pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Statins Effect on Incidence of Side Effects of Platinum Based Chemotherapy
NCT Number: NCT06553157
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Solid Tumors|Ototoxicity
Interventions: DRUG: Statin|OTHER: placebo
Sponsor: Minia University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-09-01
Completion Date: 2026-06-01
Locations: Minia University hospital, department of oncology and nuclear medicine, Minya, 61519, Egypt

Summary:
Platinum based chemotherapy (mainly Cisplatin) is known to cause a variety of adverse effects, including Ototoxicity and nephrotoxicity. Ototoxicity is estimated to affect about 36% of adult patients treated with cisplatin, many therapeutic interventions have been studied to reduce the risk of developing ototoxicity from Cisplatin treatment, Statins have been studied in animals and have shown promising results, this study is aimed to explore the effect of statins on the incidence of ototoxicity in humans.

Primary Outcome Measures: change in hearing as defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) using Audiometry as a tool, grade 1:Adults enrolled on a Monitoring Program (on a 1, 2, 4, 3, and 8 kHz audiogram): Threshold shift of 15 - 25 dB averaged at 2 contiguous test frequencies in at least one ear.

grade 2: enrolled on a Monitoring Program (on a 1, 2, 3, 4, and 8 kHz audiogram): Threshold shift of \>25 dB averaged at 2 contiguous test frequencies in at least one ear.

grade 3: enrolled on a Monitoring Program (on a 1, 2, 3, 4, and 8 kHz audiogram): Threshold shift of \>25 dB averaged at 3 contiguous test frequencies in at least one ear; therapeutic intervention indicated.

grade 4: Decrease in hearing to profound bilateral loss (absolute threshold \>80 dB HL at 2 kHz and above); nonservicable hearing, 3 months after end of treatment|EVALUATION OF THE IMPACT OF HEARING LOSS IN ADULTS (ERSA): Questionnaire, Evaluation of the impact of hearing loss in adults: a quality of life questionnaire, 3 months after end of treatment
Secondary Outcome Measures: Changes in Otoacoustic emission (OAE): hearing test, to assess the cochlear function (outer hair cell function in particular), their use allow monitoring dynamic changes in cochlear responsiveness, before apparent hearing loss, 3 months after end of treatment
Comparative Analysis of Photodynamic Therapy on Periapical Healing
NCT Number: NCT06553144
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Apical Periodontitis
Interventions: PROCEDURE: control|PROCEDURE: methylene blue|PROCEDURE: erythrosine b|PROCEDURE: curcumin
Sponsor: University of Gaziantep
Sex: ALL
Age: ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2021-02-01
Completion Date: 2021-12-12
Locations: Gaziantep Üniversitesi, Gaziantep, Adana, 01130, Turkey

Summary:
As a result of tooth decay, lesions caused by infection occur at the root tip. These teeth can heal with root canal treatment. In this study, additional applications will be made to increase the success of root canal treatment. The materials we will use are harmless. At the end of the procedure, your teeth will be monitored regularly and their healing status will be checked.

Primary Outcome Measures: healing of periapical lesions by radiography, The area of lesions in periapical radiographs, captured using the parallel technique, was calculated in mm² utilizing Image J 1.28 software (Figure 7) (National Institute of Health, USA)., long-term follow-up evaluation in 12 months|post-op pain, Participants were scheduled for follow-up appointments at 6, 12, and 24 hours, as well as at 1 week, during which they were asked to report any pain experienced. Pain levels were assessed using the Visual Analogue Scale (VAS), ranging from 0 (no pain) to 10 (most severe pain), and recorded accordingly., Participants were scheduled for follow-up appointments at 6, 12, and 24 hours, as well as at 1 week,
Evaluation of the Effect of Central Sensitivity on Pain and Functional Status After Total Knee Joint Replacement Surgery
NCT Number: NCT06553118
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Central Sensitisation|Postoperative Pain|Arthritis
Interventions: PROCEDURE: Total knee arthroplasty
Sponsor: Istanbul University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-12
Completion Date: 2026-02-12

Summary:
The study is a prospective observational study designed to determine the effects of central sensitization on pain and functional status of patients before and after total knee joint replacement surgery.

The aim of this study is to evaluate whether there is a difference in preoperative and postoperative pain and functional status between patients with and without central sensitization with knee osteoarthritis.

When the literature was reviewed, it was seen that central sensitization was one of the important mechanisms that caused pain in knee osteoarthritis, and it was determined that this had negative consequences in terms of postoperative pain and improvement in functional status. In this study, the effect of central sensitization on the results will be investigated by evaluating pain and functional status before and after knee total joint prosthesis in two groups of knee osteoarthritis patients, with and without central sensitization, and by comparing the groups.

Primary Outcome Measures: Knee pain, Knee pain will be assessed with numerical rating scale, where the patients rate their pain on a scale from 0 to 10 where 0 means no pain and 10 means the most severe pain they can imagine., Preoperative, 1 month postoperative and 3 months postoperative
Secondary Outcome Measures: Functional Status, Functionality of the patients will be assessed with WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index). Responses are typically rated on a scale from 0 (none) to 4 (extreme). Higher scores indicate greater impairment., Preoperative, 1 month postoperative and 3 months postoperative
Diagnosis and Clinical Presentation of Iliac Graft-Enteric Fistula: A Case Report
NCT Number: NCT06553105
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Case-report|Diagnosis|Digestive System Fistula|Gastrointestinal Hemorrhage|Iliac Graft-Enteric Fistula
Interventions: DIAGNOSTIC_TEST: ct scan
Sponsor: Golestan University of Medical sciences
Sex: MALE
Age: ADULT
Enrollment: 1
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-11
Completion Date: 2024-08-13

Summary:
Abstract

Introduction:

Aorto-enteric fistula (AEF) is a life-threatening complication arising from abnormal connections between the gastrointestinal tract and major arteries. One uncommon type, iliac artery-enteric fistula (IEF), can occur following vascular interventions such as arterial stent-graft placement.

Case Presentation:

We report the case of a 47-year-old male presenting with hematemesis and abdominal pain, who was diagnosed with an iliac graft-enteric fistula. Timely recognition and management were crucial for a favorable outcome.

Clinical Discussion:

Diagnosing AEFs remains challenging, requiring a multidisciplinary approach and high clinical suspicion. While computed tomography angiography (CTA) is commonly used for diagnosis, its sensitivity may be limited, emphasizing the importance of integrating clinical history and findings. Management strategies vary based on etiology and patient status, with surgery being pivotal.

Conclusion:

Aorto-enteric fistula, which can arise from a thrombosed graft, presents diagnostic challenges due to its rare formation. In patients with a history of vascular interventions and gastrointestinal bleeding, AEF should be considered. This case underscores the need for heightened awareness among healthcare professionals regarding AEF diagnosis and management to reduce severe morbidity, mortality, and prolonged hospital stays.

Primary Outcome Measures: diagnosis of fistula by ct scan, one day
Turkish Validity and Reliability Study of Hospital for Special Surgery Shoulder Surgery Expectations Survey
NCT Number: NCT06553092
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Shoulder Surgery
Interventions: OTHER: Turkish Version of the Hospital for Special Surgery Shoulder Surgery Expectations Survey
Sponsor: Gazi University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-01
Completion Date: 2025-03-30
Locations: Gazi University Hospital, Ankara, 06500, Turkey

Summary:
This study aims to evaluate the Turkish validity and reliability of the Hospital for Special Surgery Shoulder Surgery Expectations Survey. By translating the original survey into Turkish and administering it to a sample of patients who have undergone shoulder surgery, the research seeks to determine whether the survey maintains its accuracy and consistency in the Turkish context. The study will involve statistical analyses to assess the survey's reliability, internal consistency, and construct validity, ensuring that the tool is culturally appropriate and effective for Turkish-speaking patients.

Primary Outcome Measures: Validity and Reliability of the Turkish Version of the Hospital for Special Surgery Shoulder Surgery Expectations Survey, The primary outcome measure is to evaluate the psychometric properties of the Turkish version of the Hospital for Special Surgery Shoulder Surgery Expectations Survey. This includes assessing the survey's internal consistency, test-retest reliability, content validity, construct validity, and criterion validity in a cohort of Turkish-speaking patients who have undergone shoulder surgery., 6 months
Development of the Surgeon Satisfaction Self-Assessment Questionnaire for Shoulder Arthroscopy
NCT Number: NCT06553079
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Surgeon Satisfaction|Shoulder Arthroscopy
Interventions: OTHER: Surgeon Satisfaction Self-Assessment Questionnaire for Shoulder Arthroscopy
Sponsor: Gazi University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-01
Completion Date: 2025-03-01
Locations: Gazi University Hospital, Ankara, 06500, Turkey

Summary:
This observational study aims to develop and validate the "Surgeon Satisfaction Self-Assessment Questionnaire for Shoulder Arthroscopy." The study involves conducting in-depth interviews with surgeons who perform shoulder arthroscopy to identify key factors influencing their surgical satisfaction, including individual, patient-related, and surgical equipment-related factors. Based on the insights gained from these interviews, a comprehensive questionnaire will be developed. The questionnaire will then undergo validation processes, including assessments of content, construct, criterion, and reliability, to ensure it accurately and consistently measures surgeon satisfaction. The final validated tool is intended to provide a reliable method for surgeons to self-assess their satisfaction with shoulder arthroscopy procedures, contributing to improved surgical practices and outcomes.

Primary Outcome Measures: Validation of the Surgeon Satisfaction Self-Assessment Questionnaire for Shoulder Arthroscopy, The primary outcome measure is the successful development and psychometric validation of the Surgeon Satisfaction Self-Assessment Questionnaire for Shoulder Arthroscopy., 6 months
The Effect of Albumin Value, HALP Score, and LCR Value on Predicting Survival and Recurrence in Patients With Pancreatic Adenocarcinoma
NCT Number: NCT06553040
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Pancreatic Neoplasms|Pancreas Cancer
Sponsor: Ege University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 87
Study Design: Observational Model: |Time Perspective: p
Start Date: 2017-01-01
Completion Date: 2023-01-01

Summary:
The aim of this study is to investigate whether the albumin value and the ratios of biochemical markers; hemoglobin, albumin, lymphocyte and platelet (HALP score) and lymphocyte-C-reactive protein ratio (LCR) can predict the survival and recurrence of the disease in patients with pancreatic adenocarcinoma.

Primary Outcome Measures: Disease-Free Survival Times, 4 Years|HALP Score, Hemoglobin x Albumin x Lymphocyte / Platelet, 4 Years|Overall Survival Time, 4 Years|LCR Score, Lymphocyte / CRP, 4 Years
Clinical Study of Transcriptome-based Diagnostic Biomarker for Acute Febrile Illness
NCT Number: NCT06552975
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Acute Febrile Illness
Interventions: OTHER: Infection
Sponsor: Qilu Hospital of Shandong University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 900
Study Design: Observational Model: |Time Perspective: p
Start Date: 2021-09-01
Completion Date: 2025-08-30
Locations: Qilu Hospital of Shandong University, Jinan, Shandong, 250012, China

Summary:
Acute febrile illness is the main cause of outpatient visits，and bacterial and viral infections remains the most common cause. The diagnosis of infection is still based on symptoms and traditional techniques, resulting in overuse of antibacterial drugs or delay in treatment. The signature of host transcripts has a potential to reveal different modes of host-pathogen interaction and may serve as a biomarker for infection discrimination. Of note, transcriptome-microarray and RNA-seq methods need sophisticated techniques and expertise interpretation, hampering the universal implement of these platforms in low-tier hospitals and under- resourced countries. This study explores transcriptome-based diagnostic biomarker for acute febrile illness , hoping to achieve rapid, accurate and cost-effective distinction between bacterial and viral infection.

Primary Outcome Measures: AUC for distinguishing bacterial infection from viral infection, The AUC of the transcript biomarkers for distinguishing bacterial infection from viral infection reflects the diagnostic accuracy of the transcript biomarkers., Through study completion, an average of 2 years
Secondary Outcome Measures: AUC for distinguishing infectious disease from noninfectious disease, The AUC of the transcript biomarkers for distinguishing infectious disease from noninfectious disease reflects the diagnostic accuracy of the transcript biomarkers., Through study completion, an average of 2 years
A Prospective Cohort of Emergent Laparoscopic Cholecystectomy in PUMCH
NCT Number: NCT06552949
Acronym: ELC-PUMCH
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Acute Cholecystitis
Interventions: PROCEDURE: Emergent laparoscopic cholecystectomy guided by ICG cholangiography (ELC-ICGC)
Sponsor: Peking Union Medical College Hospital
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 750
Study Design: Observational Model: |Time Perspective: p
Start Date: 2020-08-01
Completion Date: 2024-06-01
Locations: Department of General Surgery, Peking Union Medical College Hospital, Peking Union Medical College & Chinese Academy of Medical Sciences, Beijing, Beijing, 100730, China

Summary:
A prospective cohort study comparing the surgical outcome of patients who underwent emergent laparoscopic cholecystectomy guided by indocyanine green cholangiography (ELC-ICGC) versus conventional laparoscopic operation. The patients were recruited in the Peking Union Medical Colleg Hospital emergency department from 1st August 2020 to 1st Feburary 2024. A database was prospectively established to collect related data. The surgical outcomes of ELC-ICGC and conventional ElC will be compared.

Primary Outcome Measures: incidence of intraoperative accidental bile tract injury, The primary outcome is incidence of intraoperative accidental injury involving the bile tract in emergent laparscopic cholecystectomy (ELC) guided by ICG fluorescence. The injury manifests as biliary obstruction, biliary leak, or biliary stricture. Medical records will be reviewed to identify an intraoperative bile tract injury event. Incidence of intraoperative accidental bile tract injury will be collected and comparison between study group (ELC guided by ICG fluorescence) and control group (conventional ELC) will be made, within 1 month|incidence of complications, incidence of complications staging 2 and above according to Clavien Dindo Grade during hospital stay, within 1 month
Secondary Outcome Measures: intraoperative bleeding (volume), Volume of intraoperative bleeding during the operation, Intraoperative|duration of postoperative hospital stay, Days of postoperative hospital stay, within 1 month|total medical expense, Cost during hospital stay, within 1 month|operation time, from cutting the incison to ending the suturing of the incision, Intraoperative
Combination Therapy Effect of Laser on Wound Healing and Bone Regeneration of Dental Sockets
NCT Number: NCT06552936
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Tooth Extraction
Interventions: OTHER: Diode Laser 980 nm.
Sponsor: Sharif Medical Research Center
Collaborators: Universiti Sains Malaysia
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 44
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-08
Completion Date: 2025-08
Locations: Sharif Medical and Dental College, Lahore, Punjab, 54000, Pakistan

Summary:
The goal of this clinical trial is to learn if the laser works to improve wound healing and bone regeneration after tooth extraction. The main question it aims to answer is:

Does laser therapy improve wound healing and bone regeneration after tooth extraction?

Researchers will compare a laser to sham laser therapy to see if the laser enhances wound healing and bone regeneration.

Participants will:

Have exposure to laser or sham laser therapy immediately after tooth extraction Record their pain intensity on days 2, 4, 6 and 14 Visit the clinic after 10 days for follow-up Again, visit the clinic after 4 months for evaluation

Primary Outcome Measures: Wound healing will be assessed in both the experimental and control groups., Wound healing will be assessed using the Landry, Turnbull, and Howley index after 7 days, and a score will be given ranging from 1 to 5, where 1 indicates very poor healing, and 5 indicates excellent healing. (score range: 1-very poor, 2-poor, 3-good, 4-very good, 5-excellent), 1 year|Bone regeneration will be assessed in both the experimental and control groups., A postoperative cone beam computed tomography (CBCT) will be taken immediately after extraction, followed by a CBCT 4 months after extraction. The immediate CBCT will be done to study the density of healthy bone in the apical region of the extracted tooth socket. This value will serve as the baseline for further assessment. The density obtained will then be compared with the bone formed at the end of 4 months in the extraction socket with and without laser therapy. Taking mean readings in the grayscale measurements from the periapical region will allow for the calculation of bone density., 1 year
Secondary Outcome Measures: Pain intensity will be measured in both the experimental and control groups., The Visual Analogue Scale (VAS) will assess pain intensity at post-extraction days 2, 4, 6, and 14. It consists of a 10 cm line with two endpoints representing 0 ('no pain') and 10 ('pain as bad as it could possibly be'). VAS is a system that classifies a score of 1 to 4 (on a 0-10 scale) as mild pain, 5 to 6 as moderate pain, and 7 to 10 as severe pain., 1 year
Extension for Community Health Outcomes (ECHO) Diabetes Program
NCT Number: NCT06552923
Acronym: ECHO
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Type 1 Diabetes|Type 2 Diabetes
Interventions: OTHER: ECHO Tele-Education
Sponsor: University of Florida
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 32796
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2021-06-01
Completion Date: 2023-12-31
Locations: CommuniCare Davis Family Health Center, Davis, California, 95616, United States|St Agnes Medical Center, Fresno, California, 93720, United States|La Clinica, Multiple Locations, California, 94601, United States|Santa Rosa Community Health Centers, Multiple Locations, California, 95403, United States|Shasta Community Health Centers, Multiple Locations, California, 96001, United States|Health Service Alliance, Rancho Cucamonga, California, 91730, United States|Hill Country Community Clinic, Redding, California, 96001, United States|CommuniCare Salud Family Health, West Sacramento, California, 95605, United States|CommuniCare Hansen Family Center, Woodland, California, 95695, United States|Premier Community Health, Dade City, Florida, 33525, United States|Community Health of South Florida (CHI), Homestead, Florida, 33190, United States|Banyan Health Systems, Miami, Florida, 33134, United States|Borinquen Medical Center, Miami, Florida, 33137, United States|Orange Blossom Family Health, Orlando, Florida, 32805, United States|Evara Health System, Pinellas Park, Florida, 33718, United States|Tampa Family Health Center, Tampa, Florida, 33610, United States|Treasure Coast Community Health, Vero Beach, Florida, 32960, United States

Summary:
The Project ECHO model is currently used in 180 countries to address chronic disease care through a provider empowerment, tele-education approach using a "hub" and "spoke" learning model. Few studies have rigorously evaluated the impact of the program on patient outcomes using randomized designs. This study evaluated implementation of an ECHO Diabetes program on patient-level, provider-level, and center-level outcomes in underserved populations receiving diabetes care from primary care providers.

Participants: Twenty Federally Qualified Health Centers (FQHCs) and FQHC "look alikes" across CA and FL were recruited to participate as spokes in the ECHO Diabetes trial. A stepped-wedge trial design was used with randomized, phased-in intervention entry for participating health centers (or "spokes").

Interventions: Spokes were provided access to 6-months of tele-education sessions with continuing medical education credits, access to real-time support for complex medical decision making with hub subspecialty teams, and access to a diabetes support coach.

Main outcomes and Measures: Participating FQHCs ("spokes") provided aggregate data including Healthcare Effectiveness Data and Information Set (HEDIS) reporting on the % of patients with HbA1c \>9%.

Primary Outcome Measures: HbA1c, The percent of patients with HbA1c greater than 9 percent, 6-months
Participatory Research for Suicide Prevention in Autism
NCT Number: NCT06552871
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Autism|Suicide Prevention
Interventions: BEHAVIORAL: Forming Love around Autistic People to Prevent Suicide
Sponsor: University of Utah
Collaborators: National Institute of Mental Health (NIMH)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-08
Completion Date: 2025-03
Locations: University of Utah, Salt Lake City, Utah, 84108, United States

Summary:
The goal of this study is to pilot test a new educational intervention for organization members focused on suicide prevention for autistic people. The main questions it aims to answer are:

* Does participating in the intervention increase participants' knowledge, skills, and actions to support suicide prevention for autistic people?
* What feedback do participants have to help improve the intervention?

Participants will:

* engage in a four-part virtual educational intervention
* answer questions via online survey before, after, and 3-months after the intervention
* participate in an optional interview to provide feedback

Primary Outcome Measures: Steps Toward Prevention (Autism Community Suicide Prevention), Self-report measure of knowledge, skills, and actions to support suicide prevention for autistic people, Pre-intervention, post-intervention (approximately 2 months after baseline), and 3-months after intervention
Secondary Outcome Measures: Qualitative Interview, Optional open-ended feedback interview, Post-intervention (approximately 2 months after baseline)
Fluzoparib Combined With Dalpiciclib for Platinum Resistant Recurrent Ovarian Cancer
NCT Number: NCT06552858
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Ovarian Cancer
Interventions: DRUG: Fluzoparib|DRUG: Dalpiciclib
Sponsor: Fudan University
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2027-01-31
Locations: Fudan university shanghai cancer center, Deparment of gynecologic oncology, Shanghai, Shanghai, 200000, China

Summary:
This study aims to investigate the safety and efficacy of combination therapy of Fluzoparib combined With Dalpiciclib for platinum-resistant recurrent ovarian cancer through a single-center, prospective, single-arm, phase II clinical trial, to improve the overall treatment level and prognosis of platinum-resistant ovarian cancer.

Primary Outcome Measures: PFS, Progression free survival, Two years
Secondary Outcome Measures: OS, Overall Survival, Two years|ORR, Overall Remission Rate, Two years
Consistency of LGE-MRI Fibrosis and EAM Low-voltage Area
NCT Number: NCT06552845
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Atrial Fibrillation
Interventions: DIAGNOSTIC_TEST: LGE-MRI Scan
Sponsor: China National Center for Cardiovascular Diseases
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-04-01
Completion Date: 2025-12-31
Locations: Fuwai Hospital, CAMS&PUMC, Beijing, Beijing, 100037, China

Summary:
This study aims to:

1. Assess the consistency of LGE-MRI bi-atrial fibrosis and electroanatomical mapping of bi-atrial low voltage region
2. To evaluate the electroanatomical characteristics of different types of fibrosis (dense fibrosis, patchy fibrosis, etc.) in different locations of the left and right atrium;
3. To explore the correlation between preoperative and postoperative bi-atrial fibrosis and long-term recurrence in patients with atrial fibrillation.

Primary Outcome Measures: Consistency of LGE-MRI fibrosis and EAM low-voltage area, Use Registration to match the corresponding spatial points of LGE-MRI and EAM。Each spatial points will contain two types of status(Fibrosis: Yes/No, Low-voltage area: Yes/No). Chi-square test will be used to assess the consistency of fibrosis and low-voltage area., Baseline (at recruit time point)
CAVEAT: An Open-Trial Feasibility Study
NCT Number: NCT06552832
Acronym: CAVEAT-OT
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Parent-Child Relations|PTSD|Dissociation
Interventions: OTHER: CAVEAT
Sponsor: University of Lausanne Hospitals
Collaborators: Sandra Rusconi Serpa
Sex: ALL
Age: CHILD, ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-01
Completion Date: 2026-07-31
Locations: Lausanne University Hospital, Child & Adolescent Psychiatry Service, Lausanne, Vaud, 1004, Switzerland

Summary:
This is an open-clinical trial to study the feasibility of a brief manualized psychotherapy for mothers interpersonal violence-related posttraumatic stress disorder (PTSD) and their very young children ages 1-3 years, entitled: Clinician-Assisted Videofeedback Exposure Approach Therapy (CAVEAT). This project, to be conducted with referred mothers and children to an academic medical center ambulatory care setting, intends to pilot along with the manualized intervention, pre- and post-intervention measures for up to 10 dyads over 2 years.

Primary Outcome Measures: Parenting Stress Index- Short Form, Self-report questionnaire, Pre- and Post-Intervention within 6 weeks after last session|Maternal Attributions Rating Scale, Clinician-rated measure, Pre- and Post-Intervention within 6 weeks after last session|Brief Infant-Toddler Social Emotional Assessment, Maternal-report questionnaire, Pre- and Post-Intervention within 6 weeks after last session
Secondary Outcome Measures: Intervention Satisfaction Questionnaire, Maternal and Therapist completed questionnaire, Post-Intervention within 6 weeks after last session
High Intensity Laser Versus Ischemic Compression on Myofascial Trigger Points in the Upper Trapezius
NCT Number: NCT06552780
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Neck Pain
Interventions: DEVICE: TENs , ultrasound therapy
Sponsor: Cairo University
Sex: ALL
Age: ADULT
Enrollment: 63
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-05-19
Completion Date: 2025-02-01
Locations: Faculty of physical therapy, Giza, Egypt

Summary:
TO Investigate the effect of high intensity laser versus ischemic compression on myofascial trigger points on neck pain, cervical range of motion,pressure pain thershold and cervical disability and to show that the more effectivness therapy will provide significant clinical value

Primary Outcome Measures: cervical range of motion (CROM), All the cervical active movements will be measured by cervical range of motion device (CROM) especially in cervical flexion ,extension and medial and lateral rotation.one tester will document the results.

cervical range of motion (cROM) will be measured by using Electronic CROM Goniometer in all ranges., 30 seconds
Secondary Outcome Measures: cervical pain, Cervical pain will be measured by Cervical range of motion device (CROM) .The patient will actively perform cervical movements in flexion ,extension and medial and lateral rotation then one tester will document the results as VAS will be used to measure pain levels .The VAS is a 10_cm line divided into 10 equal sections , with 10 expressing "unbearable pain " and 0 indicating no pain .each patient will be asked to point on this line to their level of neck pain .as pain level decreases ,the patient state improves. Pain will be assessed before and after treatment., one minute
Other Outcome Measures: pressure pain threshold (PPT), Pressure pain threshold (PPT) ,measured by Algometer is defined as the point at which painless stimulation such as pressure turns into a painful sensation,so that we will measure PPT for each patient before and after treatment by one tester as pressure Algometry is a method that objectively describes PPT, 10 seconds
Thrombosis and Inflammation in Vessels Initiative (TIVI)
NCT Number: NCT06552767
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Cardiovascular Diseases|Vascular Diseases
Sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 1000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-10
Completion Date: 2034-01-30
Locations: National Institutes of Health Clinical Center, Bethesda, Maryland, 20892, United States

Summary:
Background:

Diseases related to the immune system, blood clots, and blood vessels can affect every part of the body. These diseases are now known to be interrelated: People who have strokes, blood clots in their legs, or autoimmune disease, for example, are at greater risk of complications in the heart, brain, and other organs. Researchers want to learn more about how these diseases start, how they change over time, and how they affect different organs.

Objective:

To learn more about how inflammation and diseases of the blood vessels start and how they change over time.

Eligibility:

People aged 5 years and older with a disease related to blood clots, the immune system, or blood vessels. Healthy relatives of people with these diseases and unrelated healthy volunteers are also needed.

Design:

Participants will have a baseline visit: They will provide a medical history, physical exam and blood test. All other tests and procedures are optional; these may be spread over more than 1 day:

Tests of heart and lung function.

Fill in a family tree form.

Imaging scans

Treadmill or bike stress tests and a 6-minute walk test.

Tests of blood pressure and the flow of blood through vessels.

Photos of the face and body.

Eye exams, with photos taken of the retina.

Saliva and urine samples.

Biopsies (tissues samples) of the skin and fat.

Tests of thinking and mental function.

Evaluations by other medical specialists.

Participants may opt to return for repeat testing for up to 90 months (7.5 years).

Some visits may be done by telehealth.

Primary Outcome Measures: This is a disease discovery protocol and there are no specific endpoints associated with this protocol., Study End
Cybersickness Prevention and Mitigation in Virtual Reality for Healthy Volunteers
NCT Number: NCT06552754
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Healthy Volunteers|Virtual Reality
Interventions: BEHAVIORAL: Motion Reset|BEHAVIORAL: Placebo
Sponsor: National Human Genome Research Institute (NHGRI)
Sex: ALL
Age: ADULT
Enrollment: 150
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: PREVENTION
Start Date: 2024-09-20
Completion Date: 2025-08-07
Locations: Iowa State University, Ames, Iowa, 50011, United States|National Institutes of Health Clinical Center, Bethesda, Maryland, 20892, United States

Summary:
Background:

People use virtual reality (VR) technology to play games, socialize, work, or receive medical care. Some people have "cybersickness" after using VR. Cybersickness is similar to motion sickness. Symptoms include eye strain, nausea, dizziness, or headache. The symptoms are usually mild and go away after the person stops using VR. New software called Motion Reset is being designed to reduce symptoms of cybersickness during VR use.

Objective:

To see if Motion Reset software can reduce cybersickness in people using VR.

Eligibility:

Healthy adults aged 18 to 60 years.

Design:

Participants will have 1 clinic visit that will last about 1 hour. They will answer questions about how they are feeling. They will learn how to use the VR headset and the handheld game controllers.

The study will be broken into 2 parts. For the first part, participants will be assigned to 1 of 3 groups:

Group 1 will participate in a VR experience designed to prevent cybersickness. They will view screens and move around while they press buttons on a controller.

Group 2 will participate in a VR experience that is not designed to prevent cybersickness. They will view screens and move around while they press buttons on a controller.

Group 3 will have no VR experience.

Participants will complete 2 questionnaires about their experiences in the first part of the study.

For the second part, all participants will spend up to 20 minutes playing a commercial VR game called Jurassic World Aftermath. Every few minutes, they will be asked if they are experiencing discomfort.

After playing the game, participants will complete 12 questionnaires about their experience.

Primary Outcome Measures: self-reported cybersickness, Assessed on numerical scale, during and after VR use
Secondary Outcome Measures: discontinuation of VR use, decision to discontinue VR during active session, during VR use
The Effects of Energy Healing in Fibromyalgia
NCT Number: NCT06552728
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Fibromyalgia
Interventions: OTHER: Energy Healing
Sponsor: University of California, Irvine
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 25
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2025-05

Summary:
This study aims to study the clinical effects of Energy Healing using fMRI and determine its application to Fibromyalgia patients. We also want to find out how active Energy Healing compares to sham Energy Healing in terms of brain connectivity and pain interference scores.

Primary Outcome Measures: Neural connectivity, change in brain connectivity of the insula/salience network (SLN), sensory motor network (SMN), and default mode network (DMN) resulting from energy healing (EH) as compared to sham EH., Pre screening, Baseline, Intervention, 3- and 6-month follow ups Post-treatment
Secondary Outcome Measures: Pain severity, changes in pain severity and interference and their relationships to brain connectivity. We will determine if EH is effective in reducing clinical pain severity and interference as compared to placebo/sham EH and assess changes in their relationships before and after EH/sham EH to changes in brain connectivity., Pre screening, Baseline, Intervention, 3- and 6-month follow ups Post-treatment|Effects of Energy Healing vs sham Energy Healing on brain functional response, As exploratory outcomes, we will also explore the effects of EH vs sham EH on brain functional response to visual stimuli, insular Glx, heart rate variability, mood, sleep, and fatigue symptoms in FM patients., Pre screening, Baseline, Intervention, 3- and 6-month follow ups Post-treatment
Race and Socioeconomic Position: Examining Common Social Pathways to Disease Risk
NCT Number: NCT06552702
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Healthy Aging
Interventions: OTHER: There is no intervention
Sponsor: University of Alabama, Tuscaloosa
Collaborators: University of Alabama at Birmingham
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 32
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-03-28
Completion Date: 2022-12-16
Locations: University of AL Psychology Department, Tuscaloosa, Alabama, 35404, United States

Summary:
Black Americans and those of lower socioeconomic position (SEP) are at higher risk for multiple diseases of aging and shorter lifespans, but the psychophysiological mechanisms that may account for these effects are not clear. The overarching objective of this pilot grant is to improve our understanding of the proximal social exposures and subsequent psychobiological processes that contribute to racial and socioeconomic health disparities. Precisely understanding what these mutable social and psychological mechanisms are is necessary in order to identify intervention targets at the level of the individual.

Primary Outcome Measures: Ambulatory Systolic Blood Pressure, Mean, during four days of ambulatory monitoring|Ambulatory Diastolic Blood Pressure, Mean, during four days of ambulatory monitoring
Sutra Hemi-valve First-in-Human Study
NCT Number: NCT06552689
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Mitral Regurgitation
Interventions: DEVICE: Sutra Hemi-valve Transcatheter Mitral Valve Replacement (TMVR) System
Sponsor: Sutra Medical, Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 15
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10
Completion Date: 2025-10

Summary:
Study to evaluate the feasibility, safety and performance of the Sutra Hemi-valve Transcatheter Mitral Valve Replacement System in patients with moderate-severe and severe symptomatic mitral regurgitation who are at high risk for surgical treatment.

Primary Outcome Measures: Primary Safety Endpoint - The ability of the Sutra Hemi-valve to be placed without Major Device Related Adverse Events through thirty (30) days, including:

* Death (Cardiovascular mortality vs non-cardiovascular);
* Reintervention (operative or transcatheter) due to progressive or recurrent MR or device related complications;
* Disabling stroke;
* Myocardial infarction (MVARC);
* Major access site and vascular complications;
* Fatal or life-threatening bleeding (MVARC Type III-V);
* Renal Failure requiring dialysis;
* Cardiac tamponade., Day 30|Primary Performance Endpoint - Sutra Hemi-valve TMVR System Technical Success, defined as: successful access, delivery, and retrieval of the delivery system; and successful deployment and correct positioning of the implant; and no need for additional emergency surgery or re-intervention related to the investigational device or index procedure., Day 0
Secondary Outcome Measures: Intra-procedure MR severity is reduced by at least 1 grade from baseline per echo (e.g., from severe to moderate)., Day 0|Post-index procedure (discharge or within 7 Days post-index procedure, whichever is earliest) MR severity is reduced by at least 1 grade from baseline per echo (e.g., from severe to moderate)., Day 0 - Day 7|MR severity grade per Echo, Day 30, Month 6, Month 12|Change in NYHA functional class, Day 30, Month 6, Month 12|6 Minute Walk Test distance (6MWT), Day 30, Month 6, Month 12
Other Outcome Measures: Change in LV ejection fraction, Day 30, Month 6, Month 12|Change in LV end diastolic volume index (LVEDVI), Day 30, Month 6, Month 12|Change in LV end systolic volume index (LVESVI), Day 30, Month 6, Month 12|Change in LV stroke volume, Day 30, Month 6, Month 12|Heart failure hospitalizations, Day 30, Month 6, Month 12|Number of days alive and out of hospital, Day 30, Month 6, Month 12
riSk Factors fOR neCk phlEgmon afteR pErcutaneous tRacheostomy in ICU
NCT Number: NCT06552676
Acronym: SORCERER
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Tracheostomy Complication|Quality of Life
Interventions: PROCEDURE: Percutaneous tracheostomy
Sponsor: Azienda Usl di Bologna
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 300
Study Design: Observational Model: |Time Perspective: p
Start Date: 2018-08-09
Completion Date: 2025-01-31
Locations: Maggiore Hospital Carlo Alberto Pizzardi, Bologna, 40024, Italy

Summary:
Primary Purpose: To investigate the incidence and risk factors related to the appearance of tracheal phlegmon in patients undergoing percutaneous tracheostomy.

Participant Population/Primary Condition: Patients admitted to Intensive Care

Main Questions Aims to Answer:

1. - What are the risk factors associated with the development of tracheal phlegmon percutaneous tracheostomy?
2. - How does the appearance of tracheal phlegmon impact intensive care stay, hospital stay, mortality, and Health-related quality of life?

Participants will be followed up after undergoing tracheostomy for 7 days to identify eventual phlegmons.

At the two-year follow-up, the health-related quality of life will be assessed

Primary Outcome Measures: Neck phlegmon, Neck phlegmon in the incisional site, 7 days
Secondary Outcome Measures: Intensive Care Stay, Days of ICU stay, 1 year|Hospital Stay, Days of hospital stay, 1 year|Mortality, 30 days mortality, 30 days|Health related quality of life, 15D instrument, 2 years|Dysphagia, Eating Attitude test - EAT-10 questionnaire, 2 years|Dysphonia, Voice Handicap Index - VHI-10 questionnaire, 2 years|Dyspnoea, Modified Medical Research Council Dyspnea Scale - mMRC-10, 2 years|Cough, Leicester Cough Questionnaire - LCQ, 2 years
The Diagnostic Power Of Coronary CT Angiography In Patients With Chest Pain And Zero Calcium Score
NCT Number: NCT06552663
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: CT - Coronary Thrombosis
Interventions: DEVICE: CCTA
Sponsor: Assiut University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 75
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-01
Completion Date: 2025-12-01

Summary:
To prove the non-used wide diagnostic range of CCTA in diagnosis of other causes of chest pain in addition to the traditional known role in coronary atherosclerosis.

Primary Outcome Measures: Evaluate outcome of coronary CT angiography in cases with chest pain with zero calcium score . Evaluate outcome of coronary CT angiography in cases with chest pain with zero calcium score . Evaluate outcome of coronary CT angiography, Evaluate outcome of coronary CT angiography in cases with chest pain with zero calcium score, two years
The Safety, Tolerability, and Efficacy of KD01 in Cervical Malignancies
NCT Number: NCT06552598
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Cervical Cancer
Interventions: DRUG: KD01(the recombinant oncolytic adenovirus)
Sponsor: Tongji Hospital
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 45
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-04-01
Completion Date: 2028-04-01
Locations: Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, 430030, China

Summary:
The recombinant oncolytic adenovirus injection (KD01) primarily consists of a recombinant human type 5 adenovirus with a deletion in the E3 region, where the ADP gene is replaced by the tBID apoptosis protein gene. This virus exhibits a conditional replication capability, with a 27 base pair deletion in the E1A region corresponding to nucleotides 920-946 of Ad5. This trial is a researcher-initiated clinical study aimed at concurrently evaluating the safety, tolerability, and preliminary efficacy of intratumoral administration of KD01 in patients with cervical malignancies.

Primary Outcome Measures: The incidence rates of Serious Adverse Events (SAEs) and Adverse Events (AEs), 5 years|The Maximum Tolerated Dose (MTD) determined by the incidence rate of Dose-Limiting Toxicity (DLT)., 5 years
Secondary Outcome Measures: Evaluation of Tumor Microenvironment:, Evaluation of the virus's effect on tumor cell destruction and local immune activation; tumor lesion tissue analysis will include: a) H\&E staining; b) Detection of adenovirus-related markers; c) Assessment of PD-L1 expression levels; d) Analysis of immune cells and immune checkpoint markers such as CD3, CD4, CD8, CD56, CD68, and CD20., 5 years|Local Control (LC) Rate:, Measured via imaging methods for target lesions (injection site lesions). Superficial tumor lesions can be measured with calipers, with the longest diameter measured for non-lymph node lesions and the shortest diameter for lymph nodes., 5 years|Overall Response Rate (ORR):, Evaluated through imaging methods for all tumor lesions (superficial tumor lesions can be measured with calipers) to assess the response and determine the Objective Response Rate (ORR). Efficacy will be evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. If applicable, the modified RECIST (mRECIST) may serve as a supplementary standard for efficacy evaluation., 1 years|The biological distribution of KD01, The biological distribution of the drug in the patient's blood, urine, feces, saliva, and injection site., 1 years