST in adults in our first study (ASU IRB # STUDY00012109), for the StandUPTV Habits program. This program aims to establish a non-sedentary habit triggered by an alert from the StandUPTV application after participants engage in approximately 30 minutes of SST in the evening.

This mobile health (mHealth) pilot study aims to develop and test an intervention designed to maintain reductions in evening sedentary screen time (eSST) over a 12-month period. The study will target a nationally recruited sample of adults at risk for type 2 diabetes and will employ a novel habit formation strategy to address individual barriers to sustained behavior change. As a Phase II pilot study within the ORBIT Model framework, this research seeks to provide critical insights into the relationship between maintained reductions in eSST and metabolic health. The intervention combines theory- and evidence-based approaches, leveraging commercially available screen time monitoring tools to scale the StandUPTV application. This pilot study will lay the groundwork for a subsequent Phase III fully-powered randomized clinical trial, aiming to evaluate the impact of sustained eSST reduction on diabetes and cardiovascular disease risk in a national sample.

Eligibility Criteria:
Inclusion Criteria:

* Insufficiently active as defined by not meeting current US National Guidelines for Physical Activity of 150 minutes of MVPA/week (Measured by the Stanford
* Leisure-Time Activity Categorical Item)
* \> 3 hours of SST per day
* Use Android (8.0+) smartphone (8.0+ represents 95% of Android device coverage per https://apilevels.com/)
* Have regular broadband internet in their home or an unlimited data plan
* Able to read/understand English (\>5th grade literacy)
* Willing to download StandUPTV Habits
* Willing to wear activPAL and CGM device during study assessment periods
* Willing to have data shared in de-identified form in Dexcom Clarity platform
* Willing to be randomized to either study condition
* Not traveling overnight or longer in the next 4 months

Exclusion Criteria:

* Planned relocation
* Current smoker
* Have a major illness (e.g., heart disease, cancer, renal disease) for which MVPA is contraindicated
* Diagnosed with diabetes or gestational diabetes in the past
* Currently using a CGM
* Pregnant
* Occupation that requires substantial use of personal device for media-related activities (e.g., social media)
* Drug abuse
* Serious psychological disorder
* Not willing to use Fitbit or smart plugs for calculation of sedentary screen time for functionality of StandUPTV app
A Study of Pressure and Flow Characteristics During Inspiration and Expiration Using BreatheMAX® in Healthy Subjects

the aim of this study are to explore the characteristics of mean airway pressure, oscillatory amplitude and power spectral density (PSD) of oscillatory airway pressure that generate by various loaded and flow rate during expiration and inspiration in healthy subjects and to explore the best loaded and flow rate for airway secretion clearance using the BreatheMAX® device

For inspiratory group, the resistive load 3, 4, 5, 6 and 7 cm H2O were test with three flow rate: 0.2, 0.4, and 0.6 L/sec in each load. In each flow rate, the subjects were instructed to inspire as deeply as possible with steady flow rate for 3 seconds with end-inspiratory pause for 2-3 seconds through the inspiratory circuit and follow by passive exhalation. For expiratory group, the resistive load and flow rate were test similar inspiratory group. In each flow rate, the subjects were instructed to inspire as deeply as possible through the nose with end-inspiratory pause for 2-3 seconds and partially forced exhalation with reach to 1/3 of expiratory reserve volume (ERV) for at least 3 seconds through expiratory circuit

Eligibility Criteria:
Inclusion Criteria:

* the healthy subjects
* able to breathe against resistive load with the BreatheMAX device
* good conscious and cooperation

Exclusion Criteria:

- fever
Image Transmission Applied to Organ Transplant: Before-after Study of the Effectiveness of the Device

In the complex process of organ transplant, two of the major steps are:

1. evaluation of the organs of potential donors in health institutions:
2. proposing grafts to the transplant teams, according to rules defined at the national level.

In the absence of the possibility of transmitting the images between the deceased donor sites and the transplant teams, the visualization of these examinations does not take part in the decision-making of the transplant team. This leads in the displacement of the transplant team in order to verify the grafts after acceptance of the graft proposal.

The "Cristal Image" project is a visualisation project for the transplant teams, in real time, at the time of the proposal of the graft so that they can give an opinion (acceptance, refusal) in less than 20 minutes (legal delay for a vital organ) after analyzing the medical records provided and the imaging data (scanner, ultrasound (s), coronary angiography, etc.).

The hypothesis of the project is that the implementation of a secure image transmission (complete anonymisation of the data of the donor) before the acceptance by the team, will allow an optimization of the use of the qualified organs by reducing risks, unnecessary displacement of transplant surgical teams, and securing the allocation of organs to recipient patients.


Eligibility Criteria:
Inclusion Criteria:

* French Donors who died in brain death, at least one organ of which was proposed for transplantation (kidneys, liver, heart, lung); Recipients transplanted during the same periods.

Exclusion Criteria:

* Donors who died after cardiac arrest
* Donors taken care in a foreign country or outside the Metropolitan France
Efficacy & Safety Study of Recombinant Human Erythropoietin -Alpha, in Patients With Anemia of Chronic Renal Failure

To establish the efficacy and Safety of rHu-EPO-alpha in patients with anemia of Chronic Renal Failure.

Despite impressive advances in the safety of the blood supply, the search for therapeutic alternatives to blood continues. Recombinant Human Erythropoietin (rHu-EPO), along with iron, vitamin B12, and folic acid, has been recommended as a specific medication that should be used instead of blood transfusion if the clinical condition of the patient permits sufficient time for these agents to promote erythropoiesis.

In normal physiological conditions Erythropoietin is produced in the kidney and stimulates the division and differentiation of committed erythroid progenitors in the bone marrow. rHu-EPO is a glycoprotein which stimulates red blood cell production. Epoetin alfa, a 165 amino acid glycoprotein manufactured by recombinant DNA technology, has the same biological effects as endogenous rHu-EPO.

Eligibility Criteria:
Inclusion Criteria:

* Patients between 18 to 70 yrs of age of either sex.
* CRF patients who are EPO naïve or have been off EPO or similar Erythropoietic drugs for more than 4 weeks, falling with-in CKD stage III to V.
* Patients who are willing to give the consent
* Patient with Anemia of Chronic Renal Failure with Hb \< 10.

Exclusion Criteria:

* Patients who are known hypersensitive to rHu-EPO.
* Patient's with history of anemia due to causes other than anemia of CRF.
* Patient's with history of Active infections, Hemoglobinopathies, Neoplastic diseases, and HIV infection.
* Patient's with history of G.I. bleeding (Overt or Occult).
* Patient's with history of serious or unstable medical or psychological conditions that could compromise the patient's safety or successful trial participation.
* Patients with abnormal liver function test. However, patients with HBsAg and HCV positive shall be included provided their Transaminases are normal.
* Female patient's of child bearing potential and not having undergone permanent sterilization procedures. Pregnant and lactating female patients.
* Patients unwilling or unable to comply with the study procedures. Chronic alcoholic or drug abuse patients
Impact of Shared Decision-Making With Decision Aids on Acoustic Neuroma Treatment Choice: A Randomized Controlled Trial

Patients with acoustic neuroma had several treatment options. One of standard treatment is to receive the Gamma knife stereotactic radiosurgery, other options included suboccipital craniotomy and conservative treatment. Thus, shared decision making (SDM) is necessary to aid patients to choose an appropriate treatment that suits their needs.

The investigators have developed a decision aids (DAs) and plan to conduct a randomized controlled trial (RCT) to evaluate its impact on acoustic neuroma patients. The measurements include a battery of interview-based questionnaires and evaluations of decision regret and post-treatment depression. The investigators expect the DAs would benefit the intervention group in the aspects of knowledge, communication and anxiety status during and after their treatment sessions.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with acoustic neuroma.
2. Tumor diameter ≤ 3.5cm.
3. The tumor type is Schwannoma.

Exclusion Criteria:

1. Patients with acoustic neuroma less than 20 years old
2. Pregnant woman
3. Patients can not cooperate with Gamma Knife treatment
4. Patients with acoustic neuroma who do not have their own abilities
5. Tumor diameter \> 3.5cm.
Fecal Microbium Change in Pediatric Patients With Spina Bifida: Prospective Case-control Study

Purpose: In order to verify the hypothesis that the composition of intestinal microbiota in children with spina bifida is different from that of normal control, prospective comparative analysis would be performed.

Background of the study:

Spina bifida is a congenital neurological disorder, causing neurogenic bowel. It has been known that the intestinal microbiota in spinal cord injury patient was different than that of control. Changes in intestinal motility, mucous secretion, immune surveillance, and epithelial barrier permeability are possible causes of this change. As spina bifida is also related with neurogenic bowel, the investigators hypothesized that the intestinal microbiota in spina bifida is different from that of normal control.

Patients total 30 patients and 10 controls Inclusion for patients

Patients who meet following conditions:

1) Children over 3 years old and under 12 years old who have been diagnosed with spinal bifida with spinal MRI Exclusion for patients and controls

1) Children with known inflammatory bowel disease or cloacal anomaly

Statistical analysis Statistical processing for fecal samples is aimed at alpha or beta diversity using bioinformatics, and the Kruskal-Wallis test is used to compare similarities or differences between each fecal sample. Prior to statistical analysis, the relative abundance of the detected microorganisms is analyzed first, and microorganisms having a distribution less than 0.1% are excluded from the analysis, and the remaining microorganisms are analyzed in the 'genus' step.


Eligibility Criteria:
Inclusion Criteria:

* 1. Children aged 3-12 years, diagnosed with spina bifida in spinal MRI.

Exclusion Criteria:

* 1. The patient has an inflammatory intestinal disease known in the colon or has a cloacal anomaly.
Influence of Oxygen on Non-invasive Measurement of Hemoglobin

This study examines the effect of oxygen supplementation on the non-invasive measurement of hemoglobin.


Eligibility Criteria:
Inclusion Criteria:

* adult patients scheduled for a potentially hemorrhagic surgical procedure

Exclusion Criteria:

* anomaly (malformation, infection, swelling, irritation, ulceration, degenerative changes or significant edema) of the fingers,
* tremors.
The Effects of Laxative-probiotic Sequential Treatment in the Irritable Bowel Syndrome Patients

the laxative-probiotic sequential treatment might reduce the symptoms of IBS and alter the fecal microbiota of the patients in a more robust manner .

Probiotics can regulate intestinal immunity, repair mucosal barrier, and reportedly exert therapeutic effects on IBS patients. The laxatives could also alter the gut microflora significantly, thus the laxative-probiotic sequential treatment might affect the symptoms and the composition of fecal microbiota in the IBS patients in a more robust manner .

Eligibility Criteria:
Inclusion Criteria:

* the presence of Rome III criteria for IBS ;
* Patients scheduled for colonoscopy examination or having negative screening examinations
* Aged between 18 and 65 years old

Exclusion Criteria:

* Antibiotic, probiotic or laxative usage within 4 weeks.
* organic gastrointestinal diseases
* Severe systematic disease: diabetes mellitus, hepatic, renal or cardiac dysfunction, thyroid disease or tumor etc.
* pregnancy or lactation.
* previous major or complicated abdominal surgery.
* severe endometriosis and dementia
Physical Inactivity and Sedentary Behavior: Screening and Intervention in Ambulatory Primary Care

Physical inactivity and sedentary behaviors are among the leading modifiable risk factors for chronic diseases. In France, despite the national Sport Health strategy, awareness campaigns physical inactivity and sedentary behavior worsened between 2005 and 2015. Primary healthcare professionals, including general practitioners and physiotherapists already involved in tertiary prevention, can act for primary and secondary prevention.

In this study, we hypothesize that an innovative care pathway based on opportunistic screening by general practitioners to assess levels of physical activity and sedentary behavior, and an individualized intervention by a physiotherapist effectively supports behavioral changes towards increased physical activity and reduced sedentary behavior at 6 months in inactive adults without chronic conditions.

This multicenter study, employing an innovative stepped-wedge cluster methodology, will enable healthcare professionals from all included multidisciplinary health centers to enhance their skills in supporting health behavior changes.

For all patients, participation in the study should lead to an increased awareness of the risks associated with physical inactivity and sedentary behaviors.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients
* Not benefiting from Long-Term Illness coverage
* Followed in primary outpatient care by one of the participating centers
* Patients identified as "inactive" by the ONAPS-PAQ questionnaire during an appointment with a general practitioner in the partner Multi-Professional Health Centers, whether sedentary or not
* Patient having signed informed consent to participate in the study
* Patients who understand and speak French
* Persons affiliated with a social security scheme or beneficiaries of a similar scheme
* Patients classified as "inactive" (\< 600 MET.min/week) after 7-day actimetry analysis

Exclusion Criteria:

* Patient receiving follow-up for another reason with physiotherapists participating in the protocol
* Persons referred to in articles L1121-5 to L1121-8 of the Public Health Code
* Patient participating in another interventional research study with an exclusion period still ongoing at pre-inclusion