pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Malaria Molecular Surveillance in Mozambique (Phase 2)
NCT Number: NCT06529237
Acronym: GenMoz2
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Malaria|Falciparum Malaria|Malaria in Pregnancy
Interventions: DIAGNOSTIC_TEST: LDH-based malaria rapid diagnostic test|DIAGNOSTIC_TEST: Malaria rapid diagnostic test
Sponsor: Centro de Investigacao em Saude de Manhica
Collaborators: Barcelona Institute for Global Health|University of California, San Francisco|National Malaria Control Program, Mozambique
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 18750
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-04-01
Completion Date: 2027-03-31
Locations: Centro de Investigaçao em Saúde de Manhiça, Manhiça, Maputo, 1929, Mozambique

Summary:
Mozambique is among the ten countries with the highest burden of malaria worldwide, with an estimated 10.3 million cases in 2021. Malaria transmission is highly heterogeneous across the country, with high burden in the north and very low burden in the south, therefore requiring different strategies for effective control and potential elimination. The GenMoz study (NCT05306067, March 2021-Feb 2024) operationalized a functional malaria molecular surveillance (MMS) system to generate reliable and reproducible temporal genomic data to monitor the effectiveness of rapid diagnostic tests and antimalarials, as well as to continuously characterize transmission levels and sources. The National Malaria Control Program (NMCP) is starting a new strategic cycle (2023-2030) with a plan that includes genomic surveillance for guiding programmatic decisions on six key antimalarial tools : 1. Malaria diagnostics using rapid diagnostic tests (RDTs) based on histidine-rich protein 2 (HRP2); 2. Treatment with artemisinin-based combination therapies (ACTs), including diversification schemes to reduce emergence of resistance; 3. Chemoprevention for pregnant women and children; 4. R21/Matrix-M vaccine rollout; 5. Individual-level interventions in very low transmission settings and 6. Vector control. In Phase 2, the investigators aim to integrate MMS into this wider surveillance framework and scale MMS in Mozambique for quality, timely and appropriate optimization of the public health benefits of the NMCP 2023-2030 strategy in both a proactive and adaptive manner, selecting the combinations of interventions that maximize the impact at the individual and community level.

Primary Outcome Measures: Prevalence of molecular markers of antimalarial resistance at provincial level, Year 3|Prevalence of hrp2/3 deletions determined at regional level, Year 3|Genetic diversity of the parasite population by period, study area and population, Year 3|Genetic relatedness between pairs of samples and populations by period, study area and population, Year 3|Genetic diversity in circumsporozoite protein C-terminal region encompassing T-cell epitopes, Year 3
Social Egg Freezing: Will Health Professionals Offer it ?
NCT Number: NCT06529224
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Infertility,Female
Interventions: OTHER: Online questionnaire
Sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 2500
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-04-01
Completion Date: 2025-02
Locations: CHU Saint Etienne, Saint-Étienne, 42000, France

Summary:
In 2021, the revision of bioethics laws opened the door to elective egg freezing. This gives women, between their 29th and 37th birthdays, the opportunity to freeze their eggs in order to combat age decline fertility. However, communication about this new possibility has remained limited both toward women and their health professional.

Primary Outcome Measures: Knowledge of primary care professionals regarding age-related decline in fertility., Analysis questionnaire results., Day 1|Propensity to spontaneously broach the subject with their patients without children., Analysis questionnaire results., Day 1|Knowledge and support for the elective egg freezing., Analysis questionnaire results., Day 1
NeuroGyn Genital Neuromodulation System for iOAB Treatment
NCT Number: NCT06529198
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Overactive Bladder
Interventions: DEVICE: NeuroGyn Genital Neuromodulation System
Sponsor: Prof. Dr. med. Marc Possover
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 150
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2025-08-01
Completion Date: 2026-04-01

Summary:
The NeuroGyn study is designed to evaluate the safety and effectiveness to the NeuroGyn Genital Neuromodulation System as an aid in the treatment of the symptoms of idiopathic overactive bladder in patients who have failed or could not tolerate more conservative treatments.

Primary Outcome Measures: Reduction in Symptoms greater than or equal to 50%, Overactive Bladder Symptom Score - OABSS, 6 months - 1 year - 2 years follow up|Urodynamic testing, Noninvasive uroflowmetry, followed by invasive cystometry and a pressure-flow study + concurrent electromyography (EMG) of pelvic floor muscles and urethral pressure profiles, 6 months - 1 year - 2 years
Secondary Outcome Measures: International Consultation on Incontinence Questionnaire, International Consultation on Incontinence Questionnaire (ICIQ), 6 months - 1 year - 2 years|The PHQ-9 (Patient Health Questionnaire-9), PHQ-9, 6 months - 1 year - 2 years
Effect of Breather in COPD Patients With Intermittent Claudication
NCT Number: NCT06529185
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: COPD|PAD
Interventions: DEVICE: The BREATHER|DRUG: pharmacological treatment
Sponsor: Cairo University
Sex: MALE
Age: ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2025-03

Summary:
The aim of this study To show the effect of breather on ventilatory and vascular function in COPD patient with intermittent claudication.

Primary Outcome Measures: Ventilatory function: by spirometry test, Spirometry is a physiological test that measures the ability to inhale and exhale air relative to time., 4 weeks|Vascular function: by doppler ultrasound, Doppler ultrasound is a simple and non-invasive and method for the evaluation of early atherosclerosis. It can be used as a screening program for PAD in populations with high risk for atherosclerosis., 4 weeks
Secondary Outcome Measures: Functional capacity assessment: by 5 repetitions sit to stand test (5R-STS), (5R-STS) test is an objective test of functional impairment commonly used in various diseases including COPD which is used to measure the severity of disease and to monitor recovery., 4 weeks|Treadmill exercise testing, The results of the tests will be expressed in units of distance that will be walked up to the claudication pain (initial claudication distance) and the maximally tolerated claudication pain (maximal claudication distance)., 4 weeks
Bone Mineral Density and Bone Metabolism in Older Women
NCT Number: NCT06529172
Acronym: BMD
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Osteoporosis, Age-Related
Interventions: OTHER: Resistance training|OTHER: Yijinjing|OTHER: Baduanjing|OTHER: Control
Sponsor: Cheng Liang
Collaborators: Chengdu Sport University
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 85
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2023-06-05
Completion Date: 2024-01-20
Locations: Chengdu Sport University, Chengdu, Sichuan, 610041, China

Summary:
The objective of this study is to assess the impact of different exercise interventions on bone mineral density (BMD) in older women. It will also evaluate the safety and compliance of these interventions. The primary questions it aims to address are:

Does resistance training, Yijinjing, or Baduanjin improve BMD in postmenopausal women? What are the compliance rates and any adverse effects associated with these exercise programs? Participants will be divided into 4 groups and compared against a control group that maintains their usual lifestyle.

Participants will:

Engage in their assigned exercise program three times a week for 24 weeks Receive calcium and vitamin D supplementation daily Keep a log of exercise adherence and any side effects experienced The study will utilize the International Physical Activity Questionnaire and dual-energy X-ray absorptiometry for comprehensive assessments.

Primary Outcome Measures: Dual-energy X-ray absorptiometry measurements, A Norland XR-46 dual-energy X-ray BMD tester was used to measure the BMD of the lumbar L2-4 and proximal femur of the dominant side (femur neck, greater trochanter and Ward's triangle). Five non-re-entrant scans were performed at each measurement site. The error coefficients of the measurement location were 1-2% in the lumbar L2-4, femoral neck and greater trochanter and 2.5-5% in Ward's triangle. The coefficient of variation in the lumbar vertebrae and the proximal femur was 1.1% and 1.85%, respectively., 24 Weeks|Serum bone metabolism markers, Fasting venous blood (5 ml) was drawn between 7 a.m. and 8 a.m. at both baseline and after 24 weeks, with samples subsequently centrifuged at 3000 r/min for 5 minutes in each instance. Serum levels of PINP, OC, and β-CTX were measured using an automatic chemiluminescence analyzer, the LIAISON® XL, which is manufactured by the Italian company DiaSorin. The kit required for the experiment was purchased from Nanjing Jiancheng Bioengineering Institute and utilised in strict accordance with its instructions., 24 Weeks
Secondary Outcome Measures: Physical Activity Assessment, This study incorporated a validated assessment tool to monitor the participants' physical activity levels. For all groups, we utilized the International Physical Activity Questionnaire (IPAQ), 24 Weeks
The Effect of Dual Task on Postural Control in Children Diagnosed With Epilepsy
NCT Number: NCT06529133
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Epilepsy|Cognitive Function 1, Social|Balance; Distorted|Children
Interventions: OTHER: Evaluation of postural control
Sponsor: Bezmialem Vakif University
Sex: ALL
Age: CHILD
Enrollment: 30
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SCREENING
Start Date: 2024-07-26
Completion Date: 2024-10-15
Locations: Bezmialem Vakif University, Istanbul, Turkey

Summary:
An individual's postural control is often accompanied by other tasks in daily life, such as cognitive tasks. Cognitive dual task (cognitive dual task) is the ability to perform two or more cognitive and motor activities simultaneously. There are studies in the literature that address the postural control of different patient populations and healthy individuals while performing a cognitive task. To our knowledge, there is no study evaluating the postural control skills of children with epilepsy during a cognitive dual task using dynamic posturography (Biodex). In this respect, it is possible to say that our study constitutes the first study that can contribute to the literature on this subject.

Primary Outcome Measures: Evaluation of postural control under two conditions, Postural control abilities of the children will be evaluated with Biodex Balance System (BBS). Half an hour later, the same tests will be repeated during the cognitive dual task., Day 1
Cardiovascular Response to Isometric BFR Exercise
NCT Number: NCT06529068
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Blood Pressure
Interventions: BEHAVIORAL: Isometric handgrip exercise|BEHAVIORAL: Isometric handgrip exercise with a narrow-elastic band|BEHAVIORAL: Isometric handgrip exercise with a wide-rigid cuff
Sponsor: University of Texas at Austin
Sex: ALL
Age: ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-09
Completion Date: 2025-08

Summary:
The goal of this interventional study is to evaluate the acute impact of isometric blood flow restriction (BFR) exercise on blood pressure and other cardiovascular functions in healthy young adult volunteers. The main question it aims to answer is:

The investigators hypothesize that isometric BFR exercise with a wide-rigid cuff would lead to greater blood pressure and other cardiovascular responses and that these cardiovascular responses would be greater under isometric BFR exercise with narrow-elastic bands compared with the control condition (no cuff).

Participants will perform isometric exercises in 3 laboratory visits with different exercise conditions) no cuff control 2) BFR with wide-rigid cuff 3) BFR with narrow-elastic band.

Primary Outcome Measures: Systolic blood pressure and diastolic blood pressure, Beat-by-beat (both systolic and diastolic blood pressure) blood pressure before, during, and after exercise, 20 minutes|Brachial artery diameter evaluated by an ultrasound machine, Brachial artery diameter will be measured by an ultrasound machine to calculate flow-mediated dilation (FMD), Before and 20 minutes after exercise|Heart rate, Monitor heart rate continuously before, during, and after exercise, 20 minutes
Using Dichoptic Therapy to Treat Intermittent Exotropia
NCT Number: NCT06529016
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Exotropia Intermittent
Interventions: DEVICE: Luminopia, a virtual reality headset|OTHER: Paper pre- survey|OTHER: Paper Survey
Sponsor: Virginia Commonwealth University
Sex: ALL
Age: CHILD
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2025-06
Locations: Virginia Commonwealth University, Richmond, Virginia, 23298, United States

Summary:
Intermittent exotropia is difficult to treat. The mainstay of treatment involves surgery, and in one long-term study authors found that as many as 60% of IXT required at least one re-operation.Patching of the non-dominant eye has also been tested in a large, multi-center randomized control trial and was not found to have a large benefit. More non-surgical treatment modalities are critical to improve the care in this condition.

Primary Outcome Measures: Dichoptic therapy change of control of intermittent exotropia using the standard control score, Improvement of the control of IXT using the Exotropia control scale that runs from 0-5. 0 meaning No exotropia noted unless dissociated, recovers in \< 1 seconds (exophoria). A 5 means Constant exotropia during 30-second observation before dissociation., 3 months for primary response, and 6 months after a washout period (3 months without the device)
Secondary Outcome Measures: Change of amplitude of exotropia as measured by Alternating Prism Cover Test, The alternate prism cover test is similar to the alternate cover test, with the addition of a prism held over one eye to quantify the misalignment. The examiner performs the alternate cover test while changing the prism over the deviated eye until the misalignment is neutralized, 3 months for primary response, and 6 months after a washout period (3 months without the device)|Change of scores from the Pediatric Eye Disease Investigator Group (PEDIG) intermittent exotropia questionnaire, The Intermittent Exotropia Questionnaire (IXTQ) is a patient-derived, intermittent exotropia-specific instrument designed to evaluate health-related quality of life (HRQOL) in children with intermittent exotropia. The12-item assessment ivalues were converted to 0 (best) to 100 (worst), 3 months for primary response, and 6 months after a washout period (3 months without the device)
Western Diet on Cardiometabolic and Immune Function
NCT Number: NCT06528977
Acronym: WD
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Aging|Diet, Healthy
Interventions: OTHER: Western Diet
Sponsor: University of Delaware
Collaborators: National Institute of General Medical Sciences (NIGMS)
Sex: ALL
Age: ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-07-17
Completion Date: 2027-07
Locations: University of Delaware, Newark, Delaware, 19713, United States

Summary:
This study will implement a Western Diet (WD) to understand cardiometabolic and immune function in middle-aged adults (50- 64 years old). Vascular health, intestinal permeability, and T-cell function will be examined before, during, and after the WD. The WD is a 10-day diet and will consist of 25% of total energy from added sugars.

Primary Outcome Measures: Change in Mean Arterial Blood Pressure (mmHg), Comparison between before, during and after western diet, Over the course of 1-2 months|Change in relative brachial artery flow-mediated dilation (%), Comparison between before, during and after western diet, Over the course of 1-2 months|Change in absolute brachial artery flow-mediated dilation (mm), Comparison between before, during and after western diet, Over the course of 1-2 months|Change in T-cell mitochondria respiration (oxygen consumption rate), Comparison between before, during and after western diet, Over the course of 1-2 months|Change in T-cell flow cytometry (%), Comparison between before, during and after western diet, Over the course of 1-2 months|Change in intestinal permeability (lactulose : mannitol test), Comparison between before, during and after western diet, Over the course of 1-2 months|Change in triglycerides (mg/dL), Comparison between before, during and after western diet, Over the course of 1-2 months|Change in cholesterol (mg/dL), Comparison between before, during and after western diet, Over the course of 1-2 months
Proteinopathies Expression in Skin of Neurodegenerative Disorders
NCT Number: NCT06528964
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Alzheimer Disease|Frontotemporal Dementia|Parkinson Disease|Atypical Parkinsonism|Amyotrophic Lateral Sclerosis|Normal Pressure Hydrocephalus
Interventions: DIAGNOSTIC_TEST: Immunohistochemistry and immunofluorescence
Sponsor: Universidad Autonoma de San Luis Potosí
Collaborators: Hospital Central "Dr. Ignacio Morones Prieto"
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-12-20
Completion Date: 2024-11-01
Locations: Hospital Central Dr. Ignacio Morones Prieto, San Luis Potosí, 78290, Mexico

Summary:
The goal of this observational study is to compare the aggregation pattern of proteinopathies (alpha-synuclein, amyloid-beta, phosphorylated tau and transactive response DNA -binding protein 43 \[TDP43\]) in skin biopsies of patients with a neurodegenerative disease like Alzheimer's disease, frontotemporal lobe dementia, Parkinson's disease, atypical Parkinsonism, amyotrophic lateral sclerosis or normal pressure hydrocephalus. The main question it aims to answer is:

* Is there a specific pattern of aggregation of proteinopathies in skin biopsies in each neurodegenerative disease in comparison to healthy control subjects?

Skin biopsies will be analyzed using immunohistochemistry and immunofluorescence for detection of alpha-synuclein, amyloid-beta, phosphorylated tau and TAR DNA binding protein 43, and the aggregation patterns will be compared between patients with a neurodegenerative disease vs patient with normal pressure hydrocephalus vs healthy control subjects.

Primary Outcome Measures: Aggregation pattern of a-synuclein, amyloid-b, p-TAU and TDP-43, The detection of each proteinopathy will be compared between each of them in every patient and compared to healthy control subjects., Each patient will be recruited and sampled the same day of the evaluation which will take about 1 hour. The final report it takes a frame time around two years.
Comparing the Efficacy of Accelerated vs. Standard fMRI-guided iTBS in Treating Adolescents Depression
NCT Number: NCT06528938
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Depression|Depressive Disorder, Major
Interventions: DEVICE: Theta Burst Stimulation
Sponsor: The Royal Ottawa Mental Health Centre
Collaborators: Université de Sherbrooke
Sex: ALL
Age: CHILD, ADULT
Enrollment: 10
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2026-08-01
Locations: The Royal's Institute of Mental Health Research, Ottawa, Ontario, K1Z 7K4, Canada

Summary:
Repetitive transcranial magnetic stimulation (rTMS) is a Health Canada approved treatment for major depression. Theta burst stimulation (TBS), a type of rTMS, is a very promising new treatment for major depression in adults and adolescents. However, very few studies have assessed the efficacy of accelerated, three times a day TBS in comparison with standard once a day TBS in adolescents. The study aims to explore further evidence in hopes to conduct a large-scale, randomized, multisite, placebo-controlled clinical trial evaluating the effects of a functional magnetic resonance imaging (fMRI)-guided accelerated rTMS protocol vs. standard once/daily rTMS for treatment-resistant depression in adolescents.

Primary Outcome Measures: Compare the efficacy of accelerated intermittent theta burst stimulation (iTBS) and standard once daily iTBS on clinical response in adolescents., Clinical response will be defined as a ≥ 50% reduction in depressive symptoms based on the Children's Depression Rating Scale Revised for depression (CDRS-R). The CDRS-R is a clinician-evaluated instrument consisting of 17 items used to measure the severity of depressive episodes in a pediatric population in children 6 to 12 years of age that has been shown to be applicable in adolescents as well. The overall score ranges from 17 to 113, where scores of ≥40 suggest moderate to severe depression and ≤28 is defined as remission or asymptomatic. In this study, a response to treatment will be defined as a reduction of 50% or more on the overall CDRS-R score at the post-intervention assessment (post-treatment 30)., Administered at screening, weekly for 2 weeks in accelerated group, every 3rd week for 6 weeks in once/daily (standard) group, as well as 2-, 4- and 12-weeks post-treatment course for both treatment protocols.
Secondary Outcome Measures: Change in self-reported suicidal ideation as measured by Beck Scale for Suicidal Ideation (BSS)., The BSS is a self-administered questionnaire consisting of 19 items that assesses an individual's presence of suicidal ideations and intensity. Each item is rated on a scale of 0 to 2, with a possible total score ranging from 0 to 38. Several other questionnaires addressing anxiety, sleep quality, physical activity and stress, among others, will be administered., Administered at screening, every other day for 2 weeks in accelerated group, weekly for 6 weeks in once/daily (standard) group, as well as 2-, 4- and 12-weeks post-treatment course for both treatment protocols.
Physiotherapy in Emergency Department: a Service Analysis From a French Hospital
NCT Number: NCT06528899
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Fall Patients|Pain|Sprains|Respiratory Insufficiency|Vertigo|Illness Behavior
Interventions: BEHAVIORAL: Physical Therapy
Sponsor: Université de Nantes
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 461
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-04-01
Completion Date: 2022-12-31
Locations: CHU de Nantes, Nantes, France|Université de Nantes - MIP UR 4334 (Motricity, Movement, Interactions), Nantes, France

Summary:
The skills of physiotherapists have been employed to enhance access to optimal care in Emergency Departments (ED). No study has yet been conducted on the practices in France. The primary objective of this study was to describe the French practices of physiotherapy within an ED, and to secondary examine the effect on patient discharge.

Primary Outcome Measures: Discharge at the exit of ED, the type of discharge (home / hospitalisation), up to 7 days (date of exit)
Secondary Outcome Measures: Length of stay, duration of stay in the ED, up to 7 days (date of exit)
Other Outcome Measures: Age, Age of patients, date of presenting to ED|Day of admission, day of the week, date of presenting to ED|Chief complaint, The chief complaint for visiting the ED, date of presenting to ED|Gender, gender of patients, date of presenting to ED|Unit of referral, the unit of medical referral for E-PT, date of presenting to ED
V-notes Hysterectomy With Regional Anesthesia
NCT Number: NCT06528886
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Regional Anesthesia Morbidity
Interventions: PROCEDURE: hysterectomy by V-NOTES
Sponsor: Sanliurfa Education and Research Hospital
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-01
Completion Date: 2024-10-01
Locations: Sanliurfa Education and Research Hospital, Şanlıurfa, 63250, Turkey|Sanliurfa Education and Research Hospital, Şanlıurfa, Turkey

Summary:
Transluminal endoscopic surgery performed through the natural opening via the vagina is a more comfortable, scarless and less complicated method for patients. This method is similar to laparoscopic surgery and is usually performed under general anesthesia. Regional anesthesia is known to be the most comfortable anesthesia type and has less pain, nausea and vomiting during postoperative recovery. Our aim in this study is to evaluate the results by performing the surgery under regional anesthesia.

Primary Outcome Measures: pain score, vas score, postoperative first 24 hours|complications, bleeding, transfusion, postoperative first 24 hours
Dual-focus Soft Contact Lenses for Controlling Rapid Progressive Myopia in Young Adults
NCT Number: NCT06528860
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Myopia
Interventions: DEVICE: MiSight® 1 day soft contact lenses|DEVICE: Proclear® 1 day soft contact lenses
Sponsor: Shanghai Eye Disease Prevention and Treatment Center
Sex: ALL
Age: ADULT
Enrollment: 144
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-31
Completion Date: 2027-09-30
Locations: Shanghai Eye Disease Prevention & Treatment Center, Shanghai, Shanghai, 200041, China

Summary:
This study aims to evaluate the effectiveness and acceptability of dual-focus soft contact lenses in controlling rapid myopia progression in adults through a randomized controlled trial. By applying myopia control measures to the adult population, we hope to provide scientific evidence for the effective control of adult myopia progression and offer insights into the understanding of myopia progression during early adulthood.

Primary Outcome Measures: Change in cycloplegic spherical equivalent after 2 years, The difference in the change of cycloplegic spherical equivalent between the intervention group and the control group., 2 years after the baseline
Secondary Outcome Measures: Change in axial length after 2 years, The difference in the change of axial length between the intervention group and the control group., 2 years after the baseline
Adjuvant Benmelstobart for Stage IB, Grade 3 Invasive Lung Adenocarcinoma
NCT Number: NCT06528847
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Non-Small Cell Lung Cancer
Interventions: DRUG: Benmelstobart
Sponsor: Shanghai Pulmonary Hospital, Shanghai, China
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 62
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-05
Completion Date: 2030-06-30
Locations: Shanghai Pulmonary Hospital, Shanghai, Shanghai, 200433, China

Summary:
This study is a prospective, single-arm, phase 2 clinical trial assessing the feasibility, efficacy, and safety of the PD-L1 inhibitor Benmelstobart (TQB2450) as an adjuvant therapy regimen in patients with pathologic stage IB, IASLC grade 3 invasive lung adenocarcinoma without EGFR active mutations or ALK rearrangement.

Primary Outcome Measures: disease-free survival (DFS) rate, The disease-free survival (DFS) is defined as the time from surgery until disease recurrence, death from any cause, or the end of the study, whichever comes first., up to 2 year
Secondary Outcome Measures: disease-free survival (DFS) rate, The disease-free survival (DFS) is defined as the time from surgery until disease recurrence, death from any cause, or the end of the study, whichever comes first., up to 3 year|disease-free survival (DFS) rate, The disease-free survival (DFS) is defined as the time from surgery until disease recurrence, death from any cause, or the end of the study, whichever comes first., up to 5 year|overall survival (OS) rate, The overall survival (OS) is defined as the time from surgery to death from any cause or the end of the study, whichever comes first., up to 5 year|drug safety, The frequency of severe adverse events will be measured from participant enrollment to 30 days after the last drug administration or the initiation of new anti-cancer therapy, whichever comes first., up to 1 year
AI-Powered ECG Detecting Culprit Vessel Blood Flow Abnormality in ACS
NCT Number: NCT06528821
Acronym: AI-ECG TIMI
Status: ENROLLING_BY_INVITATION
Study Type: OBSERVATIONAL
Conditions: Acute Coronary Syndrome|STEMI|Coronary Occlusion|Coronary Syndrome|NSTEMI|NSTEMI - Non-ST Segment Elevation MI
Sponsor: Powerful Medical
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 800
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-15
Completion Date: 2025-04-01
Locations: Powerful Medical, Bratislava, Slovakia

Summary:
AI ECG TIMI is an investigator-initiated, international, and multicenter registry of acute coronary syndrome patients aimed to identify electrocardiographic findings detected by an AI model predicting coronary blood flow alteration. The aim of the study is to identify electrocardiographic findings detected by an automated artificial intelligence (AI) model that can predict coronary blood flow alteration as assessed by the TIMI grade flow at the very moment of the invasive coronary angiography in patients with acute coronary syndromes.

Primary Outcome Measures: Diagnostic Accuracy of the AI-ECG TIMI AI Model, The primary endpoint is the AI-ECG TIMI model's ability to identify patients with actively occluded (TIMI 0-1) at the time of invasive coronary angiography using only single-standard 12-lead ECGs assessed by accuracy, sensitivity, specificity, positive, negative predictive values and F1 scores., 1 year
Secondary Outcome Measures: Subgroup Performance, AI-ECG TIMI AI Model's performance across subgroups

1. Demographic
2. Risk factors \& co-morbidities
3. Electrocardiographic
4. Culprit artery territory, 1 year|Correlate established definitions of occlusion myocardial infarction (OMI) to myocardial perfusion status, 2. OMI definitions using routine angiographic and laboratory parameters will be correlated to abnormal myocardial perfusion using correlation coefficients., 1 year|ECG prediction of mechanical reperfusion, a. Correlation of AI-ECG TIMI model's raw numeric predictions (between 0 and 1) with myocardial perfusion grading post PCI., 1 year|Assessment of expert ECG interpretation blinded to all clinical information, 1. Accuracy, sensitivity, specificity, positive and negative predictive value of expert interpretation of active OMI, reperfused OMI and entirety of OMI
2. Inter-rater variability of expert interpretation of active OMI, reperfused OMI and entirety of OMI., 1 year|STEMI-equivalent ECG patterns, a. Prevalence of STEMI equivalent ECG patterns and their correlation to TIMI flow grade at angiography., 1 year|Subgroup analysis of NSTEMI-OMI patients, 9. NSTEMI-OMI stratified according to immediate (\<2h) vs. SoC (\>2h) invasive management, median: i. Peak troponin (maximum rise before fall) ii. Median LVEF at discharge iii. Length of hospital stay iv. Length of cardiac care unit (CCU) or intensive care unit (ICU) stay v. Presence of life-threatening arrhythmias, 1 year
The Effect of Breastfeeding Education Given by Pecha Kucha Method
NCT Number: NCT06528782
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Breast Feeding
Interventions: OTHER: Pecha Kucha method
Sponsor: Saglik Bilimleri Universitesi
Sex: FEMALE
Age: ADULT
Enrollment: 70
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: OTHER
Start Date: 2024-07-11
Completion Date: 2024-10-30
Locations: Ankara Etlik City Hospital, Ankara, 6010, Turkey

Summary:
To evaluate the effect of breastfeeding education given with Pecha Kucha method in the prenatal period on breastfeeding self-efficacy, infant feeding attitude and breastfeeding satisfaction in the postpartum period.

Primary Outcome Measures: Antenatal and Pospartum Breastfeeding Self-Efficacy Scale Short Form, The scale can be administered in prenatal and postnatal periods and measures how competent women feel about breastfeeding. The items of the five-point Likert-type scale are scored as not at all sure, not very sure, sometimes sure, sure, very sure. The lowest score that can be obtained from all the evaluation scores of the scale is 14 and the highest score is 70. A low total score on the scale indicates a low perception of breastfeeding self-efficacy. In the original scale, the Cronbach's alpha reliability coefficient of the prenatal form was 0.87 and the Cronbach's alpha reliability coefficient of the postnatal form was 0.86., 0,2 and 4 weeks
Secondary Outcome Measures: Infant Feeding Attitude Scale (IOWA), Women's attitudes towards breastfeeding and to predict breastfeeding duration as well as the choice of infant feeding method. The scale consists of 17 items on a 5-point Likert scale ranging from (strongly disagree) to (strongly agree). While 9 items in the scale are positive about breastfeeding, 8 items contain positive statements about formula feeding. Formula feeding items are reverse scored. The total attitude score ranged from 17 points (reflecting a positive attitude towards bottle feeding) to 85 points (reflecting a positive attitude towards breastfeeding). Cronbach Alpha internal consistency coefficient was 0.71 and the scale was found to be reliable., 0,2 and 4 weeks|Visual Assessment Scale - Satisfaction (VAS - S), The VAS is also used to measure other components besides pain, such as satisfaction.In our study, the VAS will also be used to assess mothers' breastfeeding satisfaction levels. The Visual Assessment Scale - Satisfaction (VAS-S) is a 10 cm ruler with the expression "Not satisfied" on one end and "Very satisfied" on the other end. The mother is asked to rate her satisfaction with breastfeeding after the training from 1 to 10. High scores on the scale indicate that the satisfaction of the recipients is also high., 2 and 4 weeks
A Phase II Study of All-Trans Retinoic Acid (ATRA) and Cemiplimab in Patients With Advanced Leiomyosarcoma
NCT Number: NCT06528769
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Leiomyosarcoma|Sarcoma
Interventions: DRUG: all-trans retinoic acid|DRUG: Cemiplimab|PROCEDURE: Computed Tomography|PROCEDURE: Magnetic resonance imaging
Sponsor: Gabriel Tinoco
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 16
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-12-01
Completion Date: 2025-12-31
Locations: Ohio State University Comprehensive Cancer Center, Columbus, Ohio, 43210, United States

Summary:
A phase 2 study assessing the efficacy of all-trans retinoic acid (ATRA) and Cemiplimab in patients with metastatic/locally advanced - unresectable leiomyosarcoma (LMS) who have progressed standard-of-care therapy. Patients will be enrolled in cohorts according to a Bayesian Optimal Phase II design (BOP2).

Study treatment will consist of ATRA at a starting dose of 150 mg/m2/day for 3 days orally prior to each cycle of Cemiplimab 350 mg IV q3 weeks for three cycles and then Cemiplimab monotherapy until the progress of disease or unacceptable toxicities develops.

Primary Outcome Measures: Overall Response Rate (ORR), Overall response rate (ORR) will be calculated based on modified RECIST version 1.1 and iRECIST with a 95% confidence interval (CI)., Up to 24 months
Secondary Outcome Measures: Progression-free survival (PFS), Progression free survival (PFS) will be defined as the time from initiation of therapy to the time of RECIST progression or death and will be calculated based on modified RECIST version 1.1 and iRECIST. Kaplan-Meier methods will be used to estimate PFS with 95% CI., Up to 24 months|Disease control rate (DCR), Percentage of patients whose disease shrinks or remains stable. DCR will be calculated based on modified RECIST version 1.1 and iRECIST with a 95% confidence interval (CI)., Up to 24 months|Overall survival (OS), Overall survival (OS) will be defined as time from initiation of therapy to death, or censored at last follow-up date if the Patient is alive and will be calculated based on modified RECIST version 1.1 and iRECIST. Kaplan-Meier methods will be used to estimate OS with 95% CI., Up to 24 months
Other Outcome Measures: Effect of ATRA on myeloid-derived suppressor cells (MDSCs), MDSCs in peripheral blood from study patients will be summarized using mean +/- SEM, range, and median. Changes in these measurements from baseline to after treatment, or baseline to progression will be assessed using paired t-test or Wilcoxon signed rank test., Up to 24 months
A Novel Surgical Criteria for Degenerative Cervical Myelopathy in Chinese Ethnicity
NCT Number: NCT06528730
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Degenerative Cervical Spinal Stenosis
Interventions: DIAGNOSTIC_TEST: DCM
Sponsor: The University of Hong Kong
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-10-01
Completion Date: 2025-07
Locations: The Duchess of Kent Children's Hospital at Sandy Bay, Hong Kong, 000, Hong Kong

Summary:
Degenerative Cervical Myelopathy (DCM) is an age-related irreversible degenerative disease predominantly affecting the elderly aged 50 and over. DCM is usually triggered by ossification of the posterior longitudinal ligament or ossification of ligamentum flavum or prolapsed intervertebral disc over the cervical spine. Specific clinical signs characterized the presence of cervical spinal cord compression; including Hoffmann's sign, Finger Escape Sign, Scapulohumeral Reflex, and Reverse Supinator Reflex. Hand numbness, clumsiness, and gait disturbance. These are featured clinical manifestations and well-known indicators for detailed clinical and radiographic investigation, such as Magnetic Resonance Imaging (MRI) for diagnosis and surgical planning.

Surgical intervention is considered to be the most effective treatment for DCM worldwide. It is the only evidence-based treatment to halt disease progression and allow modest improvement in function and quality of life. DCM progression is not specific to predict the timing for surgery, though it is still debated. Length of symptoms, pre-operative Modified Japanese Orthopaedic Association Scoring System for Cervical Myelopathy (mJOA) and physical performance are suggested as recovery predictors in DCM.

In current practice, the offer of surgical treatment is entirely based on the combination of the evidence of cord compression in Magnetic Resonance Imaging (MRI) and mJOA. DCM who are at risk of critical neurological deficits have a reduced anteroposterior diameter of the spinal canal less than 9 mm or cross-sectional area of the spinal cord less than 40 sq. mm; mJOA less than 13 with evidence of functional deterioration will be offered with surgical intervention. MRI and mJOA are used as the golden standard for the indication of surgical intervention in the aspect of radiological deformities and self- perceived functional deficits. The concern on the clinical predictor, the physical performance, was overlooked and lacked a compromised criterion in the physical performance tests for surgical decisions. Therefore, this study aims to develop DCM-specific criteria from physical performance tests in predicting the surgical indication for DCM in the Chinese population.

Primary Outcome Measures: 10-second Grip and Release test (GR), Counting the no. of grip-release repetitions made in 10 seconds, 24 months|10-second Stepping Test (SST) - no. of steps made in 10 seconds, Counting the no. of stepping repetitions made in 10 seconds, 24 months|Foot Tapping Test (FTT), Counting the no. of foot taps repetitions made in 10 seconds, 24 months
The Role of Maintaining External Carotid Artery Flow in Graft Interposition After Carotid Endarterectomy
NCT Number: NCT06528717
Acronym: AGICS
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Carotid Artery Diseases|Stroke|Carotid Atherosclerosis
Interventions: PROCEDURE: Carotid graft interposition
Sponsor: Institute for Cardiovascular Diseases "Dedinje"
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 250
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-12
Completion Date: 2024-12-30
Locations: Institute for Cardiovascular Diseases Dedinje, Belgrade, 11000, Serbia

Summary:
Analyzing results of carotid graft interposition with and without flow preservation through external carotid artery after endarterectomy.

Primary Outcome Measures: periprocedural stroke and death, onset of new neurological deficit or death during perioperative period, 30 days|myocardial infarction, development of new acute coronary events during perioperative period, 30 days|stroke ipsilateral to the procedure, development of new neurological events that are pathophysiological atributable to the operated side, through study completion, an average of 2 years
Secondary Outcome Measures: restenosis rate, restenosis after graft placement diagnosed by color Doppler sonographic examination or by multiplanar detection computerized tomography angiography, through study completion, an average of 2 years|graft patency, primary and primary assisted, through study completion, an average of 2 years|patient survival, defining cause of death, through study completion, an average of 2 years
The Impact of Real Time Ventilation Feedback on Ventilation Rate and Tidal Volume During Cardiac Arrest.
NCT Number: NCT06528704
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cardiac Arrest
Interventions: DEVICE: Ventilation feedback device
Sponsor: University Hospital, Ghent
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-05-20
Completion Date: 2026-12-31
Locations: AZ Zeno, Knokke, West-Vlaanderen, 8301, Belgium|Ghent University Hospital, Ghent, Belgium

Summary:
During out-of-hospital cardiopulmonary resuscitation, patient are first ventilated without ventilation feedback (but with a flowsensor connected), hereafter patients are ventilated with the use of ventilation feedback.

Primary Outcome Measures: Delivered ventilation frequency, Measured ventilation frequency (with or without ventilation feedback), 2 minutes|Delivered ventilation volume, Measured ventilation volume (with or without ventilation feedback), 2 minutes
Patients Outcomes of a Monofocal Intraocular Lens Designed for Monovision
NCT Number: NCT06528678
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Cataract
Interventions: DEVICE: Intraocular lens
Sponsor: Clinica Baviera
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 51
Study Design: Observational Model: |Time Perspective: p
Start Date: 2021-04-30
Completion Date: 2023-10-24
Locations: Clinica Baviera, Valencia, 46004, Spain

Summary:
The rationale for this observational study of a CE-marked lens is to prospectively assess the performance, safety, and patient satisfaction in a group of subjects undergoing cataract surgery with bilateral implantation of the RayOne EMV in a monovision configuration. In order to increase the evidence collected from real-world clinical data we are running a multicentre clinical study in several clinics of the Baviera Ophthalmological Group.

Study design: prospective, observational, non-comparative.

Primary Outcome Measures: Visual acuity, Visual acuity was measured using standard clinical charts, One month postoperative|Defocus curve, Defocus curve was measured using standard clinical charts, One month postoperative|Patient Satisfaction, Patient satisfaction was measured using the Cataract Assessment Patient Questionnaire 9 Short Form (Catquest 9SF) from 1 to 5, being 1 major difficulties and 5 cannot decide, One month postoperative
Secondary Outcome Measures: Safety of the device, Safety of the device was measured in terms of the frequency of adverse events related to the device, Surgery, first follow-up visit (1-month) and second follow-up visit (6-months)|Quality of vision, Quality of vision was measured using a self-administered questionnaire developed at Clinica Baviera to assess patient satisfaction regarding night vision, from 1 to 4 being 1 the maximun score and 4 the worst score, One month postoperative
Determine PK Profiles of Ozanimod and Its' Major Metabolites in Healthy Subjects
NCT Number: NCT06528665
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Multiple Sclerosis|Ulcerative Colitis
Interventions: DRUG: ZEPOSIA® indicated for the treatment of: Relapsing forms of multiple sclerosis, and active ulcerative colitis in adults
Sponsor: Corium Innovations, Inc.
Sex: ALL
Age: ADULT
Enrollment: 24
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-18
Completion Date: 2024-10-16
Locations: Hospital Ampang, Ampang, Selangor, 68000, Malaysia

Summary:
The goal of this clinical trial is to learn how Ozanimod drug can be administered to the healthy subjects via transdermal delivery system (TDS, patch) to achieve better drug absorption and delivery than via oral capsules (Zeposia). Researchers will compare two administered routes of Ozanimod TDS and oral Zeposia in drug pharmacokinetics, tolerability and safety. Participants will either take one capsule only or wear a patch on his/her arm for 7 days, and blood samples will be collected to measure drug concentrations and local skin reactions will be also observed.

Primary Outcome Measures: Plasma Pharmacokinetic- AUC 0-t (Ozanimod, CC112273, CC1084037), area under the concentration-time curve from time-zero to the time of the last quantifiable concentration, 15 days|Plasma Pharmacokinetic- AUC 0-∞ (Ozanimod, CC112273, CC1084037), area under the concentration-time curve from time-zero to infinity, 15 days|Plasma Pharmacokinetic- Cmax (Ozanimod, CC112273, CC1084037), Peak concentration within the dosing interval, 15 days|Plasma Pharmacokinetic- Tmax (Ozanimod, CC112273, CC1084037), Time to peak concentration (Cmax), 15 days|Plasma Pharmacokinetic- T 1/2 (Ozanimod, CC112273, CC1084037), Terminal elimination half-life, 15 days|Plasma Pharmacokinetic- MTR(Ozanimod, CC112273, CC1084037), Mean residence time, 15 days|Plasma Pharmacokinetic-Lambda z(λz) (Ozanimod, CC112273, CC1084037), Terminal elimination rate constant, 15 days