rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
Improvement of Depression With Use of ATP
Status: Not yet recruiting

This clinical study is a randomized, double-blind, placebo-controlled trial with an intervention period of 4 weeks. Participants will be patients with moderate to severe depression who meet the inclusion criteria during the screening period. After recruitment written informed consent form will be signed and the baseline evaluation will be done then the treatment period follows. The subjects will be randomly assigned to a control group (escitalopram plus NA) and an ATP group (escitalopram plus adenosine disodium triphosphate(ATP)) in a 1:1 ratio for treatment, with a total number of 120 recruited patients. Assessment will be carried out as an analysis of changes in Hamilton Depression Rating Scale, cognitive function test, brain functional network, inflammatory markers, and other indicators in the first, second, and fourth week of intervention which will evaluate the effectiveness of ATP in improving moderate to severe depression preliminarily.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Meet DSM-V diagnostic criteria for moderate to severe depression. HAMD-24 scores ≥ 20. 18-65 female or male. Subjects who have not used any antipsychotic drugs, antidepressants, mood stabilizers (sodium valproate, lithium carbonate) or escitalopram treatment within the first month prior to the start of this study. Individuals without contraindications to SSRI. Individuals without contraindications to ATP. Written informed consent.  Exclusion Criteria:  Conduct clinical interviews using the Chinese version of the Mini International Neuropsychiatric Interview (MINI) to evaluate participants with various mental disorders other than depression (such as bipolar disorder, schizophrenia, personality split, etc.). Individuals with neurological disorders such as dementia. Individuals with a high risk of suicide. Pregnant and lactating women. Individuals with substance use disorder within one year prior to the start of this study. Contraindications to MRI. Physician evaluation was not suitable for participants in this study. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult
Evaluation of a Nutritional Technology for Vitamin D Absorption
Status: Not yet recruiting

This is a prospective, 2-group crossover, randomized, double-blind study to evaluate nutrient absorption.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Adult participants (18-55 years of age) Body mass index (BMI) <30 kg/m2 Males and nonpregnant, nonlactating females Free of gastrointestinal disorders that my impact nutrient absorption in the small intestine, endocrine, hepatic, renal, or bone diseases  Exclusion Criteria:  Use of vitamin D or calcium supplements within 3 weeks prior to the Screening Visit. Use of a tanning booth/lamp within 3 weeks prior to the Screening Visit. Travel to sunny location within 3 weeks prior to the Screening Visit. Consumption of more than 3 alcoholic drinks per day starting 48 hours before the Screening Visit. Has an allergy or intolerance to any ingredient in the study product. Participating in another study that has not been approved as a concomitant study by Abbott Nutrition.  Use of the following medications that may have interactions with vitamin D absorption or metabolism:  Aluminum-containing phosphate binders Anticonvulsants Atorvastatin Calcipotriene Cholestyramine Cytochrome P-450 3A4 substrates Digoxin Diltiazem Orlistat Thiazide diuretics Corticosteroids Stimulant laxatives Verapamil - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 55 Years - StdAgeList: Adult
Project humAn dieTary daTa rEtuRN
Status: Not yet recruiting

This study is designed to test the effects of diet data return on human dietary patterns. The investigators' working hypothesis is that returning diet data, collected via an empirical biomarker-based assessment method, will promote participant eating behavior changes towards a more healthful diet, and that these dietary patterns may also be reflected in the structure and function of the gut microbiome and in participant health outcomes. Here, the investigators will explore this hypothesis with participants supplying stool (poop) samples that will be used to assess their diet using the investigators' DNA-biomarker based method. Participants will have their diet data returned to them, and will then supply post-intervention stool samples for dietary assessment to investigate the efficacy of diet data return in impacting subject dietary patterns and health. It is anticipated that the investigators will enroll infants, children, and adults across the age span, including infants that are currently participating in Project HOPE 1000, a longitudinal observational study of mothers and infants from pregnancy through early childhood (Pro00100000). This study represents a minimal risk to subjects; namely, the potential loss of privacy involved with study participation.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Participant's parent/legal guardian is over age 18 and able to understand English Plans to remain in the area for the next two years Primary caregiver for infant less than 12 months old Able to collect and ship the requested infant stool samples  Exclusion Criteria:  There will be no specific exclusions for this study. However, the following biospecimens will not be collected for research purposes from individuals who have a condition that, in the opinion of the site investigators and/or providers, would place the subject at unacceptable risk of injury or confound data interpretation; including but not limited to:  Health conditions that impact the infant feeding in a way that may confound interpretation of study results. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MaximumAge: 12 Months - StdAgeList: Child
Mobile Micro-course Impact on Perioperative RNs in Heart Surgery Nursing.
Status: Recruiting

The goal of this clinical trialis to compare in learning effectiveness of nurses. The main questions it aims to answer are:

Can the "Micro-course" teaching enhance the awareness of cardiac surgery nursing among operating room nurses?
Can the "Micro-course" teaching boost the learning motivation and engagement of operating room nurses?
What is the satisfaction level of nurses regarding the use of "Micro-course" in cardiac surgery nursing?
What are the relevant factors influencing the effectiveness of the "Micro-course" teaching intervention?

Participants will be divided into two groups. The control group will receive online presentations, while the experimental group will engage in mobile learning combined with micro-courses. Both groups of participants will undergo instruction through asynchronous online courses.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Currently engaged in clinical surgical nursing and possess a valid nursing license. Individuals who have not received training for cardiac surgery scrub nursing or who have received such training but have not worked as a cardiac surgery scrub nurse for more than two years. Nurses involved in the collaborative use of personnel during operating room duty.  Exclusion Criteria:  Nursing supervisors at the level of charge nurse or higher. Nurses exclusively engaged in local anesthesia surgical nursing. Nurses primarily engaged in waiting room, recovery room, and anesthesia nursing. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - StdAgeList: Child, Adult, Older Adult
Social Determinants of Health, Medication Use, and Quality of Life in Inflammatory Bowel Disease
Status: Recruiting

Optimizing health related-quality of life (HRQoL) for patients with inflammatory bowel disease (IBD), who often experience a relapsing disease course, is an essential component of care. Improving IBD disease control is linked to increased health-related quality of life. Even as many effective pharmacotherapies to promote disease control are available, evidence suggests that Hispanic and Non-Hispanic Black IBD patients may not receive full benefit from these therapies compared to their Non-Hispanic White counterparts. Underlying mechanisms that contribute to observed disparities in the use of IBD medical therapies are likely multifactorial. Adequate access to treatment has been implicated. Hispanic and Non-Hispanic Black IBD patients are more likely to be Medicaid-insured, and Medicaid insurance has been associated with increased emergency room visits, a proxy for sub-optimal IBD control. Medication adherence has also been proposed as a potential mediating factor. IBD therapies can be time-consuming and costly, which can pose a challenge in achieving medication adherence. While previous studies suggest Black IBD patients have lower medication adherence than Non-Hispanic White patients, it is unclear the extent to which social factors contribute to this observation. The purpose of this study is to evaluate the association between social determinants of health, medication adherence, and HRQoL among Hispanic and Non-Hispanic Black IBD patients. Understanding potentially modifiable psychosocial factors that contribute to medication adherence and HRQoL will provide targets for later intervention towards the goal of health equity.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  clinical diagnosis of Crohn's disease, ulcerative colitis, or indeterminate colitis ≥ 3 months investigator confirmed on the basis of supportive clinical data such as colonoscopy, pathology and/or radiology age 18 years or older ability to provide informed consent in English or Spanish basic computer proficiency (i.e. to complete online survey)  Exclusion Criteria:  race and ethnicity self-identified as other than Hispanic, Non-Hispanic Black, or Non-Hispanic White - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: All patients age 18 years or older with IBD who meet the above inclusion/exclusion criteria will be eligible to participate in the study. Participants will be grouped by race and ethnicity (Hispanic, Non-Hispanic Black, or Non-Hispanic White). Participants who identify as Hispanic will be further grouped by preferred language (English or Spanish). Participants will also be grouped into either public (e.g. Medicaid, Medicare) or private insurance. The study team plans to recruit 25 participants per cell: race and ethnicity (4), study site (2), insurance (2). Target recruitment is 200 participants per site for a total of 400 participants. - SamplingMethod: Non-Probability Sample
Unilateral vs Bilateral Application of Muscle Energy Techniques in Pelvic Somatic Dysfunction
Status: Not yet recruiting

The goal of this clinical trial is to compare the efficacy of pelvic muscle energy technique online against the traditional full length osteopathic pelvic treatment protocol. The main question it aims to answer are

• Can one single pelvic muscle energy technique can correct all pelvic somatic dysfunctions (SD)?

Participants will

be positioned by the physician into the area of treatment into a position of resistance, which is the restrictive barrier.
be instructed to use the targeted muscles for 3-5 seconds in the direction of ease while the physician provides a counterforce.
be instructed to stop contracting their muscles and evaluate the area for decreased tension, then repositions the patient into their new restrictive barrier.
These steps are repeated three to five times and then the dysfunction is reevaluated.

Subjects diagnosed with pelvic SD will be divided into two groups. One group will be treated with traditional one and be compared with the pelvic muscle energy group.

Eligibility:
- EligibilityCriteria: Inclusion criteria:  Current osteopathic medical students first-and second year.  Exclusion criteria:  Acute severe pelvic pain, Pregnancy, History of pelvic trauma or surgery, Receiving osteopathic treatment for pelvic dysfunction outside this study. - HealthyVolunteers: No - Gender: All - StdAgeList: Child, Adult, Older Adult
Cannabis for Palliative Care in Cancer
Status: Not yet recruiting

Many cancer patients suffer from pain, sleep, and mood problems and are using cannabis to relieve these symptoms. Cannabis may provide such relief but may also produce negative side effects including cognitive impairment, an especially problematic issue for cancer patients, indicating more research on cannabis use in the cancer context is required. In this endeavor, the present study seeks to compare the use of hemp-derived CBD (Cannabidiol) with and without THC (Delta-9-tetrahydrocannabinol) versus placebo on measures of sleep, pain, mood, subjective and objective cognitive functioning, and quality of life within 185 cancer patients.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Able to provide informed consent Aged ≥25 years at Visit 1 (Baseline) Have a diagnosis of any solid tumor type and is currently undergoing or has undergone either curative or palliative treatment in the past 18 months Currently experiencing symptoms of sleep problems, pain, and/or mood disturbance (i.e., depression, anxiety) Desire to use cannabis to treat their symptoms Must not have been regularly using any cannabis products (more than 3x/month) in the last 6 months Willing to practice acceptable methods of birth control until completing study medication  Exclusion Criteria:  Report of illegal drug use (e.g., cocaine, methamphetamine) in the past 90 days Current use of anti-epileptic medications (e.g., clobazam, sodium valproate, lamotrigine) Current use of medications known to have major interactions with Epidiolex (e.g., buprenorphine, leflunomide, levomethadyl acetate, lomitapide, mipomersen, pexidartinib, propoxyphene, sodium oxybate, teriflunomide) Current use of anti-psychotic medications Current use of potent CYP2C19 or CYP3A4 inducers (e.g., Rifampin, apalutamide, carbamazepine, enzalutamide, ivosidenib9, lumacaftor, ivacaftor, phenytoin, St. John's wort, Fosphenytoin, Mitotane, Phenobarbital, Primidone) Liver function tests (Alanine transaminase [ALT] and Aspartate transaminase [AST]) levels ≥2x the upper normal limits Moderate or severe liver disease Past or current diagnosis, or family history of diagnosis, of psychosis; current major psychiatric illness, such as bipolar disorder, major depression, or schizophrenia History of seizures For female participant of childbearing potential: Pregnant or lactating at the time of study enrollment or trying to become pregnant. Lack of childbearing potential confirmed by a history of amenorrhea for at least 12 consecutive months and serum FSH level within the laboratory's reference range for postmenopausal females OR documented bilateral oophorectomy and/or hysterectomy Physician response to passive consent indicating contraindications for participation. Unwilling to refrain from cannabis use other than study drug for the entire study duration Men who consume more than 2 alcoholic beverages per day and women who consume more than 1 alcoholic beverage per day - HealthyVolunteers: No - Gender: All - MinimumAge: 25 Years - StdAgeList: Adult, Older Adult
Efficacy Evaluation of Chang Geng Healthy Drink on Patients With Non-alcoholic Fatty Liver Disease
Status: Not yet recruiting

For non-alcoholic fatty liver disease, there is currently no effective treatment options. Traditional Chinese medicine (TCM) has a long history of treating liver diseases. However, TCM treatment methods are diverse, and there is currently a lack of high-quality clinical research to confirm the efficacy of Chinese herbal medicine. Thereafter, Chang-Gung Healthy Drink which is a TCM based healthy drink may be used to alleviate the clinical adverse event of non-alcoholic fatty liver disease patients.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Male and female participants aged between 20 and 75 years old. Capable of understanding and signing the Informed Consent Form (ICF) document. Diagnosed by a physician with non-alcoholic moderate fatty liver. Liver function index, AST or ALT, elevated to 2 to 5 times the normal value for more than 1 month.  Exclusion Criteria:  Diagnosed with alcoholic fatty liver, viral hepatitis, autoimmune hepatitis, Wilson's Disease, drug-induced hepatitis, or hemochromatosis. Currently suffering from major illnesses such as cancer, stroke, end-stage kidney disease, cirrhosis. Men who consume more than 140g of alcohol per week, or women who consume more than 70g of alcohol per week. Consuming other chinese herbal medicine. Pregnant or lactating women. Patients using lipid-lowering and diabetes medications. Patients with Covid-19. - HealthyVolunteers: No - Gender: All - MinimumAge: 20 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult
Prophylactic Endobronchial Tranexamic Acid to Reduce Bleeding in Transbronchial Cryobiopsy
Status: Not yet recruiting

Transbronchial cryobiopsies are common procedures used to obtain tissue samples from airways for diagnostic purposes. While these procedures are safe, there is a risk of bleeding from the biopsy site. We are conducting a research study to assess the safety and effectiveness of using tranexamic acid prior to undergoing a transbronchial cryobiopsy.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Age ≥18 Signed informed consent Receiving a transbronchial cryobiopsy  Exclusion Criteria:  Age below 18 Pregnancy Bleeding diathesis (INR >1.5 or known hematological problems) Subarachnoid hemorrhage Any active bleeding (any site) Decompensated liver disease Active intravascular clotting Prior VTE On oral contraceptive therapy Platelet count less than 50,000 Use of antiplatelet medication other than low-dose aspirin within 5 days of procedure Use of therapeutic anticoagulation within the last 24 hrs Known severe pulmonary hypertension (pulmonary artery systolic pressure > 60 mmHg) Chronic renal failure (estimated GFR below 30 mL/min) Allergy or hypersensitivity to tranexamic acid or any of its ingredients Prisoners Comfort care planned or initiated within 72 hours of admission - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Dismantling the U.S. Social Norm of the "Kids' Food" Archetype (REACH Project)
Status: Recruiting

This project is the first stage of a health promotion campaign to shift social norms about marketing and feeding children ultra-processed foods. Embedded within a longitudinal ethnographic study using photo-elicitation techniques, mothers of preschool-age children will be randomly assigned to arts-based or traditional education about ultra-processed food.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  English-speaking African American or Black or bi-racial or multi-racial African American and Black mothers >18 years Female Legal guardian of a preschool-age child (3-5 years) participating in the Leaguers, Inc.  Head Start programming.  Exclusion Criteria:  Spanish-speaking Other racial and ethnic groups Fathers - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - GenderBased: Yes - GenderDescription: Self-representation - MinimumAge: 18 Years - MaximumAge: 85 Years - StdAgeList: Adult, Older Adult
MNK Therapy in Releasing the Superficial Fascia for Patients With AAS: an Assessor-blinded, Randomised Controlled Trial
Status: Recruiting

The goal of this type of randomized controlled trial, employing a blinded evaluator methodology, to verify the clinical efficacy and safety of MNK therapy. This aims to provide a reference for clinical practitioners and AAS patients in their decision-making process.

Participants will randomly allocated into two groups using a random number table method, with forty patients in each group. The experimental group (Group 1) underwent MNK therapy to release the superficial fascia, while the control group (Group 2) received conventional acupuncture treatment.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  16 to 55 years old Clear history of trauma within 1 to 7 days Presence of localized swelling, pain, bruising, and limping symptoms in the ankle joint Pain in the ankle joint upon resistance No accompanying fractures Diagnosis of acute ankle injury according to the "Diagnostic and Therapeutic Criteria of Traditional Chinese Medicine" No prior treatment before participating in this therapy Willingness to participate in this study and signing of the informed consent form  Exclusion Criteria:  Individuals with clear indications for surgery Those suffering from gout, rheumatoid arthritis, joint tuberculosis, joint tumors, etc. Pregnant or breastfeeding women Individuals with serious primary diseases of the cardiovascular, liver, kidney, brain, and hematopoietic systems Those with local skin lesions or skin diseases Individuals with coagulation dysfunction Those with severe fear of needles Individuals unwilling to comply with the treatment regimen - HealthyVolunteers: No - Gender: All - MinimumAge: 16 Years - MaximumAge: 55 Years - StdAgeList: Child, Adult
Examining the Effect of Occupational Therapy-Based Parent Coaching on Feeding Problems in Children With a Preterm Birth
Status: Not yet recruiting

Feeding problems are common in children with a history of premature birth, and these problems continue into early childhood. Feeding problems are affected by many biopsychosocial factors, and the context in which feeding takes place and the attitudes and behaviors of parents can also be effective in the emergence or continuation of these problems. The aim of our study is to evaluate the effects of occupational therapy-based parent coaching intervention on mothers and their children, who are considered to be primarily responsible for the feeding of children in our country. 46 mothers with premature children will be included in our study and participants will be randomly assigned to intervention/control groups. Mothers will fill out a sociodemographic information form, Behavioral Pediatric Feeding Assessment Scale, Sensory Profile Questionnaire - Oral Sensory Processing Subtest, Family Feeding Strategies Scale and Parental Self-Efficacy Scale via Google forms. Mothers in the research group will be given online occupational therapy-based parent coaching training for 10 weeks. Second evaluations will be carried out after the training; Final evaluations will be applied after 1 month of follow-up.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Prematurity of the child (Birth week <37) The child is between 3-6 years old The mother must have the competence to use online platforms, technological tools and internet connection. The mother must have sufficient education to read, understand and fill out the scales. Mothers reporting complaints about feeding problems in their children  Exclusion Criteria:  It may affect the child's feeding; Having a food allergy, disability, neurodevelopmental disease, chromosomal or structural anomalies The child is fed non-orally Being receiving occupational therapy, oral motor therapy or nutritional therapy at any center Not allowing practices such as video sharing, camera/audio sharing, and recording of sessions during the intervention. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - GenderBased: Yes - GenderDescription: Our intervention is aimed at mothers of children with a history of premature birth. - StdAgeList: Child, Adult, Older Adult