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## Concurrent Aerobic Exercise and Cognitive Training to Prevent Alzheimer's in At-risk Older Adults (The Exergames Telerehabilitation Study)
- **NCT ID**: NCT06340659
- **Study ID**: AE and CT
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-07-01
- **Completion Date**: 2027-07-01
- **Lead Sponsor**: University of Minnesota
### Study Description
Significance of Research Question/Purpose: Subjective cognitive decline (SCD) is regarded as the first clinical manifestation in the AD-dementia continuum and currently has a prevalence of 11.2% in adults over the age of 45, with incidence increasing with greater age. Furthermore, population-based studies suggest that between 50% and 80% of older individuals (aged 70 years and older) who perform normally on cognitive tests, report some form of perceived decline in cognitive functioning when asked. The SCD state is unique as this population is more likely than their healthy peers to present with AD biomarkers such as neurodegeneration and amyloid burden, and therefore represents probable preclinical AD relative to other causes of SCD. Likewise, growing evidence suggests that a significant proportion of those adults are subsequently found to develop MCI, or AD, following the classic SCD-MCI-AD trajectory, with SCD increasing MCI risk 1.5-3 fold. Preventing Alzheimer's disease (AD) is arguably the most important approach to address the dementia epidemic worldwide because 99.6% of drug trials failed and no drugs can yet prevent, cure, or even slow AD. A treatment that delays the onset of AD by five years could save $89 billion in 2030.This highlights an urgent and pressing need to develop behavioral interventions to prevent AD and slow its progression.The first purpose is to develop a fully-featured version of the Virtual Reality Cognitive Training (VRCT) aspect of the Exergame that can be installed and updated remotely. We will build on the Phase II Exergame by creating the capability that allows it to be installed and updated remotely to facilitate home-based use, especially by older adults. This also helps address a strong preference from our Phase II participants to minimize interaction with outsiders due to the ongoing COVID-19 pandemic, indicating a home- based solution will greatly facilitate commercialization. The second purpose is to determine the efficacy of the Home-based (Hb)Exergame on cognition and aerobic fitness in older adults at risk for AD using a 2:2 factorial design clinical trial. We will measure the following outcomes quantitatively: a) cognition: fluid cognition (global cognition) as the primary outcome, processing speed and other cognitive domains as secondary outcomes; b) aerobic fitness, c) neuroprotective blood biomarkers.
### Conditions
- AD-dementia
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: FACTORIAL
- **Primary Purpose**: SUPPORTIVE_CARE
### Interventions
- Supervised AEx
- HbAEx
- Supervised Exergame
- HbExergame
### Outcomes
**Primary Outcomes**
- fluid cognition (global cognition)
**Secondary Outcomes**
- Cognitive Function
- Aerobic fitness
- Neuroprotective biomarkers and ApoE status.
- Exergame-specific usability and satisfaction
- Standing balance
- Four-meter walking velocity
- Repeated chair raise
- Quality of Life (QoL)
- SCD Symptoms
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
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## Washington University Participant Engagement and Cancer Genomic Sequencing Center (WU-PE-CGS)
- **NCT ID**: NCT06340646
- **Study ID**: 202106129
- **Status**: RECRUITING
- **Start Date**: 2022-10-18
- **Completion Date**: 2027-01-31
- **Lead Sponsor**: Washington University School of Medicine
### Study Description
The overall goal of the WU-PE-CGS is to build a rigorous, scientific evidence base for approaches that direct engagement of cancer patients and post-treatment cancer survivors as participants in cancer research, and to investigate the impact of directly engaging participants in decisions regarding returning of genomic results on participants' health and satisfaction. Participants in this study will be presented with the choice of types of genomic results to receive, and the Engagement Optimization Unit (EOU) will investigate the impact of this intervention on participant knowledge, expectations of benefit, personal utility, and decisional conflict.
### Conditions
- Cholangiocarcinoma
- Multiple Myeloma
- Colon Cancer
- Rectal Cancer
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: NON_RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: HEALTH_SERVICES_RESEARCH
### Interventions
- Return of Genetic Results: Biomarker information from cancer cells
- Return of Genetic Results: Inherited mutations related to cancer
- Return of Genetic Results: Inherited mutations related to other medical issues
### Outcomes
**Primary Outcomes**
- Participant knowledge of clinical genetic testing
- Participant expectations of benefit
- Participant personal utility
**Secondary Outcomes**
- Participant anxiety
- Participant satisfaction
### Location
- **Facility**: Washington University School of Medicine, Saint Louis, Missouri, 63110, United States
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## SPI-1005 in Adults Receiving Cochlear Implant
- **NCT ID**: NCT06340633
- **Study ID**: SPI-1005-261
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-07
- **Completion Date**: 2025-12
- **Lead Sponsor**: Sound Pharmaceuticals, Incorporated
### Study Description
The goal of this clinical trial is to learn about the effects of drug SPI-1005 in adults receiving a cochlear implant with a long electrode array (FLEX26 or greater) from MED-EL Cochlear Implant Systems into one ear.The main question this clinical trial aims to answer is: Is drug SPI-1005 safe and well-tolerated in adults receiving a cochlear implant, and/or what medical problems might participants experience when taking drug SPI-1005?The clinical trial will also measure the effects of SPI-1005 on hearing, word recognition, speech discrimination, tinnitus, and vertigo outcomes after receiving a cochlear implant. The purpose for this and future clinical trials is to learn whether SPI-1005 can prevent or treat these side effects after receiving a cochlear implant.Participants will take drug SPI-1005 or placebo (a look-alike substance that contains no drug) for 6 months, starting 2 days before receiving the cochlear implant. There are 5 required in-clinic visits over 6 months for audiology and other tests.The effects of SPI-1005 will be compared to the placebo (the look-alike substance that contains no drug) to study what effects SPI-1005 might have.
### Conditions
- Hearing Loss
- Cochlear Trauma
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- Ebselen
- Placebo
### Outcomes
**Primary Outcomes**
- Number of Participants with Treatment Emergent Adverse Events (TEAE)
**Secondary Outcomes**
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
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## EUS Examination Using EndoSound Vision System vs. Standard Echoendoscope
- **NCT ID**: NCT06340620
- **Study ID**: 24.017.01
- **Status**: RECRUITING
- **Start Date**: 2024-03-25
- **Completion Date**: 2027-12
- **Lead Sponsor**: Orlando Health, Inc.
### Study Description
This is a randomized trial to compare the standard echoendoscope with the newly developed EndoSound Visual System in the evaluation of lesions in the gastrointestinal tract.
### Conditions
- Pancreatic Disease
- Pancreatic Cancer
- Pancreatic Cyst
- Gastrointestinal Tumor
- Bile Duct Diseases
- Bile Duct Cancer
- Lymph Node Disease
- Submucosal Tumor of Gastrointestinal Tract
- Gastrointestinal Cancer
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: CROSSOVER
- **Primary Purpose**: DIAGNOSTIC
### Interventions
- Endoscopic ultrasound examination
### Outcomes
**Primary Outcomes**
- Rate of successful completion of the requisite EUS examination
**Secondary Outcomes**
- Ease of maneuverability of the device
- Quality of EUS imaging
- Ease of performing tissue acquisition
- Diagnostic adequacy of procured specimen on onsite evaluation
- Diagnostic adequacy of procured specimen in cell block
- Diagnostic accuracy of procured specimen
- Procedure duration
- Rate of procedure-related adverse events
- Procedure costs
### Location
- **Facility**: Orlando Health, Orlando, Florida, 32806, United States
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## Neohepatic Albumin-Bilirubin Scores on Renal Outcomes in Living-donor Liver Transplantation Recipients
- **NCT ID**: NCT06340607
- **Study ID**: 2023-0561
- **Status**: COMPLETED
- **Start Date**: 2012-01-05
- **Completion Date**: 2022-12-31
- **Lead Sponsor**: Asan Medical Center
### Study Description
This study investigates the association between post-reperfusion (neohepatic) ALBI scores and post-LT renal outcomes in living-donor LT (LDLT) recipients.
### Conditions
- Acute Kidney Injury
- Chronic Kidney Diseases
- Graft Failure
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
### Outcomes
**Primary Outcomes**
- acute kidney injury
**Secondary Outcomes**
- chronic kidney injury
- graft failure
### Location
- **Facility**: Asan Medical Center, Seoul, Song-pa Gu, 05500, Korea, Republic of
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## Single-stage ERCP and Laparoscopic Cholecystectomy for Cholecystocholedocholithiasis: Which to Start With?
- **NCT ID**: NCT06340594
- **Study ID**: RF-2-2024
- **Status**: COMPLETED
- **Start Date**: 2021-01-01
- **Completion Date**: 2024-01-30
- **Lead Sponsor**: Assiut University
### Study Description
Chronic calculous cholecystitis is associated with common bile duct (CBD) stones in approximately 12% of patients. These patients need both cholecystectomy and CBD clearance of stones. The standard for cholecystectomy is laparoscopic cholecystectomy (LC) and the mostly common treatment used for CBD clearance is Endoscopic Retrograde Cholangiopancreatography (ERCP). The two interventions can be combined to be done at the same time under single anesthesia session. Studies of single stage ERCP+LC showed confirmed the safety and efficacy of the combined technique. However, some surgeons start with the ERCP while others start with LC.The aim of this study is to compare the start with ERCP followed by LC to the start with LC followed by ERCP when the two techniques are combined at the same session for treatment of chronic calculous cholecystitis associated with CBD stones regarding efficacy and safety of the two approaches.
### Conditions
- Choledocholithiasis With Cholecystitis
- Biliary Stones
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
- Laproscopic cholecystectomy (LC)
- Endoscopic Retrograde Cholangiopancreatography (ERCP)
### Outcomes
**Primary Outcomes**
- Operative time operative time
**Secondary Outcomes**
- CBD clearance rate
- Length of hospital stay
- Mortality rate
### Location
- **Facility**: Faculty of Medicine-Assiut University -Assiut-Egypt, Assiut, Asyut, 71515, Egypt
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## A Study to Assess the Lung Exposure Bioequivalence of Budesonide, Glycopyrronium, & Formoterol (BGF) Metered Dose Inhaler (MDI) Hydrofluoroolefin (HFO) With a Spacer (Treatment B), BGF MDI Hydrofluoroalkane (HFA) With a Spacer (Treatment A), as Well as BGF MDI HFO Without a Spacer (Treatment C).
- **NCT ID**: NCT06340581
- **Study ID**: D5985C00009
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-06-17
- **Completion Date**: 2024-10-28
- **Lead Sponsor**: AstraZeneca
### Study Description
The purpose of this study is to assess the bioequivalence of the lung exposure of budesonide, glycopyrronium, and formoterol administered as budesonide, glycopyrronium, formoterol (BGF) metered dose inhaler (MDI) hydrofluoroolefin (HFO) with AeroChamber Plus Flow-Vu spacer compared with BGF MDI hydrofluoroalkane (HFA) with AeroChamber Plus Flow Vu spacer And BFG MDI HFO (Spacer vs No Spacer).
### Conditions
- Healthy
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: CROSSOVER
- **Primary Purpose**: TREATMENT
### Interventions
- Treatment A: BGF MDI HFA
- Treatment B: BGF MDI HFO
- Treatment C: BGF MDI HFO
- AeroChamber Plus Flow-Vu Spacer
### Outcomes
**Primary Outcomes**
- Area Under the Plasma Concentration-curve from Zero to the Last Quantifiable Concentration (AUClast) of BGF MDI
- Maximum Observed Concentration (Cmax) of BGF MDI
**Secondary Outcomes**
- Area Under the Plasma Concentration-curve from Zero to the Last Quantifiable Concentration (AUClast)
- Maximum Observed Concentration (Cmax)
- Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUCinf)
- Time to Reach Maximum Observed Concentration (tmax)
- Terminal Rate Constant (λz)
- Half-life Associated with Terminal Slope (λz) of a Semi-logarithmic Concentration-time Curve (t1/2λz)
- Mean Residence Time of the Unchanged Drug in the Systemic Circulation from Zero to Infinity (MRTinf)
- Apparent Total Body Clearance of Drug from Plasma After Extravascular Administration (CL/F)
- Apparent Volume of Distribution at Steady State Following Extravascular Administration (Vz/F)
- Number of Participants with Adverse Events
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
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## A Clinical Study of the Anti-cancer Effects of an Investigational Therapy or Chemotherapy in Patients With Recurring Uterine Cancer
- **NCT ID**: NCT06340568
- **Study ID**: BNT323-01
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-04
- **Completion Date**: 2028-08
- **Lead Sponsor**: BioNTech SE
### Study Description
The goal of this clinical study is to assess the efficacy of BNT323/DB-1303 compared with investigator's choice of chemotherapy in terms of progression-free survival (PFS) by blinded independent central review (BICR) in the endometrial cancer population.
### Conditions
- Endometrial Cancer
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- BNT323/DB-1303
- Doxorubicin
- Paclitaxel
### Outcomes
**Primary Outcomes**
- PFS by BICR in the endometrial cancer population
**Secondary Outcomes**
- Overall survival (OS) in the endometrial cancer population
- PFS assessed by the investigator in the endometrial cancer population
- Objective response rate (ORR) in the endometrial cancer population
- Duration of response (DoR) in the endometrial cancer population
- Number of patients with occurrence of treatment-emergent adverse events (TEAEs)
- Number of patients with occurrence of dose reduction, delay, and discontinuation of study treatments due to TEAEs
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
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## Intervention to Prevent Mental Health Disorders of Women and Their Partners Who Experienced Pregnancy Loss
- **NCT ID**: NCT06340555
- **Study ID**: PIC-156-22
- **Status**: ACTIVE_NOT_RECRUITING
- **Start Date**: 2024-03-01
- **Completion Date**: 2025-07-31
- **Lead Sponsor**: Fundació Sant Joan de Déu
### Study Description
The goal of this clinical trial is to test impact of a multiprofessional intervention in mothers and partners who suffer a pregnancy loss. The main questions it aims to answer are:* impact on mothers and partners mental heatlht status* reasons why mothers do not consent to the interventionParticipants will:* mothers and partners will complete 4 scales* mothers and partners will participate in a interviewResearchers will compare with mothers with standard care to see if the multiprofessional intervention has an impact.
### Conditions
- Stillbirth and Fetal Death
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: NON_RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: PREVENTION
### Interventions
- GUIA ATENCION MULTIDISCIPLINAR SANT BOI
- USUAL CARE
### Outcomes
**Primary Outcomes**
- Intensity of grief
**Secondary Outcomes**
- Depressive symptoms
- Anxiety symptoms
- Perinatal postraumatic stress disorder
### Location
- **Facility**: Parc Sanitari Sant Joan de Deu, Sant Boi De Llobregat, Barcelona, 08830, Spain
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## Comparison of Thoracic Mobility Exercise Versus Manual Release Technique in Minimizing Upper Back Pain
- **NCT ID**: NCT06340542
- **Study ID**: UDhaka
- **Status**: COMPLETED
- **Start Date**: 2023-11-01
- **Completion Date**: 2024-01-31
- **Lead Sponsor**: University of Dhaka
### Study Description
Methodology: study aims to evaluate the effectiveness of thoracic mobility exercise and manual release technique in terms of pain intensity, thoracic mobility, muscle strength and improving disability.Study Design: Study was conducted in Service unit of Department of Physiotherapy at university of peradeniya. Undergraduates who are currently having upper back pain for more than seven days was selected as sample. It is a randomized Controlled trail, Double blinded study. Participants allowed randomly to both groups which are experimental group which will receive thoracic mobility exercises and control group which will receive myofascial release and joint mobilization treatment. Total sample size was 60.
### Conditions
- Upper Back Pain
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- Thoracic Mobility exercises
- Manual Release technique
### Outcomes
**Primary Outcomes**
- Pain Intensity
- Range of Motion
- Muscle strength
- Disability level - self perception
**Secondary Outcomes**
### Location
- **Facility**: Vithursha Sivakumar, Jaffna, Northern, 40001, Sri Lanka
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## Comparison of the Perception of Non-technical Skills
- **NCT ID**: NCT06340529
- **Study ID**: CLS_SIMULATION
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-04-15
- **Completion Date**: 2024-06-30
- **Lead Sponsor**: University of Valencia
### Study Description
Clinical simulation has recently acquired great importance in the health sciences. It is a pedagogical methodology that is increasingly used in health science degrees, since it is very useful for the acquisition of both technical and non-technical skills (leadership, teamwork and effective communication, among others).However, if the investigators focus on physical therapy, the use of clinical simulation is a novel field and therefore requires a great deal of research. Researchers in this field do not yet have the consistency and experience as in other health branches such as medicine or nursing, where the participants have been using high-fidelity simulators for years for the learning of all their students.Clinical simulation allows students to achieve these competencies without the need to practice on real patients. For all these reasons, and because of the situation of need generated in recent years, in which internships in hospitals and clinical centers were completely suppressed, the need for our research is justified.
### Conditions
- Healthy
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: NON_RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: SCREENING
### Interventions
- Clinical Simulation
### Outcomes
**Primary Outcomes**
- Ottawa Scale
**Secondary Outcomes**
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
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## NT-proBNP to Assess Trastuzumab-induced Cardiotoxicity
- **NCT ID**: NCT06340516
- **Study ID**: HER2BNP
- **Status**: RECRUITING
- **Start Date**: 2024-03-14
- **Completion Date**: 2029-03-14
- **Lead Sponsor**: Vastra Gotaland Region
### Study Description
Trastuzumab-induced cardiotoxicity (TIC) will be monitored in patients with HER2+ breast cancer undergoing trastuzumab treatment before and after breast cancer surgery. At baseline before start of trastuzumab treatment, echocardiography (ECHO)/multigated Acquisition Scan (MUGA) and measurement of plasma NT-proBNP will be performed. NT-proBNP will be measured again at 6 months and at 12 months of trastuzumab treatment. If elevations in NT-proBNP at 6 months and 12 months occur patients will be referred for ECHO/MUGA. The aim is to assess the sensitivity and specificity to detect TIC with NT-proBNP and whether ECHO/MUGA can be safely replaced by assessment of plasma NT-proBNP levels.
### Conditions
- Cardiotoxicity
- Breast Cancer
- Treatment Side Effects
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: NA
- **Intervention Model**: SINGLE_GROUP
- **Primary Purpose**: DIAGNOSTIC
### Interventions
- Plasma NT-proBNP
### Outcomes
**Primary Outcomes**
- Sensitivity and specificity of NT-proBNP to detect trastuzumab-induced cardiotoxicity
**Secondary Outcomes**
- Prevalence of trastuzumab-induced cardiotoxicity
- Anthracycline-induced change in NT-proBNP
### Location
- **Facility**: Jubileumskliniken, Sahlgrenska University Hospital, Gothenburg, N/A, 432 45, Sweden
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## Evaluating a Physical Activity Index for Assessment and Counseling for Breast and Colon Cancer Survivors
- **NCT ID**: NCT06340503
- **Study ID**: IRB00111331
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-07
- **Completion Date**: 2025-08
- **Lead Sponsor**: Wake Forest University Health Sciences
### Study Description
The purpose of this research study is to determine whether using the physical activity index screener, exercise coaching, and self-monitoring will increase physical activity and reduce time spent sitting or being inactive in patients who had breast or colon cancer.
### Conditions
- Breast Cancer
- Colon Cancer
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: OTHER
### Interventions
- Research-grade accelerometer
- National Comprehensive Cancer Network (NCCN) Education Materials
- Garmin Vivofit activity tracker
- Exercise Consultation Calls
- Interview
- Physical Activity Index Assessment (Intervention Arm)
- Physical Activity Index Assessment (Control Arm)
- Health Surveys
### Outcomes
**Primary Outcomes**
- Number of Eligible Participants - Participation Rate
- Percentage of Participants to Complete Exercise Sessions - Adherence
- Number of Participants Who Complete Study Questionnaires - Retention
**Secondary Outcomes**
### Location
- **Facility**: Atrium Health Wake Forest Baptist Comprehensive Cancer Center, Winston-Salem, North Carolina, 27157, United States
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## A Study of RJMty19 in Refractory Systemic Lupus Erythematosus (SLE)
- **NCT ID**: NCT06340490
- **Study ID**: RJMty19-AID002
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-05-15
- **Completion Date**: 2027-12-31
- **Lead Sponsor**: Guangdong Ruishun Biotech Co., Ltd
### Study Description
This study is an open-label, single-arm, dose escalation and dose expansion study to evaluate the safety, maximum tolerated dose, pharmacokinetic characteristics of allogeneic CD19-CAR-DNT cells (RJMty19) after infusion, and preliminary efficacy in systemic lupus erythematosus (SLE) subjects.
### Conditions
- Systemic Lupus Erythematosus
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: NA
- **Intervention Model**: SINGLE_GROUP
- **Primary Purpose**: TREATMENT
### Interventions
- RJMty19 (CD19-CAR-DNT cells)
### Outcomes
**Primary Outcomes**
- Dose-Limiting Toxicity (DLT)
- Maximum Tolerated Dose (MTD)
- Incidence of abnormalities
**Secondary Outcomes**
- Pharmacokinetics (PK) indicator (Cmax)
- Pharmacokinetics (PK) indicator (AUC)
- Pharmacokinetics (PK) indicator (CAR copy numbers)
- Remission rate of SLE based on DORIS criteria
- Remission rate of SLE based on LLDAS criteria
### Location
- **Facility**: Peking University People's Hospital, Beijing, Beijing, 100044, China
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## Effect of Thoracic SNAGS on Vitals Among Individuals With Forward Head Posture
- **NCT ID**: NCT06340477
- **Study ID**: Mahnoor Arif/ REC -01802
- **Status**: RECRUITING
- **Start Date**: 2024-03-01
- **Completion Date**: 2024-07
- **Lead Sponsor**: Riphah International University
### Study Description
To determine how vitals (heart rate, blood pressure, respiratory rate, oxygen saturation) and craniovertebral angle will be affected by thoracic SNAGs in individuals with forward head posture.
### Conditions
- Neck Pain
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- Thoracic SNAGs with conventional therapy
- conventional therapy
### Outcomes
**Primary Outcomes**
- Aneroid sphygmomanometer
- Pulse oximeter
- Respiratory rate
**Secondary Outcomes**
- NPRS (Numeric Pain Rating Scale)
- Inclinometer
- Photogrammetric method for craniovertebral angle
### Location
- **Facility**: Pakistan Railway Hospital, Rawalpindi, Punjab, 46000, Pakistan
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## Preoperative Nutritional Status Scores to Predict PPC in Elderly With Cardiac Surgery
- **NCT ID**: NCT06340464
- **Study ID**: REC.67-018-8-1
- **Status**: RECRUITING
- **Start Date**: 2024-03-21
- **Completion Date**: 2026-11-30
- **Lead Sponsor**: Prince of Songkla University
### Study Description
This prospective study investigate prognostic values and compare the role of nutritional status by using GNRI, MNA, and PNI in predicting post-operative pulmonary complication among elderly patients with cardiac surgery.
### Conditions
- Cardiac Surgery
- Elderly Patient
- Postoperative Pulmonary Complication
- Nutrition Scoring System
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
- GNRI, PNI, MNA
### Outcomes
**Primary Outcomes**
- Postoperative pulmonary complication
**Secondary Outcomes**
### Location
- **Facility**: Department of Anesthesiology, Faculty of Medicine, Prince of Songkla University, Hat Yai, Songkhla, 90110, Thailand
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## Study to Assess the Efficacy and Safety of Iovera®° System in Subjects With Upper Extremity Spasticity
- **NCT ID**: NCT06340451
- **Study ID**: IOV-301
- **Status**: RECRUITING
- **Start Date**: 2024-04-16
- **Completion Date**: 2025-04
- **Lead Sponsor**: Pacira Pharmaceuticals, Inc
### Study Description
This multicenter, randomized, double-blind, sham-controlled study is designed to evaluate the efficacy and safety of the iovera° system in subjects with upper extremity spasticity. A total of approximately 132 subjects will be enrolled; 88 subjects will receive treatment with the iovera° system and 44 subjects will receive sham treatment (sham iovera° system treatment).
### Conditions
- Spasticity, Cerebral or Spinal Condition
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- iovera° system
- sham iovera° system treatment
### Outcomes
**Primary Outcomes**
- Change from baseline in the Modified Ashworth Scale score for elbow measured (0 to 4, where lower scores represent normal muscle tone and higher scores represent spasticity)
**Secondary Outcomes**
- Change from baseline in the Modified Ashworth Scale) score for shoulder (shoulder abduction) measured
- Change from baseline in the Modified Tardieu Scales for elbow (0 to 5, where lower score represents no resistance, and higher score represents joint immobility; Increase in angle from baseline [R1, and R2] represents improvement)
- Change from baseline in the Modified Tardieu Scales for shoulder (shoulder abduction)
- Change from baseline in Goal Attainment Scale score evaluated by the blinded, trained, licensed medical staff (-2 to +2, where lower score represents less expected outcomes, and higher scores represent greater expected outcomes)
### Location
- **Facility**: Shepherd Center, Atlanta, Georgia, 30309, United States
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## Investigate the Relationship Between Catastrophizing and the Perception of Itch Intensity in Healthy Individuals
- **NCT ID**: NCT06340438
- **Study ID**: N-20240004 3rd subproject
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-04-27
- **Completion Date**: 2026-12-31
- **Lead Sponsor**: Aalborg University
### Study Description
This project aims to investigate the relationship between different dimensions of catastrophizing (rumination, magnification, and helplessness) as well as some specific personality traits related to catastrophizing tendencies like anxiety sensitivity and fear sensitivity in the modulation of itch and pain intensities in an experimental setting.
### Conditions
- Histamine
- Cowhage
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: CROSSOVER
- **Primary Purpose**: BASIC_SCIENCE
### Interventions
- Histamine
- Cowhage
### Outcomes
**Primary Outcomes**
- Reinforcement Sensitivity Theory - Personality Questionnaire (RST-PQ).
- The Pittsburg Sleep Quality Index (PSQI)
- Depression, Anxiety, Stress Scale (DASS-21)
- Positive And Negative Affect Schedule (PANAS)
- Pain Catastrophizing Scale (PCS).
- Itch Catastrophizing Scale (ICS).
- Learned Helplessness Scale (LHS)
- Positive And Negative Affect Schedule (PANAS)
- Depression, Anxiety, Stress Scale (DASS-21)
- Positive And Negative Affect Schedule (PANAS)
- Pain Catastrophizing Scale (PCS).
- Itch Catastrophizing Scale (ICS).
- Learned Helplessness Scale (LHS)
- Positive And Negative Affect Schedule (PANAS)
**Secondary Outcomes**
- Assessment of itch
- Assessment of pain
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
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## The Effect of Selective Dorsal Rhizotomy on a Multidimensional Outcome Set in Children With Spastic Cerebral Palsy: a Retrospective Study
- **NCT ID**: NCT06340425
- **Study ID**: s68727
- **Status**: COMPLETED
- **Start Date**: 2018-06-26
- **Completion Date**: 2023-12-31
- **Lead Sponsor**: Universitaire Ziekenhuizen KU Leuven
### Study Description
Cerebral palsy or CP is the single largest cause of childhood physical disability, with a prevalence of 2-3 per 1000 livebirths. Children with CP experience different primary symptoms, including abnormal increased muscle tone or spasticity. Selective dorsal rhizotomy (SDR) is applied in children with spastic CP as a non-reversible tone reduction procedure. Better understanding of the effects of SDR on a multidimensional outcome set in one CP-cohort and on macroscopic muscle morphology can improve insights and clinical decision making.
### Conditions
- Cerebral Palsy
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
### Outcomes
**Primary Outcomes**
- Overall changes in spasticity
- Overall change in muscle volume of the medial gastrocnemius
- Overall changes in muscle length of the medial gastrocnemius
- Overall changes in muscle cross-sectional area at 50% of muscle belly length
- Overall changes in gait
- Overall change in gross-motor function
**Secondary Outcomes**
- Overall change of spasticity in the plantar flexors
- Overall change of selectivity in the plantar flexors
- Overall change of passive range of motion in the ankle and knee joint
- Overall change of muscle strength in the plantar flexors
- Scatter plots of muscle morphology data (same parameters as for the primary endpoints)
### Location
- **Facility**: UZ Leuven, Leuven, Vlaams-Brabant, 3000, Belgium
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## Effects of Intact and Disrupted Milk Fat Globule Membrane on Postprandial Metabolic Response to High-fat Dairy in Healthy Individuals
- **NCT ID**: NCT06340412
- **Study ID**: MFGM-FOR-HEALTH
- **Status**: RECRUITING
- **Start Date**: 2024-03-11
- **Completion Date**: 2024-10-01
- **Lead Sponsor**: University of Aarhus
### Study Description
The aim of the study is to investigate the effects of milk fat globule membrane (MFGM) content and intactness on postprandial metabolic response to a high-fat meal in humans.The investigators hypothesize that MFGM content and intactness alters the postprandial lipid profile and substrate metabolism in healthy individuals after consumption of a high-fat meal.
### Conditions
- Postprandial Lipid Metabolism
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: CROSSOVER
- **Primary Purpose**: BASIC_SCIENCE
### Interventions
- Sandwich with butter-like dairy product (40g milk fat) with intact MFGM. One sandwich for breakfast and one sandwich for lunch.
- Sandwich with butter-like dairy product (40g milk fat) with disrupted MFGM. One sandwich for breakfast and one sandwich for lunch.
- Sandwich with butter-like dairy product (40g milk fat) without MFGM. One sandwich for breakfast and one sandwich for lunch.
### Outcomes
**Primary Outcomes**
- Difference in postprandial triglycerides measured as area under the curve (AUC).
**Secondary Outcomes**
- Difference in concentration of GLP-1
- Difference in concentration of Ghrelin
- Difference in concentration of LEAP2
- Difference in concentration of FFA
- Difference in concentration of Insulin
- Difference in concentration of glucagon
- Difference in concentration of cholesterol (total, LDL and HDL)
- Difference in concentration of GIP
- Difference in concentration of CCK
- Difference in concentration concentration of Gastrin
- Difference in concentration concentration of GDF15
- Difference in concentration of LPS-BP (Lipopolysaccharide Binding Protein)
- Difference in concentration concentration of Cytokines
- Difference in concentration of apoB48
- Difference in concentration of apoB100
- Difference in glucose concentration
- Difference in appetite sensation
- Difference in gastric emptying rate
- Ad libitum meal test
- Metabolic rate
- Substrate metabolism
### Location
- **Facility**: Steno Diabetes Center Aarhus, Aarhus University Hospital, Aarhus, N/A, 8200, Denmark
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## BCAA in Patients Undergoing Gastric Cancer Surgery
- **NCT ID**: NCT06340399
- **Study ID**: 202312117RINE
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-03-28
- **Completion Date**: 2030-12-31
- **Lead Sponsor**: National Taiwan University Hospital
### Study Description
Older patients undergoing gastric cancer resection, at higher risk due to insufficient preoperative muscle mass, are more susceptible to SRML under surgical stress. This not only affects limb muscles but also impacts swallowing muscles, contributing to increased postoperative complications and mortality rates. Enhanced Recovery After Surgery (ERAS) has emerged as a multidisciplinary approach to facilitate postoperative recovery. This study aims to optimize oral nutrition under the ERAS model to observe its impact on SRML. BCAA is essential for skeletal muscles. However, there is limited research on the oral BCAA, whether before or after surgery, concerning SRML and its associated complications. The study entails an 18-month randomized controlled trial with 200 participants. One hundred individuals will take BCAA daily 5 to 14 days before surgery. After surgery, they can progress to a clear liquid diet around postoperative day five while continuing BCAA until 30 days postoperatively. The other one hundred participants will not receive BCAA. The study aims to investigate whether oral BCAA can reduce SRML, muscle loss, and decrease swallowing muscle strength, with observations on postoperative complications and outcomes within one year.
### Conditions
- Perioeprative Muscle Loss
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- BCAA
- patient not administered BCAA
### Outcomes
**Primary Outcomes**
- the occurrence of surgical related muscle loss
**Secondary Outcomes**
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
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## Italian Validation of a Tool for Assessing Sexual Function After Breast Cancer, FSFI-BC
- **NCT ID**: NCT06340386
- **Study ID**: IEO 1365
- **Status**: RECRUITING
- **Start Date**: 2020-10-19
- **Completion Date**: 2024-12-31
- **Lead Sponsor**: European Institute of Oncology
### Study Description
This is a validation study of the italian language for the Female Sexual Function Index-Breast Cancer questionnaire.The validation of the instrument in Italian will allow the identification of possible issues related to sexual health and enable the provision of adequate medical and psychosexual counseling to these patients, both in clinical practice and in research studies.
### Conditions
- Breast Cancer
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
### Outcomes
**Primary Outcomes**
- Validation of the italian translation of Female Sexual Function Index-Breast Cancer questionnaire
**Secondary Outcomes**
### Location
- **Facility**: European Institute of Oncology, Milan, N/A, N/A, Italy
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## Clinical and Angiographic Outcomes of Post-drug-coated Balloon Angioplasty in Native Coronary Lesions
- **NCT ID**: NCT06340373
- **Study ID**: NICVD/ 2023/ 32
- **Status**: RECRUITING
- **Start Date**: 2024-01-01
- **Completion Date**: 2025-06-30
- **Lead Sponsor**: National Institute of Cardiovascular Diseases, Bangladesh
### Study Description
The progression of cardiac revascularization techniques, starting with standard balloon angioplasty (POBA) and progressing to the creation of drug-coated balloons (DCB) and drug-eluting stents (DES). The study's justification is presented, with a focus on the significance of comprehending the clinical and angiographic outcomes of DCB angioplasty, especially when considering the Bangladeshi population.This study's main goal is to observe the clinical and angiographic outcomes of drug-coated balloon angioplasty after native coronary lesions that have been successfully revascularized. A few specific goals are to evaluate angiographic results (like percentage diameter stenosis, vascular remodelling, restenosis, and thrombosis) after DCB angioplasty and to assess clinical outcomes (like worsening angina, target vessel MI, ischemia-driven TLR, and cardiac mortality).This observational study will take place from January to December 2024 at the Department of Cardiology, National Institute of Cardiovascular Diseases. The study population will be individuals who had successful revascularization of native coronary lesions with DCB angioplasty six months before. The study includes non-randomized purposive sampling, and the sample size will be determined by drawing on previous studies.Every patient will receive a thorough clinical assessment that includes a history, physical examination, electrocardiogram, and biochemical testing. The data will be analysed in accordance with the assessment of angiographic outcomes by follow-up angiography.The purpose of this study is to give useful insights into the clinical and angiographic results of DCB angioplasty in Bangladeshi patients with native coronary lesions, including the growing body of knowledge on the efficacy and safety of this therapeutic strategy in specific populations.
### Conditions
- Coronary Artery Disease
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
- DCB Angioplasty
### Outcomes
**Primary Outcomes**
- CCS (Canadian Cardiovascular Society) Class of Worsening angina of each participant
- Number of participants with target vessel Myocardial infarction
- Ischemia-driven Target lesion revascularization (TLR) each participant
- Occurrence of Cardiac death in the participants
- Site of the lesion
- Lesion Length
- % of Stenosis
- Thrombolysis in Myocardial Infarction (TIMI) Flow
- Pre dilatation - Balloon Type
**Secondary Outcomes**
### Location
- **Facility**: National Institute of CardioVascular Diseases, Dhaka, N/A, 1207, Bangladesh
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## A Phase 2b Study to Evaluate Rezpegaldesleukin (Rezpeg) in the Treatment of Severe to Very Severe Alopecia Areata in Adult Patients (Rezolve AA)
- **NCT ID**: NCT06340360
- **Study ID**: 23-358-06
- **Status**: RECRUITING
- **Start Date**: 2024-03-27
- **Completion Date**: 2026-02
- **Lead Sponsor**: Nektar Therapeutics
### Study Description
This is an interventional, randomized, double blind, parallel group, placebo-controlled, Phase 2b, 3-arm study to assess the effect of pegylated-recombinant-human interleukin-2 (rezpegaldesleukin) in adult participants with severe to very severe alopecia areata.The estimated duration includes a screening period of up to 35 days, a 36-week treatment period, and a 24-week follow-up period. The maximum study duration is approximately 65 weeks for all participants.
### Conditions
- Alopecia Areata
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- Rezpegaldesleukin
- Placebo
### Outcomes
**Primary Outcomes**
- Percent change from baseline in Severity of Alopecia Tool (SALT) score at Week 36
**Secondary Outcomes**
- Percent change from baseline in SALT score
- Proportion of patients achieving improvement in Severity of Alopecia Tool (SALT) ≥ 50%/75%/90%
- Proportion of patients achieving an absolute SALT score ≤ 10/20/30
### Location
- **Facility**: Austin Institute for Clinical Research, Pflugerville, Texas, 786660, United States
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## A Study to Learn How the Body Processes the Study Medicine Called Osivelotor (PF-07940367) in People With Loss of Liver Function
- **NCT ID**: NCT06340347
- **Study ID**: C5351010
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-04-24
- **Completion Date**: 2026-02-05
- **Lead Sponsor**: Pfizer
### Study Description
The purpose of this study is to understand how Osivelotor is processed in people with loss of liver function.This study is seeking participants that are:* stable loss of liver function with mild or moderate severity* none of underlying conditions possibly affecting the study medicine being absorbed by the bodyAll participants will receive one amount of Osivelotor by mouth before breakfast on the first day at the study clinic. A number of blood samples will be collected to understand how Osivelotor is changed and removed from the body. Participants will also have to undergo physical examination and other tests. This will help to understand if Osivelotor is safe.Participants will take part in the study for a maximum of 112 days. During this time, participants will have to stay onsite for 5 days. There will be 5 study visits at the study clinic.
### Conditions
- Liver Diseases
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: NON_RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: BASIC_SCIENCE
### Interventions
- Osivelotor
### Outcomes
**Primary Outcomes**
- Area under the whole blood and plasma concentration versus time curve (AUC) from time zero (pre-dose) to the last quantifiable concentration (AUClast) of osivelotor
- Area under the whole blood and plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (AUCinf) of osivelotor
- Maximum observed whole blood and plasma concentration (Cmax) of osivelotor
**Secondary Outcomes**
- Number of Participants With Treatment-Emergent Adverse Events (AEs)
- Number of Participants With Clinically Significant Laboratory Abnormalities
- Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings
- Number of Participants With Clinically Significant With Clinically Significant Vital Signs
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
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## Efficacy and Safety of Tegoprazan Dual Therapy and Furazolidone-based Bismuth Quadruple Therapy for Helicobacter Pylori Eradication: A Prospective, Multicenter, Open-label, Randomized Controlled Clinical Study
- **NCT ID**: NCT06340334
- **Study ID**: KY20240123-05
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-03
- **Completion Date**: 2024-12-31
- **Lead Sponsor**: Nanjing First Hospital, Nanjing Medical University
### Study Description
To compare the efficacy and safety of Tegoprazan-amoxicillin dual therapy and bismuth quadruple therapy based on furazolidone in the treatment of Helicobacter pylori eradication, the eradication rate, patient compliance, and adverse drug reactions of H. pylori infection were compared in a multi-center clinical joint study in Jiangsu Province.
### Conditions
- Helicobacter Pylori Infection
- Tegoprazan
- Furazolidone
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- Tegoprazan-amoxicillin dual therapy
### Outcomes
**Primary Outcomes**
- Helicobacter pylori eradication rate
**Secondary Outcomes**
- Security observations
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
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## Impact of Metabolic Flexibility on Changes in Metabolic Health
- **NCT ID**: NCT06340321
- **Study ID**: PBRC 2023-081
- **Status**: ENROLLING_BY_INVITATION
- **Start Date**: 2024-06
- **Completion Date**: 2025-01
- **Lead Sponsor**: Pennington Biomedical Research Center
### Study Description
Metabolic flexibility is the capacity to adapt fuel oxidation to fuel availability so that ATP synthesis can match its cellular demands. Thus, for example, increases in glucose availability after a meal would increase glucose oxidation, while increases in lipid availability during fasting would increase lipid oxidation. Enhanced metabolic flexibility has been proposed to protect humans from metabolic diseases. Nevertheless, most studies examining associations between metabolic flexibility and metabolic health outcomes have used cross-sectional designs. Whether impaired metabolic flexibility causes or results from metabolic health impairment is thus unclear.In this study, the investigators will use the data from a study conducted approximately 16 years ago in healthy participants without obesity. Using the data already collected in that study, the metabolic flexibility of each participant will be calculated. To test the association between metabolic flexibility and the change in metabolic health, the investigators will call back all the participants for a single follow-up visit to reassess several metabolic health outcomes. Thus, the main aim of the study is to test the association between metabolic flexibility and the change in metabolic health outcomes after 16 years in humans.
### Conditions
- Obesity
- Metabolic Syndrome
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
- Metabolic flexibility in the fasted state
- Metabolic flexibility in euglycemic-hyperinsulinemic clamp
- Metabolic flexibility in the metabolic chamber
### Outcomes
**Primary Outcomes**
- Glucose
- Total cholesterol
- HDL cholesterol
- LDL cholesterol
- Triglycerides
- HOMA-IR
- Blood pressure
- Waist circumference
- Body mass index
- Body fat percentage
**Secondary Outcomes**
### Location
- **Facility**: Pennington Biomedical Research Center, Baton Rouge, Louisiana, 70808, United States
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## Clinical Study With Berberine-based Food Supplement, Artichoke Extract, Phytosterols, Fenugreek and SelectSIEVE® OptiChol
- **NCT ID**: NCT06340308
- **Study ID**: PARAF 986117570
- **Status**: RECRUITING
- **Start Date**: 2023-06-07
- **Completion Date**: 2024-05
- **Lead Sponsor**: University of Pavia
### Study Description
To evaluate the effects of a nutraceutical containing Berberine-based Food Supplement, Artichoke Extract, Phytosterols, Fenugreek and SelectSIEVE® OptiChol on lipid profile
### Conditions
- Dyslipidemias
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- Berberine-based Food Supplement, Artichoke Extract, Phytosterols, Fenugreek and SelectSIEVE® OptiChol
- Berberine-based Food Supplement, Artichoke Extract, Phytosterols, Fenugreek and SelectSIEVE® OptiChol
### Outcomes
**Primary Outcomes**
- Variations of lipid profile
**Secondary Outcomes**
### Location
- **Facility**: IRCCS Policlinico S. Matteo Foundation, Pavia, N/A, 27100, Italy
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## A Multicenter, Prospective Cohort Study of Preserved Ratio Impaired Spirometry(PRISm) in a Population
- **NCT ID**: NCT06340295
- **Study ID**: 2023313
- **Status**: RECRUITING
- **Start Date**: 2023-09-01
- **Completion Date**: 2026-05-31
- **Lead Sponsor**: Peking University First Hospital
### Study Description
Chronic obstructive pulmonary disease (COPD) is the most common chronic tract disease and the third leading cause of death worldwide. The treatment effect of COPD is poor, and the disease is progressive, resulting in a serious disease burden. The key reason is that early recognition is difficult and the early pathophysiological mechanism is unclear, which leads to the difficulty of early intervention.PRISm is likely to be the precursor stage of COPD, which may provide an important research object for the study of pathophysiological characteristics, inflammation and immunomodulatory mechanisms of early COPD, and may also become a new entry point for early intervention of COPD. This study attempts to establish a PRISm prospective cohort，and collects blood, EBC and urine for analysis of inflammatory factors, metabolomics, proteomics and microbiome, and performs chest HRCT to obtain imaging indicators, and conducts 3-year dynamic follow-up observation to study the evolution characteristics of pulmonary function and the incidence of COPD in the PRISm cohort. To compare the differences in imaging, inflammatory factors, metabolomics, proteomics and microbiome among the three PRISm groups, and establish a risk prediction model for progression to COPD through PRISm. It lays a foundation for understanding the characteristics of COPD at an earlier stage and exploring new early warning indicators.
### Conditions
- COPD
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
- N/A
### Outcomes
**Primary Outcomes**
- The number and proportion of newly diagnosed COPD
**Secondary Outcomes**
- The number and proportion of continuous PRISm population
- The number and proportion of PRISm to normal population
- Emerging diseases
- Death and cause of death
### Location
- **Facility**: Peking University First Hospital, Beijing, Beijing, 100034, China
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## Immersive Virtual Reality and Physical Exercise on Cognitive and Functional Performance in Hospitalized Older Patients
- **NCT ID**: NCT06340282
- **Study ID**: MOTOMED
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-04-01
- **Completion Date**: 2025-04-01
- **Lead Sponsor**: Fundacion Miguel Servet
### Study Description
This study will be conducted in a hospital in Spain to investigate how a special intervention using immersive virtual reality technology can benefit hospitalized older adults with difficulties in their daily functionality.The main objective of this study is to evaluate whether a cognitive stimulation intervention through immersive virtual reality, along with specific physical exercises, can improve the cognitive and physical function of hospitalized older patients. It is expected that this innovative intervention will have a positive impact on the quality of life of these patients.Participants eligible for the study must be over 75 years old, have severe functional dependency upon hospital admission, and be willing to participate. Those with severe dementia or other terminal illnesses will be excluded.Participants will be randomly assigned to one of four study groups: a control group without intervention and three intervention groups, including viewing Spanish landscapes through virtual reality, performing specific physical exercises, or a combination of both interventions.At the end of the study, various aspects such as cognitive and physical function, mood, quality of life, muscle strength, and acceptance of virtual reality technology by patients will be evaluated.This study aims to provide new insights into the care of hospitalized older adults and explore innovative ways to improve their well-being during their hospital stay
### Conditions
- Disability Physical
- Cognition
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: PREVENTION
### Interventions
- Virtual reality
- multicomponent exercise
### Outcomes
**Primary Outcomes**
- Mini-Mental State Examination (MMSE)
**Secondary Outcomes**
- Isometric handgrip strength
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
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## Feasibility Pilot Study to Evaluate the Safety and Performance of the MEX-CD1 Medical Device in ACLF
- **NCT ID**: NCT06340269
- **Study ID**: PJ2308-0025
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-04
- **Completion Date**: 2025-03
- **Lead Sponsor**: Mexbrain
### Study Description
The goal of this clinical trial is to test the MEX-CD1 hemodialysis medical device in patients suffering from ACLF. The main questions it aims to answer are:* Is the device safe when used according to the instructions for use?* Does the device work as expected by removing the excess of free copper from the blood?Patients will receive 3 MEX-CD1 Slow Low volume CVVHD within 1 week.
### Conditions
- Acute on Chronic Liver Failure
- Multiple Organ Failure
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: NA
- **Intervention Model**: SINGLE_GROUP
- **Primary Purpose**: TREATMENT
### Interventions
- MEX-CD1 Dialysis
### Outcomes
**Primary Outcomes**
- SADE for Safety purpose
**Secondary Outcomes**
- SAE for Safety purpose
- Performance of MEX-CD1
- Change in Acute on Chronic Liver Failure (ACLF) Grade
- Change in CLIF-C ACLF score
- Improvement in individual organ function
- Development of secondary infection
- Status of ICU
- hospital discharge
- Mortality
### Location
- **Facility**: Hôpital Croix Rousse, Service d'hépatologie et gastroentérologie, Lyon, Rhône-Alpes, 69317, France
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## Continuous Spinal Anesthesia Versus Epidural Anesthesia in Geriatric
- **NCT ID**: NCT06340256
- **Study ID**: IRB0000871253
- **Status**: COMPLETED
- **Start Date**: 2021-09-18
- **Completion Date**: 2023-08-15
- **Lead Sponsor**: Assiut University
### Study Description
60 patients aged older than 60 years, American Society of Anesthesiologists (ASA) class II or III and scheduled for major hip surgery will be randomized, in to two groups anesthetized using continuous spinal anesthesia or using continuous epidural anesthesia.
### Conditions
- Epidural Catheter
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: HEALTH_SERVICES_RESEARCH
### Interventions
- Continuous spinal anesthesia
- Continuous epidural anesthesia
### Outcomes
**Primary Outcomes**
- Hemodynamic changes
**Secondary Outcomes**
- Patient satisfaction
### Location
- **Facility**: Al-Azhar Faculty of Medicine, Assiut, N/A, N/A, Egypt
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## Risk Adapted Therapy of Hodgkin Lymphoma in Upper Egypt
- **NCT ID**: NCT06340243
- **Study ID**: HODGKIN
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-04-01
- **Completion Date**: 2026-04-01
- **Lead Sponsor**: Assiut University
### Study Description
determine if radiotherapy could be safely omitted for early hodgkin lymphoma responder patients without compromising outcome
### Conditions
- Pediatric Hodgkin Lymphoma
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
- radiotherapy
### Outcomes
**Primary Outcomes**
- assess the outcome of pediatric patients with HL treated with risk- and response-adjusted therapy
**Secondary Outcomes**
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
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## SHR-A1811 Alone or in Combination With Adebrelimab as Neoadjuvant Treatment in ER Positive/HER2 Low Breast Cancer
- **NCT ID**: NCT06340230
- **Study ID**: BC-NEO-IIT-SHR-A1811-SHR1316
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-04-15
- **Completion Date**: 2031-02-28
- **Lead Sponsor**: Shengjing Hospital
### Study Description
This is an open-label, phase II study evaluating the efficacy and safety of SHR-A1811 alone or in combination with Adebrelimab in Stage II-III ER Positive/HER2 Low Breast Cancer. Subjects will receive the neoadjuvant therapy of SHR-A1811 alone or in combination with Adebrelimab for six cycles, and then undergo surgery within 4 weeks after neoadjuvant therapy. Efficacy will be assessed every 2 cycles.
### Conditions
- ER Positive/HER2 Low Breast Cancer
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: NON_RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- SHR-A1811 Injection + Adebrelimab Injection
- SHR-A1811 Injection + Adebrelimab Injection
- SHR-A1811 Injection
### Outcomes
**Primary Outcomes**
- Total pathological complete response (tpCR: ypT0-is/ypN0)
**Secondary Outcomes**
- Breast pathological complete response (bpCR：ypT0-is)
- Residual cancer burden (RCB)
- Best overall response rate (BORR)
- Overall survival (OS)
- Disease-free survival (DFS)
- Event-free survival (EFS)
- Health-related quality of life (HRQOL) (EORTC QLQ-C30)
- Health-related quality of life (HRQOL)
### Location
- **Facility**: Shengjing Hospital affiliated to China Medical University, Shenyang, Liaoning, 110004, China
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## Washed Microbiota Transplantation for Diabetic Gastroparesis
- **NCT ID**: NCT06340217
- **Study ID**: WMT-GDP-RCT
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-04
- **Completion Date**: 2029-07
- **Lead Sponsor**: The Second Hospital of Nanjing Medical University
### Study Description
This is a randomized controlled trial to explore the efficacy and safety of washed microbiota transplantation (WMT) for diabetic gastroparesis (DGP) patients.
### Conditions
- Diabetic Gastroparesis
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- washed microbiota transplantation
- placebo
### Outcomes
**Primary Outcomes**
- The proportion of DGP with symptom relief after the procedure.
**Secondary Outcomes**
- The extent of change observed in GCSI of participants;
- The extent of change observed in Gastroparesis Core Symptom Daily Diary (GCS-DD) of participants;
- The extent of change observed in Patient Assessment of Upper Gastrointestinal Symptom Severity Index (PAGI-SYM) of participants;
- The extent of change observed in Patient Assessment of Upper Gastrointestinal Disorders-Quality of Life (PAGI-QoL) of participants;
- The extent of change observed in electrogastrogram (EGG) of participants;
- The extent of change observed in electrogastrogram (EGG) of participants;
- The extent of change observed in gastrointestinal ultrasound (GIUS) of participants;
- The incidence rate of adverse events;
- The changes in gut microbiota composition and metabolites before and after treatment.
### Location
- **Facility**: Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, 210011, China
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## Weekly Irinotecan Liposomes in Recurrent or Refractory Ewing Sarcoma
- **NCT ID**: NCT06340204
- **Study ID**: PKUPH-EWS-03
- **Status**: RECRUITING
- **Start Date**: 2024-03-25
- **Completion Date**: 2026-12-25
- **Lead Sponsor**: Peking University People's Hospital
### Study Description
The investigators explored the safety and activity of weekly irinotecan liposomes in patients with relapsed and metastatic Ewing Sarcoma.
### Conditions
- Ewing Sarcoma
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: NON_RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- Irinotecan Hydrochloride Liposome Injection
### Outcomes
**Primary Outcomes**
- maximum tolerated dose (MTD)
**Secondary Outcomes**
- Objective Response Rate (ORR)
- Progression Free Survival (PFS)
### Location
- **Facility**: Shandong Cancer Hospital and Institute, Jina, Shandong, 250117, China
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## Cueing and Pilates in Low Back Pain
- **NCT ID**: NCT06340191
- **Study ID**: UJAPIlates1
- **Status**: COMPLETED
- **Start Date**: 2023-05-02
- **Completion Date**: 2024-02-26
- **Lead Sponsor**: University of Jaén
### Study Description
The intervention involved two groups participating in supervised Pilates sessions, twice a week for 8 weeks, featuring a mix of mat and props-based exercises. Group 1 received additional cueing training to enhance alignment, muscle engagement, and movement technique, while Group 2 underwent the same Pilates regimen without this cueing component.
### Conditions
- Low Back Pain
- Pilates Exercise
- Pilates, Core Stability
- Mind-body Exercise
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- Pilates with cueing
- Pilates without cueing
### Outcomes
**Primary Outcomes**
- Low back pain
- Pain report
**Secondary Outcomes**
- Fear of movement
- Perceived Stress Scale
- Pain self-efficacy
- Patient Impression of Change
- Body Awareness
### Location
- **Facility**: University of Jaen, Jaen, N/A, 23071, Spain
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## CT-guided Lung Biopsy Risk Optimization Method
- **NCT ID**: NCT06340178
- **Study ID**: 2024-00246
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-04-01
- **Completion Date**: 2027-04-01
- **Lead Sponsor**: Insel Gruppe AG, University Hospital Bern
### Study Description
The purpose of this randomized controlled study is to evaluate the extent to which injection of a small amount of fluid in the pleural cavity at the biopsy site may reduce the risk of pneumothoraces, in addition to patient positioning to allow biopsy in gravity-dependent areas of the lung.
### Conditions
- Pneumothorax
- Biopsy, Needle
- Risk Factors
- Radiology, Interventional
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: PREVENTION
### Interventions
- Fluid application during ct-guided lung biopsy
### Outcomes
**Primary Outcomes**
- Number of patients with pneumothorax
**Secondary Outcomes**
- Number of patients with bleeding
- Number of patients with chest tube placement
- Number of patients with air embolism
### Location
- **Facility**: Inselspital, Bern University Hospital, University of Bern, Freiburgstrasse 10, Bern, N/A, 3010, Switzerland
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## A Real-world Efficacy and Safety Study of Amlotinib for HER2-negative Advanced Breast Cancer
- **NCT ID**: NCT06340165
- **Study ID**: 2023-KS-151
- **Status**: RECRUITING
- **Start Date**: 2024-02-04
- **Completion Date**: 2025-06
- **Lead Sponsor**: The First Hospital of Jilin University
### Study Description
This study analyses the efficacy and safety of amlotinib as a study drug in the treatment of HER-2 negative advanced breast cancer in the real world, including the number of treatment lines, monotherapy, combination therapy, and different molecular subtypes of breast cancer. Evidence-based medicine evidence for clinicians. Although the clinical application of amlotinib in breast cancer treatment is a supra-indication drug, in view of its high safety and possible good efficacy for advanced breast cancer, some patients have been clinically adopted to try the treatment after communicating with their families. This study provides evidence for the further use of amlotinib in breast cancer treatment by analysing the efficacy and safety of amlotinib in real-world applications.
### Conditions
- Breast Cancer
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
- Anlotinib
### Outcomes
**Primary Outcomes**
- PFS
**Secondary Outcomes**
### Location
- **Facility**: The First Affiliated Hospital of Jilin University, Changchun, Jilin, 130021, China
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## Multi-Omics for Maternal Health After Preeclampsia
- **NCT ID**: NCT06340152
- **Study ID**: 808385
- **Status**: RECRUITING
- **Start Date**: 2023-12-20
- **Completion Date**: 2028-12
- **Lead Sponsor**: University of California, San Diego
### Study Description
To develop strategies to identify postpartum women at risk for adverse cardiovascular outcomes and provide them with preventative therapies.
### Conditions
- Pre-Eclampsia
- Pregnancy Induced Hypertension
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
### Outcomes
**Primary Outcomes**
- Preeclampsia
- Gestational hypertension
- Postpartum hypertension
**Secondary Outcomes**
- Postpartum cardiovascular disease
### Location
- **Facility**: University of California, San Diego, San Diego, California, 92037, United States
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## Vestibulo-Ocular Reflex for Balance and Stimming in Autism Spectrum Disorder
- **NCT ID**: NCT06340139
- **Study ID**: Riphah/RCRAHS-ISB/REC/01742
- **Status**: RECRUITING
- **Start Date**: 2024-03-20
- **Completion Date**: 2024-08-20
- **Lead Sponsor**: Riphah International University
### Study Description
Autism spectrum disorder is a neurodevelopmental disorder that encompasses a number of disorders specifically affecting social skills, Communication and present with Rapid repetitive behaviors. Autism spectrum disorder also presents with inability of body to process sensory information which can causes symptoms such as balance deficits, sensitivity to certain sounds or an exaggerated reaction to a normal stimulus. Autism spectrum disorder can affect the quality of life of an individual to a severe extent. This disorder due to sensory processing deficits also shows difficulty in motor planning, coordination and execution of tasks which can make performing activities of daily living highly difficult to perform. It is called a developmental disorder because it affects the growth. Milestones are often delayed in individuals with autism. Due to these deficits individual with autism if not provided with therapies at the right age can stay dependent on caretaker for their whole life. Rapid repetitive behaviors also known as self-stimulatory behaviors are a way to compensate with anxiety, difficulty in processing sensory information and are often used to stimulate themselves to feel calm. Though not a diagnostic symptom autism often still presents with vestibular dysfunction which affects the balance. Several individuals with autism have showed abnormal vestibular ocular reflexes; abnormally long latency of saccades. Rehabilitation protocol of Autism often includes symptomatic treatment and several therapy protocols such as physical therapy, occupational therapy, applied behavior analysis therapy and play therapy.
### Conditions
- Autism Spectrum Disorder
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- conventional treatment
- experimental treatment
### Outcomes
**Primary Outcomes**
- Aberrant behavior checklist
- Berg Balance Scale (BBS)
- Repetitive Behavior Scale - Revised
- Functional Reach Test
**Secondary Outcomes**
### Location
- **Facility**: zamam autism Centre, Islamabad, N/A, N/A, Pakistan
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## Effects of Active Tissue Release Techniques on Groin Pain in 2nd Trimester of Pregnancy
- **NCT ID**: NCT06340126
- **Study ID**: REC/RCR & AHS/23/0567
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-04-01
- **Completion Date**: 2024-10-05
- **Lead Sponsor**: Riphah International University
### Study Description
The study will focus on the effects of active tissue release techniques on groin pain, hip range of motion, and functional disability in 2nd trimester of pregnancy. This will be a randomized controlled trial conducted on 30 participants from Prime Care Hospital. Pregnant women in the second trimester aged between 25 to 35 years, who have groin or round ligament pain will be included in this study. A sample of 30 will be divided into 2 groups. Group A will undergo treatment of active release techniques for 10 minutes thrice a week with no home plan of home relaxation exercises. In contrast, Group B will combine treatment of active release technology with home relaxation exercises. Treatment will be given for 4 weeks and pain will be assessed before and after the treatment through (NPRS) scale. Functional disability will be measured before and after the treatment through Quebec scale and Force Disability Scale Questionnaire in both groups.
### Conditions
- Groin Strain
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- Active release techniques
- Relaxation exercises
### Outcomes
**Primary Outcomes**
- Numeric Pain Rating Scale
- The Quebec questionnaire:
- Goniometer: To measure range of motion:
**Secondary Outcomes**
### Location
- **Facility**: Prime Care Hospital, Faisalābad, Punjab, 38000, Pakistan
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## Mulligan and Mckenzie Exercises Alongwith Stabilization Exercises in Patients With Chronic Neck Pain
- **NCT ID**: NCT06340113
- **Study ID**: REC/RCR & AHS/23/0108 NASHIA
- **Status**: RECRUITING
- **Start Date**: 2023-11-20
- **Completion Date**: 2024-06-01
- **Lead Sponsor**: Riphah International University
### Study Description
The goal of this \[type of study: Randomized control trial\] is to \[ compare the effectiveness of Mulligan and McKenzie Exercises along with stabilization exercises on pain, range of motion and disability \] in \[ in patients with chronic neck pain\].The main question it aims to answer is:* Wether Mulligan is more effective or Mckenzie exercises along with stabilization exercises in the treatment of patients with chronic neck pain Group 1 will recieve Mulligan and stabilization exercises Group 2 will recieve Mckenzie and stabilization exercises
### Conditions
- Neck Pain
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- MCKENZIE AND STABILIZATION EXERCISES
- MULLIGAN AND STABILIZATION EXERCISES
### Outcomes
**Primary Outcomes**
- Numeric pain rating scale
- Neck Disability Index (NDI)
- Goniometer
**Secondary Outcomes**
### Location
- **Facility**: Riphah international university, Lahore, Punjab, 54000, Pakistan
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## Association of History of Concussion With Vestibular Impairment and Cognitive Function in Sports Athletes
- **NCT ID**: NCT06340100
- **Study ID**: REC/MS-PT/01832
- **Status**: RECRUITING
- **Start Date**: 2024-03-23
- **Completion Date**: 2024-06-02
- **Lead Sponsor**: Riphah International University
### Study Description
This study investigates the potential relationship between prior concussions and their impact on both vestibular function and cognitive abilities in athletes participating in sports.
### Conditions
- Concussion, Mild
- Vestibular Impairment
- Cognitive Impairment
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
- find association between vestibular impairment , cognitive fiunction with concussin
### Outcomes
**Primary Outcomes**
- CANTU
- Sports concussion office assesment tool 6
**Secondary Outcomes**
### Location
- **Facility**: HAYATABAD Sports complex, Peshawar, Khyber Pakhtun Khawan, 24730, Pakistan
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## Impact Hesperetin in Combination With Sucrose on Blood Glucose Regulation
- **NCT ID**: NCT06340087
- **Study ID**: 706014-3
- **Status**: RECRUITING
- **Start Date**: 2024-03-31
- **Completion Date**: 2025-03-31
- **Lead Sponsor**: University of Vienna
### Study Description
The aim of this cross-over intervention study is to investigate the influence of hesperetin applied in combination with sucrose in comparison to an equally sweet-tasting sucrose-only solution and an isocaloric sucrose-only solution on markers of energy metabolism
### Conditions
- Blood Glucose Fluctuations
- Hunger
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: CROSSOVER
- **Primary Purpose**: BASIC_SCIENCE
### Interventions
- 10% Sucrose
- Sucrose+ Hesperetin
- 7% Sucrose
### Outcomes
**Primary Outcomes**
- Change in blood glucose concentration
- Change in appetite score
- Change in food intake
**Secondary Outcomes**
- Change in regulating hormones
### Location
- **Facility**: Christian Doppler Laboratory for Taste Research, Vienna, N/A, 1090, Austria
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## Helping Educational Leadership Mobilize Evidence
- **NCT ID**: NCT06340074
- **Study ID**: STUDY00010282
- **Status**: COMPLETED
- **Start Date**: 2022-08-28
- **Completion Date**: 2023-06-07
- **Lead Sponsor**: University of Washington
### Study Description
Many universal, evidence-based prevention practices (EBPPs) have been developed to prevent SEB problems, typically in elementary schools, but progress toward widespread implementation has been slow and few efforts have been made to develop and test interventions to enhance EBPP implementation in schools. Schools leaders (e.g., principals) are key to decision making and implementation of EBPPs, and their leadership has been shown to be consistently linked to student outcomes through their intentional efforts to support teacher adoption and use of innovative programs. Helping Educational Leaders Mobilize (HELM) Evidence is a pragmatic, multifaceted, organizationally-focused implementation strategy targeting the implementation leadership and implementation climate of school buildings (through principals) to enhance the adoption and delivery of EBPPs in elementary schools. This pilot study, part of the larger HELM project to adapt and test the strategy based on an existing leadership intervention, Leadership and Organizational Change for Implementation (LOCI), will be implemented in the context of Positive Greetings at the Door (PGD), a universal school-based EBPP previously demonstrated to reduce disruptive behavior and increase academic engagement.
### Conditions
- Behavior, Child
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: HEALTH_SERVICES_RESEARCH
### Interventions
- HELM
- Implementation Attention Control (IAC)
### Outcomes
**Primary Outcomes**
- Proximal Outcome: Strategic Implementation Leadership
- Proximal Outcome: Strategic Implementation Climate
- Proximal Outcome: Implementation Citizenship Behavior
- Proximal Outcome: Implementation Initiative Stability
- Implementation Outcome: Fidelity and Sustainment - Observed
- Implementation Outcome: Fidelity and Sustainment - Self Report
- Implementation Outcome: Reach
- Implementation Outcome: Facilitators and Barriers to Implementation
- Implementation Outcome: Implementation Cost
**Secondary Outcomes**
- Student Educational Outcomes
- Student Behavioral Outcomes
### Location
- **Facility**: University of Washington School Mental Health Assessment, Research, and Training (SMART) Center, Seattle, Washington, 98115-8160, United States
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## The Aim of This Study is to Investigate the Correlation Between the Severity of Glaucoma and Corneal Biomechanics as Well as Anterior Chamber Parameters.
- **NCT ID**: NCT06340061
- **Study ID**: Qianyu Wu
- **Status**: ACTIVE_NOT_RECRUITING
- **Start Date**: 2022-10-20
- **Completion Date**: 2024-12-31
- **Lead Sponsor**: Henan Provincial People's Hospital
### Study Description
The ocular biomechanical differences between the normal control group and primary glaucoma patients, including those treated with conventional medication, laser therapy, and surgery, were compared. Additionally, an investigation was conducted to explore the relationship between anterior chamber parameters, corneal biomechanics, and the severity of glaucoma
### Conditions
- Glaucoma
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
- Observational study
### Outcomes
**Primary Outcomes**
- IOP
- bIOP
- ACD
- ACW
- SSI
- VF
**Secondary Outcomes**
### Location
- **Facility**: Henan Provincial People's Hospital, Zhengzhou, Henan, 450003, China
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## Epicardial Injection of hiPSC-CMs to Treat Severe Chronic Ischemic Heart Failure
- **NCT ID**: NCT06340048
- **Study ID**: XC Liu
- **Status**: RECRUITING
- **Start Date**: 2023-09-05
- **Completion Date**: 2025-03-05
- **Lead Sponsor**: Help Therapeutics
### Study Description
The purpose of this clinical study is to evaluate the feasibility, safety and efficacy of intramyocardial injection of human induce pluripotent stem cell-derived cardiomyocytes (HiCM-188) during coronary artery bypass grafting (CABG) surgery in patients with severe chronic ischemic heart failure.
### Conditions
- Heart Failure
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: NON_RANDOMIZED
- **Intervention Model**: SEQUENTIAL
- **Primary Purpose**: TREATMENT
### Interventions
- HiCM-188 therapy
### Outcomes
**Primary Outcomes**
- The incidence of major Serious Adverse Events (SAE)
**Secondary Outcomes**
- Grade 4 or above arrhythmias
- The incidence of tumor
- Left ventricular geometry as assessed by cardiac magnetic resonance imaging (MRI)
- Size of myocardial infarction as assessed by MRI
- Ventricular wall motion as assessed by MRI
- Left ventricular ejection fraction as assessed by MRI
- Cardiac Volumes as assessed by MRI
- Cardiac output (CO) as assessed by MRI
- 10.End-diastolic myocardial mass as assessed by MRI
- Left ventricular ejection fraction (LVEF) as assessed by Echocardiography
- Fractional shortening (FS) as assessed by Echocardiography
- Left ventricular dimensions as assessed by Echocardiography
- Cardiac Volumes as assessed by Echocardiography
- Mitral valve inflow spectrum(E/A) as assessed by Echocardiography
- Longitudinal strain as assessed by Echocardiography
- Myocardial viability as assessed by SPECT
- Myocardial blood flow as assessed by SPECT
- NT-proBNP Levels
- 6-minute walking distance
- New York Heart Association (NYHA) functional classification
- Changes of Quality of Life (QoL) as assessed by Minnesota Living with Heart Failure Questionnaire (MLHFQ)
- Changes of Quality of Life(QOL) as assessed by 36-Item Short Form Survey (SF-36)
### Location
- **Facility**: TEDA International Cardiovascular Hospital, Tianjin, Tianjin, 300457, China
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## Percutaneous Peripheral Nerve Stimulation of Gluteus Nerves to Improve Hip Strength and Power
- **NCT ID**: NCT06340035
- **Study ID**: 20230901
- **Status**: ACTIVE_NOT_RECRUITING
- **Start Date**: 2023-09-01
- **Completion Date**: 2024-06
- **Lead Sponsor**: Hospital Clinic of Barcelona
### Study Description
The goal of this pilot clinical trial is to evaluate whether the ultrasound-guided percutaneous peripheral nerve stimulation through a needle results in greater gains in strength and power compared to the administration of current through surface electrodes in patients undergoing strength and power assessments. The main questions it aims to answer are:Does percutaneous stimulation of the superior and inferior gluteal nerves using ultrasound-guided needles enhance strength and power more effectively than transcutaneous stimulation through electrodes?Is the effectiveness of current delivery significantly different between percutaneous and transcutaneous methods when assessed with a linear encoder in a standarized hip extension exercise?Participants will:Be randomized into two groups: one undergoing ultrasound-guided percutaneous stimulation of the gluteal nerves (experimental group) and the other undergoing transcutaneous stimulation through electrodes (control group).The same stimulation protocol at 10 Hz frequency with the maximum muscle contraction evoked without pain will be performed in both groups. Then, the participants will undergo strength and power assessment before and after therapy administration using a linear encoder in a hip extension exercise.Researchers will compare the experimental group to the control group to see if the method of current delivery (percutaneous vs. transcutaneous) has a significant impact on the gains in strength and power. This comparison is based on the hypothesis that percutaneous delivery of current, guided by ultrasound, is more effective than simply positioning a surface electrode for transcutaneous stimulation. The evaluation of strength and power will be performed through a linear encoder that measures peak strength and concentric power in each repetition, conducted by a blind operator unaware of the patients' group allocations.
### Conditions
- Chronic Pain
- Chronic Knee Pain
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- TENS
- Percutaneous Peripheral Nerve Stimulation
### Outcomes
**Primary Outcomes**
- Hip Extension Concentric Peak Power (Watts)
- Hip Extension Concentric Peak Strength (Newtons)
**Secondary Outcomes**
- Concentric Phase Velocity (m/s)
- Maximum Strength (1RM in kgs)
### Location
- **Facility**: University of Barcelona, Barcelona, N/A, 08036, Spain
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## Pain and Anxiety Levels of Sleeperone Electronic Anesthesia System in Pediatric Patients
- **NCT ID**: NCT06340022
- **Study ID**: 2022-31
- **Status**: COMPLETED
- **Start Date**: 2023-03-13
- **Completion Date**: 2023-11-15
- **Lead Sponsor**: Eskisehir Osmangazi University
### Study Description
The conventional method used for dental anesthesia in children is the administration of a local anesthetic solution by injection. Although this process successfully eliminates pain during the procedure, it continues to be a problem for many children in terms of dental anxiety before and during anesthesia administration.The aim of this study is to compare intraosseous anesthesia with SleeperOne® 5, a computer-assisted local anesthesia system, with conventional local anesthesia techniques in terms of pain and anxiety.
### Conditions
- Dental Anxiety
- Pain
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: CROSSOVER
- **Primary Purpose**: OTHER
### Interventions
- Children's Fear Survey Schedule-Dental Subscale (CFSS-DS) scale
- Face Image Scale (FIS) scoring system
- Visual Analogue Scale (VAS)
- pulse rate
### Outcomes
**Primary Outcomes**
- The pulse rate measurements before and after the anesthesia techniques
- Determine the anxiety level before the procedures
- The anxiety measurements before and after the anesthesia techniques
- The pain measurements during the anesthesia techniques
**Secondary Outcomes**
### Location
- **Facility**: Eskisehir Osmangazi University Faculty of Dentistry, Department of Pediatric Dentistry, Eskişehir, N/A, N/A, Turkey
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## MIME THERAPY vs MOTOR IMAGERY TECHNIQUE in Bell's Palsy
- **NCT ID**: NCT06340009
- **Study ID**: REC/01743
- **Status**: RECRUITING
- **Start Date**: 2024-03-22
- **Completion Date**: 2024-08-25
- **Lead Sponsor**: Riphah International University
### Study Description
Bell's palsy, characterized by unilateral paralysis/paresis of facial muscles, is a condition with a significant impact on individuals' lives. It was first identified by scientist Sir Charles Bell, and its sudden onset can lead to social, psychological, and emotional distress. Left untreated, Bell's palsy can have long-lasting effects on a patient's quality of life, including loss of facial muscle control, emotional stress, and communication difficulties. Rehabilitation protocols encompass various physical therapy techniques, among which Mime therapy and Motor imagery technique have shown promise.
### Conditions
- Bell Palsy
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- mime therapy
- motor imagery
### Outcomes
**Primary Outcomes**
- House-Brackmann Scale (HBS)
- Facial Disability Index (FDI)
- Sunnybrook Facial Grading System
- Synkinesis Assessment Questionnaire (SAQ)
**Secondary Outcomes**
### Location
- **Facility**: Muzaffar Hospital, Sargodha, N/A, N/A, Pakistan
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## Male Supplements for Sperm Quality and Aging
- **NCT ID**: NCT06339996
- **Study ID**: KSVGH24-CT1-10
- **Status**: RECRUITING
- **Start Date**: 2024-03-26
- **Completion Date**: 2024-09-30
- **Lead Sponsor**: Kaohsiung Veterans General Hospital.
### Study Description
This study investigates the effects of a new supplement on sperm quality in men with poor sperm quality. Fifty patients will receive the supplement for three months, followed by semen analysis and assessment of sperm aging and mitochondrial function. Changes in sexual function and aging symptoms will also be evaluated.
### Conditions
- Unrecognized Condition
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: NA
- **Intervention Model**: SINGLE_GROUP
- **Primary Purpose**: TREATMENT
### Interventions
- Male supplement
### Outcomes
**Primary Outcomes**
- Semen analysis
**Secondary Outcomes**
- oxygen consumption of mitochondria
- mitochondrial function
- sexual function
- aging symptoms
### Location
- **Facility**: Kaohsiung Veterans General Hospital, Kaohsiung, N/A, N/A, Taiwan
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## Effects of Scar Mobilization Versus Myofascial Cupping Technique on Cesarean Scar
- **NCT ID**: NCT06339983
- **Study ID**: REC/RCR & AHS/23/0566
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-04-01
- **Completion Date**: 2024-10-05
- **Lead Sponsor**: Riphah International University
### Study Description
Study focuses on comparing the effects of manual scar mobilization and myofascial cupping techniques on the outcomes of pain, physical characteristics, and appearance of cesarean scars. The study aims to contribute valuable insights into tailored interventions for improving cesarean scars. The randomized clinical trial will involve 52 participants, primigravida women aged 20 to 40 with completely healed but painful cesarean scars. Excluding those with previous scar therapy or infectious scars, the participants will be divided into two groups, with Group A receiving manual scar mobilization therapy and Group B receiving myofascial cupping therapy, both administered twice a week for four weeks. Pain assessment will be conducted using a numeric pain rating scale (NPRS), while physical characteristics and appearance will be evaluated using the Manchester Scar Scale for cesarean scars (MSS). The data collected will be analyzed using SPSS version 29.
### Conditions
- Cesarean Section; Complications, Wound, Hematoma
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- Manual Scar Mobilization Therapy:
- Myofascial Cupping Therapy:
### Outcomes
**Primary Outcomes**
- Numeric Pain Rating Scale
- Manchester Scar Scale (MSS)
**Secondary Outcomes**
### Location
- **Facility**: Kulsoom Shoukat Medical Complex, Faisalābad, Punjab, 3800, Pakistan
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## Effects of Slider Versus Tensioners Nerve Gliding in Cervical Radiculopathy.
- **NCT ID**: NCT06339970
- **Study ID**: REC/RCR & AHS/23/0199 iram
- **Status**: RECRUITING
- **Start Date**: 2023-11-23
- **Completion Date**: 2024-06-01
- **Lead Sponsor**: Riphah International University
### Study Description
This study will be a randomized clinical trial in which Slider versus Tensioners Nerve Gliding Technique along with Mulligan Spinal Mobilization will be applied on the individuals with cerviculorediculopathy and changes will be recorded using different methods and tools. Convenient sampling technique will be used to collect the data. The sample size of 40 patients will be recruited. Patients will be randomly allocated into two different groups through sealed envelope method.20 patients will be allocated in each group A will be treated with Slider Nerve Gliding Technique along with Mulligan Spinal Mobilization Technique; Group B will be treated with Tensioners Nerve Gliding Technique along with Mulligan Spinal Mobilization Technique .Numeric Pain Rating Scale (NPRS), Neck Disability Index (NDI) and goniometer will be used as Data collecting tools. After data collection from defined study setting, data will be entered and analyzed.
### Conditions
- Cervical Radiculopathy
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- Slider Nerve Gliding Technique along with Mulligan Spinal Mobilization Technique
- Tensioners Nerve Gliding Technique along with Mulligan Spinal Mobilization Technique
### Outcomes
**Primary Outcomes**
- Numeric Pain Rating Scale
- Neck disability index
- Goniometer
**Secondary Outcomes**
### Location
- **Facility**: Sehat Medical Compolex, Lahore, Punjab, 54000, Pakistan
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## Rheumatology Diet Study
- **NCT ID**: NCT06339957
- **Study ID**: STUDY00006394
- **Status**: RECRUITING
- **Start Date**: 2024-03-01
- **Completion Date**: 2024-07-01
- **Lead Sponsor**: University of Central Florida
### Study Description
This study aims to collect information on rheumatology patients' dietary habits, autoimmune disease activity, dietary changes, disease symptom improvements, and perceptions on their dietary habits and how it affects their autoimmune disease. The main objective is to see if rheumatology patients change their dietary habits after their diagnosis of an autoimmune disease and if it subjectively improved their disease symptoms. It will also look at rheumatology patients' expectations for their rheumatologist when it comes to dietary advice and what resources they used to choose their new dietary habits. The study also seeks to measure the interest that rheumatology patients have in pursuing dietary changes as a means of controlling the symptoms of their autoimmune disease. It is expected that patients who changed their eating habits to healthier diets such as a Mediterranean diet would report less severe autoimmune disease symptoms. There are limited dietary recommendations for the management of many rheumatological diseases, so this study seeks to assess rheumatology patients' willingness to try dietary modifications, what improvements they had, and why they decide to make these changes in light of limited information.
### Conditions
- Diet Habit
- Rheumatologic Disease
- Autoimmune Diseases
- Rheumatoid Arthritis
- Psoriatic Arthritis
- Ankylosing Spondylitis
- Dermatomyositis/Polymyositis
- Sjogren's Syndrome
- Systemic Lupus Erythematous
- Scleroderma
- Fibromyalgia
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
### Outcomes
**Primary Outcomes**
- To determine how diet habits and activity affects autoimmune diseases using the proper statistical tests for the data set such as t-test and ANOVA.
**Secondary Outcomes**
- To identify if rheumatology patients change their dietary habits after their diagnosis of an autoimmune disease and if it subjectively improved their disease symptoms.
### Location
- **Facility**: UCF Health Clinics, Orlando, Florida, 32827, United States
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## Effects of Sensory Motor Training and Kinesthetic Exercises in Knee Osteoarthritis.
- **NCT ID**: NCT06339944
- **Study ID**: REC/RCR& AHS/23/0198RubabTalib
- **Status**: RECRUITING
- **Start Date**: 2023-11-23
- **Completion Date**: 2024-06-01
- **Lead Sponsor**: Riphah International University
### Study Description
In this study i will see the effects of kinesthetic exercises and sensory motor training on pain and range of motion in patients with knee OA.
### Conditions
- Knee Osteoarthritis
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- sensory motor training
- kinesthetic exercises
### Outcomes
**Primary Outcomes**
- VAS
**Secondary Outcomes**
- goniometer
- WOMAC questionaire
- joint position sense test
### Location
- **Facility**: Tariq Hospital, Sheikhupura, Punjab, 39350, Pakistan
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## Lumber Spine Mobilization and Spinal Traction on Lumber Radiculopathy.
- **NCT ID**: NCT06339931
- **Study ID**: REC/RCR &AHS/23/0181
- **Status**: RECRUITING
- **Start Date**: 2023-11-23
- **Completion Date**: 2024-06-01
- **Lead Sponsor**: Riphah International University
### Study Description
Lumber radiculopathy, also known as sciatica, is a condition that causes pain in the lower back and legs due to irritation or compression of the spinal nerves. group between 20 and 50 years old. This study will explore the effects of lumbar spine mobilization with leg movement and spinal traction with and without belt in patients with pain and functional limitations due to lumbar radiculopathy. A randomized control trial will be conducted at Atta Jaspal Hospital and Trauma Center through convenient sampling technique on 44 patients, which will be allocated through simple random sampling through sealed opaque envelopes into groups A and B. Group A will be treated with SMWLM, conventional electrotherapy, and traction without a belt, and Group B will be treated with SMWL, conventional electrotherapy, and lumbar traction with a belt. A pretreatment baseline will be set for pain, ROM, and disability at the lumbar spine by using the NPRS, inclinometer, and ODI questioner. Follow-up will be conducted after 4 weeks of post-treatment sessions. The intensity of pain, range of motion, and disability index will be evaluated using the NPRS, inclinometer, and ODI questionnaire. The data will be analyzed using SPSS software version 26. The conclusion of the study will be based on either accepting or rejecting the null and alternate hypotheses.
### Conditions
- Lumbar Radiculopathy
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- SMWLM combined Spinal traction with belt
- SMWLM combined spinal traction without belt
### Outcomes
**Primary Outcomes**
- Numeric pain rating scale
- Inclinometer
- Oswestry Disability Index
**Secondary Outcomes**
### Location
- **Facility**: Atta Jaspal Hospital and ortho trauma center, Bhalwal, Punjab, 40410, Pakistan
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## Combined Effects of Kegel Exercises and 4-7-8 Breathing Technique in Primary Dysmenorrhea
- **NCT ID**: NCT06339918
- **Study ID**: REC/RCR & AHS/23/0570
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-04-01
- **Completion Date**: 2024-10-05
- **Lead Sponsor**: Riphah International University
### Study Description
A randomized clinical trial will be conducted at Riphah International University QIE Campus in Lahore, using non-probability convenience sampling with 28 participants. Criteria include women aged 14-26, nulliparous, experiencing primary dysmenorrhea, with normal menstrual cycles and the ability to exercise independently. Group A will receive kegel exercises and 4-7-8 breathing techniques over 8 weeks, while Group B will only receive the breathing technique. Assessments will be done on menstrual cycle days, with follow-ups at weeks 4 and 8 using specific scales. Data will be analyzed using SPSS version 27.
### Conditions
- Primary Dysmenorrhea
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- KegelExercise
- 4-7-8 breathing technique
### Outcomes
**Primary Outcomes**
- Numeric Pain Rating Scale
- WALIDD Primary Dysmenorrhea Intensity Scale
- Pain Self-Efficacy Questionnaire (PSEQ)
**Secondary Outcomes**
### Location
- **Facility**: Riphah International University Clinic, Lahore, Punjab, 54700, Pakistan
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## The Effects of EndoActivator on Postoperative Pain and Root Canal Treatment Success
- **NCT ID**: NCT06339905
- **Study ID**: 10840098-772.02-5564
- **Status**: COMPLETED
- **Start Date**: 2022-01-01
- **Completion Date**: 2023-08-31
- **Lead Sponsor**: Istanbul Medipol University Hospital
### Study Description
This study evaluates postoperative pain and radiographic healing of asymptomatic posterior teeth with chronic apical periodontitis following root-canal treatment performed using EndoActivator for irrigation activation.
### Conditions
- Periapical Periodontitis
- Root Canal Infection
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: FACTORIAL
- **Primary Purpose**: TREATMENT
### Interventions
- Sonic Activation with EndoActivator
- Control Needle Irrigation
### Outcomes
**Primary Outcomes**
- change from baseline postoperative pain at 1 week
- change from baseline periapical index at 1 year
**Secondary Outcomes**
### Location
- **Facility**: Istanbul Medipol University, Faculty of Dentistry, Istanbul, Esenler, N/A, Turkey
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## HCMV Breakthrough Infections During Letermovir Prophylaxis
- **NCT ID**: NCT06339892
- **Study ID**: 2022-3.11/451
- **Status**: RECRUITING
- **Start Date**: 2023-01-09
- **Completion Date**: 2026-03
- **Lead Sponsor**: Foundation IRCCS San Matteo Hospital
### Study Description
The goal of this clinical trial is to compare two strategies to monitor human cytomegalovirus (HCMV) infections in transplanted patients receiving letermovir (LTV) as anti-HCMV prophylaxis.HCMV infection after transplantation is diagnosed by detection of HCMV DNA in blood. However, due to the peculiar mechanism of action of LTV, most episodes of HCMV DNA detection are caused by release in the blood stream of non-infectious HCMV DNA.In true episodes of productive infection, HCMV DNA in blood is present inside the virion and therefore is resistant to DNAse digestion. Conversely, when non-infectious free-floating HCMV DNA is released in the bloodstream, it will be degraded after treatment of plasma with DNAse and will not be detectable by real-time PCR assays.Researchers will compare determination of HCMV DNA in blood with or without previous digestion of non-infectious free-floating DNA with DNAse.In patients of the Control group HCMV DNA will be tested without DNAse digestion. If HCMV DNA is positive, patients will stop LTV prophylaxis and receive antiviral therapy with another drug.In patients of the Study group HCMV DNA will be tested after DNAse digestion. Only if HCMV DNA is positive after DNAse digestion, patients will stop LTV prophylaxis and receive antiviral therapy with another drug.The main aim of the study is to demonstrate that, by avoiding inappropriate antiviral therapy during LTV prophylaxis, transplant patients will suffer of lower antiviral-drug-related toxicity. A monitoring strategy able to identify true episodes of HCMV productive infection during LTV prophylaxis will lead to a lower rate of inappropriate antiviral therapy and drug-related toxicity without an increased risk of HCMV disease.
### Conditions
- Cytomegalovirus Infections
- Cytomegalovirus Viremia
- Hematopoietic Stem Cell Transplantation
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: DIAGNOSTIC
### Interventions
- Determination of HCMV DNA in plasma after DNAse digestion.
- Determination of HCMV DNA in blood or plasma.
### Outcomes
**Primary Outcomes**
- - Proportion of patients with positive HCMV DNAemia developing antiviral drug-related toxicity.
**Secondary Outcomes**
- Proportion of patients developing HCMV DNAemia during LTV prophylaxis.
- Proportion of patients developing HCMV disease within day 100 and between day 100 and 360 from transplant (key secondary endpoint)
- Proportion of patients stopping LTV prophylaxis and shifting to GCV/VGCV/FOS therapy.
- Proportion of patients requiring GCV/VGCV/FOS therapy between day 100 and 360.
- Proportion of patients with persisting HCMV DNAemia.
- Proportion of patients developing neutropenia between day 100 and 360.
- Proportion of patients developing HCMV-specific T-cell response at day 100, 180, and 360.
- Proportion of patients developing LTV-resistant HCMV strains.
- Cumulative incidence of acute or chronic GvHD.
- Transplant related mortality (TRM), underlying disease relapse, and 1-year survival.
### Location
- **Facility**: ASST-Spedali Civili, Brescia, BS, N/A, Italy
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## Health Effects of Grain Foods in Adults
- **NCT ID**: NCT06339879
- **Study ID**: IRB-2023-1071
- **Status**: RECRUITING
- **Start Date**: 2024-01-18
- **Completion Date**: 2026-12-31
- **Lead Sponsor**: Purdue University
### Study Description
This study will assess the effects of eating whole grain foods versus refined grain foods with different amounts of added sugar. It is hypothesized that a diet including grain products will have beneficial effects on taste hedonics, appetite, food/energy intake, body weight, blood pressure, acute and chronic glycemia and acute and chronic lipemia compared to customary diets controlling for added sugars, saturated fats and sodium.
### Conditions
- High Whole Grain and Low Sugar
- Medium Whole Grain and Low Sugar
- Low Whole Grain and Low Sugar
- Low Whole Grain and High Sugar
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: BASIC_SCIENCE
### Interventions
- High Whole Grain, Low Sugar
- Low Whole Grain, Low Sugar
- High Whole Grain, High Sugar
- Low Whole Grain, High Sugar
### Outcomes
**Primary Outcomes**
- Glycemia
**Secondary Outcomes**
- Appetite
- Taste Hedonics
- Energy Intake
- Body Weight
- Systolic and Diastolic Blood Pressure
- Lipemia
### Location
- **Facility**: Purdue University, West Lafayette, Indiana, 17907, United States
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## The Effect of Two Different Video Showings on Pain and Anxiety in Children Undergoing Adenotonsillectomy
- **NCT ID**: NCT06339866
- **Study ID**: E16734702
- **Status**: ACTIVE_NOT_RECRUITING
- **Start Date**: 2023-06-25
- **Completion Date**: 2024-06-25
- **Lead Sponsor**: Zonguldak Bulent Ecevit University
### Study Description
Purpose of the Research: The purpose of the research is to examine the effect of two different video presentations on pain and anxiety in children undergoing adenotonsillectomy.Type of Research It is planned as a randomized controlled interventional type study to examine the effects of two different video presentations on pain and anxiety in children undergoing adenotonsillectomy.
### Conditions
- Pain After Adenotonsillectomy
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: SEQUENTIAL
- **Primary Purpose**: HEALTH_SERVICES_RESEARCH
### Interventions
- The Effect of Two Different Video Interventions on Pain and Anxiety in Children with Adenotonsillectomy: A Randomized Controlled Study
### Outcomes
**Primary Outcomes**
- After the intervention, the mean score of the children in the postoperative animation and cartoon group on the Wong Baker Pain Rating Scale will be lower than those in the control group.
**Secondary Outcomes**
- After the intervention, the mean score of the Children's Anxiety Scale-Stability score of the children in the postoperative animation and cartoon group will be less than those in the control group.
### Location
- **Facility**: Mihriye, Zonguldak, N/A, 67600, Turkey
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## Study of Efficacy of Digital Cognitive Behavioral Therapy With Wearable Device for Insomnia
- **NCT ID**: NCT06339853
- **Study ID**: 1-2023-0023
- **Status**: COMPLETED
- **Start Date**: 2023-09-07
- **Completion Date**: 2024-02-29
- **Lead Sponsor**: Yonsei University
### Study Description
The purpose of the study was to examine safety and efficacy of cognitive behavioral therapy (CBT)-based wearable integrated digital therapeutics for insomnia patients
### Conditions
- Insomnia
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: NA
- **Intervention Model**: SINGLE_GROUP
- **Primary Purpose**: TREATMENT
### Interventions
- WELT-IP with wearable devices (Apple/galaxy watch. Oura ring)
### Outcomes
**Primary Outcomes**
- Change from baseline to week 9 (post-treatment) of ISI
**Secondary Outcomes**
- Secondary Outcome - Changes from baseline to week 9 of SE
- Changes from baseline to week 9 of SOL.
- Changes from baseline to week 9 of WASO.
- Changes from baseline to week 9 of PHQ-9.
- Changes from baseline to week 9 of GAD-7.
- Changes from baseline to week 9 of compliance.
### Location
- **Facility**: Department of Psychiatry, Severance Hospital, Seoul,, N/A, 120-752, Korea, Republic of
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## The Impact of Lifestyle Intervention on Weight and Fertility in Obese Males
- **NCT ID**: NCT06339840
- **Study ID**: 2024-036-01
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-04-01
- **Completion Date**: 2027-03-31
- **Lead Sponsor**: Third Affiliated Hospital of Zhengzhou University
### Study Description
Obesity, defined by WHO standards as having a body mass index (BMI) equal to or greater than 30 kg/m², affects approximately 800 million people worldwide. It is evident that obesity has become a serious public health issue, resulting in significant health burdens.Previous systematic reviews have indicated an association between obesity and male factor infertility. In populations undergoing assisted reproductive technology (ART), some studies have shown a correlation between increased male BMI and adverse ART outcomes. Furthermore, the negative effects of obesity may also be transmitted to offspring through genetic and epigenetic changes in reproductive cell DNA, increasing their risk of obesity, metabolic diseases, or other chronic conditions.Currently, there is a lack of data on the impact of weight loss in obese men on fertility, and it is unclear which nutritional pattern in lifestyle interventions can more effectively control weight, improve semen quality, and address related endocrine issues in obese men, thereby improving reproductive treatment outcomes.Based on previous literature, we hypothesize that lifestyle interventions, particularly strict low-carbohydrate diets combined with lifestyle guidance, may offer greater health benefits for obese men. These benefits include effective weight loss, improvement in semen parameters, reproductive metabolic health, quality of life related to reproductive health, and the impact on reproductive treatment outcomes. This provides a basis for non-pharmacological intervention strategies and methods for the health of obese men.
### Conditions
- Obesity
- Weight Loss
- Male Fertility
- Artificial Insemination
- IVF-ET
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: SUPPORTIVE_CARE
### Interventions
- Low-carbohydrate diet group
- Health Education Group
### Outcomes
**Primary Outcomes**
- Weight
**Secondary Outcomes**
- Semen parameter- Sperm concentration
- Semen parameter- Sperm motility
- Semen parameter- Sperm morphology
- Semen parameter- Sperm DNA fragmentation index (DFI)
- Semen parameter- Sperm progressive motility (PR)
- Semen parameter- Non-progressive motility (NP)
- Semen parameter- Immotility (IM)
- body mass index (BMI)
- Waist circumference
- Hip circumference
- Lean mass
- Fat mass
- Abdominal fat
- Visceral fat
- Blood pressure
- Heart rate
- Lipid profile-triglycerides
- Lipid profile-LDL
- Lipid profile-HDL
- Lipid profile-VLDL
- Lipid profile-total cholesterol
- Glucose metabolism-fasting glucose
- Glucose metabolism-OGTT
- Glucose metabolism-insulin
- Glucose metabolism-C-peptide
- Glucose metabolism-HbA1c
- Sex hormones
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
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## ASk Questions in GYnecologic Oncology (ASQ-GYO)
- **NCT ID**: NCT06339827
- **Study ID**: 2023-102
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-04
- **Completion Date**: 2026-02
- **Lead Sponsor**: Ira Winer
### Study Description
The goal of this clinical trial is to determine the effectiveness of the ASk Questions in GYnecologic Oncology question prompt list (ASQ-GYO QPL) at improving patient self-efficacy, distress, physician trust, and knowledge compared to usual care during new patient gynecologic oncology visits. Also to determine the acceptability of the ASQ-GYO QPL with new gynecologic oncology patients.
### Conditions
- Ovarian Cancer
- Endometrial Cancer
- Cervical Cancer
- Vulvar Cancer
- Vaginal Cancer
- Gestational Trophoblastic Disease
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: HEALTH_SERVICES_RESEARCH
### Interventions
- Administration of the ASk Questions in GYnecologic Oncology (ASQ-GYO) Question Prompt List
### Outcomes
**Primary Outcomes**
- Change in pre- and post-visit self-efficacy scores and compared by trial group
**Secondary Outcomes**
- Change in pre- and post-visit National Comprehensive Cancer Network (NCCN) Distress Thermometer scores compared by trial group
- Change in pre- and post-visit Trust in a Physician scores compared by trial group
- Knowledge Screen
- Patient perceptions of the Question Prompt List
### Location
- **Facility**: Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, 48201, United States
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## Eye Movement Desensitization and Reprocessing Group Treatment for Caregivers of Pediatric Brain Tumor Patients
- **NCT ID**: NCT06339814
- **Study ID**: 05/23-CE
- **Status**: RECRUITING
- **Start Date**: 2023-03-10
- **Completion Date**: 2024-11-30
- **Lead Sponsor**: IRCCS Eugenio Medea
### Study Description
Caregivers of pediatric brain tumor survivors may develop high levels of psychological distress, mostly depression and anxiety, with effects comparable to those of a traumatic event. Several studies suggest that Eye Movement Desensitization and Reprocessing could be a promising treatment in similar clinical populations (i.e. adults with brain tumor), but it has never been used for caregivers of pediatric brain tumor. The aims of the present study will be to test the feasibility of the Eye Movement Desensitization and Reprocessing Integrative Group Treatment Protocol for caregivers of pediatric brain tumor survivors in a clinical setting and to evaluate its effectiveness in decreasing the psychological distress in this population. The study will be monocentric, and with two parallel branches: the Eye Movement Desensitization and Reprocessing Integrative Group Treatment Protocol group, who will receive a 4-session treatment, versus the Treatment as Usual condition, who will receive standard support. Emotional distress will be measured before the treatment, immediately after the end of it, and two months later (follow-up), by means of several clinical scales. Twenty-four subjects will be recruited for each group (caregivers and controls). Statistical analysis will be performed to test the effect of the intervention. If a positive outcome occurs, it could offer preliminary results about the validity of the Eye Movement Desensitization and Reprocessing in treating this population's difficulties.
### Conditions
- Caregiver Burden
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: SUPPORTIVE_CARE
### Interventions
- Eye Movement Desensitization and Reprocessing Integrative Group Treatment Protocol
- Treatment As Usual
### Outcomes
**Primary Outcomes**
- Impact of Event Scale-Revised-Total score
- Impact of Event Scale-Revised-Intrusion score
- Impact of Event Scale-Revised-Avoidance score
- Impact of Event Scale-Revised-Hyperarousal score
- Subjective Units of Distress-Total Score
- State-Trait Anxiety Inventory-State anxiety score
- State-Trait Anxiety Inventory-Trait anxiety score
- Beck Depression Inventory-Total score
- Parenting Stress Index-Total score
- Parenting Stress Index-Parental stress score
- Parenting Stress Index-Dysfunctional interaction score
- Parenting Stress Index-Hard child score
- Stress Index for Parents of Adolescents-Total stress score
- Stress Index for Parents of Adolescents-Life restrictions score
- Stress Index for Parents of Adolescents-Relationship with spouse/partner score
- Stress Index for Parents of Adolescents-Social alienation score
- Stress Index for Parents of Adolescents-Incompetence/guilt score
- Caregiver Burden Inventory-Time-dependence burden score
- Caregiver Burden Inventory-Developmental burden score
- Caregiver Burden Inventory-Physical burden score
- Caregiver Burden Inventory-Social burden score
- Caregiver Burden Inventory-Emotional burden score
- Family Assessment Device 3-Problem Solving score
- Family Assessment Device 3-Communication score
- Family Assessment Device 3-Roles score
- Family Assessment Device 3-Affective Responsiveness score
- Family Assessment Device 3-Affective Involvement score
- Family Assessment Device 3-Behavior Control score
- Family Assessment Device 3-General Functioning score
**Secondary Outcomes**
### Location
- **Facility**: IRCCSEMedea, Bosisio Parini, Lecco, 23842, Italy
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## Role of Mucosal Impedance Measurement for the Diagnosis of Gastroesophageal Reflux Disease
- **NCT ID**: NCT06339801
- **Study ID**: HCJSM-24-193
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-06-01
- **Completion Date**: 2025-08-01
- **Lead Sponsor**: Hospital de Clinicas José de San Martín
### Study Description
Existing current tests for diagnosing GERD are suboptimal because they lack adequate sensitivity or specificity. Upper gastrointestinal endoscopy is highly specific for diagnosing GERD, particularly when erosive esophagitis is present (Los Angeles Classification B, C, or D). Nevertheless, its sensitivity is limited, as this scenario is only present in 30% of cases. Most patients will exhibit normal endoscopic findings, indicating Non-Erosive Reflux Disease (NERD). The 24-hour impedance-pH monitoring (MII) is currently considered the gold standard. However, its main limitation is that it can only measure reflux activity over a 24-hour period, in addition to the discomfort caused by the catheter. 6-8 It is noteworthy that 50% of patients with NERD will have pathological reflux, and the other 50% will have a sensory disorder. The importance of making an accurate diagnosis lies in the treatment, which varies in each case.11 Recently, a minimally invasive device was developed and validated in the USA to assess changes in esophageal mucosal impedance. This serves as a tool for evaluating tissue changes associated with chronic reflux. However, this device has recently undergone improvements. This new technology has not been tested yet for GERD diagnosis. The primary benefit would be the ability to diagnose GERD in symptomatic patients with NERD during the initial endoscopy conducted under sedation.ObjectivesThe Main objectives of this study are to:1. Evaluate the diagnostic performance of mucosal impedance measurement.2. Investigate the mucosal impedance pattern in patients with and without GERD.Secondary objectives:1. Evaluate the correlation between the global mucosal impedance measurement vs the first 3cm measurement2. Evaluate the best probability score to distinguish between GERD and non-GERD Design Prospective, cross-sectional, and analytical study Study Design and Procedures The study will be conducted in the Gastroenterology Department of the Hospital de Clínicas José de San Martin, University of Buenos Aires, Argentina. Following a 4-week screening period during which a proton pump inhibitor (PPI) washout will be performed, and baseline measurements will be taken, all patients will undergo upper gastrointestinal endoscopy with mucosal impedance measurement and 24-hour impedance/pH monitoring.
### Conditions
- Gastroesophageal Reflux
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
- MiVu
### Outcomes
**Primary Outcomes**
- diagnostic performance
- mucosal impedance pattern
**Secondary Outcomes**
- Correlations
- Probability score
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
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## Pharmacokinetics of HD-P023 and Co-administration of Teneligliptin and Empagliflozin High in Healthy Volunteers
- **NCT ID**: NCT06339788
- **Study ID**: HD-MP-106
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-04
- **Completion Date**: 2024-11
- **Lead Sponsor**: Handok Inc.
### Study Description
The purpose of this study is to compare the pharmacokinetics and safety of HD-P023 and coadministration of Teneligliptin and Empagliflozin in healthy adult volunteers
### Conditions
- Healthy Volunteers
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: CROSSOVER
- **Primary Purpose**: TREATMENT
### Interventions
- HD-P023
- Teneligliptin
- Empagliflozin
### Outcomes
**Primary Outcomes**
- Area under the plasma concentration versus time curve (AUCt) of Teneligliptin and Empagliflozin
- Peak Plasma Concentration (Cmax) of Teneligliptin and Empagliflozin
**Secondary Outcomes**
- Area under the plasma concentration versus time curve zero to time infinity (AUC∞) of Teneligliptin and Empagliflozin
- Ratio of AUCt and AUC∞ (AUCt/AUC∞) of Teneligliptin and Empagliflozin
- Time to peak drug concentration (Tmax) of Teneligliptin and Empagliflozin
- Volume of distribution (VZ/F) of Teneligliptin and Empagliflozin
- Clearance (CL/F) of Teneligliptin and Empagliflozin
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
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## Blinatumomab for Relapsed Acute B Lymphoblastic Leukemia After Transplantation
- **NCT ID**: NCT06339775
- **Study ID**: 2024318
- **Status**: RECRUITING
- **Start Date**: 2023-09-01
- **Completion Date**: 2027-06-30
- **Lead Sponsor**: Suping ZHANG
### Study Description
B-ALL patients received regular follow-up after allogeneic hematopoietic stem cell transplantation, and in case of recurrence, they were given Blinatumomab.Anti-treatment was followed by DLI, and the second course was performed 1-2 months after DLI.Patients with positive MRD were treated with Blinatumomab 28μg×5-15 days, followed by DLI treatment.(MNC infusion is about 5×10\^7/kg\~1×10\^8/kg). Patients with hematologic recurrence were given Blinatumomab 9μg D1-4,11.66μg d5-7,28μg Starting from d8 （8 to 21 days in total）, followed by DLI treatment (infusion of MNC approximately 5×10\^7/kg\~1×10\^8/kg). Objective To observe and analyze the efficacy and side effects of Blinatumomab followed by donor lymphocyte infusion in patients with relapsed acute B lymphoblastic leukemia after allogeneic hematopoietic stem cell transplantation in our hospital.
### Conditions
- Acute B-cell Lymphoblastic Leukemia
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: NA
- **Intervention Model**: SINGLE_GROUP
- **Primary Purpose**: TREATMENT
### Interventions
- Blinatumomab
### Outcomes
**Primary Outcomes**
- Overall survival
- Disease-free survival
**Secondary Outcomes**
- incidence of cytokine release syndrome （CRS）
- Incidence of acute/chronic graft-versus-host disease （GVHD）
- hematological adverse reactions Incidence rate
### Location
- **Facility**: The First Affiliated Hospital of Zhengzhou University, Zhenzhou, Henan, 450000, China
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## Self-Compassion Training Given to Relatives of Patients in Palliative Care
- **NCT ID**: NCT06339762
- **Study ID**: 2024/03-19
- **Status**: RECRUITING
- **Start Date**: 2024-02-13
- **Completion Date**: 2024-04-13
- **Lead Sponsor**: Firat University
### Study Description
The concept of self-compassion is a concept that has been frequently the subject of research lately and has gained importance along with positive psychology. It is also referred to as self-understanding and self-compassion in the literature. The concept of self-compassion used in our study represents the concept of self-compassion in its original form as used in foreign sources. Compassion is classified according to the source to which it is directed or received. It is suggested that there are three different flows: the feeling of compassion that the individual directs from himself to others, the feeling of compassion he receives from others, and the feeling of compassion that he directs directly to his own self. It means showing oneself the same compassion and understanding one does to others, accepting and being open to one's own pain, and being accepting of oneself without being judgmental. Individuals with self-compassion believe that the difficulties, flaws and shortcomings they experience are normal. At the same time, they are aware that being human has characteristics and that everyone can experience these situations. Individuals may be less compassionate towards themselves than they are towards others. Individuals with self-compassion are as understanding, forgiving and loving towards themselves as they are towards other people.
### Conditions
- Self-Compassion Training
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: SUPPORTIVE_CARE
### Interventions
- Self-Compassion Training
### Outcomes
**Primary Outcomes**
- Self-Compassion Scale:
- Care Burden Scale:
**Secondary Outcomes**
### Location
- **Facility**: Fırat university, Elazığ, Center, 25240, Turkey
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## Pregnancy Outcomes in Normotensive VS stage1 Hypertension: a Prospective Observational Study
- **NCT ID**: NCT06339749
- **Study ID**: [2024] Ethics Review NO.040
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-04-25
- **Completion Date**: 2026-02-27
- **Lead Sponsor**: FANG HE
### Study Description
In 2017, the American College of Cardiology (ACC) and American Heart Association (AHA) guidelines built on evidence that elevated blood pressure increases cardiovascular mortality in the general population, Reclassification of BP; however, these diagnostic definitions do not include pregnant women, and whether newly diagnosed stage 1 hypertension affects pregnancy complications remains unclear. In this study, the combination of maternal factors, MAP and PLGF was used to comprehensively analyze the risk factors of preeclampsia through the "Bayesian rule" developed by the British Fetal Medicine Foundation (FMF). According to the guidelines and consensus, the pregnant women were considered to be at high risk when the calculated risk was higher than 1% of the population. To compare the pregnancy outcomes of women with normal blood pressure in the first trimester and stage 1 hypertension in different risk groups, and to find out whether screening for preeclampsia can be omitted for women with normal blood pressure in the first trimester, while screening for preeclampsia should still be performed for women with stage 1 hypertension as an independent moderate risk factor, and finally to optimize the screening strategy for preeclampsia.
### Conditions
- stage1 Hypertension
- Preeclampsia
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
- blood pressure
- Clinical protocols for preeclampsia risk screening
### Outcomes
**Primary Outcomes**
- preeclampsia
**Secondary Outcomes**
- premature delivery
- fetal intrauterine growth restriction
- Severe complications of preeclampsia
### Location
- **Facility**: FANG HE, Guangzhou, Guangdong, 510150, China
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## Treatment Outcomes in Patients With Muscular Temporo-mandibular Joint Disorders
- **NCT ID**: NCT06339736
- **Study ID**: 23815
- **Status**: RECRUITING
- **Start Date**: 2022-01-10
- **Completion Date**: 2025-12
- **Lead Sponsor**: University of Pisa
### Study Description
The aim of the present study was to assess the treatment outcomes in patients affected by M-TMDs in terms of pain scores assessed with pressure pain threshold (PPT). The levels of de-pression, anxiety and the Oral-Health Impact profile were also assessed and compared to healthy controls. Patients with a clinical diagnosis of M-TMDs and a control group of healthy subjects were enrolled. At baseline, OHIP-14, PHQ-9 and GAD-7 were administered. PPT was registered at the level of masseter and temporalis muscles. The patients were then treated with oral splints and physio-kinesiotherapy following a standardized treatment protocol. At 6-months follow-up, PPT was registered, and the questionnaires were re-administered to compare treatment outcomes.
### Conditions
- TMD
- TMD/Orofacial Pain
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
- Questionnaires administered to all study participants
### Outcomes
**Primary Outcomes**
- Evaluation of the impact of muscular pain on oral health
- Evaluation of the impact of muscular pain on anxiety
- Evaluation of the impact of muscular pain on depression
**Secondary Outcomes**
- Changes in muscular pain
### Location
- **Facility**: University of Pisa, Pisa, N/A, 56126, Italy
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## Pecha Kuka Method About Percutaneous Endoscopic Gastrostomy for Caregivers Who Care for Palliative Care Patients
- **NCT ID**: NCT06339723
- **Study ID**: 2024/03-17
- **Status**: RECRUITING
- **Start Date**: 2024-02-13
- **Completion Date**: 2024-04-13
- **Lead Sponsor**: Firat University
### Study Description
Palliative care; It was started by Dame Cicely Saunders in the 1960s as a hospice for community-based provision. Today, palliative care is defined as care that begins with the patient's diagnosis, symptom management is carried out effectively, and a comprehensive, supportive, humanistic approach is based on the individual and his family. When the literature was examined, no study was found that evaluated the effectiveness of the training given by the Pecha Kuka method to caregivers caring for palliative care patients about percutaneous endoscopic gastrostomy. In addition, it is thought that the results of this research will shed light on identifying problems related to feeding practices in patients fed with PEG tubes and identifying misinformation and practices of caregivers. Determining the knowledge level and initiatives of caregivers regarding percutaneous endoscopic gastrostomy tube feeding practices will contribute to the development of educational activities and effective strategies. Study results may provide important data regarding improving the quality of care given to patients and caregivers after discharge and controlling complication rates.
### Conditions
- Pecha Kuka
- Palliative Care
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: PREVENTION
### Interventions
- Pecha Kucha
### Outcomes
**Primary Outcomes**
- Evaluation Form for Feeding Practices with Percutaneous Endoscopic Gastrostomy Tube:
- Visual Analog Scale -Anxiety:
**Secondary Outcomes**
### Location
- **Facility**: Fırat university, Elazığ, Center, 25240, Turkey
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## Short Benznidazole Regimen for Chronic Phase Chagas Disease Patients
- **NCT ID**: NCT06339710
- **Study ID**: U1111-1288-5508
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-05-01
- **Completion Date**: 2026-10-30
- **Lead Sponsor**: Evandro Chagas Institute of Clinical Research
### Study Description
Multicentric study on Chagas disease that seeks to evaluate a new treatment regimen using the drug benznidazole. Currently, existing treatment regimens are long and have frequent side effects, which leads to a high dropout rate among patients. The research proposes testing two shorter benznidazole regimens to see if they are as effective as standard treatment, but with fewer side effects.The study will have 672 participants and will be carried out in four locations, Bolivia and Colombia. The objective is to analyze the efficacy and safety of new treatment regimens, evaluating the parasitological response in comparison with standard treatment. In addition, an economic assessment will be carried out to analyze direct and indirect costs, including procedures associated with the management of adverse events.
### Conditions
- Chronic Chagas Disease
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- benznidazole 300 mg daily 8 weeks
### Outcomes
**Primary Outcomes**
- Proportion of participants with sustained negative Polymerase Chain Reaction (PCR) during the 24 months of follow-up after treatment.
**Secondary Outcomes**
- Incidence of Adverse Events (AE) leading to treatment discontinuation during treatment period
- Proportion of participants with positive PCR at different time points
### Location
- **Facility**: Israel Molina, Minas Gerais, Belo Horizonte, N/A, Brazil
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## Short-term Effects of Bowel Preparation on Gut Microbiome in Patients Undergoing Endoscopic Colon Polypectomy
- **NCT ID**: NCT06339697
- **Study ID**: 2022-KY-233
- **Status**: COMPLETED
- **Start Date**: 2022-12-01
- **Completion Date**: 2023-06-30
- **Lead Sponsor**: Zhang Yanli
### Study Description
To investigate the role of different types of laxatives (compounded polyethylene glycol electrolyte dispersions and compounded sodium pico-sulfate) on the composition, evolution and recovery of the gut microbiome of patients with colonic polyps undergoing bowel preparation.
### Conditions
- Colon Polyp
- Cathartic Colon
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: SUPPORTIVE_CARE
### Interventions
- different types of laxatives (compounded polyethylene glycol electrolyte dispersions and compounded sodium pico-sulfate)
### Outcomes
**Primary Outcomes**
- gut microbiome-taxonomy
- gut microbiome-heatmap
- gut microbiome-Alpha Diversity
- gut microbiome-Beta Diversity
- gut microbiome-Functional predictions
**Secondary Outcomes**
- Age
- Gender
- Height
- Weight
- BMI
- Whether the enrollee is a smoker
- Whether the enrollee is a drinker
- Evaluation of the effectiveness of intestinal cleansing Evaluation of the effectiveness of intestinal cleansing
- Gastrointestinal Symptom Score
- adverse event
### Location
- **Facility**: China-Japan Friendship Hospital, Beijing, Beijing, 100029, China
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## HPV Immunological Markers of Cervical Persistent Infection and Oncogenesis
- **NCT ID**: NCT06339684
- **Study ID**: 2021 0075257
- **Status**: ACTIVE_NOT_RECRUITING
- **Start Date**: 2023-03-08
- **Completion Date**: 2026-03-08
- **Lead Sponsor**: Foundation IRCCS San Matteo Hospital
### Study Description
The aim of this observational study is to build an immunological assay to quantify an immunoscore system for clinical practice, which could identify HPV lesions with a risk of persistent cervical infection, which represents the main predictive factor of neoplastic evolution. A pattern of host immunological factors and HPV-related parameters, in order to identify an algorithm of risk stratification and tailoring treatment will be identified. Finally, in patients with HPV infection, a virus specific immunity after vaccination will be quantified, in order to highlight those patients who have the most significant risk of infection persistence.
### Conditions
- HPV-Related Cervical Carcinoma
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
### Outcomes
**Primary Outcomes**
- Analysis plan for primary end-point
**Secondary Outcomes**
- Analysis plan for secondary end-points
### Location
- **Facility**: Fondazione IRCCS Policlinico San Matteo, Pavia, N/A, N/A, Italy
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## Post-operative Complications and Smoking Habits in Colorectal Surgery
- **NCT ID**: NCT06339671
- **Study ID**: PASSAGE
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-04-15
- **Completion Date**: 2025-09-25
- **Lead Sponsor**: IRCCS Ospedale San Raffaele
### Study Description
PASSAGE is a national multicenter retrospective and prospective observational cohort study in which patients who will undergo colorectal surgery will be enrolled.
### Conditions
- Colorectal Disorders
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
### Outcomes
**Primary Outcomes**
- Incidence and severity of postoperative complications surgery in three groups
**Secondary Outcomes**
- Incidence and severity of postoperative complications surgery in NF (non-smokers) group
### Location
- **Facility**: Prof. Pierpaolo Sileri, Milan, N/A, N/A, Italy
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## ICG vs Blue Patent as a Tracer in the Performance of TAD in Patients With cN1 Breast Carcinoma After Neoadjuvant Chemotherapy
- **NCT ID**: NCT06339658
- **Study ID**: TAD-ICG
- **Status**: RECRUITING
- **Start Date**: 2021-01-01
- **Completion Date**: 2026-01-01
- **Lead Sponsor**: Hospital Universitari de Bellvitge
### Study Description
To validate the use of ICG as a tracer during TAD in patients with cN1 breast carcinoma after neoadjuvant chemotherapy.
### Conditions
- Breast Cancer
- Axillary Metastases
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
- Targeted axillary dissection (TAD) by ICG
- Targeted axillary dissection (TAD) by Blue patent
### Outcomes
**Primary Outcomes**
- Detection rate of sentinel lymph node
**Secondary Outcomes**
- Detection rate of sentinel lymph node
- Adverse effects
### Location
- **Facility**: Hospital de Bellvitge, Hospitalet de Llobregat, Barcelona, 08907, Spain
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## Intravesical Platelet-rich Plasma Injection in Patients With Interstitial Cystitis/Bladder-A Retrospective Study
- **NCT ID**: NCT06339645
- **Study ID**: P00003121
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-04-01
- **Completion Date**: 2024-12-31
- **Lead Sponsor**: Hualien Tzu Chi General Hospital
### Study Description
The correlation of safety and effectiveness between intravesical platelet-rich plasma injection in patients with interstitial cystitis/bladder-A retrospective study to evaluate the correlation of safety and effectiveness between intravesical platelet-rich plasma injection of IC/BPS, with age of at least 20-84 years old in Taiwan of either sex with IC/BPS symptoms and proven of IC by cystoscopic hydrodistention. Patients who meet all eligibility requirements for entry into the study of intravesical PRP injection.
### Conditions
- Safety and Effectiveness Between Intravesical Platelet-rich Plasma Injection in Patients With Interstitial Cystitis/Bladder
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
- PRP
### Outcomes
**Primary Outcomes**
- Global response assessment (GRA)
**Secondary Outcomes**
### Location
- **Facility**: Wan Ru Yu, Hualien City, Outside U.S./Taiwan, 970, Taiwan
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## Effects of Transcutaneous Electrical Phrenic Nerve Stimulation and Transcutaneous Electrical Diaphragmatic Stimulation
- **NCT ID**: NCT06339632
- **Study ID**: AVAP-NG 3363
- **Status**: RECRUITING
- **Start Date**: 2024-04-01
- **Completion Date**: 2025-03-01
- **Lead Sponsor**: Hospital Sirio-Libanes
### Study Description
Transcutaneous electrical phrenic nerve stimulation (TEPNS) and transcutaneous electrical diaphragm stimulation (TEDS) are modalities that use surface electrodes placed on the patients' skin to generate action potentials and contractions of the muscle fibers of the diaphragm. The primary objective will be to evaluate the efficacy of TEPNS and TEDS in healthy adult individuals. Secondary objectives will be to assess the feasibility, safety, and level of discomfort reported by the individual resulting from the application of TEPNS and TEDS.
### Conditions
- Diaphragm
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: CROSSOVER
- **Primary Purpose**: TREATMENT
### Interventions
- Transcutaneous electrical phrenic nerve stimulation (TEPNS)
- Transcutaneous electrical diaphragm stimulation (TEDS)
### Outcomes
**Primary Outcomes**
- Diaphragm mobility
- Diaphragm thickness
- Thickening fraction
**Secondary Outcomes**
- Evaluation of sensory discomfort
- Safety of TEPNS and TEDS application
### Location
- **Facility**: Hospital Sírio Libanês, São Paulo, N/A, 01308-050, Brazil
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## Combination Immunotherapy of Adebrelimab With Apatinib and Tegafur for Immune Rechallenge Therapy in Esophageal Squamous Cell Carcinoma
- **NCT ID**: NCT06339619
- **Study ID**: SYSKY-2023-1262-02
- **Status**: RECRUITING
- **Start Date**: 2024-03-11
- **Completion Date**: 2026-09-01
- **Lead Sponsor**: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
### Study Description
The goal of this single-arm study is to explore the efficacy and safety of Adebrelimab in combination with Apatinib and Tegafur for the treatment of locally advanced or metastatic esophageal squamous cell carcinoma that has failed first-line standard treatment with PD-1 inhibitors in combination with chemotherapy.
### Conditions
- Locally Advanced or Metastatic Esophageal Squamous Cell Carcinoma
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: NA
- **Intervention Model**: SINGLE_GROUP
- **Primary Purpose**: TREATMENT
### Interventions
- Adebrelimab
- Apatinib
- Tegafur
### Outcomes
**Primary Outcomes**
- Objective response rate (ORR)
**Secondary Outcomes**
- Progression-free survival (PFS)
- Overall survival (OS)
- ≥Grade 3 AEs
### Location
- **Facility**: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Guangzhou, Guangdong, 510030, China
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## Pregnancy Repository
- **NCT ID**: NCT06339606
- **Study ID**: 4316
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-05-01
- **Completion Date**: 2031-04-30
- **Lead Sponsor**: Sunnybrook Health Sciences Centre
### Study Description
An essential part of clinical research is the availability and accessibility of human biospecimens for the identification of biomarkers, new treatments and measurement of response to therapy. Proteins, RNA and DNA can be extracted and studied as well. This is a critical first step in performing many fundamental molecular biology experiments. A variety of biospecimens are utilized for research including but not limited to normal and malignant tissues, blood, and other body fluids.In order to obtain high-quality biospecimens, they must be acquired serially, stored according to current standards, and matched with clinical information for maximum value. As such, the investigators would like to create a repository of biospecimens collected from pregnant patients who are seen at Mount Sinai Hospital and other research hospitals in Toronto. Mount Sinai provides personnel and infrastructure to serve the largest (7500 births/year) and highest complex Maternity program in Ontario. Of the 7500 patients a year, at least 2500 are considered high risk pregnancies, where there's a possibility of preeclampsia, placenta accreta and a host of other complications. For this study, biological specimens - blood, cervical and placental samples - will be collected from these high-risk groups in order to better understand the causes of the underlying conditions.
### Conditions
- Pregnancy Related
- Fetal Growth Retardation
- Placental Insufficiency
- Preeclampsia
- Cervix; Pregnancy
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
- Biospecimen collection
### Outcomes
**Primary Outcomes**
- Biomarker levels
- Pathology
**Secondary Outcomes**
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
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## Regional Monitoring of CF Lung Disease
- **NCT ID**: NCT06339593
- **Study ID**: 2023-0391
- **Status**: RECRUITING
- **Start Date**: 2024-01-05
- **Completion Date**: 2028-01
- **Lead Sponsor**: Children's Hospital Medical Center, Cincinnati
### Study Description
The main reason for this research study is to learn more about some new tests that are being developing for patients with Cystic Fibrosis (CF) to measure changes in the lungs. In this study, the focus will be to learn how stopping Airway Clearance (ACT) and re-starting ACT can affect these tests. These new tests include using a breathable gas called Xenon (Xe) with MRI (magnetic resonance imaging) to improve the pictures of changes in the lungs. The Xenon (Xe) gas that has been treated to have a larger MRI signal (also called hyperpolarized). The other new test is called LCI (Lung Clearance Index) that can measure how well the lungs are working. The MRI machine used in this study has been approved by the U.S. Food and Drug Administration (FDA) and is commercially available for sale in the USA. Hyperpolarized Xe gas is an FDA-approved, inhaled contrast agent for lung ventilation MRI. The new Xe MRI techniques that are being developed and used for this research study are investigational, meaning these new Xe MRI techniques are not FDA approved, but they are similar to FDA-approved techniques that are used clinically at Cincinnati Children's Hospital Medical Center (CCHMC). Xe gas and the new MRI techniques used in this research study have been used for many years in research, including in many research studies conducted at CCHMC like this one.
### Conditions
- Cystic Fibrosis
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
- Hyperpolarized Xe129
### Outcomes
**Primary Outcomes**
- Assessing structural and functional lung abnormalities via Xenon MRI
**Secondary Outcomes**
- Assessing patients who have self-withdrawn airway clearance treatment to determine ventilation abnormalities.
### Location
- **Facility**: Cincinnati Children's Hospital, Cincinnati, Ohio, 45229, United States
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## Assessment of Volume-targeted Ventilation in Patients With Neuromuscular Disease
- **NCT ID**: NCT06339580
- **Study ID**: 324456
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-04
- **Completion Date**: 2026-04
- **Lead Sponsor**: Guy's and St Thomas' NHS Foundation Trust
### Study Description
Assessment of safety and efficacy of volume-targeted ventilation in patients with neuromuscular disease.
### Conditions
- Neuromuscular Diseases
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: NA
- **Intervention Model**: SINGLE_GROUP
- **Primary Purpose**: TREATMENT
### Interventions
- Volume-targeted non-invasive ventilation
### Outcomes
**Primary Outcomes**
- Mean overnight transcutaneous carbon dioxide
**Secondary Outcomes**
- Maximum overnight transcutaneous carbon dioxide
- Overnight desaturation index
- Visual analogue scale of sleep comfort
- Health-related quality of life
- Adherence to ventilation
### Location
- **Facility**: Guy's and St. Thomas NHS Foundation Trust, London, N/A, SE1 7EH, United Kingdom
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## Evaluation of the Venous Thrombotic Biological Profile of Different PCOS Phenotypes: French Cross-sectional Study
- **NCT ID**: NCT06339567
- **Study ID**: 671_Hemo-PCOS
- **Status**: RECRUITING
- **Start Date**: 2024-02-08
- **Completion Date**: 2029-02-07
- **Lead Sponsor**: Fondation Hôpital Saint-Joseph
### Study Description
Polycystic ovary syndrome (PCOS) is the most common endocrine disorder of women of childbearing age. PCOS can be individualized into several phenotypes, taking into account in particular the presence of hyperandrogenism, insulin resistance and BMI. Hyperandrogenism and insulin resistance appear to be important factors in the development of cardiovascular cardiovascular disease. In addition, patients frequently use anti-androgenic and/or contraceptive treatments contraceptives, such as combined hormonal contraception (CHC), the use of which is associated with an increased cardiovascular and thrombo and venous thrombosis (VTE). A meta-analysis published in 2020 by Gariani et al.based on three large studies, estimated the risk of VTE in women with PCOS after adjustment for obesity and hormone therapy. This risk was significantly higher compared with women without PCOS (pooled OR 1.89, CI95% 1.60-2.24). No study has looked specifically investigated the risk of VTE according to different PCOS phenotypes. Such data would be very useful in clinical practice, as it would enable monitoring, contraceptive treatment and anti-androgenic anti-androgen treatment according to the PCOS phenotype, while limiting risks. Assessing the differences PCOS phenotypes is limited by the large sample size required. required. VTE is a rare event in women of childbearing age, and the number of PCOS phenotypes is high.PCOS phenotypes. Intermediate markers of VTE risk are used in these situations. These markers are thrombin generation tests (notably ETP) and their sensitivity to activated protein C (nAPCsr) and thrombomodulin (nTMsr), as well as sex-hormone binding globulin (SHBG).
### Conditions
- Polycystic Ovary Syndrome
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: NA
- **Intervention Model**: SINGLE_GROUP
- **Primary Purpose**: DIAGNOSTIC
### Interventions
- Thrombotic profile
### Outcomes
**Primary Outcomes**
- biological procoagulant profile
**Secondary Outcomes**
- Insuline resistance and weight
- comparison of procoagulant profile depending on insulin resistance
- comparison of procoagulant profile depending on hyperangrogenism
- comparison of procoagulant profile depending on PCOS phenotype
- comparison of procoagulant profile depending on AMH Rate
- comparison of QoL score depending on PCOS phenotype
### Location
- **Facility**: Hôpital Paris Saint Joseph, Paris, N/A, N/A, France
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## Alectinib-induced Endocrine Toxicity
- **NCT ID**: NCT06339554
- **Study ID**: 4806
- **Status**: COMPLETED
- **Start Date**: 2018-10-12
- **Completion Date**: 2023-10-30
- **Lead Sponsor**: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
### Study Description
The experimental Cohort A (male ALK+ ANSCLC patients receiving alectinib), the control Cohort B (female ALK+ ANSCLC patients receiving alectinib) and control Cohort C (male NON-ALK ANSCLC patients) were prospectively evaluated for full hormone assessment of androgen deficiency, AT 8 weeks after treatment start and in case of reported suspected symptoms. Patients with major sexual dysfunctions were referred to endocrinologist.
### Conditions
- NSCLC Stage IV
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
- Alectinib 150 MG [Alecensa]
### Outcomes
**Primary Outcomes**
- Incidence of endocrine toxicity in overall ALK-positive
- Incidence of symptomatic hypogonadism in male ANSCLC patients
**Secondary Outcomes**
### Location
- **Facility**: Fondazione Policlinico Gemelli IRCCS, Rome, N/A, 00168, Italy
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## The ACC Preclinical Research Platform for Precision Oncology
- **NCT ID**: NCT06339541
- **Study ID**: 029-FPO23
- **Status**: RECRUITING
- **Start Date**: 2023-06-05
- **Completion Date**: 2024-12-01
- **Lead Sponsor**: Fondazione del Piemonte per l'Oncologia
### Study Description
The ACC Preclinical Research Platform for Precision Oncology is a retrospective and prospective observational study focused on the implementation and validation of the application of PDCM (Patient Derived Cancer Models) generated from tissues or cells of patients with neoplastic disease, as a tool to improve molecular and biological knowledge of tumours and to test the efficacy and sensitivity of pharmacological treatments.
### Conditions
- Solid Tumor
- Hematologic Neoplasms
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
### Outcomes
**Primary Outcomes**
- number of PDCM (patient derived cancer models)
- number of Whole Exome Sequencing (WES) e RNA-seq performed
**Secondary Outcomes**
- number of PDCM shared within the network
### Location
- **Facility**: Fondazione del Piemonte per l'Oncologia-IRCCS Candiolo, Candiolo, Turin, 10060, Italy
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## Potential of Vojta's Reflex Locomotion as a Pre/Induction Method for Uterine Activity: a Pilot Study
- **NCT ID**: NCT06339528
- **Study ID**: EK-VPl421012021
- **Status**: COMPLETED
- **Start Date**: 2021-06-23
- **Completion Date**: 2024-03-01
- **Lead Sponsor**: Faculty Hospital Kralovske Vinohrady
### Study Description
The Vojta's method is neurophysiological rehabilitation method used to support and induce reflex responses of locomotor and vegetative system. It uses involuntary motor reaction of the body during pressure stimulation of so-called trigger zones. Pregnancy is currently considered a contraindication for using Vojta's therapy to potential risks of inducing regular uterine activity and risk of delivery. The aim of the study is to evaluate changes in uterine activity and also explore the possibility of using this method as a new approach for pre/induction of delivery.
### Conditions
- Induced Vaginal Delivery
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- Vojta's Reflex Locomotion
- Sham stimulation
### Outcomes
**Primary Outcomes**
- Cardiotocographic (CTG) recordings -
- subjective perception during stimulation
**Secondary Outcomes**
### Location
- **Facility**: Faculty Hospital Kralovske Vinohrady, Praha, N/A, 11000, Czechia
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## Teaching School Health Nursing Course With Universal Design Model
- **NCT ID**: NCT06339515
- **Study ID**: DuzceU-SBF-NYS-02
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-03-21
- **Completion Date**: 2025-12-01
- **Lead Sponsor**: Duzce University
### Study Description
The aim of this study is to design, implement and evaluate the School Health Nursing course in the undergraduate nursing program using the universal design model.
### Conditions
- Nursing Education
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: NA
- **Intervention Model**: SINGLE_GROUP
- **Primary Purpose**: OTHER
### Interventions
- Universal Design Model
### Outcomes
**Primary Outcomes**
- Critical Thinking Disposition Scale
- Communication Skills Scale
- Healthy Living Awareness
**Secondary Outcomes**
### Location
- **Facility**: Nuriye Yıldırım, Düzce, Duzce, 81620, Turkey
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## The Effect of the Use of Jigsaw Technique on Nursing Students' Critical Article Reviews and Students' Opinions
- **NCT ID**: NCT06339502
- **Study ID**: Duzce-U-merve0002
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-03-22
- **Completion Date**: 2024-05-24
- **Lead Sponsor**: Duzce University
### Study Description
Studies have proven that the Jigsaw learning method, one of the innovative learning methods, is an effective educational learning tool for nursing students. For nursing education to be sufficient to provide students with the modern roles required by the profession, students must actively learn instead of a memorized undergraduate education. -Training programs should enable them to participate in the teaching process. One of these programs is cooperative learning methods. The jigsaw learning technique creates a contemporary learning model by creating a positive learning environment, individualizing students and developing a sense of responsibility. No scientific literature has been found regarding the effect of the Jigsaw learning method on teaching critical article reading skills in nursing research courses in nursing education. It is assumed that the data obtained in this study will contribute to the effect of critical article reading training given using the Jigsaw technique, one of the cooperative learning techniques in nursing education, on students' critical article reviews and opinions about the technique.
### Conditions
- Education, Distance
- Students, Nursing
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: BASIC_SCIENCE
### Interventions
- Jigsaw Technique
### Outcomes
**Primary Outcomes**
- Critical Thinking Disposition Scale
- The Kolb Learning Style Inventory-III
- Self Directed Learning Skills Scale
**Secondary Outcomes**
### Location
- **Facility**: Duzce University, Duzce, N/A, 81100, Turkey
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## The Bone Metabolism Characteristics of Premature Ovarian Insufficiency
- **NCT ID**: NCT06339489
- **Study ID**: 2022DZMEC-PG-34
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-04-01
- **Completion Date**: 2025-02-01
- **Lead Sponsor**: Shi Yun
### Study Description
Explore the bone metabolism characteristics of premature ovarian insufficiency.
### Conditions
- Premature Ovarian Insufficiency
- Bone Diseases, Metabolic
- Bone Mineral Density
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
- Testing the serum levels of bone metabolic markers
### Outcomes
**Primary Outcomes**
- tartrate resistant acid phosphatase-5b, TRACP-5b
**Secondary Outcomes**
- bone specific alkaline phosphatase, BALP
- bone mineral density, BMD
### Location
- **Facility**: Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, N/A, N/A, China
@@
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## Exploring the Complex Links Between Menstrual Irregularity and Cellular Markers
- **NCT ID**: NCT06339476
- **Study ID**: Dilara ÜLGER ÖZBEK
- **Status**: COMPLETED
- **Start Date**: 2023-06-01
- **Completion Date**: 2024-03-24
- **Lead Sponsor**: Cumhuriyet University
### Study Description
A cross-sectional study design was employed, involving 56 premenopausal participants with ages ranging from 20 to 49 years. Serum samples were collected during the early follicular phase, and levels of some biochemicals parameters analyzed.
### Conditions
- Menstrual Irregularity
- Menstrual Cycle Abnormal
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: NON_RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: HEALTH_SERVICES_RESEARCH
### Interventions
- Serum ADMA, MDA and M30 levels mesurment
### Outcomes
**Primary Outcomes**
- ADMA, M30 and MDA levels mesurment in the blood serum to compare between patient and control.
**Secondary Outcomes**
### Location
- **Facility**: Sivas Cumhuriyet University Hospital, Sivas, Centre, 58050, Turkey
@@
|
## Self-Distancing for Pediatric Anxiety and OCD
- **NCT ID**: NCT06339463
- **Study ID**: AAAU7985
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-05
- **Completion Date**: 2025-05
- **Lead Sponsor**: Columbia University
### Study Description
Self-Distancing is a cognitive technique that involves shifting perspective away from first person to promote an adaptive, self-reflective stance in emotionally charged situations. This trial aims to help learn how self-distancing may increase approach during exposure and thereby improve treatment response. To find out if self-distancing works by helping children approach fear inducing stimuli, the study will look at behaviors related to approach as well as symptom severity, before, after and during treatment.The study hypothesizes that Self-Distancing will produce greater increases in approach behaviors and greater decreases in anxiety severity than in the Classic Exposure.
### Conditions
- Anxiety Disorders
- Obsessive-Compulsive Disorder
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- Self-Distancing (EXSD)
- Classic Exposure (EXC)
### Outcomes
**Primary Outcomes**
- Treatment Engagement and Adherence Ratings (TEARS)
**Secondary Outcomes**
- Anxiety Disorders Interview Schedule for DSM-5 (ADIS) Clinical Severity Rating (CSR)
### Location
- **Facility**: Columbia University Irving Medical Center, New York, New York, 10019, United States
@@
|
## Real World Environmental Exposure Study With Healthy and Cystic Fibrosis Subjects
- **NCT ID**: NCT06339450
- **Study ID**: ExpoCF
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-05-01
- **Completion Date**: 2027-12-31
- **Lead Sponsor**: Centre Hospitalier Intercommunal Creteil
### Study Description
Cystic fibrosis (CF) is the most common autosomal recessive disease that leads to early mortality in Caucasians and affects around 7500 patients in France. Progression of the disease depends on pulmonary exacerbations defined as acute deterioration of respiratory symptoms which ultimately impair lung function and quality of life. Most frequently caused by lung bacterial infections, exacerbations' effects include increased cough, increased sputum production, increased use of antibiotics, dyspnea and decreased lung function. The phenotypic variability of CF suggests the implication of other contributors especially to the CF airway disease. Beside genetic and epigenetic alterations, environmental factors - e.g tobacco smoke, air pollution, temperature changes, food intake - appear as relevant candidates. A previous review has discussed current knowledge on the effects of air pollution on the course of CF disease. Although scarce, the existing epidemiological andexperimental literature suggests a link between exposure to air pollutants and adverse health effects.Although scarce, the existing epidemiological and experimental literature suggests a link between exposure to air pollutants and adverse health effects. The EU sponsored REMEDIA project (Impact of exposome on the course of lung diseases, Grant agreement ID 874753) contributes to the understanding of the influence of the exposome on chronic obstructive pulmonary disease (COPD) and CF. Objective of work package 3 within the REMEDIA project is the development of a mobile environmental sensor toolbox that is capable to assess the external exposome. The biomarkertoolbox was developed and tested in a proof-of-concept study carried out in healthy volunteers. The next step is to validate the collectionof exhaled breath condensate (EBC) in a real-life study. In this aim, the objective of the present study will be to assess the feasibility of EBC collection in CF patients and healthy individuals
### Conditions
- Cystic Fibrosis, Pulmonary
- Environmental Exposure
- Exhaled Breath Condansate
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: NON_RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: OTHER
### Interventions
- walk tours
### Outcomes
**Primary Outcomes**
- Collection of exhaled breath condensate (EBC) for biomarker analysis
- Collection of exhaled breath condensate (EBC) for biomarker analysis
- Collection of exhaled breath condensate (EBC) for biomarker analysis
- Collection of exhaled breath condensate (EBC) for biomarker analysis
- Collection of exhaled breath condensate (EBC) for biomarker analysis
- Collection of exhaled breath condensate (EBC) for biomarker analysis
**Secondary Outcomes**
- Dysfunction or misused, failure, of EBC and sensor device
- Show correlation of biomarker signal with environmental sensor system in a clinical challenge setting in healthy and CF patients.
- Describe differences in CF subjects vs. healthy controls
- Impact of environment exposome on health status and lung function
- Show correlation of biomarker signal with environmental sensor system in a clinical challenge setting in healthy and CF patients.
- Describe differences in CF subjects vs. healthy controls
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
@@
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## Enhanced Recovery After Cholecystectomy
- **NCT ID**: NCT06339437
- **Study ID**: Adeel3
- **Status**: COMPLETED
- **Start Date**: 2023-04-01
- **Completion Date**: 2023-11-01
- **Lead Sponsor**: Children Hospital and Institute of Child Health, Lahore
### Study Description
this study will be conducted involving patients of all genders between the ages of 20 and 60 years who will undergo elective laparoscopic cholecystectomy for uncomplicated symptomatic gallstone disease. The study will be conducted in Department of West Surgical Ward, Mayo Hospital, Lahore, after receiving approval from the hospital's Ethical Committee. Patients having other co-morbid conditions, pregnant patients, and those undergoing laparoscopic cholecystectomy converted to open surgery will be excluded from the study. LFTs and other baseline investigations will be done routinely of every patient. Written informed consent will be obtained from all the patient. Patients will be divided into two groups with 30 patients in each group. Group A will consist of patient in whom ERAS protocol will be implemented and Group B in whom ERAS protocol will not be implemented.
### Conditions
- Cholelithiases
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: SUPPORTIVE_CARE
### Interventions
- ERAS Protocol
### Outcomes
**Primary Outcomes**
- PONV
- Visual Analogue Scale score
**Secondary Outcomes**
### Location
- **Facility**: The Children Hospital, Lahore, Punjab, 42000, Pakistan
@@
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## Atezolizumab and Bevacizumab With Photon Radiotherapy for Unresectable Hepatocellular Carcinoma
- **NCT ID**: NCT06339424
- **Study ID**: 202400156A3
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-03-29
- **Completion Date**: 2031-03-30
- **Lead Sponsor**: Chang Gung Memorial Hospital
### Study Description
Atezolizumab (anti-programmed death-ligand 1; anti-PD-L1) in conjunction with bevacizumab (anti-vascular endothelial growth factor; anti-VEGF) has become the established standard first-line systemic treatment for unresectable hepatocellular carcinoma (HCC). Despite an improved objective response rate (ORR) of 27%, the majority of patients face HCC progression and liver failure \[Finn et al., N Engl J Med 2020\]. Developing a new combined treatment strategy to overcome resistance to anti-PD-L1 and anti-VEGF is essential to improve patient outcomes.Radiation treatment (RT) is highly efficacious in controlling localized solid tumors and has become an integral component of the treatment algorithm for unresectable HCC. Importantly, a recent retrospective cohort described that RT combined with atezolizumab plus bevacizumab was associated with favorable median overall survival of 16.1 months (Manzar et al, Cancers 2022). Our preclinical study (Hsieh et al., Science Immunology 2022) revealed that RT combined with PD-L1/PD-1 blockade induces immunogenic cell death and tumor antigen cross-presentation in antigen-presenting cells, thereby potentiating the systemic antitumor T cell responses in murine tumor models. However, whether the combinatorial therapy with RT, atezolizumab, and bevacizumab can trigger synergistic antitumor effects and systemic immune mobilization has not yet been validated in clinical trials for unresectable HCC.Both atezolizumab/bevacizumab and X-ray RT are approved treatment methods for unresectable HCC by the U.S. and Taiwan Food and Drug Administration (FDA). The present phase II non-randomized trial aims to prospectively document the therapeutic efficacy, safety, and immunological responses in patients with unresectable HCC treated with atezolizumab/bevacizumab combined with conventional photon radiotherapy.
### Conditions
- Hepatocellular Carcinoma
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: NA
- **Intervention Model**: SINGLE_GROUP
- **Primary Purpose**: TREATMENT
### Interventions
- Atezolizumab
- Bevacizumab
- Photon radiotherapy
### Outcomes
**Primary Outcomes**
- Progression free survival (PFS)
**Secondary Outcomes**
- Local control (LC)
- Time to progression (TTP)
- Overall Response Rate (ORR)
- Overall survival (OS)
- Incidence and severity of adverse events
### Location
- **Facility**: Chang Gung Memorial Hospital at Linkou, Taoyuan City, N/A, 333, Taiwan
@@
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## Exploring Cerebrolysin in Late Thrombectomy for Stroke: Blood-brain Barrier Biomarkers and Imaging Insights
- **NCT ID**: NCT06339411
- **Study ID**: 202302239A3
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-05-01
- **Completion Date**: 2027-07-31
- **Lead Sponsor**: Chang Gung Memorial Hospital
### Study Description
Background:Stroke is a leading cause of mortality and disability globally, with acute ischemic strokes(AIS) due to Large Vessel Occlusion (LVO) presenting significant treatment challenges. Mechanical thrombectomy (MT) has emerged as an effective intervention for AIS within an 8-hour window from symptom onset. However, the potential to extend this window up to 24 hours for select patients could revolutionize outcomes for those arriving late at comprehensive stroke centers. This study investigates the efficacy and safety of Cerebrolysin as an adjunct therapy to MT in extended time window and improving patient recovery.Methods:We conducted a multi-center, prospective, randomized study within the Chang Gung Memorial Hospital system in Taiwan, targeting 100 AIS patients eligible for MT beyond the traditional 8-hour window. Participants were randomized to receive either standard care or Cerebrolysin post-MT, initiated within 24 hours of stroke onset and continued for 14 days. The study assessed neurological, neuropsychological, and biomarker outcomes at multiple time points post-stroke to evaluate the effects of Cerebrolysin on recovery.Results:The primary outcome will measure the proportion of patients achieving favorable functional outcomes (modified Rankin Scale 0-2) at 90 days. Secondary outcomes include the impact of Cerebrolysin on secondary hemorrhagic transformation, brain edema, mortality rates, and quality of life. The study aims to provide comprehensive data on the benefits of adding Cerebrolysin to the standard post-MT care, focusing on its potential to protect against reperfusion injuries and maintain blood-brain barrier integrity.Conclusion:By evaluating the role of Cerebrolysin in conjunction with MT, this study aims to extend the therapeutic window for AIS treatment, offering hope for improved outcomes for patients who would otherwise be ineligible for current reperfusion therapies. The findings may pave the way for new guidelines in stroke management, emphasizing the importance of integrated care approaches in enhancing patient recovery.
### Conditions
- Acute Ischemic Stroke
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- Cerebrolysin
### Outcomes
**Primary Outcomes**
- Functional Recovery and Complication Rates Post-Thrombectomy
**Secondary Outcomes**
- Imaging and High cortical Functional Assessment Endpoints
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
@@
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## To Evaluate the Dose-response Effects of a Defined Volume of Physical Exercise on the Change of Peripheral Biomarkers, Clinical Response and Brain Connectivity in Parkinson's Disease: a Prospective, Observational, Cohort Pilot Study
- **NCT ID**: NCT06339398
- **Study ID**: 002-2023
- **Status**: ENROLLING_BY_INVITATION
- **Start Date**: 2024-05
- **Completion Date**: 2028-05-31
- **Lead Sponsor**: Casa di Cura San Raffaele Cassino
### Study Description
This is a prospective, observational, cohort pilot study of standardize volume of aerobic exercise on changes in BDNF concentration at 4-weeks of exercise training among Parkinson disease patients.Thirty (N=30) participants will be consecutively enrolled and assigned to 2 groups: 1) Extensive Rehabilitation Group (exercise volume: 180 METs-min/week) or 2) Intensive Rehabilitation Group (exercise volume: 1350 METs-min/week).The primary objective is to evaluate the dose-response effects of two different rehabilitation settings, characterized by different workload (measured as energy expenditure), on blood BDNF levels.
### Conditions
- Parkinson Disease
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
- Aerobic exercise
### Outcomes
**Primary Outcomes**
- Change in Brain-derived neurotrophic (BDNF) concentration assessed in peripheral blood samples (ng/mL)
- Change in Brain-derived neurotrophic (BDNF) concentration assessed in peripheral blood samples (ng/mL)
- Change in Brain-derived neurotrophic (BDNF) concentration assessed in peripheral blood samples (ng/mL)
**Secondary Outcomes**
- Change in peripheral biomarker Insulin-like Growth Factor-1 (IGF-1)
- Change in peripheral biomarker Insulin-like Growth Factor-1 (IGF-1)
- Change in peripheral biomarker Insulin-like Growth Factor-1 (IGF-1)
- Change in peripheral biomarker Fibronectin type III domain-containing protein 5 (FNDC5)/Irisin
- Change in peripheral biomarker Fibronectin type III domain-containing protein 5 (FNDC5)/Irisin
- Change in peripheral biomarker Fibronectin type III domain-containing protein 5 (FNDC5)/Irisin
- Change in peripheral biomarker of inflammation
- Change in peripheral biomarker of inflammation
- Change in peripheral biomarker of inflammation
- Change in platelet distribution width (PDW) and number of platelets assessed by peripheral blood samples
- Change in platelet distribution width (PDW) and number of platelets assessed by peripheral blood samples
- Change in platelet distribution width (PDW) and number of platelets assessed by peripheral blood samples
- Change in blood lactate levels assessed using finger-stick capillary blood samples
- Change in gut microbial diversity (species diversity %) assessed by next-generation sequencing (NGS) of the V3-V4 region of the 16S rDNA gene
- Change in motor symptoms - MDS-UPDRS part II
- Change in motor symptoms - MDS-UPDRS part II
- Change in motor symptoms - MDS-UPDRS part II
- Change in motor symptoms - MDS-UPDRS part III
- Change in motor symptoms - MDS-UPDRS part III
- Change in motor symptoms - MDS-UPDRS part III
- Change in motor symptoms - MDS-UPDRS part IV
- Change in motor symptoms - MDS-UPDRS part IV
- Change in motor symptoms - MDS-UPDRS part IV
- Change in movement analysis - stride length
- Change in movement analysis - stride length
- Change in movement analysis - stride length
- Change in movement analysis - cadence
- Change in movement analysis - cadence
- Change in movement analysis - cadence
- Change in movement analysis - propulsion
- Change in movement analysis - propulsion
- Change in movement analysis - propulsion
- Change in movement analysis - Time Up and Go (TUG)
- Change in movement analysis - Time Up and Go (TUG)
- Change in movement analysis - Time Up and Go (TUG)
- Change in walking capacity
- Change in walking capacity
- Change in walking capacity
- Change in postural instability
- Change in postural instability
- Change in postural instability
- Change in cognitive function - Montreal Cognitive Assessment (MoCA)
- Change in cognitive function - Montreal Cognitive Assessment (MoCA)
- Change in cognitive function - Montreal Cognitive Assessment (MoCA)
- Change in cognitive function - Mini-Mental Examination (MMSE)
- Change in cognitive function
- Change in cognitive function
- Change in cognitive function - Frontal Assessment Battery (FAB)
- Change in cognitive function - Frontal Assessment Battery (FAB)
- Change in cognitive function - Frontal Assessment Battery (FAB)
- Change in severity of depressive symptomatology
- Change in severity of depressive symptomatology
- Change in severity of depressive symptomatology
- Change in non-motor symptoms
- Change in non-motor symptoms
- Change in non-motor symptoms
- Change in motor fluctuations
- Change in motor fluctuations
- Change in motor fluctuations
- Change in quality of life
- Change in quality of life
- Change in quality of life
- Change in cortical activity
- Change in cortical activity
- Change in Brain Connectivity
- Change in Brain Connectivity
### Location
- **Facility**: San Raffaele Cassino, Cassino, Frosinone, 03043, Italy
@@
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## Management of PADIS in Emergency Intensive Care Unit
- **NCT ID**: NCT06339385
- **Study ID**: KY 2020-153-02
- **Status**: COMPLETED
- **Start Date**: 2021-06-13
- **Completion Date**: 2021-08-12
- **Lead Sponsor**: Capital Medical University
### Study Description
Investigate the prevalence of PADIS in EICU, as well as the awareness and clinical implementation status of medical staff towards PADIS.The investigators conducted a multicenter cross-sectional survey in mainland China, including a one-day point prevalence investigation and a questionnaire survey. The inclusion criteria encompassed all adult patients admitted to the participating emergency department intensive care units (EDICUs) during the on-site screening, while exclusion criteria comprised patients aged less than 18 years, EDICU stays duration less than 24 hours before the screening, and participation in other concurrent trials. Hospital and nursing records from the 24 hours preceding enrollment were examined to document the assessment rate of pain, agitation-sedation, and delirium. Physicians and nurses on duty 24 hours before the patients\' enrollment was invited to complete the questionnaire survey regarding the ICU profiles, professional expertise, assessment and treatment of PAD, early mobilization, and sleep improvement practices.
### Conditions
- Pain
- Agitation, Emergence
- Delirium
- Critical Illness
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
- PADIS assessment
### Outcomes
**Primary Outcomes**
- PADIS assessment rate
**Secondary Outcomes**
- Rates of analgesic and sedative administration
- Rate of accidental removal of the catheter during the EICU stay
- EDICU length of stay
- The hospital length of stay
### Location
- **Facility**: Beijing Tiantan hospital, Beijing, Beijing, 100070, China
@@
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## Perioperative Supplementation With Immunonutrition and Its Impact on Surgical Outcome and Pain in Oral Cavity or Mandibular Tumours
- **NCT ID**: NCT06339372
- **Study ID**: AP1912-30102
- **Status**: COMPLETED
- **Start Date**: 2023-02-01
- **Completion Date**: 2023-08-01
- **Lead Sponsor**: Cairo University
### Study Description
The aim of this study was to investigate the effect of adding omega 3 and dipeptiven to standard feeding in head and neck patients who will undergo oral cavity tumour resection or mandibular tumour resection (immunonutrrition mixture) on wound infection, fistula formation and length of hospital stay ,total dose of intraoperative and postoperative opioids (opioid consumption and pain incidence ,mortality and other postoperative complications as urinary tract infection (UTI) and pneumonia.
### Conditions
- Immunonutrition
- Surgical Outcome
- Pain
- Oral Cavity
- Mandibular Tumor
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: SUPPORTIVE_CARE
### Interventions
- Standard feeding
- Omega 3 and dipeptiven
### Outcomes
**Primary Outcomes**
- The incidence of wound infection
**Secondary Outcomes**
- Fistula formation
- Length of hospital stay
- Total dose of intraoperative opioids
- Total dose of postoperative opioids
- Degree of pain
- The incidence of mortality
- The incidence of complications
### Location
- **Facility**: Cairo University, Cairo, N/A, 11796, Egypt
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