cyrilzakka/clinical-trials huggingface dataset:
Multidisciplinary Team Approach to Prescribe Antithrombotic Therapy in Older People With Atrial Fibrillation

Antithrombotic drugs, which include antiplatelet and anticoagulant therapies, are used to prevent and treat many cardiovascular disorders. With the increase in prevalence of cardiovascular diseases and medical progress, these treatments are increasingly being prescribed, particularly in older patients. One of the main indications of antithrombotic drugs is atrial fibrillation (AF), a disease highly prevalent in older people, a population at high risk of adverse drug events. Notably, antithrombotic drugs are the first involved in serious adverse drug events, among which 40-70% may be preventable. In this context, six units of the hospital group "Assistance Publique - Hôpitaux de Paris" have created a multidisciplinary team which assesses antithrombotic prescriptions in older patients with AF. This team, gathering geriatricians, cardiologists, neurologists and haematologist specialized in haemostasis, evaluates the patient medical profile and suggests the most appropriate antithrombotic treatment based on their expertise and the available recommendations. Here we want to look at patients outcomes in light of the intervention of this multidisciplinary team.

The primary objective of this study is to evaluate the impact of the multidisciplinary team on the composite outcome of all-cause mortality, ischemic event or bleeding event at 3 months. Secondary objectives are to evaluate this composite outcome at 6 months and all-cause mortality, occurrence of ischemic event, occurrence of bleeding event, at 3 and 6 months.

Eligibility Criteria:
Inclusion Criteria:

* 75 years old patients or more
* Diagnosis of AF
* Hospitalized in one of the 6 geriatrics unit participating in the study and / or whose clinical file is reviewed by the multidisciplinary team

Exclusion Criteria:

* opposition to data collection for research purposes
Efficacy of Ventavis Used in Real-life Setting.

This is a registry of patients diagnosed with pulmonary arterial hypertension, scheduled for treatment with Ventavis.

Typical clinical measures and quality of life will be prospectively followed in 12 months period.


Eligibility Criteria:
Inclusion Criteria:

* Pulmonary arterial hypertension in WHO functional class III or IV
* Age 18+
* Patients newly treated with Ventavis or switched from sildenafil

Exclusion Criteria:

* Retrospective documentation is not allowed
Integrated Care Analysis Response to Exercise in Community-dwelling Elders

One of the main challenges of ageing is to prevent the onset of mobility disability and its co-morbidities. Screening the risk of mobility disability in community-dwelling elders is therefore very important and at the uppermost for the care of sarcopenia and frailty. A multicomponent intervention, integrating multidisciplinary actions and combining physical exercise and nutrition, is recognized as an effective therapy for the care of mobility disability risk factors. The diagnosis of either pre-frail/frailty and/or sarcopenia at least probable is sufficient to trigger a sustained intervention as it can prevent the onset of mobility disability. Therefore, it is difficult to identify the best responder for this type of care path. As a result, studies have been interested in exploring the predictive factors related to the functional response to exercise within lifestyle interventions. It has been shown that SPPB provides useful information when associated with demographic or physical activity factors. Those predictions are reliable to an ageing population with a SPPB ≤9 but it is still unknown if these reports are reproducible to older adults with high baseline physical function. Therefore, we hypothesized that a more inclusive SPPB score at baseline could also be related to other factors to predict the functional response to exercise. We assumed that strength, age, sex or body mass index could be interesting to elicit better predictions. It is an important issue for the development of targeted-interventions and specific care orientations.

The training has to be established through an accurate schedule to optimize the response to exercise. However, it is difficult to make consensus on the best method to apply, especially for elders with mobility disability risk. Hence, the present study also focus on a specific training method planned toward different exercises modes. We aimed to propose a training with cost-effective material and the absence of machines to transpose it into daily life participants. We expected to observe benefits on physical performance after this exercise intervention.


Eligibility Criteria:
Inclusion Criteria:

* Aged ≥ 70 years old
* Diagnosed with mobility disability risk during the initial assessment (sedentary or/and pre-frail/frail or/and sarcopenia at least probable)
* Have completed the 20 collective sessions
* Have been reassessed after 3 months of intervention

Exclusion Criteria:

* Baseline SPPB \< 5
* Erroneous clinical data
Performance Assessment Study VitalSigns Camera

This Performance Assessment Study will focus on testing the performance of the VitalSigns Camera under various suboptimal use cases. The software makes it possible to measure the pulse rate (PR) and respiration rate (RR) without the device being in contact with the subject. The software delivers fast and accurate results (in less than one minute). Vital signs camera (VSC) product will be used via a demonstrator app on one of the smartphones during the study sessions (camera of the phone will be used by the VSC product). Devices will be provided by the researchers.

The subject will be asked to perform a number of assignments with the software application. The study involves taking a number of measurements of the subject's PR using the VitalSigns Camera software application (which is installed on a smartphone or laptop). In this study only PR is measured and not RR as the latter parameter is not affected by the designed test cases. The total duration of the session will be approximately 1 hour. In total, approximately 30 healthy volunteers will participate in this study.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteer must 18 years or older
* Participants willing to give informed consent
* Willingness to have vital signs measured by a medical mobile application
* Willingness to put on sunglasses
* Willingness to put on facial makeup
* Willingness to put on a face mask covering mouth and nose
* Willingness to sit still up to 2 minutes per measurement

Exclusion Criteria:

* Individuals who are not able to read and understand the English language
* Known allergic reaction to facial make-up
* COVID-19 exclusion criteria:

  * Currently displaying COVID-19-related symptoms, namely a fever, cough and/or difficulty breathing
  * Having been positively tested as infected with COVID-19 in the past 14 days
  * Travelled to or from high risk COVID-19 areas in the past 14 days
  * Been in contact with a (suspected) COVID-infected person in the past 14 days
Named Patient Program for Olverembatinib (HQP1351)

This program will allow eligible patients access to Ascentage Pharma's novel drug candidate Olverembatinib (approved in China) on a named patient basis in over 100 countries ( with the exception of the USA and China) and regions where the drug is not available.

Olverembatinib is a novel third generation BCR-ABL inhibitor that can effectively target a spectrum of BCR-ABL mutants, including the T315I mutation. Olverembatinib is approved in China for the treatment of adult patients with tyrosine kinase inhibitor (TKI)-resistant chronic phase chronic myeloid leukemia (CP-CML) or accelerated-phase CML (AP-CML) harboring the T315I mutation as confirmed by a validated diagnostic test1.

Eligibility Criteria:
Inclusion Criteria:

• Patients who are suitable to receive Olverembatinib and for whom there is reasonable expectation that Olverembatinib may provide clinical benefit based on the medical judgment of their prescribing physician.

Exclusion Criteria:

* Existing risks of serious Arterial occlusive events (AOE), including myocardial infarction, stroke, stenosis of large arterial vessels of the brain, severe peripheral vascular disease, and recent revascularization procedures
* Existing risks of serious Venous thromboembolic events (VTEs), including deep venous thrombosis, pulmonary embolism, and retinal vein thrombosis
* Existing serious heart conditions, including acute/chronic heart failure, coronary artery disease
* Existing conditions of severe liver malfunction
* Existing conditions of severe myelosuppression
* Existing conditions of severe hemorrhage
* Pregnant or baby feeding
Effects of Emotional Stimuli in Patients With Disorders of Consciousness

Disentangling the vegetative state from the minimally conscious state is often difficult when relying only on behavioral observation. In this study, the investigators explored a new event-related potential paradigm as an alternative method for the detection of voluntary brain activity and cognitive abilities in the patients with disorders of consciousness.

Auditory emotional stimuli have potential beneficial effects on cognitive functions and consciousness in patients with disorders of consciousness (DOC); however, precise and accurate quantitative indices to estimate cerebral activation to different auditory stimuli remain scarce. In this study, investigators assessed the response of different brain regions to emotional stimuli using ERP(Event-related potential),and further investigated the brain activation network.

Eligibility Criteria:
Patients:

Inclusion Criteria:

1. Disorders of consciousness (Traumatic brain injury, stroke or anoxic encephalopathy)
2. Coma diagnosis (Plum and Posner, 1966), vegetative state (Task Force, 1994) or minimally conscious state (Giacino, Ashwal et al. 2002)
3. Lack of autonomic crisis since one week minimum
4. Medical condition considered stable
5. Patients who do not present hearing loss. Peaks I and II of Brainstem Auditory Evoked Potentials (BAEP) will be normal.

Exclusion Criteria:

1. hearing Problem
2. Uncontrolled Epilepsy
3. Autonomic crises
4. Medical unstable state
5. Pregnant or likely to be (interrogation data) or breastfeeding woman

Healthy controls:

Inclusion Criteria:

1. Subjects with normal hearing
2. Absence of neurological disorder
3. Subjects able to understand the experimental instructions

Exclusion Criteria:

1. Hearing problems and / or hearing loss higher than 30 decibels Hearing Level (dB HL) at a frequency band from 250 to 8000 Hz
2. Neurological disorders
3. Pregnant or likely to be (interrogation data) or breastfeeding woman
Comparing in Dexmedetomidine With po/pr Midazolam for Procedural Sedation in the Pediatric Emergency Department

This study aims to compare efficacy of Procedural Sedation with Dexmedetomidine as compared to Midazolam in the pediatric Emergency Department.

210 children aged 6 months to 6 years will be included and randomly assigned to receiving oral or rectal midazolam (standard of care) or intranasal dexmedetomidine for procedures at the emergency department where mainly a sedation and no analgesia is sought. The procedure will be videotaped and analysis is blinded to the medication.

Pediatric sedation and analgesia is a major aspect in emergency procedures and treatments: anxiety and stress in children need to be purposefully addressed in order to perform procedures where a child needs to lie still, and to prevent anxiety in the future. An important factor to reduce stress and anxiety is the use of medication without the need of an intravenous access. To date, options for such a sedation are very limited. One of the most common medications in use is midazolam applied orally or rectally, though there are several concerns with this drug.

Pediatric developmental stage often does not allow to rationally explain procedures (e.g., wound management, emergency radiologic imaging, lumbar punctures, posing a difficult iv line), thus provoking further anxiety and non-compliance.

The medication in question (dexmedetomidine, DEX) has been proven to be a safe and reliable sedative in different settings even though its use is off-label in pediatrics. Data on its use in the pediatric emergency department (PED) are sparse, but it could be of help in a variety of situations especially in this setting.

The overall objective of this study is to determine whether intranasal (IN) DEX has better efficacy profile for PSA in the PED compared to rectal (PR)/ oral (PO) midazolam in children aged 6 months to 6 years.

Validated scores are used to describe efficacy in detail, including Procedural Sedation State Scale, Modified Yale Preoperative Anxiety Scale Short Form, University of Michigan Sedation State. Surveys to the parents and the health care professionals are used to further describe efficacy.

Procedural Sedation State Scale will be the primary outcome. Based on clinical experience we expect around 70% of patients with midazolam sedation to score 2 or 3 using the PSSS (target sedation state). Clinically relevant superiority is defined as 15% more patients with target sedation state.

Study design: single-center, prospective, randomised, active control, rater-blinded trial: procedures will be videotaped and analysed by research assistants blinded to the study medication.

Number of patients: 210 with assessable primary outcome. Duration of recruitment is expected to be 24 months

Eligibility Criteria:
Inclusion Criteria:

* Children aged between 6 months and 6 years presenting at the pediatric emergency department
* Indication for midazolam as sedation
* Signed informed consent

Exclusion Criteria:

* Contraindication for midazolam
* Contraindication for dexmedetomidine
* Contraindication for moderate sedation in general
Effect of a Virtually Implemented Cardiac Rehabilitation Program

A clinical trial investigating the effects of a virtually implemented home-based cardiac rehab program with real-time, video based exercise supervision and vitals monitoring.

This study will use a randomized, controlled trial design to test the effectiveness of a virtually implemented cardiac rehabilitation (CR) program with real-time, video based supervised exercise and vitals monitoring as compared to traditional center based rehab in patients with a clinical indication for cardiac rehab. The primary outcome of effectiveness will be change in cardiorespiratory fitness as assessed by maximal VO2 achieved at the start of CR and on upon completion of CR.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have been prescribed cardiac rehabilitation as part of their standard of care

Exclusion Criteria:

* Patients with significant exercise limitations other than cardiovascular disease
* Patients who are unable to exercise in home
* Patients with active cancer treatment
* Patients who do not have an email address or a cell phone
Intralipid® 20% for Reversal of Local Anesthetics

In order to determine if Intralipid 20% can be used to reverse the effects of local anesthetics, the investigators will recruit 18 volunteers who will be asked to come to HSS for two study visits. Small amounts of local anesthetics will be injected into the volunteers' thighs during both visits. During one visit volunteers will receive Intralipid 20% and during the other visit they will receive a saline solution. The study team will measure how quickly normal sensation returns to the thighs when the volunteers get Intralipid 20% compared to saline.

The purpose of this study is to determine if a fat solution (Intralipid 20%) given intravenously can reverse the effects of local anesthetics. Local anesthetics are drugs that cause numbness when they are injected into different parts of the body. Local anesthetics are important drugs because they allow doctors to perform surgeries and other procedures on patients; however, there are certain instances where it would be helpful to reverse the effects of local anesthetics and reduce the amount of time that they produce numbness. In order to determine if Intralipid 20% can be used to reverse the effects of local anesthetics, the investigators will recruit 18 volunteers who will be asked to come to HSS for two study visits. Small amounts of local anesthetics will be injected into the volunteers' thighs during both visits. During one visit volunteers will receive Intralipid 20% and during the other visit they will receive a saline solution. The study team will measure how quickly normal sensation returns to the thighs when the volunteers get Intralipid 20% compared to saline.

Eligibility Criteria:
Inclusion Criteria:

* English speaking
* BMI 18-25, with body weight between 50-100kg

Exclusion Criteria:

* ASA III or higher
* Pregnant Women
* Allergy to study medications (lidocaine, bupivacaine, soybeans, eggs)
* Use of drugs affecting the sensorium (including opioids, benzodiazepines, antipsychotics, gabapentinoids)
Office Worker Behavior and Health Study

This is a randomized intervention study to determine if electronic prompted interruptions in sitting time have an effect on job satisfaction, musculoskeletal complaints, and sitting time.

A sedentary lifestyle has been deemed deleterious to health. It contributes to many chronic diseases and illnesses as well as an increase in all-cause mortality. The objective of this study is to investigate if electronic prompted interruptions in sitting time can reduce sedentary behavior at work as well as have an effect on job satisfaction, and musculoskeletal complaints. The participants will be randomly assigned to one of two groups, intervention (n=31) and control (n=31). Informed consent, demographic and socioeconomic data will be obtained from each participant. A questionnaire that includes three different scales will be administered before and after the 12-week intervention to all participants: Occupational Sitting and Physical Activity Questionnaire, Job Satisfaction Index, and Nordic Musculoskeletal Symptoms. Also, physical data will be measured: BMI, percent body fat and waist circumference. All participants will be provided with the Amazfit BIP device to track steps during work hours. The intervention group will receive a prompt every hour during their workday via an iOS application, Stand-Up, through the Amazfit BIP device. The prompt is to interrupt sitting time and encourage two-minutes of physical activity. The intervention group will receive examples of physical activity in addition to educational material on the health benefits of increasing physical activity in the workplace via verbal instruction and written materials. Data analysis will be conducted to determine if there is a difference in sitting time between the two groups over time using repeated-measures ANOVA. Independent samples t-tests will be used to compare job satisfaction and the physical biomarkers for obesity among the intervention and control groups. Chi-square will be used to analyze the reported musculoskeletal complaints between the two groups. If necessary, all analyses will be controlled for age, gender, race/ethnicity, and socioeconomic status.

Eligibility Criteria:
Inclusion Criteria:

In generally good health. Access to an IOS device for the duration of the study.

Exclusion Criteria:

Pregnancy. Use of activity equipment or devices in the workplace. Extreme exerciser: run marathons, participates in team or competitive sports/activities
Efficacy of Triple-daily 15mA tACS on Adolescent NSSI

In order to assess the clinical efficacy of triple-daily 15mA-tACS stimulation by comparing the effects of active and sham tACS interventions on driving improvements in adolescent Nonsuicidal Self-Injury(NSSI), participants will be randomly assigned to either the active or sham tACS group. This trial consists of a 2-week intensified intervention phase (40 sessions), followed by a 4-week observation period. The key hypothesis is that triple-daily 15mA-tACS stimulation will enhance clinical recovery compared to sham stimulation.

Recognizing the clinical shortcomings of traditional methods for adolescent NSSI, study objective is to establish evidence supporting the efficacy of a triple-daily 15mA-tACS stimulation regimen targeting the forehead and both mastoids. This intervention will be administered five days a week over a four-week treatment period, with the aim of eliciting substantial clinical improvements in adolescent NSSI compared to a sham intervention. On the first day of the intervention, participants will receive a tACS session, followed by triple-daily tACS sessions administered for 13 consecutive days. Following the completion of treatment, participants will undergo follow-up observations every 7 days for 4 weeks. EEG and ECG recordings will be obtained at baseline, on day 1 after the first session, at the end of the 2-week intervention period (after 40 sessions), and at the 6-week follow-up. Throughout the sessions, all evaluations will be conducted under standardized conditions.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of NSSI based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria section 3 diagnostic criteria.
* Five or more NSSI episodes in the past year and at least one NSSI episode in the past month.
* Age between 12 and 21 years.
* Informed consent from parents or legal guardians.
* Informed consent from participants aged 15 years and above.

Exclusion Criteria:

* Current or history of organic brain disorders or neurological disorders.
* Elevated or imminent suicidal risk, as assessed by clinicians during routine screening.
* Previous or current exposure to electroconvulsive therapy (ECT), modified ECT, TMS, transcranial direct current stimulation (tDCS), tACS, or other neurostimulation treatments.
* Presence of cochlear implants, cardiac pacemakers, implanted devices, or metal in the brain.
* Previous or current use of psychotropic medication.
* Pregnancy or lactation.
* Participation in another concurrent clinical trial.
* Refusal to provide informed consent to participate in the trial.
* Other circumstances deemed unsuitable for participation by researchers.