rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
Erector Spinae Plane Block vs Quadratus Lumborum Block for Laparoscopic Nephrectomy
Status: Not yet recruiting

Ultrasound (US) guided Quadratus Lumborum Block (QLB) is performed at the level of the 12th rib, in the parasagittal oblique plane, at the L1-L2 level. As there are modifications of the block generally local anesthetic is given between quadratus lumborum (QL) and psoas major (PM) muscles (Anterior QLB). The QLB provides a sensory block between T7 - L1. Therefore, QLBs are used to provide postoperative analgesia for abdominal, obstetric, gynecologic, and urologic surgeries.

US-guided erector spinae plane block (ESPB) is performed at the level of the T11 transverse process. After visualization of the erector spinae (ES) muscle and the transverse process, local anesthetic is injected under the ES muscle. ESPB provides a sensory block of the anterior, posterior, and lateral thoracic and abdominal walls accordingly it's used for postoperative analgesia after thoracal wall repairs, thoracotomies, percutaneous nephrolithotomies, nephrectomies, and ventral hernia repairs.

This study aims to compare the effectiveness of US-guided ESPB and QLB on postoperative pain control after laparoscopic nephrectomy.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  American Society of Anesthesiologists (ASA) classification I-II Scheduled for living donor laparoscopic nephrectomy under general anesthesia  Exclusion Criteria:  history of bleeding diathesis, receiving anticoagulant treatment, known local anesthetics and opioid allergy, infection of the skin at the site of the needle puncture, pregnancy or lactation, patients who refuse the procedure or participation in the study - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult
Testing the Effectiveness of the Her Health Program to Add Healthcare Value in the Fourth Trimester
Status: Not yet recruiting

The goal of this clinical trial is to learn if a program Woman's Hospital has made, called the Her Health Program, can help women be healthy and get healthcare in the first year after having a baby.

The main question[s] the study aims to answer are:

Can the Her Health program increase access to healthcare in the first year postpartum?
Can the Her Health program increase knowledge about healthcare and change feelings toward the healthcare system?

Participants will complete one research visit in which they will be enrolled and told which group they will be in- "Her Health Program" group or "Usual Care" group. If they are placed in the "Her Health Program" group, they will receive their usual care + the addition of an extra healthcare team member(called a community health navigator) to to work with patients and care team for a year postpartum.

Researchers will compare those who receive the Her Health Program and those who do not receive the program to see if the Her Health Program can help women get healthcare in the first year after having a baby.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  At least 16 years old at the time of consent. Gave birth within 7 days before randomization Medicaid enrolled Address of residence within a disadvantaged area (ADI>5). Clearly understands the study procedures and visit schedule, alternative treatments, and risks involved with the study, and voluntarily agrees to participate by giving verbal and written informed consent  Exclusion Criteria:  Use of private health insurance exclusively Does not speak English. Plans to move out of state during the study time period Unwilling to provide permission to link study records, medical records, and Medicaid and Vital Records Database records. Unwilling to provide informed consent Unwilling to be randomized. - HealthyVolunteers: No - Gender: Female - MinimumAge: 16 Years - StdAgeList: Child, Adult, Older Adult
E-Based Physical Exercise in Patients With Multiple Sclerosis and Comorbidity
Status: Recruiting

Background: Physical exercise (PE) improves symptoms and quality of life in patients with multiple sclerosis (pwMS). Comorbidity is prevalent among pwMS and may contribute to disease progression. Integrating and sustaining PE is challenging and E-based PE solutions have been proposed as a tool to support the integration of PE into daily life.

Aims: To assess the effect of e-based PE in addition to usual care in pwMS on clinical outcome and the levels of inflammatory, metabolic, and neurodegenerative mediators. Furthermore, to determine whether PE plays a role in the modification of comorbidities with a focus on vascular comorbidity and related risk factors, i.e., type 2 diabetes mellitus.

Method: This study will be prospective with longitudinal follow-up of pwMS with and without comorbidities. The physical activity of pwMS will be measured at baseline and after six months by accelerometers. In a randomized controlled trial (RCT) patients will be randomly assigned in a 1:1 ratio to receive either usual care or usual care plus an e-based PE program. The exercise program consists of resistance training with resistance bands targeting the lower extremities, including leg press, knee extension, hip flexion, hamstring curl, and hip extension. The sessions will enable participants to engage in group exercises from their homes through a secure online platform, supervised virtually by physiotherapists. The primary endpoints are walking capacity using the 6-meter walk test and the NEDA-3 scale, focusing on the absence of clinical relapses and disease progression, as indicated by an increase in the Expanded Disability Status Scale score and the absence of new disease activity on MRI (including new T2 lesions or enhancing lesions). Secondary outcomes will encompass measures of quality of life and fatigue, as well as levels of potential biomarkers like neurofilament light chain in blood and cerebrospinal fluid.

Conclusion: This study will contribute to the rehabilitation and improved quality of life of pwMS particularly of patients with comorbidities. The potential for e-based PE at home to encourage sustained exercise engagement among pwMS will be evaluated, offering a significant contribution to the field of digital healthcare solutions.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Confirmed MS diagnosis as per the 2017 MS criteria. [3] Expanded Disability Status Scale (EDSS) assessment score of less than 7.0 at baseline. Adults aged 18 years or above. Commitment and mental ability to participate in a 6-month e-based physical exercise program, supervised bi-weekly by a physiotherapist.  Exclusion Criteria:  5. Change in prophylactic DMT within the last 3 months 6. Steroid treatment in the past month. 7. Drug or alcohol abuse. 8. Pregnancy. 9. Active systemic infection  - - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Risankizumab in Children With Crohn's Disease (RisaKids)
Status: Not yet recruiting

The goal of this observational study is to to prospectively explore the real life short (12 weeks) and longer term (54 weeks) clinical, biochemical and endoscopic outcomes of risankizumab in pediatric CD.

This is a 1-year prospective multi-center cohort study of children commencing on risankizumab for pediatric CD with 2 years extension for long-term follow-up. The investigators will record clinical manifestations, blood markers and fecal calprotectin, with monitoring for safety signals including infusion and injection site reactions, pyrexia and infections at various intervals as outlined below. The investigators will also include calprotectin monitoring and fecal sample collection for microbiome and serum samples for drug levels. According to available budget, the investigators will also collect fecal and serum samples for metabolome. Samples collection is optional, thus failure of bio-samples collection will not exclude patients from the study.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Children under the age of 18 years, Patients diagnosed with CD. Patients commenced on risankizumab by treating physician (at least one dose), either alone or in combination with any other CD medications, at any stage of the disease.  Exclusion Criteria:  * There will be no exclusion criteria to this study. - HealthyVolunteers: No - Gender: All - MinimumAge: 6 Years - MaximumAge: 18 Years - StdAgeList: Child, Adult
The Effects of an Online Mindfulness-based Intervention for Children With Attention-Deficit/Hyperactivity Disorder
Status: Recruiting

This study will investigate the effects of an online mindfulness-based intervention with a randomized controlled trial.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  parents of children diagnosed with ADHD by a psychiatrist and psychologist according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Ed (DSM-5) Children with ADHD aged 6 to 12. Parents who have served as the primary caregivers of their children in the last year and children with ADHD who speak and understand Cantonese Chinese. Children either not taking any medication or maintaining a stable dosage of the same ADHD medication for at least 3 months prior to study enrollment and having no plans to change medication and dosage during the study period.  Exclusion Criteria:  parents diagnosed with developmental disabilities, psychosis, or cognitive impairment, who may thus have difficulty comprehending the content of the project. Children with another developmental disability such as autistic spectrum disorder or intellectual disability. Parents who completed an eight-week MBI or equivalent program. - HealthyVolunteers: No - Gender: All - StdAgeList: Child, Adult, Older Adult
The Effect of PRP on Wound Healing in High Risk Patients Undergoing Abdominal Hysterectomy
Status: Not yet recruiting

To evaluate the effect of PRP on wound healing in high risk patients undergoing abdominal hysterectomy.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  - Female patients aged >18 years. Patients undergoing abdominal hysterectomy. Patients with a high risk of wound healing complications, including: obesity, diabetes mellitus, use of corticosteroid medication or smoking.  Exclusion Criteria:  - Patients with hemoglobin (Hb) < 10 g/dL. Patients with platelet levels < 110 × 103/uL. Patients with coagulation disorders (on anticoagulant). Patients with malignancy - HealthyVolunteers: No - Gender: Female - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Brain Connectivity Measured With High-density Electroencephalography
Status: Recruiting

Emerging scientific results show that disrupted functional connectivity in stroke can explain behavioral impairments and predict their recovery over time. However, no technique is yet available for widespread use in clinics to examine how neural synchronization in brain networks is altered in stroke patients. This is crucial to determine favorable prognostic factors and to define individualized rehabilitation protocols. Importantly, the investigators have successfully used high-density electroencephalography (hdEEG) in healthy individuals to measure neural synchronization in brain networks. In this project, the investigators will develop methods and tools based on hdEEG for assessing functional connectivity in stroke patients. These methods and tools will be employed to examine how neural changes occurring after brain lesions explain behavioral impairments. The project will open the way for the use of hdEEG at the patient's bedside, as a neurodiagnostic tool for stroke as well as other brain disorders.

Eligibility:
- EligibilityCriteria: In this study 125 stroke patients and 45 healthy participants will be recruited at the Institute for Research and Healthcare with a Scientific Character (IRCCS) San Camillo hospital.  Inclusion Criteria (patients):  right or left hemisphere damage unilateral stroke compliance with magnetic resonance imaging (e.g., no claustrophobia)  Inclusion Criteria (healthy participants):  • compliance with magnetic resonance imaging (e.g., no claustrophobia)  Exclusion Criteria (both patients and healthy participants):  • no comorbidities with psychiatric disorders - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Effectiveness of a Combination of Trimetazidine With One Hemodynamic Agent in Patients Recently Diagnosed With Stable Angina and Still Symptomatic Despite First Line Hemodynamic Therapy
Status: Recruiting

The purpose of this study is to assess in recently diagnosed stable Angina patients symptomatic despite first line hemodynamic therapy, the effect of a combination of this hemodynamic agent with a metabolic one (trimetazidine). The treatment effect will be measured by the reduction of patients' angina symptoms, physical limitation and an improvement of quality of life using the Seattle Angina Questionnaire-7 items (SAQ-7) Patients will be also proposed to complete a BEAMER (BEhavioral and Adherence Model for improving quality, health outcomes and cost-Effectiveness of healthcaRe) questionnaire which will contribute to a separate research project developed by the Innovative Medicines Initiative (IMI). Analysis of the BEAMER questionnaires will be performed outside the study by the IMI BEAMER Consortium for BEAMER purposes only.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Male and female recently diagnosed symptomatic stable Angina patients Age ≥18 years old Patient already treated by one first line antianginal haemodynamic agent (ß-blocker or Ca-channel blocker) (according to CCS management guidelines 2019) and still symptomatic after initiation of this antianginal treatment. Patient for whom the physician intends to prescribe trimetazidine based on her/his daily medical practice in the management of symptomatic Angina pectoris, respecting the SmPC in force in the country. Such treatment decision must be taken independently from the participation of the patient in the study. Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.  Exclusion Criteria:  Any contra-indication to trimetazidine according to SmPC Patient already treated with trimetazidine before entry into the study. Pregnancy or intention to become pregnant or lactating women during the study. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Male and female recently diagnosed symptomatic stable Angina patients. - SamplingMethod: Non-Probability Sample
A Study Investigating the Safety, Tolerability, Immunogenicity and Pharmacokinetics of Olamkicept in Healthy Persons
Status: Recruiting

Interleukin (IL)-6 is a cytokine produced in response to infection and tissue damage. IL-6 is believed to act as a key mediator in chronic inflammation and autoimmune diseases such as inflammatory bowel diseases. IL-6 is known to be involved in at least two distinct signalling pathways, classical and trans-signalling. The hypothesis is that classical signalling by IL-6 infers some beneficial effects (e.g. on gut barrier function), while excessive IL-6 trans-signalling may have detrimental effects. Olamkicept (FE 999301) has been shown in vitro to be a selective IL-6 trans-signalling inhibitor, and administered at lower doses (600 mg every 2nd week for 12 weeks) it has proven to induce clinical improvement for patients with ulcerative colitis. The aim of this trial is to investigate safety, tolerability, immunogenicity and pharmacokinetics of Olamkicept at higher doses (up to 2400 mg) to support the clinical development program. Our hypothesis is that treatment with higher doses of Olamkicept will result in greater clinical improvement for patients with inflammatory bowel diseases.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Men ≥18 and ≤45 years of age at screening In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead electrocardiogram (ECG), vital signs measurements, and clinical laboratory evaluations, as assessed by the investigator (or designee) at screening and on Day -1  Exclusion Criteria:  History of clinically significant medical conditions including, but not limited to, diseases of the renal, hepatic, respiratory, gastrointestinal, cardiovascular, neurological, musculoskeletal, psychiatric, immunological, haematological, oncological, endocrine, and metabolic systems and allergic diseases (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing). - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Male - GenderBased: Yes - MinimumAge: 18 Years - MaximumAge: 45 Years - StdAgeList: Adult
A Two Year Longitudinal Clinical Study of Neurocognitive and Psychiatric Symptoms in Post COVID-19 Patients
Status: Recruiting

The prospective, longitudinal, open observational study monitors patients with cognitive and neuropsychological symptoms after COVID-19 infection, in a longitudinal manner to see how the disease has affected their physical, psychological and cognitive function, their ability to be active, return to work, their health-related quality of life in correlation with potential diagnostic and prognostic markers.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  neurocognitive symptoms after lab-verified COVID-19 infection  Exclusion Criteria:  severe illness e.g cancer with a short expected survival time ongoing alcohol abuse ongoing drug abuse. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: The patients:  who have been referred for neurocognitive symptoms after Covid-19 infection to secondary health care at Örebro University Hospital (USÖ) or who themselves sought assessment at USÖ who meet inclusion criteria and do not meet exclusion criteria who agreed to study participation with a written informed consent. - SamplingMethod: Non-Probability Sample
Adult Patients With Primary Sclerosing Cholangitis
Status: Not yet recruiting

Develop an appropriate real-world data comparator cohort to support the design, execution, and serve as an external control for interventional clinical trials in PSC.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Adult patients between 18 and 75 years of age (inclusive) who can comprehend instructions, follow the study procedures and are willing to sign an Informed Consent Form (ICF). Confirmed clinical diagnosis of large duct PSC based on current AASLD Guidelines (Bowlus 2023).  Exclusion Criteria:  Clinically significant acute or chronic liver disease of an etiology other than PSC (with or without presence of features of AIH). Small-Duct PSC. Clinically diagnosed secondary or IgG4-related sclerosing cholangitis. Clinically diagnosed acute cholangitis and currently receiving treatment. Patients on chronic suppressive antibiotics will be allowed to enroll. UDCA dose >28 mg/kg  Evidence of current or historical decompensated cirrhosis based on the following clinical events:  Ascites > Grade 2 and requiring treatment Esophageal or gastric variceal bleeding requiring hospitalization Hepatic encephalopathy (as defined by a West Haven score ≥ 2) Spontaneous bacterial peritonitis defined as ascites absolute neutrophil count >250/mm3 in the absence of an intra-abdominal source of infection AKI-HRS according to AASLD Guidelines (Flamm 2021) Prior liver transplantation MELD-Na Score >15. For subjects on anticoagulation medication, baseline INR determination for MELD score calculation should take this use into account. Participants with current clinical or laboratory evidence of any severe, progressive, or uncontrolled disease, related or unrelated to PSC and which, in the opinion of the investigator, has an expected survival of less than 48 weeks. Participants who are impaired, incapacitated, or incapable of completing study- related assessments or giving informed consent. Prisoners or participants who are involuntarily incarcerated. Participants who are currently participating in an interventional clinical study. Absence of data in medical records to assess inclusion and exclusion criteria. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult - StudyPopulation: 2000 adult participants with confirmed diagnosis of large duct PSC - SamplingMethod: Non-Probability Sample
Impact of MEnstruation on Glycemic Response and Exercise In Females With Type 1 Diabetes
Status: Recruiting

The objectives of this study are to examine how sex hormones (use of hormonal birth control, menstrual cycle phase) impact glycemic control among women with type 1 diabetes (T1D), and to test adjustments to insulin dosing and food intake to ameliorate cycle-related glycemic variability. A secondary aim is to examine how the menstrual cycle and use of hormonal birth control impact patient-reported outcomes and glycemic responses to physical activity.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Women 18-45 who have had type 1 diabetes for at least 12 months Premenopausal with either menstrual cycles or currently using oral contraceptives  Exclusion Criteria:  Women who are postmenopausal, pregnant, trying to become pregnant, or have had a hysterectomy - HealthyVolunteers: No - Gender: Female - MinimumAge: 18 Years - MaximumAge: 45 Years - StdAgeList: Adult
Acetic Acid 2% Solution for Skin Ulcers
Status: Not yet recruiting

The objective of this clinical trial is to assess the effectiveness of acetic acid in patients suffering from chronic cutaneous ulcers with biofilm. The primary question it seeks to address is whether acetic acid (as a 2% topical solution) is superior to the current standard treatment for chronic cutaneous ulcers with biofilm at our center (Prontosan®).

Participants will be randomly assigned to receive either the acetic acid solution treatment or the standard current treatment.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients over 18 years of age. Continued care (hospital or outpatient) in one of the Consorci Sanitari Alt Penedes i Garraf (CSAPG) units. Presence of a cutaneous ulcer with biofilm, with an area of less than 120 cm2, and in any location (except the facial region). Plan to undergo treatment and follow-up of the lesion (at least 8 weeks) at the study center. Ability to cooperate in necessary evaluations. Informed consent for inclusion in the study, either from the participant themselves or from their legal representative.  Exclusion Criteria:  Participants diagnosed with any of the following conditions:  Ulcers with exposed bone tissue. Neoplastic-origin ulcers. Ulcers lasting more than 18 months. Participation in another clinical trial involving an experimental intervention during the period of the current trial and/or establishing a visit frequency incompatible with the current trial. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Usefulness of Metoclopramide to Improve Endoscopic Visualization in Upper Gastrointestinal Bleeding
Status: Recruiting

A prospective, randomized, double-blind study will be conducted, including all patients with upper gastrointestinal bleeding, defined as vomiting blood or black bowel movements, within 12 hours prior to admission. Patients will be randomized to receive intravenous metoclopramide 20 mg or placebo, a placebo is a look-alike substance that contains no active drug. Then endoscopy will be performed in the following 120 minutes, evaluating endoscopic visualization with the modified Avgerinos scale.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Hospitalized patients ≥18 years of age with variceal and non-variceal upper gastrointestinal tract bleeding (hematemesis and/or melena). ≤12 hours of bleeding evolution. Hemodynamic stability at the time of upper endoscopy.  Exclusion Criteria:  Patients <18 years old. Pregnant patients. Metoclopramide allergy. Refusal to be part of the study protocol. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult