cyrilzakka/clinical-trials huggingface dataset:
Thrombectomy Revascularization of Intracranial Vessel OcclusioN by Originating From Japan (TRON1-Japan)

To evaluate the efficacy and safety of catheter-based thrombectomy for reperfusion by removing a thrombus in a cerebral blood vessel in patients with acute cerebral infarction (within 8 hours after onset), in whom intravenous administration of tissue plasminogen activator (t-PA) is not indicated or reperfusion cannot be achieved by intravenous t-PA administration.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with neurological disorders caused by blood vessel occlusion associated with acute cerebral infarction
2. Patients who can receive treatment within 8 hours after onset of symptoms of acute cerebral infarction
3. Patients in whom intravenous administration of t-PA is not indicated or reperfusion cannot be achieved by intravenous t-PA administration
4. Patients who have accessible occlusion of the middle cerebral artery (M1 or M2 to 3), basilar artery, vertebral artery, posterior cerebral artery (P1 or P2), anterior cerebral artery (A1 to 2), or intracranial internal carotid artery (pre-procedure TICI score, 0 or 1) as determined by angiography
5. Patients with an NIHSS score of 8 to 30
6. Patients with an mRS score of 0 to 2 before onset
7. Patients aged between 20 and 85 years (at the time of informed consent)
8. Patients who are able to provide written consent (signature) or whose legally acceptable representative (a person with parental authority, spouse, guardian, and an individual legally responsible for his/her custody) can provide written consent (signature)

Exclusion Criteria:

1. Patients who manifest the following:

   * Carotid artery dissection
   * Vasculitis
   * An angulated vessel, making it difficult to guide an investigational device
   * Significant (\>50%) stenosis, making it difficult to guide an investigational device
   * Acute intracranial hemorrhage
   * Mass lesion or intracranial tumor
   * Widespread early ischemic changes revealed by CT or MRI
2. Patients who have two or more different major cerebrovascular occlusions requiring treatment
3. Patients with an allergy to contrast agents or who cannot receive them or those who have a serious metal allergy
4. Patients who received heparin within 48 hours and have Partial Thromboplastin Time (PTT)/Activated Partial Thromboplastin Time (APTT) \> twice the upper limit of normal
5. Patients with known bleeding tendencies or coagulation deficiency or who have received oral anticoagulants (such as warfarin), and who have (PT-) International Normalized Ratio (INR) \>3
6. Patients with platelet count \<30,000 /mm3
7. Patients with blood glucose levels \<50 mg/dL
8. Patients with uncontrolled hypertension (systolic BP \>185 mmHg and diastolic BP \>110 mmHg)
9. Patients with expected life expectancy \<90 days
10. Female patients who are pregnant or breast feeding
11. Patients who are participating in clinical trials of drugs or medical devices
12. Patients disqualified from participation in the study by the investigator (sub-investigator) due to reasons other than the above
The Comparability of Bispectral Index and Neurosense During Anesthesia

The assessment of anesthesia depth was based, until recently, on the evolution of hemodynamic parameters. Nowadays it can be evaluated by several monitoring methods, derived from electroencephalogram analysis, namely the Bispectral Index (Aspect Medical Systems, Newton, USA). A new modality is currently under development: the NeuroSENSE (Cleveland Medical Devices Inc., Cleveland, OH 44103, USA). The goal of this study is to compare both monitoring modalities during anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* Patients requiring either intravenous anesthesia or balanced anesthesia (including sevoflurane)

Exclusion Criteria:

* Pregnant women,
* Allergy to propofol, remifentanil, morphine, muscle relaxant, or to a component,
* Hypersensibility to sufentanil, remifentanil or to a derivate of fentanyl,
* History of neurological disorder or central brain lesion, of muscle disease,
* Patient carrying a pacemaker,
* Patients receiving a psychotropic treatment or a morphine agonist-antagonist,
* Alcoholic patients and patients taking opiates,
* Surgery with extracorporeal circulation,
* Surgical position incompatible with an adequate positioning of the probe.
eVusheld Assessment reaL wORld Effectiveness at UPMC

An AstraZeneca-sponsored observational, electronic healthcare record (EHR)-embedded retrospective cohort study to assess the real-world effectiveness of EVUSHELD against SARS-CoV-2 infection, COVID-19-related hospitalization, and other COVID-19 related outcomes in the total EUA-eligible patient population in the University of Pittsburgh Medical Center (UPMC) Health System.

This a Phase IV observational, secondary data study to assess the effectiveness of Evusheld in preventing COVID-19 infection and severe outcomes using the electronic medical records from the nationwide integrated health system.

The study is designed as an AstraZeneca-sponsored observational, electronic healthcare record (EHR)-embedded retrospective cohort study to assess the real-world effectiveness of EVUSHELD against SARS-CoV-2 infection, COVID-19-related hospitalization, and other COVID-19 related outcomes in the total EUA-eligible patient population in UPMC health system

Eligibility Criteria:
Inclusion Criteria:

1. Receipt of EVUSHELD under the FDA EUA for EVUSHELD
2. Eligibility for assess Evusheld use under the EUA. -

Exclusion Criteria:

* None
Study of the Bioavailability of a Food Supplement Rich in Melatonin Administered Sublingually and Orally (MELATONIN)

Sleep disorders represent an important public health problem that cause important personal problems, absenteeism and considerable health costs. Although the main drugs used for the treatment of insomnia are still Benzodiazepines and Z-drugs (Zolpidem, Zopiclone, Zaleplon), these are not entirely effective and have numerous side effects that lead to poor compliance with therapy . For the treatment of sleep disorders, alternative non-pharmacological therapies have also been implemented, such as cognitive therapy, relaxation therapy, and the introduction of new agents, including the use of melatonin as a human endogenous molecule with low or zero toxicity.

In Europe, the European Food Safety Authority (EFSA) has stated that "A cause and effect relationship is established between the consumption of melatonin and the alleviation of subjective feelings of jet lag. In order to present the declaration of health, the dose of melatonin should be between 0.5 and 5 mg and should be taken close to bedtime on the first day (and subsequent days) of the trip and the following days after arrival at destination.The target population is the general population ". On the other hand, the EFSA states that "A cause and effect relationship is established between the consumption of melatonin and the reduction of sleep onset latency. The Panel considers that to obtain the declared effect, 1 mg of melatonin should be consumed near bedtime. The target population is the general population."

The results of several studies in humans show that melatonin administered orally has a low bioavailability (approximately percentage) and a very short half-life. Therefore, it has been suggested that the sublingual route represents an attractive alternative for the administration of compounds that have a low bioavailability, since through this route, the substances are distributed throughout the body avoiding the loss of the compounds by their first-pass metabolism by the liver, as well as the loss by the process of absorption by the digestive system.

On this basis the present hypothesis is posed: the administration of melatonin sublingually will have a greater bioavailability than the administration of melatonin orally.

The main objective of this study was to quantify the bioavailability of 1 mg of melatonin when administered sublingually and orally.


Eligibility Criteria:
Inclusion Criteria:

1. Men and women over 18 years of age.
2. Firm the informed consent.

Exclusion Criteria:

1. Take supplements or multivitamin supplements or phytotherapeutic products that interfere with the treatment under study up to 30 days before the start of the study.
2. Present intolerances and / or food allergies related to melatonin.
3. Presenting anemia (hemoglobin ≤ 13 g/dL in men and ≤ 12 g/dL in women).
4. Being pregnant or intending to become pregnant.
5. Be in breastfeeding period.
6. Be a smoker
7. Participate in or have participate in a clinical trial or nutritional intervention study in the last 30 days prior to inclusion in the study.
Effect of Apical Patency and Local Corticosteroid on Pain and Neuropeptides Release in Patients With Symptomatic Irreversible Pulpitis: A Randomized Clinical Trial

The goal of this randomized clinical trial is to learn the effect of using local corticosteroids and maintaining apical patency in reducing post-preparation pain in patients with acute irreversible pulpitis in molar teeth. The main question it aims to answer is:

• How effective are using local corticosteroids and maintaining apical patency in reducing post-preparation pain in patients with acute irreversible pulpitis? Participants will be asked to fill a visual analogue scale to record their pain, after receiving a root canal treatment while using local corticosteroids or not as well as maintaining apical patency or not.

Researchers will compare the use of corticosteroids and maintaining apical patency in reducing post-operative pain.


Eligibility Criteria:
Inclusion Criteria:

* Symptomatic acute irreversible pulpitis in molar teeth.
* Normal periapical condition including periapical radiography with minimal widening of periodontal ligament.
* Normal probing depth.
* No medical condition.
* No contraindication for administration of corticosteroids and local anesthesia.

Exclusion Criteria:

* Facial or oral paresthesia.
* Pregnancy \& breastfeeding.
* Unrestorable tooth.
* Marginal periodontal disease.
* Presence of a crown on the tooth involved.
* Over instrumentation during root canal treatment.
* Long-term use of corticosteroids.
* False-positive cases of sensibility test with necrosis discovered after gaining access to the tooth.
* Cases requiring intrapulpal injection to promote anesthesia.
Interest of the Use of the Web Platform LICORNE (LIaison and COoRdination With a NumériquE Health Reseau) Concerning Coordination of Care for Dependant Elderly Patients

This project is associating partners from the public area (university hospital of Nice, Nice university) and the private area (Agfa Health Care, Radhuis, Domicalis) to create a unique medico-psycho-social shared record.

The purpose of this project is to significantly improve coordination of care, especially between hospital and home. We can expect a significant improvement in the patient's living conditions, improving its management, its security and ultimately, lower health care costs.

The LICORNE project was created to give the possibility for the medical establishments to share there medico-psycho-social informations with all actors taking part of the patient care. Indeed, current informatique systems in medical establishments have an isolated functionning, without transmission of information outsite the wall of the hospital. The idea of this project is to bring together all actors involved in the care of a patient around a single shared patient record, regardless of the structures where professionnals work. This project is associating partners from the public area (university hospital of Nice, Nice university) and the private area (Agfa Health Care, Radhuis, Domicalis) to create a unique medico-psycho-social shared record. The informations will be share between all the professionnal taking car of the patient.

The main objective of this protocol will be to determine the impact of using the LICORNE platform on the coordination of care of elderly patients with multiple diseases. We will assess the impact of using the LICORNE platform on the implementation of electronic health record (Dossier Médical Partagé, public health insurance of the social security), and the benefit of using the LICORNE platform to reduce patient's hospital readmissions.

The purpose of this project is to significantly improve coordination of care, especially between hospital and home. We can expect a significant improvement in the patient's living conditions, improving its management, its security and ultimately, lower health care costs.

Eligibility Criteria:
Inclusion Criteria:

* Age\> 60 years
* multiple pathologies : having at least two active chronic conditions.
* Polypharmacy : having at least 4 different molecules in its treatment.
* Dependence : GIR 4 or equivalent and less before hospitalization.
* Need medical care at home at least 5 days a week .
* Patient requiring social intervention ( this criterion of judgment is left to the social worker in the patient's file)

Exclusion Criteria:

* Life threatening pathology during current hospitalization .
* Patients undergoing a hospitalization home service .
* Patients without administrative or judicial freedom if the authorization of the legal representative can not be collected.
Assessing and Improving Balance Using Platform Perturbations

The purpose of this study is to compare current standing balance assessment methods to a new method that measures weight shift during small movements of a sliding platform. It will also be used to determine if balance improves with repeated exposure as part of a 4-week training program.


Eligibility Criteria:
Inclusion Criteria:

* Healthy no balance deficits age 20-35 or 50-65

Exclusion Criteria:

* moderate to severe arthritis
An Evaluation of the Causes of Anemia in Patients With Heart Failure

Anemia is frequent in patients with heart failure. Few studies have clearly addressed the causes of anemia in patients with HF. The purpose of this study is to evaluate differences in blood concentrations of various substances related to inflammation, oxidative stress, renal function and other processes between individuals with 1) heart failure and anemia, 2) heart failure without anemia and 3) patients with kidney disease without systolic heart failure. This study will help to better understand the reasons why some people with heart failure have anemia.


Eligibility Criteria:
Inclusion Criteria:

Groups 1 and 2

* Age \>18 years
* Group 1: hemoglobin \< 120g/L in women and \< 130 g/L in men (in agreement with the WHO definition of anemia)
* Group 2: hemoglobin \> or = 120g/L in women and \> or = 130 g/L in men
* Patients with chronic HF referred to a specialized HF clinic, or with a diagnosis of HF at least 6 months prior to enrolment
* NYHA functional class II-IV at the time of enrolment
* Patients already on CHF medical therapy (ACEI or ARBs, beta-blockers if tolerated, with or without digoxin, and loop diuretics), at stable doses for \> or = 1 month
* LVEF \< or = 40% within 6 months prior to patient enrolment, by echocardiography, radionuclide ventriculography or perfusion scan, or radiologic angiography

Inclusion criteria - group 3

* Age \>18 years
* At least moderate CRF (eGFR \< 60ml/min/1,73m2)
* With or without anemia
* LVEF \> or = 50% within 6 months prior to patient enrolment, by echocardiography, radionuclide ventriculography or perfusion scan, or radiologic angiography

Exclusion Criteria (all groups):

* Recent acute renal failure episode (\< 1 month)
* Red blood cells (or other blood component) transfusions or EPO therapy within 3 months prior to enrolment
* Iron, B12 or folic acid supplements used to treat anemia (\< 3 months)
* Evidence of active GI bleeding
* Recent acute coronary syndrome or decompensated HF episode (\< 1 month)
* Complex congenital heart disease
* Known malignant hematologic or other active neoplasia
* Immunosuppressive therapy, chemotherapy or radiotherapy within 3 months prior to enrolment
* Recent acute decompensation of a chronic inflammatory disease (e.g. chronic inflammatory bowel disease, rheumatoid arthritis, collagen vascular disease) within 3 months prior to enrolment
* Recent viral or bacterial syndrome (\< 2 weeks)
* Active or recent viral hepatitis (\< 3 months)
* Pregnant women
* Potential for non compliance to tests involved in this protocol
* Incapacity to provide informed consent
Role of Wrist Based Blood Pressure Monitoring in Clinical Practice

This is a pilot clinical study to test the overarching hypothesis that frequent and longitudinal blood pressure monitoring with FDA approved consumer wrist based device during the patient transition from inpatient to home to the first clinic visit will elicit valuable BP data that can assist in physician treatment of hypertension

Wrist based health devices, often with mobile connectivity, that continuously or near continuously track heart rate, blood pressure, temperature, activity and sleep are growing in everyday popularity and beginning to enter the sphere of clinical relevance. However, their accuracy and utility for clinical use is largely unstudied. As these consumer devices, some of which are FDA approved, become more commonplace, it is paramount to understand their function, know their limitations, and be able to interpret results appropriately before incorporating them into our clinical practice. The AHA/ACC 2017 guideline makes a 1A recommendation for clinical use of out of office BP measurements(1). This recommendation is based on evidence that out of office BP and frequent and longitudinal BP measurements are important in predicting cardiovascular risk and monitoring treatment efficacy(2-5). This trend towards consumer driven digital health monitoring and the new AHA/ACC guideline are essentially advancing a consumer based precision medicine strategy for diagnosis and monitoring of hypertension. As this becomes commonplace in our patient population, we need rigorous clinical study of wrist base BP monitoring to better understand its role patient care.

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years of age
* Own an iOS or Android device

Exclusion Criteria:

* Inability to give informed consent
* \<18 years of age
* Inability to understand written English language
* Hypertensive urgency or emergency as an admission diagnosis
A Study to Evaluate the Mass Balance Absorption and AME of VBR

This Phase 1 Study will determine the mass balance recovery, absorption, metabolism, and excretion of \[14C\] Vebicorvir in healthy male subjects


Eligibility Criteria:
* Consent
* Male between 18 and 55 years of age (inclusive) at the time of Screening
* Body mass index (BMI) between ≥18.0 kg/m2 and ≤32.0 kg/m2 at Screening; body weight between ≥55.0 kg and ≤100.0 kg at Screening
* Considered to be in good health by the Investigator

Exclusion Criteria:

* History or presence of any condition (e.g., chronic diarrhea) or prior surgery (e.g., gastric bypass)
* Clinically significant abnormal medical history
* History of cancer that has not been in full remission for \>5 years
* Acute illness within 14 days prior to study drug administration
Improving Survivorship Care for Older Adults After Chemotherapy

The researchers want to find out if older adults receiving a survivorship care plan followed by a geriatric assessment visit improves quality of life and satisfaction with care compared to receiving only a survivorship care plan for older adults who have completed chemotherapy for cancer treatment.

This study is a pilot randomized trial to examine whether a geriatric assessment-enhanced survivorship care plan improves satisfaction, knowledge and health-related quality of life compared to standard survivorship care plans among older adults who have completed curative chemotherapy for cancer. The investigator's hypothesis is that older adults who receive a geriatric assessment-enhanced survivorship care plan will report improved satisfaction with care, health-related quality of life, and knowledge and preparedness for survivorship care needs.

Eligibility Criteria:
Inclusion Criteria:

1. age 65 years and above and
2. Have diagnosis of cancer and have completed chemotherapy with curative (not palliative) intent and
3. have been scheduled to receive a survivorship care plan from an oncology navigator.

Exclusion Criteria:

1. advanced dementia or serious cognitive impairment that would impede ability to participate in the interview
2. nursing home resident.
Web-based Single-session Intervention of Mindset for Improving Pre-practicum Anxiety and Coping

Practicum is an essential educational component of professional training, however, the process can be challenging and sometimes frustrating, with obstacles such as the rigorous training process and mental distress. Being adequately prepared to confront the challenges and difficulties in practicum is crucial for the learning outcomes and psychological well-being of social work and/or counselling trainees. At the same time, mindset is found to be a modifiable factor in intervention, which is essential in clinical psychology, therapy, prevention, and early intervention. Instilling growth mindsets regarding intelligence, emotion, and failure-is-enhancing mindsets, respectively, is worthwhile in easing anxiety and stress coping. However, the existing intervention approaches lack of mindset integration, low intensity, distinctions of employees and interns, more objective and reliable outcome indictors and well-designed randomised controlled trials.

Using a two-arm randomised controlled trial, the proposed study will examine the efficacy of a Web-based Single-session Intervention of Mindset on Intelligence, Failure, and Emotion (We-SMILE) on reducing anxiety related to practicum and improving mental health and practicum-related outcomes.

A total of 117 students will be recruited from the social work and/or counselling programmes, and randomly assigned to existing pre-practicum training (Training As Usual, TAU) or that plus the We-SMILE. The intervention is 45 minutes in length. Participants will be assessed at three timepoints: baseline (T1), two weeks post-intervention (T2), and eight weeks post-intervention (T3). Patient and public involvement is adopted in the intervention design and implementation strategies. It is expected that the We-SMILE group will present lower anxiety related to practicum and more positive secondary outcomes (depression, anxiety, stress, psychological well-being, learning and performance orientation, academic self-efficacy, and confidence) compared to the TAU group. The intention-to-treat principle and linear-regression-based maximum likelihood multi-level models will be used for data analysis.

The study will not only provide evidence on integrated mindset intervention for trainees' mental health and learning outcomes, but also benefit social work and/or counselling supervisors and programmes as an accessible module.


Eligibility Criteria:
Pre-practicum students in social work and/or counselling programmes are eligible.

* Inclusion Criteria: students who

  1. are about to start the practicum soon;
  2. can read and write Chinese;
  3. consent to participate.
* Exclusion Criteria: students who

  1. do not consent to participate;
  2. cannot concentrate for at least 45 minutes to complete the intervention and questionnaires;
  3. have a disability or serious physical or mental illness resulting in poor condition;
  4. do not participate in the practicum.