pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Evaluation of the Efficacy and Tolerance of Two Cosmetic Products in Subjects With Rosacea
NCT Number: NCT06582043
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Rosacea|Redness|Telangiectasia|Flushing|Pustular Acne|Papule Pruritic
Interventions: OTHER: SCARCr tester 1|OTHER: Placebo
Sponsor: NAOS Argentina S.A.
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-07
Completion Date: 2024-12
Locations: Cirec Latam, Ciudad Autónoma de Buenos Aire, 1426, Argentina|MEDCIN, São Paulo, 01311-000, Brazil

Summary:
Multicentric and double-blind randomised comparative clinical study in Argentina and Brazil. Under dermatological and ophthalmological control 4 visits: inclusion \[Day(D)0\], D28, D56, D84 Ethical committee required.

Primary Outcome Measures: Investigator Global Assessment (IGA), To evaluate the efficacy of two cosmetic products (SCARCr tester 1 and SCARCr tester 2) in association to the topical medical treatment (ivermectin or metronidazole) in supporting the improvement of persistent redness due to rosacea and in soothing discomfort sensations, under dermatological and ophthalmological control (scoring scale from better to worse value: clear, minimal, mild and mild to moderate)., Day 0- Day 28- Day 56- Day 84
Secondary Outcome Measures: Cutaneous and ocular tolerance, Collection of adverse events, Day 0- Day 28- Day 56- Day 84
Other Outcome Measures: Evolution of the quality of life RosaQoL questionnaire, Scoring scale from better to worse value: never, rarely, sometimes, often and always., Day 0- Day 28- Day 56- Day 84|Evolution of the quality of life Mood Pict, Scoring scale from better to worse value: not at all, lightly, moderate, a lot and extremely., Day 0- Day 28- Day 56- Day 84|Evolution of the quality of life Feel Pict questionnaires, Scoring scale from better to worse value; low and high., Day 0- Day 28- Day 56- Day 84|Evaluate the immediate and long-lasting eficacy and cosmetic qualities, Self-assessment questionnaires by the subjects (scoring scale from better to worse value: totally agree, agree, disagree and totally disagree)., Day 0- Day 28- Day 56- Day 84
Stop Addiction Stigma
NCT Number: NCT06582030
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hematopoietic and Lymphatic System Neoplasm|Malignant Solid Neoplasm
Interventions: BEHAVIORAL: Assessment|OTHER: Educational Activity|OTHER: Educational Activity|OTHER: Educational Activity|OTHER: Educational Activity|OTHER: Educational Activity|OTHER: Educational Activity|OTHER: Training
Sponsor: Ohio State University Comprehensive Cancer Center
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 93
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2023-10-17
Completion Date: 2023-12-31
Locations: Ohio State University Comprehensive Cancer Center, Columbus, Ohio, 43210, United States

Summary:
This clinical trial evaluates the impact of a Stop Addiction Stigma (SAS) training workshop with a short description of the conditions related to addiction (vignettes) on stigmatizing attitudes toward individuals with substance abuse disorders. Reviews have shown that patients with substance abuse disorders have experienced negative attitudes from their health care providers. Negative attitudes may lead to less involvement from the provider and the patient and may lead to less effective care. Using case vignettes with a SAS workshop may be an effective method to help people learn about addiction, reduce the stigma toward addiction and improve the quality of health care.

Primary Outcome Measures: Stigmatizing attitudes, Stigmatizing attitudes will be measured with the Stigma and Attribution Assessment. The assessment score will be compared both between and within participants for each case vignette. Results will be reported with descriptive statistics, including means and standard deviations or medians and first-third quartiles for continuous variables, and frequencies and percentages for discrete variables.The linear mixed effect model will be used to study the repeated stigma and attribution measures over time (pre-workshop, immediately post-workshop, and 8 weeks post-workshop) within 6 vignettes as well as the effects between the vignettes, while controlling for the potential confounding factors (e.g., sex)., Before, immediately after and 8 weeks after the session
Secondary Outcome Measures: Attendance rate, The proportion of participants attending the workshop will be summarized with 95% confidence interval., At 90 minute session.|Response to post-workshop evaluations, The proportion of participants who respond to the post-workshop evaluations will be summarized with 95% confidence interval., Before, immediately following and 8 weeks after the session.
Comparisons of the Effects and Clinical Outcomes of CH2 Vaginal Gel Versus Placebo on CIN1
NCT Number: NCT06582004
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cervical Intraepithelial Neoplasia|Human Papillomavirus
Sponsor: National Taiwan University Hospital
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, CARE_PROVIDER)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-09
Completion Date: 2025-11

Summary:
In Taiwan, Pap smear screen has been offered every year for women over 30 years old since 1995. The incidence of cervical invasive cancer decreased from 25/100,000 person in 1995 to 7.0/100,1000 person in 2016. In contrast, the incidence of pre-cancerous lesions increased gradually. According to ASCCP, observation and repeated cytology in 6-12 months is recommended in colposcopy-diagnosed CIN1 patients. Most of the low-grade lesions regressed spontaneously without treatment; 49 percent of CIN1 regressed to negative in six months, and 70 percent regressed in 12 months.

Emerging evidence suggests associations between the composition of the vaginal microbiota (VMB), human papillomavirus (HPV) infection, and cervical intraepithelial neoplasia (CIN). Previous research included 87 patients with untreated CIN2. It reported that patients with a Lactobacillus-dominant microbiome at baseline are more likely to have regressive disease at 12 months. Lactobacillus spp. depletion and presence of specific anaerobic taxa are associated with CIN2 persistence and slower regression. 82.9 percent of women with low-grade squamous intraepithelial lesions (LSIL) tested positive for HPV. CH2 vaginal gel is a marketed health product derived from natural ingredients, including water, probiotic glycerol, and plant extracts. Investigators have designed this trial to compare the following outcomes between participants who use and those who use placebo: 1. the regression rate of CIN1, 2. the time to regression of CIN1, and 3. the HPV clearance rate in participants.

Primary Outcome Measures: pap smear result, Thinprep smear every 3 months. The report from thinprep smear and coloposcope examination. Data will be categorized as CIN1, CIN2 and above, inflammation, normal., up to 9 months
Secondary Outcome Measures: HPV clearance rate, Cervical swab for high risk HPV test, up to 9 months
Liquid Valine and Isoleucine in Maple Syrup Urine Disease
NCT Number: NCT06581991
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Maple Syrup Urine Disease
Sponsor: Meta Healthcare Ltd
Sex: ALL
Age: CHILD
Enrollment: 5
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10
Completion Date: 2026-09

Summary:
This is a prospective, observational research study in 5 children with Maple Syrup Urine Disease (MSUD). Subjects who are currently taking a valine and isoleucine supplement for MSUD will be recruited for a 56 day trial, of a new ready-to-use valine supplement and a new ready-to-use isoleucine supplement, to evaluate the tolerability and acceptability of the study products compared with their usual products.

Primary Outcome Measures: Daily data on gastrointestinal tolerance, A daily record of any gastrointestinal symptoms compared with usual valine and isoleucine supplement, From enrollment to end of treatment at 56 days|Acceptability and tolerance, Qualitative questionnaires at study start and end of Part 1 (28 days) and Part 2 (56 dys) of the study, From enrolment to end of treatment at 56|Daily data on study product adherence, A daily record of study product intake (actual versus prescribed) to check for adherence, From enrollment to the end of treatment at 56 days|3-day food diaries, A record of patient food and fluid intake for 3 days to monitor valine intake from food - at enrollment, end of part 1 and end of part 2, From enrollment to the end of treatment at 56 days|Blood results for valine, leucine, isoleucine, Routine weekly blood sample taken at home for valine, leucine and isoleucine and posted to the hospital. These will be compared with blood results prior to study commencement to check for any changes, From enrollment to end of treatment at 56 days
Secondary Outcome Measures: Weight and height measurement, Weight and height will be measured at enrollment, end of Part 1 (28 days) and end of Part 2 (56 days) of the study to check that growth is adequate, From enrollment to the end of treatment at 56 days
Early Warning and Intervention Mechanism of Foot Health Risk in Children and Adolescents
NCT Number: NCT06581978
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Flexible Flatfoot
Interventions: PROCEDURE: Whole-Body Vibration Intervention|PROCEDURE: Exercise Intervention Group
Sponsor: Nanfang Hospital, Southern Medical University
Sex: ALL
Age: CHILD, ADULT
Enrollment: 120
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-01-01
Completion Date: 2027-12-31
Locations: Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, 510515, China

Summary:
This clinical study was a prospective intervention study. The growth and development parameters and kinematic parameters of 120 children were planned to be collected for an observational study, and then the sensors were used to collect long-term gait data for 4 weeks and record the occurrence of foot pain. Children were assigned to the observation group, exercises intervention group, or WBV vertical rhythm intervention group according to their wishes. After 4 weeks of intervention, the dynamic and static foot posture differences between the intervention group and the observation group were analyzed and compared.

Primary Outcome Measures: Static foot posture, Static foot posture is evaluated using 3D morphometric scanner, X-ray, and Foot Posture Index-6, Baseline , pre-intervention and immediately after the intervention|Motional foot posture, Motional foot posture is evaluated using Passive optical motion capture, and wearable sensors, Baseline , pre-intervention and immediately after the intervention
Secondary Outcome Measures: Foot pain events, Visual Analogue Scale (VAS) is used to evaluate foot pain, which asks patients to rate their pain level on a scale of 0 to 10 (0 = no pain; 10 = "worst pain ever"). On the VAS scale, patients draw a hash mark representing their pain level on an unmarked 10-cm line, with the left side marked as "no pain" and the right side marked as "unbearable pain"., Baseline , pre-intervention|Bone maturity, Bone age taken by dual energy X ray bone age instrument, the equipment radiation is extremely low, the equivalent of flying two minutes, or about 20 minutes of walking in the sunshine, won't cause harm to human body. Bone mineral density (BMD) was measured by ultrasound bone densitometer, which can be used to measure the BMD of calcaneus in children without radiation and trauma., Baseline , pre-intervention
A Comparative Analysis of Healthy Young Adults Stratified by Gender.
NCT Number: NCT06581926
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Healthy Young Adults
Interventions: OTHER: Behavioral assessment
Sponsor: Nigde Omer Halisdemir University
Collaborators: The Scientific and Technological Research Council of Turkey
Sex: ALL
Age: ADULT
Enrollment: 506
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-05-30
Completion Date: 2025-05-30
Locations: Nigde Omer Halisdemir University, Nigde, Bor, 51200, Turkey

Summary:
This project was planned to examine whether there is a difference between nutrition knowledge level, reward-related eating behaviour and body awareness in healthy young adults according to gender.

Primary Outcome Measures: nutrition knowledge, Nutritional knowledge level for adults: A 5-point Likert-type scale with a total of 32 propositions was formed. The scores obtained from the evaluation criteria of the nutritional knowledge level scale for adults are evaluated as poor, moderate, good and very good. Participants with a basic nutrition score of less than 45 are considered to have a poor level of knowledge, those with a score between 45 and 55 have a moderate level of knowledge, those with a score between 56 and 65 have a good level of knowledge, and those with a score above 65 have a very good level of knowledge. Participants with a food preference score of less than 30 are considered to have poor knowledge, those with a score of 30-36 are considered to have moderate knowledge, those with a score of 37-42 are considered to have good knowledge, and those with a score of more than 42 are considered to have very good knowledge., Baseline|reward-related eating, Reward-Related Eating Scale (RED-13): It is a 5-point Likert-type scale consisting of 13 items in 2017. This scale has three sub-dimensions that assess lack of satiety, preoccupation with food and lack of control over eating. A maximum score of 65 and a minimum score of 13 can be obtained from the Red-13 scale. Higher scores on the Red-13 are associated with greater appetite and craving for sweets., Baseline|body awareness, Body Awareness Questionarre (BAQ): It is basically a questionnaire that questions body reactions, the individual\&#39;s estimates of body processes, the disease process and the sleep-wake cycle. It is a Likert-type questionnaire consisting of 18 items and 4 subgroups. A high score from the questionnaire means a high level of body awareness., Baseline|descriptive assessment, In the general information form of the young individuals participating in the study, demographic information (gender, age, height, body weight, body mass index, etc.) was included., Baseline
Investigation of Eating Awareness,Eating Cravings, Wellness Awareness and Health Perception
NCT Number: NCT06581913
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Healthy Young Adults
Interventions: OTHER: Behavioral assessment
Sponsor: Nigde Omer Halisdemir University
Collaborators: The Scientific and Technological Research Council of Turkey
Sex: ALL
Age: ADULT
Enrollment: 356
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-05-30
Completion Date: 2025-05-30
Locations: Nigde Omer Halisdemir University, Nigde, Bor, 51200, Turkey

Summary:
In this project, eating awareness, acceptance of food cravings, healthy life awareness and health perception will be examined in healthy young adults.

Primary Outcome Measures: Eating Awareness,, Eating Awareness Scale (EAS-30): There are 28 questions, 4-point Likert scale and 5 sub-factors. The Turkish version of the Eating Awareness Scale was used. In the new adapted scale, a 5-point Likert scale was used (1: never, 2: rarely, 3: sometimes, 4: often, 5: always). The high score obtained from each sub-factor of the scale indicates that the individual has the characteristic evaluated by that sub-factor., Baseline|Acceptance of Food Cravings,, The Food Craving Acceptance and Action Questionnaire (FAAQ): designed to assess individuals\&#39; food craving and food acceptance. The scale is a 6-point Likert-type, 10-item scale. The total score to be obtained from the scale is in the range of 10-60., Baseline|Healthy Life Awareness, Health Life Awareness Scale (HLAS) consists of 15 statements and 4 dimensions. The lowest score to be taken from the scale is 15 and the highest score is 75. A high score from the scale is considered as a high level of healthy life awareness. Healthy Life Awareness Scale is a 5-point Likert-type scale. The answers given by the participants are 1: Strongly disagree, 2: Disagree, 3: Undecided, 4: Agree and 5: Strongly Agree and 5: Strongly Agree., Baseline|Health Perception, Health Perception Scale (HPS): It is a five-point Likert-type scale consisting of 15 items and four sub-factors. The minimum score that can be obtained from the scale is 15 and the maximum score is 75., Baseline|descriptive assessment, In the general information form of the young individuals participating in the study, demographic information (gender, age, height, body weight, body mass index, etc.) was included., Baseline
Study of Vitamin B12 Metabolism in Children With Sickle Cell Disease Exposed to MEOPA
NCT Number: NCT06581900
Acronym: DREPAM
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Sickle Cells Patients
Interventions: OTHER: Vitamin B12
Sponsor: CHU de Reims
Sex: ALL
Age: CHILD, ADULT
Enrollment: 29
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09
Completion Date: 2025-12
Locations: Chu Reims, Reims, 51092, France

Summary:
Short description of the protocol intended for the lay public. Include a brief statement of the study hypothesis (Limit : 5000 characters) The sickle cells anemia is a monogenic disease linked to the presence of Hemoglobin S due to a mutation in the Hemoglobin Beta chain. The lack of circulating oxygen induces a polymerization of the Hemoglobin S which change the red cell conformation into sickle. Those cells interact and causes vaso-occlusive crisis (CVO).

The MEOPA is a medical gas used as an antalgic and a sedative especially in sickle cells disease patients. The nitrous oxide, oxide the cobalt ion in the vitamin B12 which inactivate it irreversibly creating a functional deficiency.

During the metabolism of vitamin B12, homocysteine is transformed in methionine which is used in to form the myelin sheath and helped in producing DNA. Numerous studies already shown that the longer the exposition to MEOPA is the greater the functional deficiency of vitamin B12 occur.

A few studies shown a symptomatic deficiency of vitamin B12 due to the exposition of MEOPA in sickle cells patient but there is no explanation on the necessary amount of exposure or if some patients are more at risk. When there is a deficiency of vitamin B12 the symptoms can go from a simple orthostatic hypotension to a combined spinal sclerosis.

The participation to the study will be proposed to every patient hospitalized for a CVO in the follow up of the emergency room visit or directly in pediatric reanimation. During a usual blood test, a small amount of blood (4mL) will be collected in addition to dose the Vitamin B12, the vitamin B9, the homocysteine, and the methionine. A small amount of urine will also be collected to dose the methylmalonic acid, all those elements are a part of the metabolism of B12 vitamin.

The same sample will be taken on the day of departure of the hospital. During the hospitalization the pain management, a daily neurological exam, and the exposition to the MEOPA will be assessed meticulously.

An appointment will take place at 7 days and at one month after the hospital departure to evaluate the possible neurological defect.

Each patient can only be included once.

Primary Outcome Measures: Proportion of patients who will present a Vitamin B12 deficiency, Limit : Vitamin B12 \&amp;lt;191pg/mL or homocysteine \&amp;gt; 10micromol/L in children under 15 years old or \&amp;gt; 15 micromol/L for children over 15 years old., Day 15
Defining Outcome Measures for Behavioural and Emotional Problems in Dystrophinopathies
NCT Number: NCT06581887
Acronym: D-BRAIN
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: DMD|BMD
Sponsor: University College, London
Sex: MALE
Age: CHILD
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-09-13
Completion Date: 2024-12-31

Summary:
Study aims to develop and to evaluate the neurophysiological and physiological response to a classical conditioning task.To better understand how Duchenne Muscular Dystrophy (DMD) and Becker Muscular Dystrophy (BMD) impacts mental health and how to assess it. Participants invited to complete questionnaires about behaviour, cognitive function and social interactions, complete computer tasks and have an optional MRI brain scan,

Primary Outcome Measures: Group differences between DMD, BMD and controls in the initial aversive unconditioned stimulus., Following an emotional response task, an interim analysis will be done after the first 30 patients have been tested (10 DMD, 10 BMD, 10 controls). A favourable outcome will demonstrate a difference in the emotional response of these groups. Groups will complete questionnaires, an emotional response task, and a fine motor assessment., through study completion, an average of 2 years
Secondary Outcome Measures: To observe any difference between and within BMD, DMD and control groups in regard to learning, habituation and extinction, This will be measured by analysis measuring any difference between and within groups (10 BMD, 10 DMD and 10 control). Physiological responses generated by the task will be measured, along with neural imaging., through study completion, an average of 2 years
Accuracy Performance Verification of the INVOS™ PM7100 System in Adults
NCT Number: NCT06581835
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Oxygen Saturation
Sponsor: Medtronic - MITG
Sex: ALL
Age: ADULT
Enrollment: 38
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-10-16
Completion Date: 2025-04-30

Summary:
Prospective, observational, post-market, verification study to ensure compliance to the ISO 80601-2-85:2021 standard

Primary Outcome Measures: Accuracy root mean square, Accuracy root mean square is the square-root of the average squared distances between regional oxygen saturation (rSO2) as measured by INVOS and and field saturation (fSO2) as measured by blood sampling, rSO2 and fSO2 data are recorded every 5-minutes during the procedure
Biomarkers for Pharmacoresponse in Bipolar Disorder - Coagulation
NCT Number: NCT06581822
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Bipolar Disorder
Sponsor: Karolinska Institutet
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 68
Study Design: Observational Model: |Time Perspective: p
Start Date: 2017-02-24
Completion Date: 2025-04

Summary:
Previous studies indicate an association between severe psychiatric disorders, such as bipolar disorder, and increased risk of venous thromboembolism. However, to which extent this association is influenced by lithium treatment is currently unknown. In this prospective cohort study, the investigators aim to investigate the effect of bipolar disorder and lithium treatment on coagulation and the counterpart fibrinolysis.

Primary Outcome Measures: Extracellular vesicles, Counts of plasma extracellular vesicles originating from blood platelets, leukocytes and vascular endothelial cells., From enrollment to end of examination at 2 years|Hemostatic potential, Overall hemostatic potential (OHP), coagulation potential (OCP) fibrinolytic potential (OFP) i citrate plasma., From enrollment to end of examination at 2 years
Other Outcome Measures: Plasma proteins of coagulation- or fibrinolysis-related processes, Concentration in plasma of proteins involved in coagulation or fibrinolysis such as von Willebrand factor, From enrollment to end of examination at 2 years
Pepsinogen-1 Serum Levels in Hyperemesis Gravidarum
NCT Number: NCT06581796
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Hyperemesis Gravidarum|Pregnant With Complication
Interventions: OTHER: pepsinogen-1
Sponsor: Ankara Etlik City Hospital
Sex: FEMALE
Age: ADULT
Enrollment: 40
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-15
Completion Date: 2024-11-15
Locations: Ankara Etlik City Hospital, Ankara, Yenimahalle, Turkey

Summary:
In this study, the investigators planned to investigate serum pepsinogen-1 levels in women with hyperemesis gravidarum and uncomplicated pregnancy.

The benefit the investigators expect from the study is to determine whether there is a difference in serum pepsinogen-1 levels in pregnant women with hyperemesis gravidarum compared to normal pregnant women. It should demonstrate the importance of pepsinogen-1 in predicting the pathogenesis, prognosis, perinatal outcome and severity of hyperemesis gravidarum. The study poses no risk to the pregnant woman or the fetus.

Primary Outcome Measures: Pepsinogen-1 serum level, pepsinogen-1 serum level was determined with blood samples taken from pregnant women with hyperemesis gravidarum and control group., between 5 and 14 weeks of pregnancy
Evaluation of Validity and Reliability of the Turkish Translation of the Digital Health Readiness Questionaire in Different Chronic Diseases
NCT Number: NCT06581770
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Non-Communicable Chronic Diseases|Survey and Questionnaire|Validation Studies|Digital Health
Sponsor: Istanbul Galata University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-15
Completion Date: 2025-09-15

Summary:
The World Health Organization (WHO) defines digital health as the field of knowledge and application related to any aspect of the adoption of digital technology in the stages of improvement. The combination of digital health with technology brings about a new transformation in digital media. This transformation allows for the development of communication and information in health services, the ability to conduct health-related research on digital media and the evaluation of this data. The ease of access to information and the provision of a timely feedback mechanism in the face of problems have enabled the spread of digital health systems, and have also enabled chronic disease management and epidemic disease monitoring.

It is recommended that the term digital readiness be used to cover the combination of digital access and use, digital literacy and digital health literacy. Digital health readiness is also defined as the main determinant of health and is thought to contribute to the improvement of health processes with the development of digital health literacy and to be a useful solution against health problems that may arise in the follow-up of chronic diseases.

Although there are tools in the literature that evaluate digital health readiness, there is no Turkish assessment tool that facilitates the follow-up of non-communicable chronic diseases. Therefore, the aim of our study is to evaluate the translation, validity, and reliability of the Digital Health Readiness Questionaire into Turkish in individuals with chronic non-infectious diseases.

Primary Outcome Measures: Translation of the digital health readiness questionnaire, Translation of the digital health readiness questionnaire into Turkish and application on the sample, 1 month
Secondary Outcome Measures: the validity and reliability of the survey in Turkish, To evaluate the translation, validity and reliability of the Digital Health Readiness Survey into Turkish in individuals with chronic non-communicable diseases., 11 months
Evaluation of the Predictive Value of Serum Glial Fibrillary Acidic Protein and Ubiquitin Carboxy-terminal Hydrolase L1 for Subarachnoid Haemorrhage
NCT Number: NCT06581757
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Subarachnoid Haemorrhage (SAH)
Sponsor: The Royal Wolverhampton Hospitals NHS Trust
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 900
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-11
Completion Date: 2025-11

Summary:
To verify the analytical performance of GFAP and UCH-L1 biomarkers marketed by Abbott Diagnostics and to assess diagnostic accuracy of these biomarkers in predicting subarachnoid haemorrhage

Primary Outcome Measures: Measures of diagnostic accuracy including sensitivity, specificity, negative predictive value and positive predictive value., Metrics of diagnostic accuracy to include sensitivity, specificity, negative predictive value and positive predictive value., 1 year
Non Invasive Imaging Methods for Detecting PA：a Clinical PET Study of 18F-Pentixather
NCT Number: NCT06581744
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Primary Aldosteronism Due to Adrenal Hyperplasia (Bilateral)
Interventions: OTHER: [18F]AlF-NOTA-Pentixather
Sponsor: Fangfang Sun
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-06-12
Completion Date: 2026-06-30
Locations: First Affiliated Hospital of Dalian Medical University, Dalian, Liaoning, 116022, China

Summary:
Primary aldosteronism (PA) is the most common endocrine cause of hypertension. 68Ga-pentixafor PET/CT possesses a relatively high sensitivity and specificity for Aldosterone producing adenoma (APA) detection. However, 68Ga is usually eluted from a 68Ge-68Ga generator, only a small amount of isotopes can be achieved once time. \[18F\]AlF-chelation is a promising strategy that would solve these issues. 18F labeled Pentixafor-Based Imaging Agent(\[18F\]AlF-NOTA-Pentixather) has been reported by Andreas Poschenrieder. \[18F\]AlF-NOTA-Pentixather displayed high and CXCR4-specific in vivo uptake in Daudi xenografts (13.9%±0.8% injected dose per gram \[ID/g\] at 1 hour post injection\[p.i.\]). But to date 18F-Pentixather has not been studied in humans. In this program the investigators will estimate the radiation dosimetry of \[18F\]AlF-NOTA-Pentixather, evaluate the sensitivity and specificity of the \[18F\]AlF-NOTA-Pentixather as a probe for APA.

Primary Outcome Measures: Measurement of radiation dosimetry and biodistribution of 18F-Pentixather determined with PET/CT in Patients with PA, Images were acquired using a Biograph Truepoint 64 PET/CT scanner (Siemens, Erlangen, Germany).The dosimetry analysis was performed using 3d-slicer（version 5.6.1, with slicerOpenDose3D module (https://gitlab.com/opendose/opendose3d). OpenDose: open access resources for nuclear medicine dosimetry (www.opendose.org)., 6 month|Analyze the specificity and sensitivity of 18F-pentixather PET/CT for the diagnosis of APA, Compare the 18F-Pentixather SUVmax with the CXCR4，CYP11B2 immunohistochemical score. Calculate the sensitivity and specificity of 18F-pentixafor PET/CT results for an indication of APA, IAH, or NFA lesions., 3 years
Eye Gaze Technology for Endoscopic Inspection of the Gastrointestinal Tract
NCT Number: NCT06581718
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cancer Gi
Interventions: DEVICE: Eye Gaze Control
Sponsor: Imperial College London
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 10
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DEVICE_FEASIBILITY
Start Date: 2024-05-01
Completion Date: 2024-09
Locations: Imperial College London, London, Lonodon, W21NY, United Kingdom

Summary:
Robotic controlled endoscopy of GI tract.

Primary Outcome Measures: Time of completion, 6 months|User Experience survey, 6 months|Patient Experience survey, 6 months
The C-MAC Video Laryngoscope Helps Presbyopic Anesthetists
NCT Number: NCT06581705
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Presbyopia
Interventions: PROCEDURE: Video Laryngoscope
Sponsor: Egymedicalpedia
Collaborators: Al-Azhar University
Sex: ALL
Age: CHILD
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2021-01-05
Completion Date: 2024-01-10
Locations: Al-Azhar University hospitals, Cairo, Egypt

Summary:
Endotracheal intubation is the de facto gold standard for airway management especially in neonatal and pediatric anesthesia .

An efficient neonatal airway management is challenging even in the most experienced hands and the prevalence of difficult intubation in pediatric anesthesia varied greatly on a wide range.

Primary Outcome Measures: the frequency of successful intubation, The frequency of the need for external laryngeal manipulation, head extension, or stylet curvature change to achieve intubation, 30 seconds
Non-invasive Monitoring of Miscarriage
NCT Number: NCT06581692
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Miscarriage in First Trimester
Interventions: OTHER: This is a routine procedure, no intervention will be provided.
Sponsor: Chinese University of Hong Kong
Sex: ALL
Age: ADULT
Enrollment: 150
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-01
Completion Date: 2039-08-31
Locations: Prince of Wales Hospital, Hong Kong, Hong Kong

Summary:
cfDNA is extremely useful to ascertain chromosomal causes of miscarriages at the point of miscarriage diagnosis by a simple blood test. This study aims to determine the level of cell-free DNA (cfDNA) in early pregnancy and compare the results with those of product of conception (POC) testing, in concordance with standard karyotyping.

Primary Outcome Measures: Cell-free DNA (cfDNA), Determine the use of cfDNA to ascertain chromosomal causes of miscarriages, 15 weeks
Secondary Outcome Measures: Level of cell-free DNA, To determine the level of cell-free DNA (cfDNA) in early pregnancy, 15 weeks|Aneuploidy results from product of conception, To compare the aneuploidy results from product of conception (POC), in concordance with standard karyotyping., 15 weeks
Adenomyosis and Pregnancy: Levonorgestrel vs. GnRH for Blastocyst Transfer
NCT Number: NCT06581679
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Adenomyosis
Interventions: DRUG: Triptorelin|DEVICE: levonorgestrel-releasing intrauterine system|PROCEDURE: frozen embryo transfer
Sponsor: Zagazig University
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 184
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2023-12-15
Completion Date: 2024-07-01
Locations: Zagazig university, Zagazig, Ash Sharqia Governorate, 44519, Egypt

Summary:
Adenomyosis is a condition where endometrial tissue grows into the uterine muscle, causing symptoms like pelvic pain, heavy bleeding, and infertility. This abnormal growth can lead to a variety of reproductive issues, including a higher risk of miscarriage and early pregnancy loss.

While there are treatments available for adenomyosis, they are often limited due to the lack of precise diagnostic criteria. One common approach is the use of gonadotropin-releasing hormone agonist (GnRHa), which can improve pregnancy rates in infertile women with adenomyosis. However, it's important to note that GnRHa may not restore pregnancy rates to baseline levels.

Another potential treatment option is the levonorgestrel-releasing intrauterine system (LNG-IUS). This device releases a hormone called levonorgestrel into the uterus, which can help control the symptoms of endometriosis and adenomyosis. Studies have shown that the endometrial concentration of levonorgestrel from the LNG-IUS is significantly higher than in other tissues like the myometrium, fallopian tubes, and fat tissue.

Primary Outcome Measures: Adenomyosis Treatment, Proportion of patients reporting at least a 50% reduction in pain (measured by pain, Enjoyment, and General Activities score) post-Adenomyosis Treatment., 6 monthes|Increase in Chemical and Clinical Pregnancy Rates, Proportion of patients reported with pregnancy after Frozen Embryo transfer which is assessed by finding Heartbeats in the Trans-vaginal Ultrasonography., 6 Months
Current Awareness, Perspective and Knowledge on Social Egg Freezing
NCT Number: NCT06581666
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Neoplasms
Interventions: OTHER: No special intervention, all participants will be asked to complete same set of questionnaire.
Sponsor: Chinese University of Hong Kong
Sex: ALL
Age: ADULT
Enrollment: 200
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-01
Completion Date: 2030-09-01
Locations: Pui Wah Jacqueline Chung, Hong Kong, Hong Kong

Summary:
Hong Kong's fertility preservation service is underutilized and limited, with low awareness among clinicians and young adults. Traditional Chinese culture may lead to social stigma, preventing discussion of fertility issues. A survey aims to explore awareness, knowledge, and acceptance of oocyte cryopreservation, enabling resource allocation for a culturally acceptable public education program and a dedicated referral system to improve oocyte cryopreservation services.

Primary Outcome Measures: Awareness, perspective and knowledge, To evaluate the difference in the level of awareness, perspective and knowledge towards social egg freezing between patients who have undergone or will seek fertility preservation services and the general public., through study completion, an average of 1 year
Secondary Outcome Measures: Awareness, To evaluate the awareness of oocyte cryopreservation among the general public and patients, through study completion, an average of 1 year|Factors that may affect the uptake rate, To determine any factors that may affect the uptake rate of oocyte cryopreservation, through study completion, an average of 1 year|Utilization rate, To assess the utilization rate of social egg freezing, through study completion, an average of 1 year
Medication Adherence to Phone-supervised Pancreatic Enzyme Replacement Therapy
NCT Number: NCT06581653
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Chronic Pancreatitis|Pancreatic Exocrine Insufficiency
Interventions: BEHAVIORAL: Phone-based PERT education intervention
Sponsor: Changhai Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 206
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-08-25
Completion Date: 2025-12-30
Locations: Changhai Hostipal, Shanghai, Shanghai, China

Summary:
This study aims to explore whether regular telephone intervention in patients with chronic pancreatitis can improve their Pancreatic Enzyme Replacement Therapy's Medication Adherence.

Primary Outcome Measures: MA good rate at 6 months, At the 6th month, the proportion of patients with good drug compliance (MMAS≥6) was in this group，The medication adherence MMAS-8 score was used, with a minimum score of 0 and a maximum score of 8, with a score of \< 6 indicating poor adherence, 6th months
Secondary Outcome Measures: MA good rate at 12 months, At the 12th month, the proportion of patients with good drug compliance (MMAS≥6) was in this group,The medication adherence MMAS-8 score was used, with a minimum score of 0 and a maximum score of 8, with a score of \< 6 indicating poor adherence, 12th months|MA score at 6 months, MMAS scores of patients at the sixth month,The medication adherence MMAS-8 score was used, with a minimum score of 0 and a maximum score of 8, with a score of \< 6 indicating poor adherence, 6th months|MA score at 12 months, MMAS scores of patients aAt the 12th month,The medication adherence MMAS-8 score was used, with a minimum score of 0 and a maximum score of 8, with a score of \< 6 indicating poor adherence, 12th months
Other Outcome Measures: Nutritional status of the patient, This data is mainly used for descriptive analysis,Height, weight, fat-soluble vitamins，The patient's height changes，weight changes by taking the drug，, Average 1 year|Internal and external pancreatic secretory function, Exocrine function of patients Pancreatic exocrine function was assessed by fecal elastinase-1, and pancreatic endocrine function was assessed by fasting blood glucose, C-peptide,This data is mainly used for descriptive analysis,, Average 1 year|Other adverse events associated with chronic pancreatitis in patients with chronic pancreatitis at 12 months of enrollment, The incidence of abdominal pain (frequency of attacks, VAS score), pancreatic duct stones, pancreatic pseudocyst, bile duct stenosis, cancer, severe acute pancreatitis, This data is mainly used for descriptive analysis,, Average 1 year|Quality of Life score SF-36, The SF-36 Quality of Life Assessment Scale quantifies a respondent's quality of life through a range of questions, including health, energy, social functioning, emotional functioning, and mental health，Based on the overall score, there are five categories: excellent (100-85), good (84-70), average (69-60), below average (59-40) and poor (≤39)., Average 1 year
Chimeric Antigen Receptor Modified T Cells Targeting BCMA for the Treatment of Relapsed/Refractory Multiple Myeloma
NCT Number: NCT06581640
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Multiple Myeloma|Relapsed/Refractory
Interventions: BIOLOGICAL: CAR-T treatment
Sponsor: The First Affiliated Hospital of Xiamen University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 5
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-28
Completion Date: 2028-12-31
Locations: The First Affiliated Hospital of Xiamen University, Xiamen, Fujian, 361000, China

Summary:
To evaluate the safety and tolerability of chimeric antigen receptor gene-modified T cells targeting BCMA for the treatment of relapsed/refractory multiple myeloma

Primary Outcome Measures: Complete remission rate (CR), Negative serum and urine immunofixation electrophoresis, disappearance of soft tissue plasmacytoma, and less than 5% plasma cells in the bone marrow. For patients who rely solely on serum FLC levels as a measurable lesion, in addition to meeting the above CR criteria, it is also required that the ratio of serum FLC is restored to normal in two consecutive evaluations., Up to 36 months
Secondary Outcome Measures: Adverse events (AE), Any adverse and unexpected signs, symptoms, or diseases., Up to 36 months
Masticatory Performance Evaluation
NCT Number: NCT06581614
Acronym: MPE
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Masticatory Performance
Sponsor: National Taiwan University Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-31
Completion Date: 2026-08-31

Summary:
The purpose of this experiment is to combine research on masticatory efficiency with the reconstructive expertise of the prosthodontics clinic, focusing on implant-supported fixed dentures as the contemporary gold standard for reconstruction. The goal is to investigate the impact of such prosthetic reconstructions on masticatory efficiency. We will invite patients who have lost their second molar and have undergone single-implant-supported fixed denture reconstruction at the Prosthodontics Department of National Taiwan University Hospital to participate in masticatory function tests. The tests will use a new and relatively simple chewing gum, with the aim of enhancing patients\&amp;#39; masticatory function through implant reconstruction in a clinical setting, thereby improving patient well-being and understanding of dental implants. On the research side, the study aims to provide guidance for strategies in the reconstruction of masticatory function.

Primary Outcome Measures: the masticatory performance of patients, During the test, participants will be given a piece of chewing gum to assess their masticatory function when the second molar implant-supported fixed restoration is in place., After second molar implant reconstruction was done(at least 1 month after reconstruction)
Apneic Oxygenation by Transnasal Humidified Rapid Insufflation Ventilator Exchange Obstructive Sleep Apnea Patients
NCT Number: NCT06581588
Acronym: THRIVE
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Obstructive Sleep Apnea Syndrome
Sponsor: Beijing Tongren Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 56
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: OTHER
Start Date: 2024-09
Completion Date: 2025-12-30

Summary:
The purpose of the study is to compare effectiveness of different methods of achieving oxygenation in obstructive sleep apnea patients. The investigators intend to compare transnasal humidified rapid-insufflation ventilator exchange (THRIVE) combined with nasopharyngeal airway with THRIVE alone.

Primary Outcome Measures: Following the induction of general anaesthesia and muscle relaxation, the time (minutes and seconds) to peripheral oxygen saturations (SpO2) of 95%. Comparing oxygenation with THRIVE combined with nasopharyngeal or THRIVE technique., oxygenation is delivered either by THRIVE combined with nasopharyngeal or the THRIVE technique alone. General anaesthesia is induced and muscle relaxation is given. The time for the peripheral oxygen saturations (SpO2) to fall to 95% is recorded. When this occurs the trial is stopped and the patient is intubated.If 18 minutes is reached before SpO2 = 95% then the trial is stopped., duration from apnea to eighteen (18) minutes
Secondary Outcome Measures: Arterial partial pressure of oxygen (PaO2), Unit: mmHg, at the time apnea start, five/ten minutes after apnea and at the end of apnea|Arterial carbon dioxide pressure (PaCO2), Unit: mmHg, at the time apnea start, five/ten minutes after apnea and at the end of apnea|Concentration of arterial blood lactate, mmol/L, at the time apnea start, five/ten minutes after apnea and at the end of apnea|Arterial blood pH, Unitless, at the time apnea start, five/ten minutes after apnea and at the end of apnea|mininmum SPO2, mininmum SPO2, from apnea start to 1minute after intubation|desaturation duration(SPO2 100-99%,-98%,-95%), desaturation duration(SPO2 100-99%,-98%,-95%), from apnea start to 1minute after intubation|Transcutaneous CO2 (tc CO2 increase rate, mmHg= (the tcCO2 value at the end of apnea duration minus the tcCO2 value at the beginning of the apnea duration)/apnea duration, duration from apnea start to 18 minutes|End-tidal carbon dioxide (ETCO2) increase rate, mmHgmmHg= (the ETCO2 value at the end of apnea duration minus the ETCO2 value at the beginning of the apnea duration)/apnea duration, duration from apnea start to 18 minutes|highest ETCO2 value ( after intubation the first PetCO2 and the highest PETCO2 among the first five), mmHg, duration from apnea start to 20 minutes