rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
NEwborn Infant of a Mother With Obesity - Fecal Microbiome Transplantation, RCT
Status: Not yet recruiting

The goal of this clinical trial is to investigate the differences in microbiota, height and weight between infants born by cesarean section to obese mothers and randomized to receive fecal microbiota transplant after birth. The main questions it aims to answer are:

Could fecal transplant be used improve gut microbiota and prevent overweight or obesity.
Is the source of colonization a modifiable factor and can it be changed by using an early fecal microbiota transplant.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Pregnant women age 18-49 years with obesity (prepregnancy BMI ≥ 30 kg/m2) scheduled for elective CS at term, are recruited at 36 weeks of gestation during a visit for the assessment of mode of delivery at Oulu university Hospital, Oulu, Finland.  Exclusion Criteria:  Use of regular immunosuppressive biological medication, immunodeficiency disorder of mother or other first degree family member of the unborn baby, known or suspected fetal major congenital abnormality, travelling abroad outside European countries or United States within the last three months and antibiotic treatment within 3 months of delivery (excluding the prophylactic cefuroxime (or other in case of allergy) given prior to the elective CS). Infant exclusion criteria are preterm birth (birth before 37 weeks of gestation), birth weight below 2500 g, admission to neonatal intensive care unit, need for respiratory support or antibiotic treatment of the newborn before discharge. In case of a suspected infection or newborn screening result for severe combined immunodeficiency (SCID) is out of the normal range, of the newborn the randomization code can be opened. - HealthyVolunteers: No - Gender: Female - GenderBased: Yes - GenderDescription: Pregnant women. - MinimumAge: 18 Years - MaximumAge: 49 Years - StdAgeList: Adult
Optima Coil Performance in The Interventional Management of Intracranial Aneurysms Registry
Status: Recruiting

This is a prospective, open-label, consecutive enrollment, multi-center, U.S. registry of patients with intracranial aneurysms who are treated with the Optima Coil System.

The primary objective of this registry is to evaluate the safety and effectiveness of the OptimaTM Coil System, including the OptiMAX Coils, in the real-world treatment of intracranial aneurysms. Imaging will be analyzed by a designated core neuroimaging lab to assess procedural success and aneurysm occlusion rates. Intent to treat population total: 700 patients 600 patients, up to 100 screen failures.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients enrolled in this registry must be treated in accordance with the FDA-cleared indication for the Optima Coil System.  In addition:  Patient age ≥ 18 years; Candidate aneurysm is a previously untreated, saccular intracranial aneurysm measuring ≤ 24 mm in maximal diameter and suitable for embolization with coils; OptimaTM coil system accounts for at least 75% of the total number of implanted coils; Patient/ LARreceived the IRB-approved Consent Information Sheet to augment clinical procedure consent, and provided verbal consent to participate in the study Subject willing to comply with the protocol follow-up requirements; and Hunt & Hess classification of equal to or less than 4 for ruptured aneurysms, if applicable.  Exclusion Criteria:  Since this is a real-world registry, few exclusion criteria are defined. Adjustments for baseline patient characteristics and aneurysm morphology will be used to identify outliers and unique cohorts.  Life expectancy less than 1 year. Patient previously enrolled in the OPTIMA Registry. Known multiple intracranial aneurysms, apart from the targeted aneurysm for the OPTIMA study, requiring treatment during the index procedure or within the study follow-up period. Patient is unwilling or unable to comply with the protocol follow-up schedule and/or based on the Investigator's judgment the patient is not a good registry candidate. Participation in another confirmed interventional clinical study that could confound the evaluation of this registry, per PI discretion. Pre-planned staged procedures on unruptured target aneurysms - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: 600 subjects with intracranial saccular aneurysms (maximum dimension ≤ 24 mm), ruptured or unruptured, treated with the OptimaTM Coil System. - SamplingMethod: Non-Probability Sample
Role of 3D Echocardiography Knowledge-based Reconstruction in ACHD
Status: Not yet recruiting

The main objective of this study is to evaluate the reproducibility and accuracy of TTE-3DKBR in assessing RV volume and EF compared to the reference method of CMR in a group of ACHD patients with known moderate or severe PR after ToF repair.

As part of the validation study, the reproducibility of the TTE-3DKBR in assessing RV volume and EF will also be tested in a group of healthy adult volunteers. Additionally, TTE-3DKBR evaluation will be compared in both groups to the conventional 2D echocardiography measurements used in routine clinical practice, such as tricuspid annular plane systolic excursion (TAPSE), tissue Doppler imaging (TDI), fractional area change (FAC), and global longitudinal strain (GLS).

Another objective of the study is also to evaluate the effects of chronic RV volume overload with an interval of one-year follow-up using TTE-3DKBR and compare it with the conventional non-geometric echocardiography measurements, particularly with GLS.

The study will end when the required number of patients have been enrolled and when the last subject undergoes the research dataset acquisition. The study may be terminated prematurely if it becomes apparent that the recruitment target cannot be met within the projected recruitment phase.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Group 1 of healthy adult volunteers - Minimum aged of 18 years old without evidence of structural heart disease.  Group 2 of ACHD patients - ACHD patient minimum aged of 18 years old with diagnosis of moderate or severe pulmonary regurgitation after ToF repair.  Exclusion Criteria:  Group 1 of healthy adult volunteers - No informed consent, evidence of structural heart disease.  Group 2 of ACHD patients - No informed consent, pacemaker or defibrillator non-compatible with CMR, limited echocardiographic images for image acquisition, and evidence of moderate or severe right ventricle inflow and/or right ventricle outflow tract obstruction. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Group 1 of healthy adult volunteers  Group 2 of ACHD patients with repaired Tetralogy of Fallot and known moderate or severe pulmonary regurgitation - SamplingMethod: Probability Sample
The Effect of Mindfulness Meditation
Status: Not yet recruiting

Cancer is a disease that causes the most deaths worldwide and is challenging for patients and caregivers both physically and psychosocially. Physicians and nurses working in oncology clinics perform a demanding profession providing compassionate care and treatment to patients struggling with life-threatening diseases. The emotional cost of caring for patients diagnosed with cancer can lead to compassion fatigue, burnout, and decreased psychological well-being among healthcare professionals. For this reason, this research is planned as a randomized controlled study to examine the effect of Mindfulness meditation practice on compassion fatigue, burnout, and psychological well-being in physicians and nurses working in oncology units.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Actively working in oncology clinics At least 1 year of working experience in an oncology clinic Not having a physical/mental/psychological disorder that would prevent participation in the research. Oncology nurses with a high school, undergraduate, associate or graduate degree in nursing Physicians and nurses who volunteer to participate in the research will be included in the research sample.  Exclusion Criteria:  Physicians and nurses who have been diagnosed with a psychological disease in the last two years and are continuing their medical treatment • Physicians and nurses who did not agree to participate in the research - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Pain and Screen Addiction in University Students
Status: Recruiting

One of the most important factors why young people spend inactive time is the time they spend in front of the screen. Sedentary screen time refers to time spent using a screen-based device, such as a computer, television, smartphone, or tablet while being sedentary in any environment. The last decade has seen a disturbing increase in the amount of time young people spend in front of screens. Research shows that musculoskeletal disorders in the hand, wrist, arm, and neck occur at a high rate due to long-term and repetitive use of the smartphone, one of the electronic devices. People with musculoskeletal pain often complain of more than one area of pain.

The primary purpose of this study is to investigate the relationship between university students' use of various screen-based devices, the time they spend in front of the screen, and the number of painful areas they report on the body. Our secondary aim is to evaluate the relationship between pain, and screen time, and physical activity level.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  All students between the ages of 18-25 People who use screen-based devices for at least 2 hours a day  Exclusion Criteria:  Presence of congenital deformity History of trauma to the musculoskeletal system in the last 6 months History of serious surgery Presence of neurological disease - Gender: All - MinimumAge: 18 Years - MaximumAge: 25 Years - StdAgeList: Adult - StudyPopulation: All students between the ages of 18-25 who use screen-based devices for at least 2 hours a day will be included in the study. Those with congenital deformities, those who have experienced trauma to the musculoskeletal system in the last 6 months, and those with serious surgical or neurological diseases will be excluded from the study. - SamplingMethod: Probability Sample
Effects of Music Therapy on Psychological States Among Cancer Patients Undergoing MRI Scans and A Relevant Mediator
Status: Recruiting

The primary objective of this study is to examine the effects of a music therapy protocol on improving anxiety, symptom distress, and relaxation among cancer patients who are going through MRI scanning. Physiological data, such as pulse rates and respiration rates will be collected. Furthermore, data about scanning efficiency will be collected to assess if scanning efficiency is affected by the protocol implementation. The secondary study objective is to assess whether or not there is a relationship between patient attention to music during the intervention process and the changes in anxiety, symptom distress, and relaxation.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  The subject is diagnosed with cancer; The subject is between 18- 60 years old; The subject understands Mandarin, Cantonese, or English; The subject did not use medication for sedatives, anxiolytics, and/or sleep aids; The subject is awake without cognitive disorders; the subject rates more than 0 on the 0-10 VAS for anxiety; The subject has finished primary school level education.  Exclusion Criteria:  The subject withdraws the MRI scan; The subject needs other intervention(s) to complete the scan; The subject has hearing and/or visual impairments; The subject has a history of a severe somatic psychiatric disease or clinically diagnosed mental disorders. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 60 Years - StdAgeList: Adult
Pharmacological and Non-pharmacological Treatment Effects on Children With Different Predicted Myopia Progression Rate
Status: Recruiting

The goal of this clinical trial is to compare pharmacological and non-pharmacological treatment effects on the children with different predicted myopia progression rate measured by modified multifocal electroretinogram. The main questions it aims to answer are:

the effectiveness of using 0.05% atropine and prescribing DIMS lens for myopia control in children with different myopia progression rates
the contribution of L/M cones in juvenile myopia progression and changes of retinal activities under atropine and DIMS treatment.

Participants will have baseline and follow-up eye examinations and given either pharmacological treatment with 0.05% atropine or non-pharmacological treatment with DIMS lens for myopia control.

Researchers will compare the changes of refractive errors and axial length after different types of interventions and investigate the relations between the parameters of mfERG responses and the thicknesses of retinal layers and choroid.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  be aged between 7 and 9 years have no reported eye disorder and no family history of eye disease be able to participate in this study for 24 months not have any current or history of epilepsy not have any current or history of asthma have refractive error between 0.50 D and 4.00 D and less than 1.50D of astigmatism with best corrected visual acuity of LogMAR 0.0 or better have no detected eye diseases or disorders after eye examination, except myopia - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 7 Years - MaximumAge: 9 Years - StdAgeList: Child
Eravacycline Combination Therapy for MRAB
Status: Recruiting

The goal of this observational study is to learn about the eravacycline combination therapy in multidrug-resistant acinetobacter gaumannii pneumonia. The main question is to evaluate the the effectiveness and safety.

Participants will be given Eravacycline and Polymyxin，or other antibiotcs that the Investigator considered suitable. During the clinical trial, participants will be monitored for blood drug concentrations and drug concentrations in the ELF (Epithelial Lining Fluid。Clinical efficacy rate and microbiological clearance rate will be assessed at the same time

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  ≥18 years old; Meets the diagnostic criteria for pneumonia specified by the Chinese Medical Association Respiratory Branch. CRAB is identified or predominant pathogenic bacteria, and drug sensitivity test indicates that Eravacycline is sensitive to the strain; Patients expected to receive Eravacycline for ≥4 days; Has already signed the informed consent  Exclusion Criteria:  Pregnant or lactating; Concurrent intracranial infection, urinary tract infection, or bloodstream infection; Individuals in a moribund state; The investigator believes there is any medical history, current condition, treatment, laboratory abnormalities, or other circumstances that may affect the trial results, interrupt the trial process (or the subject's inability to complete all trial requirements, operations, and visits), or increase the subject's risk with the experimental medication. Patients with terminal illnesses or evidence of immediately life-threatening diseases are excluded; Patients with a history of allergic reactions to tetracyclines or any excipients in the investigational drug formulation - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: This study plans to include patients diagnosed with CRAB pneumonia who seek medical attention at the Intensive Care Medicine Department of Fujian Medical University Union Hospital from January 2024 to April 2024 - SamplingMethod: Non-Probability Sample
Shear Wave Elastography for Diagnosis of Heart Failure With Preserved Ejection Fraction
Status: Not yet recruiting

The diagnosis of heart failure with preserved ejection fraction (HFpEF) is often complex. Echocardiography has the advantages of being a non-invasive, simple operation, low price, and high repeatability, and is of great value in the diagnosis of HFpEF. However, the current echocardiographic assessment of left ventricular diastolic dysfunction and elevated filling pressure is based on multi-parameter indirect judgment, and new parameters are urgently needed to achieve accurate judgment of left ventricular diastolic function and an accurate diagnosis of HFpEF. Myocardial stiffness refers to the ability of the myocardium to undergo stress and strain. It is an important part of the pathophysiology of cardiac diastolic dysfunction and an important parameter for clinical evaluation of the diastolic function of HFpEF. Shear-wave elastography is a novel ultrasound-based elastography technology. Based on the shear wave generated by the remote induction of the radiation force of the focused ultrasound beam, the hardness of myocardial tissue can be measured quantitatively, locally, and noninvasively, and the change in myocardial stiffness in patients with HFpEF can be directly reflected. Currently, no relevant studies have applied shear-wave elastography to the diagnosis of HFpEF. This study aims to identify changes in myocardial stiffness measured by shear-wave elastography in patients with HFpEF based on a multicenter study and apply myocardial stiffness parameters to the diagnosis of HFpEF.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Age ≥18 years old Clear epidemiological and population characteristics of HFpEF Symptoms and/or signs of heart failure Echocardiographic examination of LVEF≥50% Objective evidence of cardiac structural and/or functional abnormalities consistent with left ventricular diastolic dysfunction and/or elevated left ventricular filling pressure, including elevated levels of natriuretic peptides HFpEF score ≥6 or HFA-PEFF score ≥5  Exclusion Criteria:  Any one item per patient was excluded from the study:  Arrhythmia. ischemic heart disease. Valvular heart disease or congenital heart disease with severe hemodynamic changes. History of pacemaker implantation or other cardiac surgery. Poor ultrasonic image quality cannot meet the parameter measurement and analysis. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients with heart failure with preserved ejection fraction - SamplingMethod: Non-Probability Sample
Early Prediction and Warning for Cardiotoxicity Due to Anthracycline-Based Breast Cancer Chemotherapy
Status: Recruiting

This multicenter clinical study aims to build an intelligent and accurate diagnosis and dynamic prediction and early warning model of cardiotoxicity due to anthracycline-based breast cancer chemotherapy, clarify the value of the early warning model in guiding the targeted prevention of myocardial protection, providing an important theoretical basis for reducing the mortality rate of breast cancer and improving the prognosis.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Age ≥18 years Histologically or cytopathological confirmed stage I-III HER2+ breast cancer, scheduled to receive consecutive anthracycline chemotherapy or subsequent sequential trastuzumab targeted therapy LVEF≥53% before chemotherapy  Exclusion Criteria:  life expectancy ≤12 months Participating in other ongoing oncology clinical trials Prior treatment with anthracyclines or chest radiation therapy Pregnant or lactating women Ultrasound images of the heart are of very poor quality - HealthyVolunteers: No - Gender: Female - MinimumAge: 18 Years - MaximumAge: 80 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Breast cancer patients with anthracycline-based breast cancer chemotherap - SamplingMethod: Probability Sample
Photobiomodulation for Lower Back Pain Post Spinal Fusion and Decompression Surgery
Status: Recruiting

After spinal fusion and decompression surgery there is a possible risk of developing chronic back pain. After surgery there is typically inflammation around the operation site and this inflammation can be painful and debilitating to patients.

Many possible treatment plans have been incorporated to assist the patient with recovery - notably medications, physical therapy, and braces. However, few studies have looked at laser diodes that utilize high-power laser lights that are aimed at decreasing pain and inflammation. Investigators aim to look compare patients using a back brace with laser diodes within versus those who wear a normal brace used as a placebo. Investigators will also assess the patient's surgical wound to monitor the progression of wound healing while using the brace.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Subject will have undergone minimally invasive spinal fusion surgery or spinal decompression surgery in their lower back L1-S1. Have low back pain of >3 months and a pain threshold of > 4 (as described by the the subject), age > 18 years, and English speaking to eliminate possible miscommunication and consequent human error regarding belt use. Subject must have had surgery at minimum to 1 year prior to start of study and no more than 5 years prior to start to study  Exclusion Criteria:  Patients with tumors Current infection Drug misuse history Skin conditions preclude the use of laser belt Severe spondylolisthesis, spondylolysis, spinal stenosis, ankylosing spondylitis Previous low back surgery exceeding 5 years to initial start date. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult
Physiotherapists' Placebo or Nocebo Communication Regarding VR in CMP
Status: Not yet recruiting

Rationale: Chronic musculoskeletal pain (CMP) is a common and disabling condition. Physiotherapy is the most frequently administered non-pharmacological treatment option for patients with CMP and recently virtual reality (VR) was introduced in physiotherapy care as a novel treatment modality. Proper communication about physiotherapy treatment (modalities) is important to improve treatment outcomes, by applying placebo effects enhancing communication and avoiding nocebo effects enhancing communication. However, yet is still unknown to what extent this applies to communication of physiotherapists about VR in patients with CMP.

Objective: To determine the effect of physiotherapists' placebo or nocebo therapeutic communication about VR, on treatment credibility and expectation in patients with CMP

Study design: Web-based randomized controlled trial.

Study population: 100 participants

Intervention: The placebo intervention group will be shown an educational video about VR, containing placebo effects enhancing verbal language. The nocebo intervention group will be shown an educational video about VR, containing nocebo effects enhancing verbal language.

Primary study parameters: The primary study parameters are treatment credibility and treatment expectation. Treatment credibility and treatment expectations will be measured using the Dutch credibility and expectancy questionnaire (CEQ).

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  aged ≥ 18 access to the internet provide informed consent suffers from CMP  Exclusion Criteria:  lacked comprehension of the Dutch language had experience with therapeutic VR - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult