cyrilzakka/clinical-trials huggingface dataset:
A Multi-centre Survey of Epidemiology, Treatment and Outcome of Patients Suffering an Out-of-hospital Cardiac Arrest

There is considerable variation in the incidence of out-of-hospital cardiac arrest (OHCA) across Europe. The likelihood of attempted resuscitation also varies. To better understand the factors that contribute to variation, more data on incidence, management and outcomes from OHCA is required. A European, multi-centre study provides the opportunity to uncover differences throughout Europe and may help find explanations for these differences. Results may also have potential to support the development of quality benchmarking between European Emergency Medical Services (EMS).

This prospective European study will involve 27 different countries. It provides a common Utstein-based dataset, data collection methodology and a common data collection period for all participants, thereby potentially increasing comparability.

Study research questions will address the following: OHCA incidence in different European regions; incidence of cardiopulmonary resuscitation (CPR) attempted; initial presenting rhythm in patients where bystanders or EMS starts CPR or any other resuscitation intervention; rate of any return of spontaneous circulation (ROSC); patient status at handover to a hospital i.e. ROSC, ongoing CPR, dead; incidence of patients still alive 30 days after OHCA; incidence of patients discharged alive from hospital.

The participating registries will transfer unprocessed anonymised data. Transmission of aggregated data should be avoided whenever possible; only in case of limitations due to national laws or ethical requirements should a participating registry transmit aggregated data. Every single case requires a data sheet (DS). Data will be collected within the national, regional or local participating registries (either as a computer-based export from the national, regional or local registry or as a paper-based DS. After validation and anonymisation of data by participating registries the data will then be transferred only via the national coordinator (computer-based) to the study centre. National coordinators are responsible for quality control i.e. the completeness reliability and accuracy of the of data, including timely submission of data to the study management group. Every DS will be identified by a unique number, including the country and region of origin. Registries that cannot transfer unprocessed original data due to the reasons mentioned above will collect data themselves. These registries will then send aggregated data to the study centre. Participating registries must collect basic EMS data on the region and population served. This registry-specific information must only be transmitted once during the study period. Data (computer and paper-based) will be handled according to national laws concerning data security; the national coordinator is responsible for maintaining the necessary standards. Access to the data will be protected by username and password.

Eligibility Criteria:
Inclusion Criteria:

* All patients who suffer an out of hospital cardiac arrest and are attended by the EMS at any stage during the event.
Deep Brain Stimulation in Patients With Parkinson's Disease

The purpose of this study is to determine the effect of deep brain stimulation surgery on movement-related cortical potentials in patients with Parkinson's disease.

Patients who have had deep brain stimulation surgery for Parkinson's disease at Mayo Clinic Arizona will have electroencephalographic (EEG) measurements with the stimulator on followed by EEG measurements with the stimulator off. Patients who are scheduled to have deep brain stimulation surgery for Parkinson's disease will have EEG measurements before and after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have had deep brain stimulation surgery for Parkinson's disease at Mayo Clinic Arizona, or who are scheduled to have deep brain stimulation surgery for Parkinson's disease at Mayo Clinic Arizona.

Exclusion Criteria:

* Patients unable to do repetitive dorsiflexion of the wrist due to orthopedic problems.
* Pregnant women.
* Prisoners or institutionalized individuals.
A Study to Evaluate the Ability of Conducting a Study of Oral Risperidone Followed by Paliperidone Palmitate in Rwandan Healthcare Facilities

The purpose of this study is to evaluate the feasibility of conducting a study of oral risperidone followed by paliperidone palmitate for once monthly (PP1M) and paliperidone palmitate for every 3 months (PP3M) in rwandan healthcare facilities with mental healthcare capabilities.


Eligibility Criteria:
Inclusion Criteria:

* Participants with diagnosis of schizophrenia by mini international neuropsychiatric interview (MINI)- Screen/ MINI (Module K) that requires treatment initiation or a change in treatment to better address safety or efficacy limitations of current treatment
* Participants at least moderately ill as measured by the clinical global impressions - severity of schizophrenia (CGI-SS) scale for schizophrenia, or experiencing poorly tolerated side effects from their current medications, or having difficulty with adequate adherence to treatment, per the investigator's judgement
* Participants have a primary caregiver who is willing to participate in this study (caregiver should be knowledgeable about the participant's condition and is expected to be with the participant for greater than (\>) 24 hours each week for the duration of the study)
* Participants able to give consent to participate in a clinical study that includes treatment with risperidone and long-acting injectable formulations of paliperidone palmitate. Participants must be willing to receive injections. The participant and the caregiver participant must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study
* Participants must be willing and able to provide responses for all self-administered questionnaires

Exclusion Criteria:

* Participants have a physical, mental, or legal incapacity that prevents a valid consent or capacity to complete about 12 months of treatment with antipsychotic medication and compliance with this study protocol
* Participants with history of organic brain syndromes, comorbid psychiatric and/or physical illnesses, or significant comorbid substance abuse that is likely to interfere with understanding of or compliance with study requirements
* Participants with known allergies, hypersensitivity, or intolerance to risperidone or paliperidone palmitate or their excipients
* Participants with poor prior response to risperidone
* Participants who received an investigational medication (including investigational vaccines) or used an invasive investigational medical device within 30 days before the planned first dose of study medication, or is currently enrolled in an investigational study
Study To Compare On-Demand Treatment To A Prophylaxis Regimen Of BeneFIX In Subjects With Moderately Severe to Severe Hemophilia B

The purpose of this study will be to determine if a once-weekly prophylaxis regimen of BeneFIX in subjects with moderately severe to severe Hemophilia B is safe and effective.


Eligibility Criteria:
Inclusion Criteria:

* Documented history of moderately-severe to severe hemophilia B (FIX activity \</=2%).
* Male subjects, aged 12 years to 65 years.
* Subjects with at least 100 exposure days (EDs) to factor IX products.
* Subjects with a minimum of 12 bleeding episodes, 6 of which must be joint bleeds, in the 12-month period before the Screening visit.

Exclusion Criteria:

* Subjects who have received FIX as a primary or secondary prophylaxis regimen within the last 12 months prior to the Screening visit.
* Subjects who have had major surgery or an orthopedic surgical procedure within the past 3 months prior to Screening visit.
* Subjects for which major surgery or orthopedic surgery is planned within the duration of study participation.
* Subjects with a past history of, or current FIX inhibitor, defined as \>ULN (upper limit of normal) of the reporting laboratory.
* Subjects with a known hypersensitivity to any FIX product or hamster protein.
Safety and Efficacy of Carbon Dioxide Gas for Endoscopy

The goal of this clinical trial is to compare the efficacy and safety of air versus carbon dioxide gas insufflation for endoscopy in children.

The main question\[s\] it aims to answer are:

•to determine safety of CO2 Assess patient comfort (abdominal pain, flatulence and bloating) with CO2 use when compared to air.

In this study, children (6 months -18 years) undergoing all endoscopic procedures that includes an upper endoscopy including but not limited to Esophagogastroduodenoscopy (EGD/ upper endoscopy), EGD/ Colonoscopy, Endoscopic Retrograde Cholangiopancreatography (ERCP), Endoscopic ultrasound (EUS) e.t.c after appropriate consent, will be randomized 1:1 to either Air or CO2 gas for endoscopic insufflation. We will record demographics (name, age, sex, MRN, race/ethnicity), anthropometrics including weight, height/length, weight for length (WFL), WFL z score, BMI, BMI z score, indication/ reason for scope, other co-morbidities (other medical problems), personnel involved (faculty only, vs faculty + trainee), minute by minute end tidal CO2 levels, minute by minute minute ventilation levels, baseline blood pCO2, and blood pCO2 after each procedure. Pre and post procedure patient reported abdominal pain, bloating and flatulence. Pre and post procedure nurse assessed pain. Pre and post procedure vital signs. Patients will be randomized using a sealed envelope method by the endoscopy technician. Both patients and providers will be blinded to arm of enrollment.

Eligibility Criteria:
Inclusion Criteria:

- Infants and children 6 months to 18 years undergoing any upper endoscopy related procedure including but not limited to EGD/Colonoscopy, ERCP, EGD only, EUS, EGD with foreign body removal, Enteroscopy.

Exclusion Criteria:

* Patients with American Society of Anesthesiology (ASA) Physical Status Classification System of 4 and above
* Children with chronic lung disease,
* Children who are wards of the state will be excluded.
* Children needing language interpreting services that is not Spanish.
Motivational Interviewing in Physiotherapy for Patients With Low Back Pain

This study aims to evaluate the efficacy of motivational interviewing (MI) on adherence to exercises and on levels of pain and incapacity in patients who engage in physiotherapy for low back pain. Sixty patients attending a 15-day program of physiotherapy for low back pain were allocated to experimental (EG) and control groups (CG). A regular treatment of physiotherapy with at-home exercises is offered to all participants. On day seven, MI is applied to the EG. The CG receives an anti-inflammatory information program.


Eligibility Criteria:
Inclusion Criteria:

* Adults with low back pain receiving physiotherapy with home exercises

Exclusion Criteria:

* Adults receiving physiotherapy without home exercises or for conditions other than low back pain
Prevention of Vaso-occlusive Painful Crisis by Using Omega-3 Fatty Acid Supplements

140 SCD patients \[70 on Hydroxyurea\] will receive Omega-3 capsules whereas another 140 SCD patients \[70 on Hydroxyurea\] will receive placebo and will be recruited from the Sultan Qaboos University Hospital \[SQUH\] haematology specialty clinics. Patients will be randomized in a 1:1 ratio to receive placebo or Omega-3 for 52 weeks. The aim is to investigate the therapeutic potential of omega-3 fatty acids in the prevention of vaso-occlusive crisis in Omani patients with sickle cell disease\[SCD\].


Eligibility Criteria:
Inclusion Criteria:

* Moderate to severe Sickle cell disease patients.
* Patients already receiving Hydroxyurea\[HU\] are eligible for the study.
* Patients able and willing to comply with the procedures in the study protocol.

Exclusion Criteria:

* Acute episodes (infection, vaso-occlusive crises (VOC), acute chest syndrome (ACS), stroke, priapism, splenic sequestration) in the past one month before enrolment.
* Previous stroke, and other co-morbid diseases like Essential Hypertension, Cardiomyopathy and Heart failure, Diabetes, Chronic Renal Failure.
* Patients with a history of adverse reaction to omega-3 fatty acid supplementation.
* Blood transfusion in the previous 3 months.
Mesenchymal Stem Cells for Prevention of Bronchopulmonary Dysplasia in Infants

The clinical study with UMC119-01 is designed to investigate the safety in patients with bronchopulmonary dysplasia ("BPD"). This will be a dose escalation, open-label, single-center study in infants at high risk for BPD.

UMC119-01 is ex vivo cultured human umbilical cord tissue-derived mensenchymal stem cells product which is intended for prevention of Bronchopulmonary dysplasia.

Eligibility Criteria:
Inclusion Criteria:

Neonatal infants who fulfil all of the following criteria will be enrolled:

1. Subjects of postnatal age between 3 to 30 days.
2. Are male and female infants born at GA between 23 weeks to 29 weeks. The postmenstrual age of subject received UMC119-01 should be no more than PMA36 weeks.
3. Subjects with birth weight between 501g to 1249 g.
4. Have endotracheal tube in place as part of SoC for preterm infants with BPD at screening and on treatment visit (Day 0), and that they will have not been intubated for the purposes of this study.
5. A subject who is intubated and receiving mechanical ventilation with a fraction of inspired oxygen (FiO2) of 0.25 or greater at Screening.
6. A subject who has had either a deterioration or no change in the setting of mechanical ventilation within the 24 hours before trial enrollment.
7. Written informed consent has been provided by the subject's parents, legal guardians, or a legal representative, who agree to comply with all of the study procedures, including those in the long-term safety surveillance period.

Exclusion Criteria:

Neonatal infants who meet any of the following criteria will be excluded:

1. Have a major congenital abnormality, including neurological (including anencephaly and similar malformations), hepatic, renal, cardiovascular abnormality (except for patent ductus arteriosus, PDA).
2. Have a known genetic syndrome.
3. Have a condition that makes them ineligible for participation in this study, as determined by the investigator.
4. Have C-reactive protein (CRP) \>30 mg/L; or any infections including pneumonia, sepsis, or shock.
5. Have pre-existing severe intraventricular hemorrhage (IVH) (grade ≥3).
6. Have active pulmonary hemorrhage or air leak syndrome.
7. Have abnormal hepatic (AST, ALT \>150 U/L or direct bilirubin \>2 mg/dL or total bilirubin \>15 mg/dL) or renal function (serum creatinine \>1 mg/dL or oliguria).
8. Are known to be infected with HIV or CMV.
9. Are expected to have surgery within 24 hours prior to and/or after UMC119 01 instillation.
10. Are expected to receive any other intratracheal treatments, including surfactant within 72 hours prior to and/or after UMC119 01 instillation.
11. Are currently participating in any other interventional clinical trial.
Cervical Pessary to Prevent Preterm Birth in Singleton Pregnancies With a Sonographically Measured Short Cervix

The purpose of this study is to learn if the Arabin pessary can reduce preterm birth less than 37 weeks 0 days in singleton pregnancies that have a short cervix.

This is an open label randomized controlled study. The pessary will be offered to those patients who have a transvaginal cervical length less than 25 mm before 23 weeks 0 days. The control group will receive the current standard of care which includes surveillance of cervical length, vaginal progesterone, and emergency cerclage. The primary outcome of the study is preterm delivery less than 37 weeks 0 days.

Eligibility Criteria:
Inclusion Criteria:

* singleton
* cervical length \< 25 mm measured by transvaginal ultrasound prior to 23 weeks 0 days
* agrees to refrain from sexual intercourse

Exclusion Criteria:

* major fetal anomalies
* painful regular uterine contractions
* active vaginal bleeding
* ruptured membranes
* evidence of chorioamnionitis or other maternal/fetal infectious morbidity
* placenta previa
* cervical cerclage in situ
* visual cervical dilation of 2 cm or greater with visible amnion/chorion
* significant maternal-fetal complications (chronic hypertension, insulin dependent diabetes mellitus, systemic lupus erythematosus with nephritis, chronic hypertension, red cell alloimmunization, drug abuse)
Positive Communication and Clinical Performance in Anaesthetic Care.

The emotional and cognitive impact of positive communication between caregivers remains uninvestigated. The investigators hypothesize that positive communication during medical transmission can increase clinical performance for managing a subsequent stressful unexpected adverse event.

When caregivers deal with acute stressful adverse events, cognitive overload and negative emotions can impair cognitive abilities and decrease clinical performance. The beneficial effect of positive communication on patients' emotions has widely been studied. However, the emotional and cognitive impact of positive communication between caregivers remains uninvestigated. The primary purpose of this trial is to study the impact of positive communication between anaesthetic teams during medical transmissions on clinical performance for managing a subsequent stressful unexpected adverse event. Secondary outcomes are to study the impact of positive communication on physiological (heart rate variability) and psychological (psychometric scales) levels of stress.

Eligibility Criteria:
Inclusion criteria

Anaesthetic teams composed with :

* 1 resident in anaesthesiology and critical care AND
* 1 anaesthetic nursing student in second year OR 1 anaesthetic nurse graduated less than 5 years ago

Non-inclusion criteria

* Refusal to be videotaped
* No consent to participate
* Anaesthetic nurses working in a paediatric operating room.
Safety and Efficacy of Longan and Lingzhi Mushroom Syrup on Immune and Inflammatory Responses in Healthy Volunteers

This study aimed to preliminarily determine safety and efficacy of longan and lingzhi mushroom syrup on immune and inflammatory responses. Apparently healthy Thai adults (N = 8) aged 18-60 years were recruited into a prospective, single-group study. All participants were assigned to consume 5 mL of longan and lingzhi mushroom syrup daily for 12 weeks. Blood concentrations of fasting plasma glucose (FPG), glycated hemoglobin (HbA1c), aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), BUN (blood urea nitrogen), creatinine (Cr), immunoglobulins (IgG, IgM, IgA, and IgE), and C-reactive protein (CRP) were measured at baseline (week 0), week 4, week 8, and week 12.


Eligibility Criteria:
Inclusion Criteria:

1. Apparently healthy adults at Mae Fah Luang University and Chulalongkorn University
2. aged 18-60 years
3. HbA1c \< 7%

Exclusion Criteria:

1. self-reported immunodeficiency diseases, autoimmune diseases, infectious diseases, diabetes, thyroid diseases, cancer, hepatic- and/or renal dysfunction, uncontrollable illnesses and life-threatening diseases
2. being allergic to longan and lingzhi products
3. taking medications, herbs, and diet supplements affecting immune system, inflammatory response, and blood glucose a month before study enrollment
4. pregnant and breastfeeding women
Switching to E-cigarette After PCI

Despite the increasing popularity of electronic cigarettes (E-cigarettes), the prognostic impact of switching to E-cigarettes in smokers with coronary artery disease (CAD) who underwent percutaneous coronary intervention (PCI) remains uncertain.

Recently, several studies have reported that, although lower than combustible cigarette users, E-cigarette users had a significantly higher risk of future myocardial infarction (MI) or cardiovascular disease compared with non-smokers or quitters. However, because all previous studies has focused on the general healthy population, these results cannot be extrapolated for patients who already proven atherosclerotic cardiovascular disease (ASCVD), such as undergoing percutaneous coronary intervention (PCI) for coronary artery disease (CAD). Although Busch et al. previously reported that a significant minority of patients are using E-cigarettes post-acute coronary syndrome smokers, a paucity of data exists regarding the impact of such transitions on clinical outcomes in current smoker patients with CAD who have undergone PCI. In light of these considerations, the current study sought to address this gap in knowledge by evaluating the prognostic implications of smoking habit changes, including E-cigarette use, among CAD patients with current smoking status following PCI.

Eligibility Criteria:
Inclusion Criteria:

* patients who underwent health screening 3 years before and after the PCI

Exclusion Criteria:

* history of cancer
* history of ischemic stroke
* died within the first 3 months of follow-up from the index date
* Newly developed acute MI or received additional PCI or CABG from the index PCI date to the study index date
Evaluation of the Effect of Nurse Coaching Program on Self-management and Skin Care Behaviors in Patients With Diabetes

This research will be conducted in a pre-test-post-test randomized controlled, single-blind experimental design to evaluate the effects of a nurse coaching program on self-management and skin care behaviors in patients with diabetes. The key question(s) it aims to answer are:

* Does the nurse coaching program have no effect on self-management behaviors and skin care behaviors in patients with diabetes?
* Does the nurse coaching program have no effect on self-management behaviors and skin care behaviors in patients with diabetes?

The study will be conducted in the internal medicine units of Mut State Hospital in the Mut district of Mersin between January 2025 and June 2025. An average of 100 patients with type 2 DM apply to the hospital per day. According to Cohen's effect size coefficients; it was decided to include 21 people (N=42) in the groups, assuming that the evaluations to be made between two independent groups would have a large effect size (d=0.8; large) according to the calculations made. The consents of 42 type 2 DM patients who constitute the study group of the experimental research will be obtained. After the preliminary tests are performed, a series of random numbers will be generated by an independent statistician and 21 will be assigned to the intervention group and 21 to the control group using the simple randomization method.

Personal Information Form, Diabetes Self-Management Scale, and Skin Care Behavior Monitoring Form will be used as Data Collection Tools. In addition, the "Diabetes Education Booklet" designed and prepared by the researchers will be used as an intervention material in the research study.The follow-up of the implementation process will be recorded with the MSF and KBIF prepared by the researcher.Before starting the research, 3 measurements will be taken at week 6 and week 12. The data collection process of the research will be completed by using face-to-face training opportunities in the first 6 weeks and reminders (message, phone call, etc.) in the following periods. The control group will receive standard training and the same measurement tools will be used.

Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 18-65,
* Having a Type 2 DM diagnosis period of 6 months or more,
* Not having any psychiatric disorders or mental problems,
* Having hemoglobin A1c values \<8 mmol/mL,
* Individuals who can perform diabetes self-management behaviors and skin care behaviors (regular eating habits, physical activity, regular monitoring of blood sugar, compliance with treatment, ability to solve problems, coping strategies and minimizing risks).

Exclusion Criteria:

* Exclusion criteria for the study;
* Having verbal communication problems,
* Having been diagnosed with Type 1 Diabetes Mellitus,
* Having been diagnosed with gestational diabetes mellitus,