pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
The REgistry of Very Early Estrogen and AnovuLation
NCT Number: NCT06583408
Acronym: REVEAL
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Hypothalamic Amenorrhea, Functional|Hypothalamic Amenorrhea|Functional Hypogonadotropic Hypogonadism
Interventions: OTHER: Automated Self-Administered 24-hour Dietary Assessment Tool (ASA24)|OTHER: REVEAL Questionnaire
Sponsor: Mayo Clinic
Sex: FEMALE
Age: ADULT
Enrollment: 100000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-01
Completion Date: 2029-08-01
Locations: Mayo Clinic, Jacksonville, Florida, 32224, United States|Mayo Clinic, Rochester, Minnesota, 55905, United States

Summary:
The purpose of this study is to to build a registry of women with early estrogen loss due to Functional Hypothalamic Amenorrhea (FHA) to understand the prevalence, racial and ethnic diversity of this condition.

Primary Outcome Measures: Study Participants, Establish and maintain a comprehensive registry of patients diagnosed with Functional Hypothalamic Amenorrhea (FHA). This registry will include detailed demographic information, clinical data, and longitudinal follow-up to track the prevalence, underlying causes, risk factors, and prognosis of FHA. It will also facilitate the collection of data on racial and ethnic disparities, lifestyle factors, psychological stressors, hormonal imbalances, and the impact of various treatment interventions on long-term health outcomes collected through questionnaires done at baseline and yearly., 5 years
Secondary Outcome Measures: Assessing the Impact of Amenorrhea on Women's Health: Symptoms, Care Experiences, and Work Productivity, Improve understanding of women's overall experience of Functional Hypothalamic Amenorrhea (FHA) by documenting the types of care received, frequency and quality of healthcare interactions, and patient satisfaction with the care provided. This includes detailed assessments of specific treatments or therapies received, the involvement of multidisciplinary care approaches, and the extent of follow-up care. Additionally, to quantify the impact of FHA on lost work productivity, including the number of workdays missed, impact on work performance, and economic burden associated with amenorrhea-related issues, measured at baseline and then yearly using questionnaires., 5 years|Impact of Social, Early Life, and Pregnancy Factors on Functional Hypothalamic Amenorrhea, Enhance the understanding of how social determinants of health-such as socioeconomic status, education, access to healthcare, and community environment-contribute to the development of Functional Hypothalamic Amenorrhea (FHA). Additionally, the study will explore the impact of childhood adversity, including exposure to trauma, abuse, neglect, or chronic stress, on the likelihood of developing FHA. The relationship between pregnancy complications, such as preterm birth, miscarriage, or gestational conditions, and the onset of FHA will also be analyzed. Data will be collected through baseline and annual questionnaires throughout the study, providing a comprehensive understanding of these factors' roles in the development of FHA., 5 years
Cementation of Cup and the Risk of Second Revision
NCT Number: NCT06583382
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Total Hip Arthroplasty (THA)|Revision Hip Arthroplasty
Sponsor: Bispebjerg Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-10-01
Completion Date: 2026-10-01

Summary:
Background:

The fixation method of the acetabular component during the primary total hip arthroplasty (THA) affects the surgical techniques implemented in the revision surgery and may influence the risk of second revision.

Objectives:

The objectives of this study are to investigate the risk of second revision of the cup alone or any component after first cup revision following cemented or non-cemented cup in the primary THA.

Methods/design:

The study is a nationwide register-based cohort study and will follow the reporting of studies Conducted using Observational Routinely collected health Data (RECORD) guidelines. We will compare the risk of undergoing a second revision between cemented and uncemented revised acetabular component by reporting the absolute risk of second revision of 1) the acetabular component and 2) any other component. The cumulative incidence of revision will be estimated using Fine-Gray regression to model the cumulative incidence function, accounting for the competing risk of death. We will apply both a crude and a multivariable adjusted model adjusting for age, sex, Charlson Comorbidity Index (CCI) and the 5-year intervals during which the primary operation was performed.

Primary Outcome Measures: The absolute risk of second revision of the cup, The abolute risk of undergoing a second revision of the acetabular component after having first revision with exchange of the acetabular component.

Revision is defined as any surgical procedure that involves skin incision in the ipsilateral hip joint due to acetabular component failure as reported in the Danish hip register or having one of the following NOMESCO (Nordic Medico-Statistical Committee) Classification of Surgical Procedures codes in the DNPR: KNFC2, KNFC01, KNFC3, KNFC4, KNFC10, KNFC11,KNFC21, KNFC31, KNFC41, KNFC29, KNFC20, KNFC40, KNFC49, minimum of 1 year and a maximum of 15 years
Secondary Outcome Measures: The absolute risk of second revision of any other component, The abolute risk of undergoing a second revision of any other component after having first revision with exchange of the acetabular component. Revision is defined as any surgical procedure that involves skin incision in the ipsilateral hip joint due to acetabular component failure as reported in the Danish hip register or having one of the following NOMESCO (Nordic Medico-Statistical Committee) Classification of Surgical Procedures codes in the Danish national patient register: KNFC02, KNFC20, KNFC22, KNFC23, KNFC32, KNFC33, NFC42, KNFC43, KNFC59, KNFC99, KNFA0, KNFA1, KNFA2, KNFG09, KNFS19, KNFS49, NFS99, KNFW49, KNFW69, KNFW89, KNFW99, KNFW59, KNFW79, NFU1Y, NFU89, NFU99, NFT99, NFP29, minimum of 1 year and a maximum of 15 years
The Efficacy and Safety of Liangxue Ointment in the Treatment of Hand-foot Syndrome Caused by VEGFR-TKI Drugs
NCT Number: NCT06583369
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hand-Foot Syndrome
Interventions: DRUG: Liangxue ointment（Traditional Chinese Ointment）|DRUG: Urea cream
Sponsor: Peking University Cancer Hospital & Institute
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 220
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-03-25
Completion Date: 2025-03-25
Locations: Beijing Cancer Hospital, Beijing, 100142, China

Summary:
This study was a prospective, single-center randomized controlled trial. The subject of this study is to evaluate the effectiveness and safety of traditional Chinese medicine Liangxue Ointment in the treatment of hand-foot syndrome caused by VEGFR-TKI drugs.

Primary Outcome Measures: 2-week treatment effectiveness, According to the patient's NCI CTCAE grade improvement, it is divided into: 1) The clinical symptoms completely disappear, which is a complete remission; 2) The symptom grade decreases by 1 level or more (not including falling to level 0), which is a partial remission; 3) There is no change in symptoms. , is invalid. Calculate the treatment effectiveness at different time points respectively, and take the 2-week treatment effectiveness as the main research endpoint., Participants will be followed for an expected average of 4 weeks
Secondary Outcome Measures: Quality of life improvement value, Quality of life improvement value: According to the HFS-14 scale, patients' quality of life scores were scored before and after treatment. Quality of life improvement value = quality of life score before treatment - quality of life score after treatment. The quality of life improvement values were calculated each week during treatment, 2 weeks, and 4 weeks after the end of treatment., The quality of life improvement values were calculated each week during treatment, 2 weeks, and 4 weeks after the end of treatment.|Pain relief rate, Pain relief rate: The NRS numerical scoring method is used to evaluate the pain before and after treatment: 1) The disappearance of pain after treatment is complete relief; 2) The pain score after treatment / the pain score before treatment ≤50% is effective; 3) There is no change in pain, which is invalid. Pain relief rate = (number of complete relief cases + number of effective cases)/total number of cases × 100%., Participants will be followed for an expected average of 4 weeks|Drug discontinuation and dose reduction rate, Drug discontinuation and dose reduction: the rate of drug discontinuation or dose reduction in the two groups due to severe hand-foot syndrome caused by VEGFR-TKI drugs., Participants will be followed for an expected average of 4 weeks
Motivational Interviewing Intervention For Risky Drinking Treatment Among Indigenous Population
NCT Number: NCT06583356
Acronym: MIRDIP
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Alcohol Abuse
Interventions: BEHAVIORAL: Motivational interviewing
Sponsor: Department of Public Health Medicine, MARA University of Technology
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 36
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10-01
Completion Date: 2025-05-31
Locations: RPS Kedaik & Kampung Jemeri, Kuala Rompin, Pahang, 26800, Malaysia

Summary:
The goal of this single-arm trial is to adapt and evaluate the effectiveness of motivational interviewing intervention for treating risky drinking behaviour among indigenous population in Pahang, Malaysia.

To achieve this, the investigators will:

i) Translate 3 questionnaires regarding alcohol consumption from English into Jakun language (a language of one of Malaysia\&amp;amp;amp;#39;s indigenous communities) ii) Adapt a motivational interviewing intervention for treatment of risky drinking for this community iii) Implement the intervention and measure its outcomes using the translated questionnaires

Participants will:

i) Answer translated questionnaires during the validation of questionnaires (phase 1) ii) Receive 3 sessions of motivational interviewing (phase 2)

Primary Outcome Measures: Severity of alcohol consumption, The extent of alcohol-related consequences e.g. social, legal, physical, and psychological problems (Babor et al., 2001). Measured by Alcohol Use Disorders Identification Test (AUDIT-10) score (validated Malay version - already available). Higher AUDIT-10 score indicates more severe alcohol consumption., 4 months
Secondary Outcome Measures: Readiness to change, The extent to which an individual is cognitively and emotionally inclined to accept, embrace, and adopt a particular plan to purposefully alter the status quo (Holt et al., 2007). Measured by - Readiness to Change Questionnaire (Revised Version) (RCQ) (Jakun version - to be validated). Outcomes can be pre-contemplation, contemplation, or action stage., 4 months|Motivation, An internal state or condition that activates behaviour and gives it direction (Edelman, 1997). Measured by Motivation Thought Frequency Scales for Alcohol (MTF-A) (Jakun version - to be validated). Higher MTF-A score implies higher motivation to quit or cut down alcohol use., 4 months|Self-efficacy, Individuals' beliefs or confidence in their capability to produce desired outcomes that affect their lives (Bandura \& Wessels,1994). Measured by Brief Alcohol Abstinence Self-Efficacy 12-Item (AASE) Scale (Jakun version - to be validated). Higher AASE score indicates higher self-efficacy., 4 months
A Multicenter, Open-Label, Non-Inferiority Randomized Controlled Trial of Postoperative VTE Prevention in Chinese Patients After Colorectal Cancer Surgery
NCT Number: NCT06583330
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Colorectal Surgery|VTE (Venous Thromboembolism)
Interventions: DRUG: Low Molecular Weight Heparin (dalteparin)
Sponsor: Beijing Friendship Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1448
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-10
Completion Date: 2027-03

Summary:
research objective

1. Optimize VTE prevention management after CRC surgery.
2. Improve the prevention and treatment level of VTE in current perioperative patients.
3. Reduce the social burden of VTE related diseases.

Participants will:

1. start low molecular weight heparin prophylaxis within 24 hours post-surgery.
2. The prophylactic regimen for the experimental group lasted 14 days, while the control group received it for 28 days. Low molecular weight heparin is given subcutaneously at a dose of 0.3ml once daily.
3. atients underwent lower limb color Doppler ultrasound on postoperative days 7 ± 2, 14 ± 3, and 28 ± 5, which included screening for thrombosis in the proximal deep veins (femoral, popliteal), distal deep veins (posterior tibial, fibular, and muscular veins), and their perforating branches.

Primary Outcome Measures: VTE events, including deep vein thrombosis (DVT) and pulmonary thromboembolism (PE)., From enrollment to the end of treatment at 4 weeks
Recurrent Pneumonia in Children
NCT Number: NCT06583317
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Pneumonia|Lower Respiratory Tract Infection|Chest Infection
Sponsor: Assiut University
Sex: ALL
Age: CHILD, ADULT
Enrollment: 53
Study Design: Observational Model: |Time Perspective: p
Start Date: 2025-01-01
Completion Date: 2026-01

Summary:
This study aimed to analyses the clinical characteristics, risk factors and underlying causes as predictors of recurrent pneumonia in children attending AUCH

Primary Outcome Measures: To delineate risk factors of recurrent chest infection., Characteristics of studied children in AUCH as in feeding, nutritional status and growth parameters., Baseline
Hematological Indices in Pediatric Diagnosed with Familial Mediterranean Fever
NCT Number: NCT06583304
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Familial Mediterranean Fever (FMF )
Sponsor: Assiut University
Sex: ALL
Age: CHILD, ADULT
Enrollment: 93
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-10-13
Completion Date: 2026-03-31

Summary:
To investigate the relationship between the hematological indices and subclinical inflammation in FMF patients during their attack-free period, additionally this study aims to assess the potential of these indices as predictive markers for ongoing inflammation in these patients population at Assuit university hospital of pediatrics.

Primary Outcome Measures: investigate the association of haematological indices with subclinical inflammation, investigate the association of hematological indices with subclinical inflammation and to evaluate their usability as predictors of ongoing inflammation in FMF patients during their attack-free period in Assiut university hospital and to describe the clinical characteristics of patients diagnosed as FMF in Upper Egypt, and to find the most common presenting symptoms., Baseline
iDAP Injection in the Treatment of Parkinson's Disease
NCT Number: NCT06583291
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: EARLY_PHASE1
Conditions: Parkinson Disease
Interventions: DRUG: Allogeneic dopaminergic neural precursor cell(iDAP)
Sponsor: Anhui Provincial Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 12
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10-01
Completion Date: 2028-10-01

Summary:
The goal of this clinical trial is to evaluate the safety, tolerability and preliminary efficacy that iDAP has on Parkinson's disease (PD) patients.

Primary Outcome Measures: Incidence and severity of adverse events., Safety and tolerability, Within 24 months post-transplantation
Secondary Outcome Measures: Assessment of changes in Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS), part III, in comparison with baseline values., Minimum score: 0; Maximum score: 132; Higher scores mean a worse outcome., Within 24 months post-transplantation|Assessment of changes in Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS), part I,II,IV, in comparison with baseline values., Higher scores mean a worse outcome., Within 24 months post-transplantation|Assessment of changes in Hoehn & Yahr scale in comparison with baseline values., Comprehensive clinical assessment for examining the improvements in Parkinson disease., Within 24 months post-transplantation|Assessment of changes in Mini-mental State Examination (MMSE), Hamilton Depression Scale (HAMD)-17 and Hamilton Anxiety Scale (HAMA)-14 in comparison with baseline values., Comprehensive clinical assessment for examining the improvements in mental state., Within 24 months post-transplantation|Assessment of changes in Activity of Daily Living Scale (ADL) in comparison with baseline values., Comprehensive clinical assessment for examining the improvements in activity of daily living., Within 24 months post-transplantation|Brain network connectivity patterns as demonstrated on positron emission tomography(PET) compared with baseline in the 'off' state., Evidence of cell survival, Within 24 months post-transplantation|Brain DAT intake index as demonstrated on PET dopamine transporter(DAT) compared with baseline in the 'off' state., Evidence of cell survival, Within 24 months post-transplantation|Patient L-dopa equivalent dose compared with baseline., Measure of dopaminergic drug dose., Within 24 months post-transplantation
Impact of Endometrial Compaction on Clinical Pregnancy Rate in Frozen Embryo Transfers
NCT Number: NCT06583265
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: IVF
Sponsor: Ain Shams University
Sex: FEMALE
Age: ADULT
Enrollment: 80
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-01-01
Completion Date: 2024-09

Summary:
To find out if the percentage of endometrial compaction is correlated to clinical pregnancy rate in down regulated frozen embryo transfer cycle. Endometrial compaction is the change in endometrial thickness between the end of the estrogen only phase and the day of embryo transfer. In concept, the compaction of the endometrium after progesterone initiation indicates that the endometrium is responsive to progesterone and could therefore be used as a proxy for endometrial receptivity predictability of FET cycle outcome

Primary Outcome Measures: clinical pregnancy rate, Clinical pregnancy rate, determined by visualizing a viable embryo within the uterine cavity by ultrasound 3-4 weeks after ET, in patients with endometrial compaction in down regulated FET cycles in comparison to non endometrial compaction., 3-4 wks after ET
Secondary Outcome Measures: Percentage of change of endometrial thickness between the end of estrogen administration only phase and the day of embryo transfer., 3-4 wks after ET|Chemical pregnancy rates, detected by positive hCG test in the absence of pregnancy findings on TVUS, 3-4 wks after ET|Number of estrogen administration days, 10 days before ET
Effect of Multimodal Monitoring Cluster Management on Patients with Severe Traumatic Brain Injury
NCT Number: NCT06583252
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Multimodal Monitoring
Sponsor: Xiangya Hospital of Central South University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-01
Completion Date: 2026-06-30

Summary:
Traumatic brain injury (TBI) is a serious global health problem, with about 27 million new cases each year. Severe head trauma can lead to intracranial hypertension and a range of complications such as cerebral edema and hypoxia of brain tissue. Intracranial pressure monitoring is key to modern TBI treatment, but this approach does not fully reflect all relevant pathophysiological changes. Multimodal monitoring allows for a more comprehensive assessment of the severity of TBI and guidance for individualized treatment to improve patient outcomes by integrating different monitoring methods. Although more research is needed to confirm its efficacy, multimodal monitoring has been recognized as an important clinical decision support tool in neuroscience intensive care. Future studies may further optimize this approach to monitoring and provide a more effective treatment strategy for patients with TBI.

Primary Outcome Measures: Glasgow Outcome Score-Extended at 6 months, Glasgow Outcome Score-Extended at 6 months, 6 months
Hub-Based Engagement Navigator Service to Reduce CSC Disengagement
NCT Number: NCT06583239
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Disengagement
Sponsor: University of Maryland, Baltimore
Sex: ALL
Age: CHILD, ADULT
Enrollment: 555
Study Design: Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2025-12-01
Completion Date: 2029-11

Summary:
This project will develop a hub-based engagement navigator service for participants and families at high risk for disengagement. We will use robust Participatory Research methods to ensure integration of Coordinated Specialty Care (CSC) program staff, participants, and family members in developing all aspects of and materials for the service, conduct feasibility/acceptability testing in three CSC programs, and use this information to guide refinements. This will be followed by a mixed methods hub wide evaluation using a hybrid type I open cohort stepped wedge design to examine feasibility, acceptability, and effectiveness to improve disengagement outcomes and address target mechanisms.

Primary Outcome Measures: Rate of discharge, We will compare rate of disengagement for CSC participants with ENS access to those in usual care who do not have ENS access., From enrollment to end of treatment at 2 years|Time in treatment, We will compare time in treatment for participants with ENS access to that of participants in usual care who do not have ENS access., From enrollment to end of treatment at 2 years
The Effect of Two Different Approaches on Palatal Donor Site
NCT Number: NCT06583226
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Wound Heal
Interventions: DEVICE: Gelatin sponge stabilization with suture and cyanoacrylate|PROCEDURE: Gelatin sponge stabilization with suture and cyanoacrylate and coconut oil application
Sponsor: Medipol University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: NA|Intervention Model: PARALLEL|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2023-10-10
Completion Date: 2024-05-20
Locations: Istanbul Medipol University, Istanbul, Fatih, Turkey

Summary:
An epithelialized gingival graft will be harvested from the palate for the treatment of various mucogingival deformities. The donor site will be treated with either a combination of a collagen sponge, cyanoacrylate and suspending sutures or a collagen sponge, cyanoacrylate, suspending sutures and coconut oil.

Primary Outcome Measures: Donor site pain perception, Patients score their daily donor site pain perception using visual analog score level by giving numbers from 0 to 10 according to the visual analog scale (0: no pain, 1: minimal pain, 10: severe pain), everyday in first week|Secondary bleeding time, Patients will record presence or absence of secondary bleeding (presence=1 or absence=0)., during first week
Secondary Outcome Measures: Graft height, Dimensions will be measured during surgery by clinician using Michigan O probe (will be reported in mm), during surgery|Graft width, Dimensions will be measured during surgery by clinician using Michigan O probe.(will be reported in mm), during surgery|Graft thickness, Dimensions will be measured during surgery by clinician using Michigan O probe (will be reported in mm), during surgery|Working time, Harvesting process will be recorded by an blinded research assistant, during surgery|Quantity of analgesics, Patients recorded the quantity of analgesics taken will be reported as quantity of pill, first week|Sensation loss, Sensation loss will be scored by the help of clinician comparing with the symmetrical side an will be recorded as no-loss, medium loss or severe loss, first week, second week , third week, fourth week.|Color match, Color match with the adjacent tissue was determined by researcher using a Visual Analog Pain Scale scale (0: absence of harmony, 10: excellent harmony), first week, second week, third week, fourth week.|Epithelization level, Epithelization level was scored by researcher as none, partial or full epithelization by means of bubble formation after dripping hydrogen peroxide (3%) to the wound surface, first week, second week, third week, fourth week.|The Oral Health Impact Profile-14 is a questionnaire that measures how oral disorders impact a patient&#39;s quality of life., The questionnaire has 14 items with answers rated on a 5-point Likert scale (from 1 = never to 5 = very often) to indicate a level of different problems related to oral health, first week
Conventional Spinal Anaesthesia Versus Fractional Spinal Anaesthesia on Hemodynamics
NCT Number: NCT06583213
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hip Fractures
Sponsor: Ain Shams University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: PREVENTION
Start Date: 2024-09-01
Completion Date: 2025-10-01

Summary:
compare the systemic haemodynamic response to fractional spinal anaesthesia versus conventional spinal anaesthesia , in a group of elderly and comorbid patients with hip fracture.

Primary Outcome Measures: Is to measure blood pressure change intra-operative operative operative (2 hours), blood pressure monitoring, 2 hours
Secondary Outcome Measures: Postoperative pain score for 24 hours, pain score using the Visual Analogue Scale, within 24 hours
Fluid Responsiveness in Post Cardiac Surgery Patients
NCT Number: NCT06583200
Acronym: Cardiac
Status: ENROLLING_BY_INVITATION
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cardiac Complication
Sponsor: Ain Shams University
Sex: ALL
Age: ADULT
Enrollment: 46
Study Design: Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, OUTCOMES_ASSESSOR)|Primary Purpose: SCREENING
Start Date: 2023-01-01
Completion Date: 2024-09-12

Summary:
The aim of the study is to compare end expiratory occlusion test to passive leg raising test for prediction of fluid responsiveness in post cardiac surgery mechanically ventilated patients.

Primary Outcome Measures: Predictive value of EEO and passive leg raising, Predictive value of EEO and passive leg raising to fluid responsiveness in post cardiac surgery mechanically ventilated patients Pulse pressure variation before and after passive leg raising test, One year
Secondary Outcome Measures: Arterial blood pressure, Effect of EEO and passive leg raising to fluid responsiveness on arterial blood pressure in post cardiac surgery mechanically ventilated patients, One year|Heart rate, Effect of EEO and passive leg raising to fluid responsiveness on heart rate in post cardiac surgery mechanically ventilated patients, One year
Other Outcome Measures: Central venous pressure, Effect of EEO and passive leg raising to fluid responsiveness on central venous pressure in post cardiac surgery mechanically ventilated patients, One year
Evaluation of the Relationship Between Breastfeeding Attitudes and Nutrition Knowledge Levels
NCT Number: NCT06583174
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Breastfeeding
Sponsor: Nigde Omer Halisdemir University
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 270
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-05-30
Completion Date: 2025-05-30

Summary:
The importance of breast milk, whose physiological nutritional properties for an infant are not equal to any other food, has been the subject of many studies. In this study, it is aimed to evaluate the relationship between breastfeeding attitude and nutritional knowledge levels of mothers who have 0-6 months infants.

Primary Outcome Measures: Nutrition Knowledge, Nutrition Knowledge Scale (NBS): The scale is a 5-point Likert scale with 31 questions. Scale items are scored between 0 and 4 (strongly agree 4 points, strongly disagree 0 points). The highest score that can be obtained from the scale, which is evaluated over the total score, is 126. The higher the score obtained from the scale, the higher the level of nutritional knowledge, and the lower the score, the lower the level of nutritional knowledge., Baseline|Breastfeeding Attitude, Breastfeeding Attitude Evaluation Scale: The scale is a 5-point Likert-type scale consisting of 46 items. The total score of the scale is 184. The score of positive items is 88 and the score of negative items is 96. The higher the score, the more positive the breastfeeding attitude is evaluated., 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
Effect of Motivational Interviewing on Sleep Hygiene, Sleep Quality and Quality of Life
NCT Number: NCT06583135
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Sleep Hygiene
Interventions: OTHER: Sleep hygiene education and motivational interviewing|OTHER: face-to-face sleep hygiene training
Sponsor: Akdeniz University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 44
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-08-10
Completion Date: 2024-11
Locations: Akdeniz University Hospital, Antalya, Turkey|Antalya Training and Research Hospital, Antalya, Turkey

Summary:
* Sleep hygiene education and motivational interviewing have an effect on increasing sleep hygiene in individuals undergoing hemodialysis treatment
* Sleep hygiene education and motivational interviewing have an effect on increasing sleep quality in individuals undergoing hemodialysis treatment
* Sleep hygiene education and motivational interviewing have an effect on increasing quality of life in individuals undergoing hemodialysis treatment

Primary Outcome Measures: It has the effect of improving sleep hygiene., The sleep hygiene index is a 5-point Likert-type scale consisting of 13 items, scored from 1 to 5.

A score below 26 indicates good sleep hygiene, and a lower score indicates better sleep hygiene., 10 weeks|It is effective in improving sleep quality., The sleep quality index includes 24 questions consisting of 7 components.

Evaluation, Each item of the scale is evaluated with 0-3 points. Seven "component" scores are created from nineteen items. The last 5 items are not included in the scoring. The total score has a value between 0-21. High values indicate poor sleep quality and high levels of sleep disturbance. A total score of 5 and above indicates poor sleep quality, 10 weeks|Has an effect on improving the quality of life, The quality of life scale consists of 36 items in 5 sub-dimensions that measure quality of life specific to kidney disease. Scores in each dimension range from 0 to 100, with higher scores indicating better health-related quality of life. A score of "0" indicates the worst health status, while a score of "100" indicates the best health status., 10 weeks
Ultrasound Guided Radiofrequency Ablation of the Occipital Nerve
NCT Number: NCT06583122
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Nerve Pain
Sponsor: University of Kansas Medical Center
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2022-07-01
Completion Date: 2024-12-31

Summary:
Study an ultrasound guided approach to radiofrequency ablation of the occipital nerve that makes it possible to see the needle during treatment procedure. It is hoped this will reduce the amount of pain after the standard of care procedure.

Primary Outcome Measures: Reduction pain scores reported using an 11-point numeric rating scale (NRS), Pain scores will be assessed 0-10 at the beginning of the study and at the end. We will compare mean pain scores pre-intervention and post-intervention, and we expect mean pain scores will decrease by 4 points on the NRS, 18 Months
Secondary Outcome Measures: Frequency of headache days, We will compare frequency of headache days pre-intervention and post-intervention, 18 months|Frequency of moderate-severe headaches, We will compare frequency of moderate-severe headaches days pre-intervention and post-intervention, 18 months|Use of acute pain medications, We will compare frequency of Use of acute pain medications pre-intervention and post-intervention, 18 Months
Prediction Model of Treatment Efficacy for Age-related Macular Degeneration Based on Multi-source Imaging Modalities
NCT Number: NCT06583109
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Age-related Macular Degeneration (ARMD)
Sponsor: Beijing Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 2600
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-10-01
Completion Date: 2026-06-01

Summary:
Age-related macular degeneration (AMD) is one of the main causes of blindness in the elderly population. Intraocular injection of anti-VEGF drugs for neovascular AMD (nAMD) is the main treatment method at present. However, patients have different responses to anti-VEGF therapy, and some patients do not respond well to short - and long-term treatment.

In this study, a retrospective study was adopted to collate and analyze the clinical data and imaging data of nAMD in the past, and to extract the imaging features from the multimodal modalities before and after treatment for deep learning, and to evaluate and quantify the clinical features, and to construct two multi-source feature models for predicting the short-term and long-term prognosis of nAMD patients. By verifying the accuracy of the model to predict the curative effect, the classification efficiency of the above characteristic models was compared, and the optimal model was selected. Its clinical application value was evaluated by calibration curve and decision curve. In addition, patients with poor treatment response in the study cohort were retrospectively analyzed, and the efficacy and safety of the combination of other treatment options in the actual clinic were analyzed. The purpose of this study is to provide scientific basis for early prediction, dynamic monitoring and optimization of overall treatment strategies for nAMD.

Primary Outcome Measures: BCVA, best-corrected visual acuity using LogMAR, Baseline, 3 months after anti-VEGF treatment, 1 year after anti-VEGF treatment
Secondary Outcome Measures: CMT, central macular thickness measured on OCT, Baseline, 3 months after anti-VEGF treatment, 1 year after anti-VEGF treatment
College Student Stress: Transitions Over Time
NCT Number: NCT06583096
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Depressive Symptoms
Sponsor: University of Michigan
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-09
Completion Date: 2025-05

Summary:
This research study is being conducted to better understand how college students develop and cope with stress and to identify opportunities to help students notice and respond to stress early before symptoms contribute to significant negative consequences.

This project will be completed in two parts. In the first part (not a trial) participants will be asked to complete a screening survey to determine eligibility. Eligible participants (i.e., those with mild-to-moderate depressive symptoms and not receiving mental health care) will continue into the clinical trial portion (part two). It is anticipated that 100 students will continue to the clinical trial phase of the study, where they will be randomly assigned to the "assessment only" (n=25) or "intervention" (n=75) conditions.

Primary Outcome Measures: Percentage of eligible participants that agree to participate in the trial, 10-20 days after screen survey|Percentage of completed follow-ups, Baseline up to six-week follow-up|Percentage of participants that remain active (i.e. do not request to stop messages) on the text-message group, Baseline up to six-week follow-up|Number of withdrawals, Baseline up to six-week follow-up|Total percent of feedback reports that were viewed across all sent feedback reports, Baseline up to six-week follow-up|Percent of participants (in the intervention arm) that viewed a personalized feedback report at least once, Baseline up to six-week follow-up|Participant self-reported satisfaction with the intervention components, There are 8 questions regarding satisfaction (1-Strongly disagree, 4 Neither agree nor disagree, 7-Strongly Agree) that the participant will complete regarding the study. Additionally, two questions will be open ended to collect information about the study. A higher score means more satisfaction with the study., Six-week follow-up
Sintilimab With P-GEMOX Versus the P-GEMOX in the Teatment of Advanced-stage Extranodal Natural Killer/T Cell Lymphoma
NCT Number: NCT06583083
Acronym: SPIRIT-02
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type
Interventions: DRUG: Sintilimab with P-GEMOX Regimen|DRUG: P-GEMOX Regimen
Sponsor: Sun Yat-sen University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 84
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-28
Completion Date: 2026-08-28
Locations: Sun Yat-sen Universitiy Cancer Center, Guangzhou, Guangdong, 510060, China

Summary:
Extranodal NK/T-cell lymphoma is a rare and highly aggressive subtype of non-Hodgkin lymphoma. While the overall survival rates have improved for early-stage ENKTL patients, the prognosis for those with advanced disease remains poor, and there is currently no standard treatment. PD-1/PD-L1 inhibitors have demonstrated significant efficacy in various cancers, and recent studies have shown promising results in extranodal NK/T-cell lymphoma as well. Although PD-1 antibodies have exhibited efficacy in relapsed or refractory patients, their effectiveness when combined with chemotherapy as a first-line treatment remains unclear. This study aims to evaluate the efficacy and safety of sintilimab combined with chemotherapy in a randomized controlled trial for newly diagnosed advanced extranodal NK/T-cell lymphoma patients, while also exploring potential biomarkers that may predict treatment outcomes, offering new therapeutic options for extranodal NK/T-cell lymphoma patients.

Primary Outcome Measures: PFS, progression free survival, Up to 4 years
Secondary Outcome Measures: ORR rate, objective response rate, Up to 4 years|CR rate, complete response rate, Up to 4 years|OS, overall survival, Up to 4 years|Adverse events, The incedence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs), Up to 4 years
Multicenter Comparison of Thermal Ablation Versus Thyroid Lobectomy for Subcapsular Papillary Thyroid Microcarcinoma
NCT Number: NCT06583057
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Thyroid Cancer|Papillary Thyroid Microcarcinoma
Interventions: PROCEDURE: Thermal ablation|PROCEDURE: Thyroid lobectomy
Sponsor: Chinese PLA General Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 2000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2019-01-01
Completion Date: 2024-07-31
Locations: ChinaPLAGH, Beijing, Beijing, 100853, China

Summary:
To compare the clinical outcomes of Thermal ablation with those of thyroid lobectomy in patients with subcapsular papillary thyroid microcarcinoma.

Primary Outcome Measures: Progression-free survival, Interval between the date of treatment and the date of detection of disease progression or last follow-up., From date of enrollment of the first patient until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months
Secondary Outcome Measures: Complication, Complications included hoarseness, infection, hematoma, airway obstruction, and permanent hypoparathyroidism., From date of treatment until the date of first documented complication, assessed up to 24 months
Bruxism Awareness in Dental Students
NCT Number: NCT06583044
Acronym: BADS
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Bruxism
Interventions: OTHER: Questionnaire
Sponsor: Abant Izzet Baysal University
Sex: ALL
Age: ADULT
Enrollment: 128
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-05
Completion Date: 2024-06-25
Locations: Bolu Abant İzzet Baysal University, Bolu, 14030, Turkey

Summary:
Clinical students in the Faculty of Dentistry were diagnosed with bruxism according to the bruxism assessment consensus 2018. A total of 128 students with (64) and without (64) bruxism, were asked 33 questions about their knowledge and self-awareness about bruxism.

Primary Outcome Measures: Bruxism Awareness Survey, Determines how much information the participants have about bruxism diagnosis, symptoms, risk factors, and treatment methods. It consists of yes-no questions with two options. One is an answer., Baseline|Bruxism Knowledge Level Survey, Participants are assessed to determine the extent to which they can diagnose bruxism through self-assessment. It consists of 3 to 7 multiple-choice questions. One of the answers is the correct answer, and the assessment is based on this., Baseline
Secondary Outcome Measures: Bruxism symptoms Survey, It includes information about whether the participants experience bruxism symptoms and the impact of these symptoms. It consists of 3 to 7 multiple-choice questions. One of the answers is the correct answer, and the assessment is based on this., Baseline|Treatment and Follow-up Survey, It includes questions about whether patients with bruxism are treated, what treatment methods are used, and whether there is an improvement in symptoms after treatment. It consists of 3 to 7 multiple-choice questions. One of the answers is the correct answer, and the assessment is based on this., Baseline
Vibrotactile Coordinated Reset for Parkinsons Patients Who Are on Dopaminergic Medication
NCT Number: NCT06583005
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Parkinson Disease, Idiopathic
Interventions: DEVICE: Vibrotactile Coordinated Reset
Sponsor: Stanford University
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2025-02-15
Completion Date: 2027-05-15

Summary:
The purpose of this clinical trial is to test the efficacy of vibrotactile coordinated reset stimulation to improve movement ability and other symptoms of human subject participants with Parkinsons Disease who take dopaminergic medication and are unable to withhold this medication. Participants will be followed for five years and make a total of five study visits.

Primary Outcome Measures: MDS-UPDRS Part 3, The Movement Disorder Society Unified Parkinsons Disease Rating Scale Part 3 assessment, obtained while the participant is off medication, is a scale that measures motor ability within Parkinsons patients. For part 3, the scales minimum values are 0 and max value is 132. Higher scores indicate more impaired motor ability, while lower scores indicate less impaired motor ability. A score of 0 indicates no motor impairment., Baseline, 6 months, 12 months, 18 months, 24 months
DNA Methylation Trajectories in Aging
NCT Number: NCT06582992
Acronym: EPI-GERAS
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Heart Failure|Aging
Interventions: OTHER: RRBS
Sponsor: University of Campania "Luigi Vanvitelli"
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 150
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-11
Completion Date: 2025-11
Locations: University of Campania Luigi Vanvitelli, Naples, No States Available, 80138, Italy

Summary:
The goal of this observational study is to profile changes in DNA methylation of circulating CD4+ T and CD8+ T cells from healthy young to aged with diagnosis of HFpEF, a particular phenotype of HF which is highly prevalent in aging.

The main question it aims to answer is:

-Do DNA methylation biomarkers help us to understand the role of inflammation in HFpEF during aging?

Our goal is to provide a simple large-scale panel of epigenetic-sensitive biomarkers useful in aged patients with HF in the early natural history of the disease (HFpEF).

Primary Outcome Measures: Number of differentially methylated positions and regions as assessed by RRBS, We will identify a panel of positions and regions of the genome which are differentially methylated using as measure diff.meth more than or minor than 2 and p minor than 0.05, 6 months
Effect of Computer-Based Game and HIIT Towards Symptoms, Executive Function and Neuroplasticity in Teens with IGD
NCT Number: NCT06582979
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Internet Gaming Disorder
Sponsor: Indonesia University
Sex: ALL
Age: CHILD
Enrollment: 44
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2025-01-16
Completion Date: 2025-07-21

Summary:
The goal of this clinical trial is to learn how effective a combined therapy of computer-based game and also high-intensity interval training (HIIT) physical exercise to improve the clinical symptoms, executive function and neuroplasticity in teenagers with Internet Gaming Disorder (IGD). Executive function refers to the brain's ability to manage tasks such as planning, problem-solving, and decision-making. BDNF is a protein crucial for brain health and development. Neuroplasticity is the brain's ability to change and adapt throughout life. High-intensity interval training involves short bursts of intense exercise followed by periods of rest or recovery. The main questions it aims to answer are:

* How effective are computer-based game and HIIT exercises in reducing addiction symptoms of IGD?
* Will computer-based game and HIIT exercise help teens who are addicted to video games to improve their executive function (become more able to plan ahead and meet goals, display self-control and also follow multiple-step directions)?
* Do computer-based game and HIIT exercise help brains of teens with IGD to be more able to change and adapt?

Researchers will compare the improvement before and after the therapies.

Participants will:

* Undergo both therapies (computer-based game and HIIT) every week for 7 weeks. Computer-based game will be done 3 times/week and HIIT 2 times/week
* fill out forms, interviewed and also have their blood sample taken for a total of three times (before the start of the therapy, during the 4th week of therapy and after the final therapy session on the 7th week)

Primary Outcome Measures: Clinical Symptoms, Clinical Symptoms of Internet Gaming Disorder evaluated with Ten-Item Internet Gaming Disorder Test (IGDT-10) questionnaire, Baseline (T0), 4th week of intervention (T1), 7th week of intervention (T2)|Executive Function, Executive Function assessed with Behavior Rating Inventory of Executive Function (BRIEF) questionnaire, Baseline (T0), 4th week of intervention (T1), 7th week of intervention (T2)|Neuroplasticity, Neuroplasticity measured with serum brain-derived neurotrophic factor (BDNF) levels, Baseline (T0), 4th week of intervention (T1), 7th week of intervention (T2)