pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Safety and Efficacy of NK520 to Treat Relapsed/Refractory Acute Myeloid Leukemia
NCT Number: NCT06541444
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: EARLY_PHASE1
Conditions: Relapsed/Refractory Acute Myeloid Leukemia
Interventions: DRUG: NK520
Sponsor: Base Therapeutics (Shanghai) Co., Ltd.
Collaborators: Shanghai Pudong Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 9
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-01
Completion Date: 2026-06-01
Locations: Shanghai Pudong Hospital, Shanghai, Shanghai, 201202, China

Summary:
This study will evaluate the safety and efficacy of NK520 in the treatment of relapsed/refractory acute myeloid leukemia. NK520 will be administered by intravenous injection. The safety and efficacy of this treatment will be evaluated.

Primary Outcome Measures: Dose-Limiting Toxicity, To evaluate the DLT during NK520 treatment, From the first dose of NK520 to 4 weeks after last infusion of NK520|Complete Response Rate (CRR), Effectiveness Metrics, From the date of first infusion of NK520 up to 104 weeks.
Secondary Outcome Measures: Overall response rate (ORR), Effectiveness Metrics, From the date of first infusion of NK520 up to 104 weeks.|Event-Free Survival (EFS), Effectiveness Metrics, From date of enrollment up to 104 weeks, or date of progression, or date of death, whichever came first.|Overall Survival (OS), Effectiveness Metrics, From date of enrollment up to 104 weeks or date of death, whichever came first.|Duration of Response (DOR), Effectiveness Metrics, From the date of enrollment up to 104 weeks
The Effect of Behavior Exchange Program on Risky Behaviors
NCT Number: NCT06541418
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Risk Behavior
Interventions: BEHAVIORAL: Transtheoretic Model Based Behavior Change Program
Sponsor: Istanbul Medipol University Hospital
Collaborators: Medipol University
Sex: ALL
Age: ADULT
Enrollment: 79
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2020-10-15
Completion Date: 2021-07-15
Locations: Istanbul Medipol University, Istanbul, Beykoz, 34810, Turkey

Summary:
Risky behaviors, which derive their source from features specific to adolescence, may also pose problems in other periods of a person's life and have features that prevent them from becoming responsible adults. These behaviors are defined by Jessor as behaviors that cause personal, social or developmental undesirable consequences and are life-threatening or harmful to health and even actions that can lead to death. Risky behaviors in young people are frequently listed as smoking, alcohol/substance use, nutrition, suicide, school dropout, and destructive behaviors (violence against self/others, etc.). It has been conducted with studies that generally do not take into account the stage of change or accept that all individuals' readiness for behavior change is the same. However, the Transtheoretic Model states that the most appropriate initiatives should be used to facilitate the change in which the individual is at the stage of change. He also states that the initiatives applied without considering the individual's readiness for behavior change develop resistance against behavior change. In this study, it was aimed to determine the effect of the behavior change program prepared based on the transtheoretic model on the risky behaviors of university students receiving health education.

Primary Outcome Measures: Risky behaviors scale-university form, The scale consists of 60 items and sevendimensions such as; antisocial behaviors, smoking, alcohol use, substance use, suicide tendency, eating habitsand school dropout.

RDÖUF (RBS-UF) is a Likert-type scale consisting of 60 items and seven dimensions. The five-point scale is answered as "always= 5", "usually= 4", "sometimes= 3", "rarely=2" and "never=1". There is no reverse scored item in the scale. Getting a high score on each dimension indicates a higher level of risk in that dimension., 1 year|self-efficacy scale, For each item on the 23-item scale; 1-" drink what I don't know", 2-"describes me a little", 3-"I'm undecided", 4-" me best defines me", S-"describes me very well" is requested. The score given for each item is taken as a basis. But 2,4,5,6,7, 10, 11, 12,14,16,17,18,20,22. items are scored in the opposite direction. So from the scale a minimum of 23 and a maximum of 115 points can be obtained.The increase in the total score obtained from the scale, the individual's self-efficacy-efficacy It means that the perception is at a good level., 1 year
Safety and Efficacy of NK520 to Treat Pediatric Relapsed/Refractory Acute Myeloid Leukemia
NCT Number: NCT06541405
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: EARLY_PHASE1
Conditions: Relapsed/Refractory Acute Myeloid Leukemia
Interventions: DRUG: NK520
Sponsor: Base Therapeutics (Shanghai) Co., Ltd.
Collaborators: Shanghai Children's Medical Center
Sex: ALL
Age: CHILD, ADULT
Enrollment: 9
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-01
Completion Date: 2025-06-01
Locations: Shanghai Children's Medical Center, Shanghai, Shanghai, 200127, China

Summary:
This study will evaluate the safety and efficacy of NK520 in the treatment of pediatric relapsed/refractory acute myeloid leukemia. NK520 will be administered by intravenous injection. The safety and efficacy of this treatment will be evaluated.

Primary Outcome Measures: Dose-Limiting Toxicity, To evaluate the DLT during N520 treatment, From the first infusion of NK520 to 4 weeks after last infusion of NK520|Complete Response Rate (CRR), Effectiveness Metrics, from the date of first infusion of NK510 up to 104 weeks
Secondary Outcome Measures: Overall response rate (ORR), Effectiveness Metrics, from the date of first infusion of NK510 up to 104 weeks|Duration of Response (DOR), Effectiveness Metrics, From the date of enrollment up to 104 weeks|Event-Free Survival (EFS), Effectiveness Metrics, From date of enrollment up to 104 weeks, or progression, or date of death, whichever came first.|Overall Survival (OS), Effectiveness Metrics, From date of enrollment up to 104 weeks, or date of death, whichever came first.
The Efficacy of Proper Breakfast Times on Cognitive Function
NCT Number: NCT06541392
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Eating, Time Restricted|Cognitive Change|Blood Pressure|Nutrition, Healthy
Interventions: OTHER: breakfast 6.30 am|OTHER: breakfast 7.31 am
Sponsor: University of Muhammadiyah Aceh
Sex: ALL
Age: ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-08-15
Completion Date: 2025-01-30

Summary:
The goal of this cluster randomized controlled trial is to learn if a proper breakfast time may increase cognitive function. It will also learn about the effectiveness of proper breakfast time on health outcomes. The main questions it aims to answer are:

Does a proper breakfast time increase cognitive function and health outcomes?

Participants will:

* wake up in the morning at 6 o'clock
* Having breakfast at 6.30 - 7.30 am or 7.31-8.31 am, or having breakfast time according to their wishes.
* Having lunch started at 12.00 pm.

Primary Outcome Measures: Focus, To determine the changes in focus between the groups using the Army alpha test, 8 weeks|Mood, To determine the changes in mood between the groups using the profile of moods state (POMS) questionnaire, 8 weeks
Secondary Outcome Measures: Systolic blood pressure, To determine the changes in systolic blood pressure between the groups using the sphygmomanometer, 8 weeks|Diastolic blood pressure, To determine the changes in diastolic blood pressure between the groups using the sphygmomanometer, 8 weeks|Heart rate, To determine the changes in heart rate between the groups using the sphygmomanometer, 8 weeks|macro nutrition intake, To determine the changes in macro nutrition intake between the groups using the 3-day food record, 8 weeks|micro-nutrition, To determine the changes in micro-nutrition intake between the groups using the 3-day food record, 8 weeks
Physical Capacity of Spina Bifida and Factors Affecting
NCT Number: NCT06541366
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Spina Bifida
Interventions: OTHER: case-control study
Sponsor: Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
Sex: ALL
Age: CHILD
Enrollment: 2
Study Design: Observational Model: |Time Perspective: p
Start Date: 2019-02-01
Completion Date: 2020-01-01
Locations: University of Health Sciences, Diyarbakır Gazi Yaşargil Training and Research Hospital, Diyarbakır, 21090, Turkey

Summary:
Objective: It was aimed to evaluate the physical characteristics of the cases with spina bifida and to review the factors that may affect the etiology of the disease.

Methods: 48 cases with spina bifida and 48 control groups in other disease groups evaluated. A physiotherapist physically evaluated the cases after their personal information was obtained. A survey form examining the possible factors in the etiology of spina bifida was applied to the families.

Primary Outcome Measures: Results of Groups, FACTORS AFFECTING DURING PREGNANCY QUESTIONARRE, 1-2 month|Antropomethric measures, body mass index (kg/cm2), 1-2 month
Prognostic Model for Long-Term Cardiac Function After Pulmonary Embolism Based on Dynamic Electrocardial Signal and Circulating Biomarkers
NCT Number: NCT06541353
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Pulmonary Embolism
Sponsor: China-Japan Friendship Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 500
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-01
Completion Date: 2026-06-30
Locations: China-Japan Friendship Hospital, Beijing, Beijing, 100029, China

Summary:
Pulmonary embolism (PE) is a highly morbid and fatal cardiovascular disease. Right ventricular dysfunction (RVD) secondary to PE indicates a poor prognosis and serves as a critical basis for risk stratification. Recent studies have shown that over one-third of patients continue to experience RVD one year after PE, with the mechanisms and regression remaining unclear. Although electrocardiography (ECG) is the most commonly used test for cardiac disease, its diagnostic specificity for PE is limited.

In recent years, artificial intelligence (AI) has successfully extracted hundreds of features from data that are difficult for the human eye to recognize. The correlation between daily vital signs monitored by wearable devices and functional signs of chronic cardiovascular disease suggests the potential of AI in detecting disease progression. There is a lack of specific markers for right ventricular function post-PE, and the significance and changes of these markers in disease progression have not yet been explored.

This study aims to develop a predictive model for the progression of RVD after PE using AI, combining electromyography, wearable devices, and vitality markers. In this prospective cohort study, 500 patients with acute PE at intermediate or higher risk were enrolled. Approximately 200 patients with RVD at discharge were followed for one year, with daily electromyographic data collected using portable electromyographs. Biospecimens were collected at the following time points: admission, discharge, and follow-up at 3, 6, and 12 months and a variety of inflammatory markers were measured using a multifactorial assay on liquid suspension cores. These data were integrated into a continuous disease diagnostic model based on a deep learning restrictive updating strategy.

Ultimately, a continuous disease diagnosis and prognosis algorithm was developed, yielding a model for predicting the progression of RVD after PE using multifactorial assays on liquid suspension cores to measure various inflammatory markers.

Primary Outcome Measures: the prevalence of right ventricle dysfunction, the prevalence of RVD defined by functional parameters of the right ventricle through echocardiography according to Guidelines for the Echocardiographic Assessment of the Right Heart in Adults: A Report from the American Society of Echocardiography., 1 year
Cellular Immunotherapy for Relapsed or Refractory Lymphoma Data Collection
NCT Number: NCT06541327
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Lymphoma, Non-Hodgkin
Interventions: DRUG: Chimeric Antigen Receptor
Sponsor: Ruijin Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-05-15
Completion Date: 2040-12-31
Locations: Department of Hematology, Shanghai Institute of Hematology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China

Summary:
This study aims to collect clinical data from adult patients with relapsed or refractory non-Hodgkin's lymphoma (r/r NHL) receiving cellular immunotherapy to establish a large database of cellular immunotherapy for Chinese patients.

Primary Outcome Measures: Complete Response (CR) Rate in 3 months, Complete Response rate in 3 months is defined as the incidence of subjects achieving complete remission (CR) within 3 months after CAR-T infusion according to the Lugano Classification (Cheson et al, 2014), as determined by study investigators., 3 months post CAR-T infusion
Secondary Outcome Measures: Objective remission rate (ORR) in 3months, ORR in 3 moths is defined as the incidence of either a CR or a partial response (PR) within 3 months after CAR-T infusion per the Lugano Classification as determined by study investigators., 3 months post CAR-T infusion|Overall Survival (OS), OS is defined as the time from CAR-T infusion to the date of death from any cause., 2 years post CAR-T infusion|Adverse events (AEs), Types, frequency, and severity of adverse events and laboratory anomalies Physiological parameter, 2 years post CAR-T infusion
Fluzoparib Neoadjuvant Therapy for Ovarian Cancer
NCT Number: NCT06541314
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Ovarian Cancer
Interventions: DRUG: Fluzoparib
Sponsor: Qilu Hospital of Shandong University
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 48
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-18
Completion Date: 2026-05-31
Locations: Qilu Hospital of Shandong University, Jinan, Shandong, 250000, China

Summary:
This study is an interventional, single-arm, open-label clinical trial. To evaluate the safety and efficacy of Fluzoparib as neoadjuvant therapy in patients with FIGO stage III and IV , BRCA mutations or HRD positive epithelial ovarian cancer who cannot achieve R0 surgery as assessed by imaging (Suidan's CT score) or laparoscopy (Fagotti score), or cannot tolerate surgery.

Primary Outcome Measures: ORR, Objective response rate. After completing neoadjuvant monotherapy with Fluzoparib, the proportion of patients who achieve complete response and partial response according to the RECIST 1.1 criteria., From the diagnosis of epithelial ovarian cancer until the completion of neoadjuvant monotherapy with Fluzoparib, assessed up to 10 weeks.|R0 Resection Rate, To evaluate the proportion of patients with advanced epithelial ovarian cancer, initially deemed non-R0 resectable or unable to tolerate surgery, who achieve R0 resection following neoadjuvant monotherapy with Fluzoparib., From the completion neoadjuvant monotherapy with Fluzoparib until the date of surgery, with the assessment of R0 resection rate occurring within 1 to 2 weeks after treatment completion.
Secondary Outcome Measures: PFS, Progression-free survival. The time from patient enrollment to tumor progression or death., The time from patient enrollment until the date of first documented tumor progression or death from any cause, whichever occurs first, assessed up to 60 months.|OS, Overall survival. The time from patient enrollment to death., From the time from patient enrollment until the date of death from any cause, assessed up to 120 months.
PICC-ports Versus Chest - Ports for Long Term Chemotherapy Deliverance in Oncology Patients
NCT Number: NCT06541301
Acronym: PICCHEST
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Solid Tumor
Interventions: DEVICE: PICC-port|DEVICE: Chest-port
Sponsor: European Institute of Oncology
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 852
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-08
Completion Date: 2026-02
Locations: CRO (Centro di Riferimento Oncologico), Aviano, 33081, Italy|Ospedale Careggi, Florence, 50134, Italy|European Institute of Oncology, Milan, 20141, Italy|Ospedale Santo Spirito, Pescara, 65122, Italy

Summary:
Central venous access devices are extensively used in oncology patients. The current standard is represented by devices inserted by direct ultrasound guided cannulation of deep veins of supra/infraclavicular area with a reservoir placed in a subcutaneous pocket of the upper chest wall ("chest-ports"). More recently, PICC (Peripherally Inserted Central Catheters)-ports have been proposed as an alternative to chest-ports.

Aim of this study is to demonstrate the non-inferiority of PICC ports compared to thoracic ports in terms of efficacy and safety.

Primary Outcome Measures: Incidence of device failures, Number of unscheduled removal of the device due to complications, 6 months
Secondary Outcome Measures: Incidence of adverse events associated to device, Number of adverse events associated with the implantation and use of the device that do not necessitate its removal, 6 months
A Prospective Cohort Study Comparing AI Prediction Model With Imaging Assessment to Diagnose Lymph Node Metastasis in Cervical Cancer
NCT Number: NCT06541288
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Uterine Cervical Neoplasms
Interventions: DIAGNOSTIC_TEST: AI Prediction Model|DIAGNOSTIC_TEST: Conventional Imageing Assessment
Sponsor: Obstetrics & Gynecology Hospital of Fudan University
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 230
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: FACTORIAL|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-08
Completion Date: 2027-12
Locations: The Obstetrics and Gynecology Hospital of Fudan University, Shanghai, Shanghai, 200090, China

Summary:
The goal of this prospective cohort study is to learn whether artificial intelligence multimodal fusion prediction models are effective in diagnosing pelvic lymph node metastasis in cervical cancer. The main question it aims to answer is: can artificial intelligence multimodal fusion prediction models improve the accuracy of preoperative diagnosis of pelvic lymph node metastasis in cervical cancer? The researchers compared the AI multimodal fusion prediction model with traditional imaging physician assessments to see if the prediction model could yield more accurate lymph node metastasis determinations. Participants will undergo pelvic MRI after pathologically confirming a diagnosis of cervical cancer, and the results will be used to determine pelvic lymph node metastasis status by the predictive model and the imaging physician, respectively. Subsequent pathology results after surgical lymph node clearance will be used as the gold standard to determine the accuracy of the two preoperative lymph node diagnostic modalities.

Primary Outcome Measures: Accuracy in determining pelvic lymph node metastasis, After the subjects underwent surgical treatment, surgical pathology served as the gold standard for evaluating the accuracy of the AI predictive model in comparison to traditional imaging diagnosis. In the statistical analysis phase, sensitivity and specificity were utilized as the primary indicators to assess the accuracy of both diagnostic modalities., The time frame was from subject enrollment until surgical pathology results were obtained. The time between subject enrollment and the availability of surgical pathology results was approximately 1 to 1.5 months.
Reduction in Volume and Prolonged Shrinkage of Brain Aneurysms After Combined Endovascular Interventions
NCT Number: NCT06541275
Status: ENROLLING_BY_INVITATION
Study Type: OBSERVATIONAL
Conditions: Brain Aneurysm
Interventions: DIAGNOSTIC_TEST: brain MRI and CT
Sponsor: National Centre for Neurosurgery, Republic of Kazakhstan
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 102
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-17
Completion Date: 2026-12
Locations: National Centre for Neurosurgery, Astana, 010000, Kazakhstan

Summary:
The goal of this observational study is to learn about the long-term effects of combined endovascular interventions in participants over the age of 18 who take endovascular interventions employing endoluminal flow diverter stents, with or without coils, and a hybrid approach of combining bypass anastomosis and parent artery occlusion using the endovascular method to treat their giant symptomatic intracranial aneurysms. The main question it aims to answer is:

• How does the methods of endovascular intervention chosen affect the value of the aneurysmal sac shrinkage and volume reduction? Participants underwent endovascular intervention at the hospital will be recruited with further follow-up of 6, 12, and 24 months.

Primary Outcome Measures: A value of the aneurysmal sac shrinkage and volume reduction, A detailed analysis and interpretation of the results obtained from selective cerebral angiography and MRA post-surgery at 6, 12, and 24 months will be performed on participants who underwent endovascular interventions for giant symptomatic brain aneurysms. The analysis will assess the dynamic volume reduction and sac shrinkage., From enrollment to the further follow-up of 6, 12, and 24 months.
Silmitasertib (CX-4945) in Combination With Chemotherapy for Relapsed Refractory Solid Tumors
NCT Number: NCT06541262
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Neuroblastoma Recurrent|Ewing's Sarcoma Recurrent|Osteosarcoma Recurrent|Rhabdomyosarcoma Recurrent|Liposarcoma Recurrent
Interventions: DRUG: Silmitasertib|DRUG: Irinotecan|DRUG: Temozolomide|DRUG: Vincristine
Sponsor: Milton S. Hershey Medical Center
Sex: ALL
Age: CHILD, ADULT
Enrollment: 114
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2035-09-01

Summary:
The purpose of this study is to evaluate the investigational drug, silmitasertib (a pill taken by mouth), in combination with FDA approved drugs for solid tumors. An investigational drug is one that has not been approved by the U.S. Food \& Drug Administration (FDA), or any other regulatory authorities around the world for use alone or in combination with any drug, for the condition or illness it is being used to treat.

The goals of this part of the study are:

* Establish a recommended dose of silmitasertib in combination with chemotherapy
* Test the safety and tolerability of silmitasertib in combination with chemotherapy in subjects 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: Phase I- Number of Participants with Adverse Events as a Measure of Safety and Tolerability, To characterize the safety profile of silmitasertib in combination with chemotherapy, 2 years plus 30 days|Phase I- Number of Participants with Dose Limiting Toxicities to determine RP2D, To determine the Recommended Phase 2 Dose (RP2D) of silmitasertib in combination with chemotherapy, 21 days|Phase II- Determine the Overall Response Rate (ORR) of Participants using INSS Response, To evaluate the efficacy of silmitasertib in combination with chemotherapy in 2 disease cohorts, based upon Overall response rate (ORR), 2 years
Secondary Outcome Measures: Phase I- Determine the Overall Response Rate (ORR) of Participants using INSS Response, To evaluate the efficacy of silmitasertib in combination with chemotherapy in 2 disease cohorts based upon Overall response rate (ORR), 2 years|Number of participants with progression free survival (PFS) during study, To evaluate the efficacy of silmitasertib in combination with chemotherapy in 2 disease cohorts based upon Progression Free Survival (PFS), 2 years|Phase II- Length of time that participants experience Overall Survival (OS), To evaluate the efficacy of silmitasertib in combination with chemotherapy in 2 disease cohorts based upon Overall Survival (OS), 2 years|Phase II- Number of Participants with Adverse Events as a Measure of Safety and Tolerability, To characterize the safety profile of silmitasertib in combination with chemotherapy, 2 years plus 30 days
Alveolar Ridge Preservation After Tooth Extraction Using Autologous Dentin Matrix
NCT Number: NCT06541236
Acronym: ADM for ARP
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: To Evaluate the Quality of the Newly Formed Cortical Tissue in the Area of the Condylar Condyle Using Different Bone Grafting Materials
Interventions: PROCEDURE: Alveolar Ridge Preservation After Tooth Extraction Using Autologous Dentin Matrix
Sponsor: Moscow State University of Medicine and Dentistry
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2019-09-01
Completion Date: 2024-09
Locations: Moscow State Univerciry of medicine and dentistry, Moscow, 123022, Russian Federation

Summary:
According to the scientific literature, the loss of any tooth can be accompanied by a pronounced resorption of the alveolar ridge in the corresponding area, which leads to the formation of various defects. In the post-extraction period, bone tissue resorption 4 months after tooth extraction is up to 45% horizontally and 43% vertically.Despite the considerable amount of research on this problem, the improvement of pre-implantation preparation of patients with adentia after tooth extraction continues to be an extremely urgent task. The solution to this problem requires a comprehensive approach based on a unified assessment of the success of dental implantation in the post-extraction zone. The aim of our study is to conduct a comprehensive comparative analysis of osteoplastic materials after preservation of the extraction wells of extracted teeth. The null hypothesis is that the ADM technique can be used in patients and the newly formed bone regenerate will be sufficient for implant placement.

Primary Outcome Measures: Level of bone persorption after Alveolar Ridge Preservation Using Autologous Dentin Matrix, 3 and 6 months after surgery
Multimedia-assisted Informed Consent Procedure for Patients Undergoing Mastectomy and Implant-based Reconstruction
NCT Number: NCT06541223
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Breast Cancer
Interventions: OTHER: Standard informed consent procedure|OTHER: Multimedia video
Sponsor: European Institute of Oncology
Sex: FEMALE
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 265
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-01-02
Completion Date: 2024-06-25
Locations: European Institute of Oncology, Milan, 20141, Italy

Summary:
Breast reconstruction is a women's right with positive psychological effects and it is an integral part of breast cancer treatment and care. A preoperative counselling is mandatory, providing information about oncologic surgery, the type of reconstruction and the expected results. This study plans to compare conventional informed consent process supported by informational brochures with a multimedia video-assisted procedure supported by the same informational brochures in breast cancer patients undergoing immediate implant-based reconstruction. The two processes will be compared in terms of information retention, patient satisfaction of the informed consent process and anxiety levels before surgery.

Primary Outcome Measures: Evaluation of current state of anxiety, Collection of Spielberger State/Trait Anxiety Inventory (STAI) Y1 questionnaire (minimum value: 1, maximum value: 4 - higher scores mean greater anxiety), 2 weeks|Evaluation of anxiety proneness, Collection of Spielberger State/Trait Anxiety Inventory (STAI) Y2 questionnaire (minimum value: 1, maximum value: 4 - higher scores mean greater anxiety), 2 weeks|Evaluation of uncertainty and perceptions of effective decision-making, Collection of Decisional Conflict Scale (DCS) questionnaire (minimum value: 1, maximum value: 5 - higher scores mean higher decisional conflict), 2 weeks|Evaluation of patients' understanding of plastic reconstruction procedures and surgical complications, Collection of Reconstructive Breast Surgery Comprehension Questionnaire (minimum value: 1, maximum value: 4 - higher scores mean better understanding), 2 weeks
Building Community Living Labs in Black Communities to Advance Prostate Health Equity and Reduce Prostate Cancer Disparities in Black Men
NCT Number: NCT06541210
Acronym: CoLLab
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Prostate Carcinoma
Interventions: OTHER: Non-Interventional Study
Sponsor: Mayo Clinic
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 250
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-11-01
Completion Date: 2027-11-30
Locations: Mayo Clinic in Florida, Jacksonville, Florida, 32224-9980, United States

Summary:
This study evaluates the possibility of establishing a Community Living Labs (CoLLab) Learning Health System to facilitate access to prostate health REACH services for Black men.

Primary Outcome Measures: Create real-life user centric CoLLab Learning Health System (program production), Qualitative data collection will be employed during a town hall meeting with the CoLLab Community Advisory Board (CAB) to ensure that we get unbiased and objective feedback from participants., Up to 12 months|Impact of the CoLLab Learning Health Systems, Will be assessed using pre-test and post-test survey scores from a Prostate Health Resources Questionnaire, which consists of 6 multiple choice questions, 8 true/false/don't know questions, 13 questions answered on a 5-point scale (e.g., very favorable to unfavorable or strongly agree to strongly disagree), and 20 yes/no questions., Baseline; up to 12 months|Feasibility of Replication - cost analysis, Will be assessed using cost analysis of direct and indirect costs., Up to 24 months|Feasibility of Replication - cost analysis, Will be assessed qualitatively based on interviews of key personnel and users, Up to 24 months
A New Fast DWI-based MR Protocol for Surveillance in Patients With a High Risk of Ovarian Cancer Recurrence During PARP-inhibitors Maintenance to Enhance Secondary Cytoreduction Results
NCT Number: NCT06541171
Acronym: FOFU
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Ovarian Cancer|Recurrent Ovarian Carcinoma
Interventions: OTHER: Magnetic resonance imaging as fpr clinical practice
Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 220
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-01
Completion Date: 2027-08-31
Locations: Fondazione Policlinico Universitaro "A. Gemelli" IRCCS, Roma, 00168, Italy

Summary:
In ovarian cancer (OC), complete surgical debulking and platinum-based chemotherapy are the standard treatment, now followed by maintenance therapy with PARP inhibitors or Bevacizumab. However, in advanced-stage ovarian cancer, recurrence is common, with a progression-free survival of about 16 months. Secondary cytoreductive surgery (SCS) at the time of recurrence prolongs the overall survival and gives the possibility to extend the use of PARP-i. SCS is possible only when recurrence has limited extension. However, in OC, there is no well-established and widely accepted scheme for surveillance during maintenance therapy; ESMO guidelines suggest physical examination for the follow-up and allow ultrasound, CT, PET-CT and MRI to confirm the recurrence and plan surgical treatment if appropriate.

Primary Outcome Measures: Cytoreductive surgery rate, Optimal cytoreductive surgery rate, 36 months
Secondary Outcome Measures: Concordance rate between MRI results and CA125 variations, Percentage of Concordance between MRI results and CA125 variations, 36 months|Concordance between MRI results and CT findings, Percentage of Concordance between MRI results and CT findings, 36 months|Rate of Survival, Progression-Free Survival and Overall Survival Rate, 36 months
Bacterial Decolonization Within Dyads
NCT Number: NCT06541145
Acronym: BADMC
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Bacterial Colonization
Interventions: DRUG: Mupirocin|DRUG: Chlorhexidine baths
Sponsor: Duke University
Collaborators: Bristol-Myers Squibb
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-08
Completion Date: 2025-06

Summary:
The goal of this study is to measure bacterial burden, specifically Staph aureus, and how it spreads between mothers and their infants. Researchers will evaluate if the amount of bacteria on their skin remains the same after mothers use a skin antisepsis treatment prior to delivering their infants. The investigators also aim to assess participant interest in and compliance with skin antisepsis treatments. The hypothesis is that increased maternal interest will align with increased treatment compliance.

Primary Outcome Measures: Staph aureus burden within maternal-infant dyads after exposure to a decolonization regimen, Mucosal swabs collected in the parent study, Project HOPE biorepository are stored in RNALater to assess burden by PCR (polymerase chain reaction) at a later date., 12 months|Staph aureus epidemiology within maternal-infant dyads after exposure to a decolonization regimen, S. aureus isolates will undergo spa typing for comparison., 12 months|Participant interest in skin decolonization, Measured by a descriptive survey, Perception of Safety Survey for Pregnant Women Undergoing Skin Treatment., 12 months|Participant compliance with skin decolonization, Measured by a descriptive survey, Perception of Safety Survey for Pregnant Women Undergoing Skin Treatment., 12 months
Positive Association of US-FLI With the Severity of CAD
NCT Number: NCT06541132
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Coronary Artery Disease of Significant Bypass Graft|Metabolic Dysfunction-associated Fatty Liver Disease|SYNTAX Score|Ultrasonography
Interventions: OTHER: Observational study without human intervention
Sponsor: Chongqing Medical University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 190
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-07-01
Completion Date: 2025-04-28
Locations: The Second Affiliated Hospital of Chongqing Medical University, Chongqing, Chongqing, 400000, China

Summary:
As a multisystem disease, metabolic dysfunction-associated fatty liver disease (MAFLD) is closely linked to the onset and progression of coronary heart disease (CHD). Ultrasonographic fatty liver indicator (US-FLI) is a semi-quantitative tool for evaluating the degree of hepatic steatosis. Our study aims to explore the relationship between US-FLI based on MAFLD and the severity of CHD.

Primary Outcome Measures: SYNTAX score, The complexity of coronary artery disease (CAD) is a predictor of cardiovascular events in patients with \>50 % diameter stenosis as determined by SYNTAX score. The range of US-FLI is 0-8. Fatty liver was diagnosed when US-FLI ≥ 2., at baseline
Effect of Selective Strengthening of Peroneus Longus on Pain , Joint Alignment and Foot Function in Hallux Valgus
NCT Number: NCT06541119
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hallux Valgus
Interventions: OTHER: Selective Peroneus longus excercise|OTHER: Conventional physical therapy programme
Sponsor: Cairo University
Sex: ALL
Age: ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2024-11-15
Locations: Cairo university, Giza, Egypt

Summary:
Purpose of this study is to measure Change in Hallux valgus angle (HVA )as measured by kinovea software Change in pain as measured by numerical pain rating scale (NPRS) Change in function as measured by Foot function index (FFI )Egyptian version With the peroneus longus strengthening exercise versus the use of conventional physical therapy programme in cases of hallux valgus patients

Primary Outcome Measures: Hallux valgus angle HVA, Hallux valgus angle will be measures musing kinovea software, Baseline , 6 weeks (after study completion )|Level of pain, Will be measured using numerical pain rating scale Where 0 represents no pain and 10 represents worst pain imaginable, Baseline , 6 weeks after study completion|Foot function, Will be measured using Foot Function Index FFI Egyptian version Which is divided into 3 sub categories Pain 0 no pain , 10 worst pain Disability 0 least 10 worst Activity limitation 0 no limitation , 10 worst limitation For the total score, the minimum score is 0% (no pain or difficulty), and maximum score is 100% (worst pain and extreme difficulty requiring assistance)., Baseline , 6 weeks after study completion
The Effect of Perioperative Heated Sock Use in Preventing Hypothermia During Total Hip Prosthesis Surgery
NCT Number: NCT06541054
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hip Fractures|Hip Injuries
Interventions: OTHER: WARM SOCKS
Sponsor: Istanbul University - Cerrahpasa (IUC)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 70
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2021-09-01
Completion Date: 2022-12-31
Locations: Seval Ulubay, Samsun, Atakum/Samsun, 55200, Turkey

Summary:
Warm sock application; It has been proven that wearing battery-operated warm socks on patients in the preoperative period strengthens the central thermoregulation system, maintains core body temperature, controls the shivering response, and ensures the subjective thermal comfort of patients.

Primary Outcome Measures: The Effect of Perioperative Heated Sock Use in Preventing Hypothermia During Total Hip Prosthesis Surgery: A Randomized Controlled Trial, As a result of the measurement in this study: Body temperature is measured tympanically. Hypothermia is generally classified based on cases where the body temperature falls below 35.0 °C. Hypothermia symptoms may vary as body temperature drops, so hypothermia is divided into three levels according to its severity.Body Temperature: Monitoring body temperature before and after surgery. Specifically, evaluating whether preoperative warm sock application helps maintain body temperature within normal ranges.

Target Body Temperature: Assessing whether the targeted body temperature range (e.g., 36-37°C) for preventing hypothermia is achieved., 36 weeks
Reducing Stigma in People Who Inject Drugs (PWID) With HIV Using a Rapid Start Antiretroviral Therapy Intervention (ART)
NCT Number: NCT06541028
Acronym: RS-ART
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hiv|Drug Use
Interventions: BEHAVIORAL: Rapid-Start ART (RS-ART)
Sponsor: Yale University
Collaborators: National Institute of Mental Health (NIMH)|Fogarty International Center of the National Institute of Health
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 135
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-08
Completion Date: 2026-08
Locations: Kajang Prison, Kajang, 43000, Malaysia|Centre of Excellence for Research in AIDS (CERiA) - University of Malaya, Kuala Lumpur, 50450, Malaysia|Primary Healthcare Centers, Kuala Lumpur, 50450, Malaysia|SSPs, Kuala Lumpur, 50450, Malaysia

Summary:
This study seeks to develop an RS-ART implementation strategy by utilizing the Delphi method and interviewing experts and PWID regarding their experiences with ART. This strategy will then be pilot tested in a randomized controlled trial (Aim 3). The research will not impact the type of medication and dose prescribed, but rather, how soon providers are able to prescribe ART after diagnosis. The focus of this registration is Aim 3.

Primary Outcome Measures: HIV Stigma Framework Scale, The scale consists of 24 statements related to the devaluation of people with HIV that are scored on a 5 point Likert-type scale, with higher scores corresponding to higher levels of HIV stigma. Total score range from 24-120. The scale also contains sub-scales for enacted (9 items, score range 9-45), anticipated, (9 items, score range 9-45) and internalized stigma (6 items, score range 6-30)., Baseline and 6 months|Substance Use Mechanism Scale, All responses are given on a 5-point Likert-type scale, with higher scores indicating greater endorsement of substance use stigma. The scale contains a total of 18 items, with scores ranging from 18-90. Enacted (6 items, score range 6-30), Anticipated (6 items, score range 6-30), and Internalized (6 items, score range 6-30) sub-scales can be created by taking the average of the item responses given for each stigma mechanism respectively., Baseline and 6 months
Secondary Outcome Measures: Viral Load, Mean HIV viral load (in copies/mL) will be obtained through medical record review. A viral load of 200 copies/mL or less is considered 'undetectable' with no risk of HIV transmission., 6 months
Effect of Transcutaneous Electrical Nerve Stimulation on Post-stroke Patients
NCT Number: NCT06541015
Acronym: TENS
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hemiplegia and/or Hemiparesis Following Stroke|Anterior Circulation Stroke of Uncertain Pathology
Interventions: DEVICE: InTENSity 10 TENS Stimulator
Sponsor: University of Texas Southwestern Medical Center
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2019-06-21
Completion Date: 2025-12-31
Locations: University of Texas Medical Center, Dallas, Texas, 75390, United States

Summary:
The subjects will be asked to attend minimum 15 separate sessions, 6 for testing changes in reflex behaviors, 3 for testing changes in the influence of descending motor tracts on spinal motor neurons, 3 for each testing functional movement in response to a trip event and cross-tilt walking adaptation pattern, as part of their participation in the research study. The estimated amount of time to enroll and collect the data for each of the subjects is four months' time. The data will be analyzed and ready for grant preparation (if successful) in approximately four months after the start of the study.

Primary Outcome Measures: Reflex Testing, Test if tsDCS (transcutaneous spinal direct current stimulation) has any beneficial effect on reflexes in post-stroke individuals, 3 months|Walking Testing, Test if tsDCS (transcutaneous spinal direct current stimulation) has any beneficial effect on walking in post-stroke individuals, 3 months|Adaptation Testing, Test if tsDCS (transcutaneous spinal direct current stimulation) has any beneficial effect on adaptation pattern in post-stroke individuals, 3 months
Noise-augmented Automatic Speech Recognition for Speech Treatment in Parkinson's Disease
NCT Number: NCT06540989
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: EARLY_PHASE1
Conditions: Parkinson Disease
Interventions: BEHAVIORAL: Immediate treatment|BEHAVIORAL: Deferred treatment
Sponsor: Teachers College, Columbia University
Collaborators: Temple University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 42
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (CARE_PROVIDER, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2027-06-30
Locations: Teachers College, Columbia University, New York, New York, 10027, United States

Summary:
The goal of this clinical trial is to learn whether noise-augmented feedback using automatic speech recognition improves intelligibility and social participation in individuals with Parkinson's disease. The main questions the investigators will address are:

Does noise-augmented feedback lead to increased intelligibility, as measured by transcription accuracy scores?

Does a self-managed speech protocol lead to increased social participation, as measured by the Communicative Participation Item Bank and the Communicative Effectiveness Index questionnaires?

Participants will:

Receive 2-4 initial speech assessments in-person in our lab. Engage in speech treatment sessions at home using their phone and computer four days a week for four weeks. Four of those sessions will be directly monitored online by a speech-language pathologist. The rest of the sessions are completed by the participant.

Come to the lab for two post-treatment assessments following completion of treatment.

Come to the lab six months after treatment completion for an additional assessment.

Primary Outcome Measures: Intelligibility, Transcription accuracy (% words correctly understood by listeners), 3 years
Secondary Outcome Measures: Social participation, Communicative Participation Item Bank questionnaire (10 questions, 0 = very much to 3 = not at all), 7-8 months|Social participation, Communication Effectiveness Index questionnaire (8 questions, 1 = not at all effective, 4 = very effective), 7-8 months