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## GIST Oral Paclitaxel(Liporaxel)
- **NCT ID**: NCT06326346
- **Study ID**: AMC2401
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-06-01
- **Completion Date**: 2027-03-31
- **Lead Sponsor**: Asan Medical Center
### Study Description
The purpose of this study is to evaluate safety and efficacy of Liporaxel for patients with GIST who failed on prior standard treatments, including imatinib, sunitinib, and regorafenib, and with low P-glycoprotein expression.
### Conditions
- Gastrointestinal Stromal Tumors
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: NA
- **Intervention Model**: SINGLE_GROUP
- **Primary Purpose**: TREATMENT
### Interventions
- Liporaxel
### Outcomes
**Primary Outcomes**
- 16 week disease control rate
**Secondary Outcomes**
- Progression-free survival
- Overall survival
- Objective response rate
- Adverse event assessed by NCI-CTCAE Version 5.0
### Location
- **Facility**: Asan Medical Center, University of Ulsan College of Medicine, Seoul, Songpagu, 138-736, Korea, Republic of
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## Combination of Parasternal and Serratus Anterior Plane Block in Coronary Artery Bypass Graft Surgery
- **NCT ID**: NCT06326333
- **Study ID**: E.Kurul-E2-24-6176
- **Status**: COMPLETED
- **Start Date**: 2024-02-07
- **Completion Date**: 2024-04-18
- **Lead Sponsor**: Ankara City Hospital Bilkent
### Study Description
Postoperative analgesia is a critical risk factor for the development of pulmonary and cardiovascular complications in coronary artery bypass graft (CABG) surgery. If patients with high pain levels cannot breathe effectively, it may lead to atelectasis, cardiac ischemia, and arrhythmias. This prolongs the time it takes for patients to be discharged and increases the frequency of postoperative pulmonary complications and postoperative morbidity.In addition to intravenous medications, various neuraxial and peripheral nerve blocks can be used in cardiac surgery. In recent years, neuraxial anesthesia has been avoided due to the use of intraoperative high-dose heparin. As an alternative, peripheral nerve blocks have recently gained popularity. Parasternal block (PSB) and serratus anterior plane block (SAPB) are very superficial and easy to reach. Recently, in the literature, the number of cases performed with these blocks under ultrasound guidance and the number of randomized controlled prospective studies have increased.With this study, it was aimed to observe the analgesic effects on both the sternum and the drain site by applying PSB and SAPB applications simultaneously in the postoperative analgesia of CABG patients.
### Conditions
- Parasternal Block
- Serratus Anterior Plane Block
- Acute Pain
- Postoperative Analgesia
- Cardiac Surgery
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: NA
- **Intervention Model**: SINGLE_GROUP
- **Primary Purpose**: TREATMENT
### Interventions
- Combined parasternal block and serratus anterior plane block
### Outcomes
**Primary Outcomes**
- Pain Scores
- Pain Scores
- Pain Scores
- Pain Scores
- Pain Scores
**Secondary Outcomes**
- Remifentanyl Consumption
### Location
- **Facility**: Ankara City Hospital, Çankaya, Ankara, 06290, Turkey
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## Combined SAPB in MICS
- **NCT ID**: NCT06326320
- **Study ID**: E.Kurul-E2-24-6175
- **Status**: RECRUITING
- **Start Date**: 2024-02-07
- **Completion Date**: 2024-05-17
- **Lead Sponsor**: Ankara City Hospital Bilkent
### Study Description
Minimally invasive cardiac surgery (MICS) has begun to be performed frequently in recent years. Compared to sternotomy, MISC reduces the risk of mediastinitis, leaves a more aesthetic scar, facilitates postoperative rehabilitation, and shortens the hospital stay. MICS requires a thoracic incision in the right 4th or 5th intercostal space. This incision causes intense and long-lasting pain in the postoperative period. Pain is exacerbated by breathing movements, coughing, and respiratory physiotherapy.Postoperative analgesia is a critical risk factor for the development of pulmonary and cardiovascular complications in any type of cardiothoracic surgery. If patients with high pain levels cannot breathe effectively, it may lead to atelectasis, cardiac ischemia, and arrhythmias. This prolongs the time it takes for patients to be discharged and increases the frequency of postoperative pulmonary complications and postoperative morbidity.In addition to intravenous medications, various neuraxial and peripheral nerve blocks can be used in cardiac surgery. In recent years, thoracic epidural analgesia has been avoided due to the use of intraoperative high-dose heparin. As an alternative, peripheral nerve blocks have recently gained popularity. SAPB is one of them. SAPB can be applied in three ways. While deep SAPB (DSAPB) is applied under the serratus anterior muscle, superficial SAPB (SSAPB) is applied above the serratus anterior muscle. Combined SAPB (CSAPB) is applied both below and above the serratus anterior muscle. These blocks can be performed with a single injection anywhere between the second and seventh ribs on the lateral chest wall.In this study, the analgesic effects of ultrasound-guided CSAPB application in patients undergoing MICS will be evaluated.
### Conditions
- Serratus Anterior Plane Block
- Acute Pain
- Postoperative Analgesia
- Minimal Invasive Cardiac Surgery
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: NA
- **Intervention Model**: SINGLE_GROUP
- **Primary Purpose**: TREATMENT
### Interventions
- Combined SAPB
### Outcomes
**Primary Outcomes**
- Pain Scores
- Pain Scores
- Pain Scores
- Pain Scores
- Pain Scores
**Secondary Outcomes**
- Remifentanyl Consumption
### Location
- **Facility**: Ankara City Hospital, Çankaya, Ankara, 06290, Turkey
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## Effectiveness of Puppet Modeling Technique on Children Undergoing Stressful Dental Procedures
- **NCT ID**: NCT06326307
- **Study ID**: 247-05-21
- **Status**: COMPLETED
- **Start Date**: 2023-01-01
- **Completion Date**: 2023-12-01
- **Lead Sponsor**: King Abdulaziz University
### Study Description
The goal of this RCT is to compare puppet modeling technique vs tell show and do on children undergoing stressful dental procedures'* The main question\[s\] it aims to answer are: 1. To compare the effect of puppet modeling vs tell show and do on the cooperation of children during the administration of local anesthesia. 2. To compare the effect of puppet modeling vs tell show and do on the anxiety level of children during the administration of local anesthesia.type of study: clinical trial participant population/health conditions: HealthyIn this randomized crossover clinical trial, study subjects were randomly allocated into two groups:* Group I : Children who received puppet behavior guidance during their first visit and tell-show-do guidance in their second visit, 2 weeks later. (P-TSD)* Group II : Children who received the tell-show-do behavior guidance during their first visit and puppet behavioral guidance in their second visit, 2 weeks later.(TSD-P)
### Conditions
- Behavioral Guidance in Pediatric Dentistry
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: CROSSOVER
- **Primary Purpose**: TREATMENT
### Interventions
- Tell Show and Do Guidance
- Puppet Guidance
### Outcomes
**Primary Outcomes**
- Heart rate
- Facial Image Scale
- Vehnam Anxiety Rating Scale
- Frankl behavior rating scale
- FLACC Pain scale
- Venham Scale of Dental behavior
**Secondary Outcomes**
### Location
- **Facility**: King Abulaziz university dental hospital, Jeddah, Makkah, 21589, Saudi Arabia
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## Assessment of the Effectiveness of TA Versus LEEP for Cervical Cancer Risk Reduction in WLHIV in Mozambique
- **NCT ID**: NCT06326294
- **Study ID**: 727/CNBS/23
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-04
- **Completion Date**: 2027-12
- **Lead Sponsor**: Instituto Nacional de Saúde, Mozambique
### Study Description
Given that WLWH are more likely to develop persistent HPV infection and CC, effective screening and the management and treatment of pre-cancerous cervical abnormalities is critical to decrease the global burden of cervical cancer. The vast majority of WLWH live in SSA, where resources are more constrained. Therefore, simple, affordable, and effective tools are needed for the prevention of cervical cancer in SSA. In this setting, the best method for treatment of screen-positive WLWH has not been determined. The proposed study will compare the effectiveness of TA vs. LEEP, for treating precursor lesions (CIN 2/3) and HPV infection in WLWH, identify the determinants of treatment failure, and develop a strategy to predict patients in whom treatment is likely to fail so that alternative treatments can be provided. Moreover, local evidence of the optimal method of treatments is necessary to inform health policy and promote adherence.
### Conditions
- HIV Infections
- HPV Infection
- CIN 2/3
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- Thermal ablation
- LOOP ELECTROSURGICAL EXCISION PROCEDURE
### Outcomes
**Primary Outcomes**
- Comparison of treatment success rates for biopsy-confirmed CIN 2/3: Thermoablation (TA) vs. Loop Electrosurgical Excision Procedure (LEEP)
**Secondary Outcomes**
### Location
- **Facility**: INSMozambique, Maputo, N/A, N/A, Mozambique
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## Postoperative Pain Management in Laparoscopic Cholecystectomies
- **NCT ID**: NCT06326281
- **Study ID**: ACHBILKENT-ANEST-BK-01
- **Status**: COMPLETED
- **Start Date**: 2023-07-01
- **Completion Date**: 2024-02-28
- **Lead Sponsor**: Ankara City Hospital Bilkent
### Study Description
This study is to demonstrate the effectiveness of external oblique intercostal plane block, a new block method, in the treatment of postoperative pain occurring after laparoscopic cholecystectomy operations, which are frequently and widely performed today.It aims to add new applications to multimodal analgesia methods, which provide the greatest contribution to the early recovery process after surgery, and to contribute to the early recovery process by increasing patient satisfaction.
### Conditions
- Cholecystitis/Cholelithiasis
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- external oblique intercostal plane block group
- oblique subcostal TAP block group
- Local anesthetic infiltration group
- control group
### Outcomes
**Primary Outcomes**
- Visual Analogue Scale Score
**Secondary Outcomes**
### Location
- **Facility**: Ankara Bılkent City Hospital, Ankara, N/A, 06100, Turkey
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## Interest of Light Therapy in Hematology - The PHOTO-TREAT Study
- **NCT ID**: NCT06326268
- **Study ID**: 2023-019
- **Status**: RECRUITING
- **Start Date**: 2024-04-17
- **Completion Date**: 2025-09-17
- **Lead Sponsor**: Institut de cancérologie Strasbourg Europe
### Study Description
Chemo-induced mucositis is a common complication in patients treated for hematologic malignancies. They can manifest itself as a simple local irritation with erythema and inflammation but can also progress to erosions and ulcerations of the entire oral mucosa and are also responsible for an increased risk of infection in these immunocompromised patients.The only therapies currently offered are local care and intravenous analgesics. Studies in pediatric hematology show the effectiveness of prevention and low-dose laser treatment in chemo-induced mucositis, both in terms of reducing the number of mucositis developed but also in terms of reducing the grade of mucositis. This currently results in a recommendation for the use of photobiomodulation by international bodies such as ESMO (European Society for Medical Oncology).
### Conditions
- Leukemia, Myeloid, Acute
- Lymphoma
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: NA
- **Intervention Model**: SINGLE_GROUP
- **Primary Purpose**: SUPPORTIVE_CARE
### Interventions
- Phototherapy system CareMin650TM
### Outcomes
**Primary Outcomes**
- Evaluate the impact of Photobiomodulation (PBM) therapy in the management of chemo-induced mucositis in terms of prevalence of mucositis
**Secondary Outcomes**
- Evaluate the impact of PBM in the management of chemo-induced mucositis in terms of reduction in analgesic consumption.
- Evaluate the impact of PBM in terms of infection by bacterial translocation risk reduction.
- Evaluate the impact of PBM in terms of reduction of the use of artificial feeding.
- Evaluate the impact of PBM in terms of reduction of the length of hospital stay.
- Evaluate the impact of PBM in terms of reduction of the number of transfusions.
- Evaluate the impact of PBM in terms of pain reduction
- Evaluate the impact of PBM on patient's satisfaction regarding pain management during hospital stay
### Location
- **Facility**: Institut de cancérologie Strasbourg Europe, Strasbourg, N/A, 67033, France
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## Feasibility and Acceptability of Laughter Yoga in Children With Autism Spectrum Disorder and Their Parents
- **NCT ID**: NCT06326255
- **Study ID**: LYASD
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-03-15
- **Completion Date**: 2025-12-31
- **Lead Sponsor**: The Hong Kong Polytechnic University
### Study Description
This is a pilot randomised controlled trial to explore the acceptability and feasibility of laughter yoga about anxiety and depression reduction in children with ASD and parenting stress reduction for their parents. Hypotheses of this study include:1. Laughter yoga is acceptable to children with ASD and their parents.2. Laughter yoga is feasible for anxiety and depression reduction in children with ASD and parenting stress reduction in their parents.3. Participants in the experimental group will have significantly more reduction in depression, anxiety and parental stress than those in the wait-list-control group.
### Conditions
- Autism Spectrum Disorder
- Parenting Stress
- Depression
- Anxiety
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: PREVENTION
### Interventions
- laughter yoga
### Outcomes
**Primary Outcomes**
- Response rate
- Attrition rate
- Attendance rate
- Perception on laughter yoga
- Difficulties in laughter yoga
- Safety issues
**Secondary Outcomes**
- Depression
- Anxiety
- Parenting Stress
- Child-parent Relationships
### Location
- **Facility**: The Hong Kong Polytechnic University, Hong Kong, N/A, N/A, Hong Kong
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## What Unmet Need for the Patients?A Focus on the Social Determinants of Health in Phase 1 Clinical Trials
- **NCT ID**: NCT06326242
- **Study ID**: IEO 1648
- **Status**: RECRUITING
- **Start Date**: 2023-03-27
- **Completion Date**: 2024-12-31
- **Lead Sponsor**: European Institute of Oncology
### Study Description
An observational prospective study of patients enrolled and treated with experimental drugs in Phase I studies.
### Conditions
- Solid Tumor
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
- Solid Tumor
### Outcomes
**Primary Outcomes**
- The geographical accessibility of patients attending the Phase 1 facility of the European Institute of Oncology (IEO).
**Secondary Outcomes**
- The characterization of enrolled patients involves assessing their participation in clinical trials
- The characterization of enrolled patients based on therapeutic compliance.
- The protocol prescriptions in relation to socioeconomic and geographical determinants.
### Location
- **Facility**: European Institute of oncology, Milano, N/A, 20141, Italy
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## Clinical Validation of Musculoskeletal ICF Core Set in Primary Care Physiotherapy
- **NCT ID**: NCT06326229
- **Study ID**: CEIm 3096
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-05-06
- **Completion Date**: 2025-09-26
- **Lead Sponsor**: University of Valladolid
### Study Description
The aim of this observational study is to validate the content of a tailored ICF core set for the management of musculoskeletal conditions in primary care physiotherapy services.The main question it aims to answer is:- Are the ICF entities included in the ICF Core Set under evaluation useful from a clinical point of view?Participants will evaluate the relevance of each ICF entity included in the ICF core set according to their musculoskeletal condition.
### Conditions
- Musculoskeletal Diseases
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
- ICF entities assessment
### Outcomes
**Primary Outcomes**
- ICF core set for post-acute musculoskeletal conditions (adapted version for primary care physiotherapy services)
**Secondary Outcomes**
### Location
- **Facility**: Ólvega Primary Care Physiotherapy service, Ólvega, Soria, 42110, Spain
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## Determination of Baseline Levels for Prostate Cancer-Derived Extracellular Vesicles Following Local Treatment of Prostate Cancer
- **NCT ID**: NCT06326216
- **Study ID**: 19-011292
- **Status**: RECRUITING
- **Start Date**: 2020-06-10
- **Completion Date**: 2025-07-01
- **Lead Sponsor**: Mayo Clinic
### Study Description
This study is being done to determine whether levels of prostate cancer derived extracellular vesicles from blood and urine specimens correlate with response to primary local treatment (surgery) in prostate cancer.
### Conditions
- Prostate Carcinoma
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
- Non-Interventional Study
### Outcomes
**Primary Outcomes**
- Levels of prostate cancer-derived extracellular vesicles (EVs) - radical prostatectomy
- Levels of prostate cancer-derived extracellular vesicles (EVs) - negative controls
- Correlation between prostate specific antigen (PSA) levels and prostate cancer-derived EVs
- Prostate cancer-derived EV levels
**Secondary Outcomes**
### Location
- **Facility**: Mayo Clinic in Rochester, Rochester, Minnesota, 55905, United States
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## Cell Therapy for Lower Limb Ulcers in Patients With Critical Limb Ischemia
- **NCT ID**: NCT06326203
- **Study ID**: UPECLIN-MB-8
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-07-01
- **Completion Date**: 2027-12-31
- **Lead Sponsor**: UPECLIN HC FM Botucatu Unesp
### Study Description
Peripheral arterial disease (PAD) can progress to critical limb ischemia (CLI) of the affected lower limb, characterized by pain at rest, ulcerations or gangrene, with a high risk of amputation. In this phase, the best treatment is arterial limb revascularization, but this is not always possible or even effective for promoting pain relief, healing of ulcers or preventing amputations, in addition to the high socioeconomic cost caused by the disease. Recent advances in cell therapy represent a promising supporting alternative for the treatment of PAD in cases where conventional alternatives have run out. Objective: To evaluate the safety and efficacy of cell therapy with expanded autologous mesenchymal stem cells in the treatment of patients with PAD with CLI and chronic arterial ulcers. Methods: An open randomized clinical study will be performed with 2 groups of 20 patients with CLI: in group 1, a fragment of abdominal fat tissue (10g) will be collected to obtain mesenchymal stem cells, which will be expanded and applied using subcutaneous perilesional injection in the affected lower limb, in addition to the application in the form of a personalized curative biological on the wounds. Group 2 will receive conventional treatment with a Hydrogel dressing with essential fatty acids. Periodic clinical evaluations, complementary exams and photographic record will be carried out. The main outcome of effectiveness will be partial or total wound healing. Safety outcomes will be monitored for infections, gangrene, amputations and deaths. Participants will be monitored for 120 days. Major amputation cases will not be included. An independent external evaluator and blind to the groups will evaluate the results. It is an innovative procedure with high impact and financial return for SUS, in view of the high prevalence of the disease and the high socioeconomic impact of the disease when it progresses to limb amputation.
### Conditions
- Peripheral Arterial Disease
- Leg Ulcer
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- CELULAS TRONCO
- CONVENTIONAL DRESSING
### Outcomes
**Primary Outcomes**
- Major Amputation
- Ulcer Healing
**Secondary Outcomes**
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
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## 177Lu-DOTATATE for Recurrent Meningioma
- **NCT ID**: NCT06326190
- **Study ID**: EORTC-2334-BTG
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-11-06
- **Completion Date**: 2028-12-22
- **Lead Sponsor**: European Organisation for Research and Treatment of Cancer - EORTC
### Study Description
Novel treatments are urgently needed for meningiomas progressing after local therapies (surgery, radiotherapy). So far, no effective systemic therapies are known in this situation. The LUMEN-1 trial will investigate in a prospective randomized trial the efficacy of the precision medicine "theranostic" concept of combining diagnostic patient selection using PET-based molecular imaging and target-specific therapeutic intervention using a systemically administered radioligand.The rationale for the LUMEN-1 trial is based on the following: (a) high somatostatin receptor (SSTR) expression in meningiomas, (b) wide-spread availability of clinically established SSTR-PET imaging, (c) proven efficacy of SSTR-targeting radioligand therapy using \[177Lu\]Lu-DOTATATE in another tumor type (neuroendocrine tumors), and (d) promising experiences with \[177Lu\]Lu-DOTATATE therapy in compassionate use applications and retrospective case series and interim results from one ongoing uncontrolled prospective trial in meningiomas. LUMEN-1 is the first randomized clinical trial to investigate \[177Lu\]Lu-DOTATATE therapy in refractory meningioma and may open new avenues for treatment and research in this area.
### Conditions
- Recurrent Meningioma
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- Local standard of Care
- 177Lu-DOTATATE
### Outcomes
**Primary Outcomes**
- Progression Free Survival (PFS)
**Secondary Outcomes**
- Overall Survival (OS)
- Radiological response rate
- Radiological response rate
- The magnitude of change in Health-related quality of life (HRQoL)
- The magnitude of change in Health-related quality of life (HRQoL)
- The magnitude of change in Health-related quality of life (HRQoL)
- Neurological function (NANO scale)
- Toxicity According to CTCAE Version 5.0
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
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## Investigating Association Between Spine, Scapular, Shoulder and Core in Swimmers
- **NCT ID**: NCT06326177
- **Study ID**: Yeditepe U - Poyraz Tuncer
- **Status**: ENROLLING_BY_INVITATION
- **Start Date**: 2024-06-15
- **Completion Date**: 2024-09-01
- **Lead Sponsor**: Yeditepe University
### Study Description
The aim of this observational study is to investigate relationship between cervical, thoracic, lumbar and thoracolumbar spine posture, spine movement, isometric and eccentric shoulder strength, scapular dyskinesis and core muscle endurance in healthy competitive young swimmers in comparison with healthy recreational swimmers. The main question is whether spine posture affects spine movement, shoulder strength, scapular dyskinesia and core endurance. Participants will asked to complete a warm up period, after that spine posture, spine movement, scapular dyskinesia, shoulder strength and core endurance will be assessed by examiner. Researchers will compare competitive swimmer group and recreational swimmer group. Additionally correlation between spine posture, spine movement, scapular dyskinesia, shoulder strength and core muscle endurance will be investigated in competitive swimmer group. Aim of the study is to determine whether posture have any effect upon these parameters.
### Conditions
- Postural Kyphosis
- Postural Lordosis
- Movement, Abnormal
- Spine Injury
- Cervical Lordosis
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
- Spine Posture Assessment
- Spine Movement Assessment
- Core Muscle Endurance Assessment
- Scapular Dyskinesia
- Shoulder Strength
### Outcomes
**Primary Outcomes**
- Spinal Posture
- Cervical Movement
- Thoracic Movement
- Lumbar Movement
- Thoracolumbar Movement
**Secondary Outcomes**
- Anterior Core Musculature Assessment
- Lateral Core Musculature Assessment
- Posterior Core Musculature Assessment
- Core Musculature Ratio Assessment
- Shoulder Strength Assessment
- Shoulder Strength Ratio Assessment
- Scapular Dyskinesia
### Location
- **Facility**: PT Academy, Istanbul, Kadıköy, 34744, Turkey
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## Effect of Kinesio-taping of Lower Limbs
- **NCT ID**: NCT06326164
- **Study ID**: sample
- **Status**: RECRUITING
- **Start Date**: 2024-02-15
- **Completion Date**: 2024-07-18
- **Lead Sponsor**: Kafrelsheikh University
### Study Description
The goal of this clinical trail is to test if kinesio-taping on lower limbs has an effect on balance and gait in children with diplegic cerebral palsy. Children in study group will have designed physiotherapy for gait and balance, the control group will have designed physiotherapy in addition to kinesio-taping on both lower limbs.
### Conditions
- Cerebral Palsy
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- kinesio-taping.
- A designed physiotherapy program.
### Outcomes
**Primary Outcomes**
- Change in gait.
- Change in balance.
**Secondary Outcomes**
### Location
- **Facility**: Asmaa Mohamed Khalil Sedeek, Kafr Ash Shaykh, N/A, N/A, Egypt
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## Interdisciplinary Psychoeducational Intervention Programme for Caregivers of Dependent Older Adults
- **NCT ID**: NCT06326151
- **Study ID**: UMAPS-UDATO
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-09-01
- **Completion Date**: 2025-12-31
- **Lead Sponsor**: University of Salamanca
### Study Description
Background: Caring for an older dependent adult with cognitive impairment can have negative consequences for the family caregiver. Interdisciplinary interventions are necessary to address their needs jointly and comprehensively. While attempts have been made to improve their situation from different disciplines in isolation, a collaborative approach is required to ensure the best possible outcome.Methods: A parallel, randomized, controlled clinical trial with two arms will be conducted at the Occupational Therapy Teaching and Care Unit (UDATO) and the Municipal Psychosocial Support Unit for the Elderly (UMAPS), both of which belong to the University of Salamanca and are in agreement with the City Council of Salamanca, Spain. The trial will also be conducted at the University Care Centre of Salamanca (CAUSA). People aged 60 years or older will be recruited as family caregivers of dependent older adults with cognitive impairment in a chronic situation. Participants will be divided into two groups: the intervention group (IG) will carry out an interdisciplinary psychoeducational programme from the perspective of psychology and occupational therapy, and the control group (CG) will carry out a controlled follow-up. Participants will complete 12 sessions over a period of 3 months, followed by three monthly reinforcement sessions after the intervention. At the beginning and end of the intervention, participants will be assessed and socio-demographic data will be collected along with the following scales: the Spanish version of the Caregiver Burden Interview (CBI), the Spanish version of the Center for Epidemiologic Studies-Depression Scale (CES-D), the Psychosocial Support Questionnaire adaptation (PSQ), the General Health Questionnaire (GHQ), the World Health Organization Quality of Life Assessment - AGE (WHOQOL-AGE) and the Bayer-Activities of Daily Living Scale (B-ADL).Discussion: The objective of this study is to enhance conventional clinical practice for family caregivers of dependent older adults. This will be achieved through an interdisciplinary psychoeducational intervention that aims to reduce overload and depressive symptomatology, increase social support, improve health and perceived quality of life, and enhance understanding of the syndrome/illness. The intervention will also focus on managing difficult situations associated with day-to-day caregiving, managing emotions and associated erroneous beliefs, and promoting self-care. Additionally, the study aims to improve the functionality of the cared-for person.
### Conditions
- Dependent Older People
- Family Caregiver
- Interdisciplinary
- Intervention
- Occupational Therapy
- Psychoeducational
- Psychology
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: SUPPORTIVE_CARE
### Interventions
- Interdisciplinary Psychoeducational Programme
- Health Education Programme
### Outcomes
**Primary Outcomes**
- Mini Mental State Examination (MMSE)
- Barthel Index
- Caregiver Burden Interview
**Secondary Outcomes**
- Centre for Epidemiological Studies Depression Scale
- Adaptation of the Psychosocial Support Questionnaire
- General Health Questionnaire
- World Health Organization Assessment of Quality of Life - AGE (WHOQOL-AGE)
- The Bayer-Activities of Daily Living Scale (B-ADL)
### Location
- **Facility**: Eduardo Jose Fernandez Rodriguez, Salamanca, Castilla Y Leon, 37002, Spain
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## Pharmacokinetics and Pharmacodynamics of Edoxaban Before and After Bariatric Surgery
- **NCT ID**: NCT06326138
- **Study ID**: 22121
- **Status**: WITHDRAWN
- **Start Date**: 2024-03-11
- **Completion Date**: 2024-03-11
- **Lead Sponsor**: Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
### Study Description
The study will be conducted at a single site in the Canada, Quebec. Participants will be recruited from the bariatric surgery clinic and will be required to be either, waiting for sleeve gastrectomy surgery (n=12, restrictive bariatric surgery, Group 1) or Roux-en-Y gastric bypass (n=12, mixed bariatric surgery, Group 1), or had underwent Roux-en-Y gastric bypass 12 ± 3 months ago (n=12, Group 2).Participants in Group 1, edoxaban pharmacokinetic and pharmacodynamics will be evaluated before and 48 ± 5 hours after bariatric surgery (sleeve gastrectomy and Roux-en-Y gastric bypass). Participants in Group 2, edoxaban pharmacokinetic and pharmacodynamics will be evaluated only once, at 12 ± 3 months following their Roux-en-Y gastric bypass.All participants will be received single oral doses of 60 mg edoxaban at each pharmacokinetic and pharmacodynamics evaluation.
### Conditions
- Bariatric Surgery Candidate
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: NON_RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: OTHER
### Interventions
- Edoxaban Pharmacokinetics and Pharmacodynamics
### Outcomes
**Primary Outcomes**
- Pharmacokinetics edoxaban parameter
- Pharmacokinetics edoxaban parameter
- Pharmacokinetics edoxaban parameter
- Pharmacokinetics edoxaban parameter
**Secondary Outcomes**
- Pharmacodynamics edoxaban parameter
- Pharmacodynamics edoxaban parameter
- Pharmacodynamics edoxaban parameter
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
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## Pharmacology and Non-pharmacology Approaches in Reducing Children's Pain and Fear During Painful Procedures
- **NCT ID**: NCT06326125
- **Study ID**: SherzadSH
- **Status**: ENROLLING_BY_INVITATION
- **Start Date**: 2023-12-15
- **Completion Date**: 2024-04-10
- **Lead Sponsor**: Uppsala University
### Study Description
This study Will contribute in the knowledge of pediatric nurses during painful procedures such venipuncture
### Conditions
- Pain
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: PREVENTION
### Interventions
- TICK-B
- TKTX-Cream
- TICK-B and TKTX-C
### Outcomes
**Primary Outcomes**
- severity of Pain
**Secondary Outcomes**
- Fear
### Location
- **Facility**: Sherzad Khudeida Suleman, Duhok, Erbil, 42012, Iraq
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## Role of Active Deresuscitation After Resuscitation:
- **NCT ID**: NCT06326112
- **Study ID**: 4588
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-05-01
- **Completion Date**: 2025-06-30
- **Lead Sponsor**: Unity Health Toronto
### Study Description
The RADAR-Canada trial is a pilot RCT undertaken to assess the acceptability of, compliance with, and biologic consequences of a deresuscitation protocol designed to expedite the removal of excess interstitial fluid in patients who remain in a positive fluid balance following admission to an intensive care unit (ICU).
### Conditions
- Fluid Overload
- Critical Illness
- Sepsis
- ARDS
- Trauma
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- Furosemide Injection
- Metolazone Tablets
### Outcomes
**Primary Outcomes**
- Efficacy: Mean cumulative fluid balance
- Compliance with deresuscitation protocol
- Acceptability of protocol
**Secondary Outcomes**
- All cause mortality
- New onset organ dysfunction
- Organ support-free days
### Location
- **Facility**: Unity Health Toronto, Toronto, Ontario, M5B 1W8, Canada
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## Brief Binge Eating and Drinking Online Intervention
- **NCT ID**: NCT06326099
- **Study ID**: R34AA030655
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-05-01
- **Completion Date**: 2026-04-30
- **Lead Sponsor**: University of Southern California
### Study Description
This pilot project targets both binge drinking and binge eating behavior in college students through a mobile-based online program that provides students with evidence-based intervention material designed to reduce the incidence of both behaviors and encourage students to seek more formal in-person counseling.
### Conditions
- Binge Eating
- Binge Drinking
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- Brief Online Binge Eating and Drinking Intervention
### Outcomes
**Primary Outcomes**
- Frequency of past 28-day binge drinking
- Frequency of past 28-day binge eating
- Brief Young Adult Alcohol Consequences Questionnaire (B-YAACQ)
**Secondary Outcomes**
- Mental Health/Substance Use Disorder Treatment History Inventory
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
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## Differences in Rate of Decline in CT-defined Skeletal Muscle Mass and Physical Performance in Patients With Advanced Non-small Cell Lung Cancer Receiving Chemotherapy and Targeted Therapy/Immunotherapy, Before and After Treatment.
- **NCT ID**: NCT06326086
- **Study ID**: REC.65-080-7-1
- **Status**: RECRUITING
- **Start Date**: 2022-08-01
- **Completion Date**: 2024-08-01
- **Lead Sponsor**: Prince of Songkla University
### Study Description
Lung cancer is a common disease leading to 18 % of cancer deaths worldwide. Despite various improvement in treatment, there still remains low 5-year survival rate of 10-20 % in advanced lung cancer patients. Skeletal muscle mass and physical performance have been shown to effect overall survival and prognosis in lung cancer. This research focuses on effects of different treatment of lung cancer such as chemotherapy, targeted therapy and immunotherapy on skeletal muscle mass and physical performance.
### Conditions
- Advanced Lung Cancer
- Sarcopenia
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
- Chemotherapy drug
- Targeted Agent
- Immunotherapy
### Outcomes
**Primary Outcomes**
- To determine the differences in the rate of decline in CT defined skeletal muscle index at L3 vertebra and physical performance in advanced NSCLC patients receiving chemotherapy and targeted therapy/ immunotherapy, before and after treatment.
**Secondary Outcomes**
- To determine validity of gender based cut off for CT-defined skeletal muscle index at L3 lumbar vertebra (L3SMI) based on recommendation of JSH/AWGS in Thai population.
### Location
- **Facility**: Prince of Songkla University, Hat Yai, Songkla, 90110, Thailand
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## Interaction Between Smoking, GCF Periostin, IL17A, IL17E and Non-surgical Periodontal Therapy
- **NCT ID**: NCT06326073
- **Study ID**: OMUKAEK2019/324
- **Status**: COMPLETED
- **Start Date**: 2019-07-01
- **Completion Date**: 2021-07-01
- **Lead Sponsor**: Ondokuz Mayıs University
### Study Description
It was aimed to evaluate the changes in the levels of Periostin, IL-17A and IL-17E cytokines in the gingival crevicular fluid (GCF) of periodontitis patients which non-surgical (Phase I) periodontal treatment applied to and their interactions with smoking. The study included systemic healthy smokers(SP)(n:11) and non-smokers(P)(n:11) with periodontitis, smokers (SS)(n:11) and non-smokers(S)(n:11) with periodontal healthy individuals Phase I periodontal treatment was applied to the groups with periodontitis. Before treatment (day 0), clinical measurements evaluating periodontal status were recorded and GCF samples were collected. GCF samples were collected from the same tooth regions on the 15th and 30th days after treatment and clinical measurements were repeated. GCF Periostin, IL-17A and IL-17E levels were determined by ELISA method. All data were evaluated statistically.
### Conditions
- Periodontitis
- Smoking
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: DIAGNOSTIC
### Interventions
- Non Surgical Periodontal Treatment
### Outcomes
**Primary Outcomes**
- Evaluation of Periostin levels
- Evaluation of IL-17A levels
- Evaluation of IL-17E levels
**Secondary Outcomes**
- Interaction Between Smoking and GCF Periostin, IL17A, IL17E levels
### Location
- **Facility**: Ondokuz Mayıs University Faculty of Dentistry Department of Periodontology, Samsun, N/A, 55270, Turkey
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## A Research Study Comparing How Well Different Doses of the Medicine NN0519-0130 Help People With Excess Body Weight Lose Weight
- **NCT ID**: NCT06326060
- **Study ID**: NN9541-5015
- **Status**: RECRUITING
- **Start Date**: 2024-03-18
- **Completion Date**: 2025-05-05
- **Lead Sponsor**: Novo Nordisk A/S
### Study Description
This study will look at how a new medicine called NNC0519-0130 helps people with excess body weight lose weight. The study will test up to 6 different doses of NNC0519-0130. Participants will take 1-2 injections once a week. The study medicine will be injected under skin with a thin needle in the stomach, thigh, or upper arm. The study will last for about 42 weeks.
### Conditions
- Obesity
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- NNC0519-0130
- Placebo
- Tirzepatide
### Outcomes
**Primary Outcomes**
- Relative change in body weight
**Secondary Outcomes**
- Change in body weight
- Achievement of greater than equal to (≥) 5% weight reduction
- Achievement of ≥ 10% weight reduction
- Achievement of ≥ 15% weight reduction
- Achievement of ≥ 20% weight reduction
- Change in body mass index (BMI)
- Change in waist circumference
- Change in glycated hemoglobin (HbA1c)
- Change in fasting plasma glucose (FPG)
- Change in systolic blood pressure (SBP)
- Change in high sensitivity C-Reactive protein (hsCRP)
- Change in total cholesterol
- Change in high-density lipoprotein (HDL) cholesterol
- Change in low-density lipoprotein (LDL) cholesterol
- Change in triglycerides
- Change in Impact of Weight on Quality of Life-Lite Clinical Trials (IWQOL-Lite-CT) Physical composite score
- Change in IWQOL-Lite-CT Psychosocial composite score
- Change in IWQOL-Lite-CT Physical Function score
- Change in IWQOL-Lite-CT Total score
- Number of adverse events
### Location
- **Facility**: Centricity Research-Arizona, Mesa, Arizona, 85206, United States
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## A Research Study Comparing How Well Different Doses of the Medicine NN0519-0130 Lower Blood Sugar in People With Type 2 Diabetes
- **NCT ID**: NCT06326047
- **Study ID**: NN9541-4945
- **Status**: RECRUITING
- **Start Date**: 2024-03-18
- **Completion Date**: 2025-08-26
- **Lead Sponsor**: Novo Nordisk A/S
### Study Description
This study will look at how well a new medicine called NNC0519-0130 helps people with type 2 diabetes lower their blood sugar and body weight. The study will test up to 7 different doses of NNC0519-0130. Which treatment participant will get is decided by chance. Participants will take 1-3 injections once a week. The study medicine will be injected under skin with a thin needle in the stomach, thigh, or upper arm. The study will last for about 40 weeks.
### Conditions
- Diabetes Mellitus, Type 2
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- NNC0519-0130
- Placebo
- Trizepatide
### Outcomes
**Primary Outcomes**
- Change in Glycated haemoglobin (HbA1c)
**Secondary Outcomes**
- Change in Glycated haemoglobin (HbA1c)
- Relative change in body weight
- Change in body weight
- Change in fasting plasma glucose (FPG)
- Continuous glucose monitoring (CGM): Change in time in range (TIR) 3.9-10.0 millimoles per liter (mmol/L) (70-180 milligrams per deciliter (mg/dL))
- Change in waist circumference
- Change in systolic blood pressure (SBP)
- Change in high sensitivity C-Reactive Protein (hsCRP)
- Change in total cholesterol
- Change in high-density lipoprotein (HDL) cholesterol
- Change in low-density lipoprotein (LDL) cholesterol
- Change in triglycerides
- Number of adverse events
### Location
- **Facility**: Velocity Clin Res-Chula Vista, Chula Vista, California, 91911, United States
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## Impact of Dapagliflozin as Add-on Therapy on Glycemic Status and Quality of Life in Type 2 Diabetic Patients
- **NCT ID**: NCT06326034
- **Study ID**: AAA234
- **Status**: COMPLETED
- **Start Date**: 2022-05-01
- **Completion Date**: 2023-01-01
- **Lead Sponsor**: Mohammed Mahmood Mohammed
### Study Description
Type 2 Diabetes Mellitus (T2DM) is a syndrome of metabolic dysregulation that needs a multifactorial behavioral and pharmacological treatments to prevent or delay complications, morbidity and mortality. Uncontrolled hyperglycemia can be negatively affecting the patient's physical and psychological status and thus lower the patient's quality of life (QoL) (Verma \& Dadarwal, 2017)(Vanstone et al., 2015)(Gebremedhin et al., 2019). According to American Diabetes Association (ADA), when hyperglycaemia remain uncontrolled (HbA1c ≥1.5% above the glycemic target), a second therapy for T2DM is needed (Davies et al., 2022).It has been certained by ADA, beside the glucose lowering effect the add-on antidibetic medication should have an impact on weight management to achieve and maintain the optimum glycemic and weight control which are the goals in people without established cardiorenal risks (Vijan et al., 2014((Inzucchi et al., 2012). Although metformin still the first-line pharmacotherapy in most T2DM patients, according to American Diabetes Association (ADA) (Association, 2020) but has little or even weight neutral effect, as well as gliptins (Hermansen \& Mortensen, 2007)(Sazan et al., 2012). Other old antidibetic classes such as thiazolidinediones (TZDs) and sulfonylureas (SUs) inspite of their efficacy in controlling glycemia but their use is associated with weight gain and other adverse effects (Derosa \& Maffioli, 2010)(Najim et al., 2014)(Fonseca, 2003). However, The newest class of antidibetic drugs, sodium-glucose cotransporter 2 inhibitors (SGLT2i), are approved for the treatment of T2DM as add-on or even initial therapy (Tamez-Pérez et al., 2013). This class is act by inducing glycosuria and thus improving glycemic status without affecting insulin level (Merovci et al., 2015). Dapagliflozin is a highly selective inhibitor of SGLT2. It has been well tolerated and its safety and efficacy approved in the clinical trials, mostly on cardio-renal outcomes with additional benefits of weight loss and low risk of hypoglycemia (Heerspink et al., 2020)(Solomon et al., 2022)(Wiviott et al., 2019)(McMurray et al., 2019). To date, no clinical data regarding SGLT2i recorded in Iraqi patients with limited data available on Arabic population. On Qatari, assessment of Dapagliflozin effectiveness revealed a significant improvement in the glycemic status after 6 months when used in combination with standard therapy, a reduction (Al AdAwi et al., 2019). In Saudi Arabia, Dapagliflozin was found to be well-tolerated and effective treatment option for T2DM patients after 6 months (Alguwaihes, 2021).
### Conditions
- Diabetic Nephropathy Type 2
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: NA
- **Intervention Model**: SINGLE_GROUP
- **Primary Purpose**: TREATMENT
### Interventions
- Dapagliflozin
### Outcomes
**Primary Outcomes**
- Quality of Life Assessment tool
**Secondary Outcomes**
### Location
- **Facility**: Mohammed Mahmood Mahmood, Baghdad, N/A, 00964, Iraq
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## Optimised CD33 (FL-33) CAR T Therapy for Refractory/Relapsed Acute Myeloid Leukaemia
- **NCT ID**: NCT06326021
- **Study ID**: BJGBYY-IIT-LCYJ-2024-004
- **Status**: RECRUITING
- **Start Date**: 2024-04-11
- **Completion Date**: 2026-12-30
- **Lead Sponsor**: Beijing GoBroad Hospital
### Study Description
This study is a single-center, open-label, non-randomised, single-arm phaseⅠclinical trial to explore the safety and efficacy of FL-33 CAR T therapy for refractory/relapsed acute myeloid leukaemia. The primary endpoints are incidence and type of dose limiting toxicity within 21 days of CAR T infusion; total number, incidence and severity of adverse events (AE) 30 days after CAR T infusion. The secondary endpoints are total number, incidence and severity of AEs 30 days to 2 years after CAR T infusion; objective response rate (ORR), complete response rate (CR) and complete response with incomplete haematological recovery (CRi) by dose group at 15, 30 and 90 Days after CAR T Infusion; duration of response (DOR), progression-free survival (PFS), overall survival (OS); pharmacokinetic characteristics. The trial will use BOIN12 design to explore the optimal biological dose (OBD) of FL-33 CAR T cells for refractory/relapsed acute myeloid leukaemia. FL-33 CAR T is set at two dose levels: 5\*10\^5 (±20%) CAR-T cells/kg for dose 1 (DL-1) and 1\*10\^6 (±20%) CAR-T cells/kg for dose 2 (DL-2), and after the optimal biological dose (OBD) is determined in the dose exploration phase, the dose expansion phase will expand the trial by 6-12 cases at the OBD, enrolling up to 21-27 cases. Enrolment of more than 21 cases can be reported for analysis and the trial will be stopped when enrolment reaches 27 cases.
### Conditions
- Refractory/Relapsed Acute Myeloid Leukaemia
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: NON_RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- autologous FL-33 CAR T therapy
- prior-HSCT donor-derived FL-33 CAR T therapy
### Outcomes
**Primary Outcomes**
- Dose-limiting toxicity(DLT)
- Adverse events (AEs)
**Secondary Outcomes**
- Long-term Adverse events (AEs)
- Objective Response Rate (ORR)
- Duration of response (DOR)
- Progression-free survival (PFS)
- Overall survival (OS)
- The persistence of FL-33 CAR T cells
### Location
- **Facility**: BeijingGoBroadH, Beijing, N/A, N/A, China
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## Safety, Tolerability, and Pharmacokinetics of Donor-derived CD19 CAR Therapy Bridged Allo-HSCT and Sequential Donor-derived CD22 CAR Therapy for r/r B-ALL: a Clinical Trial
- **NCT ID**: NCT06326008
- **Study ID**: BJGBYY-IIT-LCYJ-2023-002
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-04-15
- **Completion Date**: 2026-06-30
- **Lead Sponsor**: Beijing GoBroad Hospital
### Study Description
This is an investigator-initiated, single-arm, open-label, non-randomised phase I clinical study. The objective of this trial is to evaluate the safety, tolerability and pharmacokinetics of donor-derived CD19 CAR Therapy bridged Allo-HSCT and sequential donor-derived CD22 CAR Therapy for r/r B-ALL and to explore the efficacy of this therapy preliminarily. The primary endpoints are incidence and type of dose-limiting toxicity (DLT) within 28 days (i.e., 43 days after donor-derived CD19 CAR T-cell infusion) after donor-derived CD19 CAR T-cell therapy bridged allogeneic haematopoietic stem cell transplantation; total number, incidence and severity of adverse events from donor-derived CD19 CAR T cell infusion back to 30 days after donor-derived CD22 CAR T cell infusion (i.e., within 120 days of donor-derived CD19 CAR T cell infusion). The secondary endpoints are total number, incidence and severity of adverse events from 120 days to 2 years after donor-derived CD19 CAR T-cell infusion; ORR(CR+CRi) on days 45, 90, 120; duration of response(DOR), event-free survival(EFS), overall survival(OS); pharmacokinetics characteristics. The trial plan to enroll 3\~12 cases in dose escalation phase and 36 cases in dose expansion phase.
### Conditions
- B-cell Acute Lymphoblastic Leukemia
- Acute Lymphoblastic Leukemia, in Relapse
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: NA
- **Intervention Model**: SINGLE_GROUP
- **Primary Purpose**: TREATMENT
### Interventions
- Donor-derived CD19 CAR Therapy Bridged Allo-HSCT and Sequential Donor-derived CD22 CAR Therapy
### Outcomes
**Primary Outcomes**
- Dose-limiting toxicity (DLT)
- Adverse events (AEs)
**Secondary Outcomes**
- Long-term Adverse events (AEs)
- Objective response rate(ORR)
- Duration of response (DOR)
- Event-free survival (EFS)
- Overall survival (OS)
- The persistence of CD19/CD22 CAR T cells.
- The Maximum concentration (Cmax) of CD19/CD22 CAR T cells.
- The time to maximum plasma concentration (Tmax) of CD19/CD22 CAR T cells.
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
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## Hypofractionated Post-prostatectomy Radiotherapy (HYPORT)for Localized Prostate Cancer
- **NCT ID**: NCT06325995
- **Study ID**: Changhai HHHospital
- **Status**: RECRUITING
- **Start Date**: 2023-10-01
- **Completion Date**: 2030-10-01
- **Lead Sponsor**: Changhai Hospital
### Study Description
The aim of this trial is to compare the safety outcomes of Hypofractionated postprostatectomy radiotherapy (HYPORT) and Conventionally fractionated postprostatectomy radiotherapy(COPORT) in treating patients with localized prostate cancer.Accumulating evidence has proven the safety and feasibility of HYPORT for localized prostate cancer.But for localized prostate cancer,the optimal dose per fraction of HYPORT is still on its way.It is not yet known whether giving HYPORT(57.5-65 Gy in 23-26 daily fractions of 2.5 Gy ) with or COPORT may work better in treating patients with prostate cancer.
### Conditions
- Localized Prostate Cancer
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- Conventional radiation therapy
- Hypofractionated radiation therapy
### Outcomes
**Primary Outcomes**
- Incidence of radiotherapy-related gastrointestinal and urogenital tract adverse events
**Secondary Outcomes**
- 5-year progression-free survival (PFS)
- quality of life (QoL)
- medical expenses
- Overall survival (OS)
- Prostate cancer-specific survival
### Location
- **Facility**: Changhai hospital, Shanghai, Shanghai, 200433, China
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## Clinical Observation of Drug Retention Enema in Preventing Acute Radiation-induced Rectal Injury
- **NCT ID**: NCT06325982
- **Study ID**: BYFFL-01
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-05-01
- **Completion Date**: 2025-12-31
- **Lead Sponsor**: Fujian Cancer Hospital
### Study Description
The main objective of this study was to evaluate the efficacy and safety of drug retention enema for the prevention of acute radiation rectal injury in the real world.
### Conditions
- Radiation Injuries
- Rectal Diseases
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: NA
- **Intervention Model**: SINGLE_GROUP
- **Primary Purpose**: PREVENTION
### Interventions
- Triethanolamine cream
### Outcomes
**Primary Outcomes**
- Occurrence time of acute and chronic radiation rectal injury
- Evaluation of acute and chronic radiation rectal injury
**Secondary Outcomes**
- Clinical symptom assessment
- Quality of life assessment assessed by IBDQ
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
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## PCOS Patients Immune Status Evaluation
- **NCT ID**: NCT06325969
- **Study ID**: PCOS Immune
- **Status**: RECRUITING
- **Start Date**: 2024-03-16
- **Completion Date**: 2026-03-08
- **Lead Sponsor**: Shanghai 10th People's Hospital
### Study Description
In this study, the investigators will include PCOS patients and healthy women who meet the trial criteria from the clinical research centers of 3 hospitals, introduce the content of this study to participants, and invite participants to participate. Flow cytometry was used to detect the immune function of peripheral blood samples of PCOS patients, to clarify the immune function characteristics of PCOS patients, and to try to establish an evaluation method of the immune function of PCOS patients.
### Conditions
- Polycystic Ovary Syndrom
- Metformin
- Immune Function
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
- Detect the immune function of peripheral blood samples
### Outcomes
**Primary Outcomes**
- The number of cell groups expressing different markers were counted by the fluorescence detection system on flow cytometry.
- The percentage of cell groups expressing different markers were counted by the fluorescence detection system on flow cytometry.
**Secondary Outcomes**
- Homeostasis model assessment of insulin resistance
- body mass index
- menstrual frequency
- fasting glucose
- fasting insulin
- Total cholesterol
- Triglycerides
- HDL-c
- LDL-c
- total testosterone
- free testosterone
- Sex hormone-binding globulin
- Androstenedione
- Dehydroepiandrosterone
### Location
- **Facility**: Department of Endocrinology, Shanghai Tenth People's Hospital, Shanghai, N/A, 200072, China
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## PCOS Immune Function Predicts Metformin Efficacy
- **NCT ID**: NCT06325956
- **Study ID**: Immune status and metformin
- **Status**: RECRUITING
- **Start Date**: 2024-03-16
- **Completion Date**: 2026-07-01
- **Lead Sponsor**: Shanghai 10th People's Hospital
### Study Description
In this study, the investigators will include PCOS patients who meet the trial criteria, introduce participants to the content of this study, and invite participants to participate. The immune function of peripheral blood samples of PCOS patients was detected by flow cytometry. Participants were further treated with metformin for 6 months and followed up after the intervention. The objective of this study was to investigate immune markers related to the efficacy of metformin in PCOS patients and to predict the efficacy of metformin in PCOS patients using immune function.
### Conditions
- Polycystic Ovary Syndrome
- Metformin
- Immune Function
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: NA
- **Intervention Model**: SINGLE_GROUP
- **Primary Purpose**: TREATMENT
### Interventions
- Metformin
### Outcomes
**Primary Outcomes**
- The number of cell groups expressing different markers were counted by the fluorescence detection system on flow cytometry.
- The percentage of cell groups expressing different markers were counted by the fluorescence detection system on flow cytometry.
**Secondary Outcomes**
- Homeostasis model assessment of insulin resistance
- body mass index
- menstrual frequency
- fasting glucose
- fasting insulin
- Total cholesterol
- Triglycerides
- HDL-c
- LDL-c
- total testosterone
- free testosterone
- Sex hormone-binding globulin
- Androstenedione
- Dehydroepiandrosterone
### Location
- **Facility**: Department of Endocrinology, Shanghai Tenth People's Hospital, Shanghai, N/A, 200072, China
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## Rituximab in Chronic Inflammatory Demyelinating Polyradiculoneuropathy
- **NCT ID**: NCT06325943
- **Study ID**: CIDPRIT
- **Status**: COMPLETED
- **Start Date**: 2019-04-01
- **Completion Date**: 2023-11-30
- **Lead Sponsor**: Istituto Clinico Humanitas
### Study Description
Randomized double-blind controlled study of rituximab versus placebo in patients with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) on chronic treatment with immunoglobulins. The primary objective of the study is to determine whether rituximab treatment is effective in preventing the disease from getting worse after stopping immunoglobulin treatment for six months in patients with CIDP. The secondary objective is to evaluate whether treatment with rituximab can improve the response to therapy compared to placebo in patients treated with immunoglobulins and whether it can allow to delay the mean time of worsening after discontinuation of immunoglobulin therapy.Exploratory objectives are the correlation between response to rituximab therapy and the clinical form of CIDP and the presence of antibody reactivity against node of Ranvier antigens. Intervention will be Rituximab or placebo, 1 g by intravenous infusion on day 1 and 15 after randomization and concomitant treatment for 6 months with intravenous or subcutaneous immunoglobulin at the same dosage as before randomization.
### Conditions
- Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- Rituximab
- Placebo
### Outcomes
**Primary Outcomes**
- Inflammatory Neuropathy Cause and Treatment (INCAT) scale, range 0-10 points with higher values meaning more severe disability
- Medical Research Council (MRC), range 0-60 with lower values meaning more severe disability
- Inflammatory Rasch-built Overall Disability Scale (I-RODS), range 0-48 with lower values meaning more severe disability
**Secondary Outcomes**
- Inflammatory Neuropathy Cause and Treatment (INCAT) scale, , range 0-10 points with higher values meaning more severe disability
- Inflammatory Neuropathy Cause and Treatment (INCAT) scale, range 0-10 points with higher values meaning more severe disability
- treatment suspension
- time to worsening
- Short Form Health Survey 36 (SF-36), range from 0 to 100, with a higher score defining a more favorable health state
### Location
- **Facility**: IRCCS Istituto Clinico Humanitas, Rozzano, N/A, N/A, Italy
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## A Study to Investigate the Absorption, Metabolism, and Excretion of [14C]-HU6
- **NCT ID**: NCT06325930
- **Study ID**: RIV-HU6-105
- **Status**: RECRUITING
- **Start Date**: 2024-03-26
- **Completion Date**: 2024-05-22
- **Lead Sponsor**: Rivus Pharmaceuticals, Inc.
### Study Description
This is a single-center, non-randomized, open-label Phase 1 study to characterize the absorption, metabolism, excretion, mass balance, pharmacokinetics (PK), safety and tolerability of HU6 following administration of a single dose of \[14C\]-HU6 in a fed state with a standard meal administered approximately 15 minutes prior to dosing.
### Conditions
- Healthy
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: NA
- **Intervention Model**: SINGLE_GROUP
- **Primary Purpose**: TREATMENT
### Interventions
- [14C]-HU6
### Outcomes
**Primary Outcomes**
- To assess the mass balance
**Secondary Outcomes**
### Location
- **Facility**: Pharmaron Clinical Pharmacology Center (CPC), Baltimore, Maryland, 21201, United States
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## Effect of Diabetes Self-management Education and Support on Glycemic Control Among Patients With Type 2 Diabetic
- **NCT ID**: NCT06325917
- **Study ID**: 101271-5
- **Status**: ACTIVE_NOT_RECRUITING
- **Start Date**: 2022-11-01
- **Completion Date**: 2024-07-30
- **Lead Sponsor**: University of Jordan
### Study Description
Introduction: Diabetes mellitus (DM) is one of the chronic diseases that can have an impact on increasing morbidity, disability, and death. Social media has become a valuable resource for people with diabetes in improving self-management skills Applying diabetes self-management education with ongoing support using social media produces behavioral changes, empowerment, and cost-effectiveness.purpose: the purpose of this study is to examine the effect of self-management education with ongoing support using social media (WhatsApp) on glycemic control among patients with uncontrolled diabetes.Method: 140 patients with diabetes type 2 attending outpatients' diabetes clinic setting in Aqaba will participate in a two-arm randomized controlled trial study. Self-management education will be applied for all participants, ongoing support using social media (what's app) will be applied to the intervention group, and only usual diabetes care by a diabetes specialist nurse will be applied to the control group.
### Conditions
- Diabetes Mellitus, Type 2
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: SUPPORTIVE_CARE
### Interventions
- what's app ongoing support
- usual care
### Outcomes
**Primary Outcomes**
- glycemic control
**Secondary Outcomes**
- diabetes self management behaviors
### Location
- **Facility**: University of Jordan, Amman, N/A, 11942, Jordan
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## Uniportal VATS Versus Chest Tube for Early Empyema
- **NCT ID**: NCT06325904
- **Study ID**: 9138930
- **Status**: COMPLETED
- **Start Date**: 2021-03-01
- **Completion Date**: 2023-12-01
- **Lead Sponsor**: Minia University
### Study Description
This randomized controlled study compared uniportal video-assisted thoracoscopic surgery (U-VATS) versus chest tube drainage for initial (first-line) treatment of stage I (exudative) and stage II (fibrinopurulent) empyema in adult patients (\>18 years old). The primary end-point of outcome was the overall success of treatment (no need for re-intervention or death). The main results demonstrated the safety of minimally invasive U-VATS procedure in the initial treatment of early stages of pleural empyema in comparison to traditional chest tube drainage. Initial use of U-VATS was safe and feasible due to postoperative freedom from complex or marked effusion, in addition to significant reduction in the need for additional intervention, postoperative complications, length of hospital stay, and total cost.
### Conditions
- Empyema, Pleural
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- Uniportal VATS
- Tube thoracostomy
### Outcomes
**Primary Outcomes**
- Need for further management
- Mortality
**Secondary Outcomes**
### Location
- **Facility**: Minia University, Minya, N/A, 61111, Egypt
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## Microbiota in Gastric Cancer by Gastric Mucosal Brushing
- **NCT ID**: NCT06325891
- **Study ID**: RP025
- **Status**: RECRUITING
- **Start Date**: 2024-02-01
- **Completion Date**: 2025-05-31
- **Lead Sponsor**: King Chulalongkorn Memorial Hospital
### Study Description
Many studies have shown a significant change of diversity and composition in gut microbiota across the gastric carcinogenesis process, particularly in patients with gastric cancer. However, there has been no analysis of gastric microbiota using the mucosal brushing technique, despites its favoring benefit in microbiota study. Therefore, our study aims to evaluate microbiota profile in patients with gastric cancer, compared to those without gastric cancer by using mucosal brush sampling. This will improve current knowledge of the potential role of the microbiome in patient gastric cancer as a future biomarker marker using brushing sampling.
### Conditions
- Gastric Cancer
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
- Gastric mucosal brusing
- Gastric mucosal biopsy
### Outcomes
**Primary Outcomes**
- Microbiome analysis using gastric mucosal brushing
**Secondary Outcomes**
- Microbiome analysis using gastric mucosal biopsy
### Location
- **Facility**: King Chulalongkorn Memorial Hospital, Bangkok, N/A, 10330, Thailand
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## Genetic Architecture of Chronic Inflammatory Demyelinating Polyradiculoneuropathy
- **NCT ID**: NCT06325878
- **Study ID**: NEU2-OSS-2022-001
- **Status**: RECRUITING
- **Start Date**: 2022-11-15
- **Completion Date**: 2025-12-31
- **Lead Sponsor**: Istituto Clinico Humanitas
### Study Description
The objective of this study is to characterize the genetic architecture of a large cohort of CIDP patients to evaluate whether specific alleles/haplotypes are implicated in the risk of CIDP, in its clinical and immunological variability, severity, therapeutic response, and association with diabetes and other autoimmune diseases. We will genotype \>700,000 single nucleotide polymorphisms (SNPs) by using the Illumina Global Screening Array (GSA), of approximately 1000 patients with CIDP. About 3500 healthy controls from the Italian population have been already genotyped using GWAS from our genetic department. Alleles/haplotypes will be also compared between patients with typical CIDP and its variants, between CIDP patients with and without specific antibodies, between CIDP patients with and without comorbidities, between CIDP patients with low and high levels of disability and between CIDP patients with and without response to each individual treatment (IVIg, steroids, plasma exchange)
### Conditions
- Chronic Inflammatory Demyelinating Polyradiculoneuropathy
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: NON_RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: BASIC_SCIENCE
### Interventions
- Genome-wide association study
### Outcomes
**Primary Outcomes**
- single nucleotide polymorphisms (SNPs)
**Secondary Outcomes**
### Location
- **Facility**: IRCCS Istituto Clinico Humanitas, Rozzano, N/A, N/A, Italy
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## Perception of Unpleasant Sensations During Study Procedures in ALS Patients
- **NCT ID**: NCT06325865
- **Study ID**: 23C305
- **Status**: RECRUITING
- **Start Date**: 2023-04-19
- **Completion Date**: 2024-12
- **Lead Sponsor**: Istituto Auxologico Italiano
### Study Description
Diagnosis of Amyotrophic Lateral Sclerosis (ALS) is considered a traumatic life event for both the patient and their next-of-kin/carers, due to the lack of treatment. Clinical Trials can offer pioneering treatment to reduce the impact of the disease and improve future treatments worldwide. Research protocols may involve routine diagnostic and/or therapeutic procedures which the patients may be already aware of and, therefore, expecting specific sensations. These could compromise participation or drop-out rate. Despite everything, participation in a clinical trial can guarantee continuity of care also thanks to the execution of these same procedures, through preferential access compared to other patients.Aim of this study is to investigate the unpleasant sensations perceived by ALS patients during procedures in clinical trials. Analysing what type of pain/discomfort frightens patients during diagnostic and/or therapeutic procedures, including the different methods of administration of the study drug. Provide data to implement effective therapy and offer constant patients support throughout ALS specific and needed procedures. Evaluate if this support could influence adherence rate of ALS patients to conduct clinical trials as required. Provide information for future studies to create an ALS Clinical Trials multiple-retention-factors adherence scale. Create and implement an ALS-specific pain scale accounting for its impact on daily activities, aiding an interdisciplinary approach of pain management. Identify the best pain management strategies and compliance techniques to address ALS, not merely in clinical trials. Provide the best individualized care for ALS patients improving their quality of life and mental state.This is a descriptive phenomenological study and data will be analyzed according to Sundler's method. Based on the experience of the researchers and the recommendations proposed by Sandelowski, a total of 20 interviews are estimated in order to reach the theoretical saturation per category of reference. Data collection will be carried out through in-depth semi-structured interviews recorded (13 open-ended questions after the execution of the procedures).
### Conditions
- Amyotrophic Lateral Sclerosis
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
- Interview
### Outcomes
**Primary Outcomes**
- Prevalence of experience of unpleasant sensations or pain
- Study procedure that causes unpleasant sensations or pain
- Duration of unpleasant sensations or pain caused by the study procedure
**Secondary Outcomes**
- HADS score
- ALSFRS score
### Location
- **Facility**: Istituto Auxologico italiano IRCSS, San Luca Hospital, Milano, N/A, 20145, Italy
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## Directional Bilateral Thalamic Patterned Stimulation (Chronos)
- **NCT ID**: NCT06325852
- **Study ID**: 22-5772
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-04-01
- **Completion Date**: 2027-01-01
- **Lead Sponsor**: Alfonso Fasano
### Study Description
Population Size and Eligible Patients: The investigators aim to recruit 5 to 10 patients with tremors who have previously undergone Ventral Intermedius Deep Brain Stimulation (VIM-DBS) treatment but have experienced early or late loss of benefits. Additionally, the investigators will enroll ten patients with essential tremor who require VIM-DBS surgery. These individuals will undergo bilateral implantation of Boston Scientific Genus Implantable Pulse Generator (IPG) devices, connected to Boston Scientific Cartesia™ 8-contact Directional Leads.Study Design: This study comprises two distinct phases. Phase 1 is a cross-sectional investigation designed to identify the optimal algorithm for patterned stimulation in the VIM region . Phase 2 is a prospective clinical trial focusing on the assessment of safety and efficacy of bilateral VIM-DBS in patients with essential tremor.Objectives: The primary objective in Phase 2 is to evaluate the safety and effectiveness of bilateral VIM-DBS in individuals with essential tremor. In Phase 1, the investigators seek to explore the impact of the Chronos programming software on tremor patients who have experienced early or late loss of benefits.
### Conditions
- Essential Tremor
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: NON_RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- DBS programing
### Outcomes
**Primary Outcomes**
- Tremor Rating Scale (Part A-B)
- Tremor analysis
- Tremor Rating Scale (A-C)
- Tremor analysis (meter per second squared)
- Gait speed (meter per second)
- Base of support (meter)
- Step length (meter)
- Stride length (meter)
- Single stance time and double stance time (seconds)
- Tandem gait
- Posturography (newtons)
- Quality of life in Essential Tremor Questionnaire (QUEST)
- Speech analysis
**Secondary Outcomes**
### Location
- **Facility**: Movement Disorders Centre - Toronto Western Hospital, Toronto, Ontario, M5T 2S8, Canada
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## Effects of HypnoBirthing Training and Oxytocin Massage in Primiparous Pregnants
- **NCT ID**: NCT06325839
- **Study ID**: GRU-SBF-ES-01
- **Status**: COMPLETED
- **Start Date**: 2023-04-01
- **Completion Date**: 2023-09-10
- **Lead Sponsor**: Giresun University
### Study Description
This study was conducted to determine the effects of hypnobirthing training and oxytocin massage on birth and postpartum period in primiparous pregnant women.
### Conditions
- Pregnancy Related
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: SUPPORTIVE_CARE
### Interventions
- HypnoBirthing training and oxytocin massage group
### Outcomes
**Primary Outcomes**
- Wijma Birth Anticipation/Experience Scale A (W-DEQ-A)
**Secondary Outcomes**
- Wijma Birth Expectancy/Expectation Scale B (W-DEQ-B)
- Postpartum Breastfeeding Self-Efficacy Scale - Short Form
- Mother-Infant Attachment Scale (MICS)
- Birth satisfaction scale short form (BSS-SF)
### Location
- **Facility**: Giresun Gynecology and Children's Diseases Hospital, Giresun, Center, 28200, Turkey
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## The Study of the Validation of General Evaluation Score (GES) in the Prediction of Hepatocellular Carcinoma Risk Among Patients With Advanced Fibrosis and Cirrhosis Who Achieved Sustained Virological Response for Hepatitis C Virus After Direct Acting Antiviral Drugs
- **NCT ID**: NCT06325826
- **Study ID**: GES
- **Status**: ACTIVE_NOT_RECRUITING
- **Start Date**: 2022-02-01
- **Completion Date**: 2025-06-30
- **Lead Sponsor**: Egyptian Liver Hospital
### Study Description
This cohort study aims to evaluate the validation of general evaluation score in the prediction of hepatocellular carcinoma risk among patients with advanced fibrosis (F3) and cirrhosis (F4) who achieved sustained virological response for hepatitis c virus after direct acting antiviral drugs and determine the group of these patients who require intensified surveillance.
### Conditions
- Hepatocellular Carcinoma
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
- General Evaluation Score (GES)
### Outcomes
**Primary Outcomes**
- Hepatocellular Carcinoma
**Secondary Outcomes**
### Location
- **Facility**: Egyptian Liver Hospital, Talkha, Dakahlia, 36681, Egypt
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## ADHD PreSMA Response Inhibition Therapy
- **NCT ID**: NCT06325813
- **Study ID**: CIN001 - ADHD PreSMART
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-05-01
- **Completion Date**: 2026-12-31
- **Lead Sponsor**: Children's Hospital Medical Center, Cincinnati
### Study Description
ADHD children have abnormal inhibitory control, meaning they have trouble stopping themselves from doing something they should not do. This ability to control involves an area in the brain called the pre-supplementary motor area (pre-SMA). Scientists have previously shown that the pre-SMA is abnormal in ADHD patients. In this study, we will use Transcranial Magnetic Stimulation (TMS) to stimulate the pre-SMA and determine the effects on measures that are related to inhibitory control.
### Conditions
- Attention Deficit Hyperactivity Disorder
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: BASIC_SCIENCE
### Interventions
- Active repetitive TMS
- Sham repetitive TMS
### Outcomes
**Primary Outcomes**
- TMS-based Short-Interval Intracortical Inhibition (SICI)
- EEG-based beta activity
- TMS-based Cortical Silent Period (cSP)
- EEG-based alpha activity
**Secondary Outcomes**
- Stop Signal Reaction Time
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
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## Glycoxidation, Arterial Biomechanics, and Target Organ Damage
- **NCT ID**: NCT06325800
- **Study ID**: 2021401/2023007
- **Status**: RECRUITING
- **Start Date**: 2024-01-01
- **Completion Date**: 2029-12-31
- **Lead Sponsor**: Complejo Hospitalario Universitario de Santiago
### Study Description
Vascular target organ damage (TOD), defined as structural or functional deleterious changes in large and small arteries, is related to unfavorable arterial biomechanics, atherosclerosis and arteriosclerosis. Endothelial dysfunction due to unfavorable redox and glycation states on the bases of these phenomena. However, little is known about the role of glycoxidation on arterial biomechanics and TOD in apparently healthy individuals. The main hypothesis is that glycation and glycoxidation status are associated with arterial biomechanical abnormalities and TOD in patients with moderate to high cardiovascular risk. This is an observational, ambispective, and multicenter project that will include non-smoking patients over 18 years, without diabetes mellitus or established cardiovascular disease. Demographic, epidemiological, and clinical-anthropometric variables will be collected, including data from ambulatory blood pressure monitoring. The investigators will measure the serum percentage of glycated hemoglobin, glycated albumin, and fructosamine levels; along with quantification of skin advanced glycation and glycoxidation end productos (AGEs). Plasma concentration, activity, and structure of catalase, glutathione peroxidase, and superoxide dismutase in relation to the patient's glycation and glycoxidation status will be also evaluated. Concurrently, several biomechanical parameters will be assessed in the Common, Internal Carotid Artery, and distal limb arteries using ultrasound exploration. Incipient microvasculature damage will be also evaluated by retinal image. Patients will be followed up for the development of arterial biomechanical abnormalities and TOD, along with cardiovascular events.
### Conditions
- Oxidative Stress
- Cardiovascular Risk
- Target Organ Damage
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
### Outcomes
**Primary Outcomes**
- Assessment of redox status (1)
- Assessment of redox status (2)
- Evaluation of glycation status (1)
- Evaluation of glycation status (2)
- Evaluation of glycation status (3)
- Evaluation of glycation status (4)
- Assessment of Glycoxidation status (1)
- Assessment of Glycoxidation status (2)
- Quantification of arterial targen organ damage (TOD) during the follow-up (1)
- Quantification of arterial targen organ damage (TOD) during the follow-up (2)
**Secondary Outcomes**
- Evaluation of cardiovascular disease during the follow-up
### Location
- **Facility**: Complejo Hospitalario Universitario de Santiago de Compostela, Santiago De Compostela, A Coruña, 15706, Spain
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## Image-guided Thermal Ablation vs. Lobectomy for Solitary Papillary Thyroid Microcarcinoma
- **NCT ID**: NCT06325787
- **Study ID**: S2021-211-02
- **Status**: COMPLETED
- **Start Date**: 2013-05-01
- **Completion Date**: 2024-01-31
- **Lead Sponsor**: Chinese PLA General Hospital
### Study Description
To evaluate the clinical outcomes of image-guided thermal ablation versus thyroid lobectomy for the treatment of papillary thyroid microcarcinoma
### Conditions
- Papillary Thyroid Cancer
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: NON_RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- thyroid lobectomy
- image-guided thermal ablation
### Outcomes
**Primary Outcomes**
- disease progression
- disease-free survival
**Secondary Outcomes**
- complications
- procedure time
- cost
- estimated blood loss
- hospitalization
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
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## Radical Hypofractionated Radiotherapy for Localized Prostate Cancer
- **NCT ID**: NCT06325774
- **Study ID**: Changhai HHospital
- **Status**: RECRUITING
- **Start Date**: 2024-04-01
- **Completion Date**: 2031-04-01
- **Lead Sponsor**: Changhai Hospital
### Study Description
The aim of this trial is to study the safety outcomes of hypofractionated radiotherapy in treating patients with localized prostate cancer.Hypofractionated radiotherapy delivers higher doses of radiotherapy in a shorter time period, may enabling the killing of more tumor cells with fewer side effects.Accumulating evidence has proven the safety and feasibility of hypofractionated radiotherapy for localized prostate cancer.But for localized prostate cancer,the optimal dose per fraction of hypofractionated radiotherapy is still on its way.
### Conditions
- Localized Prostate Cancer
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: NA
- **Intervention Model**: SINGLE_GROUP
- **Primary Purpose**: TREATMENT
### Interventions
- Hypofractionated radiation therapy
### Outcomes
**Primary Outcomes**
- Incidence of radiotherapy-related gastrointestinal and urogenital tract adverse events
**Secondary Outcomes**
- biochemical progression-free survival (bPFS)
- local progression-free-survival(LPFS)
- distant metastasis free survival(DMFS)
- Overall survival (OS)
- Quality of life (QoL)
### Location
- **Facility**: Changhai hospital, Shanghai, Shanghai, 200433, China
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## A Study to Evaluate the Food Effects on Pharmacokinetics of SY-5007 Tablets in Healthy Subjects
- **NCT ID**: NCT06325761
- **Study ID**: SY-5007-I-02
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-04-01
- **Completion Date**: 2024-05-01
- **Lead Sponsor**: Shouyao Holdings (Beijing) Co. LTD
### Study Description
This study is a single-center, randomized, open-label, single-dose, two-period, two-treatment crossover trial aimed at evaluating the pharmacokinetic (PK) profiles and safety of SY-5007 tablets administered orally to healthy subjects in both fasting and fed states in China.
### Conditions
- Health Subjects
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: CROSSOVER
- **Primary Purpose**: TREATMENT
### Interventions
- SY-5007
- SY-5007
### Outcomes
**Primary Outcomes**
- Cmax for SY-5007
- Tmax for SY-5007
- AUC0-t for SY-5007
- AUC0-∞ for SY-5007
- t½ for SY-5007
- CL/F for SY-5007
- Vz/F for SY-5007
**Secondary Outcomes**
- Safety of SY-5007
### Location
- **Facility**: West China Hospital of Sichuan University, Chengdu, Sichuan, 610041, China
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## SENTI-202: Off-the-shelf Logic Gated CAR NK Cell Therapy in Adults With CD33 and/or FLT3 Blood Cancers Including AML/MDS
- **NCT ID**: NCT06325748
- **Study ID**: SENTI-202-101
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-06
- **Completion Date**: 2040-08
- **Lead Sponsor**: Senti Biosciences
### Study Description
This is an open-label study of the safety, biodynamics, and anti-cancer activity of SENTI-202 (an off-the-shelf logic gated CAR NK cell therapy) in patients with CD33 and/or FLT3 expressing blood cancers, including AML and MDS.
### Conditions
- AML/MDS
- CD33 Expressing Hematological Malignancies
- FLT3 Expressing Hematological Malignancies
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: NA
- **Intervention Model**: SINGLE_GROUP
- **Primary Purpose**: TREATMENT
### Interventions
- SENTI-202
### Outcomes
**Primary Outcomes**
- Safety and tolerability for dose determination of SENTI-202
**Secondary Outcomes**
- Anti-cancer activity of SENTI-202
- Pharmacokinetic (PK) and pharmacodynamic (PDn) profile of SENTI-202
- Host immune response to SENTI-202
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
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## Combined Systemic Inflammatory Indices and Birth Weight
- **NCT ID**: NCT06325735
- **Study ID**: 98
- **Status**: COMPLETED
- **Start Date**: 2019-12-01
- **Completion Date**: 2024-04-01
- **Lead Sponsor**: University of Campania "Luigi Vanvitelli"
### Study Description
The study aimed to explore the complex relationship between various systemic inflammatory indices and birth weight
### Conditions
- Systemic Inflammation Markers
- Birth Weight
- Combined Systemic Inflammatory Indices
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
- None intervention
### Outcomes
**Primary Outcomes**
- Systemic inflammatory indices and birth weight
**Secondary Outcomes**
### Location
- **Facility**: Università degli studi della Campania "Luigi Vanvitelli"- OB & Gyn -, Napoli, Italia, 80138, Italy
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## Diet Order Effects of Low Fat vs. Low Carb Diets on Body Fat Change
- **NCT ID**: NCT06325722
- **Study ID**: 10001680
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-05-01
- **Completion Date**: 2026-07-31
- **Lead Sponsor**: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
### Study Description
Background:In a previous study, participants were lived at the NIH and randomly received either a low-fat or a low-carbohydrate diet for 2 weeks and then switched to the other diet for 2 more weeks. Participants who received the low-carbohydrate diet first lost more body fat at the end of the study than those who received the low-fat diet first. Researchers want to see if they can repeat that result in a longer weight loss study when participants live at home.Objective:To test the effects of diet order in people receiving either a low-fat or low-carbohydrate diet first for 4 weeks and then immediately switched to the other diet for another 4 weeks.Eligibility:Adults aged 19 to 50 years with a body mass index of 25 or more.Design:Participants will complete the study at their homes, but there will be 3 required visits to the NIH. Participants will drink a special type of water 2 weeks before the baseline NIH visit and collect urine samples at home to measure how many calories they burn. Before the diets begin, participants will visit the NIH for baseline testing when they will have a metabolism test while relaxing in a bed with a plastic hood over their head to collect the air they breathe out. They will have scans to measure their bone density and how much muscle and body fat they have. They will give stool, blood, and urine samples.Participants will be asked to eat a specific diet for 4 weeks followed by a different diet for 4 weeks. All meals will be delivered to the participants homes. They will eat only the foods delivered.Participants will weigh themselves daily. They will wear a monitor to track their physical activity and a sensor to measure their glucose levels. They will prick their finger each morning to test a drop of blood for ketones. Participants will meet virtually as a group with the study team weekly. Participants will have two more NIH visits towards the end of each diet period....
### Conditions
- Overweight
- Obesity
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: CROSSOVER
- **Primary Purpose**: BASIC_SCIENCE
### Interventions
- Low-carbohydrate Diet
- Low-fat Diet
### Outcomes
**Primary Outcomes**
- Change in total fat mass
**Secondary Outcomes**
- Rate of body weight change from baseline to week 8
- Rate of body weight change during low-carbohydrate diet
- Rate of body weight change during low-fat diet
### Location
- **Facility**: National Institutes of Health Clinical Center, Bethesda, Maryland, 20892, United States
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## Base Editing for Mutation Repair in Hematopoietic Stem & Progenitor Cells for X-Linked Chronic Granulomatous Disease
- **NCT ID**: NCT06325709
- **Study ID**: 10001580
- **Status**: ENROLLING_BY_INVITATION
- **Start Date**: 2024-04-17
- **Completion Date**: 2032-12-31
- **Lead Sponsor**: National Institute of Allergy and Infectious Diseases (NIAID)
### Study Description
Background:Chronic granulomatous disease (CGD) is a rare immune disorder caused by a mutation in the CYBB gene. People with CGD have white blood cells that do not work properly. This places them at risk of developing infections that may be life-threatening. Stem cell transplant can cure CGD but transplanting stem cells donated by other people can have serious complications. In addition, not everyone has a matched donor. Another approach is a type of gene therapy that involves base-editing to correct the mutation in a person s own stem cells. Researchers want to know if the base-edited stem cells can improve the white cells' functioning and result in fewer CGD-related infections.Objective:To learn if base-edited stem cells will improve white blood cells' ability to fight against infections in people with CGD.Eligibility:Males aged 18 years and older with X-linked CGD.Design:This is a non-randomized study. Participants with the specific mutation under study will be screened during the initial phase.During the development phase, participants will undergo apheresis to collect stem cells for base-editing correction of the mutation.During the treatment phase, participants will receive the base-edited cells after chemotherapy with busulfan. Participants will remain in the hospital until their immunity recovers.Follow-up visits will continue for 15 years.
### Conditions
- Chronic Granulomatous Disease (CGD)
- X-Linked Chronic Granulomatous Disease
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: NA
- **Intervention Model**: SINGLE_GROUP
- **Primary Purpose**: TREATMENT
### Interventions
- Base-edited hematopoietic stem and progenitor cells
- Busulfan
- Palifermin
- Filgrastim
- Plerixafor
### Outcomes
**Primary Outcomes**
- To evaluate the safety of base-edited autologous CD34+ cells
- To evaluate the efficacy of base-edited autologous CD34+ cells
**Secondary Outcomes**
- Evaluate the efficiency of base-editing.
- Evaluate the engraftment capability of base-edited hematopoietic stem progenitor cells.
- Evaluate the efficiency in restoring gp91phox expression.
- Evaluate efficacy in restoring NADPH oxidase function.
- Evaluate clinical efficacy
- Evaluate the stability of gene correction
### Location
- **Facility**: National Institutes of Health Clinical Center, Bethesda, Maryland, 20892, United States
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## H01 in Adults With Interstitial Lung Disease (The SOLIS Study)
- **NCT ID**: NCT06325696
- **Study ID**: 10001577
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-05-01
- **Completion Date**: 2025-12-31
- **Lead Sponsor**: National Institute of Environmental Health Sciences (NIEHS)
### Study Description
Background:Interstitial lung disease affects the tissues that aid the transfer of oxygen and carbon dioxide between the air and the bloodstream. The disease can cause fibrosis, a thickening and scarring of lung tissue. Fibrosis often continues getting worse, and most people with this disease die in 3 to 5 years.Objective:To test a study drug (hymecromone) in people with interstitial lung disease or lung fibrosis.Eligibility:People aged 18 years and older with interstitial lung disease or lung fibrosis.Design:Participants will have at least 7 clinic visits over 5 months.Participants will have screening and baseline visits. They will have blood tests and tests of their heart function. They will give a sputum sample. Other tests will include:Spirometry: Participants will breathe in and out through a mouthpiece to measure how much air they can hold in their lungs and how hard they can breathe.Diffusion capacity of lungs for carbon monoxide: Participants will breathe in a gas that contains a small amount of carbon monoxide. Then they will breathe through a mouthpiece. This test measures how well oxygen moves from the air into the blood.Resting energy expenditure. Participants will lie still for 30 minutes with a clear dome over their head. This test measures the calories their body burns at rest.6-minute walk test. Participants will walk at their normal pace for 6 minutes. Their vital signs and blood oxygen levels will be checked.Hymecromone is a tablet taken by mouth. Participants will take 2 tablets every morning and 2 tablets every night for 12 weeks. Tests will be repeated at study visits.
### Conditions
- Interstitial Lung Disease
- Idiopathic Pulmonary Fibrosis
- Lung Diseases, Interstitial
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: NA
- **Intervention Model**: SINGLE_GROUP
- **Primary Purpose**: TREATMENT
### Interventions
- hymecromone
### Outcomes
**Primary Outcomes**
- To evaluate the efficacy of H01 in reducing serum hyaluronan levels in participants with progressive ILD
**Secondary Outcomes**
- Evaluate the safety and tolerability of oral H01 in participants with progressive ILD.
- Evaluate the change in clinical and functional measures in participants with progressive ILD treated with H01.
- Evaluate biomarkers of fibrosis in participants with progressive ILD treated with H01.
- Evaluate pharmacokinetic changes from baseline in participants with progressive ILD treated with H01.
### Location
- **Facility**: NIEHS Clinical Research Unit (CRU), Research Triangle Park, North Carolina, 27709, United States
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## Anti-Lag-3 (Relatlinib) and Anti-PD-1 Blockade (Nivolumab) Versus Standard of Care (Lomustine) for the Treatment of Patients With Recurrent Glioblastoma
- **NCT ID**: NCT06325683
- **Study ID**: NCI-2024-01995
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-06-21
- **Completion Date**: 2028-07-15
- **Lead Sponsor**: National Cancer Institute (NCI)
### Study Description
This phase II trial compares the safety, side effects and effectiveness of anti-lag-3 (relatlinib) and anti-PD-1 blockade (nivolumab) to standard of care lomustine for the treatment of patients with glioblastoma that has come back after a period of improvement (recurrent). Relatlimab and nivolumab are monoclonal antibodies that may interfere with the ability of tumor cells to grow and spread. Lomustine is a chemotherapy drug and in a class of medications called alkylating agents. It damages the cell's deoxyribonucleic acid (DNA) and may kill cancer cells. Relatlinib and nivolumab may be safe, tolerable, and/or effective compared to standard of care lomustine in treating patients with recurrent glioblastoma.
### Conditions
- Recurrent Glioblastoma
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- Biopsy
- Biospecimen Collection
- Lomustine
- Magnetic Resonance Imaging
- Nivolumab
- Relatlimab
- Surgical Procedure
### Outcomes
**Primary Outcomes**
- Overall survival (OS)
- OS rate
**Secondary Outcomes**
- Progression-free survival (PFS)
- Radiographic response
- Incidence of adverse events (AEs)
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
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## Type 2 Diabetes and Binge Eating Disorder (BED)
- **NCT ID**: NCT06325670
- **Study ID**: 23/50374
- **Status**: RECRUITING
- **Start Date**: 2024-02-23
- **Completion Date**: 2025-06
- **Lead Sponsor**: Odense University Hospital
### Study Description
The goal of this research project is to improve the treatment of individuals living with both type 2 diabetes (T2D) and Binge Eating Disorder (BED). The research hypothesizes that BED treatment will not only improve BED symptoms but also improve T2D severity and associated cardiovascular risk factors. The research involves a multidisciplinary team, including experts in endocrinology, psychology, and eating disorders.The main questions it aims to answer are:* Does treatment for Binge Eating Disorder lead to improvements in BED symptoms?* Does treatment for Binge Eating Disorder lead to improvements in T2D severity and associated cardiovascular risk factors?Participants will undergo a comprehensive treatment program targeting both BED and T2D. This program will include psychotherapy sessions focusing on cognitive-behavioral techniques to address binge eating behavior.Researchers will compare participants' outcomes before and after the treatment program to assess changes in BED symptoms, T2D severity, and associated cardiovascular risk factors.
### Conditions
- Diabetes Mellitus, Type 2
- Binge-Eating Disorder
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- BED treatment
- Waitlist
### Outcomes
**Primary Outcomes**
- Number of binge eating episodes
**Secondary Outcomes**
- Binge Eating Disorder Questionnaire
- Glucose Sensor Data for Blood Glucose Profile
- HbA1c
### Location
- **Facility**: Region Of Southern Denmark Locations, Odense, Region Of Southern Denmark, 5000, Denmark
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## A Study to Learn About the Vaccine RSVpreF In Pregnant Participants With HIV and Their Infants
- **NCT ID**: NCT06325657
- **Study ID**: C3671032
- **Status**: RECRUITING
- **Start Date**: 2024-03-12
- **Completion Date**: 2025-06-11
- **Lead Sponsor**: Pfizer
### Study Description
The purpose of the study is to learn about the safety and immune activity of the RSVpreF vaccine. It will be studied in infants born to mothers living with HIV. These infants may have higher chances of getting sick or dying due to RSV infection. Respiratory Syncytial Virus (RSV) is a common type of virus (germ) that can cause severe illness (airway diseases), where medical help is needed. Vaccines help your body make antibodies which help fight against diseases. The antibodies are substances your body uses to fight off an infection. The antibodies can be passed to the infant through the placenta of the mother.The study will look at the safety, tolerability, and immune activity in mothers and their infants.This study is seeking pregnant women who are:* Less than or equal to 49 years old and have HIV (Human immunodeficiency virus -* Receiving standard medical care during the pregnancy* Do not have syphilis (bacterial sexually transmitted disease), Hepatitis B Virus ((HBV) liver infection), Tuberculosis ((TB) bacterial lung infection).* Have been on stable (anti-retroviral) HIV treatment for more than or equal to 90 days.* agree to be present for all study visits, procedures, and blood draws.Participants will either receive:* RSVpreF vaccine* A placebo. A placebo does not have any medicine it but looks just like the study vaccine.Pregnant participants will be involved in the study from:* consent during their current pregnancy, and* for 6 months after delivery of their baby (around 10 months in total). Pregnant participants will have at least 5 planned visits in this study. Infant participants: All eligible babies born to enrolled mothers will be followed up from birth for up to 6 months. Infant participants will have at least 3 study visits, with some site visits allowed to happen via home visits or over the telephone.
### Conditions
- Respiratory Syncytial Virus
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: PREVENTION
### Interventions
- RSVpreF vaccine
- Placebp
### Outcomes
**Primary Outcomes**
- Maternal Participants Primary Safety - The proportion of participants reporting systemic reactions
- Maternal Participants Primary Safety - The proportion of participants reporting local reactions
- Maternal Participants Primary Safety - The proportion of participants reporting Adverse Events (AEs)
- Maternal Participants Primary Safety - The proportion of participants reporting Adverse Event of Special Interests (AESIs)
- Maternal Participants Primary Safety - The proportion of participants reporting Serious Adverse Events (SAEs)
- Infant Participants Primary Safety - The proportion of participants reporting Specific Birth Outcomes
- Infant Participants Primary Safety - The proportion of participants reporting Adverse Events (AEs)
- Infant Participants Primary Safety - The proportion of participants reporting SAEs and Newly Diagnosed Chronic Medical Conditions (NDCMCs)
**Secondary Outcomes**
- Maternal Participants: Secondary Immunogenicity - GMT of NTs for RSV A and RSV B
- Maternal Participants: Secondary Immunogenicity - GMFR of NTs for RSV A and RSV B
### Location
- **Facility**: Synergy Biomed Research Institute, East London, Eastern CAPE, 5241, South Africa
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## Well-Formulated Ketogenic Diet Polycystic Kidney Disease
- **NCT ID**: NCT06325644
- **Study ID**: 2023H0258
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-04-01
- **Completion Date**: 2027-04-01
- **Lead Sponsor**: Ohio State University
### Study Description
This is a prospective study to determine ketogenic diet effect on htTKV, GFR, microalbuminuria. This is a single-center study of 20 patients with ADPKD and deemed high risk for progression to ESRD. This determined by combination of features of ADPKD and htTKV as assessed by prior computed tomography (CT) or MRI. Patients will be recruited from the Polycystic Kidney Disease (PKD) Clinic at Ohio State University Wexner Medical Center. Enrolled patients will have MRI for htTKV, urinary studies, blood tests at baseline, 6 months, and 52 weeks. Blood for GFR will be assessed three times over the course of the study including baseline, 6 months, and 1 year. Participants will follow ketogenic diet for 52 weeks. Investigatory diet team will manage the ketogenic diet.
### Conditions
- Polycystic Kidney Disease
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: NA
- **Intervention Model**: SINGLE_GROUP
- **Primary Purpose**: BASIC_SCIENCE
### Interventions
- Ketogenic Diet
- Ketone/Glucose Monitoring
- CGM/CKM
- Blood Draw
- Body Composition
- Change in glomerular filtration rate (mg/mmol) via magnetic resonance imaging (MRI) .
### Outcomes
**Primary Outcomes**
- Finger Stick Beta-Hydroxybutyrate
- Finger Stick Glucose
**Secondary Outcomes**
- Blood Pressure
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
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## Comparative Evaluation of the Results of Facet Joint Injections
- **NCT ID**: NCT06325631
- **Study ID**: Ankara City Hospital Bilkent
- **Status**: RECRUITING
- **Start Date**: 2023-01-02
- **Completion Date**: 2024-04-30
- **Lead Sponsor**: Oznur Uzun
### Study Description
Low back pain affects 60 to 90% of the total population. It is one of the most common causes of disability in adults. Low back pain can be originated from a wide variety of structures, and the facet joint is one of these structures. It is thought that 21 to 41% of low back pain originates from the facet joint. A wide variety of conservative treatments, including intra-articular injections, are used to treat low back pain originating from the facet joint. However, there is still no consensus on the most effective treatment method. With appropriate patient selection, facet joint injections can provide significant improvements in patients' pain scores. After Goldthwait defined the facet joint concept in 1911, Ghormley defined facet joint syndrome in 1933. The source of pain in 40-50% of patients is the lumbar facet joints. Innervation of the lumbar facet joints is provided by the medial branches of the dorsal roots of the spinal nerves. In 1975, Shealy described the coagulation of the articular nerve support of the spinal facet joints with the radiofrequency method. These methods have been further developed over time. The results of facet joint injections are satisfactory in well-selected patient groups. It has been shown that intra-articular steroid injection to the facet joint is superior to systemic steroid use in patients with low back pain. In this study, it was aimed to methodically compare the facet joint injections applied to patients diagnosed with facet syndrome in the outpatient clinic of the Physical Therapy and Rehabilitation Hospital in terms of patient pain scores, application time, effort spent and patient anxiety. Intra-articular injections will be performed under by fluoroscopy or ultrasound guidance or anatomic location.
### Conditions
- Low Back Pain, Mechanical
- Facet Syndrome of Lumbar Spine
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: CROSSOVER
- **Primary Purpose**: TREATMENT
### Interventions
- Intra-articular injection to lumbar facet joint
### Outcomes
**Primary Outcomes**
- Visual Analogue Scale
**Secondary Outcomes**
### Location
- **Facility**: Ankara Bilkent Şehir Hastanesi, Ankara, N/A, N/A, Turkey
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## Lymphedema, Low-grade Inflammation and the Vasculature in Turner Syndrome
- **NCT ID**: NCT06325618
- **Study ID**: 1-10-72-138-23
- **Status**: RECRUITING
- **Start Date**: 2024-01-08
- **Completion Date**: 2027-08
- **Lead Sponsor**: University of Aarhus
### Study Description
100 women with karyotype verified TS, previously examined at 4 study visits during a 19-year period will be asked to participate in a 5th study visit. Healthy age-matched females will be included as controls in a ratio 2:1.The aim is to examine and quantify the cardiovascular and lymphatic system in women with TS. The investigators will study a possible causal mechanism between the known pathologic phenotype and alterations in these systems to understand, prevent or treat the life-threatening complications in TS.
### Conditions
- Turner Syndrome
- Cardiovascular Diseases
- Lymphedema
- Inflammation
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
- No intervention other than obtaining biopsies
- Indocyanine green (ICG)
### Outcomes
**Primary Outcomes**
- Grade dysfunction of clinical and subclinical lymphedema using Indocyanine Green Lymphography and Magnetic Resonance Lymphangiography.
- Detecting low-grade inflammation in Turner Syndrome preforming FDG-PET/CT-scans to locate low grade inflammation.
- Heat maps of the distribution of wall shear stress in the aorta
**Secondary Outcomes**
- MRI evaluation and description of vascular abnormalities in Turner Syndrome
- Cardiac MRI to evaluate function
- Cardiac MRI to evaluate fibrosis of the myocardium
- Mapping DNA-methylations patterns in multiple tissues
- Immunologic changes in Turner Syndrome
### Location
- **Facility**: Aarhus University Hospital, Aarhus N, N/A, 8200, Denmark
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## Efficacy and Safety of Bifidobacterium Combined With High-frequency Transcranial Magnetic Stimulation in the Treatment of Adolescent Depression
- **NCT ID**: NCT06325605
- **Study ID**: GRYY-LL-KJ2022-064
- **Status**: COMPLETED
- **Start Date**: 2022-03-01
- **Completion Date**: 2022-10-31
- **Lead Sponsor**: Zhen-Hong Hu
### Study Description
A total of 100 patients with adolescent depression who were admitted to our hospital between March 2022 and October 2022 were selected. On the basis of double blinding, these patients were randomly divided into the observation group(n=50) and the control group(n=50) using a random number table. 5S management method was used in the whole process of treatment to improve the hospital environment, increase the work efficiency and reduce the occurrence of cross infection through the effective implementation of the five steps of sort(Seiri), set in order(Seiton), shine (Seiso), standardize(Seiketsu) and sustain(Shitsuke).
### Conditions
- Adolescent Depression
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- Bifidobacterium
- High-frequency rTMS
- Escitalopram Oxalate
### Outcomes
**Primary Outcomes**
- HAMD-24 scores
- TNF-α
- IL-1β
- IL-6
- DA
- 5-HT
- COR
- Serum miR-16
- Serum miR-195
**Secondary Outcomes**
### Location
- **Facility**: Tangshan Workers' Hospital, Tangshan, Hebei, 063003, China
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## Association Between Surgical Timing and Route of Total Hysterectomy After LEEP and Perioperative Risk in Patients With Cervical HSIL
- **NCT ID**: NCT06325592
- **Study ID**: REHSIL2023V1.1
- **Status**: COMPLETED
- **Start Date**: 2023-10-01
- **Completion Date**: 2024-03-01
- **Lead Sponsor**: Sichuan Cancer Hospital and Research Institute
### Study Description
This study aimed to analyze perioperative information in patients with high-grade squamous intraepithelial lesion (HSIL) undergoing total hysterectomy (TH), offering insights into optimal surgery timing, selecting the operation path, and enhancing surgical operation details.
### Conditions
- High-Grade Squamous Intraepithelial Lesions
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
- surgical timing and operation path
### Outcomes
**Primary Outcomes**
- Postoperative fever
- Postoperative therapeutic use of antibiotics
**Secondary Outcomes**
- Postoperative complications
- Postoperative hospitalization days
- Postoperative hemoglobin
- Postoperative white blood cell count
- Postoperative erythrocyte count
- Postoperative albumin number
- Postoperative CRP value
### Location
- **Facility**: Sichuan Cancer Hospital and Research Institute, Chengdu, Sichuan, 610000, China
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## Immersive Virtual Reality for Dysphagia
- **NCT ID**: NCT06325579
- **Study ID**: AA29411356
- **Status**: COMPLETED
- **Start Date**: 2021-05-24
- **Completion Date**: 2023-03-31
- **Lead Sponsor**: Sheffield Hallam University
### Study Description
People who have suffered a stroke are at high risk of suffering from oropharyngeal dysphagia with long and intensive exercise programmes. Early access to treatment and engaging therapies is very important for recovery. Immersive virtual reality technology presents an innovative treatment that could help patients improve swallowing. The aim of this study is to improve swallowing in stroke patients using two bespoke immersive virtual reality treatment with real-time feedback. The study consisted in a small feasibility study with stroke patients suffering dysphagia (n = 6, aged of 39 to 80 (M=71.17, SD=15.94). Results obtained through interviews with the patients indicated no discomfort reported during the game. All patients reported enjoying the game and feeling engaged and immersive and four out of six patients reported that they would like to use it every day as part of their Speech and Language therapy. The SALT assistant involved in the study stated that the system had the potential to encourage patients to swallow, being more functional than conventional speech therapy. She identified improvements needed for a better functioning of the VR rehabilitation system for Dysphagia. In a future study, wireless headsets will be used, without a laptop, and it will be important to improve the reliability and design of the strain gauge or innovate in the use of a different technology.
### Conditions
- Virtual Reality
- Dysphagia
- Treatment Compliance
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: NA
- **Intervention Model**: SINGLE_GROUP
- **Primary Purpose**: DEVICE_FEASIBILITY
### Interventions
- Immersive Virtual Reality for Dysphagia Treatment
### Outcomes
**Primary Outcomes**
- Feasibility of the system. Semi-structure Interviews with patients and staffs. Qualitative outcomes.
- Feasibility of the system. Semi-structure Interviews with patients. Quantitative outcomes.
**Secondary Outcomes**
### Location
- **Facility**: Sheffield Hallam University, Sheffield, South Yorkshire, S1 2NU, United Kingdom
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## Efficacy and Safety of Rexlemestrocel-L Combined With HA* in Participants With Moderate to Severe Chronic Low Back Pain
- **NCT ID**: NCT06325566
- **Study ID**: MSB-DR004
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-05
- **Completion Date**: 2027-08
- **Lead Sponsor**: Mesoblast, Ltd.
### Study Description
The primary purpose of this study is to evaluate the efficacy of rexlemestrocel-L+HA compared to control in reducing low back pain at 12 months post-treatment and safety of a single injection of rexlemestrocel-L+HA injected into a lumbar intervertebral disc compared to control through 12 months post-treatment.
### Conditions
- Degenerative Disc Disease
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- Rexlemestrocel-L + HA mixture
- Saline
### Outcomes
**Primary Outcomes**
- Mean Change From Baseline in Daily Average Low Back Pain at 12 Months Post-treatment Based on Visual Analog Scale (VAS) Score
- Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
**Secondary Outcomes**
- Percentage of 30% VAS Pain Responders at 12 Months Post-treatment
- Mean Change From Baseline in Quality of Life Measured by Euroqol-5D (EQ-5D) Index Score at 12 Months Post-treatment
- Percentage of Minimal Pain Responders at 12 Months Post-treatment
- Mean Change From Baseline in Function as Measured by Oswestry Disability Index (ODI) Questionnaire Score at 12 Months Post-treatment
- Percentage of Participants With 30% VAS and 10-point ODI Treatment Success at 12 Months Post-treatment
- Percentage of Participants Who Ceased Opioid Usage at 24 Months Post-treatment
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
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## Incidence of Platelet Refractoriness in Adult Acute Leukemia Patients Receiving Prestorage Filtered Blood and Comparing With Historical Control
- **NCT ID**: NCT06325553
- **Study ID**: 022_2566
- **Status**: RECRUITING
- **Start Date**: 2024-03-30
- **Completion Date**: 2026-03-30
- **Lead Sponsor**: Siriraj Hospital
### Study Description
This research project is evaluate the incidence of platelet refractoriness in newly diagnosed acute leukemia patients receiving PFB during induction and first consolidation phase chemotherapy compared to 2 historical control groups which are patients receiving non-leukocyte depleted blood product group and leukocyte depleted blood product group and demonstrate cost-effectiveness of using blood products with filtered process to prevent clinical platelet refractoriness compare with using HLA-matched blood products after platelet refractoriness occurs
### Conditions
- Platelet Refractoriness in Adult Acute Leukemia
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
### Outcomes
**Primary Outcomes**
- Descriptive statistics
- Inferential statistics
**Secondary Outcomes**
### Location
- **Facility**: Siriraj hospital, Bangkok, N/A, 10700, Thailand
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## Clinical Success of Indirect Pulp Capping: 1-Year Follow-Up
- **NCT ID**: NCT06325540
- **Study ID**: pulpcapping
- **Status**: COMPLETED
- **Start Date**: 2023-01-01
- **Completion Date**: 2024-02-15
- **Lead Sponsor**: Saglik Bilimleri Universitesi
### Study Description
The goal of this clinical trial is to compare the clinical success of theracal pt, therabase, and biodentine indirect pulp capping on primary molars with deep dentin caries. Indirect pulp capping was used on the primary molars of the participants with deep dentin caries. It is aimed to compare the success of biodentine, which is considered the gold standard used in capping treatments, and the currently marketed Teracal PT and Therabase materials after 1, 6 months and 1 year, with biodentine and with each other, and find out which material is more successful.
### Conditions
- Dentin, Carious
- Indirect Pulp Capping
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- indirect pulp capping with theracal pt
- indirect pulp capping with therabase
- indirect pulp capping with biodentine
### Outcomes
**Primary Outcomes**
- successful completion of research
- unseccessful completion of research
**Secondary Outcomes**
### Location
- **Facility**: Sağlık Bilimleri Üniversitesi, Istanbul, N/A, N/A, Turkey
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## Cognitive Impairment Cohort Study of the Elderly Population in YuGarden
- **NCT ID**: NCT06325527
- **Study ID**: YuGarden-01
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-04-01
- **Completion Date**: 2031-06-01
- **Lead Sponsor**: Ruijin Hospital
### Study Description
The goal of this prospective observational research with an 8-year follow-up is to study the cognitive changes in the elderly in YuGarden community, Shanghai, China.The main questions it aims to answer are:* incidence of cognitive impairment in community (converting to mild cognitive impairment or Alzheimer's disease)* to build a predictive model for the progression of cognitive impairment
### Conditions
- Alzheimer Disease
- Neurodegenerative Diseases
- Cognitive Impairment
- Mild Cognitive Impairment
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
### Outcomes
**Primary Outcomes**
- Incidence of cognitive impairment
**Secondary Outcomes**
- The change of Mini-Mental State Examination (MMSE)
- The change of Barthel Index for Activities of Daily Living (ADL)
- The change of blood biomarkers
- The change of urine biomarkers
- The change of feces biomarkers
- The change of gingival crevicular fluid biomarkers
- The change of electroencephalogram (EEG)
- The change of speech information
- The change of structural MRI
- The change of functional MRI
- The change of magnetic susceptibility
- The change of perfusion MR imaging
- Positron emission tomography (PET)
### Location
- **Facility**: Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, Shanghai, N/A, China
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## Artificial Intelligence Based Program to Classify Oral Cavity Findings Based on Clinical Image Analysis
- **NCT ID**: NCT06325514
- **Study ID**: NA2024
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-04-01
- **Completion Date**: 2024-09-01
- **Lead Sponsor**: Cairo University
### Study Description
This study aims to develop an AI program that can classify oral findings into Normal/variation of normal or an oral disease by clinical photos analysis, aiding in lowering the percentages of false positive and false negative diagnosis of oral diseases.
### Conditions
- Oral Cancer
- Oral Lichen Planus
- Fordyce Granule
- Leukoplakia
- Erythroplakia
- Leukoedemas, Oral
- Lichenoid Reaction
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
- Artificial intelligence based program
### Outcomes
**Primary Outcomes**
- risk stratification
**Secondary Outcomes**
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
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## Misoprostol Versus Oxytocin Infusion On Reducing Blood Loss During Abdominal Myomectomy
- **NCT ID**: NCT06325501
- **Study ID**: AA-2024-1
- **Status**: RECRUITING
- **Start Date**: 2024-03-01
- **Completion Date**: 2025-01-01
- **Lead Sponsor**: Cairo University
### Study Description
Uterine leiomyomas, or fibroids, are common benign tumors among women, especially those over 35 years old. They can cause various issues, including heavy menstrual bleeding, anemia, pelvic pain, and pressure symptoms. Surgery is often necessary for symptomatic fibroids, with hysterectomy recommended for women over 40 and myomectomy for those wishing to preserve their uterus. Myomectomy can be performed using different surgical approaches but can be associated with significant morbidity, particularly major blood loss, especially in abdominal myomectomy, where up to 20% of women may require blood transfusion.Various interventions have been introduced to reduce bleeding during myomectomy, such as tourniquets, bupivacaine plus epinephrine infiltration, vasopressin injection, preoperative GnRH agonist administration, and preoperative ascorbic acid injection. However, these strategies may have complications, be ineffective, expensive, or require extra steps.Oxytocin, primarily secreted from the pituitary gland, is crucial for uterine contraction during labor and delivery, and is used to prevent postpartum uterine atony and bleeding. However, caution is needed in its use, especially in women with heart disease or hypovolemia.Misoprostol, a prostaglandin E1 analogue, can reduce bleeding during myomectomy by promoting myometrial contractions and reducing uterine artery blood flow. It can be administered via multiple routes, with rectal administration showing advantages in maintaining high plasma concentrations during surgery. Studies have investigated the effectiveness of single preoperative rectal doses of misoprostol versus preoperative oxytocin in reducing bleeding during abdominal myomectomy.
### Conditions
- Myoma;Uterus
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: SUPPORTIVE_CARE
### Interventions
- Misoprostol 200mcg Tab
- Oxytocin
### Outcomes
**Primary Outcomes**
- intra-operative blood loss
**Secondary Outcomes**
- blood transfusion
- post-operative Hb
- total surgery time
### Location
- **Facility**: faculty of medicine, Kasr el ainy hospital, Cairo university, Cairo, N/A, 11562, Egypt
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## Fibrosis, Inflammation, Oxygenation of Renal Tissue In FabrY Disease
- **NCT ID**: NCT06325488
- **Study ID**: H-23035668
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-04-01
- **Completion Date**: 2025-06-01
- **Lead Sponsor**: Caroline Michaela Kistorp
### Study Description
The overall objective of this study is to investigate Fabry-associated renal organ involvement by using a novel magnetic resonance imaging (MRI) approach, focusing on changes in renal oxygen levels by blood oxygenation-level dependent (BOLD) imaging. Furthermore, to correlate renal oxygenation to the phenotypic presentation of patients with Fabry-associated nephropathy regarding circulating and imaging-derived biomarkers of kidney inflammation, fibrosis and injury as compared with healthy age- and sex-matched controls.The study will achieve this by:1) Using a non-invasive, contrast-free MRI protocol focusing on parameters of oxygenation, inflammation, fibrosis, and injury in the kidney.2) Using an extensive, in-depth biomarker blood panel to investigate the pathological pathways associated with Fabry disease and Fabry-associated nephropathy.
### Conditions
- Fabry Disease
- Chronic Kidney Diseases
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
### Outcomes
**Primary Outcomes**
- Renal hypoxia (Fabry patients according to renal impairment)
**Secondary Outcomes**
- Renal hypoxia (Fabry patient vs controls)
- Renal cortical perfusion (Fabry vs. controls)
- Renal medullar perfusion (Fabry vs. controls)
- Renal inflammation (Fabry vs. controls)
- Renal fibrosis (Fabry vs. controls)
### Location
- **Facility**: Rigshospitalet, Copenhagen, N/A, 2100, Denmark
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## Comparison of Patients' Postpartum Recovery Using ObsQoR-10 Score in Pregnant Women in Vaginal Delivery With and Without Neuraxial Labor Analgesia
- **NCT ID**: NCT06325475
- **Study ID**: B.30.2.ATA.0.01.00/530
- **Status**: RECRUITING
- **Start Date**: 2024-03-26
- **Completion Date**: 2024-08-26
- **Lead Sponsor**: Ataturk University
### Study Description
The aim of this study was to compare the postpartum recovery of pregnant women who had vaginal delivery with and without neuraxial labor analgesia using the ObsQoR-10 scoring system.
### Conditions
- Analgesia
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- labor with neuraxial labor analgesia
- labour without noroaxial labor analgesia
### Outcomes
**Primary Outcomes**
- ObsQoR-10 scores of postpartum patients
**Secondary Outcomes**
### Location
- **Facility**: Atatürk University, Erzurum, N/A, N/A, Turkey
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## The Influence of Anesthetic Technique on Cerebral Oxygenation During Spinal Surgery
- **NCT ID**: NCT06325462
- **Study ID**: E2232/2023
- **Status**: RECRUITING
- **Start Date**: 2024-02-10
- **Completion Date**: 2024-12
- **Lead Sponsor**: Prince Sultan Military Medical City
### Study Description
Postural changes during anesthesia can lead to decreased cerebral blood flow and oxygenation, especially when moving from a supine to a prone position. This is particularly relevant during spinal surgery with controlled hypotension. Cerebral oximetry, monitored in the frontal cortex using an O3 sensor, is a noninvasive and continuous method to investigate the impact of anesthetic techniques on cerebral oxygenation in such scenarios.
### Conditions
- Cerebral Oxygenation
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
- sensors of regional cerebral oxygen saturation (O3 regional oximeter, Masimo Corp, Irvine, CA) FDA Reg No. 3011353843
### Outcomes
**Primary Outcomes**
- regional cerebral oxygen saturation
**Secondary Outcomes**
### Location
- **Facility**: Prince Sultan Military Medical City, Riyadh, N/A, 11159, Saudi Arabia
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## Correlating Improvement in PCOS Symptoms to the Percentage of Body Weight Lost in Females Also Living With Obesity
- **NCT ID**: NCT06325449
- **Study ID**: 5323
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-04-01
- **Completion Date**: 2026-01-01
- **Lead Sponsor**: Ottawa Hospital Research Institute
### Study Description
The goal of this clinical trial is to study the effects of a intensive weight loss program (STREAM) in patients living with PCOS. The main questions the investigators aim to answer are: how much weight will these patients lose over a 24-week program, and what other health markers (ie., insulin sensitivity) will improve and by how much?Participants will complete a 24-week weight loss program (STREAM). During this program they will:* weigh themselves* complete regular bloodwork and* fill out a Quality of Life questionnaire at regular intervals
### Conditions
- Polycystic Ovary Syndrome
- Obesity
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: NA
- **Intervention Model**: SINGLE_GROUP
- **Primary Purpose**: TREATMENT
### Interventions
- STREAM program
### Outcomes
**Primary Outcomes**
- Weight loss
- Change in Endocrine parameters (EP) as measure by blood test
- Change in insulin sensitivity (IS) as measure by blood test
- Change in Lipid profile (LP) as measure by blood test
- Change in liver enzyme profile (LEP) as measure by blood test
- Change in Menstrual Cyclicity
- Quality of Life (QoL) Scale
**Secondary Outcomes**
### Location
- **Facility**: LEAF Weight Management Clinic, Ottawa, Ontario, K1J9L3, Canada
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## Objective Scores in Variceal Bleeding
- **NCT ID**: NCT06325436
- **Study ID**: scores in variceal bleeding
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-03
- **Completion Date**: 2026-01-01
- **Lead Sponsor**: Assiut University
### Study Description
To assess the prognostic performance of the ALBI associated scores (ALBI, PALBI and INR-ALBI score) and new MELD .3 in predicting the short-term outcomes (early re-bleeding and early mortality) of patients with cirrhosis presenting with acute variceal bleeding, comparable to the CTP and MELD and MELD Na scores.
### Conditions
- Variceal Hemorrhage
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
### Outcomes
**Primary Outcomes**
- assess the prognostic performance of the ALBI_associated scores and new MELD .3 in predicting the short-term outcomes of patients with cirrhosis presenting with acute variceal bleeding.
**Secondary Outcomes**
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
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## Predicting Response to Neoadjuvant Chemotherapy in Muscle-invasive Bladder Cancer
- **NCT ID**: NCT06325423
- **Study ID**: response to NAC in MIBC
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-04
- **Completion Date**: 2027-06
- **Lead Sponsor**: Assiut University
### Study Description
Bladder cancer (BC) is the 10th most commonly diagnosed cancer worldwide and the second most common cancer among Egyptian males.The mainstay of treatment of muscle-invasive BC( MIBC) is neoadjuvant chemotherapy (NAC) followed by radical cystectomy (RC) or bladder preservation(BP) using maximal transurethral resection of the bladder tumor followed by chemoradiation. The rationale to use NAC before RC or BP is to eradicate micro-metastasis and to downstage the primary tumor.The 5-year cancer-specific survival for responders to NAC is 90%, in contrast to 30-40% for those not obtaining an objective response. Drawbacks of NAC are disappointing delay of surgery in non-responders and the potential toxicity. So, predictors of response to NAC are necessary to identify patients who may achieve pathologic complete response and will benefit from BP, and the others who may not respond to NAC and spare them NAC toxicity and RC delay.Tumor microenvironment (TME), including neutrophil extracellular traps (NETs), and CD8+ T lymphocytes is a promising predictor of response to NAC in MIBC.NETs are reticulated DNA structures decorated with various protein substances (e.g., histones, myeloperoxidase, neutrophil elastase).NETs are involved in tumor growth, metastasis, and treatment resistance. Moreover, NETs can inhibit T cell responses, thereby promoting tumor growth.On the other hand, immune cells that are present in the TME play a major role in slowing down tumor progression. CD8+T lymphocytes play a central role in immune-mediated control of cancer . Also, they have been found to be a prognostic tool for advanced BC.
### Conditions
- Muscle-Invasive Bladder Carcinoma
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
- neoadjuvant chemotherapy
### Outcomes
**Primary Outcomes**
- Evaluation of the expression of NETs and CD8 in paraffin-embedded TUR biopsies
- - Response to platinum-based chemotherapy in localized MIBC in relation to: NETs expression, CD8 expression, NET/CD8 ratio and baseline clinicopathological features
**Secondary Outcomes**
- Local recurrence-free survival (RFS)
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
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## Prognostic Factors Influencing the Recurrence Rate and Survival of Patients With Colorectal Cancer: a Single Institution Experience
- **NCT ID**: NCT06325410
- **Study ID**: #11279-20-11-2023
- **Status**: COMPLETED
- **Start Date**: 2013-01
- **Completion Date**: 2022-12
- **Lead Sponsor**: Zagazig University
### Study Description
over the past decade colon cancer has emerged as the second most deadly and the third most common type of cancer in the world with increasing incidence in Egypt due to life style and diet change. some research showed relation between colon cancer recurrence and advanced tumor staging. To investigators knowledge, this is the first time to be done in Zagazig University.Data was collected from records in a retrospective cohort study
### Conditions
- Colorectal Cancer
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
- resection of colorectal cancer
### Outcomes
**Primary Outcomes**
- age
- sex
- medical disease
- previous surgery
- CEA
- tumor grade
- tumor site
- tumor size
- surgical margins of resected tumor
- neoadjuvant therapy
- adjuvant therapy
- diet
- occupation
- family history
- type of surgery(laparoscopic or open)
- soiling by during surgery
- hand sewen or stappled anastmosis
- post operative complications
- site of recurrence
- type of resected tumor
**Secondary Outcomes**
### Location
- **Facility**: Zagazig University Hospitals, Zagazig, N/A, 44519, Egypt
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## Less Discomfort and Less Pharmacology. Cataract Surgery at Physiologic Intraocular Pressure (IOP)
- **NCT ID**: NCT06325397
- **Study ID**: IIT #88313865
- **Status**: RECRUITING
- **Start Date**: 2023-10-23
- **Completion Date**: 2024-06
- **Lead Sponsor**: Matthew Rauen
### Study Description
To investigate the impact of high vs low Intraocular Pressure (IOP) on the intraoperative experience for the patient and surgeon. Operating at a more physiologic IOP using Active Sentry hand piece during cataract surgery will result in significantly less discomfort/pain as assessed by the decreased need for rescue medication
### Conditions
- Nuclear Cataract
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
- High Intraocular Pressure (IOP)
- Low Intraocular Pressure (IOP)
### Outcomes
**Primary Outcomes**
- Medication Rescue
**Secondary Outcomes**
- Physiologic Responses associated with pain/inflammation:
- Physiologic Responses associated with pain/inflammation:
- Surgeon Experience: Assessment on patient cooperation
- Surgeon Experience: Surgeon intraoperative experience
- Cost- analysis
### Location
- **Facility**: Wolfe Eye Clinic, West Des Moines, Iowa, 50266, United States
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## Real World Evaluation of Lifelight®: A Contactless Vital Signs Monitor for Self-monitoring Blood Pressure and Its Comparison to Standard of Care
- **NCT ID**: NCT06325384
- **Study ID**: IRAS ID:1008701
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-07-01
- **Completion Date**: 2025-08-31
- **Lead Sponsor**: Xim Limited
### Study Description
A randomised controlled trial for comparison of real-world feasibility and clinical outcomes of two different methods of home blood pressure monitoring Participants aged 18 years or over with diagnosed and treated hypertension (including via lifestyle interventions) that is not controlled (i.e. in-clinic measurement is 140/90 mmHg or greater) will be recruited from hypertension hospital clinics
### Conditions
- Hypertension
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: OTHER
### Interventions
- Lifelight
- Blood Pressure Cuff
### Outcomes
**Primary Outcomes**
- Blood Pressure Measurement Non Inferiority
**Secondary Outcomes**
- Adherance to Blood Pressure Measurement
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
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## Italian Multicentric Study on the Treatment of Visceral Aneurysms With the Flow Diversion Stent Derivo Peripher and Derivo 2
- **NCT ID**: NCT06325371
- **Study ID**: 0028201
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-04-01
- **Completion Date**: 2025-06-30
- **Lead Sponsor**: University of Turin, Italy
### Study Description
This is a multicentric voluntary observational study with a retrospective evaluation of prospectively collected data concerning the treatment of visceral aneurysms with flow diversion stent Derivo Peripher and Derivo 2 (DED, Acandis GmbH) Follow-up will include clinical and radiological (CT) evaluation at least 12 months after the intervention.The enrollment period will be of 54 months (01/01/2020-30/06/2024). Minimum sample size will be of 50 Patients.
### Conditions
- Aneurysm Abdominal
- Arterial Aneurysm
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
- Visceral aneurysm stenting
### Outcomes
**Primary Outcomes**
- Efficacy of the stenting in terms of patency and side branches
- Efficacy of the stenting in terms of aneurysm thrombosis rate
- Efficacy of the stenting in terms of aneurysm volume assessment
- Safety in terms of morbidity
- Safety in terms of mortality
- Safety in terms of technical issues
**Secondary Outcomes**
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
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## the EXPOSITION Study
- **NCT ID**: NCT06325358
- **Study ID**: 0040083/23
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-04-15
- **Completion Date**: 2024-12-30
- **Lead Sponsor**: University of Pavia
### Study Description
This is a cross-sectional study to evaluate the variation of biological biomarkers of oxidative stress and inflammation in response to the external exposome, in people with Multiple Sclerosis (pwMS).The objective is to study the variation of biological biomarkers of oxidative stress and inflammation in response to external exposome in pwMS, controlling for other biomarkers (cytokine, neurofilaments, microbiome), gender, age, anthropometric measurements, vitamin D levels and medical history. Specifically, the variation of microRNAs is defined as the primary outcome, in response to urban air pollution, urbanization, lifestyle and quality of life components of the external exposome. Following the functional exposome approach:(1)Information on a pwMS sample about socio-demographic characteristics and medical history will be collected and specific components of the (2) On the same pwMS sample, the internal exposome variation will be measured. MicroRNA levels and gut and nasal microbiota alpha- and beta-diversity and relative bacterial abundances will be considered as biomarkers of oxidative stress and inflammation. At the same time, cytokines and neurofilament proteins (NfL) will be measured as biomarkers of neurodegeneration and axonal damage. Adults (≥ 18 years) pwMS, with relapsing-remitting course, diagnosis of MS according to 2017 McDonald criteria and residing in Pavia or Milan (Italy) will be included. Potentially eligible pwMS will be screened by a neurologist expert in MS who will verify that all the inclusion criteria will be fulfilled. To validate variation among 7 selected MS diagnostic miRNA, in response to urban air pollution, urbanization, lifestyle and quality of life components of the external exposome, the differential expression (ΔCT) for each miRNA will be considered as the outcome measure. Two hundred eligible pwMS who meet the inclusion criteria and sign the informed consent will be included in the study, to consider 15% dropout at the blood sampling stage.
### Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Environmental Exposure
- Lifestyle Factors
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
### Outcomes
**Primary Outcomes**
- microRNAs
- Air quality
- Nutritional assessment
- Neurofilament (NfL)
- Cytokines
- the Body Mass Index (BMI)
- Physical activity
- Quality of life related to MS
- Sleep Quality
- Smoking habits
- Dietary supplements use
- Adherence to Mediterranean diet
- Effect of diet on inflammation
- waist and height ratio (WHtR)
- Bioelectrical impedance
**Secondary Outcomes**
- Microbiome and biological biomarkers of oxidative stress and inflammation
### Location
- **Facility**: IRCCS Foundation C. Mondino, Pavia, N/A, 27100, Italy
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## RCT of Gut-directed Hypnotherapy in Ehlers-Danlos Syndromes and Generalized Hypermobility Spectrum Disorders
- **NCT ID**: NCT06325345
- **Study ID**: 22-5277
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-04-01
- **Completion Date**: 2025-04-01
- **Lead Sponsor**: University Health Network, Toronto
### Study Description
This randomized, controlled trial (RCT) will evaluate the effectiveness of gut-directed hypnotherapy for management of Irritable Bowel Syndrome (IBS) in individuals diagnosed with Ehlers-Danlos Syndromes or Generalized Hypermobility Spectrum Disorders (G-HSD). Consenting patients recruited from the Toronto General Hospital GoodHope Ehlers-Danlos Syndrome Clinic will be randomly assigned to one of two groups: (1) standard medical therapy or (2) standard medical therapy plus eight sessions of gut-directed hypnotherapy. The main questions this study will answer are:1. Is gut-directed hypnotherapy an efficacious treatment for IBS symptoms among individuals with EDS or G-HSD?2. Does gut-directed hypnotherapy improve other gut symptoms, quality of life, visceral sensitivity, and emotional distress?3. Is the activity of the parasympathetic nervous system (i.e. the body's "rest and digest" system) associated with IBS symptoms or treatment outcomes among individuals with EDS or G-HSD?All participants will be asked to meet with a gastroenterologist three times as part of the standard medical therapy. At each physician visit, they will undergo electrocardiogram recording and complete self-report measures of gastrointestinal symptoms, quality of life, visceral sensitivity, and emotional distress. Participants randomized to receive gut-directed hypnotherapy will also eight weekly remotely-delivered sessions of gut-directed hypnotherapy delivered by a trained behavioral therapist in between the first and second physician visit. At each session of gut-directed hypnotherapy, a voluntary, pleasant, and dream-like state of deep relaxation will be induced and suggestions made for greater relaxation, abdominal comfort, and normalization of gut function. The first session will also include 30 minutes of education on the nature of the gut-brain axis and hypnotherapy prior to hypnosis.Researchers will compare study groups to see if participants who engaged in gut-directed hypnotherapy had greater improvement in IBS symptoms, other gastrointestinal symptoms, quality of life, visceral sensitivity, and emotional distress. Exploratory analyses will examine the relationships among heart rate variability, an index of parasympathetic nervous system activity, and study outcomes.
### Conditions
- Ehlers-Danlos Syndrome
- Irritable Bowel Syndrome
- Hypermobility Syndrome
- Gastrointestinal Dysfunction
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- Gut-directed hypnotherapy
- Standard Medical Therapy
### Outcomes
**Primary Outcomes**
- IBS Symptom Severity
**Secondary Outcomes**
- Upper Gastrointestinal Symptoms
- IBS-related Quality of Life
- Visceral Sensitivity
- Emotional Distress
### Location
- **Facility**: Toronto General Hospital, Toronto, Ontario, M5G 2C4, Canada
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## BEYFORTUS™ (Nirsevimab) Effectiveness Against Medically-Attended RSV Events in Infants (BEAR Study)
- **NCT ID**: NCT06325332
- **Study ID**: RSV00080
- **Status**: RECRUITING
- **Start Date**: 2024-04-01
- **Completion Date**: 2025-04-01
- **Lead Sponsor**: Sanofi Pasteur, a Sanofi Company
### Study Description
The primary objectives of the study are: To estimate the effectiveness of nirsevimab against polymerase chain reaction (PCR)-confirmed RSV (1) lower respiratory tract (LRTD) and (2) related medical encounters.the secondary objectives are:1. To estimate the effectiveness of nirsevimab against medical encounters with a respiratory related diagnosis.2. To estimate the effectiveness of nirsevimab against medical encounters with an LRTD diagnosis.3. To estimate the impact of nirsevimab on PCR-confirmed RSV.4. To estimate the impact of nirsevimab on medical encounters with an otitis media diagnosis.5. To estimate the impact of nirsevimab on antibiotic prescription.
### Conditions
- Respiratory Syncytial Virus
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
- Nirsevimab
### Outcomes
**Primary Outcomes**
- Incidence of first episodes of polymerase chain reaction (PCR)-confirmed RSV with an lower respiratory tract disease (LRTD)
- Number of medical encounters associated with the first episode of PCR-confirmed RSV with a LRTD diagnosis
**Secondary Outcomes**
- Number of respiratory-related medical encounters
- Number of respiratory-related medical encounters for LRTD by ICD-10 codes
- Incidence of PCR-confirmed RSV (first occurrence of season)
- Number of medical encounters for otitis media by ICD-10 codes
- Number of antibiotic prescriptions by National Drug Code (NDC) codes
### Location
- **Facility**: Kaiser Permanente Northern California: Site number 0001, Oakland, California, 94612, United States
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## Effect of Community Engagement Using M-Mama Champions
- **NCT ID**: NCT06325319
- **Study ID**: Ref. No. MA.84/261/02/1/115
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-03
- **Completion Date**: 2024-05
- **Lead Sponsor**: University of Dodoma
### Study Description
This study aims to determine the effectiveness of community engagement using M-MAMA Champions on awareness of Obstetric Danger Signs, Birth Preparedness, and Complication Readiness among Pregnant Women in Bahi, Dodoma. This is a community-based, cluster randomized controlled trial (cRCT) study, whereby 120 first and second-trimester pregnant women will be randomized at a ratio of 1:1 to the intervention and control groups. The intervention of sensitizing pregnant women on Obstetric danger signs, birth preparedness, and complication readiness by the empowered M-MAMA Champions to the intervention arm clusters will be done for one month, a two-hour session will be delivered every two weeks, using participatory learning and action model for women groups to test the effectiveness of M-MAMA Champions in improving literacy level of obstetric danger signs, birth preparedness and complication readiness and its practice among pregnant women.The following is the hypothesis being testedNull Hypothesis; There is no difference in improvement of awareness of Obstetric Danger Signs, Birth Preparedness, and Complication Readiness among Pregnant Women when community engagement is done using M-MAMA Champions compared to routine approaches.Alternative hypothesis; Community engagement using M-MAMA Champions to improve awareness of Obstetric Danger Signs, Birth Preparedness, and Complication Readiness among Pregnant Women is more effective than routine approaches.During each 2-hour session, five (5) women will gather up and discuss the obstetric danger signs, birth preparedness, and complication readiness with the assistance of the M-MAMA Champion as a facilitator. An approved brochure on the concerned subject will be used for sensitization. Baseline data will be collected before and after the intervention.The control arm won't receive any intervention.
### Conditions
- Obstetric Complication
- Woman's Role
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: PREVENTION
### Interventions
- Community engagement using M-MAMA Champions to improve awareness on obstetric danger signs, bith preparedness and complication readiness among pregnant women
### Outcomes
**Primary Outcomes**
- Improvement in scores from a semi-structured interviewer-administered questionnaire on awareness of obstetric danger signs among pregnant women.
- Improvement in scores from a semi-structured interviewer-administered questionnaire of awareness of birth preparedness and complication readiness among pregnant women
**Secondary Outcomes**
- Improvement in scores from a semi-structured interviewer-administered questionnaire on reported practice of birth preparedness and complication readiness
### Location
- **Facility**: University of Dodoma, Dodoma, N/A, 259, Tanzania
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## Physical Literacy-Based Intervention for Chronic Disease Management
- **NCT ID**: NCT06325306
- **Study ID**: 2023/392
- **Status**: RECRUITING
- **Start Date**: 2024-03-04
- **Completion Date**: 2024-10-30
- **Lead Sponsor**: University of Liege
### Study Description
The goal of this quasi-experimental study is to evaluate the effectiveness of a physical literacy-based intervention for chronic disease management in adults with chronic diseases participating in adapted physical activity group sessions in Belgium. The main questions it aims to answer are:* How does incorporating physical literacy elements in adapted physical activity sessions affect participants overall physical literacy levels?* Can a physical literacy-oriented adapted physical activity program enhance long-term engagement in physical activities and improve health outcomes for chronic disease patients?Participants will:* Undergo assessments for physical literacy levels and health outcomes at the beginning, after three months, and at the end of the six-month period.* Engage, in intervention groups, in adapted physical activity sessions, which may include physical fitness exercises and educational components on physical literacy.Researchers will compare 3 groups: a control group, a traditional Adapted Physical Activity (APA) group, and a Physical Literacy Oriented APA (APA+PL) group to see if integrating physical literacy components results in improved physical literacy levels, better sustained engagement in physical activities, and enhanced health outcomes.
### Conditions
- Chronic Disease
- Chronic Disease Management
- Aging
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: NON_RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- Traditional APA
- APA+PL
### Outcomes
**Primary Outcomes**
- Global Physical Literacy Score
- Physical Activity Behavior and Engagement
- Motivation and Confidence in Physical Activity
- Physical Competence
- Knowledge and Understanding of Physical Activity
- Environment interactions
- Meaningful and Purposeful Activities
**Secondary Outcomes**
### Location
- **Facility**: Centre Sportif du Sart-Tilman, Liège, N/A, 4000, Belgium
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## A Trial of Placebo Versus Macrolide for Mycoplasma Pneumoniae Childhood Pneumonia: MYTHIC Study
- **NCT ID**: NCT06325293
- **Study ID**: 2023-01295
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-07-01
- **Completion Date**: 2028-06-30
- **Lead Sponsor**: Christoph Berger
### Study Description
The goal of this clinical trial is to compare a placebo (a look-alike substance that contains no active drug) with a commonly used antibiotic in children with Mycoplasma pneumoniae (a specific bacterium) induced community-acquired pneumonia. The main question it aims to answer is:Is antibiotic treatment needed in Mycoplasma pneumoniae (a specific bacterium) induced pneumonia?Participants will receive either a placebo or a antibiotic treatment and track their symptoms and vital signs until they are healthy.Researchers will then compare the length of symptoms between the placebo and the antibiotic group.
### Conditions
- Community Acquired Pneumonia in Children
- Mycoplasma Pneumoniae
- Mycoplasma Pneumoniae Pneumonia
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- Azithromycin Pfizer®
- Placebo
### Outcomes
**Primary Outcomes**
- Co-primary outcome: days to normalization of all vital signs
- Co-primary outcome: community-acquired pneumonia(CAP)-related change in patient care status
**Secondary Outcomes**
- Overall clinical outcome
- Time (days) to normalization of CAP-related symptoms
- Quality of Life (QoL) Assessment assessing impact of the child's pneumonia on the family's social and health-related well-being
- Time (days) to return to daily routine
- Incidence of Mp-associated extrapulmonary manifestations development in patients assessed by clinical examination and/or parent report
### Location
- **Facility**: Children's Hospital Aarau, Switzerland, Aarau, Aargau, 5001, Switzerland
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## Exercise MRI to Evaluate Cardiorespiratory Fitness in Children With Heart Disease
- **NCT ID**: NCT06325280
- **Study ID**: Pro00132542
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-05-01
- **Completion Date**: 2027-12-31
- **Lead Sponsor**: University of Alberta
### Study Description
There are many barriers to heart-healthy lifestyles in pediatric patients with acquired and congenital heart disease. Investigators want to further understand how participants heart and skeletal muscles work together during exercise and evaluate the impact on cardiac function. To do this, the investigators will use magnetic resonance imaging (MRI) to scan the heart and skeletal muscles during exercises to assess blood flow, oxygenation and function.
### Conditions
- Pediatric ALL
- Congenital Heart Disease
- Heart Transplantation
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
- Exercise cardiac MRI Assessment
- Cardiopulmonary Exercise Test
### Outcomes
**Primary Outcomes**
- MRI assessment of cardiac structure at rest
- MRI assessment of cardiac function at rest
- Maximal exercise MRI assessment of cardiac structure
- Cardioplumonary Exercise Test
**Secondary Outcomes**
### Location
- **Facility**: University of Alberta, Edmonton, Alberta, T6G 2B7, Canada
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## Clinical Characteristics of Primary Liver Cancer
- **NCT ID**: NCT06325267
- **Study ID**: PLC
- **Status**: RECRUITING
- **Start Date**: 2010-01-01
- **Completion Date**: 2024-08-31
- **Lead Sponsor**: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
### Study Description
Primary liver cancer (PLC) is the sixth most common malignancy in the world and the third most common cause of malignancy death. In 2020, there were about 905,677 new cases of PLC worldwide, and 830,180 deaths. Despite the availability of a variety of treatments for PLC, the 5-year net survival rate is still only 5% to 30%. How to effectively reduce the disease burden of PLC is a major public health problem that needs to be solved worldwide. The clinical characteristics and prognosis of PLC caused by different pathogenic factors are different. Therefore, it is of great significance to fully identify the risk factors of PLC, be familiar with the clinical characteristics and prognosis of disease development, and understand the relevant monitoring and follow-up strategies for the prevention and treatment of PLC.
### Conditions
- Primary Liver Cancer
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
### Outcomes
**Primary Outcomes**
- Epidemiological characteristics of overall cohort by liver disease etiology
- Clinical characteristics of overall cohort by liver disease etiology
**Secondary Outcomes**
- Survival rates of overall cohort and different etiologies
- Risk factors of prognosis in overall cohort and different etiologies
### Location
- **Facility**: Nanjing Drum Tower Hospital, Nanjing, Jiangsu, 210008, China
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## Clinical Characteristics of Metabolic Associated Fatty Liver Disease
- **NCT ID**: NCT06325254
- **Study ID**: MAFLD
- **Status**: RECRUITING
- **Start Date**: 2010-01-01
- **Completion Date**: 2024-08-31
- **Lead Sponsor**: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
### Study Description
Metabolic associated fatty liver disease (MAFLD), which can lead to liver fibrosis, cirrhosis, liver failure and even hepatocellular carcinoma, poses a significant burden on society. With the improvement of living standards and changes in dietary habits, MAFLD patients show a younger and increasing trend, but there is still no specific drug. The clinical features and prognosis of MAFLD may be different with different metabolic disorder phenotypes and treatment measures. Therefore, further systematic study of the clinical characteristics and prognosis of MAFLD patients will be of great significance for the formulation of corresponding clinical prevention and treatment strategies.
### Conditions
- Metabolic Associated Fatty Liver Disease
- Clinical Features
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
### Outcomes
**Primary Outcomes**
- Clinical characteristics and follow-up outcomes of MAFLD patients
**Secondary Outcomes**
- Clinical characteristics and follow-up outcomes of MAFLD patients under different subgroups
- Baseline clinical characteristics MAFLD patients
- Risk factors for progression to cirrhosis and hepatocellular carcinoma
### Location
- **Facility**: Nanjing Drum Tower Hospital, Nanjing, Jiangsu, 210008, China
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## Validating the Use of Frailty Measurements to Predict Care & Quality of Life
- **NCT ID**: NCT06325241
- **Study ID**: 20200048-01H
- **Status**: ACTIVE_NOT_RECRUITING
- **Start Date**: 2022-12-12
- **Completion Date**: 2025-03-31
- **Lead Sponsor**: Ottawa Hospital Research Institute
### Study Description
The aim of this research program is to validate frailty measurements as a risk stratification tool to predict deteriorations in patient-reported outcomes, to gain a better understanding of patient preferences for care within varying degrees of frailty, and to assess differences in frailty measurement between patients and their clinicians.This work will provide a foundation in the development of customized interventions for people with COPD and varying degrees of frailty, with the goal of improving quality of life and optimizing health system service delivery for patients and their care givers.
### Conditions
- Chronic Obstructive Pulmonary Disease
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
- No intervention
### Outcomes
**Primary Outcomes**
- Respiratory Health Related Quality of Life
**Secondary Outcomes**
- Burden of symptoms - COPD Assessment
- Burden of symptoms - Dyspnea
- Psycho-social well being - Anxiety
- Psycho-social well being - Depression
### Location
- **Facility**: The Ottawa Hospital, General Campus, Ottawa, Ontario, K1J 0J2, Canada
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## Musculoskeletal Injuries, Sports Performance, Sports Specialization, and Quality of Life in Young Athletes
- **NCT ID**: NCT06325228
- **Study ID**: NKBBN/241/2023
- **Status**: ACTIVE_NOT_RECRUITING
- **Start Date**: 2023-02-01
- **Completion Date**: 2025-09-01
- **Lead Sponsor**: Medical University of Gdansk
### Study Description
The primary aim of this observational cohort study is to assess sports specialization, sports performance, history of injuries (prevalence, types, areas, duration) and quality of life in young healthy athletes aged 8-16 from Poland. Athlete profiles will be created based on the variables (explained in detailed description) examined. Furthermore, the investigators will perform one-year injury follow-up.The main questions it aims to answer are:* Do athletes with a specific profile (lower values in athletic performance tests, low values in quality of life) evaluated at one time point, suffer injury in the future in annual observation?* Do athletes with high sports specialization will sustain injury in one-year follow-up?* Does sports specialization have a relationship with sports performance tests, and quality of life?* Does sport specialisation, training volume, geographical factor relate to injury history?* Does sports specialisation, injury history differ between sports (individual and team sports)?* Does value of the specific muscle (lower limb) isometric strength will be associated with the dynamic balance scores in young healthy athletes?
### Conditions
- Sport Injury
- Healthy
- Injury;Sports
- Quality of Life
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
### Outcomes
**Primary Outcomes**
- Number of Participants with sports injury after one-year follow-up
- Type, location, duration, and return to sports in participants with injury at one-year follow up
**Secondary Outcomes**
- Sports Specialization
- History of sports-related injuries
- Health-related quality of life: EQ-5D-Y
- Y-Balance Test - dynamic balance test
- Functional Movement Screen (FMS)
- Hand-Held Dynamometer (HHD) measurement - Isometric Strength of the lower extremities muscle
### Location
- **Facility**: Department of Immunobiology and Environment Microbiology, Medical University of Gdańsk, Gdańsk, N/A, 80-211, Poland
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## The Effect of Hydrocolloid to Prevent Nasal Injuries in Preterm Infants
- **NCT ID**: NCT06325215
- **Study ID**: SCaglar
- **Status**: COMPLETED
- **Start Date**: 2022-05-05
- **Completion Date**: 2022-11-05
- **Lead Sponsor**: Istanbul University - Cerrahpasa (IUC)
### Study Description
The aim of this study is to evaluate the effect of using hydrocolloid tapes in preventing pressure injuries on the nose and columella regions caused by non-invasive mechanical ventilation (NIMV) in preterm infants.
### Conditions
- Pressure Injury
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: SUPPORTIVE_CARE
### Interventions
- Hidrocolloid Bant
### Outcomes
**Primary Outcomes**
- Neonatal Skin Condition Score
- Pressure İnjury Staging Scale
**Secondary Outcomes**
- Neonatal Skin Risk Assessment Scale
### Location
- **Facility**: Abide-i Hurriyet Cad. Istanbul University-Cerrahpaşa, Florence Nightingale Faculty of Nursing, Istanbul, N/A, 34381, Turkey
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## Closed Loop and Education for Hypoglycemia Awareness Restoration
- **NCT ID**: NCT06325202
- **Study ID**: STUDY00020946
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-07-01
- **Completion Date**: 2027-12-31
- **Lead Sponsor**: Milton S. Hershey Medical Center
### Study Description
The purpose of the CLEAR study is to determine the effect on counterregulatory responses (CRR) of intervening (by attempting to strictly avoid hypoglycemia) to improve awareness of hypoglycemic symptoms among adults with type 1 diabetes (T1D) who have impaired awareness of hypoglycemia (IAH). IAH affects 20-25% of adults with T1D, and rises with increasing duration of T1D.
### Conditions
- Diabetes Mellitus, Type 1
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: SEQUENTIAL
- **Primary Purpose**: TREATMENT
### Interventions
- Omnipod 5 or Medtronic 780G
- My HypoCOMPaSS Education
- HARPdoc Education
### Outcomes
**Primary Outcomes**
- epinephrine (pg/ml)
- Towler questionnaire
**Secondary Outcomes**
- geometric mean of plasma glucagon
- geometric mean of plasma pancreatic polypeptide
- geometric mean of plasma free fatty acids
- glucose infusion rate
- HbA1c
- % of time with sensor hypoglycemia <70 mg/dL
- % of time with sensor hypoglycemia <54 mg/dL
- number of hypoglycemia events
- % time with sensor glucose in range
- sensor glucose coefficient of variation
- sensor use as the average numbers of days per week
- glycemia risk index
- Trail Making Test - Part B
- Four Choice Reaction Time
- sleep duration
- sleep quality
- 24-hour step count
- exercise bouts
- resting heart rate
- heart rate during exercise
- heart rate variability
- Hypo-METRICS questionnaire
- Hypoglycemic Confidence Scale
- Hypoglycemia Fear Survey-II
- Attitudes to Awareness of Hypoglycaemia
- Type 1 Diabetes Distress Scale
- Diabetes Self-Management Questionnaire
- Diabetes Management Experiences Questionnaire
- PROMIS Sleep Disturbance - Short Form 8a
- Hospital Anxiety and Depression Scale
- 12-Item Hypoglycemia Impact Profile
- EQ-5D-5L
- device-related adverse events
- severe hypoglycemic events, self-reported on a CLEAR data collection form
- diabetic ketoacidosis (DKA) events
- number of participants with hospitalizations
- number of participants with emergency room (ER) visits
- major adverse cardiovascular events (MACE)
- all-cause mortality
### Location
- **Facility**: University of California, San Diego, La Jolla, California, 92037, United States
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## Effects of Aerobic Interval Training on Fatigue Level and Functional Performance in Post Angioplasty Patients
- **NCT ID**: NCT06325189
- **Study ID**: Rec-42336
- **Status**: COMPLETED
- **Start Date**: 2023-07-20
- **Completion Date**: 2023-12-10
- **Lead Sponsor**: Riphah International University
### Study Description
The goal of this randomized controlled trial is to determine the effects of aerobic interval training on levels of tiredness and functional performance in post-angioplasty patients. The main question it aims to answer is:Does aerobic interval training reduce fatigue and improve functional performance compared to medication alone in post-angioplasty patients?Participants will:Be randomly assigned to either the control group (medication) or the experimental group (medication + aerobic interval training) Perform aerobic interval training for 30 minutes, three times a week, for six weeks (experimental group only) Complete pre and post-intervention assessments using the fatigue severity scale, the 6-minute walk test, and the one minute sit to stand test Researchers will compare the two groups to see if aerobic interval training leads to significant improvements in fatigue levels and functional performance.
### Conditions
- Coronary Artery Disease
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- Aerobic Interval Training
### Outcomes
**Primary Outcomes**
- Fatigue Severity Scale
- Six Minute Walk Test
- 1 minute sit to stand:
**Secondary Outcomes**
### Location
- **Facility**: Gulab Devi Chest Hospital, Lahore, Punjab, 54000, Pakistan
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## Comparative Effects of Cryotherapy and Infrared Light on Pain, Redness, and Healing of Episiotomy Wound
- **NCT ID**: NCT06325176
- **Study ID**: REC/RCR & AHS/23/0569
- **Status**: RECRUITING
- **Start Date**: 2024-03-20
- **Completion Date**: 2024-10-15
- **Lead Sponsor**: Riphah International University
### Study Description
The study will be a randomized clinical trial and will be conducted in Bahawalpur Victoria Hospital, Bahawalpur. The subjects (n=24) will be divided into two groups. Group A will include 12 postnatal women and for treatment, cryotherapy will be applied for 20 minutes. Group B will include 12 women and receive infrared light, an infrared lamp will be put at a distance of 45 cm from the perineum, and the heat produced with 230 volts for twenty minutes. The participant will be checked after the first five minutes to make sure that she is not being burned. This procedure will be done twice a day for 7 consecutive days.
### Conditions
- Episiotomy Wound
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- Cryotherapy
- Infrared light therapy
### Outcomes
**Primary Outcomes**
- Numeric Pain Rating Scale
- The standardized REEDA scale:
**Secondary Outcomes**
### Location
- **Facility**: Bahawalpur Victoria Hospital(BVH), Bahāwalpur, Punjab, 63100, Pakistan
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## Accuracy of Artificial Intelligence Technology in Detecting Number of Root Canals in Human Mandibular First Molars Obturated and Indicated for Retreatment: Diagnostic Accuracy Experimental Study
- **NCT ID**: NCT06325163
- **Study ID**: MIU-IRB-2223-219
- **Status**: COMPLETED
- **Start Date**: 2023-01-25
- **Completion Date**: 2023-10-10
- **Lead Sponsor**: Misr International University
### Study Description
evaluate the accuracy of new AI technology for detecting root canals in mandibular first molars retreatment cases in comparison to dentist clinical access cavity and CBCT imaging.
### Conditions
- Missed Canals
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: NA
- **Intervention Model**: SEQUENTIAL
- **Primary Purpose**: DIAGNOSTIC
### Interventions
- CBCT
- clinical examination under dental operating microscope
- canal detection AI software (diagnocat)
### Outcomes
**Primary Outcomes**
- Number of canals
**Secondary Outcomes**
- linear morphological variations in failed cases
### Location
- **Facility**: Misr International University, Cairo, N/A, N/A, Egypt
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## The Impact of Light Exposure on Cognitive Function in Classrooms
- **NCT ID**: NCT06325150
- **Study ID**: STUDY00008572
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-05-01
- **Completion Date**: 2028-02-01
- **Lead Sponsor**: Michigan State University
### Study Description
Humans are constantly exposed to a variety of light types, created naturally or through artificial means. Light exposure captured by the eyes impacts many physiological functions in humans, including but not limited to cognitive output, fatigue levels, and mood regulation. The level of impact on cognitive learning from different types of light on undergraduate adult students remains unclear.
### Conditions
- Healthy
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: CROSSOVER
- **Primary Purpose**: BASIC_SCIENCE
### Interventions
- Light emitting glasses
### Outcomes
**Primary Outcomes**
- Assessment of attention
**Secondary Outcomes**
- Determine how time of day impacts attention
### Location
- **Facility**: Michigan State University, East Lansing, Michigan, 48824, United States
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## Transcriptome Analysis in Idiopathic Nephrotic Syndrome: Steroid Responsiveness
- **NCT ID**: NCT06325137
- **Study ID**: RC 24/2022
- **Status**: RECRUITING
- **Start Date**: 2023-03-16
- **Completion Date**: 2025-03
- **Lead Sponsor**: IRCCS Burlo Garofolo
### Study Description
Idiopathic nephrotic syndrome (INS) affects the glomerular barrier by damaging the podocytes with foot process effacement, leading to a pathological increase of permeability and protein loss. INS classification is based on the clinical response to glucocorticoid (GC) therapy. When GCs treatment fails to induce remission in a four-six weeks course, patients are defined as affected with steroid-resistant nephrotic syndrome (SRNS).The whole transcriptome sequencing could consent the INS classification at onset, prior to glucocorticoids (GCs) treatment, allowing to reduction of unuseful GCs treatment. RNA sequencing technologies allow an extensive characterization of the transcriptomic profile and permit global changes in gene expression levels between different conditions such as active and remission of the disease.Of great interest is the research of a molecular biomarker to predict steroid resistance, a predictor that is not yet available. Among the candidate biomarkers, pharmacogenomic determinants are promising, even if available studies are still limited. Among these, some epigenetic factors have been previously suggested. Data obtained in animal models suggests that nucleotide-binding oligomerization domain-like receptors (NOD-like receptor) pyrin domain containing 3 (NLRP3) inflammasome can be deregulated in a wide variety of glomerular diseases, including those causing INS. Another potential marker involved in steroid response is the long noncoding RNA GAS5. Data reported in the literature indicate that abnormal levels of GAS5 in peripheral blood mononuclear cells (PBMCs) may alter steroid effectiveness in autoimmune diseases, such as inflammatory bowel disease.Preliminary findings show that the study of NLRP3 promoter methylation could be reduced in the blood of SRNS compared with steroid-sensitive nephrotic syndrome (SSNS) patients. Moreover, unpublished encouraging results on the association between Growth Arrest Specific 5 (GAS5) expression and steroid response in INS in PBMCs were obtained in a preliminary study conducted on 8 patients with the first episode of INS. PBMCs were obtained and GAS5 gene expression was evaluated using TaqMan technology. Patients affected with SRNS presented significantly higher levels of GAS5 in comparison with the SSNS group. In PBMCs from SRNS patients, the GAS5 expression could reduce the availability for binding to GCs target genes of the activated GCs receptor and suppresses GC transcriptional activity.
### Conditions
- Nephrotic Syndrome
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
- Transcriptome analyses
### Outcomes
**Primary Outcomes**
- Between groups differences in molecular signature by whole transcriptome analysis
**Secondary Outcomes**
### Location
- **Facility**: Institute for Maternal and Child Health - IRCCS "Burlo Garofolo", Trieste, N/A, 34137, Italy
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## Muscle Energy Technique of Lower Limb Muscles in Forward Head Posture
- **NCT ID**: NCT06325124
- **Study ID**: REC/01805 MARIA NAWAZ
- **Status**: RECRUITING
- **Start Date**: 2024-03-26
- **Completion Date**: 2025-04-20
- **Lead Sponsor**: Riphah International University
### Study Description
The aim of this randomized controlled trial is to find the effect of muscle energy technique of muscles involved in lower limb superficial backline (hamstring and Gastro-soleus) on improving craniovertebral angle and cervical proprioception and minimizing pain among patients with forward head posture
### Conditions
- Forward Head Posture
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- Muscle energy technique
- Conventional PT
### Outcomes
**Primary Outcomes**
- Neck disability index (NDI)
- Numeric Pain Rating Scale NPRS
**Secondary Outcomes**
- Bubble inclinometer
- FHP Mobile Application (To measure Craniovertebral angle)
- Cervical Joint Position Error
### Location
- **Facility**: We Care Physical Therapy Clinic street 13 phase 4A, Ghouri town Islamabad, Islamabad, Punjab, N/A, Pakistan
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## Determinants of Glycaemic Control in Children With Type 1 Diabetes
- **NCT ID**: NCT06325111
- **Study ID**: RC 06/2023
- **Status**: RECRUITING
- **Start Date**: 2023-05-29
- **Completion Date**: 2026-04-30
- **Lead Sponsor**: IRCCS Burlo Garofolo
### Study Description
Type 1 diabetes (T1D) is a common chronic disease of childhood associated with a significantly increased risk of micro- and macro-vascular complications, including neuropathy, nephropathy and cardiovascular diseases. The risk of development T1D comorbidities is associated with glycaemic control, a complex mechanism involving biological, physiological environmental factors.While more than 60 genetic variants were already associated with Glycated hemoglobin (HbA1c) in healthy subjects, very few genes have been identified in T1D individuals. Also, hyperglycaemia could be the cause of epigenetic changes at specific target genes, such as DNA methylation, histone modifications and microRNAs, correlated to accelerated development of diabetes-related complications. Most recently, increasing evidence also suggested that human microbiome may play a crucial role in the onset and progression of T1D and dysbiosis of the gut and oral microbiota was reported as a typical feature of hyperglycaemia.However, potential differences among poorly and good managed T1D subjects have not been still studied. Also, the exact mechanism by long-term hyperglycaemia's acts in T1D remains poorly understood. Therefore, this project will explore an emerging area of research by the study of possible genetic, epigenetic and environmental biomarkers among T1D subjects with different glycaemic control.
### Conditions
- Diabetes Mellitus, Type 1
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
- Determinants of T1D glycaemic control
### Outcomes
**Primary Outcomes**
- Identification of genes involved in T1D glycaemic control
- Identification of DNA methylation patterns involved in T1D glycaemic control
- Identification of microRNAs involved in T1D glycaemic control
- Identification of oral microbiome characteristics associated to T1D glycaemic control
**Secondary Outcomes**
### Location
- **Facility**: Institute for Maternal and Child Health - IRCCS "Burlo Garofolo", Trieste, N/A, 34137, Italy
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## Implementation of a Diagnostic Workflow for Personalized Diagnosis of Nephrotic Syndrome
- **NCT ID**: NCT06325098
- **Study ID**: PER-NEPH
- **Status**: RECRUITING
- **Start Date**: 2022-01-26
- **Completion Date**: 2026-06-30
- **Lead Sponsor**: Meyer Children's Hospital IRCCS
### Study Description
Nephrotic syndrome (NS) is a clinical picture common to several diseases resulting from damage to podocytes and glomerular filtration barrier. Currently, there is limited consensus regarding the diagnostic pathway and management of the specific etiology. Some patients show complete response to first-line steroid therapy (steroid-sensitive nephrotic syndrome, SSNS), especially in children and young adults. The prognosis of this group is generally favorable. In contrast, patients unresponsive to steroids (steroid-resistant NS, SRNS) frequently undergo immunosuppressive therapies, which are burdened with numerous side effects. Resistance to treatment is associated with a high likelihood of progression to chronic renal disease (CKD) and kidney failure (ESKD). Recent evidence suggests that immunological mechanisms (including permeabilizing factors) are involved in the pathogenesis of post-transplant NS recurrence and SSNS.Providing patients with NS with a correct diagnosis is the cornerstone of personalized medicine, reducing morbidity and side effects of therapies, ensuring their appropriate prescription, and slowing or preventing progression to ESKD.
### Conditions
- Nephrotic Syndrome
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: NON_RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: DIAGNOSTIC
### Interventions
- Anti-nephrin antibodies
- u-RPC cultures
### Outcomes
**Primary Outcomes**
- Role of anti-nephrin antibodies in the pathogenesis of NS
**Secondary Outcomes**
- Functional role of VUS in the pathogenesis of SRNS
- Identification of potential predictive biomarkers of renal outcome.
- Cost-effectiveness analysis
### Location
- **Facility**: Meyer Children's Hospital IRCCS, Firenze, N/A, N/A, Italy
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## Compensatory and Restorative Rehabilitation Techniques in Stroke
- **NCT ID**: NCT06325085
- **Study ID**: Ayesha Saddiqa
- **Status**: RECRUITING
- **Start Date**: 2024-04-16
- **Completion Date**: 2025-04-20
- **Lead Sponsor**: Riphah International University
### Study Description
The aim of this randomized controlled trial is to find the combined effects of restorative and compensatory cognitive rehabilitation techniques in mild cognitive impairment after stroke.
### Conditions
- Cognitive Impairment
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- compensatory and restorative rehabilitation techniques
- Traditional cognitive rehabilitation training
### Outcomes
**Primary Outcomes**
- Montreal cognitive assessment test (Urdu version)
- Cognitive assessment scale for stroke patients (CASP)
**Secondary Outcomes**
- Stroke specific quality of life questionnaire (Urdu version)
- Modified Rankin Scale (MRS)
### Location
- **Facility**: Shafi Hospital Dina, Dina, Punjab, N/A, Pakistan
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## Set-up of a Platform for Personalized Diagnosis of Rare Kidney Diseases (NIKE)
- **NCT ID**: NCT06325072
- **Study ID**: NIKE
- **Status**: ACTIVE_NOT_RECRUITING
- **Start Date**: 2021-07-09
- **Completion Date**: 2024-06-30
- **Lead Sponsor**: Meyer Children's Hospital IRCCS
### Study Description
Chronic kidney disease (CKD) is a major health problem, with steadily increasing incidence and prevalence and the threat of a true "epidemic". Converging evidence suggests a high prevalence of genetic etiology in rare kidney diseases and the list of new disease-causing genes is constantly updated. Recent advances in next-generation sequencing (NGS) technologies have prompted a significant improvement in the diagnosis of rare kidney diseases. Notwithstanding this, NGS generates high numbers of information that need to be properly analysed by the joint efforts of geneticists, nephrologists and bioinformatics in order to integrate clinical and genetic information in a personalized manner. In addition, in selected cases, the contribution of researchers proves essential for the development of experimental models of the disease to study and understand the pathogenic features and propose a personalized therapeutic approach. Such an innovative, integrated diagnostic paradigm is currently available in few centers all over the world and cannot be easily translated in daily clinical practice.The aim of the study is to set-up an integrated diagnostic algorithm to extend the newest personalized diagnostic and treatment strategies for rare kidney diseases to all patients in the Tuscany region, under 40 years of age with kidney disease. This algorithm will be based on a constant cross-talk between participating centers and a dedicated multidisciplinary team. Diagnostic and therapeutic performances will be validated at European level.
### Conditions
- Chronic Kidney Diseases
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: NON_RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: DIAGNOSTIC
### Interventions
- Conclusive genetic testing
- Genotype-phenotype correlation for personalized diagnosis
- Personalized study of variants of uncertain clinical significance (VUS) through functional studies on 3D organ-on-a-chip
### Outcomes
**Primary Outcomes**
- Validation of genetic diagnosis
**Secondary Outcomes**
- Identification of molecular pathways
- Explore the applicability of gene editing in rare kidney diseases
### Location
- **Facility**: Azienda Ospedaliero Universitaria Careggi, Firenze, N/A, N/A, Italy
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## The Role of Renal Progenitors and Polyploid Tubular Cell Response in Glomerular and Tubular Diseases
- **NCT ID**: NCT06325059
- **Study ID**: BIO-KIDNEY
- **Status**: RECRUITING
- **Start Date**: 2023-03-22
- **Completion Date**: 2047-11-30
- **Lead Sponsor**: Meyer Children's Hospital IRCCS
### Study Description
Renal progenitors are a subset of parietal epithelial cells (PECs) localized at the urinary pole of Bowman's capsule. Experimental models of podocyte damage showed that PECs can potentially regenerate lost podocytes by migrating from Bowman's capsule to the glomerular tuft, acquiring the morphological and functional features of mature podocytes. Podocyte loss and damage, as well as the inability of PECs to replace lost podocytes, lead to glomerular scarring and chronic kidney disease (CKD) progression.In addition, the investigators of the present study and others have recently demonstrated the existence of a specific subpopulation of tubular cells in the human kidney with a high potential for regeneration and resistance to death, thus acting as tubular progenitors. These cells are involved in tubular response to damage during acute kidney injury (AKI) trough endoreplication (polyploidization).Kidney biopsy is the cornerstone of diagnosis in many kidney diseases leading to CKD and AKI, allowing unambiguous diagnosis in some cases and presumptive diagnosis of ongoing disease in others. Very recently, super resolution imaging techniques proved to maintain current diagnostic standards while allowing to study morphological features of pathophysiological mechanisms of glomerular and tubular diseases.The rationale of this project is to study the role of renal progenitors (PECs and tubular progenitors) in the pathogenesis of CKD and AKI trough super resolution imaging applied to human renal biopsies, to the aim of identifying relevant connections with clinical data and markers of damage and/or disease progression.
### Conditions
- Nephropathy
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: NA
- **Intervention Model**: SINGLE_GROUP
- **Primary Purpose**: BASIC_SCIENCE
### Interventions
- Study of renal progenitors
### Outcomes
**Primary Outcomes**
- Evaluation of the role of renal progenitors in the progression of glomerular diseases
**Secondary Outcomes**
- Evaluation of the role of tubular endoreplication in mechanisms of acute kidney injury (AKI)
- Evaluation of the role of tubular endoreplication in mechanisms of acute kidney injury (AKI) trough DNA and RNA analysis
### Location
- **Facility**: Meyer Children's Hospital IRCCS, Firenze, N/A, N/A, Italy
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