rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
Effects of Mediterranean Diet on Subjective Cognitive Decline
Status: Recruiting

Research Questions:

Due to the fact that most participants in past clinical trials on the Mediterranean diet were cognitively healthy individuals, and while the observed effects were significant, they were not particularly substantial, does the Mediterranean diet have similarly significant and more pronounced effects on both physical and cognitive functions in older adults with subjective cognitive decline (SCD)?
What is the mechanism behind the effects of the Mediterranean diet on physical or/and cognitive function? Is it through vascular protection or improvements in brain structure/brain network function?

Research Objective:

Conduct a cross-over randomized controlled trial to investigate the effects of a three-month Mediterranean diet on the physical and cognitive functions of older adults with subjective cognitive decline (SCD) in the community. Utilize brain MRI and circulatory biomarkers measurements to elucidate the underlying mechanisms.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Subjective cognitive decline (SCD)-plus subjects, individuals must meet five criteria:  Subjective memory decline without impairment in other cognitive domains (MMSE > 26; MMSE > 14 for <6 years of education). Onset of subjective cognitive decline within the past 5 years. Age at the onset of subjective cognitive decline is >60 years. Concern and preoccupation with memory decline. Perceived functional decline relative to peers and meet one of three criteria: a. Caregiver perceives cognitive decline; b. Carries APOE ε4 genotype; c. Clinical evidence of preclinical Alzheimer's disease biomarkers.  Exclusion Criteria:  Exclude individuals who:  Cannot comply with or accept the dietary intervention (e.g., dietary restrictions, vegetarianism, lactose intolerance). Have walking speed ≤ 0.3 meters/second. Have significant medical conditions affecting physical and cognitive functions. Have chronic kidney disease (eGFR <30 ml/min/1.73m2) or undergo dialysis. Experience poorly controlled cardiovascular diseases or malignant tumors. Have severe visual and hearing impairments preventing assessments. Have undergone hormone therapy in the preceding three months or are expected to during the trial. - HealthyVolunteers: No - Gender: All - MinimumAge: 60 Years - StdAgeList: Adult, Older Adult
Alveolar-capillary Reserve After Exercise in Chronic Obstructive Pulmonary Disease (COPD) (COP-DTPA)
Status: Not yet recruiting

It is unknown whether individuals with COPD exhibit abnormal alveolar-capillary breaching during exercise, and whether this contributes to exertional dyspnoea. The aim of this study is to investigate whether individuals with COPD exhibit an abnormal increase in alveolar-capillary breaching during exertion, as indicated by an increase alveolar-capillary permeability with a concomitantly exacerbated increase in lung tissue mass.

Eligibility:
- EligibilityCriteria: Inclusion criteria - individuals with COPD  Men and women 45-80 years old COPD (GOLD stage I to III) Resting arterial oxygenation > 90%  Inclusion criteria - healthy controls  Men and women 45-80 years old Non-smokers Normal lung function Same sex, age (± 3 years) as the COPD group  Exclusion criteria - individuals with COPD  Symptoms of ischemic heart disease Known heart failure Symptoms of illness, including fever, within 2 weeks prior to the study Pregnancy • Known renal or liver diseaseActive smoking (within 3 weeks)  Exclusion criteria - healthy controls  Known chronic lung disease Symptoms of ischemic heart disease Known heart failure Symptoms of illness, including fever, within 2 weeks prior to the study Pregnancy Known renal or liver disease Active smoking (within 3 weeks) - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 45 Years - MaximumAge: 80 Years - StdAgeList: Adult, Older Adult
Role of FAPI PET/MR Combined With Gadoxetate Disodium in Assessing Hepatic Malignancies
Status: Recruiting

This study aimed to prospectively evaluate the utility of fibroblast activation protein inhibitor (FAPI) positron emission tomography (PET)/magnetic resonance (MR) combined with gadoxetate disodium in patients with clinical suspected hepatic malignancies (lesion diameter ≤ 3.0cm), with histopathological findings obtained from biopsy or resected surgical specimens, or follow-up results as reference standards.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patient ≥ 18 years of age at the time of consent; Patients with suspected, newly diagnosed, or previously treated liver cancer; Estimated creatinine clearance > 30ml/min; Provided written informed consent authorisation before participating in the study.  Exclusion Criteria:  Allergic to the gadoxetate disodium； MRI contraindications, not limited to cardiac implantable electronic devices and claustrophobia; Weight > 90Kg; Pregnancy or lactation; Active inflammation may affect FAPI imaging. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: The subjects the investigators selected are adults who are not restricted by gender. - SamplingMethod: Probability Sample
An Exploratory RWE Study Exploring Effects of a Goat Milk Based Young Child Formula on Health Benefits
Status: Not yet recruiting

This is an exploratory real-world study designed to gain insight into the role of the product in terms of health benefits in toddlers, with the potential to generate hypotheses on key and other exploratory objectives.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Age between 1-2 years of age Healthy term infants, gestational ages 37~42 weeks Birth weight within normal range for gestational age and sex (10th to 90th percentile of the Chinese Child Growth Chart); Normal weight, height at screening (10th to 90th percentile of the Chinese Child Growth Chart) Chinese population; Subjects whose parents/guardians are intending to goat formula feed according to protocol during the study period; Informed consent from one parent or legal representative; Subjects whose parents/guardians are adults, have sufficient ability in Chinese to complete informed consent and other study documents; Subjects whose parents/guardians are able to use smart phone with cameras; install and use a secure WeChat platform on the mobile phone during the study period; connect to the network through the mobile phone; take photos to record stool; complete questionnaires; Subjects whose parents/guardians can be directly contacted by telephone or WeChat throughout the study.  Exclusion Criteria:  Probiotics or probiotics-supplemented products use within 4 weeks prior to enrolment; Goat-milk based formula or fresh goat milk use within 4 weeks prior to enrolment; Special infant formula use within 4 weeks prior to enrolment, including but not limited to hydrolysed infant formula, lactose-free infant formula and anti-reflux infant formula etc.; Known allergy to milk products or soy product; Medially diagnosed disorders requiring a special diet, including but not limited to reflux esophagitis, phenylketonuria etc; Significant congenital abnormality or other health conditions that could affect the outcome measurements; Investigator's uncertainty about the willingness or ability of the parents to comply with the protocol requirements; Participation in any other studies involving investigational or marketed products concomitantly or within 4 weeks prior to entry into the study. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 1 Year - MaximumAge: 2 Years - StdAgeList: Child
Experience of Parents/Carers of Children With Severe Motor Disabilities Suffering From Spinal Pain?
Status: Not yet recruiting

Parents of disabled children suffer from back pain more frequently than the general population. At present, the literature does not identify any specific factors responsible for this suffering.

For patients suffering from chronic back pain, there are specific treatment programmes in the Physical Medicine and Rehabilitation Department, with a focus on pain management.

The investigators would like to develop specific programmes for parents/carers of children/adolescents with severe motor disabilities.

To achieve this, it is important to gain a better understanding of the factors that contribute to the onset of pain.

With this in mind, the investigators are conducting a qualitative study to gain a better understanding of the day-to-day lives of these parents.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Parents or carers of children with severe motor disabilities complaining of spinal pain  Exclusion Criteria:  Parent/carer refusing to participate - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Parents or carers of children with severe motor disabilities complaining of spinal pain - SamplingMethod: Probability Sample
5-Years PMCF Study of Ceramic Dental Implants One-piece Versus Two-piece.
Status: Recruiting

The goal of this cohort observational study is to compare in the survival rate of ceramic dental implants placed in patients with missing or hopeless teeth . The main question[s] it aims to answer are:

Are there any significant differences in survival rate between the use of one-piece ceramic implant versus the two-piece (TL) variant?
What are the complications associated to the procedure and differences between the two groups.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Clinical Diagnosis of partial or total edentulism. Specially indicated for patients with metal allergies and chronic illness due to metal allergies.  Exclusion Criteria:  General Contraindications:  Local and Systemic contraindications for surgery. Poor oral hygiene Patients with health problems, disease or any physical or psychological condition to which an oral surgery may be contraindicated.  Relative Contraindications:  Previously irradiated bone diabetes anticoagulant medication hemodynamic problems bruxism Para functional habits bad bone anatomy smokers none controlled periodontitis malocclusions TMJ problems diseases in the oral cavity pregnancy insufficient oral hygiene for adequate health.  Local contraindications  insufficient bone quantity or quality remaining of roots localized periodontal disease Any pathology in the neighboring teeth. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: The geographic population of study will be the patients in two different private dental centers located in Barcelona (Spain) and Boulder (Colorado, USA). - SamplingMethod: Non-Probability Sample
Video-respiratory Polygraphy in Children
Status: Not yet recruiting

The diagnosis of obstructive sleep apnea-hypopnea syndrome in children (OSAS) requires a polysomnography (PSG) in a sleep lab with video surveillance and monitoring by a nurse. But PSG is a cumbersome exam, sometimes difficult to perform in children. Simplified exams as respiratory polygraphy (RP) which uses only respiratory signals can be used for the diagnosis of OSAS but studies show that it underestimates the obstructive apnea-hypopnea index (OAHI) because the total sleep time cannot be accurately estimated. The use of a video camera with software synchronous with the RP software could compensate for this disadvantage, by estimating when the child is sleeping or not.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Children with suspicion of OSAS Interpretable polysomnography  Exclusion Criteria:  Non-interpretable polysomnography - HealthyVolunteers: No - Gender: All - MinimumAge: 2 Years - MaximumAge: 19 Years - StdAgeList: Child, Adult - StudyPopulation: Children aged 2 to 19 years adressed for a PSG in routine clinical care for suspicion of OSAS by the ear-nose-throat physician, pediatric pulmonologist, sleep specialist, endocrinologist, genetician. - SamplingMethod: Non-Probability Sample
The Predictive Biomarkers in Patients With Locally Advanced Non-small Cell Lung Cancer
Status: Recruiting

This study is a prospective cohort study to evaluate the peripheral blood lymphocyte subsets as predicative biomarkers reflecting the efficacy and toxicity in patients with locally advanced non-small cell lung cancer (NSCLC) received chemoradiotherapy (CRT) with or without immune checkpoint inhibitors (ICIs).

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Age 18-75 years; ECOG score 0-2. Pathologically confirmed locally advanced NSCLC according to the 8th AJCC staging system. Received definitive radiotherapy, concurrently or sequentially combined with platinum-based doublet chemotherapy. No serious medical diseases and dysfunction of major organs, such as blood routine, liver, kidney, heart and lung function.  Exclusion Criteria:  Pathologic type was adenocarcinoma with EGFR gene mutation or ALK gene rearrangement. Patients with other active malignancies within 5 years or at the same time. Active or previously documented autoimmune or inflammatory diseases (including inflammatory bowel disease, diverticulitis [except diverticular disease], systemic lupus erythematosus, Sarcoidosis syndrome, Wegener' s syndrome). History of allogeneic organ transplantation. History of active primary immunodeficiency. Patients with uncontrolled concurrent diseases, including but not limited to persistent or active infection (including tuberculosis, hepatitis B, hepatitis C, human immunodeficiency virus, etc.), symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, uncontrolled arrhythmia, active interstitial lung disease, severe chronic gastrointestinal disease with diarrhea or mental illness. Women of child-bearing potential who are pregnant or breastfeeding. The investigator judged other situations not suitable for inclusion in this study. - Gender: All - MinimumAge: 18 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Consecutive locally advanced NSCLC patients treated with definitive CRT with or without ICIs at hospital. - SamplingMethod: Non-Probability Sample
Semaglutide 2.4mg for Low Responders After Bariatric Surgery
Status: Not yet recruiting

In 20 - 30% of the patients, the low responders, sufficient weight loss is not achieved after bariatric surgery. Secondary and/or tertiary bariatric procedures can lead to successful weight loss and resolution of comorbid conditions though, morbidity and mortality rates of these procedures are high. Therefore, additional pharmacotherapy has been suggested. Semaglutide is one of the medications that might improve outcome in the post-bariatric population. Semaglutide is a Glucagon-like peptide-1 (GLP-1) receptor analogue developed to treat type 2 diabetes. It causes glucose-dependent insulin secretion, promotes satiety and inhibits glucagon secretion. In obese (non-bariatric) patients, semaglutide has shown to improve glycemic control, decrease blood pressure, lower cardiovascular risk, and decrease body weight.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  BMI before surgery was ≥ 35.0 kg/m2 Patient is treated with group consultation at the NOK Patient has undergone a primary (banded) RYGB or (banded) sleeve gastrectomy (SG) Patient is in the lowest %TWL quartile, 3 months after surgery and will be enrolled in the plus module.  Exclusion Criteria:  Gastropareses or gastro-intestinal complaints after bariatric surgery Type 1 or type 2 diabetes and/or diabetic retinopathy Decreased renal function (creatinine clearance < 30 ml/min) Liver failure (all) Congestive heart failure or angina pectoris NYHA class III and IV Malignancy in history Pancreatitis (in history) (expected) Pregnancy / breast-feeding Inflammatory Bowel Disease Thyroid malignancy in history Use of warfarin or other coumarin derivates - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult
An Investigation Into Taste Problems Associated With Xerostomia in Patients With Advanced Cancer
Status: Recruiting

Taste problems and xerostomia (dry mouth) are common among patients with advanced cancer. These symptoms can affect the pleasure of eating and drinking, reduce dietary intake, cause low mood, and a lower quality of life. This study will explore the relationship between dry mouth and taste problems in patients with advanced cancer.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  18 years of age Diagnosis of locally advanced or metastatic cancer Referred to palliative care/oncology services Dry mouth rated 'moderate' or worse over previous 2-week period Taste problems rated 'moderate' or worse over previous 2-week period Good understanding of English  Exclusion Criteria:  Cognitive impairment (unable to provide consent / complete questionnaire) Dry mouth precedes cancer diagnosis. Taste problems precedes cancer diagnosis. Head and neck surgery Head and neck radiotherapy Salivary gland disorders (e.g., Sjogren's Syndrome) In the 'Deteriorating' or 'Terminal' Phase of illness - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients who are currently under the care of oncology or palliative care who have an incurable cancer. Patients will be identified by the clinical teams at the study sites, informed about the study, and (if interested in taking part in the study) referred to the research team.  Participants will be screened for inclusion by asking, "1. Over the last 2 weeks have you experienced having a dry mouth? 2. Over the past 2 weeks have you experienced taste problems?" If yes to either question, "How severe was it? (Options- Slight/Moderate/Severe/Very severe)". Patients must score as moderate/severe/very severe. - SamplingMethod: Non-Probability Sample
High-heeled Shoes in a Sample of Young Women
Status: Recruiting

At a postural level, many doctors, physiotherapists and chiropractors are convinced that lower back pain induced by heels is due to an increase in lumbar lordosis associated with an anterior pelvic tilt; this thought is even shared by the American Chiropractic Association and the American Physical Therapy Association.

Furthermore, in most of the websites consulted, even by non-experts, the reason for the onset of spinal pain is attributed to hyperlordosis and pelvic anteversion. However, this thought is not entirely in agreement with other scientific publications. Therefore it is necessary to pay attention to online searches which often answer these questions without taking EBM into account.

None of the studies reported above take into consideration the time factor. In fact, all the studies have evaluated the immediate changes brought about by heel raising. Women who complain of lower back pain when wearing high-heeled shoes rarely experience pain as soon as they start wearing them.

The objective of the research arises from these considerations. The aim of this study (primary outcome) is to investigate whether wearing high-heeled shoes for at least 2 hours modifies the spinopelvic parameters compared to the barefoot condition and as soon as the shoes are worn.

The secondary outcome will be to verify in the sample analyzed whether there are different behaviors between the subgroups of those who have complained in their anamnesis and those who have never complained of lower back pain when using high-heeled shoes for a few hours.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  female subjects aged between 20 and 40 years Usual users of shoes with heels at least 7 cm high, with a frequency of at least twice a week and/or less than 3 hours/week  Exclusion Criteria:  structural or neurological anomalies that may prevent you from remaining weight-bearing, for approximately 2 hours, with shoes having a heel (difference between the heel and the plateau) of at least 7 cm high; - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - MinimumAge: 20 Years - MaximumAge: 40 Years - StdAgeList: Adult - StudyPopulation: Usual female users of shoes with heels at least 7 cm high, with a frequency of at least twice a week and/or less than 3 hours/week - SamplingMethod: Non-Probability Sample
Revolade Tablets Specified Drug-use Survey
Status: Not yet recruiting

This is a multicenter, single-arm, non-interventional study (NIS) to confirm the safety and efficacy of eltrombopag in Anti-Thymocyte Globulin (ATG) treatment naive pediatric patients with aplastic anemia (AA).

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients whose legally acceptable representative has given written consent for cooperation in this survey prior to enrollment in this survey Patients aged ≥ 6 years and < 18 years at the start of treatment with eltrombopag Pediatric patients with AA who receive eltrombopag for the first time in combination with ATG after the approval of additional dosage and administration for "ATG-naïve pediatric patients with AA"  Exclusion Criteria:  Patients who have received ATG without concomitant use of eltrombopag Patients with congenital AA Patients with suspected or confirmed diagnosis of myelodysplastic syndrome (MDS) at the start of treatment with eltrombopag Patients who have received any drug products containing the same ingredient as eltrombopag (including investigational products) - HealthyVolunteers: No - Gender: All - MinimumAge: 6 Years - MaximumAge: 17 Years - StdAgeList: Child - StudyPopulation: The survey will be conducted in pediatric patients with Aplastic anemia (AA) who receive eltrombopag for the first time in combination with ATG after the approval of additional dosage and administration for "ATG-naïve pediatric patients with AA." - SamplingMethod: Non-Probability Sample
Feasibility and Acceptability of Incorporating Smartwatches Into an Exercise is Medicine Program in Older Individuals
Status: Not yet recruiting

The effects of exercise on prevention and improved control of chronic diseases, reduced mortality, and improved quality of life are well established. Exercise has been shown to prevent heart disease, stroke, type 2 diabetes, depression, and certain types of cancers. In addition to prevention, physical activity is included in the standard or care for many chronic diseases and used in treatment. For example, the American Diabetes Association has identified positive health behaviors like physical activity as foundational in the treatment and management of disease and improving overall quality of life.

The Ohio State University Wexner Medical Center Exercise is Medicine Program (EIM) is a physician referral program that aims to increase physical activity to prevent and reduce complications from chronic disease.

The integration of technology among a 65+ population of EIM participants provides a novel approach to improving individual's health. Thus, our study aims to provide EIM participants aged 65+ with smartwatches in the hopes of increasing their overall physical activity levels.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Age 65+ No healthcare provider-imposed limitations on physical activity English-speaking  Exclusion Criteria:  Symptoms suggestive of coronary artery disease (CAD) or congestive heart failure (CHF) (i.e. chest pain, dizziness, syncope, excessive dyspnea on exertion) Myocardial infarction within the last 12 months Revascularization within the last 12 months Stroke/transient ischemic attack (TIA) within the past 12 months Unstable angina Congestive heart failure (New York Heart Association (NYHA) Class II, III or IV) Ventricular arrhythmia Clinically significant cardiac valve disease Blood pressure >160/100 mmHg Uncontrolled seizure disorder Major surgery within the past three months Severe or frequent hypoglycemia Inability to independently manage blood glucose during activity Severe autonomic or peripheral neuropathy Active foot ulcers Unstable retinopathy. - HealthyVolunteers: No - Gender: All - MinimumAge: 65 Years - StdAgeList: Older Adult