rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
The Effect of Mandala Therapy on Anxiety and Comfort in Kidney Transplant Recipients
Status: Not yet recruiting

The aim of this study is to evaluate the impact of mandala art therapy on the anxiety and comfort levels of living kidney transplant recipients. While kidney transplantation improves the recipients' quality of life, it may also expose them to psychological, physical, and social challenges post-transplant. This situation can increase recipients' levels of anxiety, making them cope with psychiatric issues and affecting their comfort levels. Feeling psychologically and physiologically comfortable is a crucial component of a successful recovery process for recipients.

Mandala art therapy is known as an effective method that supports the mental health, physical functioning, and social and emotional well-being of individuals with health issues. Mandalas can contribute to comfort by promoting inner peace, focusing attention, and encouraging creative expression. This study aims to investigate the impact of mandala art therapy on anxiety and comfort levels in kidney transplant recipients. To achieve this goal, a mixed-methods study using a randomized controlled and nested experimental design is planned.

The results of this study will provide valuable insights to healthcare providers by elucidating the impact of mandala art therapy on comfort and anxiety levels in living kidney transplant recipients. This information may guide healthcare professionals in enhancing kidney transplant recipients' psychological and emotional well-being, reducing stress, and promoting higher levels of comfort through mandala art therapy.

H0a: There is no effect of Mandala Art Therapy on the perceived anxiety level in living kidney transplant recipients.

H0b: There is no effect of Mandala Art Therapy on the comfort level of living kidney transplant recipients.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Being 18 years of age or older Being a kidney transplant recipient Willing to participate voluntarily in the study Having person, place, and time orientation Undergoing kidney transplant for the first time  Exclusion Criteria:  Having a diagnosed psychiatric illness Having a physical disability that would hinder drawing - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Specifying the Anti-inflammatory Effects of Ziltivekimab
Status: Not yet recruiting

The goal of this randomized, double blind, placebo controlled trial is to study whether ziltivekimab therapy reduces arterial wall inflammation as assessed by imaging, and reduces the systemic inflammatory tone as assessed by circulating monocytes, inflammatory biomarkers and proteomics.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Aged 50 years and older. Multi-vessel coronary artery disease (defined as CAD-RADS ≥2). Serum hsCRP level ≥2 mg/L.  Exclusion Criteria:  Coronary stents in situ. Chronic or recent (<1 month) (serious) infections and/or clinical signs of acute (serious) infection. History of severe auto-immune diseases, or other (severe) (recurrent or chronic) inflammatory disorders. Use of preventive systemic antibiotics (antibiotics used to treat latent tuberculosis are exempted). Stable lipid lowering treatment for less than 4 weeks, including statins, ezetimibe and PCSK9 inhibition. Untreated latent tuberculosis, active hepatitis B (positive HBsAg and/or positive anti-HBc with detectable HBV DNA) or C, human immunodeficiency virus (HIV) not on stable antiretroviral regimen Uncontrolled diabetes (HbA1c >90 mmol/mol). Renal insufficiency, defined as eGFR <45 ml/min/1.73 m2. Platelet count <120,000 and >450,000 /mm3. Elevated liver enzymes (>3 ULN of liver transaminases), acute liver failure or known (severe) liver disease. Premenopausal women not using birth-control. History of gastrointestinal perforation, active diverticulitis (within 5 years) or active inflammatory bowel disease (within 12 months). Uncontrolled hypertension (systolic >180 mmHg; diastolic >110 mmHg). Diagnosis of (active) malignancy in last 5 years. Standard contra-indications to 68Ga-DOTATATE PET, and CT based on physician's experience and current practices. Inability or unwillingness to comply with the protocol requirements, or deemed by investigator to be unfit for the study. - HealthyVolunteers: No - Gender: All - MinimumAge: 50 Years - MaximumAge: 85 Years - StdAgeList: Adult, Older Adult
Feasibility of Aerobic Exercise for Recovery From Work-related Concussion
Status: Not yet recruiting

There is a lot of research on how to treat people with sport-related concussion. There has not been a lot of research on the treatment of injured workers with concussion. An exercise program has been developed for people with sport-related concussion. It is suspected that this program may be helpful for injured workers with concussion too. This study will test the effect of this exercise in injured workers with concussion.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Aged 18-40 Received a concussion at work and are engaged with the workers compensation program Within 3 weeks of concussive injury  Exclusion Criteria:  3-point or less difference between current and pre-injury symptoms as measured by the Post-Concussion Symptom Inventory (PCSI) Moderate or severe TBI Injury involving loss of consciousness for >30 minutes or post-traumatic amnesia > 24 hours Pre-existing conditions or presence of polytrauma that prevent participation in active testing and/or rehabilitation History of more than 3 diagnosed concussions Active substance abuse/dependence Report of injury mechanism occurring due to physical assault Unwillingness to perform intervention Limited English proficiency. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 40 Years - StdAgeList: Adult
The Effect of Using a Stress Ball During Vaginal Examination on Anxiety and Pain Levels: A Randomized Controlled Study
Status: Not yet recruiting

Women who will undergo vaginal examinations randomly assigned to intervention (n = 44) and control (n = 44) groups at a public hospital in Turkey will participate in the study. Stress ball application before vaginal examination will be explained to women in the intervention group. These women will be asked to tighten and loosen the stress ball given to them during the vaginal examination and continue this process until the examination is completed. Data regarding pain and anxiety outcomes will be collected before and after the examination.

The main questions it aims to answer are:

question 1: What is the effect of stress ball application on women's anxiety level during vaginal examination?
question 2: What is the effect of stress ball application on women's pain level during vaginal examination?

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Volunteer to participate in the research, Those between the ages of 18-65, Applying to the polyclinic for vaginal examination, It is planned to recruit women who can read and write Turkish.  Exclusion Criteria:  Pregnant, Having a diagnosed psychiatric problem such as depression, anxiety disorder, panic attack, bipolar affective disorder or schizophrenia It is planned to exclude women with visual, hearing, speech, physical, or mental disabilities. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult
Sensory Motor Interventions on Preterm Infants
Status: Not yet recruiting

Preterm infants experiencing bottle feeding difficulties will be included in this study. Two distinct interventions, oral stimulation (OS) and infant massage (IM), will be administered in this study. The objective of this clinical trial is to compare the effectiveness of these two approaches, either individually or in combination, in improving the feeding performance and development of participants.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  < 34 weeks' gestational age 34~40 weeks' postmenstrual age at enrollment being fed by oral for at least 2 days but with poor feeding performance defined as consuming less than 80% of the prescribed volume for the half or more feedings weaning the ventilator and maintaining stable physiological status  Exclusion Criteria:  Congenital anomalies Confirmed or suspected chromosomal or genetic abnormalities Unsolved seizure, sepsis, necrotizing enterocolitis(NEC) - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MaximumAge: 34 Weeks - StdAgeList: Child
Correlation of Blood Gene Expression (TruGraf Liver) With Liver Biopsy in Pediatric Liver Transplant Recipients
Status: Recruiting

Liver transplant rejection is when the body's immune system attacks and damages the liver of a transplant recipient. Currently the best way to see if that is happening is with a liver biopsy. The purpose of this research study is to see if a simple blood test can diagnose if a transplanted liver is being rejected.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  • All liver transplant patients at least 1 year of age and less than 18 years of age undergoing surveillance or for-cause liver biopsy  Exclusion Criteria:  • Non-English, non-Spanish Speaking - HealthyVolunteers: No - Gender: All - MinimumAge: 1 Year - MaximumAge: 17 Years - StdAgeList: Child - StudyPopulation: Pediatric Liver Transplant - SamplingMethod: Non-Probability Sample
EQUITY GI: A Prospective Study to Enhance Quality, Inclusivity, and Trial Participation in Black Patients With Gastrointestinal Cancer.
Status: Not yet recruiting

This research study is being conducted to improve the quality of care of participants who have a diagnosis of gastrointestinal cancer (anal, colon, rectal, esophageal, stomach, small bowel, appendix, pancreas, gall bladder, liver, neuroendocrine tumor of gastrointestinal origin).

This study has 3 components as follows-

Ensuring appropriate biomarker testing and evidence-based care: Biomarkers are molecules in the tumor or blood that indicate normal or abnormal processes in participant's body and may indicate an underlying condition or disease. Various molecules, such as DNA (genes), proteins, or hormones, can serve as biomarkers since they all indicate something about participant's health. Biomarker testing can also help choose participant's treatment. Additionally, a tumor board will be conducted periodically to provide treatment recommendations to participant's treating physician. Participants will receive standard-of-care treatment if participant enroll in this study. Participant will not receive any experimental treatment.
Assistance with clinical trial enrollment. The study team will help participants enroll in a clinical trial appropriate for participant's condition. However, enrolling in a clinical trial is totally up to the participant.
Health literacy: The study team will provide information relevant to participant's diagnosis to enrich participant's understanding of participant's condition and treatment. Investigator will provide questionnaires to assess participant's understanding before and after participant's have been provided with educational/informational material appropriate for participant's diagnosis.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Adult ≥ 18 years old. Newly diagnosed Black GI cancer participants irrespective of stage. Eligible tumor types include anal carcinoma, rectal cancer, colon cancer, small bowel cancer, appendix carcinoma, hepatobiliary cancer, pancreatic cancer, gastroesophageal cancer, gastrointestinal neuroendocrine tumors, and gastrointestinal stromal tumor. Patient able and willing to comply with study procedures The patient is able to understand and willing to sign and date the written informed consent form at the screening visit.  Exclusion Criteria:  NONE - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Hemodynamic Monitoring During Craniosynostosis Surgery: Comparing Traditional and Newer Technology Monitors (CRASY-PRAM)
Status: Recruiting

Hemodynamic evaluation during pediatric anesthesia is essential to care management. Intraoperative cardiovascular instability is frequent in major surgeries, and appropriate monitoring is necessary to ensure safe anesthetic conduction and promptly detect changes in blood pressure, cardiac output, blood volume, and organ perfusion. In this context, advanced hemodynamic monitoring, continuous measuring, and estimating various parameters can allow a more specific hemodynamic profile and help identify the causal mechanisms of its variability. Moreover, the reference ranges of hemodynamic values in different pediatric ages and how to best monitor hemodynamic status in pediatrics are still debated.

Surgical treatment of craniosynostosis is usually performed at an early age, between 3 and 8 months of age. The operation is burdened by a high risk of hemodynamic instability related mainly, but not only, to potential substantial hemorrhagic losses.

This study aims to characterize the hemodynamic events occurring during corrective craniosynostosis surgery, recorded simultaneously with standard monitoring and Pressure Recording Analytic Method (PRAM), and to analyze the paired measurements.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Infants with craniosynostosis undergoing corrective surgery Ages between 3 and 8 months Physical status classification of the American Society of Anesthesiologists (ASA) </= 2 Consent obtained from the patients' parents/legal guardians  Exclusion Criteria:  Congenital or acquired cardiac disease Preoperative cardiac dysfunction Metabolic diseases Gestational age at birth <30 weeks Body weight less than 3 kg Dislocation or malfunction of the arterial catheter Malfunctioning of monitoring devices - HealthyVolunteers: No - Gender: All - MinimumAge: 3 Months - MaximumAge: 8 Months - StdAgeList: Child - StudyPopulation: Consecutive infants aged 3 to 8 months with craniosynostosis admitted to the operating room of IRCCS AOU of Bologna Polyclinic Sant'Orsola to undergo corrective surgery. - SamplingMethod: Non-Probability Sample
Management With Fear of Cancer in Women Undergoing Colposcopy: Randomized Controlled Study
Status: Recruiting

Cervical cancer is the fourth most common cancer in women worldwide. Due to advances in early diagnosis and treatment, the number of survivors of cancer has increased over the past 50 years. Therefore, the current standard of care for the detection of cervical neoplasm, a Papanicolaou smear and then a colposcopic biopsy, requires a high degree of diagnostic accuracy. In particular, the fear of developing cancer after cancer screening tests is becoming an increasingly significant problem, with an impact on psychosocial health in individuals. For people who are afraid of cancer, meditation and awareness training can make it easier for emotions to self-regulate in times of distress and pain. This study aim to conducted to determine the impact of the Awareness-Based Initiation Program on cancer fear and level of awareness in women undergoing colonoscopy.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Colposcopy procedure due to HSIL, LSIL, ASC-H or HPV on cervical cytology Volunteering to participate in the 6-session Mindfulness-Based Coping Programme Knowing what a colposcopy procedure means,  Exclusion Criteria:  interference with verbal communication, being diagnosed with major depressive disorder or psychiatric disorder, having participated in MBSR training or meditating before Lack of skills to use smart phones and computers learning biopsy results during the programme - HealthyVolunteers: No - Gender: Female - GenderBased: Yes - GenderDescription: women - MinimumAge: 18 Years - MaximumAge: 70 Years - StdAgeList: Adult, Older Adult
A Central Preservation and Assessment Service to Optimize Donor Kidney Allocation
Status: Not yet recruiting

This is a study to collect information to assess if transporting hard-to-place (HTP) donor kidneys to a central preservation and assessment facility with dedicated organ assessment capabilities increases allocation success to transplant hospitals.

Eligibility:
- EligibilityCriteria: Donor Kidney Inclusion Criteria:  Be considered HTP, by receiving refusals from every transplant center within the 250 nm allocation radius or similar definition by the local OPO. From a Male or female deceased donor, aged 16- 75 years old. Kidney initially procured, preserved, and packaged with intent to transplant. LAP provides informed consent for organ donation for transplant and research purposes. The HTP donor kidney must be allocated to a participating transplant center by a participating OPO, and the transplant center makes the decision to send kidney to Sponsor's central preservation and assessment facility for SNMP assessment and preservation prior to determining suitability for allocation.  Donor Kidney Exclusion Criteria:  From a Donor with pre-admission diagnosis of end stage renal failure. Obvious surgical damage to artery(s), vein(s), or ureter(s) preventing machine perfusion. From a donor with confirmed HIV (+), HBVSAg (+) and/or HCV NAT (+) serology results. No LAP consent for both transplant and research purposes. Cannot arrive to Sponsor's central preservation and assessment facility before reaching 24 hours of cold ischemic time (CIT). - HealthyVolunteers: No - Gender: All - MinimumAge: 16 Years - MaximumAge: 75 Years - StdAgeList: Child, Adult, Older Adult - StudyPopulation: The study population includes hard-to-place (HTP) deceased donor kidneys retrieved from donation after brain death (DBD) and donation after circulatory death (DCD) donors aged 16- 75. - SamplingMethod: Non-Probability Sample
Allopregnanolone as a Regenerative Treatment for Parkinson's Disease
Status: Recruiting

The goal of this open-label, pilot clinical trial is to test allopregnanolone as a regenerative treatment in patients with Parkinson's disease (PD). The main questions this study aims to answer are:

Is a large-scale clinical trial testing how well it works in patients with PD feasible?
Is allopregnanolone safe and well-tolerated in patients with PD.
Can we see any signals of changes in imaging and clinical scales?

Participants will receive a weekly infusion in their vein of allopregnanolone for a total of 12 weeks. There is no placebo so everyone receives allopregnanolone and "Open-label" means the study is not blinded so both the participant and investigators know the assigned treatment.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  History of Idiopathic sporadic Parkinson disease Hoehn & Yahr stage 1-4 Have been on stable doses of all anti-Parkinson's medications for 30 days prior to screening Provision of signed and dated informed consent form  Exclusion Criteria:  Evidence of Parkinsonian syndrome. Any conditions that would contraindicate MRI studies. Undergone deep brain stimulation (DBS) surgery as treatment for PD. Iodine allergy, known serious hypersensitivity to ioflupane I-123, or other inability to undergo DaTscan. Clinically significant abnormal laboratory value and/or clinically significant unstable medical or psychiatric illness. History within the last 5 years of a primary or recurrent malignant disease, with the exception of resected cutaneous squamous cell carcinoma in situ, basal cell carcinoma, cervical carcinoma in situ, or prostate cancer in situ with a post-treatment prostatic-specific antigen within normal range. Serious or unstable illnesses including cardiovascular, hepatic, renal, gastroenterologic, respiratory, endocrinologic, neurologic (other than PD), psychiatric, immunologic, or hematologic disease, and any other conditions that, in the investigator's opinion, could interfere with the safety and efficacy analyses in this study. History of chronic alcohol or substance abuse/dependence within the past 3 years. Current use of benzodiazepines, anticonvulsants, antipsychotics, or other drugs that might interact with the gamma-aminobutyric acid-A (GABA-A) receptor complex; use of calcium-channel blockers (e.g., amlodipine); use of dietary supplements containing Pregnenolone. Treatment with another investigational drug within 3 months of screening. - HealthyVolunteers: No - Gender: All - MinimumAge: 40 Years - MaximumAge: 85 Years - StdAgeList: Adult, Older Adult
Effectiveness of Pilates and Taping in Office Workers With Neck Pain
Status: Recruiting

The aim of this study is to investigate the effectiveness of pilates and kinesiotape applications in office workers with neck pain. In this direction, neck pain and disability, pain threshold, muscle strength, range of motion, core endurance, postural awareness and quality of life will be evaluated.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Have been office workers for at least 1 year Using a computer at a desk for at least 3 hours a day Having neck pain for more than 6 weeks Having neck pain rated at or above 3/10 on a visual analog scale  Exclusion Criteria:  Having neurological and rheumatologic chronic diseases Having received physical therapy in the last 6 months Having a history of trauma to the spine Having a history of surgery in the cervical spine Having diagnosed cervical/lumbar disc and spine pathologies Having an allergic reaction to taping - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Therapeutic Play Before Nasopharyngeal Swabbing in Children
Status: Recruiting

The study will be conducted with the randomized controlled experimental method. Children who apply to the Child Health and Diseases Polyclinic and Child Health and Diseases Service and who will have nasopharyngeal swab applied will be divided into two groups by drawing lots. After the randomization children in the therapeutic play group the nasal swab will be shown on the doll to the child by the researcher before being taken. The child is then allowed to play with the doll accompanied by the researcher. No intervention will be performed on children in the control group. The parents will also be found next to their children in both groups during the procedure.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Being between the ages of 3 and 6, Children who have not received medical attention in the last 24 hours, Children without speech, hearing, psychological or neurological problems, Children who can speak and understand Turkish at native level, Children and their parents who agree to participate in the research.  Exclusion Criteria:  Being younger than 3 years old and older than 6 years old, Children who received medical intervention in the last 24 hours, Children with any speech, hearing, psychological or neurological problems, Children who do not speak Turkish as their native language, Children and their parents who do not agree to participate in the research. - HealthyVolunteers: No - Gender: All - MinimumAge: 3 Years - MaximumAge: 6 Years - StdAgeList: Child
Recognition and Early Intervention for Alcohol and Substance Abuse in Adolescence in Adolescent
Status: Recruiting

ASSIST mini-intervention is applied in an electric form in adolescent outpatients to see if it

Eligibility:
- EligibilityCriteria: Inclusion Criteria: Admitted to the Kuopio University Hospital (KUH) adolescent psychiatric outpatient clinic during the years 2016-2019  Exclusion Criteria: Unable to understand the questionnaires - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 14 Years - MaximumAge: 19 Years - StdAgeList: Child, Adult