pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
The Effect of Nutrition and Fluid Intake in the First Stage of Labor
NCT Number: NCT06547177
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Labor Pain|Nutrient Intake|Fluid Therapy
Interventions: OTHER: fruit juice
Sponsor: Hilal Yuvacı
Sex: FEMALE
Age: ADULT
Enrollment: 90
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER
Start Date: 2022-03-22
Completion Date: 2024-01-20
Locations: Sakarya University School of Medicine, Sakarya, Turkey

Summary:
Birth is a process that requires large amounts of energy. As a result of skeletal and smooth muscle contractions at birth, the body's basal metabolic rate, energy requirement, hydration requirement, and insensible fluid loss are significantly increased. Information regarding the safety and effectiveness of increased hydration during labor is still controversial. There is no consensus on whether this hydration should be given with intravenous solutions or orally. The study aims to determine the effect of fluid intake in labor on the delivery process, maternal-fetal outcomes, and postpartum satisfaction of the mother.

Primary Outcome Measures: Maternal outcome, During the research, duration of the latent and active phase of labor will be recorded., The duration of the labor will measured from the latent phase of labor to birth.|Maternal pain outcome, A visual analogue scale (VAS) was used to measure the levels of labor pain. VAS scores will be recorded from the latent phase of labor to birth.The VAS was a 0 to 100 mm line (from no pain to worst imaginable pain). Over 60 mm on the VAS indicates severe pain, moderate pain ranges from 40 - 60 mm and mild pain is under 40 mm. The higher scores implied the higher level of pain., The study will be conducted from the latent phase of labor to birth.|fetal outcomes, The Apgar score is a standardized assessment of a neonate's status immediately after birth and the response to resuscitation efforts and remains the gold standard for evaluating neonates., APGAR scores will be recorded after birth.
Study to Understand Novel Biomarkers in Researching Dementia
NCT Number: NCT06547099
Acronym: SUNBIRD
Status: ENROLLING_BY_INVITATION
Study Type: OBSERVATIONAL
Conditions: Alzheimer Disease|Mild Cognitive Impairment|Dementia
Interventions: DIAGNOSTIC_TEST: Clinical tau PET|DIAGNOSTIC_TEST: Clinical amyloid test|OTHER: Research blood collection|OTHER: Cognitive assessments
Sponsor: Washington University School of Medicine
Collaborators: National Institute on Aging (NIA)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1800
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-14
Completion Date: 2028-12
Locations: Washington University School of Medicine, Saint Louis, Missouri, 63110, United States

Summary:
The purpose of this study is to determine the relationships between amyloid, tau, and neurodegeneration biomarkers in the blood and the presence of Alzheimer's disease (AD) pathology, clinical cognitive decline, and diagnosis. We aim to understand how well blood-based biomarkers can diagnose and predict Alzheimer's disease, which will help to further develop and validate blood tests for the disease.

Primary Outcome Measures: Area under the curve (AUC) of plasma amyloid-beta 42/40 in predicting amyloid PET status, Baseline|Area under the curve (AUC) of plasma %p-tau217 in predicting amyloid PET status, Baseline|Area under the curve (AUC) of plasma p-tau217 in predicting tau PET status, Baseline|Area under the curve (AUC) of plasma p-tau205 in predicting tau PET status, Baseline|Area under the curve (AUC) of plasma neurofilament light in predicting tau PET status, Baseline|Area under the curve (AUC) of plasma %p-tau205 in predicting clinical diagnosis, Baseline, 1 year, 2 years, 3 years, 4 years, 5 years|Area under the curve (AUC) of plasma %p-tau217 in predicting clinical diagnosis, Baseline, 1 year, 2 years, 3 years, 4 years, 5 years|Area under the curve (AUC) of plasma amyloid-beta 42/40 in predicting clinical diagnosis, Baseline, 1 year, 2 years, 3 years, 4 years, 5 years|Area under the curve (AUC) of plasma neurofilament light in predicting clinical diagnosis, Baseline, 1 year, 2 years, 3 years, 4 years, 5 years
Army-SPRING Army-Suicide Prevention Research
NCT Number: NCT06547008
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Suicide
Interventions: BEHAVIORAL: Army-SPRING|BEHAVIORAL: Risk Reduction Group (Control)
Sponsor: University of Pennsylvania
Collaborators: Yale University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 57
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-09
Completion Date: 2028-08
Locations: Connecticut Army National Guard, Hartford, Connecticut, 06103, United States|Yale University, New Haven, Connecticut, 06520, United States|Center for the Treatment and Study of Anxiety, University of Pennsylvania, Philadelphia, Pennsylvania, 19104, United States

Summary:
Every unit in the Connecticut Army National Guard has a Suicide Intervention Officer to provide suicide intervention education awareness for their unit, monitor for soldiers in crisis and connect soldiers with helping resources and agencies. Suicide Intervention Officers need support in this difficult role, yet there is limited guidance on how to help them. This study will shed light on how to support Suicide Intervention Officers and whether this support results in reduced suicide risk in their units.

Primary Outcome Measures: Reach - Self, Use of ASIST for self, URI-3 item 75, Year 1|Reach - Buddy, Use of ASIST for buddy, URI-3 item 74, Year 1|Reach - Interactions with soldiers involving discussions about suicide risk, Number of soldier interactions reporting suicide risk/Total number of interactions with soldiers, Weekly for 1 year
Secondary Outcome Measures: Suicidal ideation, URI-3 item 15, Year 1|Suicide plans:, URI-3 item 15a, Year 1|Suicide attempts, URI-3 item 15b, Year 1|Adoption, Suicide intervention officer willingness to initiate all SIO duties; This will be operationalized as the total number of SIOs who reported completing all their ASIST-related activities, Up to 24 weeks|Implementation, Fidelity to all assigned suicide intervention officer duties; Fidelity will be assessed using self-report by the SIO, including the following questions: 1) Does your battalion know that you are their SIO?; and 2) Have you completed any trainings related to suicide prevention with your battalion? Finally, among SIOs randomized to ARMY-SPRING, we will assess their fidelity of leading the battle drills in a manner consistent with ASIST principals., Up to 24 weeks|Acceptability, Acceptability of Intervention Measure (AIM), Up to 24 weeks|Appropriateness, Intervention appropriateness measure (IAM), Up to 24 weeks|Qualitative Interviews, Qualitative Interviews (Acceptability, appropriateness, climate, etc.), Up to 24 weeks
Other Outcome Measures: Intentions, attitudes, norms, Theory of Planned Behavior Questionnaire, Baseline, quarterly, year 1, year 2|Organizational culture, Organizational culture measure culture and climate in their battalion, feasibility and acceptability of implementing suicide prevention tasks, Baseline, quarterly, year 1, year 2
Diagnosis and Staging of Typhoid Fever Using Surface-enhanced Raman Spectroscopy Liquid Biopsy
NCT Number: NCT06546982
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Typhoid Fever
Interventions: DIAGNOSTIC_TEST: Surface-enhanced Raman Spectroscopy
Sponsor: University Hospital, Aachen
Collaborators: University of Agriculture Faisalabad|Nishtar Medical University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: SINGLE (PARTICIPANT)|Primary Purpose: DIAGNOSTIC
Start Date: 2023-07-15
Completion Date: 2024-12
Locations: Roger Molto Pallares, Aachen, Northwest, 52074, Germany

Summary:
The goal of this project is to adapt the gold nanoparticle-based surface-enhanced Raman spectroscopy (SERS) technology to clinical application. In this exploratory study a measurement protocol will be established to subsequently investigate whether SERS allows to diagnose patients infected with typhoid fever as well as to stage the disease.

Primary Outcome Measures: SERS measurements to differentiate between healthy and typhoid fever patients, SERS assessment of healthy and typhoid fever patient samples to identify unique spectroscopical characteristics to discriminate between healthy and typhoid fever patients, Through study competition, up to 1 year
Secondary Outcome Measures: SERS measurements to stage typhoid fever patients, SERS assessment of early-stage and consolidated-stage typhoid fever patient samples to identify unique spectroscopical characteristics to stage the infection., Through study competition, up to 1 year
Glucose Monitoring in Youth With Cystic Fibrosis During Pulmonary Exacerbations
NCT Number: NCT06546943
Acronym: GeM-PEx
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Cystic Fibrosis Pulmonary Exacerbation
Sponsor: University of Colorado, Denver
Collaborators: Cystic Fibrosis Foundation|Baylor College of Medicine
Sex: ALL
Age: CHILD, ADULT
Enrollment: 50
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-02-04
Completion Date: 2025-10-31
Locations: Children's Hospital Colorado, University of Colorado Denver, Aurora, Colorado, 80045, United States

Summary:
The goal of this study is to investigate the prevalence of dysglycemia with continuous glucose monitoring (CGM) obtained during pulmonary exacerbations, both outpatient and inpatient, in youth with cystic fibrosis (CF).

Primary Outcome Measures: CGM standard deviation, Measures of glycemic variability from CGM during the exacerbation (CGM-PEx) compared measure derived from recovery period (CGM-post), 14 days|CGM coefficient of variation, CGM measure of glycemic variability during the exacerbation (CGM-PEx) with recovery measure (CGM-post), 14 days|MAGE (mean amplitude of glycemic excursions), CGM measures of glycemic variability (MAGE) during the exacerbation (CGM-PEx) with recovery measures (CGM-post), 14 days
Secondary Outcome Measures: Forced expiratory volume at one second (FEV1) at each visit, Collected clinically at baseline during routine visits, and at the start of a pulmonary exacerbation (PEx) for those admitted inpatient and in clinic, and at next in person routine clinic visit; b)by home spirometer during routine clinic visits, and in the hone setting (if not in person) once for the baseline visit, and at the onset of exacerbation and twice/week for 14 days, and once upon recovery (at least 6 weeks after PEx), up to 2 years|Need for additional antibiotics within 28 days following initial treatment, If initial Rx for antiobiotics proves unsuccessful and participant requires additional treatment, up to 2 years|Chronic Respiratory Infection Symptom Score questionnaire, Questionnaire tracking exacerbation symptoms, up to 2 years|sputum culture as available from clinical data, Will be collected when available from clinical data, up to 2 years|markers of inflammation when available, hsCRP (highly sensitive C-Reactive Protein) and cytokines (eg; Interleukin-6 \[IL 6\] \& Interleukin-8 \[IL8\]) at visits, up to 2 years|Cystic Fibrosis Questionnaire Revised (CFQR) questionnaire, quality of life questionnaire, up to 2 years
Artificial Intelligence Empowered Anesthesia Ultrasound Guided Regional Anesthesia Training
NCT Number: NCT06546904
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Ultrasound-guided Regional Anesthesia
Interventions: DEVICE: Artificial intelligence empowers anesthesia with ultrasound assistance
Sponsor: Tongji Hospital
Sex: ALL
Age: ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: OTHER
Start Date: 2024-09-01
Completion Date: 2026-10-31
Locations: Tongji hospital, Wuhan, Hubei, 430030, China

Summary:
Evaluate the effectiveness of AI powered anesthesia ultrasound in ultrasound-guided regional anesthesia (UGRA) training.

Primary Outcome Measures: Success rate of ultrasound-guided puncture, Success rate of ultrasound-guided puncture at the first attempt, 1day
Secondary Outcome Measures: Location time, the time from the placement of the US transducer on the skin to the time of piercing of the skin., 1day
The Effect of Fluid Training Given to Hemodialysis Patients on Interdialytic Fluid Intake and Blood Pressure
NCT Number: NCT06546852
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Education|Nursing Caries
Interventions: BEHAVIORAL: education
Sponsor: University of Beykent
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 71
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: PREVENTION
Start Date: 2023-01-01
Completion Date: 2023-04-28
Locations: Ülkü Yılmaz, Istanbul, Turkey

Summary:
The research evaluated the effect of nutrition and fluid restriction training on interdialytic fluid intake and intradialytic hypotension in hemodialysis patients. The study sample, conducted with an experimental design, consisted of 71 patients (36 experimental and 35 control) who received dialysis treatment in a private dialysis centre affiliated with the Istanbul Provincial Health Directorate.

Primary Outcome Measures: Complying with fluid restriction, Thanks to the training given, patients consume less fluid. posttests were performed usingthe fluid control scale on Hemdodialysis patients.

The lowest score from the scale is 24 and the highest score is 72. from scale As the score increases, patients' compliance with fluid control also increases., 14 weeks,
SPSIPB vs SAPB for Thoracoscopic Surgery
NCT Number: NCT06546839
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Lung Diseases|Lung Cancer|Lung Neoplasms|Lung Cancer Metastatic|Thoracic Diseases|Thoracic Cancer|Thoracic Neoplasms
Interventions: DRUG: SPSIPB blcok|DRUG: SAPB block|DRUG: Postoperative analgesia management
Sponsor: Medipol University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-10
Completion Date: 2024-10-25
Locations: Istanbul Medipol University Hospital, Istanbul, Bagcilar, 34070, Turkey

Summary:
Video-assisted thoracic surgery (VATS) has recently been evaluated as the standard surgical procedure for lung surgery. Although VATS is less painful than thoracotomy, patients may feel severe pain during the first hours of the postoperative period. Analgesia management is very important for these patients in the postoperative period since insufficient analgesia can cause pulmonary complications such as atelectasis, pneumonia, and increased oxygen consumption. Ultrasound (US) guided serratus posterior superior block (SPSPB) is a new interfacial plane block defined by Tulgar et al in 2023. It is based on injection on the serratus posterior superior muscle at the level of the 2nd or 3rd rib. This block provides analgesia in conditions such as interscapular pain, chronic myofascial pain syndromes, scapulocostal syndrome, and shoulder pain. The SPS muscle is located at the C7-T2 level. It attaches to the lateral edges of the second and fifth ribs. It is innervated by the lower cervical and upper intercostal nerves. With the SPS block, these nerves are blocked and analgesia is provided. It has been reported that SPSIPB provides effective analgesia after VATS. US-guided serratus anterior plane (SAP) block provides effective analgesia in the thorax's anterior, posterior, and lateral dermatomes. It has been reported that SAP block provides effective postoperative pain management following thoracotomy, breast surgery and VATS. There is no clinical randomized study in the literature evaluating the efficacy of SPSIPB and SAP block following VATS.

Primary Outcome Measures: Opioid consumption (Fentanyl PCA), The primary aim is to compare postoperative opioid consumption from the PCA device., Changes from baseline opioid consumption at postoperative 1, 2, 4, 8, 16 and 24 hours.
Secondary Outcome Measures: Pain scores (Numerical rating scale-NRS), The secondary aim is to compare NRS at the postoperative 24 h. Postoperative pain assessment will be performed using the NRS (0 = no pain, 10 = the most severe pain felt). The NRS scores will be recorded, Changes from baseline pain scores at postoperative 1, 2, 4, 8, 16 and 24 hours|Need for rescue analgesia (meperidine), The secondary aim is to compare rescue analgesia used in the postoperative 24 h., Postoperative 24 hours period|Adverse events, The secondary aim is to compare the adverse events (nausea, vomiting, itching) related to opioid use, Postoperative 24 hours period
Alveolar Ridge Preservation After Tooth Extraction
NCT Number: NCT06546826
Acronym: CRES-PRES
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Alveolar Bone Loss
Interventions: PROCEDURE: BARP
Sponsor: International Piezosurgery Academy
Collaborators: University of Trieste, Department of Medicine, Surgery and Health Sciences|Universidade do Porto
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 16
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-03-06
Completion Date: 2024-10-01
Locations: University of Trieste, Departmen of Medicine, Surgery, Health Sciences, Trieste, 34100, Italy

Summary:
Post-extractive alveolar ridge remodeling represents a physiological phenomenon that may hamper successive implant insertion. Several techniques have been proposed without any significant difference of efficacy among them. Moreover several research protocols of analysis have been proposed, including histomorphometric, radiological, clinical analysis.

The purpose of the present study is to test different alveolar ridge preservation techniques using histomorphometric and optical scanning analysis.

Primary Outcome Measures: histomorphometric analysis, bone volume/total volume, 6 months post-extraction
Secondary Outcome Measures: alveolar volume, optical scanning comparison, 6 months post-extractive
SPECIAL INVESTIGATION FOR ABRYSVO IN INDIVIDUALS AGED 60 YEARS OR OLDER
NCT Number: NCT06546800
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Respiratory Syncytial Virus Infection
Interventions: BIOLOGICAL: RSVpreF vaccine
Sponsor: Pfizer
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-31
Completion Date: 2026-06-10
Locations: Pfizer, Tokyo, 151-8589, Japan

Summary:
This post-marketing study is a multicenter cohort study in individuals aged 60 years or older vaccinated with Abrysvo (RSV vaccine）designed to confirm the safety in individuals aged 60 years or older under actual clinical practice in Japan.

Primary Outcome Measures: Percentage of individuals aged 60 years or older reporting Adverse Reactions for 28 days after vaccination., Adverse reaction (including serious) in individuals aged 60 years or older will be assessed., From the day of vaccination up to 28 days after vaccination.|Percentage of individuals aged 60 years or older reporting Serious Adverse Reactions from the day of vaccination up to 28 days after vaccination., Serious adverse reaction in individuals aged 60 years or older will be assessed., From the day of vaccination up to 28 days after vaccination.
The Effect of Interpersonal Relationships Psychotherapy on Breast Cancer Patients
NCT Number: NCT06546787
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Breast Cancer Patients Diagnosed
Interventions: OTHER: PSYCHOTHERAPY
Sponsor: Koç University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 42
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-08-15
Completion Date: 2025-06-01
Locations: Koc University, Istanbul, Nursing Department, 34020, Turkey

Summary:
This study is planned to examine the effect of Interpersonal Relationship Psychotherapy on depression, interpersonal emotion regulation and multidimensional perceived social support levels of breast cancer patients with depression risk.

Primary Outcome Measures: Beck Depression Screening Scale for Primary Care, Each question has four answers. The lowest possible score is zero and the highest possible score is three. A total maximum score of 21 and a minimum score of zero can be achieved. Depression scores of breast cancer patients are expected to decrease after treatment. It is expected to fall below 4 points., Through study completion, an average of 6 months|Interpersonal relationships emotion regulation scale, The highest score that can be obtained from the scale is 100 and the lowest score is 20. The high score obtained from each sub-dimension of the scale indicates that the individual has the characteristic evaluated by the relevant sub-dimension. Scores obtained from the scale were found to be related to the total score of the Difficulties in Emotion Regulation Scale and also to depression and anxiety.An increase in the interpersonal relations emotion regulation scale score is expected in breast cancer patients after treatment. This increase shows that it has a positive effect on individuals' emotion regulation., Through study completion, an average of 6 months|Multidimensional Perceived Social Support Scale:, The lowest score that can be obtained from the scale is "12" and the highest score is "84". An increase in the total score of the scale means an increase in the level of perceived social support. Social support scores of breast cancer patients are expected to increase after treatment., Through study completion, an average of 6 months
The Effect of Melatonin Supplementation on Cumulus Cells and IVF Outcomes
NCT Number: NCT06546774
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Unrecognized Condition
Interventions: DIETARY_SUPPLEMENT: Melatonin
Sponsor: Kaohsiung Veterans General Hospital.
Sex: FEMALE
Age: ADULT
Enrollment: 200
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2021-05-01
Completion Date: 2025-12-31
Locations: Department of Obstetrics and Gynecology, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan, Kaohsiung, 886, Taiwan

Summary:
This study investigates the effects of melatonin supplementation on cumulus cell gene expression and in vitro fertilization (IVF) outcomes in women over 35 years old. In the study group, patients will receive melatonin supplementation for at least two months prior to their IVF cycles. Cumulus cells will be collected after oocyte retrieval, and IVF outcomes will be assessed.

Primary Outcome Measures: Live birth rate (%), a viable infant after 24 weeks of gestation, through study completion, an average of 4 year|oxygen consumption rate of mitochodria (%), to assess mitocondrial function in cumulus cells, through study completion, an average of 4 year|mRNA levels of cumulus cell genes, to assess cumulus cells gene expression analysis, through study completion, an average of 4 year
Secondary Outcome Measures: Clinical pregnancy rate (%), the presence of a fetal heartbeat detected via transvaginal sonography at 6-7 weeks of gestation, through study completion, an average of 4 year|Ongoing pregnancy rate (%), the continuation of the pregnancy beyond 12 weeks of gestation, through study completion, an average of 4 year|Amount of ATP production (moles/min) of mitochodria, to assess mitocondrial function in cumulus cells, through study completion, an average of 4 year
Selective Coronary Revascularization in Carotid Artery Disease Patients After Carotid Revascularization (SCORECAD Trial)
NCT Number: NCT06546761
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Carotid Stenosis|Coronary Artery Disease
Interventions: DIAGNOSTIC_TEST: Coronary CT angiography and FFRct analysis
Sponsor: Pauls Stradins Clinical University Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 300
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-25
Completion Date: 2029-06-25
Locations: Pauls Stradins Clinical University Hospital, Riga, Latvia

Summary:
The primary objective of this study is to determine whether among symptomatic and asymptomatic carotid artery stenosis (CAS) patients with no known coronary artery disease (CAD) who had undergone carotid artery revascularization (endarterectomy of stenting) a strategy of best medical therapy (BMT) plus selective coronary revascularization based on FFRct assessment of lesion-specific coronary ischemia can reduce adverse cardiac events and improve survival compared to BMT alone. Lesion-specific coronary ischemia is defined as FFRCT ≤0.80 distal to stenosis in a major (≥2 mm) coronary artery with severe ischemia defined as FFRCT ≤0.75.

Primary Outcome Measures: Major Adverse Cardiac Events, A composite of cardiac death, myocardial infarction (MI) or urgent coronary revascularization, 2 years
Secondary Outcome Measures: Major Adverse Cardiac Events and survival, Cardiac death, cardiovascular death, myocardial infarction (MI), urgent coronary revascularization, all-cause death, 2 years
Mini Crush or Double Kissing Crush Stenting Techniques For Complex Left Main Bifurcation Lesions
NCT Number: NCT06546748
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Left Main Coronary Artery Disease
Sponsor: Istanbul Mehmet Akif Ersoy Educational and Training Hospital
Collaborators: Koşuyolu Kartal Heart Training and Research Hospital|Basaksehir Cam & Sakura City Hospital|Medipol University|Sisli Hamidiye Etfal Training and Research Hospital|Bağcılar Training and Research Hospital|Ankara Etlik City Hospital|Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 300
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-22
Completion Date: 2024-11-30
Locations: Ahmet Güner, Istanbul, 33484, Turkey

Summary:
The Crush technique has evolved significantly since its introduction to the literature by Colombo et al in 2003, with multiple iterations including mini-crush (MC) and double kissing-crush (DKC) stenting techniques. The main principle of crush techniques for complex bifurcation lesions is to protrude the side branch (SB) stent towards the main branch to adequately cover the SB ostium and minimize the risk of SB ostium restenosis. It was noticed that the 4-5 mm protrusion of the SB stent resulted in a large volume of the crushed stent and the technique was modified into MC which aimed for approximately 1-2 mm protrusion by Galassi et al in 2007. Despite all the disadvantages of the crush technique, the final kissing balloon inflation (KBI) rate of this technique, along with several iterations has been up to 98%. Moreover, a recent meta-analysis showed that MC was associated with a reduction in risk of major cardiovascular events compared to provisional stenting, crush, and culotte techniques. The DKC is a planned 2-stent technique introduced by Chen et al. The ultimate innovation of this approach is that it is designed to increase the success rate of the final KBI. Provided recrossing of the crushed stent occurs through the proximal cell: another advantage of the DKC technique is to improve the success of KBI. The DKC significantly reduced major cardiovascular events (MACE) compared to provisional stenting, crush, TAP, and culotte. Until now, no clinical investigation has compared the DKC and MC in patients with complex left main bifurcation lesions. Therefore, this study sought to determine the clinical results of DKC and MC stenting techniques under long-term follow-up.

Primary Outcome Measures: Major cardiovascular events (MACE), Cardiac death, clinically-driven target lesion revascularization, target vessel myocardial infarction, 12 months
Efficacy and Safety of Two Fixed-dose Combinations in Men With Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia. (BENIPRO)
NCT Number: NCT06546735
Acronym: BENIPRO
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Benign Prostatic Hyperplasia With Lower Urinary Tract Symptoms
Interventions: DRUG: N0728|DRUG: Vesomni®
Sponsor: Eurofarma Laboratorios S.A.
Sex: MALE
Age: ADULT, OLDER_ADULT
Enrollment: 614
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2026-11-30
Completion Date: 2028-08-30
Locations: Eurofarma Laboratorios S.A, São Paulo, SP, 06696-00, Brazil

Summary:
The clinical trial to evaluate the fixed-dose combination (N0728), with the aim of providing the Brazilian market with an alternative, potentially effective, safe and convenient therapeutic approach for the treatment of Lower Urinary Tract Symptoms (LUTS) in men with Benign Prostatic Hyperplasia (BPH). The fixed-dose combination has synergistic action between drugs from different classes and offers significant potential advantages, such as better adherence to treatment. The trial will assess the non-inferiority in efficacy and safety of the proposed fixed-dose combination compared to alpha-adrenergic antagonists.

Primary Outcome Measures: The mean number of urgency episodes per day, Change from baseline (RV) to the end of 12 weeks of treatment (FV) in the mean number of urgency episodes per day, based on the 3-day voiding diary., 12 weeks
Secondary Outcome Measures: The mean number of voids per day, Change from baseline (RV) to the end of 12 weeks of treatment (FV) in the mean number of voids per day, based on the 3-day voiding diary., 12 weeks|The mean number of incontinence episodes per day, Change from baseline (RV) to the end of 12 weeks of treatment (FV) in the mean number of incontinence episodes per day, based on the 3-day voiding diary., 12 weeks
Transversus Thoracic Plane Block for Perioperative Analgesia in Cardiac Surgery
NCT Number: NCT06546722
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Transversus Thoracic Plane Block|Cardiac Surgery|Post Operative Pain
Interventions: PROCEDURE: Transversus Thoracic Plane Block
Sponsor: Saint-Joseph University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 150
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-09-01
Completion Date: 2025-12-30
Locations: Hotel Dieu de France, Beirut, 166830, Lebanon

Summary:
The goal of this clinical trial is to learn if perioperative Transversus Thoracic Plane Block (TTPB) decrease perioperative pain after cardiac surgery. The main questions it aims to answer are:

1. does Transversus Thoracic Plane Block decrease perioperative pain after cardiac surgery more than the standard analgesic treatment?
2. Are the results different if the investigators perform Transversus Thoracic Plane Block before surgery or at the end of surgery?

Primary Outcome Measures: postoperative pain score, The primary outcome is Postoperative Pain Score:

Numeric rating scale (NRS) ratings will be assessed at T1 (= upon patient awakening), T2 (= 12 hours postoperatively), T3 (= 24 hours postoperatively) as well as during various painful moments (coughing, drain removal, mobilization).

Numeric rating scale (NRS) is a unidimensional measure of pain intensity. It consists of the patient evaluating his pain out of a series of numbers ranging from 0 to 10, where the 2 respective endpoints are "0 = no pain" and "10 = worst possible pain.", First 24h postoperatively
Secondary Outcome Measures: Perioperative opioid requirement, Total dose of opioids required during surgery and 24h postoperatively, First 24h postoperatively|Time to first opioid administration, Time to first opioid administration after surgery, First 24h postoperatively|Time to extubation, Time between arrival to cardiac intensive care unit and extubation, First 24h postoperatively|Patient satisfaction at 24 hours post surgery, Patient satisfaction is measured by asking patients one question at 24 hours post surgery:

"On a scale from 0 to 10, 0 = not satisfied at all, 10 = extremely satisfied, how satisfied do you feel concerning pain management during the first 24 hours after surgery? ", First 24h postoperatively|Length of stay at cardiac intensive care unit and hospital stay, Length of stay at cardiac intensive care unit and hospital stay, 3 months postoperatively|Incidence of postoperative pneumonia and pneumothorax in cardiac intensive care unit, Incidence of postoperative pneumonia and pneumothorax in cardiac intensive care unit, First 24h postoperatively
The ADAPT Trial: Adapting Evidence-Based Obesity Interventions in Community Settings
NCT Number: NCT06546696
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Childhood Obesity
Interventions: BEHAVIORAL: Competency Based Approaches to Community Health (COACH)
Sponsor: Vanderbilt University Medical Center
Sex: ALL
Age: CHILD
Enrollment: 750
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-10-01
Completion Date: 2028-12-01
Locations: Vanderbilt University Medical Center, Nashville, Tennessee, 37212, United States

Summary:
Evidence-based obesity treatment is inaccessible to most children in the United States. This lack of access is a source of health inequity, whereby children from rural and minority communities, who have the highest rates of childhood obesity, are also the least likely to receive an evidence-based intervention. Developing strategies to improve access to evidence-based obesity interventions could reduce health disparities by improving reach to these underserved communities. The premise of this study is that using a systematic framework to adapt a community-based behavioral intervention for childhood obesity that accounts for individual, family, and community factors will increase reach and effectiveness among low-income, minority, and rural populations. COACH is a multi-level obesity intervention that supports 1) the individual child through developmentally appropriate health behavior curriculum, 2) the family by directly addressing parent weight loss and engaging parents as agents of change for their children, and 3) the community by building the capacity of local community centers to offer parent-child programming. The investigators propose testing the process of adapting COACH in a cluster-randomized trial.

Primary Outcome Measures: Child Percent of the 95th Body Mass Index Percentile, Calculated from CDC growth curves, 6 months post randomization
Secondary Outcome Measures: Child Percent of the 95th Body Mass Index Percentile, Calculated from CDC growth curves, 6 weeks post randomization
Other Outcome Measures: Child Diet, Child Nutrition and Physical Activity Behavior Scale. Possible range of 0-9 with higher scores indicating healthier diet and physical activity practices., 6 months post randomization|Child Physical Activity, Child Nutrition and Physical Activity Behavior Scale. Possible range of 0-9 with higher scores indicating healthier diet and physical activity practices., 6 months post randomization|Child Media Use, Child Media Use Index, 6 months post randomization|Child Sleep, Children's Sleep Habits Questionnaire, 6 months post randomization|Parent Body Mass Index, Measured by study staff, 6 weeks post randomization|Parent Body Mass Index, Measured by study staff, 6 months post randomization
Glucose Variability in Type 1 Diabetes (T1D) and Glycaemic Responses to Food Composition.
NCT Number: NCT06546657
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Type 1 Diabetes
Interventions: OTHER: Breakfast
Sponsor: University of Stirling
Sex: ALL
Age: CHILD
Enrollment: 96
Study Design: Observational Model: |Time Perspective: p
Start Date: 2021-02-06
Completion Date: 2021-11-20
Locations: Faculty of Health Sciences and Sport, Stirling, Stirlingshire, FK9 4LA, United Kingdom

Summary:
The study proposed to recruit approximately 435 children and young people who have T1D and who regularly use Dexcom continuous glucose monitoring (CGM). Recruitment was be via their local dietitian. The dietitian was asked to provide baseline information about the participants which will include demographic data and information on clinical data, treatment and anthropometrics. Participants will be asked to provide access to Dexcom CGM data throughout the period of recording. Participants were issued with, for seven consecutive days, two survey questionnaires, one in the morning at breakfast time and the other in the evening. The morning survey will include questions on the breakfast meal (including a photograph of the meal) and insulin dosage, similarly the evening survey will also include questions on diabetes management and food and fluid intake in addition to questions on activities all of which took place during the four-hour postprandial period. These data will be statistically described using univariate, bivariate and multivariate analysis.

Primary Outcome Measures: Mean Postprandial Glucose, From CGM data, 4 hours
Secondary Outcome Measures: Mean Glucose Excursion, From CGM data, 4 hours|Peak glucose excursion, From CGM data, 4 hours|Time to peak, From CGM data, 4 hours|Area under the curve, From CGM data, 4 hours|Coefficient of Variation percentage, From CGM data, 4 hours|Time in range, time above range , time below range, From CGM data, 4 hours|Coefficient of Variation percentage, From CGM data, 90 days
A Structured School-based Health Intervention for the Obesity Prevention
NCT Number: NCT06546644
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Child Obesity|Child Behavior|Obesity, Childhood
Interventions: BEHAVIORAL: Structured school-based intervention
Sponsor: Universiti Putra Malaysia
Collaborators: University of Lahore
Sex: ALL
Age: CHILD
Enrollment: 1200
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-08-15
Completion Date: 2025-04-15
Locations: City School Nawab shah, Nawab shah, Sindh, 67450, Pakistan

Summary:
The proposed research aims to assess how well a structured intervention is intended to reduce childhood obesity. The intervention addresses food and physical activity behaviors, important determinants of obesity, by concentrating on these elements. The goal of nutritional and physical education is to raise knowledge about the negative effects of obesity and encourage healthy eating habits in children and their caregivers. These educational campaigns will be delivered primarily through schools, guaranteeing a wide audience and consistent messaging.

Primary Outcome Measures: Dietary knowledge, Dietary knowledge will be measured by 24-hour dietary recall questionnaire

Healthy Eating Index (HEI):

Scores range from 0 to 100, with higher scores indicating better diet quality. Below 51: Poor diet. 51-80: Needs improvement. Above 80: Good diet, 6-months from baseline|Physical activity education, Physical activity education will be measured by Global physical activity questionnaire(WHO)

Total Physical Activity (MET-minutes): The intensity of activities is expressed in Metabolic Equivalent of Task (MET) minutes. MET values are:

Vigorous-intensity activity: 8.0 METs. Moderate-intensity activity: 4.0 METs. Walking: 4.0 METs. Low Activity: \< 600 MET-minutes/week Moderate Activity: 600-2999 MET-minutes/week High Activity: ≥ 3000 MET-minutes/week Sedentary Behavior: More than 8 hours/day of sitting may indicate high sedentary behavior., 6-months from baseline
Secondary Outcome Measures: Health-related quality of life, Health-related quality of life will be measured by kids screen questionnaire. 10 items Scoring: Each item is scored on a 5-point Likert scale, summed and transformed into T-scores. Higher scores indicate better overall quality of life.

T-scores below 40 typically indicate lower quality of life and potential areas of concern.

T-scores between 40 and 60 are considered within the average range. T-scores above 60 indicate higher than average quality of life., 6-months from baseline|Body mass index (BMI), Body mass index (BMI) will be measured by BMI calculator, 6-months from baseline
Little Cigar and Cigarillo Warnings to Reduce Tobacco-Related Cancers and Disease - Eye Tracking
NCT Number: NCT06546618
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Tobacco Use
Interventions: BEHAVIORAL: pictorial warning and no flavor|BEHAVIORAL: pictorial warning and 'sweet' flavor|BEHAVIORAL: text-only warning and no flavor|BEHAVIORAL: text-only warning and 'sweet' flavor
Sponsor: UNC Lineberger Comprehensive Cancer Center
Collaborators: National Cancer Institute (NCI)|Food and Drug Administration (FDA)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-08
Completion Date: 2024-11
Locations: University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, 27599, United States

Summary:
The goal of this research is to determine how removal of little cigar and cigarillo (LCC) flavor descriptors on packaging impacts attention and affective responses to LCC warnings. A study will be conducted using eye tracking, electrodermal activity (galvanic skin response), and survey measures of affect to measure participant responses to LCC packages varied by warning type (pictorial vs. text only) and flavor contents ('Sweet' flavor descriptor vs. no flavor descriptor).

Primary Outcome Measures: Attention to warning areas of interest, Attention to warning areas of interest will be measured by dwell time to pre-defined areas of interest on the little cigars or cigarillos (LCCs) package. The total amount of time in iseconds that participants spend looking at warnings will be determined., Baseline|Attention to flavor area of interest, Attention to flavor area of interest will be measured by dwell time to pre-defined areas of interest on the little cigars or cigarillos (LCCs) package. The total amount of time inseconds that people spend looking at the area where the flavor of the LCC is shown will be determined., Baseline
Secondary Outcome Measures: Electrodermal activity, Electrodermal activity indexes emotional arousal by sensing sweat on the hands, it will be measured using a Shimmer 3 galvanic skin response sensor placed on the non-dominant hand.Electrodermal activity is measured in units of microsiemens (µS), an increase in electrodermal activity indicates an increase in emotional arousal., Baseline|Affective response to warnings, Affective response to warnings will be measured using an adaptation of the Discrete Emotions Questionnaire. The affective responses questionnaire will include 12 different emotions (6 positive, 6 negative) to measure participant's emotional responses to the cigarillo packages. Participants will rate to what extent they experienced each emotion while viewing the LCC package on a scale of 1 to 7, where 1=not at all and 7=an extreme amount. Higher affective responses indicate stronger emotional reactions to the LCC package.

., Baseline
The Safety and Efficacy of Telitacicept in the Treatment of Systemic Sclerosis
NCT Number: NCT06546540
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Systemic Sclerosis
Interventions: DRUG: Telitacicept
Sponsor: Peking University Third Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-06-08
Completion Date: 2026-03-30
Locations: Peking Third Hospital, Beijing, China

Summary:
Systemic sclerosis (SSc) is a chronic, multisystem autoimmune disease characterized by potentially widespread and progressive skin fibrosis and vascular abnormalities, and may involve the musculoskeletal, gastrointestinal, pulmonary, cardiac, renal, neuromuscular, and urogenital systems. At present, there is no clear and effective drug treatment for the progression of scleroderma skin lesions, and there is a lack of authoritative treatment recommendations. In recent years, research on the treatment of B cells in SSc suggests that targeted B cell therapy has certain safety and effectiveness for SSc patients. Telitacicept is a fully human fusion protein that is a fusion of TACI protein and IgG1 protein. Telitacicept can inhibit the further development and maturation of immature B cells by blocking BLyS. At the same time, Telitacicept can also inhibit the differentiation of mature B cells into plasma cells by blocking APRIL, and affect the secretion of abnormal self reactive plasma cell autoantibodies, better controlling disease activity. The effectiveness and safety of SSc treatment require further research. This study is an evaluator blind, parallel controlled clinical trial that included 20 SSc patients who still had skin progression despite conventional treatment. The patients were divided into two groups, one group included patients who did not improve with conventional treatment for skin lesions, and the other group included patients who received traditional conventional treatment. The main outcome of the study was to evaluate the efficacy and safety of Telitacicept in the treatment of progressive skin lesions in SSc, and the secondary outcome was to evaluate the impact of Telitacicept on lung function, gastrointestinal symptoms, pulmonary arterial hypertension, disease activity, and quality of life in SSc.

Primary Outcome Measures: Changes of mRSS in patients after 52 weeks of treatment, The range and degree of skin thickening can be evaluated using the modified Rodnan skin score (mRSS) . The evaluator palpated 17 areas of the patient's body, and calculated the skin thickness of each area on a scale of 0-3 points, with a total score of 51 points. The skin progression was evaluated through changes in mRSS scores., base line and week 52|The safety of Telitacicept, Evaluate adverse drug reactions, up to 52 weeks
Study of [177Lu]Lu-PSMA-137 In Metastatic Castrate Resistant Prostate Cancer（mCRPC）
NCT Number: NCT06546527
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: EARLY_PHASE1
Conditions: Prostate Cancer
Interventions: DRUG: [177Lu]Lu-PSMA-137
Sponsor: Peking University First Hospital
Sex: MALE
Age: ADULT, OLDER_ADULT
Enrollment: 12
Study Design: Allocation: NA|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2026-12-01

Summary:
This study is a prospective, single-center, single-arm clinical trial consisting of two parts. In Part A, 3 participants were enrolled to receive sequential administrations of low doses of \[177Lu\]Lu-PSMA-137 and \[177Lu\]Lu-PSMA-617. Pharmacokinetics（PK） sampling and single-photon emission computed tomography/computed tomography (SPECT/CT) scans were performed at scheduled time according to the protocol. Based on quantitative pharmacological results, the optimal dosing regimen for \[177Lu\]Lu-PSMA-137 was derived. In Part B, 3 participants were enrolled to receive treatments with 50% and 100% of the optimal dose of \[177Lu\]Lu-PSMA-137, to preliminarily evaluate the safety, tolerability, radiation dosimetry, and efficacy of \[177Lu\]Lu-PSMA-137 in participants with metastatic castration resistant prostate cancer (mCRPC).

Primary Outcome Measures: Incidence of treatment-related adverse events (safety and tolerability), Number of participants with treatment-related adverse events as assessed by common terminology criteria for adverse events (CTCAE) version 5.0., From the time of signing informed consent until 42 days after the completion of study treatment