rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
Study to Evaluate the Pharmacokinetics and Safety of EXPAREL for Postoperative Analgesia in Subjects Undergoing Cardiac Surgery
Status: Not yet recruiting

This Phase 1, multicenter, open-label, randomized, bupivacaine-controlled study is designed to evaluate the pharmacokinetics (PK) and safety of EXPAREL vs. bupivacaine HCl for postsurgical analgesia in pediatric subjects aged 0 to less than 6 years of age undergoing cardiac surgery, utilizing local infiltration analgesia (LIA).

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Parent/guardian able to speak, read, and understand the language of the ICF and provide informed consent for the subject. American Society of Anesthesiologists (ASA) Class 1-3. Male or female subjects from 0 to less than 6 years of age on the day of surgery. For Part 1, the subject's age should be 2 years to less than 6 years. For Part 2, the subject's age should be 6 months to less than 2 years. For Part 3, the subject's age should be 0 to less than 6 months. Parent/guardian able to adhere to the study visit schedule and complete all study assessments for the subject.  Exclusion Criteria:  History of hypersensitivity or idiosyncratic reactions or contradictions to bupivacaine HCl or other amide-type local anesthetics or to opioid medications. Administration of EXPAREL or bupivacaine HCl within 30 days prior to study drug administration. History of coagulopathies or immunodeficiency disorders. Clinically significant medical or psychiatric disease that, in the opinion of the investigator, indicates an increased vulnerability to study drugs and/or procedures. History of pre-term birth (babies born before 37 weeks of pregnancy). Administration of an investigational drug within 30 days or 5 elimination half-lives of such investigational drug, whichever is longer, prior to study drug administration, or planned administration of another investigational product or procedure during the subject's participation in this study. Concern about a subject's recent or potential exposure to COVID-19, or if the subject is not medically fit/cleared for surgery due to suspected COVID-19 illness/symptoms (or other serious illness). - HealthyVolunteers: No - Gender: All - MinimumAge: 0 Years - MaximumAge: 6 Years - StdAgeList: Child
A Study to Evaluate the Safety, PK/PD of (OriCAR-017) in Subjects With RR/MM
Status: Not yet recruiting

The is a first clinical study for Oricell Therapeutics Inc. in the United States to evaluate the safety, PK, PD and preliminary efficacy of our anti-GPRC5D cell product (OriCAR-017) in subjects with relapsed/refractory multiple myeloma.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Capable of giving signed informed consent  Subjects aged 18 to 75 years (inclusive) at Screening (signing the ICF).  Expected survival period is >12 weeks.  Diagnosis of MM according to the IMWG criteria (2016 version).  One of the following criteria must be met:  If immunoglobulin (Ig)G type MM, then serum M protein >10 g/L; if IgA, IgD, IgE or IgM type MM, then serum M protein >5 g/L  Urine M protein level >200 mg/24 hour  If light chain type MM, then serum free light chain (sFLC) >100 mg/L and K/λ FLC ratio is abnormal.  Extramedullary lesions (>1 cm for diameter of the short axis).  For Phase I (dose-escalation) - Subjects who had received at least 3 prior lines of therapy, had previous exposure to BCMA-Ag+ therapies, and were refractory to the last line of therapy.  For Phase I (dose-expansion) and Phase II: Subjects with previous exposure to BCMA directed therapies including BCMA bispecific antibody (e.g., teclistamab), BCMA antibody directed conjugate (such as BLENREP), and BCMA-CAR-T (such as CARVYKT1TM)  Subjects with adequate hematologic, renal, hepatic, pulmonary and cardiac function.  Subject and partners willing to take and or use effective contraceptive measures until 2 years post IMP infusion.  Exclusion Criteria:  Pregnant or breastfeeding.  Seropositive for history of human immunodeficiency virus Active Hepatitis B infection and or Hepatitis C infection  Known active or prior history of CNS involvement  History of autoimmune diseases (such as Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus) caused damage to terminal organs or required systemic application of immunosuppressive or other drugs in the past 2 years  Presence of uncontrolled active infection  Subjects who received autologous hematopoietic stem cell transplantation (ASCT) within 8 weeks of Screening Visit or who plan to undergo ASCT during the study.  Subjects who received allogeneic stem cell therapy.  Any condition that in the opinion of the Investigator, would interfere with evaluation of the IMP.  Received Bendamustine treatment 1 year prior to Screening Visit. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult
Effect of Multicomponent Exercises VIVIFRAIL® in Older Adults
Status: Not yet recruiting

This study employs a randomized, controlled, paired, single-blind clinical trial design. The targeted demographic comprises individuals aged 60 and above. Following the initial assessment, participants will be randomly allocated to two groups: the Intervention Group (ViviFrail) and the Group Suggestions for a Healthy Life (CG), maintaining a 1:1 allocation ratio. Both the ViviFrail group and CG group will exhibit homogeneity in terms of their clinical characteristics and functional performance. The allocation of participants into respective groups will remain concealed from all assessors, ensuring a single-blind approach.

In the intervention group (ViviFrail), 25 participants will be instructed to engage in tailored physical exercises outlined in the VIVIFRAIL® protocol within the confines of their homes, with adaptations made according to their clinical conditions and functional performance.

Conversely, the Group Suggestions for a Healthy Life (CG) comprising 25 participants will receive exercise suggestions and guidance to maintain a healthy routine for a duration of three months. Subsequently, participants in the CG will undergo the VIVIFRAIL® program intervention for an additional three months.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Eligible participants are older adults of both genders, aged at least 60 years. Participants must be actively participating in regular meetings of elderly groups within the social assistance program in Porto Alegre. Participants should not have severe visual, hearing, or cognitive impairments that could impede the safe completion of proposed assessments or exercises  Exclusion Criteria:  Participants with scheduled surgeries or procedures within the next eight months hindering engagement in the exercise program are excluded. Those unable to sit unsupported for at least 10 minutes during the functional assessment or demonstrating an inability to respond to verbal commands in the cognitive assessment are excluded. Exclusion criteria specific to the VIVIFRAIL® exercise protocol include: Recent acute myocardial infarction or unstable angina within 6 months History of uncontrolled arrhythmias Dissecting aortic aneurysm Severe aortic stenosis Acute endocarditis/pericarditis Uncontrolled hypertension Acute thromboembolic disease Severe acute heart failure Severe acute respiratory failure Uncontrolled orthostatic hypotension Acute decompensation of diabetes mellitus or uncontrolled hypoglycemia Recent fracture within the last month Any other circumstances deemed prohibitive or risky for engaging in physical activity are also grounds for exclusion. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 60 Years - StdAgeList: Adult, Older Adult
The Effect of Acupressure Applied to Icu on Pain and Physiological Parameters
Status: Recruiting

The aim of this experimental study is to determine the effect of acupressure applied to intensive care patients on pain and physiological parameters (blood pressure, heart rate, respiration and oxygen saturation).

The main questions that the study aims to answer are:

Acupressure applied to intensive care patients has no effect on pain. Acupressure applied to intensive care patients has an effect on pain. Acupressure applied to intensive care patients has no effect on physiological parameters.

Acupressure applied to intensive care patients has an effect on physiological parameters.

Participants will be included in the study after obtaining consent from patients who were treated in the intensive care unit, who scored 9 and above on the glaskow coma scale by evaluating their consciousness status, and had pain after evaluating their pain.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Being 18 years or older Volunteering to participate in the research. Getting a score of 9 and above on the Glasgow Coma Scale and being able to communicate meaningfully, Oxygen saturation of 85 and above Mean arterial pressure of 65 mmHg and above  Exclusion Criteria:  Diagnosis of suspected acute stroke bleeding Taking antihypertensive and beta-blocker drugs the start of the study Receiving sedation (dormicum, propofol, brunette) Presence of ulcers, bilateral paralysis, necrotic tissue and signs of infection (fever, redness, discharge, temperature) at the pressure points Situations that will cause the participant to leave the study (death, transfer to another unit, discharge or unwillingness to continue working) Receiving inotropic therapy (dopamine, steradine, etc.) Absence of analgesic therapy in routine treatment. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Dynamic-orthosis Programs for Stroke Hand Function
Status: Recruiting

This study aims to investigate the training benefits of modular 3D printed dynamic orthoses on upper limb function in stroke survivors.

Eligibility:
- EligibilityCriteria: Inclusion criteria:  Onset of stroke at least three months ago; Upper limb Brunnstrom stage II~IV; Shoulder can actively flex at least 45 degrees.  Exclusion criteria:  Affected hand has regained autonomous grasping function, able to grasp and release a tennis ball 10 times within 2 minutes; Joint deformity or stiffness in the affected hand that prevents the use of the dynamic orthosis; Diagnosis of other neurological disorders affecting motor control, such as neglect, Parkinson's disease, etc.; Inability to follow therapist guidance; Currently undergoing other specific treatments affecting motor function recovery (such as rTMS and BTX). - HealthyVolunteers: No - Gender: All - MinimumAge: 20 Years - MaximumAge: 80 Years - StdAgeList: Adult, Older Adult
Avoid With Locoregional Analgesia Persistant Postoperative Pain In Children
Status: Not yet recruiting

Persistent postoperative pain is a substantial pain (scores 4-10 using a 0-10 numeric scale) that develops 3 months after surgery.

Persistent postoperative pain can be a problem even in ambulatory surgery. Loco-regional analgesia could prevent the occurrence of this pathology but contradictory results are found in ancient studies.

This study is the first randomized controlled study in children about loco-regional analgesia and persistent postoperative pain in traumatologic orthopedic surgery.

One interventional arm will receive a locoregional analgesia after general anesthesia and before incision. The other arm will only receive systemic analgesia during general anesthesia.

The incidence of persistent postoperative pain at 3, 6 and 12 months will be compared in these two groups.

The goal is to show the decrease of the incidence of the persistent postoperative pain in the group "locoregional analgesia".

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Age between 5 years old and 15 years and 3 months Traumatologic orthopedic surgery in CHU Nantes No contraindication to Locoregional Analgesia Patient member of the social security system Oral consent of the patient Signed consent of one of the two holders of parental authority  Exclusion Criteria:  Refusal to participate of the patient or one of the two holders of parental authority Neurologic deficit of the operated limb before intervention Ischemia of the operated limb before intervention Polytraumatized patient Allergia to Carbocaïne Patient included in an other study about analgesia Anticoagulant treatment Uncontrolled epilepsy despite treatment Porphyria - HealthyVolunteers: No - Gender: All - MinimumAge: 5 Years - MaximumAge: 183 Months - StdAgeList: Child
Identification of Explanatory Factors for the Lack of Muscle Strength Gain Following a Pulmonary Rehabilitation Program in COPD Patients
Status: Recruiting

Chronic Obstructive Pulmonary Disease (COPD) is a chronic respiratory disease associated with various comorbidities, including muscle weakness (MW), which is very worrying due to its negative impact on patients' quality of life and survival. To address this issue, muscle strengthening is incorporated into pulmonary rehabilitation programs. However, its effectiveness is unclear, as although there is an average improvement in muscle strength, one in two patients does not show a clinically relevant improvement. To understand this non-response, it is crucial to examine the effect of muscle strengthening programs on the two main determinants of force production: the muscle and the central command. Muscle adaptations following a muscle strengthening program are well-documented, showing improvements in muscle function (cross-sectional area, lean mass, etc.). Conversely, only one study has investigated central adaptations after a muscle strengthening program, clearly demonstrating a lack of effect.

The investigators hypothesize that patients showing no improvement in muscle strength after pulmonary rehabilitation (non-responders) have a significantly lower level of voluntary activation before starting the program compared to responding patients (responders).

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients aged 40 to 80 years Patients admitted to a 4-week inpatient pulmonary rehabilitation program Patients diagnosed with COPD (Stage I to IV) according to internationally recognized criteria determined by the GOLD Patients able to understanding, speaking, reading, and writing French Patients for whom informed consent will be obtained after a maximum 24-hour reflection period Patients affiliated with a French social security system or beneficiaries of such a system  Exclusion Criteria:  Diagnosis of neurological and/or cerebrovascular disease corresponding to code 8 of the International Classification of Diseases (ICD-11) Possession of any invasive metallic medical devices (pacemaker, prosthesis, etc.) except for dental prostheses (crowns and bridges). Epileptic risk factors (chronic alcoholism, brain surgery, recent head trauma) Orthopedic conditions that may affect the completion of protocol tests and assessments Recent exacerbation (within 4 weeks) Patients in a period of relative exclusion compared to another protocol Adults protected by law or patients under guardianship or conservatorship Individuals deprived of liberty by a judicial or administrative decision Pregnant or breastfeeding women - HealthyVolunteers: No - Gender: All - MinimumAge: 40 Years - MaximumAge: 80 Years - StdAgeList: Adult, Older Adult
Internet-based Behavior Therapy for Adults With Tourette Syndrome
Status: Recruiting

This study protocol outlines a parallel-group, randomized controlled trial (RCT) designed to evaluate the effectiveness of Internet-delivered behavior therapy (BT) based on exposure with response prevention (ERP) for adults with Tourette syndrome (TS) or chronic tic disorder (CTD). The primary aim is to evaluate the effects of Internet-delivered ERP-based BT on tic severity compared to a control condition offering general psychological support at week 11 counting from the treatment start. The primary outcome measure is the Yale Global Tic Severity Scale - Total Tic Severity subscale (YGTSS-TTS). Secondary outcomes include measures of tics-related impairment, work and social adjustment, rates of responders, self-rated tic severity, symptoms of depression, and quality of life. Long-term maintenance of results will be assessed at week 23 and 14 months after the treatment start. Participants will be recruited nationwide. The intervention group will receive 10 weeks of ERP-based therapy delivered through an online platform, with therapist support. The control group will receive psychoeducational content and general psychological support. Adherence to treatment, adverse events, and patient safety will be closely monitored throughout the trial. The study population will be intent-to-treat and the between-group differences at the primary endpoint will be assessed using an analysis of covariance (ANCOVA) with pre-score of the measure as covariate. A health-economic evaluation will assess the cost-effectiveness of the intervention.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  ≥ 18 years of age.  Primary diagnosis of TS/CTD, according to criteria in Diagnostic and Statistical Manual of mental disorders 5th edition.  Provided digital informed consent.  Have a Total Tic Severity Score (TTS) of >15, or >10 for individuals with motor or vocal tics only, in the past week, as measured by the Yale Global Tic Severity Scale (YGTSS).  Being willing and able to follow the study procedures and participate in the 10-week treatment program.  Being fluent in Swedish.  Have regular access to a computer connected to the Internet, sufficient technical skills to use the treatment platform, as well as a mobile phone to receive text messages.  Exclusion Criteria:  Ongoing or planned psychological treatment for TS/CTD.  Previous BT for tics of a minimum of 8 sessions with a qualified therapist within 12 months prior to assessment.  Adjustment of medication for tics within the last two months prior to assessment.  Severe psychiatric comorbidities such as organic brain disorders, bipolar disorder, ongoing psychosis, anorexia nervosa or substance use disorders that can interfere with the treatment for TS/CTD.  Acute psychiatric problems such as severe depression or suicidal risk needing immediate psychiatric care.  Severe tics causing immediate risk to the participants themselves or to others and requiring urgent medical attention. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Analysis of Correlation Between Skin Carotenoid Level and Basic Indicators of Health Status Related to Lifestyle in Vietnamese: An Observational Study
Status: Recruiting

To clarify the relationship between vegetable intake and lifestyle-related disease in Vietnam, we measure skin carotenoid levels and basic indicators of health status related to lifestyle and analyze the correlation between them. This is an important study that can lead to dietary suggestions for preventing lifestyle-related diseases in Vietnam.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Adults aged 18 years or older Healthy people or patients with metabolic diseases as obesity, diabetes, hypertension, lipid abnormalities, hyperuricemia People who agreed to participate in the study and be able to complete the Informed Consent Form  Exclusion Criteria:  Hospitalized patients Patients with other diseases than metabolic diseases as written in inclusion criteria. People judged to be inappropriate by the principal investigator - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Visitors to Dr. Binh_TeleClinic - SamplingMethod: Non-Probability Sample
Process Mapping and Data Collection to Inform a Computer Simulation Model of Hospitalised Patients With Bloodstream Infection, Sepsis and Systemic Infection
Status: Not yet recruiting

The goal of this study is to create a computer simulation of patients with bloodstream infection to understand how changes in healthcare policies and resources affect patient treatment. This simulation will help doctors and health-care decision makers make better choices in treating these patients and avoid overusing antibiotics that can lead to antibiotic resistance. Antibiotic resistance is when bacteria can't be killed by antibiotics anymore. Participants will not receive treatments as this is an observational study, but the study will involve:

Interviews with healthcare staff to understand patient care pathways.
Analysis of historical data on bacteria causing infections and antibiotic treatments.
A 30-day observational study to observe patient treatment for bloodstream infections.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Sub-study 2 (retrospective data collection)  Patients who were managed within a LUFT acute hospital site (Aintree or Royal) and had a concurrent blood culture investigation requested Age ≥ 18 years at the time of the study. Sub-study 3 (observational study) Patients with blood culture investigation requested during the observation period, and staff caring for the patients.  Exclusion Criteria:  Age < 18 years at the time of the study Blood culture requested but patient not managed on an acute hospital site. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients with presumed bloodstream infection/sepsis/systemic infection. - SamplingMethod: Non-Probability Sample
Neurological Dry Eye Study Stimulating Both Lacrimal and Vagus Nerves
Status: Not yet recruiting

This is a study on neurological dry eye disease, focusing on a patented over-the-counter supplement supporting tear production neurologically, including the lacrimal and vagus nerves.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Must have dry eye (OSDI score 30 and above) Tear break up time of less than or equal to 7 seconds Must be able to come for baseline tests and again at 4 weeks  Exclusion Criteria:  Demodex Corneal scarring must not take Physostigmine (glaucoma), Pyridostigmine (Mestinon), Neostigmine (for Myasthenia Gravis); Aricept (for Alzheimer's), or ingredients to NeuroTears No known allergies to ingredients in NeuroTears - HealthyVolunteers: No - Gender: All - MinimumAge: 20 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult