rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
The Effect of Therapeutic Touch on Exam Anxiety
Status: Recruiting

Aim: This study was planned to determine the effect of therapeutic touch applied to nursing students on test anxiety.

Method: Students who met the inclusion criteria were divided into therapeutic touch and control groups using the randomization method. After the groups were determined, the students filled out the Introductory Information Form and the State Exam Anxiety Scale. 30 minutes before the exam, therapeutic touch was applied to each of the students, who were divided into groups, for 20 minutes. No application was made to the control group, and they were told to wait in the classroom where the group was waiting as they wished.Immediately after the application was completed, the scale was re-applied to both groups.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  To be over 18 years of age, To know Turkish and to agree to participate in the research Being a fourth year nursing student Not having received any energy therapy (reiki, therapeutic touch) before  Exclusion Criteria:  Presence of existing psychiatric illness, Using anxiolytic and antidepressant medications - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 30 Years - StdAgeList: Adult
A Comparative Study of the Treatment of Real-world Patients With Clear Cell Carcinoma of the Ovary
Status: Not yet recruiting

The goal of this observational study is to learn about the treatment effectiveness of physician's choice of chemotherapy and the immune checkpoint inhibitor (ICI)-based therapy in patients with relapsed/refractory ovarian clear cell carcinoma (OCCC), and compare the treatment response with the phase II, single-arm clinical trial INOVA to investigate the efficacy of combinational therapy of sintilimab plus bevacizumab. The main questions it aims to answer are:

What is the efficacy of physician's choice of chemotherapy in relapsed/refractory OCCC patients in the real world?
Is ICI-based therapy more effective than physician's choice of chemotherapy in real-world for relapsed/refractory OCCC patients?
Dose the combinational regimens of sintilimab plus bevacizumab in Sintilimab Plus Bevacizumab in Recurrent/Persistent Ovarian Clear Cell Carcinoma (INOVA) trial more effective than physician's choice of chemotherapy?

Participants will be respectively retrieved and extracted de-identified, longitudinal electronic health records (EHR)-derived data.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Female patients with age ≥ 18 years old and ≤ 75 years old. There must be a histological diagnosis of ovarian clear cell carcinoma. Patients with recurrent or persistent ovarian clear cell carcinoma must have at least one-line pretreated platinum-containing chemotherapy. Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 2. Expected survival time ≥ 12 weeks.  Exclusion Criteria:  1.Histological evidence of non-ovarian clear cell carcinoma. - HealthyVolunteers: No - Gender: Female - MinimumAge: 18 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients with relapsed/persistent OCCC were extracted de-identified, longitudinal electronic health records (EHR)-derived data from 12 tertiary hospitals in China since October 2008. Consecutive patients were enrolled with no restriction on treatment regimens. - SamplingMethod: Non-Probability Sample
Long-term Effect of Steroid on Metabolic Diseases in Asthmatics
Status: Recruiting

The goal of this retrospective/observational study is to compare the clinical outcomes between the high-cumulative-dose group and the low- cumulative-dose group of oral/inhaled corticosteroid in the long-term management of asthma patients. The main hypothesis are:

i. High cumulative dose of corticosteroid is related to the prevalence of osteoporosis/osteoporosis in the long-term management of adult asthma.

ii. High cumulative dose of corticosteroid can affect populations that have a high-risk of osteoporosis (females over 50 years of age).

iii. High cumulative dose of corticosteroid is related to the prevalence of diabetes mellitus, hypertension, and hyperlipidemia in the long-term management of adult asthma.

iv. High cumulative dose of corticosteroid affects bone metabolism-related diagnostic tests and laboratory values and the prescription rate of bone metabolism-related medications.

Eligibility:
- EligibilityCriteria: A. Inclusion criteria i. Adult asthmatics (over 18 years) who have maintained inhaled corticosteroid with or without systemic corticosteroid for more than 12 months before the index date in our Medical Center.  ii. At least 1 asthma diagnosis within 1 year before the first corticosteroid exposure date by asthma specialists at Ajou University Medical Center (AUMC, Suwon, South Korea) with informed consent.  iii. A high cumulative dose is defined as the dose of corticosteroids above the mean cumulative dose of corticosteroids prescribed during 1 year.  iv. The equivalent dose will use for calculating the mean cumulative dose of each inhaled corticosteroid inhaler or systemic corticosteroid prescribed.  v. Prescriptions within 365 days from the first prescription will be assumed to be continuous, and the cohort end date will be defined as the end of the continuous drug exposure.  B. Exclusion criteria i. Patients younger than 18 years ii. Patients younger than 50 years and males in high-risk population cohorts iii. Patients with osteoporosis or osteoporosis-related major fracture outcomes (pathological fracture due to osteoporosis, closed fracture of the femur, pelvis, and vertebral column) before the index date iv. Patients with corticosteroid-related outcomes (diabetes mellitus, hypertension, hyperlipidemia) before the index date (for secondary endpoint). - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Adult asthma patients that visited AUMC (Ajou University Medical Center) from 1994 to 2023 - SamplingMethod: Probability Sample
Investigation of the Influence of the Human Microbiome on the Pathogenesis and Recurrence Probability in Giant Cell Arteritis
Status: Recruiting

The longitudinal observational study aims to assess the impact of the microbiome especially the gut-microbiome in the emergence and course of giant cell arteritis (GCA) patients. At diagnosis and 6 month follow up we will analyze the oral, blood and gut microbiome from GCA patients and healthy controls. Thereby identified potential candidate commensal will be further analyzed for possible interactions and influence on the immune system.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  • Diagnosis of Giant cell arteritis (only in one arm)  Exclusion Criteria:  chronic infection (viral, funghi, bacteria) including HIV, Hepatitis B/C acute infection with usage of antibiotics less then 90 days before screening major gastro-intestinal surgery <5 years from screening gastro-intestinal bleeding <90 days before screening inflammatory bowel disease (confirmed bioptically) bullimia or anorexia nervosa adipositas (BMI ≥ 40) intake of high dosage of probiotics (>109 KBE per day) <90 days before screening not controlled Diabetes mellitus Malignancy within one year (except for squamous skin - and basal skin carcinoma without metastasis, cervix carcinoma with curative surgery, CTCL) known abuse of alcohol oder drugs. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: no specific requirements, usually over 50 years - SamplingMethod: Non-Probability Sample
Adolescent Projections During Transition in Prader-Willi Syndrome
Status: Not yet recruiting

Single-center, cross-sectional qualitative study seeking to collect the experience of adolescence and the transition to adulthood of people affected by Prader-Willi syndrome in a population. To do this, the present will carry out a qualitative study with a reflexive thematic analysis of the data collected through semi-structured interviews using an interview guide.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients with genetically confirmed Prader-Willi syndrome Patients affiliated or beneficiaries of a social security system Patients known and followed by the reference center, presenting sufficient intellectual skills to answer the interview questions  Exclusion Criteria:  Refusal of family participation (if minor) Refusal of participation by the patient or his guardian (if of legal age) - HealthyVolunteers: No - Gender: All - MinimumAge: 15 Years - MaximumAge: 20 Years - StdAgeList: Child, Adult
Clinical Observation of Exosomes in Patients After Q-switched Laser Surgery
Status: Recruiting

the goal of this half-face controlled study is to evaluate the effect of exosome-containing liquid dressings on the recovery of patients after Nd:YAG laser 532 treatment.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  It meets the diagnostic criteria of seborrheic keratosis or freckle； pepole are able to follow the treatment rules of the study and were followed up for 8 weeks； informed consent  Exclusion Criteria:  History of keloids ; Pregnancy or lactation; Any cosmetics containing growth factor-related ingredients used within 6 months prior to treatment Patients with incomplete observation data and incomplete course of treatment were excluded - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 60 Years - StdAgeList: Adult
Comparison of Cryoablation of Pericapsular Nerve Group (PENG) to Fascia Iliaca Catheter in Patients With a Hip Fracture
Status: Not yet recruiting

The purpose of this study is to determine if patients with hip fractures who undergo cryoablation of the PENG have improved pain control 30 days from surgery when compared to those who have a fascia iliaca catheter.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients undergoing hip fracture repair aged 18-85.  Exclusion Criteria:  Patients who have an exclusion to regional anesthesia. Patients who are pregnant assessed via self-report or pregnancy test if they have taken one. Non-English speakers Patients who already had their fracture repaired" - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 85 Years - StdAgeList: Adult, Older Adult
Comparing Myopia Treatments in Youth: Defocus Spectacles, Glasses, and Ortho-K
Status: Recruiting

The research project titled "A Comparative Study on the Clinical Efficacy, Quality of Life, and Cost of Use of Peripheral Defocus Spectacles, Frame Glasses, and Orthokeratology Lenses in Myopic Children and Adolescents" aims to evaluate different non-surgical myopia correction methods in children. It focuses on assessing the impact of peripheral defocus spectacles, frame glasses, and orthokeratology lenses on the quality of life, clinical effectiveness, and costs associated with each method. The study is a prospective cohort study involving 300 children aged 13-17 years with myopia ranging from -1.00D to -6.00D. It aims to compare the psychological, social, and educational aspects of these correction methods, alongside their costs and clinical outcomes over a period of one year.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Children aged 13-17 years. Myopia between -1.00D and -6.00D; astigmatism <±1.5D; best corrected visual acuity ≥1.0. No prior use of peripheral defocus spectacles, single-vision frame glasses, or orthokeratology lenses (meaning first-time wearers). Willingness to participate in the entire study process, completing all examinations, surveys, and cost recordings as required. Ability to maintain contact throughout the study, with a fixed address and contact information.  Exclusion Criteria:  Other eye conditions: history of strabismus, amblyopia, anisometropia, fundus diseases, dry eye, etc. Allergies: history of allergies to certain materials or medications. Surgical history: recent eye surgery. Non-compliance with required wear, follow-up, or lack of cooperation. Severe psychological disorders or behavioral problems. - HealthyVolunteers: No - Gender: All - MinimumAge: 13 Years - MaximumAge: 17 Years - StdAgeList: Child - StudyPopulation: The study population comprises children and adolescents aged 13-17 years with myopia ranging from -1.00D to -6.00D and astigmatism less than ±1.5D. Participants are first-time wearers of either peripheral defocus spectacles, single-vision frame glasses, or orthokeratology lenses. They are willing and able to complete all study requirements, including examinations, surveys, and cost recordings, and can maintain contact throughout the study duration with a stable address and contact information. - SamplingMethod: Non-Probability Sample
Families Filming Infants Learning Movement
Status: Recruiting

The study objective is to improve accuracy in the early detection of neurodevelopmental impairment, especially CP, by evaluating the timepoint (in weeks post term age) that the Prechtl GMA is most useful for prediction of neurodevelopmental impairment at two years of age in children with and without medical complexity. The study team plans to recruit 100 healthy, term-born infants and 250 infants at risk of developing CP for a total of 350 enrolled infants.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Infants born full-term with typical development, bithweight >2500g Infants with a history of brochopulmonary dysplasia, defined as having a preterm birth (<33 weeks gestational age) and requiring supplemental oxygen beyond 36 weeks gestational age Infants with neonatal encephalopathy, who required hypothermic cooling treatment Infants born <36 weeks gestational age Infants born in a multiple gestation pregnancy Infants with a diagnosis of Trisomy 21 Infants born and diagnosed with SMA prenatally, via newborn screening assessment or prior to 10 weeks corrected age Infants are less than 10 weeks corrected age at time of enrollment  Exclusion Criteria:  Children who are enrolled in DCFS custody Parent or infant guardian does not have a smartphone - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 10 Weeks - MaximumAge: 20 Weeks - StdAgeList: Child - StudyPopulation: Infants aged 10-20 weeks adjusted age. Not of other target special populations. - SamplingMethod: Non-Probability Sample
Efficacy and Tolerability of Test Product Versus Cysteamine 5% in Treatment of Facial Epidermal Melasma
Status: Recruiting

This interventional, randomized, investigator blinded, controlled study conducted in one centre consists in a 4-month evaluation period within the same season avoiding sunny season on 140 subjects with facial epidermal melasma.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Facial epidermal melasma (exclude mixed and dermal melasma) Subjects free of excessive hair, acne, cuts, abrasions, fissures, wounds, lacerations, or any other active skin conditions on the face  Exclusion Criteria:  Subjects with any other signs of significant irritation or skin disease Subjects using oral contraceptive pills or hormonal implants as birth control measures during the study Subjects who had a skin lightening procedure in the past 8 weeks - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 20 Years - MaximumAge: 50 Years - StdAgeList: Adult
Lifestyle Tailored Offloading for Diabetic Foot Ulcers
Status: Not yet recruiting

The goal of this pilot clinical trial is to develop and test a tailored occupational therapist-led lifestyle-focused intervention to aid patients in improving diabetic foot ulcer care. The main questions it aims to answer are:

- Determine the acceptability and feasibility of taking a tailored lifestyle-focused approach as part of comprehensive diabetic foot ulcer management.

Patient participants with DFUs who require offloading treatment will receive the tailored lifestyle-focused self-management intervention.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  English or Spanish speaking Age 21 years or older History of active DFU necessitating offloadingExclusion Criteria: Capacity to provide informed consent Access to telehealth (internet connection and equipment) Ability to walk independently Self-reported life expectancy of more than one year  Exclusion Criteria:  - Self-reported deafness or blindness - HealthyVolunteers: No - Gender: All - MinimumAge: 21 Years - StdAgeList: Adult, Older Adult
Evaluating Signs of Safety: A Deaf-Accessible Therapy Toolkit for AUD and Trauma
Status: Not yet recruiting

The U.S. Deaf community - a group of more than 500,000 Americans who communicate using American Sign Language (ASL) - experiences nearly triple the rate of lifetime problem drinking and twice the rate of trauma exposure compared to the general population. Although there are several treatments for alcohol use disorder (AUD) and posttraumatic stress disorder (PTSD) in hearing populations, none have been developed for or tested with Deaf clients. To address these barriers, the study team developed Signs of Safety, a Deaf-accessible therapy toolkit for treating AUD and PTSD. Their aims are to conduct a nationwide, virtual clinical trial to compare (1) Signs of Safety with (2) treatment as usual and (3) a no treatment control, to collect data on clinical outcomes, and to explore potential mediators and moderators of outcome.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Self-identification as Deaf or hard-of-hearing Proficiency in American Sign Language (ASL) Age 18 years or older Access to videoconferencing technology for informed consent and, if applicable, study therapy sessions Access to online survey technology for study assessments "Problematic alcohol consumption, drinking behaviors, and alcohol-related problems" on the AUD Identification Test (AUDIT), a 10-item screening measure developed by the World Health Organization that demonstrates good sensitivity and specificity in many populations (past-month referent time period; score ≥ 8 for men or ≥ 6 for women) "Subthreshold or full PTSD," on the PTSD Checklist for DSM-5 (PCL-5), a 20-item measure of PTSD symptoms reliably used to monitor symptom change (past-month referent time period; "subthreshold" = meets at least two DSM-5 diagnostic categories (B, C, D, and/or E) at moderate or high severity)  Exclusion Criteria:  Participation in concurrent formal psychotherapy (Note: Participants in all study conditions will be asked to refrain from concurrent formal psychotherapy. Participants who engage in formal psychotherapy outside of the research will be removed from the study at the point of treatment initiation. Outside treatment engagement will be queried at each assessment timepoint. If endorsed, the participant will be removed from the study at that timepoint, but data collected prior to treatment initiation will remain in the dataset. Aligning with the Seeking Safety model, Alcoholics Anonymous/Narcotics Anonymous/Dual Recovery Anonymous attendance will be encouraged; attendance will be tracked as a potential outcome mediator.) Members of the following special populations: Adults unable to consent; Individuals younger than 18 years; Prisoners; Pregnant women (Note: We will not knowingly include pregnant women as participants; however, we will not assess participants' pregnancy status.) - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Trigeminal Nerve Stimulation in Treatment-resistant Generalized Anxiety Disorder: a Feasibility Study
Status: Recruiting

This is a feasibility study for trigeminal nerve stimulation (TNS) in patients with treatment-resistant generalized anxiety disorder (TR-GAD). Ten participants will receive TNS for 8 weeks as an augmentation strategy to pharmacological treatment for generalized anxiety disorder (GAD).

The primary objective is to ascertain if TNS is a safe and well-tolerated treatment for patients with TR-GAD.
The secondary objective will be to monitor changes in GAD symptom severity throughout the study.

Results from this study will inform a randomized controlled trial to be conducted in the future.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Meet DSM5 criteria for generalized anxiety disorder. Subjects on a stable dose of an SSRI or SNRI for at least 8 weeks. Treatment-resistant - treatment resistance will be defined as lack of response to at least two drugs, from two different classes of drugs considered first-line or second-line for GAD. Only trials lasting at least 8 weeks, and with at least the minimum effective dose of the given medication will be considered failed trials.  Exclusion Criteria:  Moderate to severe major depressive disorder Moderate to high suicidality Diagnosis of OCD, PTSD, bipolar disorder, schizophrenia, schizoaffective disorder, personality disorders, substance use disorders, intellectual disabilities and dementia or other neurological diseases including trigeminal neuralgia Pregnant or breastfeeding women Participants who are experiencing seizures Implanted VNS or other electrical devices Participants who are already undergoing transcutaneous electrical nerve stimulation Consumption of cannabis, any cannabis by-products, illicit drugs, or alcohol above 3 drinks per week Consumption of natural health products that may affect anxiety or depression symptoms - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult
Early Neutropenic Fever De-escalation of Antibiotics Study
Status: Not yet recruiting

This is a randomized, open label clinical trial among individuals with hematologic conditions. The trial aims to evaluate the safety and clinical outcomes of de-escalating antibiotic therapy among stable individuals diagnosed with neutropenic fever, in which no bacterial infection has been identified.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Participant or healthcare proxy with the ability to understand and willingness to sign an informed consent. Adults >18 years old. Likely to have neutropenia > 7 days including such conditions as: acute leukemia; lymphoproliferative disease; multiple myeloma; myelodysplastic syndrome; bone marrow aplasia and autologous or allogeneic hematopoietic stem cell transplantation. Neutropenia defined as absolute neutrophil count <500. Received or planned to receive cytotoxic chemotherapy. No restrictions on prior therapy regarding dose or agent. High-risk neutropenia defined as expected duration of absolute neutrophil count less than 500 cells/µL for seven or more days. Admitted as an inpatient at Mass General Brigham or Dana Farber Cancer Institute (DFCI). Initial fever (defined as a single oral temperature of ≥38.3°C or a temperature of ≥38.0°C sustained over a one-hour period) during hospital admission or as reason for admission. Has been afebrile for 48 hours.  Exclusion Criteria:  Microbiologically or clinically suspected bacterial infection after index fever. Exposure to treatment antibacterial therapy 72 hours before first fever occurrence other than antibiotics deemed as prophylaxis. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult