cyrilzakka/clinical-trials huggingface dataset:
Serious Game Versus Online Course to Pre-train Medical Students on the Management of an Adult Cardiac Arrest.

The objective of this study is to compare two forms of pre-training (an online narrative presentation and a serious game) to prepare 2nd year medical students for a hands-on training with physical simulators about out-of-hospital cardiac arrest management.

Technology-enhanced simulation allows mastery learning. Mastery learning is a variety of competency-based education which has demonstrated its efficacy for skills acquisition and their transfer to actual settings. While traditional education defines fixed learning time and allows outcomes to vary, in mastery learning, all trainees must achieve a predefined level of proficiency while their learning time can vary. The main limitation of mastery learning is that it takes more time than non-mastery learning. This is of concern because the main barrier to simulation-based training is the lack of faculty time. Thus, new solutions should emerge to conciliate mastery learning and time constraints on physical simulators.

Pre-training with a "simulation game" may be a mean to reach this objective. Simulation games are serious games which are at the cross roads between (1) educational games which are "applications using the characteristics of video and computer games to create engaging and immersive learning experiences", and (2) simulation, the imitation of situations which can be encountered in real-life. They combine the advantages of educational games (active, personalized learning) and simulation (realistic and safe environment for experiential learning). By contrast, pre-training with an online course using a PowerPoint presentation with voiceover narration lecture is both passive and abstract.

The objective of this study is to evaluate the time-efficiency of pre-training using a simulation game versus an online course to reach mastery learning in the management of an adult out-of-hospital cardiac arrest.

Eligibility Criteria:
Inclusion Criteria:

* Second-year medical students from the medical schools of Paris Descartes and Paris Diderot University who are not opposed to participate in the study.

Exclusion Criteria:

* Opposition to participate in the study
Use of Febuxostat in Hyperuricemia Among Hemodialysis Patients

Hyperuricemia is not infrequently encountered among hemodialysis patients. However, there is no clear data about use of febuxostat among hemodialysis patients, apart from very small case series. The aim of this study is to investigate the efficacy of using febuxostat for the treatment of Hyperuricemia among hemodialysis patients.


Eligibility Criteria:
Inclusion Criteria:

* Age above 18 years
* Hemodialysis patient
* Hyperuricemia (Uric acid level above 6.0 mg/dL in females and 7.0 mg/dL in males)

Exclusion Criteria:

* Patient currently and/or recently received drugs for hyperuricemia within the last three months
* Patient had recent (within 3 months) change of erythropoiesis stimulating drugs or other drug known to increase uric acid e.g furosemide
Smoking, Stress & Allopregnanolone Response

This study aims to characterize the effect of smoking on stress-induced allopregnanolone (ALLO) response in women by menstrual phase. The investigators hypothesize that women who smoke will have a blunted ALLO response to stress.

Cigarette smoking persists as the leading cause of preventable morbidity and mortality. Thus, finding ways to maximize quitting behavior is critical. Women have a more difficult time achieving smoking abstinence than men. The risk for smoking relapse appears to vary by menstrual phase such that the follicular phase is associated with greater risk compared to the luteal phase. Women are also more likely to smoke in response to stressful stimuli than men. Allopregnanolone (ALLO) is a stress-reducing neuroactive steroid that is primarily metabolized from the sex hormone progesterone and, therefore, varies by menstrual phase in women. Recent preclinical literature has indicated that ALLO may protect against drug abuse behaviors. Unfortunately, ALLO remains largely unexplored in clinical samples containing women.

In this study we aim to characterize the effect of smoking on stress-induced ALLO response in women by menstrual phase. To achieve this goal, we will recruit a sample of premenopausal women who smoke (n=30) and do not smoke (n=30) to participate in a controlled cross-over study. All participants will complete two four-hour lab sessions timed to occur in the Follicular (F; low ALLO) and Luteal (L; high ALLO) menstrual phases. Each lab session will contain an acute stressor along with a timed series of assessments including blood samples (for ALLO measurement) and self-report of mood and perceived stress.

Eligibility Criteria:
Inclusion Criteria:

* Female between the ages of 18-40 years old
* Stable physical/mental health,
* Self-report of regular menstrual cycles,
* Self-report of either smoking either current or never smoking,
* English fluency,
* Ability to provide informed consent

Exclusion Criteria:

* Self-report of current use of illicit drugs, other tobacco products, nicotine, or smoking cessation medications,
* Current or recent pregnancy or breastfeeding,
* Current or recent use of exogenous hormones (including birth control pills),
* Current or recent use of psychotropic medications.
TEXTO : Total EXposure To Organic Pollutants

People are, especially in industrialized countries, exposed to a growing number of ubiquitous chemical substances. It thus increases human exposure pathways: diet, inhalation, soil and dust dermal contact...), notably for semi-volatile organic compounds. Diet is generally sought to contribute the most to total exposure for many chemicals, the relative contribution of each pathway is nevertheless poorly described, and can be different among populations. This is in particularly the case For young children, who can be more exposed via the environment, because of frequent contact with object and dust and hand to mouth behaviors. Children are in addition considered more sensitive to chemical risk due to their maturating systems.

In this context, the objective of this project is to characterize the young children's exposure to a particular class of semi volatile organic compounds. It will encompass the relative contribution of different pathways to the external dose, and to try to match the internal and external doses with a physiologically based pharmacokinetic (PBPK) model for molecules for which it is possible.

The present demand concerns a feasibility study on 2 children, for Perfluorinated Alkylated Substances (PFAS), used in numerous consumer products.

Pilot study for testing feasibility of cross sectional integrative exposure study.

Strategy : Exposure assessment of young children to PFAS with simultaneous measurement of internal (serum) and external doses (diet, indoor environment: contamination data and human exposure factors; quantity ingested and breathed).

Expected outcomes :

Assessment of feasibility to obtain:

* original data on children's body burden
* original contamination data for food, water, air and dust ;
* Matching of these data to identify main sources and pathways of exposure.

Eligibility Criteria:
Inclusion Criteria:

Young children (2-6 months ; 12-18 months)

* In outpatient pediatric or pediatric surgery ;
* From their homes ;
* With home located less than 30km from Rennes ;
* Living at their home (not at childcare facility or child-minder);
* With a scheduled blood sampling apart from this study ;
* For child 2 - 6 months :
* With diet exclusively based on milk (maternal exclusively or commercial exclusively)
* In case of breastfeeding, with mother accepting milk sampling ;
* With a free, enlightened and signed written consent from the parents.

Breastfeeding mother :

* \> 18 years ;
* Exclusive breastfeeding ;
* With a free, enlightened and signed written consent.

Exclusion Criteria:

Children :

* Metabolic illness ;
* Renal or hepatic insufficiency ;
* Malabsorption
* With known HIV+, HBV+, HCV+, CMV+ serology
* Simultaneously participating to other biomedical survey

For breastfeeding mother :

* Under legal protection (judicial protection, guardianship) ;
* mixed breastfeeding ;
* with Known HIV+, HBV+, HCV+, CMV+ serology
A Drug-Drug Interaction Study Between XW003 and Metformin, Warfarin, Rosuvastatin or Digoxin

This is a study of a drug-drug interaction between XW003 and Metformin, Warfarin, Rosuvastatin or Digoxin

This is a single-center, open-label, fixed-sequence study designed to assess the effect of once-weekly subcutaneous injections of XW003 on the pharmacokinetics of metformin, warfarin, rosuvastatin or digoxin. Approximately 56 healthy subjects are to be enrolled into 2 parallel trial groups, with 28 subjects and 2 drugs evaluated in each of the trial group

Eligibility Criteria:
Inclusion Criteria:

1. Male or female, 18-45 years old, inclusive;
2. BMI: 20.0 to 30.0 kg/m2 , body weight: ≥50.0kg.
3. Ability and willingness to participate in the study, give written informed consent, and comply with the study requirements and all protocol procedures.

Exclusion Criteria:

1. Presence of clinically significant conditions (including but not limited to respiratory system, cardiovascular system, gastrointestinal system, endocrine system, immune system, integumentary system, nervous system, ENT or other related diseases);
2. History of allergic diseases including asthma, urticaria or eczema, or history of sensitivity to GLP-1 products, digoxin, warfarin, rosuvastatin or metformin;
3. Known difficulty in swallowing tablets or history of gastrointestinal diseases affecting drug absorption;
4. History of receiving any procedures that might affect drug absorption, distribution, metabolism or excretion;
5. History of acute or chronic pancreatitis;
6. History of documented or suspected hypoglycemic episodes within 6 months prior to screening;
Osteogenic Potential of Cissus Quadrangularis Alveolar Ridge Distraction

Deficient alveolar mandibular ridge corrected distraction osteogenesis to facilitate dental implant placement. Patients grouped into 2 groups: one group received Cissus quadrangularis during the consolidation period, and the other group received placebo.

OPGs were taken immediately after distractor placement, at end of activation period, at 1st,2nd month of consolidation period, and at end of consolidation period. Change in bone height was evaluated immediately after distractor placement, at end of activation and end of consolidation periods.

CBCT were taken immediately after implant installation, and 6 months later to evaluate change bone density and marginal bone level about the dental implant.

histological evaluation was done by biopsy obtained, by trephine bur, from implant site during its preparation. The bone biopsy fixed in 4% formalin solution for 7 days, rinsed in water, and dehydrated in sequent phases of ethanol (70, 80, 90, and 100%) and then specimens were stained by hematoxylin- eosin for microscopic evaluation.

Radiographic evaluation

Eligibility Criteria:
Inclusion Criteria:

* Patients were included if they were free from any disease that may affect healing. Also, presented with 2-3 missing teeth at least in posterior area and CBCT showed bone height above inferior alveolar canal (IAC) ranged 8-10mm.

Exclusion Criteria:

* patients were excluded if they suffered from any disease affect tissue healing, bad oral hygiene or heavy smoking patients
#KindGirlsInACTion: A Programme for the Promotion of Mental Health of Female Adolescents

The #KindGirlsInACTion project started in 2017 and developed and implemented a psychotherapeutic intervention program in Portuguese female adolescents. This program aimed to improve the overall quality of life and well-being of the participants, and specifically to promote a qualitative improvement in body image and interpersonal relationships, through the promotion of self-compassion, compassion and psychological flexibility. #KindGirlsInACTion is a school-based program, with 9 sessions over 9 weeks. It is essentially practical and interactive, with exercises created specifically for the program, as well as the regular practice of mindfulness.


Eligibility Criteria:
Inclusion Criteria:

* being a female adolescent;
* being aged between 12 and 18;
* being a part of a classroome with immediate availability to attend the sessions.

Exclusion Criteria:

* Having a clinical condition that could compromise the completion of self-report questionnaires;
* Having a significant score on screening measures administered pre-intervention.
Email Campaign to Increase Uptake of myGeisinger

The purpose of the current study is to test different email messages to determine the most effect way of promoting enrollment in Geisinger's patient portal, called myGeisinger.

Online patient portals are convenient tools that improve patient access to healthcare services while often reducing burden to both patients and providers. However, fewer than half of patients have enrolled in Geisinger's patient portal, myGeisinger.

The purpose of the current study is to assess what kind of messaging improves the effectiveness of an email campaign targeted at enrolling patients into Geisinger's online patient portal, called myGeisinger. Currently, Geisinger sends an email every month to patients who have started but not completed the enrollment process (they have had an activation code generated but have not yet used that code to enroll). This study will A/B test 5 email messages to assess if they perform better than the current standard email message.

Performance will be assessed based on whether patients open the email, click on the myGeisinger enrollment link, and enroll in myGeisinger. Statistical analyses will employ generalized linear models with a binary distribution and log-link function.

Eligibility Criteria:
Inclusion Criteria:

* Geisinger patients whose myGeisinger status is "Pending", meaning an activation code has been generated for them, but they have not completed activation

Exclusion Criteria:

* Patients without email addresses on file
* Patients who received emails from this monthly myGeisinger marketing campaign within the last 2 months
Effect of Advanced Care at Home vs. Traditional Brick-and-Mortar Hospital Care in Acutely Ill Adults: A Pragmatic Clinical Trial

The purpose of this study is to compare two care delivery models that are currently being implemented in routine practice settings. The findings from this study will inform future clinical decision making, such as which patients might be more suited for which care delivery model.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, 18 years of age and older
* Present to one of the participating hospitals
* Have a chief complaint of one of the target diagnoses
* Are within a certain geographical area (based on zip codes)
* Have a health insurance plan that covers ACH services
* Have the capacity to consent or could assent with the consent of a health care proxy who is physically present

Exclusion Criteria:

* Not suitable for ACH or inpatient hospital care as determined by the patient's clinical team
* Do not have the capacity to consent or assent with the assistance of a health care proxy
Cholecalciferol and Calcifediol Are Both Useful to Improve Vitamin D Serum Levels

Patients with hypovitaminosis D are randomized into three arms of treatment:

Group A: Calcifediol 0,266mg each month Group B: Cholecalciferol 25000UI each 15 days Group C: Calcifediol 4 drops per day. Serum levels of vitamin D are dosed after one month of treatment

Patients with hypovitaminosis D are randomized into three arms of treatment:

Group A: Calcifediol 0,266mg each month Group B: Cholecalciferol 25000UI each 15 days Group C: Calcifediol 4 drops per day. Serum levels of vitamin D are dosed after one month of treatment to support the best dosage of Vitamin D intake.

Eligibility Criteria:
Inclusion Criteria:

* Hypovitaminosis D (\<20ng/mL)

Exclusion Criteria:

* Osteoporosis (T score \<-2.5SD)
* Renal or hepatic diseases
Combining Physical Therapy With Vestibular Stimulation to Improve Postural Stability in Pusher's Syndrome

The study is evaluating the effect of combining Galvanic Vestibular Stimulation (GVS) with standard Physiotherapy treatment in patients admitted to a neurological rehabilitation unit with Pusher syndrome (PS). Patients will be randomised to receive standard Physiotherapy treatment or standard treatment with GVS.

Perceived verticality data will also be collected and analysed on age-matched controls. This data will be used to compare these results with the patients with PS.

The investigators hypothesis that GVS and standard Physiotherapy treatment will lead to a greater improvement in functional ability and awareness of perceived verticality compared to standard Physiotherapy alone.

Pusher syndrome (PS) can be described as disordered balance and orientation which causes patients to perceive they are in an upright position when in fact they are positioned towards their affected side. These patients use their unaffected limbs to 'push' themselves away from their unaffected side in an attempt to correct their perceived postural alignment. PS is a common disorder and can affect 16% of stroke patients.

Patients with PS have shown to take longer to improve in rehabilitation than non-PS patients and tend to stay in hospital for longer.

Galvanic Vestibular Stimulation (GVS) involves passing a small electrical current behind the ear to stimulate the vestibular system to in-turn cause the head and body to move.

Eligibility Criteria:
Pusher Inclusion Criteria:

* Identified hemiparetic neglect - identified PS from a stroke or acquired brain injury (using the Scale of Contraversive Pushing and The Burke Lateropulsion Scale)
* Consenting to participate in the trial

Pusher Exclusion Criteria:

* Severe cognitive impairment
* Receptive aphasia
* Medical co-morbidities
* Opthalamic impairment
* Vestibular impairment
* Peripheral neuropathy
* Also any contraindications to GVS including:

  * Brain metallic implants
  * Pacemakers
  * Recent brain surgery
  * Skull defect
  * Preceding epileptic seizures
  * Sensitive skin behind the ears.

Healthy volunteers inclusion criteria:

* 40 years old minimum age
* Consent to taking part in the trial

Healthy volunteers exclusion criteria:

* Vestibular impairment
* History of medical/psychiatric/neurological disorders
* Currently taking any psychoactive medication
* Drunk more than 3 units of alcohol in the past 24 hours
Pilot Study of ORG 25935 Modulation of Ketamine-induced Behavioral and Cognitive Effects in Healthy Male Subjects

Org 25935 is a new putative antipsychotic agent developed by N.V. Organon.The primary objective of this study is to investigate the effect of Org 25935 on ketamine-induced impairments in immediate recall.


Eligibility Criteria:
Inclusion Criteria:

* Male, 18 - 55 years

Exclusion Criteria:

* History of sensitivity/idiosyncrasy to the drugs used in the study or chemically related compounds or excipients which may be employed in the study or to any other unknown drug used in the past.
GLP-1 Analogue in Preventing Progression of Small Vessel Disease (GAPP-SVD)

Cerebral small vessel disease (cSVD), a result of neurovascular cell dysfunction, is a major cause of stroke, dementia and mobility problems worldwide. Vascular risk factor control alone may not be sufficient to prevent the development of vascular cognitive impairment (VCI) in patients with cSVD according to previous clinical trials.

The presence of glucagon-like peptide-1 receptor (GLP-1R) in cerebral microglia may reveal a potential therapeutic target for prevention of cSVD progression and its disabling clinical outcomes. At the cellular and animal experimentation levels, GLP-1R agonist demonstrated reversal of some pathogenic processes in cSVD. However, its application to cSVD patients remains to be elucidated.

Investigator aims to investigate the safety and efficacy of GLP-1R agonist in patients with moderate-to-severe cSVD.

In this single-center, open-label (assessor blinded), randomized controlled study, 110 patients with cSVD of Age-Related White Matter Changes Scale of 2 or 3 will be randomized into "treatment arm" with GLP-1R agonist and standard medical therapy, and "control" arm with standard medical therapy alone in a 1:1 ratio. In this 78 weeks pilot study, investigators shall evaluate the tolerability and safety profile of exenatide, a GLP-1R agonist in SVD patients, together with changes in clinical, imaging and sonographic parameters.

Clinical and biochemical measures will be assessed at baseline, 12 weeks, 26 weeks and 52 weeks. Transcranial Doppler Ultrasound (TCD) will be performed at baseline, 12 weeks, 26 weeks, 52 weeks and 78 weeks. MRI will be performed at baseline and 78 weeks

Eligibility Criteria:
Inclusion Criteria:

1. Chinese ethnicity;
2. Age 55 to 80 years old;
3. Age-Related White Matter Change (ARWMC) Scale of 2 or early 3 in FLAIR MRI;
4. Modified Functional Ambulation Classification 5 or above;
5. Montreal Cognitive Assessment (MoCA) score \< 25;
6. Both diabetic and non-diabetic patient are eligible;
7. Patient who understands the purpose and requirements of the study, and able to provide an informed consent;

Exclusion Criteria:

1. Dementia or MoCA score lower than 2nd percentile of the age and education adjusted cutoff ;
2. Cerebral white matter changes unrelated to neurodegenerative, e.g. CADASIL, X-linked adrenoleukodystrophy, metabolic diseases, multiple sclerosis, etc.;
3. Contraindication to GLP-1R agonist, including thyroid carcinoma, pancreatic pathology, proliferative retinopathy, hypersensitivity to GLP-1R agonist and history of family history of multiple endocrine neoplasia;
4. BMI \<18.5kg/m2;
5. Contraindication to proposed imaging, e.g. chronic kidney disease (KDNIGO) stage 4 or above, acute kidney injury, hypersensitivity to gadolinium-based contrast, non-MRI conditional implants or prosthesis;
6. Medical condition that would not allow the patient to adhere to the protocol or complete the study.;
7. Patient with established neurodegenerative disorders (e.g. Parkinson's Disease, Alzheimer's Disease, etc.);
8. Pregnancy.
Open Label Study (Everyone Who Participates Receives Drug) to Further Determine How Safe and Effective Oral Treatment of Seletracetam is in Patients With Refractory Epilepsy.

This is a safety and efficacy study of add on therapy with seletracetam in patients experiencing refractory epilepsy.


Eligibility Criteria:
Inclusion Criteria:

* An IRB/IEC approved written informed consent form signed and dated Male/Female patients age 18 (or 16 years where permitted by law) to 65.
* Minimum body weight of 40 kg.
* Patients with a confirmed diagnosis of refractory epilepsy of ≥ 6 months.
* Patients must be receiving 1 - 3 concomitant AEDs.
* Female patients without childbearing potentials (2 years post-menopausal or surgical sterilization) are eligible. Female patients with childbearing potential are eligible if they use a medically accepted non-hormonal contraceptive method.

Exclusion Criteria:

* Seizures occurring in clusters (seizures occurring either too frequently or indistinctly separated to be reliably counted).
* Status epilepticus within 3 months of Visit 1.
* History of non-epileptic seizures.
* Patients on vigabatrin.
* Patients on felbamate, unless treatment has been continuous for ≥ 18 months.
* Use of benzodiazepines (for any indication) taken at a higher frequency than an average of once a week, unless counted as one of the concomitant AEDs.
* Ongoing psychiatric disease other than mild controlled disorders.
* Patients with a clinically significant organ dysfunction.
* Known allergic reaction or intolerance to pyrrolidine derivatives and/or excipients.
* Pregnant or lactating women. Any woman with childbearing potential who is not using a medically accepted, non-hormonal method of birth control.