rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
Specified Drug-use Survey of Leqvio for s.c. Injection.
Status: Not yet recruiting

The objective of this study is to evaluate the long-term safety of Leqvio in patients with familial hypercholesterolaemia or hypercholesterolaemia in post-marketing clinical practice

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients who provided written informed consent to participate in this survey prior to the start of treatment with Leqvio. Patients who received treatment with Leqvio as per the package insert.  Exclusion Criteria:  Patients who received treatment with a formulation containing the same ingredients as Leqvio in the past. Patients participating in other interventional studies at the time of informed consent. Patients planning to participate in other interventional studies during this survey. - HealthyVolunteers: No - Gender: All - MinimumAge: 15 Years - StdAgeList: Child, Adult, Older Adult - StudyPopulation: Patients treated with inclisiran - SamplingMethod: Non-Probability Sample
HONEY for the Treatment of POst-Tonsillectomy Pain
Status: Recruiting

Double-blind, randomised, placebo controlled, single-site trial in adults to compare the effect of Manuka honey with standard of care compared to placebo with standard of care on post-tonsillectomy pain and postoperative outcomes.

Main aim is to investigate a potential improvement in post-tonsillectomy pain control, with a low cost and freely available alternative to conventional analgesics. Recent systematic review and multidisciplinary consensus suggest a potential role for the inclusion of honey for this purpose. Clinical efficacy over placebo remains to be conclusively demonstrated in robust clinical trials.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Adult (≥18years old at the time of giving consent) Consented and listed for bilateral tonsillectomy or adenotonsillectomy Tonsillectomy performed within the trial study period  Exclusion Criteria:  Any concurrent Head & Neck (H&N) malignancy Unilateral tonsillectomy Pregnancy Concurrent pharyngeal or upper aerodigestive tract biopsy Robotic tonsillectomy Previous H&N malignancy Previous H&N radiotherapy Type 1/2 diabetes mellitus Known allergy to bee related products Known allergy to golden syrup History of chronic pain History of fibromyalgia Current usage of chronic (>6weeks) analgesia High-risk anaesthetic patients Children or adolescents <18years old Adults unable to consent for themselves - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Forecasting Seizures Using Intelligent Wearable Technology for Health Tracking
Status: Not yet recruiting

The goal of this interventional study is to develop a personalized seizure risk forecast tool in people with epilepsy.

The main questions it aims to answer are:

can we develop a future seizure probabilities tool that is more accurate than chance based on the pattern and frequency of previous generalized tonic-clonic seizure (GTCS) events, as well as changes in physiological and behavioral variables.
does this tool improve the lives of people with epilepsy?

Researchers will compare a group that does not have access to the forecast tool to a group that does and see if it is accurate and if people with it report that it improved their quality of life.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Subjects must be diagnosed with or be at risk of epilepsy Subjects or their parents or guardians must understand and consent to be in the study; Subjects or their parents or guardians must be able to read and communicate in English; Subjects or their parents or guardians must be willing and able to comply with study procedures and duration; Subjects must have a wrist circumference suitable for wearing the EmbracePlus device.  Exclusion Criteria:  Subjects, or their parents or guardians for minor study participants, who do not understand the study and the risks; Subjects, or their parents or guardians for minor study participants, who are either physically or cognitively incapable of performing study activities (e.g. filling in surveys and daily e-diary); Subjects who would be placed at undue medical risk associated with any procedure called for in the protocol; or Subjects that are Empatica employees and actively participated in the development of this protocol or development of the Seizure Wise algorithms. - HealthyVolunteers: No - Gender: All - MinimumAge: 6 Years - StdAgeList: Child, Adult, Older Adult
Implementing an Education- and Health System Task-shifting Approach for Child Mental Health Promotion in Uganda
Status: Recruiting

This study will adapt a school version (mhGAP-IGs) of the World Health Organization´s (WHO) "Mental Health Gap Action Programme Intervention Guide" (mhGAP). Both teachers and health workers will receive training in mhGAP, and systems for collaboration between the school and health sector as well as other relevant stakeholders will be developed and integrated. The project is conducted in close collaboration with key stakeholders from the Ministry, the health and education sector, the police, and religious leaders. The aim is to increase mental health literacy among school staff, facilitate a healthy school environment, and increase detection of mental health needs among primary school aged children.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  A teacher/ staff member at a preselected TREAT INTERACT primary school in Mbale. Child-caregiver pairs are eligible when a learner is enrolled in a selected primary school in Mbale, the child has a caregiver living with him or her and provides ascent, and the caregiver with a child in the selected school providing informed consent.  Exclusion Criteria:  Not part of preselected primary school Lack of informed consent - HealthyVolunteers: No - Gender: All - MinimumAge: 5 Years - MaximumAge: 18 Years - StdAgeList: Child, Adult
Maladaptive Anger Treatment
Status: Recruiting

From a psychoevolutionary perspective, anger is a universal emotion that can serve the function of making us aware of wrongdoing and motivating us to undo/correct the wrongdoing. However, it is well recognized in clinical psychology that anger can be maladaptive, often causing distress and impairment in various areas of day-to-day life; untreated maladaptive anger has been found to raise the risk of certain physical health problems e.g., hypertension and coronary heart disease. At the very extreme, rage has been implicated in aggression and violence. Not surprisingly, there has been a widespread quest for anger treatments or what is popularly called "anger management". One treatment approach that has received increasing empirical support is Cognitive Behavioral Affective Therapy (CBAT), which has been applied to patients with chemical dependence and individuals with chronic pain. To extend this programmatic line of research, the proposed research aims to evaluate the efficacy of CBAT in reducing multiple (psychometric and self-monitored) measures of anger within a community sample.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Live in the United States Have maladaptive anger (as assessed by the STAXI-2) Do not currently have any serious psychiatric illnesses (e.g., schizophrenia, autism, dementia, suicidal ideation) Are not currently undergoing psychological or psychiatric treatment Are not currently undergoing an anger treatment program Speak English  Exclusion Criteria:  Does not live in the United States Does not have maladaptive anger, as assessed by the STAXI-2 Has a current serious psychiatric illness (e.g., schizophrenia, autism, dementia, suicidal ideation) Is currently undergoing psychological or psychiatric treatment Is currently undergoing an anger treatment program Does not speak English - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult
Trial Evaluating the Efficacy of Remimazolam in Endobronchial Ultrasound Guided Transbronchial Needle Aspiration
Status: Not yet recruiting

Study to evaluate the efficacy and safety of remimazolam in patients undergoing endobronchial ultrasound-guided transbronchial needle aspiration

Primary Outcome Evaluate and compare the success of the procedure in patients undergoing EBUS-TBNA (Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration) when administered with remimazolam in the experimental group, versus Real world midazolam (Control Group 1), and On label midazolam (Control Group 2).

Secondary Outcome In patients undergoing EBUS-TBNA, compare the following aspects when administered with remimazolam in the experimental group versus Real world midazolam (Control Group 1) and On label midazolam (Control Group 2): Procedure start time, Time taken to achieve full alertness, Need for flumazenil administration, Total dose of fentanyl used, Scale of coughing/discomfort/convenience, Changes in vital signs, Complications related to the procedure.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Adult males and females aged 18 and above ASA 1-3 BMI 18.5~30.0 Saturation pulse oximeter (SpO2) ≥ 90% in ambient air or with no more than 2 liters/min of O2 support Patients who can comply with the procedures according to this clinical study protocol and who have voluntarily signed the consent form themselves  Exclusion Criteria:  Patients undergoing radial EBUS or electromagnetic navigation bronchoscopy (ENB) simultaneously ASA 4 or higher Mallampati score 4 BMI < 18.5, BMI >30.0 Known sensitivity to benzodiazepines, flumazenil, opioids, naloxone, or a medical condition in which these agents Bronchoscopy outside the bronchoscopy unit chronic kidney disease on dialysis Patients with a current active acute infection or uncontrolled chronic inflammatory lung disease Patients considered inappropriate for the study at the investigator's discretion - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Accelerating Healthcare Engagement in Healthy Food Interventions - Food Rx in High Risk Pregnant Mothers With About Fresh and Texas Children's Health Plan
Status: Not yet recruiting

The purpose of the study is to assess if the Fresh Connect food prescription (Fresh Connect Food Rx) program that provides consistent access to healthy fresh produce through purchases at the grocery store plus nutrition education impacts gestational weight gain, other pregnancy and birth outcomes, and food and nutrition security in low-income, ethnically diverse, at-risk women residing in Houston, Texas. Enrollment of participants will begin in pregnancy at the time of the first prenatal visit (as long as the first visit occurs before the end of the first trimester); each participant will be followed until 60 days post-partum (up to 11 months follow-up per participant).

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  high-risk pregnant mothers receiving care at Texas Children's Health Plan (TCHP) managed care organizations in Houston, Texas <20 weeks medically confirmed viable pregnancy overweight/obese pre-pregnancy or at first trimester (self-report or measured BMI>30.0), and/or prior history of diabetes or gestational diabetes, and/or prior history of hypertension or pregnancy-induced hypertension  Exclusion Criteria:  not a high-risk pregnant mother receiving care at Texas Children's Health Plan (TCHP) managed care organizations in Houston, Texas - HealthyVolunteers: No - Gender: Female - MinimumAge: 18 Years - MaximumAge: 44 Years - StdAgeList: Adult
Use of Bivalirudin for Anticoagulation in Patients With Extracorporeal Membrane Oxygenation
Status: Not yet recruiting

The purpose of this study was to evaluate the efficacy and safety of bivalirudin in anticoagulation therapy in patients with extracorporeal membrane oxygenation (ECMO) compared with unfractionated heparin.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Age ≥ 18 years old Accept VA-ECMO or VV-ECMO the ECMO team believes that systemic anticoagulation is necessary and that APTT should be maintained at 50-70s. sign the informed consent form  Exclusion Criteria:  previous history of allergy to heparin or bivalirudin previous diagnosis of heparin-induced thrombocytopenia. the pre-random ECMO assistance time is more than 48 hours. pregnant female have participated in this study before. the researchers believe that there are other factors that are not suitable to participate in this study. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Ability to Maintain Saturation Levels Without Oxygen Supplementation as a Extubation Criteria Without TOF Monitoring Equipment
Status: Not yet recruiting

Patients undergoing general anesthesia will have an endotracheal tube inserted. Adequate muscle strength recovery in the recovery room is crucial to ensure before extubation. One of the criteria we use to determine the recovery of muscle strength post-use of muscle relaxants in conditions without specific monitoring devices is the ability to maintain body oxygen levels without oxygen assistance for 3 minutes. This study aims to determine the muscle strength value in the recovery room using extubation strategies without muscle strength monitoring compared to extubation strategies with muscle strength monitoring.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Elective surgery Adult patiens aged 18-60 years ASA physical status I-II Not receiving oxygen supplementation during pre-operative care  Exclusion Criteria:  History of hypersensitivy or allergy to neostigmine, muscular blockade agents, or anesthetic agents given Head or neck surgery Inability to access the ulnar nerve for TOF measurement device placement History of lung diseases such asthma, COPD, or pleural effusion Hepatic impairment with liver enzyme values > 50% of the normal range Renal insufficiency (serum creatinine > 1.8 mg/dl) or kidney failure Patients with neuromuscular diseases Body mass index (BMI) > 35 kg/m2 Consumption of medications that affect neuromuscular transmission such as aminoglycoside, polymyxin, lincomycin, clindamycin, and tetracycline; local anesthetic agent, procainamide, quinidine, lithium, magnesium sulfate, furosemide, cyclosporine, dantrolene, anti-estrogens, anticonvulsant, calcium, steroid, and azathioprine. Patients with contraindications to neostigmine or atropine sulfate Planned post-operative intensive care unit treatment - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 60 Years - StdAgeList: Adult
Evaluation of Transforaminal Epidural Steroid Injection in Radicular Low Back Pain According to MSU Classification
Status: Not yet recruiting

Low back pain is a common disease in all ages and it effects seriously quality of life. Medical treatment,interventional methods and surgery are the treatment options. Transforaminal epidural steroid injections (TFSI) is one of the interventional method for radiculopathy with low back pain. Michigan State University(MSU) classification is a MRI based disc herniation classification. It helps to classified disc herniation in types, places and sizes.

The aim of this study to evaluate the pain and oswestry disability index in patients who have radiculopathy with low back pain, undergone TFSI according to MSU classification.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  between the ages of 18-65 After outpatient evaluation, a decision was made to perform transforaminal steroid injection, Low back pain of more than 6 on a numeric rating scale (NRS) Radiculopathy for more than 4 weeks and less than one year and straight leg raising <45 Disc herniation at the L4-L5 or L5-S1 level on MRI Failure to respond to medical treatment for at least one month  Exclusion Criteria:  Neurological deficit, Bleeding problems, Localized infection, Spinal pathologies (such as tumors), Fractures, Severe stenosis, Uncontrolled diabetes, Pregnancy, Red flag symptoms (such as motor and/or sphincter dysfunction) Patient reluctance, Computed tomography (CT) and MRI findings in favor of sequestrated fragments from herniated disc, Sphincteric disorders, Previous spine surgeries - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult
Safety and Efficacy of Multisensory Stimulation Virtual Reality for Stroke Patients.
Status: Not yet recruiting

This was a single-blind randomized controlled trial of multisensory stimulation virtual reality to improve motor and cognitive dysfunction in stroke patients.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Diagnosis of stroke by neuroimaging (CT or MRI) assessment 18-85 years old Be able to walk with minor assistance Can tolerate the rehabilitation training of this experiment First stroke Be able to follow instructions to complete the test Patients who signed informed consent  Exclusion Criteria:  The test could not be tolerated due to organic disease There is a serious mental illness resulting in inability to cooperate with or tolerate this test is participating in another clinical trial involving an investigational drug or physical therapy Patients who have not signed informed consent - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 85 Years - StdAgeList: Adult, Older Adult
STROKESTOP III - Optimized Method for Atrial Fibrillation Screening
Status: Not yet recruiting

Atrial fibrillation is the most common sustained cardiac arrhythmia affecting more than 3% of the adult population. The symptoms of atrial fibrillation can range from asymptomatic to debilitating. It can be permanent in its nature, but also paroxysmal with only short bursts of atrial fibrillation randomly occurring and can therefore remain unnoticed. Atrial fibrillation increases the risk of stroke five fold if left untreated.

Screening for atrial fibrillation in elderly populations above age 65 years can result in detection of new atrial fibrillation cases ranging from 0,5% new AF with a single time-point ECG, up to 30% AF if an implantable loop recorder is inserted for 3 years.

Currently opportunistic screening using pulse palpation, or a single time-point ECG is recommended by the European Society of Cardiology guidelines. Systematic screening in individuals aged 75 or above, or at a high stroke risk should be considered.

Overall, participation in systematic atrial fibrillation screening trials has been shown to be relatively low with almost 50% non-participants. Participants are generally healthier, with higher socioeconomic status, hence the ones who would potentially benefit the most remain absent.

Opportunistic screening has shown promising results with higher participation rates and the possibility of better outreach. There is a lack of data from randomized trials on the difference in participation rates in systematic and opportunistic screening approaches when screening with prolonged ECG monitoring.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Individuals aged 75/76 in 2024 (born 1948, 1949) Must reside in the region of Värmland Must be listed at a primary care facility  Exclusion Criteria:  Treatment with oral anti coagulation treatment (OAC) Contraindications for OAC treatment Prior atrial fibrillation Unable to provide consent - HealthyVolunteers: No - Gender: All - MinimumAge: 75 Years - MaximumAge: 76 Years - StdAgeList: Older Adult
68Gallium-FAPI PET/CT Imaging in Chronic Inflammatory and Fibrotic Diseases
Status: Not yet recruiting

This single-center pilot study is designed to explore the preliminary utility of the [68Ga] Ga-FAPI imaging agent in positron emission tomography (PET) combined with computed tomography (CT) for a range of chronic inflammatory and fibrosing diseases. The study focuses on the potential of [68Ga] Ga-FAPI, a novel radiotracer targeting Fibroblast Activation Protein (FAP), to improve diagnostic accuracy in various medical conditions. Thirteen distinct clinical situations have been selected for this investigation, including rheumatoid arthritis, liver fibrosis, and systemic lupus, among others. This approach aims to ascertain the value of further clinical development in each area and refine the use of this imaging modality in routine care for both initial evaluation and ongoing monitoring of these diseases.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patient aged 18 or over Affected by one of the pathologies concerned by the study Satisfying the consensus classification criteria of the pathology, detailed in the protocol Satisfying the corresponding clinical situation, detailed in the protocol  Exclusion Criteria:  Pregnant or breastfeeding woman Patients unable to consent Patients refusing to participate in research Known active cancer - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Qualitative Study of Emotional Regulation in Schizophrenia
Status: Not yet recruiting

The main aim of this study is to investigate emotional regulation in individuals with schizophrenia using a qualitative methodology (semi-structured interview) and, therefore, from the person's point of view.

Given the qualitative nature of the methodology used in this study, the investigators have no specific hypothesis. The investigators have a general hypothesis suggesting that the patients' discourse will enable us to highlight the emotional regulation difficulties described in the literature.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Schizophrenia or schizoaffective disorder verified using the criteria of the M.I.N.I. (Mini International Neuropsychiatric Interview) scale (First, Spitzer, Gibbon, Williams, & others, 1995) based on the DSM-5 (Diagnostic and Statistical Manual of Mental Disorders) (Association & others, 2013). Patient in free care, under psychiatric care at the request of a third party or under curatorship. In the case of patients under curatorship, the investigator will inform the curator of the participant's non-opposition and therefore of his or her participation in the research. Able to read, understand and speak French. Age ≥ 18 years and < 60 years Must consent to the study and be able to give oral non-opposition.  Exclusion Criteria:  Psychological instability (i.e., Agitation or major suicidal risk on clinical examination by psychiatrist prior to study entry). Neurological history/comorbidity (head injury, epilepsy, multiple sclerosis, Parkinson's disease, amyotrophic lateral sclerosis, Huntington's disease, stroke). - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 60 Years - StdAgeList: Adult - StudyPopulation: Participants will be drawn from a clinical population diagnosed with schizophrenia, aged between 18 and 60. - SamplingMethod: Non-Probability Sample