rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
Positron Emission Mammography and Liquid Biopsy in Women With High-risk Breast Screenings
Status: Recruiting

The goal of this pilot research study is to compare two experimental tests, namely Liquid Biopsy and Positron Emission Mammography (PEM) in women at high risk of breast cancer. The plan for this study is to evaluate if findings from Liquid Biopsy can be matched to images obtained by PEM.

Liquid Biopsy is a blood test that can detect early tumours in patients with malignancies, while PEM is an imaging tool equipped with a high-resolution camera that uses an injected positron emitting isotope to locate breast tumours. Participation in this study entails a blood draw for Liquid Biopsy test and a PEM imaging exam before undergoing a magnetic resonance imaging (MRI) - guided biopsy for a suspicious breast lesion.

If correlations between paired samples are observed between imaging using PEM and the Liquid Biopsy data, further studies will be conducted to evaluate if these techniques can help refine screening investigations and ultimately reduce the unnecessary biopsies and anxiety in high-risk populations.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Individuals who are older than 18 years of age Individuals who are planned to undergo an MRI-guided biopsy based on high- risk screening imaging detected lesions Individuals with the ability to understand and the willingness to sign a written informed consent document  Exclusion Criteria:  High-risk Individuals with screening-imaging studies without suspicious lesions detected by the standard of care mammogram and/or MRI Individuals who are pregnant or who think they may be pregnant Individuals who are breast-feeding - HealthyVolunteers: No - Gender: Female - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
A Comparative Study of AI Methods for Fetal Diagnostic Accuracy in Ultrasound
Status: Not yet recruiting

This study serves as a supplemental investigation to the randomized controlled SCAN-AID study (NCT0632187). This study will evaluate and compare the fetal growth estimation outcomes of AI-supported groups, expert sonographers, and control groups using a secondary AI predictive model.

Eligibility:
- EligibilityCriteria: Pregnant women:  Inclusion Criteria:  Singelton pregnant. Gestational age: 30-38 weeks Maternal age < 40 years  Exclusion Criteria:  Oligo hydramnion Severe fetal anomaly e.g. fetal heart anomaly, omphalocele etc. Severe fetal macrosomia or growth restriction. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Medical students are recruited from the Medical universities in Denmark (mainly Copenhagen University) Pregnant women are chosen from the fetal medical departement at Rigshospitalet, Copenhagen. - SamplingMethod: Non-Probability Sample
Effects of Exercise-Based Interventions on Symmio Self-Movement Screen
Status: Not yet recruiting

Musculoskeletal screening for physical risk factors requires equipment and a trained healthcare or fitness professional to perform and interpret the scoring so that appropriate exercise interventions can be prescribed. However, barriers such as healthcare costs and accessibility, low perceived need to seek medical care, and previous unfavorable evaluation of seeking medical care are associated with healthcare avoidant behaviors. This research aims to explore the effectiveness of the Symmio Self-Screen application to generate specific exercise interventions to address an individual's associated physical risk factors. The ability of the Symmio application to prescribe a targeted exercise program which can reduce asymmetries, improve movement quality, and enhance overall function is unknown. Therefore, the purpose of this study is to determine the effectiveness of the Symmio application in designing individualized exercise interventions which target the unique movement limitations and asymmetries in adults.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Willing participants between the ages of 18 to 65 years of either sex At least 1 less than optimal movement pattern scored on the Symmio Self-Movement Screen.  Exclusion Criteria:  Optimal scores on all Symmio movement patterns Current lower extremity injury Lower extremity or upper extremity amputation Lack of medical clearance from physician/primary care to participate in exercise Undergoing current medical treatment for musculoskeletal injury Concussion within the past 3 months Inability to read and comprehend English. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult
Is the Plasma Concentration of CAPGDF15 Increased in Pregnancy? A Pilot Study
Status: Not yet recruiting

Background and Purpose During pregnancy, the hormone GDF15 rises between 100-200 times higher than before pregnancy. The significance of this dramatic increase is not clarified, but it has been shown that pregnant women with insufficient increase in GDF15 have a higher risk of spontaneous abortion. CAPGDF15 is a small peptide consisting of 12 amino acids recently found in plasma in both mice and humans, and this peptide is part of the prohormone from which GDF15 is synthesized. Therefore, the assumption is that CAPGDF15 is secreted simultaneously with GDF15. The significance of CAPGDF15 in the organism is completely unknown, except that injection into mice reduces food intake. Therefore, the investigators are interested in investigating whether there is a similar dramatic upregulation of CAPGDF15 as with GDF15 itself. The investigators will not set up a large-scale study without having some prior knowledge of whether this is indeed the case. Therefore, the investigators will conduct a pilot study on 3 pregnant women and 3 control women to examine whether there is any reason to proceed with an actual scientific experiment. Since the increase in GDF15 itself is very large at least100 fold, a pilot study involving only 3 pregnant women and 3 non-pregnant women will be sufficient to gain an impression of whether there is also a significant increase in CAPGDF15. The data will be used to assess whether an actual research project is worth establishing.

Purpose:

The purpose of conducting this pilot study is to investigate whether there is an upregulation of CAPGDF15 similar to that of the hormone GDF15 during pregnancy. By conducting a pilot study on 3 pregnant women and 3 control women, the investigators will see if this is actually the case before setting up an actual scientific experiment.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Healthy and fit pregnant women in the 3rd trimester. Healthy control subjects will be matched based on age and weight and must not be taking medication.  Exclusion Criteria:  Ongoing illness and/or medication intake - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - MinimumAge: 18 Years - MaximumAge: 40 Years - StdAgeList: Adult
Hearing and Structure Preservation Via ECochG
Status: Not yet recruiting

The goal of the study is to determine the benefit of using an ECochG-based corrective action guide during cochlear implant surgery compared to the traditional surgical approach without ECochG surveillance and guidance.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Aged 18 years of age or older Within cochlear implant inclusion criteria by local regulations/guidelines at the time of implantation Severe to profound hearing loss (average air conduction unaided hearing threshold of ≥ 70 dB HL for 500, 1000, 2000 and 4000 Hz) in the ear to be implanted Air conduction unaided hearing threshold ≤ 70 dB HL at 500 Hz in the ear to be implanted Less than 15 years of severe to profound deafness on the implant ear prior to surgery Post-lingually acquired hearing loss in the ear to be implanted Normal cochlear anatomy as confirmed by pre-operative imaging in the ear to be implanted Listed for an Advanced Bionics HiRes Ultra (3D) HiFocus SlimJ electrode array Listed for cochlear implant surgery under general anaesthesia Fluent in local language Given informed consent to participate in the study  Exclusion Criteria:  Abnormal cochlear anatomy (including ossification) as identified by pre-operative radiological evaluation in the ear to be implanted Any pre-existing cochlear or middle ear pathology, such as otosclerosis, cholesteatoma, or previous middle ear surgery in the ear to be implanted Any medical conditions that would increase the risk of local complications during cochlear implantation, such as autoimmune diseases or active local infections Diagnosis of auditory spectrum neuropathy disorder Deafness due to lesions of the acoustic nerve or central auditory pathway Deafened by meningitis Single sided deafness (average for 500, 1000, 2000 and 4000 Hz in the better ear ≤ 30 dB HL) Asymmetric hearing loss (average for 500, 1000, 2000 and 4000 Hz in the better ear > 30 dB HL and ≤ 55 dB HL) History of previous cochlear implantation/re-implantation on either ear Any contraindications to computed tomography (CT) scans Concurrent participation in other cochlear implant related studies - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Adding Adjuvant Cisplatin and Gemicitabine Versus Capecitabine in Triple-negative Breast Cancer Patients in Non pCR After Neoadjuvant Standard Chemotherapy
Status: Not yet recruiting

In our study; investigator aim To show efficacy and toxicity of Adjuvant cisplatin and gemcitabine in triple-negative breast cancer patients with non pathologically complete response after neoadjuvant chemotherapy To compare outcome of adjuvant cisplatin and gemcitabine versus capecitabine

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Age: 20 years and older. Patients with no clinical/radiologic distant metastasis. Tumor type: Invasive ductal carcinoma or invaive lobular carcinoma. Tumor subtype: triple negative patients had operable, primary invasive, noninflammatory early stage I-IIIB TNBC (ER and PR <1%, HER2 score: 0 or 1) Patients with a good performance status (0/1) Patients with adequate hematological, cardiac, renal, and hepatic function  Exclusion Criteria:  Patients who achieve pathologic complete response after neoadjuvant chemotherapy inflammatory breast cancer Breast cancer patients with distant metastasis Patient with hormonal receptor positive /HER2 +ve - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Feeding Pattern and Hypoalbuminemia in Pediatrics With Chronic Kidney Disease.
Status: Not yet recruiting

To determine the impact of feeding pattern on the development of hypoalbuminemia and out come of pediatric patients with chronic kidney disease.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  The study will include patient on maintenance hemodialysis with hypoalbuminemia according to] Mites SedBuffone GJed Pediatric Clinical Chemistry. 3rd ed., Press(1989)[ (Hypoalbuminemia was defined as an albumin level of less than 3.4 g/dL for patients 7 months or older and less than 2.5 g/dL for patients younger than 7 months. ) who fulfilled the following criteria will be included in the study:  Age range from 2-16 years old. Both sexes. On maintenance hemodialysis with hypoalbuminemia  Exclusion Criteria:  other causes of hypoalbuminemia such as heart disease, diabetes mellitus , hepatic failure . chronic kidney disease without hypoalbuminemia. - Gender: All - MinimumAge: 2 Years - MaximumAge: 16 Years - StdAgeList: Child - StudyPopulation: Based on determining the main outcome variable ,the estimated minimum required sample size is77. The sample size was calculated using Epi-info version 7 software, based on the following assumptions:  Main outcome variable is the role of feeding in treating hypoalbuminemia in pediatric patients with CKD . Based on previous studies ( O.S. Catherine. et al. 2002 ) the percentage of patients of chronic kidney disease with hypoalbuminemia53.1% and based on the percentage confidence limits of 7% and a Confidence level =80 - SamplingMethod: Non-Probability Sample
Non-invasive Vagal Neurostimulation (nVNS) in Adolescents With Postural Orthostatic Tachycardia Syndrome (POTS)
Status: Not yet recruiting

The purpose of this study is to determine if nVNS will decrease autonomic symptom intensity (COMPASS-31 and Child Functional Disability Inventory) in adolescent patients with postural orthostatic tachycardia syndrome (POTS) in comparison to standard recovery STEPS management.

Eligibility:
- EligibilityCriteria: Inclusion criteria:  Patient's age 12-19 years of age Newly diagnosed POTS at Mayo Clinic in Rochester Head up tilt table test results in a heart rate increase of 40 or more bpm Consent is able to be obtained appropriately per age  Exclusion criteria:  POTS patients with orthostatic hypotension POTS patients with vasovagal syncope Use of medications other than midodrine or metoprolol Inability to independently utilize the GammaCore device Inability to independently complete surveys or patient logs Patients receiving hormonal therapy other than birth control Pregnancy Prior neck surgery Metallic implant present Cardiac disorder Presence of an eating disorder Use of a feeding tube - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 12 Years - MaximumAge: 19 Years - StdAgeList: Child, Adult
Surgical-imaging Research on Obesity (SIRO)
Status: Recruiting

The global obesity epidemic is well established, and is an important public health issue. The previous researches had applied the clues that obesity is a kind of systemic disease. The investigators hypothesized that a serious alteration of the body systems will occur after bariatric surgery, which may shed light on the mechanisms of obesity. Thus, the research aims to combine the imaging and surgery to investigate the alterations of the body that induced by obese and alterations after surgery.

Eligibility:
- EligibilityCriteria: Inclusion Criteria for obesity group:  Meeting the obesity criteria (BMI > 28); 2) Meeting the indications for bariatric surgery, planning to undergo surgery for the first time; 3) Age between 18-65 years old, no gender restrictions; 4) Right-handed, of Han ethnicity; 5) Informed consent to the study, willing to cooperate with the research, and able to sign an informed consent form.  Inclusion Criteria for the Control Group:  Healthy volunteers with a BMI between 18.5-23.9; Age between 18-65 years old, no gender restrictions; Right-handed, of Han ethnicity; Informed consent to the study, willing to cooperate with the research, and able to sign an informed consent form.  Exclusion Criteria for obesity group:  Secondary obesity caused by other organic diseases or medication (such as hormone use, etc.); Unable to undergo surgery as planned; Pregnant or breastfeeding; Low cognitive ability and incapable of cooperating with the study; Eating disorders; Alcohol or drug dependence; Meeting the criteria for organic mental disorders, severe mental disorders (schizophrenia, etc.), or other serious mental illnesses requiring clinical intervention; Contraindications for MR scanning (pacemakers, cochlear implants, metal objects in the body, claustrophobia, weight exceeding the machine's load limit, etc.); History of neurological organic diseases (brain tumors, epilepsy, cerebrovascular accidents, severe head trauma, etc.); History of congenital heart disease (myocardial infarction, severe arrhythmias, heart failure, cardiomyopathy, rheumatic heart disease, congenital heart disease, etc.); Severe liver, kidney, lung, digestive dysfunction, endocrine, and blood system diseases; Active infections within the last two weeks (fever, upper respiratory infection, acute gastroenteritis, etc.); Use of drugs affecting the nervous system or psychotropic drugs within the last six months.  Exclusion Criteria for the Control Group:  The same criteria as points 3) to 13) above. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Aged between 18 and 65, regardless of gender. Initially diagnosed as obesity (BMI>28) and plan to undergo bariatric surgery. - SamplingMethod: Non-Probability Sample
Electro-acupuncture to Treat Disorder of Consciousness
Status: Recruiting

With the rapid development of life support technology, more and more people can survive severe brain injury. Some survivors regain consciousness after a period of coma, however, many patients develop prolonged disorders of consciousness (DOC), which poses a therapeutic challenge for clinicians and a heavy burden for their families. The investigators design an Electro-acupuncture to treat disorder of consciousness (AcuDoc) trial with the aim of validating the clinical effect of electroacupuncture in treating DOC and exploring its therapeutic mechanisms by integrating EEG, neuroimaging, evoked potential tests, and behavioral assessments.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Age ≥ 18 years; With cerebral damage due to TBI； Diagnosed with UWS or MCS based on at least two CRS-R assessments; From 4 to 16 weeks from the onset of brain injury; Informed consent obtained.  Exclusion Criteria:  With a history of neurological or psychiatric disorder prior to the brain injury; With uncontrolled seizures or status epilepticus; Unstable vital signs and requiring the use of vasoactive agents; With the use of general anesthetics or central acting sedative; With contraindications to the MRI; Without intact skin at acupoints or sham points; Concomitant medical illness that would interfere with the outcome assessments and/or follow-up Pregnant patients; Currently participating in other investigational trials; High likelihood of not adhering to the study treatment or the follow-up regimen - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Home-Based Action Observation Training for Chewing and Swallowing Function
Status: Recruiting

The goal of this clinical trial is to investigate the effects of home-based Action Observation Training (AOT) applied together with Functional Chewing Training (FuCT) on chewing and swallowing functions and feeding behavior in children with Cerebral Palsy (CP) who have chewing disorders. The main questions it aims to answer are:

Is the application of Home-Based AOT together with FuCT effective on chewing function in children with CP?
Is the application of Home-Based AOT together with FuCT effective on swallowing function in children with CP?
Is the application of Home-Based AOT together with FuCT effective on feeding behavior in children with CP? Within the scope of the study, children with CP will be divided into two groups as the study group and the control group. All groups will implement FuCT routines, comprising 5 sets per day, 5 days a week, for 12 weeks. Additionally, the study group will be included in an AOT program, conducted via telerehabilitation, for 1 set per day, 3 days a week, for 12 weeks, with the guidance of a physiotherapist. All children with CP will be evaluated at the beginning, after 6 weeks, and at the end of the study.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Diagnosed with Cerebral Palsy, Age between 6 and 18, IQ level of 70 or above, Having complaints related to chewing function and inability to manage solid food intake Feeding orally.  Exclusion Criteria:  Having a neurodegenerative disease other than Cerebral Palsy Having additional chronic illnesses such as systemic diseases, cancer, kidney diseases, gastrointestinal system diseases, etc., that may affect nutritional status, Experiencing visual or hearing impairment, Using any medication and/or oral device that may affect chewing performance, Having received previous chewing and/or swallowing training. - HealthyVolunteers: No - Gender: All - MinimumAge: 6 Years - MaximumAge: 18 Years - StdAgeList: Child, Adult
Interoception-Based Yoga for Chronic Pain
Status: Recruiting

The purpose of this research is to examine the feasibility and acceptability of an interoception-based yoga program for chronic pain. Interoception involves your ability to feel sensations in your body (such as your heartbeat or muscle tension) as well as how you think about and interpret those sensations. Interoception may be an important component of chronic pain and the research team is studying whether yoga can change how you feel, think about, and interpret sensations in your body.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Self-reported chronic pain lasting ≥ 3 months (such as widespread musculoskeletal pain, fibromyalgia, migraine etc.) In the past week, has pain interfered with your day-to-day activities? Yes Self-reported ambulatory ability without an assistive device Self-reported ability to get on and off the floor without assistance. No ongoing mind-body practice (<1x/week over the past 6 months). Physical Activity Readiness Questionnaire Screen Pass or Physician Consent English-speaking Able and willing to provide consent No plans to move or travel outside the area in the next 2 months  Exclusion Criteria:  Ages <18 or ≥ 65 at time of screening Pain lasting < 3 months In the past week, has pain interfered with your day-to-day activities? No Use of any assistive device (e.g. cane, walker, wheelchair). Inability to get on and off the floor without assistance. A consistent ongoing mind-body practice (mindfulness, yoga, meditation, tai chi, qigong), at least 1x/week over the past 6 months Physical Activity Readiness Questionnaire Screen Fail or non-consent of physician Non-English speaking Non-consent Plans to move or significant travel outside the area in the next 2 months Known pregnancy Recent surgery or acute bone, joint or nerve injury (within the past 6 months) Severe or progressive neurological conditions such as Parkinson's disease, dementia, multiple sclerosis, or acquired brain injury Separate pain-related diagnoses: cancer-related pain, complex regional pain syndrome, postural orthostatic tachycardia syndrome, functional neurological/ movement disorders Active or planned worker's compensation or personal injury claim Concurrent participation in another interventional study (e.g. physical activity, mind-body or drug trials) - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 64 Years - StdAgeList: Adult
Effect of Omega 3 on Oxidative Stress and Nutritional Status of Children on Regular Dialysis
Status: Recruiting

evaluaion the effects of oral omega-3 supplementation on nutritional status and oxidative stress in pediatric patients with end stage renal disease on regular hemodialysis

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  ESRD children and adolescents on regular hemodialysis for at least 3 months Age ranging from 6 to18 years.  Exclusion Criteria:  Systematic disease other than CKD eg SLE Severe active infection. Allergies to any of the ingredients in omega-3 product used in this study (e.g. fish oil, bovine gelatin). Omega-3 fatty acid or any other antioxidants consumption within the last 6 months. - HealthyVolunteers: No - Gender: All - MinimumAge: 6 Years - MaximumAge: 18 Years - StdAgeList: Child, Adult