pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Posterior Cingulate Cortex and Executive Control of Episodic Memory
NCT Number: NCT06540976
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Episodic Memory
Interventions: BEHAVIORAL: Cognitive testing
Sponsor: University of Pennsylvania
Sex: ALL
Age: ADULT
Enrollment: 130
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2023-01-18
Completion Date: 2027-04-30
Locations: Hospital of the University of Pennsylvania - Pavilion, Philadelphia, Pennsylvania, 19104, United States

Summary:
This project will use intracranial recordings and stimulation of the human brain to understand the unique contributions of the posterior cingulate cortex (PCC) to episodic memory behavior. The goal is to test how distinct subregions of the PCC differentially contribute to memory-based decisions (e.g., have I seen this picture before?). The ability to perform invasive studies of the human brain is through routine clinical monitoring of brain activity which occurs during the neurosurgical treatment of epilepsy. However, this project only focuses on the basic science of PCC and memory behavior. Specifically, the investigators will use single-0cell and population measures of brain activity to test a new theory of PCC function which focuses on the executive processes needed to support memory retrieval and memory-based decisions. By studying the PCC, a convergence zone of memory and executive brain systems, progress can be made in elucidating how the failure to successfully leverage past experiences in daily behavior can occur as a common symptom of both neurodegenerative disease (e.g., Alzheimer's disease) and multiple psychiatric conditions (e.g., schizophrenia) implicating PCC dysfunction.

Primary Outcome Measures: Episodic/Executive behavioral task performance accuracy, Participants will perform three tasks each testing the accuracy of executive (reward) or episodic (memory strength) based decisions. Outcome measures will be decision accuracy (% correct)., Outcome assessed 10 minutes after intervention|Episodic/Executive behavioral task performance speed, Participants will perform three tasks each testing the speed of executive (reward) or episodic (memory strength) based decisions. Outcome measures will be response/decision reaction time (milliseconds)., Outcome assessed 10 minutes after intervention|Changes in high-frequency electrophysiological brain response, During behavioral task performance, electrophysiological signals recorded from the brain will be quantified for changes in the mean high-frequency activity (70-150 Hz) amplitude during correct and incorrect episodic/executive decisions. The goal is to track this electrophysiological activity to quantify if and when brain activity in the posterior cingulate cortex occurs during memory and non-memory based decisions., Outcome assessed 1 hour after intervention
Tipifarnib and Naxitamab for Relapsed/Refractory Neuroblastoma
NCT Number: NCT06540963
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Neuroblastoma Recurrent
Interventions: DRUG: Tipifarnib|DRUG: Naxitamab
Sponsor: Giselle Sholler
Sex: ALL
Age: CHILD, ADULT
Enrollment: 98
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10-01
Completion Date: 2035-08-01
Locations: Penn State Milton S. Hershey Medical Center and Children's Hospital, Hershey, Pennsylvania, 17033, United States

Summary:
The purpose of this study is to evaluate the investigational drug, tipifarnib (a pill taken by mouth), in combination with the Food and Drug Administration (FDA) approved drug, naxitimab, administered intravenously (IV; a liquid that continuously goes into your body through a tube that has been placed during a surgery into one of your veins). Naxitamab is FDA approved for pediatric patients 1 year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy, it may not be approved in the type of disease used in this study.

The goals of this part of the study are:

* Test the safety and tolerability of tipifarnib in combination with naxitimab in patients with cancer
* To determine the activity of study treatments chosen based on:
* How each subject responds to the study treatment
* How long a subject lives without their disease returning/progressing

Primary Outcome Measures: Determine the Overall Response Rate (ORR) of Participants using INSS Response, To evaluate the activity of Tipifarnib in combination with Naxitamab based on Overall response rate (ORR), 6 months
Secondary Outcome Measures: Number of participants with progression free survival (PFS) during study, To evaluate the activity of Tipifarnib in combination with Naxitamab based on Progression free survival (PFS), 6 months plus 5 years follow up|Length of time that participants experience Overall Survival (OS), To evaluate the efficacy of Tipifarnib in combination with Naxitamab based upon Overall Survival (OS), 6 months plus 5 years follow up|Number of Participants with Adverse Events as a Measure of Safety and Tolerability, To evaluate the safety and tolerability profile of Tipifarnib in combination with Naxitamab in pediatric and young adult subjects., 6 months plus 30 days
Efficacy and Safety of Concurrent Chemoradiotherapy With Oral Vinorelbine in Patients With Non-small Cell Lung Cancer
NCT Number: NCT06540950
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Vinorelbine
Interventions: DRUG: vinorelbine
Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 47
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-03-20
Completion Date: 2026-06-10
Locations: Cancer Hospital Chinese Academy of Medical Sciences, Beijing, Beijing, 100021, China

Summary:
To evaluate the efficacy and safety of concurrent chemoradiotherapy with oral vinorelbine, and immune maintenance therapy in patients with unresectable stage III non-small cell lung cancer after neoadjuvant chemo-immunotherapy, with a view to providing an effective treatment regimen for these patients.

Primary Outcome Measures: Overall survival, The time between the start of treatment and death from any cause in the one-arm trial, 5 years|objective response rate, The ratio of complete response and partial response at 3 months after the end of radiotherapy, 3 months
Phase II Clinical Study of Leflunomide in the Treatment of MEN-1 Neuroendocrine Tumor
NCT Number: NCT06540937
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Neuroendocrine Tumors
Interventions: DRUG: Leflunomide Pill
Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2020-07-01
Completion Date: 2024-12-30
Locations: National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China

Summary:
This phase II trial studies aim to evaluate the initial efficacy of leflunomide tablets in second-line treatment of advanced MEN-1 neuroendocrine tumors, and to provide evidence for phase III clinical trials.

Primary Outcome Measures: Overall response rate (ORR) assessed by RECIST 1.1, ORR is defined as the percentage of patients with a complete response (CR) or partial response (PR) according to RECIST v1.1., up to 36 weeks|Progression-free survival (PFS), PFS is defined as the duration from the date of randomization to the onset of tumor progression or death of any cause., up to 36 weeks
Secondary Outcome Measures: Overall Survival (OS), OS is defined as the time from the date of randomization until death of any cause., up to 36 weeks
Investigation of LBX1, TIMP2, GPR126 and CHD7 Gene Polymorphisms in Adolescent Idiopathic Scoliosis Patients
NCT Number: NCT06540924
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Adolescent Idiopathic Scoliosis|Single Nucleotide Polymorphisms
Interventions: OTHER: single nucleotide polymorphisms
Sponsor: Uludag University
Sex: ALL
Age: CHILD, ADULT
Enrollment: 301
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-07-08
Completion Date: 2023-07-08
Locations: Uludag University, Bursa, 16059, Turkey

Summary:
Adolescent Idiopathic Scoliosis (AIS) is a common disease of the spine observed in individuals aged 10-18 who typically do not have any other health issues. Despite numerous genetic studies conducted across different ethnic groups worldwide, the specific genes contributing to the development of scoliosis have not yet been definitively identified. Therefore, the aim of our study is to investigate whether there is an etiological relationship between AIS and the polymorphisms of the LBX1 (rs11190870, rs625039, rs11598564), TIMP2 (rs8179090), GPR126 (rs6570507), and CHD7 (rs121434341) genes in the Turkish population and to determine the relationship of these polymorphisms with gender, age, age at diagnosis and Cobb angle in these patients.

Primary Outcome Measures: Investigation of LBX1, TIMP2, GPR126, and CHD7 Gene Polymorphisms in 201 Turkish Adolescents With Idiopathic Scoliosis, Despite numerous genetic studies conducted across different ethnic groups worldwide, the specific genes contributing to the development of scoliosis have not yet been definitively identified. Therefore, the aim of investigator is to investigate whether there is an etiological relationship between adolescent idiopathic scoliosis and the polymorphisms of the LBX1 (rs11190870, rs625039, rs11598564), TIMP2 (rs8179090), GPR126 (rs6570507), and CHD7 (rs121434341) genes in the Turkish population., 12 months
Deep Learning for Histopathological Classification and Prognostication of Gynaecologic Smooth Muscle Tumours
NCT Number: NCT06540846
Acronym: STUMP
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Stump
Interventions: OTHER: No intervention
Sponsor: Institut Bergonié
Sex: FEMALE
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 392
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-12-01
Completion Date: 2024-12
Locations: Institut Bergonie, Bordeaux, France

Summary:
Smooth muscle tumors of the uterus that do not fit the diagnostic criteria of benignity (such as leiomyomas) or malignancy (such as leiomyosarcomas) are called STUMP (smooth muscle tumor of uncertain malignant potential). A potential solution to this problem could be the application of predictive models using artificial intelligence (AI) to aid in the histopathological classification and prognosis of gynecological smooth muscle tumors. Deep learning using convolutional neural networks represents a specific class of machine learning, in which predictive models are trained by considering small groups of pixels in digital images and iteratively identifying salient features. In this study, we aim to develop deep learning models capable of accurately subclassifying and predicting the prognosis of gynecological smooth muscle tumors, based on histopathological features of hematoxylin and eosin (H\&E) slides. The aim is to develop a diagnostic and prognostic algorithm to help pathologists better classify and diagnose uterine smooth muscle tumors and predict their clinical course.

Primary Outcome Measures: Develop deep learning models that can accurately subclassify gynaecologic smooth muscle tumours, Develop deep learning based on digitalized slides, throughout the conduct of the study - an expected average of 6 months after data collection
A Study to Assess the Efficacy and Safety of ITI-1284 in the Treatment of Psychosis Associated With Alzheimer's Disease
NCT Number: NCT06540833
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Psychosis Associated With Alzheimer's Disease
Interventions: DRUG: ITI-1284|DRUG: Placebo
Sponsor: Intra-Cellular Therapies, Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 370
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2027-10
Locations: Clinical Site, Anaheim, California, 92805, United States|Clinical Site, Costa Mesa, California, 92626, United States|Clinical Site, Los Alamitos, California, 90720, United States|Clinical Site, Newport Beach, California, 92660, United States|Clinical Site, Coral Springs, Florida, 33067, United States|Clinical Site, Hialeah, Florida, 33012, United States|Clinical Site, Maitland, Florida, 32751, United States|Clinical Site, Miami Springs, Florida, 33166, United States|Clinical Site, Miami, Florida, 33032, United States|Clinical Site, Miami, Florida, 33155, United States|Clinical Site, Miami, Florida, 33156, United States|Clinical Site, Sarasota, Florida, 34239, United States|Clinical Site, Toms River, New Jersey, 08755, United States

Summary:
This is a multicenter, randomized, double-blind, parallel-group, placebo-controlled, flexible-dose study evaluating the efficacy, safety, and tolerability of ITI-1284 compared with placebo in the treatment of psychosis in patients with AD.

Primary Outcome Measures: BEHAVE-AD psychosis subscale score, The BEHAVE-AD psychosis subscale is comprised of 7 items from the paranoid and delusional ideations domain and 5 items from the hallucinations domain. The scale is rated on a 4--point scale of severity, from 0 (not present) to 3 (present, generally with an emotional and physical component). The maximum score for the psychosis subscale is 36., Week 6
Secondary Outcome Measures: CGI-S score, The CGI-S is a clinician-rated scale to assess a patient's overall mental health. The scale ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients), Week 6
NEUROENDOCRINE REGULATION OF BONE-FAT CROSSTALK IN OBESITY
NCT Number: NCT06540820
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Obesity; Endocrine|Pituitary Dysfunction|Bone Health
Interventions: DIAGNOSTIC_TEST: Dexa or Biompedance analysis with clinical and biochemical evaluations
Sponsor: IRCCS San Raffaele
Collaborators: Federico II University|University of Catanzaro|Istituto Auxologico Italiano
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 150
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09
Completion Date: 2025-09

Summary:
To study the effect of neuroendocrine dysfunctions on bone health in obesity

Primary Outcome Measures: To study the neuroendocrine control of bone-fat crosstalk in obesity. Obese patients with and without neuroendocrine dysfunctions will be enrolled in the study to evaluate bone health, as well as the content of circulating adipokines/osteokines., The following assessments will be performed:

1. Biochemical exams to determine the presence of primary or secondary hypogonadism or other alterations of the neuroendocrine axis.
2. Bone health: -Blood and urine samples -Hip, lumbar and ultradistal BMD by DXA; -Vertebral fractures assessment on lateral dorso-lumbar spine DXA scans by a quantitative morphometric approach. -Bone microarchitectural and microstructural characteristics, performing TBS. -Distal HRpQCT -Bone Strain index (BSi) parameters from hip and lumbar DXA scans, obtaining a qualitative index of bone strength based on finite element analysis.

b) Adipokines and obesity-associated cytokines serum content. c) Osteokines serum content., 2 weeks
SafeHeal Anastomosis Feasibility Evaluation (SAFE)-2023 Study
NCT Number: NCT06540807
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Colorectal Cancer
Interventions: DEVICE: Colovac Colorectal Anastomosis Protection Device|PROCEDURE: Stoma creation
Sponsor: SafeHeal Inc
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 15
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-01
Completion Date: 2025-01-31
Locations: AKFA, Tashkent, Uzbekistan

Summary:
A feasibility study to assess the early safety and effectiveness of the Colovac 2 device in providing temporary protection of the anastomosis in patients undergoing low anterior resection for colon cancer.

Primary Outcome Measures: Ostomy avoidance, Rate of ostomy avoidance, 10 days|Colon Cleanliness, Boston Bowel Preparation Score, 10 days|Migration, Rate of migration, 10 days
The Efficacy of Wet Cupping Therapy on Cerebral Oxygenation
NCT Number: NCT06540781
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cerebral Hypoxia
Interventions: PROCEDURE: wet cupping therapy
Sponsor: Karabuk University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-08-01
Completion Date: 2025-05-01
Locations: Kayseri City Hospital, Kayseri, Turkey

Summary:
The aim of this clinical trial is to investigate the efficacy of wet cupping therapy (WCT) on cerebral oxygenation using the NIRS device. With the demonstration of the positive effect of the WCT on cerebral oxygenation, it was aimed to use it effectively in stroke rehabilitation.

In the outpatient clinic setting, firstly the sensor pads of the NIRS device will be attached to the arcus superciliaris (GB14) under the tuber frontalis on both sides. After the measurement is initiated, WCT will be applied to the planum occipitale (DU 20) and to the pars squamosa (GB6-8) of the temporal bone on the sides. Measurement will continue for 10 minutes during and after the WCT application. NIRS and oxygenation measurement data will be compared before, during, and after the WCT application.

Primary Outcome Measures: Oxygen levels, Cerebral oxygenation levels measured by NIRS device, Just before WCT application and 10 minutes after the application
Therapeutic Normothermia in TBI
NCT Number: NCT06540768
Acronym: MAMBA-FT
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Traumatic Brain Injury
Interventions: OTHER: Therapeutic Normothermia Group
Sponsor: London Health Sciences Centre
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2025-12

Summary:
This feasibility trial is the first step in testing the hypothesis that maintenance of normal body temperature, called therapeutic normothermia (TN), for 72 continuous hours in traumatic brain injury (TBI) patients can improve cognitive function. The trial aims to answer the following questions:

1. Is it feasible to conduct this study? Conducting the trial includes the ability to identify and enroll appropriate participants, implement TN, and collect the required data.
2. Can the Creyos Health platform cognitive assessment tool be used to assess and quantify cognitive outcomes in TBI patients?

Researchers will address the aforementioned questions by looking at the following factors:

1. Identification and enrollment rates of appropriate patients
2. Implementation of the intervention and appropriate data collection while admitted
3. Accurate follow up and continued data collection post-discharge
4. Accessibility and ease of use of the Creyos Health platform cognitive assessment tool

Participants will undergo the following procedure:

1. Admission to the Critical Care Trauma Centre through the trauma service
2. Allocation to the intervention or no intervention group
3. Implementation of the intervention or of usual care for a continuous 72 hours
4. Completion of the Creyos Health platform cognitive assessment tool at 3 and 6 months post-discharge from the Critical Care Trauma Centre

Primary Outcome Measures: Study Execution, To assess the feasibility of conducting a randomized controlled trial of therapeutic normothermia compared to no therapeutic normothermia in LHSC patients with TBI., 18 months|Creyos Health, To assess the feasibility of using the Creyos Health platform as a cognitive assessment tool in patients with TBI., 12 months
Secondary Outcome Measures: Mortality, To assess any differences in in-hospital mortality between the two study groups., 12 months.|Cognitive Outcomes, To assess any differences in cognitive outcomes between the two study groups., 12 months
Analysis of Pregnancy-Associated Plasma Protein-A and Interleukin-6 Gene Polymorphisms in Patients With Periodontitis
NCT Number: NCT06540755
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Periodontitis|Polymorphism, Restriction Fragment Length
Interventions: GENETIC: genetic polymorphism analysis
Sponsor: Marmara University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 226
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-12-02
Completion Date: 2024-01-28
Locations: Marmara University Dental Faculty Periodontology Departmen, İstanbul, Turkey

Summary:
The aim of this study is to evaluate the relationship between pregnancy associated plasma protein-A (PAPP-A) and interleukin-6 (IL-6) gene polymorphisms and stage 3 grade B and C (S3GBC) periodontitis, and to compare periodontitis patients with healthy individuals.

Primary Outcome Measures: The genotypic or allelic distributions of PAPP-A and IL-6 gene polymorphisms, they were similar between groups, baseline
Multimodal Imaging Diagnosis and Decision Aid System for Hepatic Echinococcosis Based on Image Omics and Vision Macromodel
NCT Number: NCT06540742
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Hepatic Echinococcosis
Interventions: DIAGNOSTIC_TEST: Artificial intelligence identifies liver hydatids
Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 1000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-01
Completion Date: 2026-03-31
Locations: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Guangzhou, China/Guangdong, China

Summary:
Hepatic echinococcosis (hepatic echinococcosis) is an important zoonotic disease widely existing in the agricultural and pastoral areas of northwest China. The disease can be parasitic in any part of the human body and may affect multiple organs. In severe cases, patients will lose the ability to work. At present, the disease faces challenges in diagnostic accuracy, specific type identification, preoperative activity assessment, postoperative recurrence prediction, and decision evaluation of T-tube indentation. This problem is particularly significant in high incidence areas with uneven distribution of medical resources and shortage of excellent imaging physicians and clinicians. Our previous studies have demonstrated that the use of visual large models and imaging omics algorithms can effectively segment liver echinococcus lesions, extract key features, and provide clinicians with accurate and reliable diagnosis and treatment recommendations. We believe that on the basis of the transformation of different medical image modes (such as MRI, CT and ultrasound) based on a broader multicentre large data set, the goal of effective identification, diagnosis, surgical decision support, and postoperative accurate prediction of hepatic echinococcosis can be achieved. We will use artificial intelligence technology solutions such as adversarial generation network, vision large model, image omics and decision level fusion, taking into account diagnosis and treatment efficiency, diagnosis and treatment automation and interpretability of diagnosis results, to build a comprehensive accurate diagnosis and prognosis system for hepatic echinococcosis

Primary Outcome Measures: Receiver operating characteristic curve, 2024.7-2026.3|Area under the ROC curve, 2024.7-2026.3|Confusion matrix, 2024.7-2026.3
Disitamab Vedotin (RC48) in Combination With AK104 (PD-1/CTLA-4 Bispecific) and Bevacizumab for the Treatment of Recurrent and Persistent Clear Cell Ovarian Cancer: a Single-arm, Phase II, Multicenter Study (DAB OCC Study)
NCT Number: NCT06540729
Acronym: DAB
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Ovary Cancer
Interventions: DRUG: Disitamab vedotin in combination with AK104 and bevacizumab for the treatment of recurrent and persistent clear cell ovarian cancer
Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 39
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-31
Completion Date: 2030-08-01

Summary:
Disitamab vedotin (RC48) in combination with AK104 (PD-1/CTLA-4 bispecific) and bevacizumab for the treatment of recurrent and persistent clear cell ovarian cancer: a single-arm, phase II, multicenter study (DAB OCC study)

Primary Outcome Measures: Objective Response Rate, Objective response rate of advanced or recurrent ovarian clear cell carcinoma, 2 years
Secondary Outcome Measures: Time to progress, Time to progress of advanced or recurrent ovarian clear cell carcinoma, 2 years|Adverse event, Adverse event rate of treatment with RC48 in combination with AK104 and bevacizumab, 2 years|The time to the first subsequent therapy, The time to the first subsequent therapy for enrolled patients, 2 years|Time to response, Time to response for enrolled patients, 2 years|Duration of response, Duration of response of advanced or recurrent ovarian clear cell carcinoma, 2 years|Disease control rate, Disease control rate of patients with recurrent or advanced ovarian clear cell carcinoma receiving intervention, 2 years|Progression free survival, Progression free survival of enrolled patients with recurrent or advanced ovarian clear cell, 2 years|Overall survival, Overall survival of enrolled patients with recurrent or advanced ovarian clear cell, 2 years|Eastern Cooperative oncology group performance status score, ECOG score of enrolled patients, 2 years
Other Outcome Measures: Biomarker, Explore biomarkers for predicting the response of OCCC to combination therapy, including but not limited to PD-L1, TMB, MMRd, MSI-H, HRR related genes, and lymphocyte infiltration, 2 years
Inspire Singapore Study
NCT Number: NCT06540716
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Obstructive Sleep Apnea|OSA|Sleep Apnea
Interventions: DEVICE: Inspire System
Sponsor: Inspire Medical Systems, Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 44
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2025-12
Locations: National University Hospital, Singapore, Singapore|Singapore General Hospital, Singapore, Singapore

Summary:
Prospective, multicenter, open-label study designed to confirm device performance of Inspire system in Singapore.

Primary Outcome Measures: Inspiratory Overlap, Percentage (%) of inspiratory overlap as measured by polysomnography (PSG), 0-3 months post-therapy activation
Secondary Outcome Measures: Therapy Effectiveness, Change in Apnea-Hypopnea Index (AHI), 6 months post-therapy activation|Symptom Reduction, Mean Epworth Sleepiness Scale (ESS) Score of less than 10. ESS scores range from 0-24 with a score of less than 10 indicating normalized daytime sleepiness., 6 months post-therapy activation
Other Outcome Measures: Rate of Adverse Events, Report of procedure/device/therapy-related adverse events, 6 months post-therapy activation|Therapy Adherence, Mean therapy use (hours per day), 6 months post-therapy activation|Functional Outcomes of Sleep Questionnaire (FOSQ) Score, Changes in Functional Outcomes of Sleep Questionnaire (FOSQ). Total score range 5-20, with higher scores indicating better functional status., 6 months post-therapy activation|Inspiratory Overlap, Percentage (%) of inspiratory overlap as measured by polysomnography (PSG), 6 months post-therapy activation
Keto Diet and PET Imaging in Anorexia Nervosa
NCT Number: NCT06540703
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Anorexia Nervosa
Interventions: DIETARY_SUPPLEMENT: Therapeutic Ketogenic Diet (TKD)
Sponsor: University of California, San Diego
Sex: ALL
Age: ADULT
Enrollment: 90
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2030-01
Locations: University of California San Diego, San Diego, California, 92121, United States

Summary:
This is a longitudinal study with an open design in weight recovered anorexia nervosa (wrAN) individuals. Healthy controls (HC) will also be assessed. Study participants will be carefully assessed and will have 18F-fluorodeoxyglucose (\[18F\]FDG) positron emission tomography (PET) scans for assessment of regional brain glucose uptake. The wrAN group will be compared to healthy controls. Participants in the wrAN group will then complete 14 weeks of therapeutic ketogenic diet (TKD). At the end of the TKD study, participants will have assessments and a second \[18F\]FDG and TMS/EEG scan. Study participants will be followed over six months after the intervention. This follow-up procedure will help determine whether symptom improvement will be stable or worsen in individuals who choose to continue or discontinue the TKD intervention. This will be a naturalistic follow-up.

Primary Outcome Measures: [18F]fluorodeoxyglucose (FDG) uptake, To test whether TKD will be associated with reduced brain \[18F\]fluorodeoxyglucose (FDG) uptake, Difference in pre/post Therapeutic Ketogenic Diet PET/CT scans
Efficacy and Safety of Auricular Acupuncture in Treating Insomnia Post-stroke
NCT Number: NCT06540664
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Insomnia, Secondary|Post-stroke Depression
Interventions: OTHER: Auricular Acupuncture needles|OTHER: Sham Auricular Acupuncture needles
Sponsor: University of Medicine and Pharmacy at Ho Chi Minh City
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-03-01
Completion Date: 2024-08
Locations: HoChiMinh University of Medicine and Phamacy, Ho Chi Minh City, Vietnam

Summary:
The goal of this clinical trial is to learn if Auricular acupuncture works to treat Insomnia Post-stroke patients. It will also learn about the safety of Auricular. The main questions it aims to answer are:

* Does Auricular acupuncture reduce the time it took participants to fall asleep?
* Dose Auricular acupuncture increase the number of hours participants slept?
* Dose Auricular acupuncture improve sleep quality as measured by The Pittsburgh Sleep Quality Index (PSQI)?
* What medical problems do participants have when taking Auricular acupuncture? Researchers will compare Auricular acupuncture to a sham Auricular acupuncture (a look-alike acupuncture needles that contains no needles) to see if Auricular acupuncture works to treat insomnia post-stroke.

Participants will:

* Take Auricular acupuncture or sham Auricular acupuncture every 5 days for 4 weeks.
* Checkups and evaluate sleep onset time, sleep hours, and sleep quality every 5 days for 4 weeks.
* Keep a diary sleep of their symptoms and the number of times they use sleeping pills.

Primary Outcome Measures: Change sleep quality as measured by The Pittsburgh Sleep Quality Index (PSQI), The Pittsburgh Sleep Quality Index (PSQI) is a validated, self-reported instrument assessing sleep quality over 1 month. Possible scores range from 0 to 21. PSQI \< 5 (good sleep quality), PSQI \>5 (poor sleep quality), Baseline and Week 4
Secondary Outcome Measures: Change number of hours slept as measured by The Pittsburgh Sleep Quality Index (PSQI), The Pittsburgh Sleep Quality Index (PSQI) is a validated, self-reported instrument assessing sleep quality over 1 month. The score of hours slept range 0 (hours of sleep \> 7 hours) to 3 (Hours of sleep \< 4 hours), Baseline and Week 4|Change the time it took participants to fall asleep as measured by The Pittsburgh Sleep Quality Index (PSQI), The Pittsburgh Sleep Quality Index (PSQI) is a validated, self-reported instrument assessing sleep quality over 1 month. The score of time it took participants to fall asleep range 0 (\<15 minutes) to 3 ( \>60 minutes), Baseline and Week 4
Efficacy of Light Therapy in Treatment of Chronic Cluster Headache
NCT Number: NCT06540651
Acronym: LUMIAVFc
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cluster Headache
Interventions: OTHER: use of Luminettes ® with active light emission|OTHER: use of Luminettes ® with a light emission presumed to have no therapeutic effect
Sponsor: Assistance Publique Hopitaux De Marseille
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 48
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-12-01
Completion Date: 2028-11-30
Locations: Hopital La Timone, Marseille, 13005, France|Hôpital de Cimiez, Nice, 06000, France

Summary:
Cluster headache is a primary headache. The chronic form of the disease is often difficult to treat. It is now considered a chronobiological disease. This chronobiological character is based on clinical, biological and radiological arguments.

This study focuses on the use of light therapy in cluster headache. Light therapy has already been used in the treatment of other chronobiological diseases, such as seasonal depression, but also recently in the therapy of other primary headaches (such as migraine). Its aim is to re-adjust chronobiological rhythms, and it therefore seems worth testing in the chronic form of cluster headache.

Light therapy is delivered to the patient using a consumer electronics device.The main objective is to evaluate the prophylactic efficacy of light therapy in patients with chronic cluster headache.

Primary Outcome Measures: The median weekly number of cluster headache attacks, The difference in the median weekly number of cluster headache attacks between the month prior to randomization and the month of the double-blind period, between the two arms., At day 28
Secondary Outcome Measures: Incidence and nature of adverse reactions, Headache, eye fatigue, dry eyes, nausea, Daily|Intensity of cluster headache, mild, moderate, severe, very severe, Daily|Use of acute treatments, sumatriptan and oxygen therapy, Daily|Patient's Global Impression of Change (PGIC) score, From better outcome, score 1 (Highly improved) to worse outcome, score 7 (Highly aggravated), At day 28
Cognitive Health Awareness Program in Surgical Patients
NCT Number: NCT06540638
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Dementia|Cognitive
Sponsor: University Health Network, Toronto
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 150
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-08-12
Completion Date: 2025-06-30

Summary:
Addressing brain health and cognitive impairment (CI) in the aging population is important, especially in those undergoing surgery. While certain adverse outcomes are beyond control due to various factors, some may be preventable, such as delirium. It is crucial for patients and their families to be fully aware of the heightened risks associated with CI. By discussing the implications for individuals and their families, patients can make informed decisions about their health. Additionally, patients can be better prepared for their post-operative care and informed about post-operative complications. Education is a practical and viable solution to promote awareness and empower individuals to manage their cognitive health, especially in the context of surgery. Also, it can act as an early intervention. Thus, there is a need to proactively educate older adults about brain health.

The objective of the Web-Based Brain Health Education Study is to determine the impact of preoperative education on the knowledge of cognitive health of older surgical patients. Specifically, our study will examine the changes in knowledge scores after patients participate in a web-based education program on promoting brain health during their surgical journey. We hypothesize that a web-based education program will increase patient knowledge and empower them proactively about their brain health during the surgical journey.

Primary Outcome Measures: Change in knowledge scores, A knowledge questionnaire was developed to assess patient's knowledge of brain health during their surgical journey based on our education e-module. Our questionnaire contains 20 True/False questions. Each correct answer is worth one point, giving a minimum value/score of 0 and maximum value/score of 20. Higher values/scores indicate greater knowledge of brain health. The pre- and post-education questionnaires are identical., At pre-surgery
Secondary Outcome Measures: Participant satisfaction, Participants will be asked to rate their level of satisfaction with the educational program., At pre-surgery
Validation of a Novel Handheld Device for Accurate Cricoid Pressure in Healthy Volunteers
NCT Number: NCT06540625
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Cricoid Pressure
Interventions: DEVICE: the use of CP device application on human subjects.
Sponsor: University Health Network, Toronto
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 63
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-01
Completion Date: 2025-03-01

Summary:
Pulmonary aspiration of gastric contents is a leading cause of anesthesia-related morbidity and mortality, particularly in emergency surgeries and among patients who are not appropriately fasted prior to airway intervention. The application of cricoid pressure (CP), also known as the "Sellick maneuver" is the current clinical practice to prevent aspiration of gastric content during Rapid-sequence induction (RSI) of general anesthesia. This conventional CP uses manual pressure over the cricoid cartilage during RSI procedure for patients at high risk of aspiration. Since its incorporation into clinical practice, the utility and technique of CP have garnered considerable debate, mainly due to the inability to standardize the magnitude and consistency of the applied force. Too little force may be ineffective at preventing regurgitation and excessive force may impede ventilation and actually worsen laryngoscopy views, making intubation more difficult.

A significant challenge in current clinical practice of CP is the inconsistency in the force applied, which often falls short of the necessary intensity and duration. To address this issue, we developed a groundbreaking handheld device capable of monitoring applied pressure in real-time, aiding providers in delivering precise and reproducible CP. Furthermore, our device utilizes sensor fabrication technology, integrating microelectronic systems and microprocessors to measure and display force in real-time, all while remaining portable. However, before implementation in clinical practice, rigorous testing through human volunteer studies and subsequent clinical trials is imperative. Hence, this study aims to validate the efficacy of our novel CP device in helping Providers apply the accurate target force.

Primary Outcome Measures: Assess whether the Providers can use the CP device with an accurate target force and maintain the force in an acceptable range over one minute., We set a target of 10N force for the study, with an acceptable range of 10N ± 2N., one day
Secondary Outcome Measures: Usability of the device based on feedback from both Participants and Providers, Proportion of Providers who think CP device will be useful in clinical practice, one day|Effectiveness of the video training based on feedback from Providers, Proportion of Providers who think the video training was useful, One day
Optimizing Analgesia for Endometrial Biopsy
NCT Number: NCT06540599
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Analgesia
Interventions: DRUG: Analgesic
Sponsor: Gaziosmanpasa Research and Education Hospital
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 197
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2022-09-01
Completion Date: 2022-11-01
Locations: Gaziosmanpaşa Training and Research Hospital, Istanbul, Turkey

Summary:
Comparison of the effectiveness of intrauterine lidocaine-paracervical block-dexketoprofen tromematol- lidocaine spray in endometrial biopsy analgesia

Primary Outcome Measures: comparing analgesics in endometrial biopsy using The Visual Analogue Scale (VAS)., post operative VAS scores will be compared for each drug.The VAS measures pain intensity. The VAS consists of a 10 cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be'). In this context, higher scores represent worse results., 1 hour
Postoperative Analgesic Efficacy of Modified TAPA and QL Blocks in Laparoscopic Cholecystectomies
NCT Number: NCT06540586
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Postoperative Pain Management|Postoperative Pain|Analgesia|Nerve Blocks|Cholecystectomy
Interventions: PROCEDURE: anterior Quadratus lumborum block
Sponsor: Gaziosmanpasa Research and Education Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 70
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, CARE_PROVIDER)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2023-06-01
Completion Date: 2024-07-27
Locations: Gaziosmanpasa Research and Education Hospital, Istanbul, 34000, Turkey

Summary:
Comparison of Postoperative Analgesic Effects of M-TAPA and Anterior Quadratus Lumborum Blocks in Laparoscopic Cholecystectomies.

Primary Outcome Measures: Total amount of opioid requirements, The total tramadol use of the patients in 24 hours will be recorded., within 24 hours after the surgery
Secondary Outcome Measures: rescue analgesia, The rescue analgesia requirement and time of the need of the rescue analgesia requirement, within 24 hours after the surgery
Other Outcome Measures: intraoperative remifentanil consumption, The total remifentanil use to be used in the maintenance of 0.05-0.2 mcg/kg remifentanil will be recorded by titration according to the hemodynamic data of the intraoperative patients., during operation procedure]|Visual Analogue Scale values, Visual Analogue Scale is a scale of 0-10 cm in length, expressed by non-standard verbal descriptors (no pain-unbearable pain..) indicating the limits of pain intensity on both sides, horizontally or vertically., at 1st, 4th,8th 12th and 24th hours after the surgery]|side effects such as nausea, vomiting and shoulder pain, The incidence of postoperative side effects such as nausea, vomiting and shoulder pain will be evaluated.a, within 24 hours after the surgery
Exploring Patient Treatment Preferences for Chronic Pelvic Pain: A Mixed Methods Study
NCT Number: NCT06540560
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Chronic Pelvic Pain
Interventions: BEHAVIORAL: My Pelvic Plan website
Sponsor: University of Michigan
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-10
Completion Date: 2025-10
Locations: University of Michigan, Ann Arbor, Michigan, 48109, United States

Summary:
This research is studying what things change the way people think about treatment for chronic pelvic pain (CPP). The study team is also interested in whether a web-based educational and self-management program for chronic pelvic pain changes how people think about chronic pelvic pain treatments. The program contains several different self-guided modules that include cognitive and behavioral structuring, self-administration of acupressure, engaging in physical activity, and a brief introduction to pelvic floor physical therapy techniques.

The study hypothesis is that patients with CPP will report that prior treatment experiences and most trusted source of medical information will be associated with baseline perceptions of various CPP treatment modalities.

Primary Outcome Measures: Explore factors that influence patient perceptions of treatment modalities for chronic pelvic pain, Explore prior treatment experiences, attitudes/perceptions of treatment modalities, sources of medical information. Baseline questionnaire and individual structured interview will be used., Baseline
Secondary Outcome Measures: Change in self-reported interest in treatment modalities, To evaluate whether brief exposure to a novel web-based educational and self-management program for chronic pelvic pain increases willingness to consider various treatment modalities one question will be asked.

The question states are participants interested in trying six different treatment modalities and select from "yes, definitely interested", "would consider", "not sure, need to hear more about this option", or "not interested"., Baseline, 3 weeks (post baseline)|Change in credibility/expectancy questionnaire (CEQ), The CEQ is a self-report measure assessing the credibility and expectancy of treatment received. It consists of 6 items, 4 items with a 9-point Likert-type rating of 1 (not at all) to 5 (very much) with a scoring range of 3-27. The other 2 items are on a percentage scale from 0%-100% in increments of 10 with a scoring range of means 0-100%. Higher scores denote higher treatment credibility and expectancy., Baseline, 3 weeks (post baseline)
Moms Managing Attention-Deficit/Hyperactivity Disorder (ADHD) Study
NCT Number: NCT06540547
Acronym: MomMA
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: ADHD|Parenting
Interventions: BEHAVIORAL: MomMA Intervention
Sponsor: University of Pittsburgh
Collaborators: YourMomCares Foundation
Sex: FEMALE
Age: ADULT
Enrollment: 10
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10-01
Completion Date: 2025-12-31
Locations: University of Pittsburgh, Pittsburgh, Pennsylvania, 15213, United States

Summary:
The study will develop and test a behavioral program for pregnant individuals with Attention-Deficit/Hyperactivity Disorder (ADHD). This behavioral program will include skills for managing ADHD and related symptoms during pregnancy and after delivery and will be taught by a behavioral therapist in OB care settings.

Primary Outcome Measures: Intervention Acceptability, Therapist and participant report of intervention acceptability will be assessed using the 4-item Acceptability of Intervention Measure (AIM), rated from rated from 1 (completely disagree) to 5 (completely agree), with scores greater than or equal to 16 indicating good acceptability., Post Intervention at 4-month postpartum|Intervention Appropriateness, Therapist and participant report of intervention appropriateness will be assessed using the 4-item Intervention Appropriateness Measure (IAM), rated from 1 (completely disagree) to 5 (completely agree), with scores greater than or equal to 16 indicating good appropriateness., Post Intervention at 4-month postpartum|Intervention Feasibility, Therapist and participant report of intervention feasibility will be assessed using the 4-item Feasibility of Intervention Measure (FIM), rated from 1 (completely disagree) to 5 (completely agree), with scores greater than or equal to 16 indicating good feasibility., Post Intervention at 4-month postpartum