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## Acoustic Emission Biomarkers for the Detection and Monitoring of Early Knee Osteoarthritis
- **NCT ID**: NCT06351059
- **Study ID**: UE-0083
- **Status**: ACTIVE_NOT_RECRUITING
- **Start Date**: 2023-01-01
- **Completion Date**: 2024-12-31
- **Lead Sponsor**: Schulthess Klinik
### Study Description
The aim of this exploratory study is to further investigate the potential of acoustic emission biomarkers, assessed by the inmodi knee brace, to diagnose osteoarthritis (OA) at earlier stages. Therefore, 20 healthy participants and 100 patients with increased risk of knee OA will be recruited from the Schulthess Klinik in Zurich and examined twice with 9 ± 3 months' time interval. Anthropometric data, EOS radiographs and MR images of both knees, PROMs and acoustic emission data will be collected and evaluated. Artificial Intelligence algorithm will then be used to identify and validate the most promising acoustic emission biomarkers with a prognosis value in the prediction of knee osteoarthritis progress.
### Conditions
- Osteoarthritis, Knee
- Diagnosis
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
- InModi acoustic emission analysis
### Outcomes
**Primary Outcomes**
- acoustic emissions
- kinematic data
- MRI / MOAKS
- EOS / leg alignment
- PROMS
**Secondary Outcomes**
### Location
- **Facility**: Schulthess Klinik, Zürich, ZH, 8008, Switzerland
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## Preventive Interventions for Chronic Pain Worsening
- **NCT ID**: NCT06351046
- **Study ID**: NCT05178082_WP3
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-08-01
- **Completion Date**: 2027-01-30
- **Lead Sponsor**: Rigshospitalet, Denmark
### Study Description
This is an open label randomized controlled trial (RCT), which will be conducted with patients of the Copenhagen Wound Healing Center at Bispebjerg Hospital in Copenhagen (DK). The trial has three arms (1:1:1): Mindfulness Based Stress Reduction (MBSR) group, Virtual Reality based Pain Self-management (VRPS) program group, and a control group (usual care). Included will be 78 patients at least 18 years old; fluent in the Danish language; complaint of pain lasting 3 months or more; in average pain intensity score ≥ 3 (numerical rating scale 0 to 10); access to internet; and willing and available to participate in the study. Excluded will be specialized or multidisciplinary pain treatment at baseline; history of epilepsy, seizure disorder, nausea or dizziness, hypersensitivity to flashing light or motion or other diseases that may prevent use of virtual reality equipment; injury to eyes, face or neck.
### Conditions
- Chronic Non-Cancer Pain
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: FACTORIAL
- **Primary Purpose**: PREVENTION
### Interventions
- Online Mindfullness Based Stress Reduction Program
- Virtual Reality-based Pain Self-management program
### Outcomes
**Primary Outcomes**
- Pain intensity
**Secondary Outcomes**
- Pain intensity and interference in daily activities
- Pain catastrophizing
- Pain acceptance
- Health status
- Health related quality of life
- Anxiety
- Depression
- Use of medication
- Use of healthcare system
- Number of absent days at work
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
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## Ozonized Oil as Dietary Supplement in Macular Degeneration
- **NCT ID**: NCT06351033
- **Study ID**: ADP_012023
- **Status**: ACTIVE_NOT_RECRUITING
- **Start Date**: 2023-10-31
- **Completion Date**: 2024-12
- **Lead Sponsor**: Alba Di Pardo
### Study Description
Macular degeneration, also called age-related macular degeneration (AMD), is a leading cause of visual impairment and severe vision loss.AMD is a disease with a multifactorial etiology. The main factors which, associated with the genetic ones, increase the risk of WMD onset are represented by smoking, obesity, hypertension, cardio-vascular diseases, a diet rich in dietary fat and alcohol intake. From an organic point of view, AMD is a disease that affects the macular region of the retina, causing progressive loss of central vision.Retinal cells are characterized by high oxygen consumption. Reactive oxygen species (ROS), such as superoxide anion, hydrogen peroxide and hydroxyl radical are the standard product of cellular metabolism within the mitochondria. Under physiological conditions, ROS are neutralized by a system of antioxidants. In case of cellular metabolism disturbances or insufficiency of the antioxidant system, an excess of ROS can be produced which contributes to oxidative stress, widely described as exerting deleterious effects on cells. The high oxygen requirement and low levels of antioxidant enzymes make the retina extremely sensitive to oxidative stress and more susceptible to cell death. Prevention of neuronal death in the retina becomes a crucial aspect for the management of WMD.The treatment of choice for AMD today is the use of anti-VEGF (Vascular Endothelial Growth Factor) drugs, they are effective for neo-vascular AMD, acting on the inhibition of the angiogenic protein VEGF, which is produced in the retina and induced by hypoxia and other conditions. It is practice, however, to support the integration of nutritional supplements such as zinc, resveratrol, carotenoids such as lutein and zeaxanthin, vitamin E and Omega-3 fatty acids.The aim of this study is to evaluate the efficacy of ozonated oil with high ozonides (HOO) administered orally as gastro-resistant capsules (O3Zone, GS Pharma, Malta), as an integrative and complementary treatment in patients affected by macular degeneration in the possible slowing of disease progression.
### Conditions
- Maculopathy
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
- High ozonide (HOO) ozonated oil
### Outcomes
**Primary Outcomes**
- evaluation of any slowing down of the maculopathy
- evaluation of any slowing down of the maculopathy
- evaluation of any slowing down of the maculopathy
- evaluation of any slowing down of the maculopathy and closure of the study
**Secondary Outcomes**
### Location
- **Facility**: IRCCS Neuromed, Pozzilli, N/A, N/A, Italy
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## LM-302 for the Treatment of Subjects With Claudin18.2-Positive Gastric and Gastroesophageal Junction Adenocarcinoma.
- **NCT ID**: NCT06351020
- **Study ID**: LM302-03-101
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-04-01
- **Completion Date**: 2026-12-15
- **Lead Sponsor**: LaNova Medicines Zhejiang Co., Ltd.
### Study Description
This study will assess the efficacy and safety of LM-302 Versus Treatment of Physician's Choice (TPC) in Subjects With locally advanced or metastatic, Claudin (CLDN) 18.2-positive, Gastric or Gastroesophageal Junction Adenocarcinoma who have progressed on or after 2 lines of systemic therapy
### Conditions
- Locally Advanced or Metastatic GC and GCJ Adenocarcinoma
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- LM-302
- Apatinib
- Irinotecan
### Outcomes
**Primary Outcomes**
- Overall Survival (OS)
- Progression Free Survival (PFS)
**Secondary Outcomes**
- Objective response rate (ORR)
- Duration of response (DoR)
- Disease control rate (DCR)
- AE and SAE
- Evaluate the immunogenicity of LM-302
- Evaluation of pharmacokinetic characteristics of LM-302
- Evaluation of pharmacokinetic characteristics of LM-302
- Evaluation of pharmacokinetic characteristics of LM-302
- Evaluation of pharmacokinetic characteristics of total antibody
- Evaluation of pharmacokinetic characteristics of total antibody
- Evaluation of pharmacokinetic characteristics of total antibody
- Evaluation of pharmacokinetic characteristics of MMAE
- Evaluation of pharmacokinetic characteristics of MMAE
- Evaluation of pharmacokinetic characteristics of MMAE
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
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## Educational Program on Dietary Adherence and Nutritional Knowledge in Chronic Kidney Disease Patients (EPAK)
- **NCT ID**: NCT06351007
- **Study ID**: NMM-4650-23-24-1
- **Status**: RECRUITING
- **Start Date**: 2023-09-19
- **Completion Date**: 2024-07
- **Lead Sponsor**: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
### Study Description
A fundamental strategy to improve adherence to nutritional treatment in patients with chronic kidney disease is the implementation of educational programs. The aim of this study is to evaluate the effect of a multidisciplinary educational program on dietary adherence, nutritional knowledge, nutritional status, metabolic control and quality of life in patients with chronic kidney disease, predialysis, peritoneal dialysis and hemodialysis.A randomized clinical trial will be carried out, in which patients who meet the inclusion criteria will be randomly assigned to three possible groups: predialysis educational intervention, dialysis educational intervention and control group. At the initial visit, the nutritional status will be evaluated by means of anthropometric parameters, screening and dynamometry, the biochemical parameters of interest will be extracted from the clinical record, nutritional knowledge and quality of life will be evaluated, and the diet will be explained. In the second visit, adherence to the diet will be evaluated and the food registry will be carried out. In the intervention groups, the educational program will begin with a duration of five months. Patients will come twice a month to the hospital to participate in the educational sessions and attend group psychology sessions. After completion of the educational program, the same measurements as at the beginning of the study will be carried out in the three groups.
### Conditions
- Chronic Kidney Disease
- Predialysis
- Peritoneal Dialysis
- Hemodialysis
- Educational Activities
- Adherence
- Nutritional Status
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- Nutritional education and psychological intervention
- Standard care
### Outcomes
**Primary Outcomes**
- Patients´ dietary attitude
- Dietary adherence
- Nutritional knowledge
**Secondary Outcomes**
- Muscle status
- Muscle functionality
- Nutritional status of predialysis patients
- Nutritional status of dialysis patients
- Patients´ quality of life
### Location
- **Facility**: Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, N/A, 14080, Mexico
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## Early Assessment of Cardiac Function After Treatment With CAR-T Cells
- **NCT ID**: NCT06350994
- **Study ID**: APHP230625
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-09
- **Completion Date**: 2027-01
- **Lead Sponsor**: Assistance Publique - Hôpitaux de Paris
### Study Description
CAR-T cells (Chimeric Antigen Receptor) are a new immunotherapy, based on the genetic modification of autologous T lymphocytes. CAR-T cell therapy is not devoid of complications.Among the most frequent complications are the risk of infection, cytokine release syndrome (CRS) and neurotoxicity. Nevertheless, some authors have reported serious acute cardiac events in a limited number of patients, often contemporaneous with CRS or sepsis, questioning the imputability of CAR-T cells in this heart disease.This study aims to estimate the incidence of a possible early cardiotoxicity associated with CAR-T cells.The main endpoint will be the change in cardiac function (LVEF: left ventricular ejection fraction) assessed by ultrasound between the pre CAR-T assessment and the early post CAR-T ultrasound (D3-D5).
### Conditions
- Car T- Cell
- Hematologic Malignancy
- Acute Lymphoblastic Leukemia
- Lymphoma, B-Cell
- Multiple Myeloma
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
### Outcomes
**Primary Outcomes**
- Estimation of the incidence of possible early CAR-T cells infusion-induced cardiotoxicity
**Secondary Outcomes**
- Characterization of the putative CAR-T cells infusion-induced cardiotoxicity: incidence, phenotype, clinical, rhythmic and biological manifestations
- Determination of its possible association with a cytokine release syndrome and the levels of inflammatory biomarkers from the analysis of the serum library of these patients
### Location
- **Facility**: Critical care medicine department, Paris, N/A, 75012, France
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## Analgesic Requirement for Post-Operative Pain Control in TLIP Interbody Fusion
- **NCT ID**: NCT06350981
- **Study ID**: FORE813
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-04-01
- **Completion Date**: 2025-03-01
- **Lead Sponsor**: Foundation for Orthopaedic Research and Education
### Study Description
The goal of this clinical trail is to to compare the efficacy of thoracolumbar interfascial plane block with Exparel vs with standard of care 0.25% Bupivacaine HCl in patients undergoing 1-3 level elective transforaminal lumbar interbody fusion. The investigators hypothesize that thoracolumbar interfascial plane block with Exparel will outperform standard of care (supplemented with interfascial plane block of 0.25% Bupivacaine HCl) with regards to pain reduction, narcotic use, length of hospital stay, time to mobilization with physical therapy, narcotic usage in the hospital, and post operative pain scores.
### Conditions
- Back Pain
- Surgery-Complications
- Narcotic Use
- Physical Stress
- Post Operative Pain
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- Exparel
- Bupivacain
### Outcomes
**Primary Outcomes**
- Compare efficacy of thoracolumbar interfacial plane block with Exparel vs. standard of care (0.25% Bupivacaine HCL) is surgical subjects undergoing 1-3 level elective transforaminal lumbar interbody fusion.
**Secondary Outcomes**
- Total Postsurgical opioid consumption
- Time to discharge
- Time to ambulation
- Maximum ambulated distance
- Numeric Rating Pain Scale (Physical Therapy)
- Numeric Rating Pain Scale
- Oswestry Disability Index (ODI)
- Pain Catastrophizing Scale (PCS)
### Location
- **Facility**: Foundation for Orthopaedic Research and Education, Tampa, Florida, 33607, United States
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## Implementation of Online Advance Care Planning Tool for (Hemato-)Oncological Patients Within the Cancer Network Concord
- **NCT ID**: NCT06350968
- **Study ID**: MEC-2023-0151
- **Status**: RECRUITING
- **Start Date**: 2023-10-01
- **Completion Date**: 2026-12-31
- **Lead Sponsor**: Erasmus Medical Center
### Study Description
The aim of this mixed-methods study is to describe both the implementation process and outcomes of the online module Advance Care Plan for (hemato-)oncology patients within the oncology-network CONCORD.The main question is: How is implementation and assurance of the advance care plan in daily care for (hemato-)oncological patients within CONCORD achieved, so that early integration of advance care planning in oncological care takes place and patient preferences are discussed?Healthcare providers and patients are asked to use the module and share their experiences with it.
### Conditions
- Oncology
- Advance Care Planning
- Implementation
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
### Outcomes
**Primary Outcomes**
- Implementation outcome
**Secondary Outcomes**
- Intervention outcome
- Implementation outcome
### Location
- **Facility**: Joica Benschop, Rotterdam, N/A, 3023TB, Netherlands
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## IV Iron-induced Hypophosphatemia After RYGB
- **NCT ID**: NCT06350955
- **Study ID**: 2022-01389
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-05
- **Completion Date**: 2026-06
- **Lead Sponsor**: Lucie Favre
### Study Description
The primary objective of the study is to compare the incidence of hypophosphatemia in RYGB patients treated with intravenous (IV) single dose of iron isomaltoside (Monofer®) or ferric carboxymaltose (Ferinject®).
### Conditions
- Hypophosphatemia
- Roux-en-Y Gastric Bypass
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- Iron isomaltoside
- Iron Carboxymaltose
### Outcomes
**Primary Outcomes**
- incidence of hypophosphatemia in RYGB patients treated with intravenous iron
**Secondary Outcomes**
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
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## One Trocar-assisted Retroperitoneoscopic Ureteroureterostomy for Ureteral Duplication
- **NCT ID**: NCT06350942
- **Study ID**: 1451_01/BVNTW-VNCSKTE
- **Status**: COMPLETED
- **Start Date**: 2016-09
- **Completion Date**: 2024-02
- **Lead Sponsor**: National Children's Hospital, Vietnam
### Study Description
Ureteral duplication, a common anomaly affecting about 0.8% of the population, presents challenges in pediatric urology due to its diverse clinical presentations and anatomical complexity. Traditional treatments like upper pole moiety (UPM) heminephrectomy can lead to loss of renal function in the remaining lower pole moiety (LPM). Ureteroureterostomy (UU) is a safer alternative, increasingly preferred regardless of renal function or reflux presence. Minimally invasive techniques like laparoscopic and robotic procedures show promise, but robotic-assisted UU is costly, while laparoscopic UU has technical challenges. A novel approach is proposed: single-trocar retroperitoneoscopic-assisted UU, combining laparoscopic visualization advantages with simplified extracorporeal suturing, offering a promising solution for managing complete ureteral duplication. The present study was designed to describe the operative technique and outcome of OTAU in 40 cases of complete ureteral duplication in children.
### Conditions
- Ureteral Duplication
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
- one trocar-assisted retroperitoneoscopic ureteroureterostomy (OTAU)
### Outcomes
**Primary Outcomes**
- Mean operating time
- Intraoperative complications
- Conversion to open
- Early postoperative complications
- Median length of hospital stays
- Mean UPM renal pelvis' APD
- Mean SFU of UPM renal pelvis
- Mean UPM ureter's diameter
- Mean UPM DRF
- Mean DRF of operated side
**Secondary Outcomes**
### Location
- **Facility**: The National Hospital of Pediatrics, Hanoi, N/A, N/A, Vietnam
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## Norepinephrine in the Management of General Anesthesia-Induced Arterial Hypotension in Chronic Heart Failure Patients
- **NCT ID**: NCT06350929
- **Study ID**: RC31/24/0017
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-04
- **Completion Date**: 2025-05
- **Lead Sponsor**: University Hospital, Toulouse
### Study Description
Arterial hypotension is a frequent complication of general anesthesia and a significant contributor to postoperative complications. It is a critical marker for the development of acute renal failure and postoperative myocardial infarction. Chronic heart failure (CHF) patients are increasingly encountered in the operating room, and their perioperative morbidity and mortality are substantial, with specific management lacking precise recommendations.The main objective is to assess the impact of a diluted norepinephrine bolus on cardiac output in chronic heart failure patients experiencing arterial hypotension after anesthesia induction.
### Conditions
- Hypotension
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
- Cardiac output monitoring by the Starling™ SV Sebac®
### Outcomes
**Primary Outcomes**
- Evaluation of the impact of a bolus of diluted norepinephrine on cardiac output in chronic heart failure patients presenting with arterial hypotension after anesthetic induction.
**Secondary Outcomes**
- Evaluation of the role of preload dependence before anesthetic induction in the variation of cardiac output after a norepinephrine bolus.
- Evaluation of the impact of the norepinephrine bolus on blood pressure correction.
- Evaluation of the impact of the norepinephrine bolus on heart rate.
- Evaluation of the safety of use of norepinephrine in chronic heart failure patients during hospitalization.
### Location
- **Facility**: CHU Toulouse Rangueil, Toulouse, N/A, 31400, France
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## Application to Improve Patient Engagement and Decrease Postoperative Opioid Consumption in Patients for Colorectal Surgery
- **NCT ID**: NCT06350916
- **Study ID**: IRB00082594
- **Status**: COMPLETED
- **Start Date**: 2021-01-28
- **Completion Date**: 2021-10-01
- **Lead Sponsor**: Wake Forest University Health Sciences
### Study Description
The purpose of this study is to evaluate whether patient-centered educational material delivered before and immediately after surgery can help improve outcomes for patients undergoing colorectal surgery.
### Conditions
- Colorectal Surgery
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
- SeamlessMD® Mobile Application
### Outcomes
**Primary Outcomes**
- Perioperative ERAS metric completion rate
- Postoperative hospital length of stay
- Postoperative complications
- 30-day readmission
**Secondary Outcomes**
- Postoperative Opioid Consumption
### Location
- **Facility**: Levine Cancer Institute, Charlotte, North Carolina, 28204, United States
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## Suppression With Empagliflozin as an Alternative To High-Fat Low-Carbohydrate Diet for Myocardial F-fluorodeoxyglucose Positron Emission Tomography (FDG-PET) Imaging
- **NCT ID**: NCT06350903
- **Study ID**: ICM 2024-3356
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-06
- **Completion Date**: 2025-06
- **Lead Sponsor**: Matthieu Pelletier-Galarneau, MD MSc
### Study Description
The overall objective of this study is to assess if the empagliflozin has the potential to substitute the high fat low carb (HFLC) diet for the preparation of cardiovascular FDG-PET studies.
### Conditions
- Myocardial Suppression
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: CROSSOVER
- **Primary Purpose**: DIAGNOSTIC
### Interventions
- Fast + High-fat low-carbohydrate diet
- Fast + Empagliflozin
### Outcomes
**Primary Outcomes**
- Levels of serum Beta-hydroxybutyrate (BHB) mmol/L
**Secondary Outcomes**
- Proportions of serum Beta-hydroxybutyrate (BHB) >0.5 mmol/L
- Proportions of glycemia levels (mmol/L) <3.5 mmol/L
- Acceptability and tolerance of each protocol, as reported by patients by a dedicated survey.
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
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## Efficacy and Safety of Berberine Ursodeoxycholate (HTD1801) in Patients With Type 2 Diabetes
- **NCT ID**: NCT06350890
- **Study ID**: HTD1801.PCT105
- **Status**: RECRUITING
- **Start Date**: 2023-11-05
- **Completion Date**: 2025-09
- **Lead Sponsor**: HighTide Biopharma Pty Ltd
### Study Description
The goal of this clinical study is to evaluate the efficacy and safety of Berberine Ursodeoxycholate (HTD1801) compared to placebo in patients with type 2 diabetes, inadequately controlled with diet and exercise alone.
### Conditions
- T2DM (Type 2 Diabetes Mellitus)
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- HTD1801
- Placebo
### Outcomes
**Primary Outcomes**
- Primary Endpoint: Mean Change in HbA1c
**Secondary Outcomes**
- Double Blind (DB) Phase: Mean Change in Fasting Plasma Glucose
- DB Phase: Mean Change in 2-Hour Postprandial Glucose
- DB Phase: Proportion of patients achieving HbA1c <7.0%
- DB Phase: Proportion of patients achieving HbA1c <6.5%
- DB Phase: Mean Change in Insulin Sensitivity (HOMA-IR)
- DB Phase: Mean Change in Low-Density Lipoprotein Cholesterol (LDL-C)
### Location
- **Facility**: Xuancheng People's Hospital, Xuancheng, Anhui, N/A, China
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## 1:1 and Group-based Exercise Intervention for Post-secondary Student Mental Health and Well-being
- **NCT ID**: NCT06350877
- **Study ID**: PA RCT
- **Status**: RECRUITING
- **Start Date**: 2024-01-08
- **Completion Date**: 2025-01
- **Lead Sponsor**: University of Toronto
### Study Description
Post-secondary students report alarming rates of feeling overwhelmed, hopeless, anxious, and depressed. To better support student mental health, there is a well-documented need to improve the range and quality of mental health services available to students. Focussing on formalized treatment approaches and strategies supporting well-being in the campus community more generally are needed. Physical activity is an alternative therapeutic approach that could be implemented as an evidence-based lifestyle intervention for supporting mental health and well-being on post-secondary campuses.Despite the growing evidence supporting physical activity for student mental health, there are significant knowledge gaps in the literature. First, there is a paucity of research exploring the effects of different delivery styles (i.e., one-on-one (1:1) vs. group) on primary (i.e., mental health symptomology including anxiety symptoms, depression symptoms, psychological distress) and secondary (i.e., social support, social connectedness) outcomes. Secondly, the maintenance effects of a physical activity program on mental health or sustained physical activity behaviour change are largely unknown. Lastly, limited research has explored contextual implementation factors (e.g., intervention reach, adherence, and program satisfaction) that may influence the sustainability and scale-up of physical activity programs for student mental health. Examining contextual implementation factors is critical for optimizing physical activity intervention delivery and for facilitating wider dissemination of research findings into practice. The goal of this 3-arm parallel randomized controlled trial is to test the effectiveness of 1:1 physical activity intervention and group-based physical activity intervention compared to a wait-list control group in supporting post-secondary student mental health. The main questions include:* Are there group differences between 1:1, group-based delivery, and waitlist control in the immediate (post-intervention) and follow-up (1-month) maintenance effects on the primary and secondary outcomes?* Grounded in recommendations for process evaluation of complex interventions, what are contextual implementation factors that may be linked to variation in primary and secondary outcomes while offering insight for wider dissemination?Trial participants will be randomly assigned to one of the following groups:1. 1:1 physical activity training;2. Group-based physical activity training consisting of small 5-8 person groups; or3. Waitlist control. Students will participate in the physical activity intervention after the intervention and follow-up period (10 weeks); however, their participation will not be monitored or evaluated.The physical activity training will involve a 6-week physical activity intervention consisting of weekly 1-hour sessions. Each session involves: (1) 30-minutes of behaviour change coaching (e.g., goal setting, action-planning, brainstorming strategies to overcome barriers to engaging in physical activity); and (2) 30-minutes of supervised and structured physical activity training. To address the aims of the study, participants will complete self-report questionnaires at baseline, post-intervention (following completion of the 6-week physical activity intervention), and 1-month following completion of the physical activity intervention. Questionnaires will assess demographic characteristics, primary outcomes (i.e., mental health symptomology including anxiety symptoms, depression symptoms, psychological distress), secondary outcomes (i.e., social support, social connectedness, physical activity behaviour) and contextual implementation factors (e.g., intervention reach, adherence, and program satisfaction) that may be linked to variation in primary and secondary outcomes while offering insight for wider dissemination. It is hypothesized that there will be no group differences between 1:1 delivery and group-based delivery on the primary outcomes. It is also hypothesized that group-based delivery, in comparison to 1:1 delivery will achieve greater improvements and more favourable maintenance effects in the secondary outcomes. Lastly, it is hypothesized that in comparison to the control group, 1:1 delivery and group-based delivery will be more effective in achieving change in the primary and secondary outcomes.
### Conditions
- Physical Activity
- Mental Health Issue
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: SUPPORTIVE_CARE
### Interventions
- Physical Activity Intervention
### Outcomes
**Primary Outcomes**
- Depression
- Anxiety
- Psychological distress
**Secondary Outcomes**
- Social Support
- Social Connectedness
- Physical Activity Behaviour
- Intervention Reach
- Therapeutic Alliance
- Intervention Satisfaction
- Coach Perceptions
### Location
- **Facility**: University of Toronto, Mental Health and Physical Activity Research Centre, Toronto, Ontario, M5S 2W6, Canada
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## HFNC Versus Conventional Oxygen Therapy in Prolonged Upper Gastrointestinal Endoscopy in the ICU
- **NCT ID**: NCT06350864
- **Study ID**: FMASU R11/2024
- **Status**: RECRUITING
- **Start Date**: 2024-01-20
- **Completion Date**: 2024-07
- **Lead Sponsor**: Ain Shams University
### Study Description
Conventional supplemental oxygen therapy (COT) during upper gastrointestinal (UGI) endoscopy via nasal catheter is considered the standard practice in maintenance of oxygenation and prevention of hypoxia. However, it is still unclear if this oxygen delivery method is optimal in a prolonged (more than 15 minutes) procedure in patients admitted to the ICU. Because of shortage of data in this concern, this prospective, randomized, controlled clinical trial study will aim to evaluate and compare the efficacy of high-flow nasal cannula (HFNC) oxygen therapy versus COT in patients who will undergo prolonged either diagnostic or therapeutic UGI endoscopy in the intensive care unit (ICU) .
### Conditions
- Upper Gastrointestinal Bleeding
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: PREVENTION
### Interventions
- High-flow nasal cannula (HFNC)
- Conventional nasal oxygen therapy (COT)
- Upper gastrointestinal endoscopy (UGE) including gastroscopy
- Upper gastrointestinal endoscopy (UGE) including Endoscopic ultrasound (EUA)
### Outcomes
**Primary Outcomes**
- Any occurrence of at least moderate hypoxemia of any duration measured by pulse oximetry during the procedure.
**Secondary Outcomes**
- The median lowest SpO2 -Any episode of hypoxia -Clinically significant hypoxia -Sedation and procedure related adverse effects -Endoscopy procedure time -Anesthetic time -Propofol total used doses
- Any episode of hypoxia occurring less than 1 minute, from 1 to 5 minutes, or more than 5 minutes
- Clinically significant hypoxia
- Sedation related adverse effects (SRAEs)
- Procedure-related adverse events (PRAEs)
### Location
- **Facility**: Ain Shams University-Faculty of Medicine, Cairo, N/A, N/A, Egypt
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## Development of a New Rapid Diagnostic Test to Support Onchocerciasis Elimination
- **NCT ID**: NCT06350851
- **Study ID**: BA161WP1
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-04
- **Completion Date**: 2025-04
- **Lead Sponsor**: Bioaster
### Study Description
Onchocerciasis, also known as river blindness, is one of the disease targeted for elimination by the World Health Organization (WHO) in the group of Neglected Tropical Diseases. Existing diagnostic tools for onchocerciasis have limitations that make mapping, epidemiological assessments and verification of elimination of onchocerciasis difficult. It is in this context that WHO, in its 2021-2030 roadmap for onchocerciasis, has identified the development of new diagnostic tests, or the improvement of existing diagnostic tests, as a critical condition for achieving the goal of eliminating onchocerciasis transmission.To this end, a series of cross-sectional studies will be carried out in Cameroun over a one year period to collect and characterize biological samples for the development and evaluation of a new rapid diagnostic test for onchocerciasis. The study will target individuals aged 18 and over, mono-infected with one of the filarial species Onchocerca volvulus, Loa loa or Mansonella perstans; and non-infected.At the end of this study, data on the endemicity of onchocerciasis, loiasis and mansonellosis in the selected communities will be updated. More importantly, a new rapid diagnostic test will be developed, which can then be used to monitor the activities of onchocerciasis control programs.
### Conditions
- Onchocerciasis
- Loiasis
- Mansonelliasis
- Healthy Volunteers
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: NON_RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: DIAGNOSTIC
### Interventions
- Biological samples collection (blood drawing + feces)
### Outcomes
**Primary Outcomes**
- Evaluation of the performance of the prototype diagnostic test
**Secondary Outcomes**
### Location
- **Facility**: Higher Institute for Scientific and Medical Research, Yaounde, N/A, 5797, Cameroon
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## Clinical Study to Investigate the Safety and Tolerance of Therapeutic BCG in Postoperative Adjuvant Therapy in Subjects With Moderate to High-risk Non-muscular Invasive Bladder Cancer (NMIBC)
- **NCT ID**: NCT06350838
- **Study ID**: KN-BCG-I
- **Status**: COMPLETED
- **Start Date**: 2022-11-11
- **Completion Date**: 2023-02-13
- **Lead Sponsor**: Chengdu CoenBiotech Co., Ltd
### Study Description
Phase I clinical study to investigate the safety and tolerance of therapeutic BCG in postoperative adjuvant therapy in subjects with moderate to high-risk non-muscular invasive bladder cancer (NMIBC)
### Conditions
- Non-muscular Invasive Bladder Cancer
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: NA
- **Intervention Model**: SINGLE_GROUP
- **Primary Purpose**: TREATMENT
### Interventions
- BCG for Therapeutic Use
### Outcomes
**Primary Outcomes**
- Incidence of Treatment-Emergent Adverse Events(TEAE) and serious Treatment-Emergent Adverse Events;
- Effects on clinical laboratory tests index of blood biochemistry, such as the concentration of alanine aminotransferase (ALT).
- Effects on clinical laboratory tests index of blood routine, such as white blood cell count, red blood cell count, platelet count.
- Effects on clinical laboratory tests index of coagulation function, such as activated partial thromboplastin time (APTT).
- Effects on clinical laboratory tests index of urine routine, such as white urine albumin count, urine red blood cell count.
- Effects on vital signs,such as temperature.
- Effects on P wave, QRS complex, QT interval and so on by 12-lead electrocardiogram.
- Effects on the periodic activity of echocardiography，such as the heart wall recorded as the relationship curve between the corresponding activity and time of each structure.
- Effects on physical examination, refers to the detection and measurement of the development level of human form, structure and function.
**Secondary Outcomes**
- Exposure condition of the test drug in the blood, refer to plasma concentration of the test drug(BCG).
- Shedding condition of the test drug in urine.
- To investigate the immune response characteristics of therapeutic BCG in patients with moderate and high- risk non-invasive bladder cancer after surgery.
### Location
- **Facility**: Hunan Cancer Hospital, Changsha, Hunan, 415000, China
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## Cytoreductive Prostatectomy Combined With Triple or Dual Systemic Therapy in mHSPC Patients
- **NCT ID**: NCT06350825
- **Study ID**: 2023-SR-543
- **Status**: RECRUITING
- **Start Date**: 2016-01-01
- **Completion Date**: 2028-12-31
- **Lead Sponsor**: The First Affiliated Hospital with Nanjing Medical University
### Study Description
To evaluate: The radiographic progression-free survival (rPFS) of metastatic hormone-sensitive prostate cancer (mHSPC) patients treated with androgen deprivation therapy (ADT) + second-generation antiandrogens±chemotherapy combined with cytoreductive prostatectomy (CRP)
### Conditions
- Metastatic Prostate Cancer
- Therapy, Directly Observed
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- Cytoreductive prostatectomy or brachytherapy
- ADT+second-generation antiandrogens ± chemotherapy
### Outcomes
**Primary Outcomes**
- rPFS
**Secondary Outcomes**
- Safety of CRP in mHSPC patients
### Location
- **Facility**: The First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, 210029, China
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## A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of PB-119 Injection in Chinese Obese Subjects
- **NCT ID**: NCT06350812
- **Study ID**: PB119110
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-05-30
- **Completion Date**: 2025-04-29
- **Lead Sponsor**: PegBio Co., Ltd.
### Study Description
The trial is conducted in a single-center, randomized, double-blind, placebocontrolled, dose-increasing design. To evaluate the safety, tolerability, PK characteristics, efficacy and immunogenicity of PB-119 injection in Chinese obese subjects.
### Conditions
- Obesity
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- PB-119
- Placebo
### Outcomes
**Primary Outcomes**
- Incidence of Treatment-Emergent Adverse Events
**Secondary Outcomes**
- Pharmacokinetic profile
- Pharmacokinetic profile
- Pharmacokinetic profile
- Pharmacokinetic profile
- Effectiveness index
- Effectiveness index
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
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## Chronic Obstructive Pulmonary Disease and Community Health Worker Home-visits
- **NCT ID**: NCT06350799
- **Study ID**: 01741
- **Status**: COMPLETED
- **Start Date**: 2019-03-14
- **Completion Date**: 2023-04-28
- **Lead Sponsor**: VA Puget Sound Health Care System
### Study Description
We examined a Community Health Worker (CHW) program for Chronic Obstructive Pulmonary Disease (COPD) in Veteran Participants. The goal of this study was to assess participants' perceived acceptability, appropriateness, and feasibility of the intervention, explore participants' COPD health outcomes, and gather insights from participants and CHWs to inform potential improvements.Veteran participants enrolled in the 12-week intervention and received a series of 9 CHW home, phone, or video visits. These visits provided education and chronic disease self-management practices to improve COPD health.Researchers examined the participant and CHW perception of the intervention through qualitative interviews and surveys.
### Conditions
- COPD
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
### Outcomes
**Primary Outcomes**
- Acceptability, Appropriateness, Feasibility
**Secondary Outcomes**
### Location
- **Facility**: VA Puget Sound Health Care System, Seattle, Washington, 98108, United States
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## Conditioned Open-label Placebos to Facilitate Opioid Reduction in Patients With Chronic Non-cancer Pain
- **NCT ID**: NCT06350786
- **Study ID**: ROM Study
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-04
- **Completion Date**: 2025-07
- **Lead Sponsor**: Cosima Locher
### Study Description
This study aims to evaluate whether the reduction of the daily morphine equivalent dose (MED) in patients with chronic non-cancer pain (CNCP) can be decreased with an open-label placebo (OLP) intervention in comparison to an electronic monitoring (EM) control group. The participants will receive the intervention (OPL or EM) over the duration of six weeks. Diverse psychological and health measures will be assessed with questionnaires over the course of the intervention. Furthermore, evaluation outcomes, qualitative outcomes and safety outcomes will be assessed. It is hypothesized that the OLP-intervention group in comparison to the EM-control group will have a significantly lower consumption of MED over the course of the study. Furthermore, this study aims to evaluate whether the OLP intervention can reduce opioid withdrawal symptoms in comparison to the control group.
### Conditions
- Chronic Non-cancer Pain
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- P-Dragees blue Lichtenstein, Placebo dragees
- Control group (EM)
### Outcomes
**Primary Outcomes**
- Daily opioid consumption (MED):
**Secondary Outcomes**
- Subjective opioid withdrawal symptoms
- Pain severity
- Pain disability
- Anxiety
- Depression
- Pain Opioid Analgesics Beliefs Scale - Cancer
- Treatment Expectancy
- Placebo pill count
- Opioid adherence
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
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## Phosphodiesterase Type 5 Inhibitors in Patients With Group 2 Pulmonary Hypertension
- **NCT ID**: NCT06350773
- **Study ID**: FMBSUREC/06122022/ Zaher
- **Status**: RECRUITING
- **Start Date**: 2023-01-10
- **Completion Date**: 2024-11
- **Lead Sponsor**: Beni-Suef University
### Study Description
The goal of this clinical trial is to test the efficacy of tadalafil in patients with group II pulmonary hypertension with elevated pulmonary vascular resistance (PVR). The main question it aims to answer is:• Can tadalafil improve patients with group II pulmonary hypertension with elevated PVR? Participants will undergo right heart catheterization (RHC) to make sure they are fulfilling the inclusion criteria, then will be asked to take tadalafil 20 mg for two weeks then 40 mg if tolerated for 12 weeks, then participants will be followed up. Investigators will compare the drug group with another age- and sex- matched control placebo group.
### Conditions
- Group 2 Pulmonary Hypertension
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- tadalafil 20 mg then 40 mg if tolerated
### Outcomes
**Primary Outcomes**
- Functional capacity of the patients
- heart failure symptoms
**Secondary Outcomes**
- right ventricular function
- right ventricular function
- right ventricular function
- right ventricular function
- right ventricular function
### Location
- **Facility**: Beni Suef University, Cairo, Beni Suef, 62511, Egypt
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## Transdiagnostic, Indicated Preventive Intervention for Adolescents At High Risk of Emotional Problems W/Add-On Modules
- **NCT ID**: NCT06350760
- **Study ID**: UJA_PROCARE-I+
- **Status**: RECRUITING
- **Start Date**: 2023-03-15
- **Completion Date**: 2024-12-31
- **Lead Sponsor**: University of Jaén
### Study Description
PROCARE is a preventive intervention that has shown its effectiveness in selective prevention to reduce young people's risk of developing emotional problems. In this study, an uncontrolled pre-post study is carried out where this personalized transdiagnostic preventive intervention in online mode is applied in the indicated population, with the following objectives: 1) provide data about whether there are improvements in the emotional state of adolescents after implementing PROCARE-I+; and 2) evaluate if there is any risk factor that predicts anxiety-depressive symptoms and/or emotional difficulties. The sample was made up of 30 adolescents who showed symptoms of anxiety and/or depression and a high risk of developing an emotional disorder and who benefited from the preventive, transdiagnostic, online and personalized intervention called PROCARE-I+. After the analysis of the data collected at the pre-intervention and post-intervention time, the data revealed that the intervention had an impact on improving the emotional state of the adolescents in terms of anxious-depressive symptomatology, quality of life and emotional regulation. On the other hand, the data revealed the absence of predictive relationships between the presence of a risk factor and suffering from symptoms of anxiety and depression; In contrast, predictive relationships were found between the presence of the family risk factor and suffering from some emotional difficulty.
### Conditions
- Anxiety Disorders and Symptoms
- Depressive Symptoms
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: PREVENTION
### Interventions
- Active control condition
- PROCARE-I+ 8-session
### Outcomes
**Primary Outcomes**
- Self-reported anxiety and mood symptomatology
- Factors associated with adolescents' mental health
- Resilience measure
- Health-related quality of life
- Absence of emotional disorders
**Secondary Outcomes**
- Economic evaluations
- Psychological flexibility
- Emotional regulation
### Location
- **Facility**: Universidad Miguel Hernández, Elche, Alicante, 03202, Spain
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## The Effect of Laughter Yoga on Nurses' Perceived Stress, Sleep Quality, and Burnout Levels
- **NCT ID**: NCT06350747
- **Study ID**: CelalBayarU-SBF-OT-02
- **Status**: RECRUITING
- **Start Date**: 2024-04-01
- **Completion Date**: 2024-07-30
- **Lead Sponsor**: Celal Bayar University
### Study Description
The aim of the study was to investigate the effects of laughter yoga on nurses' perceived stress, sleep quality, and burnout levels.
### Conditions
- Healthy Participants
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: SUPPORTIVE_CARE
### Interventions
- Laughter Yoga
### Outcomes
**Primary Outcomes**
- Perceived Stress Scale
- Jenkins Sleep Scale
- Maslach Burnout Scale
**Secondary Outcomes**
### Location
- **Facility**: Manisa Celal Bayar Üniversitesi Hafsa Sultan Hastanesi, Manisa, N/A, 45060, Turkey
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## Quality of Life After Treatment for Bladder Cancer: The Bladder Cancer Survivorship Study
- **NCT ID**: NCT06350734
- **Study ID**: 18-004675
- **Status**: RECRUITING
- **Start Date**: 2018-10-12
- **Completion Date**: 2029-01-31
- **Lead Sponsor**: Mayo Clinic
### Study Description
This study evaluates the effect of bladder cancer treatment on quality of life.
### Conditions
- Stage 0a Bladder Cancer AJCC v8
- Stage 0is Bladder Cancer AJCC v8
- Stage I Bladder Cancer AJCC v8
- Stage II Bladder Cancer AJCC v8
- Stage IIIA Bladder Cancer AJCC v8
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
- Non-Interventional Study
### Outcomes
**Primary Outcomes**
- Change in quality of life outcomes - PROMIS-29
- Change in quality of life outcomes - Bladder Cancer Index
- Patient level characteristics
**Secondary Outcomes**
### Location
- **Facility**: Mayo Clinic in Arizona, Scottsdale, Arizona, 85259, United States
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## Feasibility, Usability and Safety of the Vestibular Rehabilitation Using the Immersive Virtual Reality Software DizzyVR
- **NCT ID**: NCT06350721
- **Study ID**: DizzyVR
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-04-01
- **Completion Date**: 2024-10-01
- **Lead Sponsor**: Universidad Loyola Andalucia
### Study Description
The goal of this pilot study is to assess the safety and feasibility of the immersive virtual reality system called DizzyVR in participants diagnosed with a vestibular disorder. The main questions it aims to answer are:* To assess the feasibility, usability and safety of the system DizzyVR for the vestibular rehabilitation in participants with vestibular disorders.* To detect and record possible adverse events due to the use of DizzyVR.* To examine the degree of adherence of the participants to the intervention.* To know the average success rate of the different games in each session.* To evaluate the average difficulty levels overcome throughout the intervention.* To know the usability and satisfaction with the system reported by participants and therapists.Participants will receive the vestibular rehabilitation based on the novel immersive virtual systema, DizzyVR.
### Conditions
- Vestibular Disorder
- Physical Disability
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: NA
- **Intervention Model**: SINGLE_GROUP
- **Primary Purpose**: DEVICE_FEASIBILITY
### Interventions
- DizzyVR
### Outcomes
**Primary Outcomes**
- Retention rate of participants
- User Satisfaction Evaluation Questionnaire (USEQ)
- Register of risk and number of adverse events experimented by the stakeholders
- Adherence rate
- Dropout rates
**Secondary Outcomes**
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
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## Virtual Reality (VR) Paediatric Tracheostomy Training
- **NCT ID**: NCT06350708
- **Study ID**: 2024-18304-33663
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-04-01
- **Completion Date**: 2024-07-10
- **Lead Sponsor**: University of Manchester
### Study Description
This study aims to evaluate the use of an unsupervised virtual reality training tool. This tool is used to teach nurses, doctors and other healthcare workers and their students how to manage tracheostomy emergencies in children.
### Conditions
- Educational Study
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: NA
- **Intervention Model**: SINGLE_GROUP
- **Primary Purpose**: OTHER
### Interventions
- Virtual reality (VR) tracheostomy educational tool
### Outcomes
**Primary Outcomes**
- Performance in simulation (time to key specific intervention, time to completion of scenario, and number of correct interventions completed)
**Secondary Outcomes**
- Knowledge using a bespoke knowledge multiple choice questionnaire adapted from a validated question bank.
- Participant satisfaction measured using a bespoke data collection tool.
- Virtual Reality Sickness
- Usability using the validated system usability scale
### Location
- **Facility**: University of Manchester, Manchester, Greater Manchester, M13 9PL, United Kingdom
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## The ROle of Compression StocKings in Heart Failure Patients
- **NCT ID**: NCT06350695
- **Study ID**: HP-00103478
- **Status**: RECRUITING
- **Start Date**: 2024-01-17
- **Completion Date**: 2026-01-01
- **Lead Sponsor**: University of Maryland, Baltimore
### Study Description
Congestive heart failure (CHF) occurs when the heart is weak and not able to effectively pump blood to the body. One of the common manifestations of CHF is fluid overload and swelling of the legs. Diuretics or "water pills" are usually the treatment for fluid overload and leg swelling; however, in some patients' diuretics are no longer effective or the effectiveness is limited due to poor kidney function. The presence of chronic swelling of the legs could potentially damage the veins; additionally, it could lead to chronic skin changes in the legs and in the worst cases to a leg ulcer. Compression stockings are used in patients with venous diseases to reduce the swelling of the legs and improve mobility and quality of life. Although, there is a theoretical risk that compression stockings might push the fluid of the legs back to the heart and lungs worsening the CHF. The purpose of this study is to determine whether the use of knee-high tight socks (tight stockings with strong compression) vs. knee-high soft socks (soft stockings with minimum compression) are effective in preventing swelling and skin changes and safe in patients with CHF. During the first visit (in-person) a routine medical test will be performed including blood tests, review of the medication doses, current weight, an ultrasound images of the veins, (venous reflux ultrasound), questions about health status and a brief physical exam. The participants will be randomly assigned to receive tight compression vs. soft compression socks. Participants will be asked to wear the socks at least 8 hours a day for 5 days a week. There will be a total of 3 virtual visit (by video or telephone); the first one after one week, then after one month and two months. During the virtual visit participants will be asked about symptoms, current medications and doses, and current weight. The participants are expected to return to the clinic after 3 months for a second in-person visit. During this visit the investigators will ask questions about participant's health, they will perform a brief physical exam of their legs, and check participants weight and medicines; also, a venous ultrasound of the legs, questions about health status will be performed. The duration of the study is 3 months.
### Conditions
- Heart Failure，Congestive
- Leg Edema
- Venous Insufficiency
- Venous Ulcers
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- low grade compression stockings (10-15 mmHg)
- high grade compression stockings (20-30 mmHg)
### Outcomes
**Primary Outcomes**
- Incidence of adverse events.
- Change in symptoms of heart failure.
- Change in kidney function.
**Secondary Outcomes**
- Change in venous reflux.
- Change in C Class from the CEAP classification for venous insufficiency.
- Mobility of the patient
### Location
- **Facility**: University of Maryland, Baltimore, Maryland, 21201, United States
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## Resilient HIV Implementation Science With SGM Youths Using Evidence
- **NCT ID**: NCT06350682
- **Study ID**: HP-00107323
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-05
- **Completion Date**: 2028-06
- **Lead Sponsor**: University of Maryland, Baltimore
### Study Description
The Resilient HIV Implementation Science with SGM Youths using Evidence (RISE) Clinical Research Center will use a Type 2 hybrid-effectiveness-implementation study to evaluate the effectiveness and implementation of HMP, a youth-tailored digital health platform. It is hypothesized that SGM youths in the HMP intervention group will demonstrate improved PrEP initiation and viral load suppression over 12 months compared to the delayed HMP group.
### Conditions
- Hiv
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: SINGLE_GROUP
- **Primary Purpose**: HEALTH_SERVICES_RESEARCH
### Interventions
- HealthMPowerment (HMP)
### Outcomes
**Primary Outcomes**
- PrEP initiation for HIV seronegative seropositive
- Viral load suppression for HIV
- RE-AIM
**Secondary Outcomes**
- HIV testing cascade
- PrEP continuum
- HIV care and treatment continuum
- Implementation effectiveness
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
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## App-supported Vestibular Rehabilitation (RCT)
- **NCT ID**: NCT06350669
- **Study ID**: 9576-22-SMC
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-05
- **Completion Date**: 2026-03
- **Lead Sponsor**: University of Haifa
### Study Description
A randomized controlled trial to assess the efficacy of an app-assisted vestibular rehabilitation in increasing adherence to VR and treatment outcomes
### Conditions
- Vestibular Disorder
- Vestibular Diseases
- Vestibular Abnormality
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- Vestibular rehabilitation phone application
### Outcomes
**Primary Outcomes**
- Adherence measures
- Timed up and go (TUG)
**Secondary Outcomes**
- Demographics and medical history intake
- Vestibular functions- physical examination
- Oculomotor functions- physical examination
- Visual Analogue Scale (VAS)
- Dizziness Handicap Inventory (DHI)
- Activities-specific Balance Confidence Scale (ABC)
- Dynamic Gait Index (DGI)
- 10-Meters Walk Test (10MWT)
- 2-Minute Walk Test (2MWT)
- Dynamic Visual Acuity (DVA)
- Video Head Impulse Test (vHIT)
- Suppression Head Impulse Test (SHIMP)
- Exercise difficulty levels and symptoms severity
- Cognitive reserve index questionnaire (CRIQ)
### Location
- **Facility**: Sheba Medical Center, Ramat Gan, N/A, N/A, Israel
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## Study of Cerebral Compliance in Neurosurgical Intensive Care Units (EC2)
- **NCT ID**: NCT06350656
- **Study ID**: IRBN282022/CHUSTE
- **Status**: RECRUITING
- **Start Date**: 2023-03-31
- **Completion Date**: 2024-04
- **Lead Sponsor**: Centre Hospitalier Universitaire de Saint Etienne
### Study Description
Despite the massive use of intracranial pressure in neuro-resuscitation, there is still no cerebral compliance evaluation index used in current practice to guide therapy.In treatment guidelines for intracranial hypertension, patients are placed in a prone position at about 30 degrees. Several times a day, during nursing care, patients are flattened, which corresponds to a cerebral compliance test by adding a volume of cerebrospinal fluid to the cranial box.
### Conditions
- Cerebrospinal; Disorder
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
- Clinical data collection
- Therapeutic data collection
- IntraCranial Pression (ICP) values collection
### Outcomes
**Primary Outcomes**
- Intracranial pressure (mmHg)
**Secondary Outcomes**
- Correlation between ICP (Intra Cranial Pressure) doses and cerebral compliance
### Location
- **Facility**: CENTRE HOSPITALIER Charponnay, Chaponnay, N/A, 69970, France
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## The Black Health Block Quit and Screen Project
- **NCT ID**: NCT06350643
- **Study ID**: 287064
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-07
- **Completion Date**: 2024-12
- **Lead Sponsor**: University of Arkansas
### Study Description
The Black Health Block Quit and Screen Project seeks to engage Black health care providers in helping Black smokers quit tobacco use, including menthol cigarettes and flavored cigars, and screen for lung cancer early as strategies to reduce multiple chronic disease disparities.The goal of this clinical trial is to test the feasibility and impact of the Black Health Block Culturally Tailored Training alone versus the Health Disparities and Lung Cancer Screening Training + the Black Health Block Culturally Tailored training modules on changes in knowledge, attitudes, and behavioral intentions related to provider advice to quit smoking and referrals for low dose computed tomography among health care providers randomly assigned to each condition. Participants will complete the training modules and complete pre- and post-tests to assess these outcomes.
### Conditions
- Knowledge
- Attitudes
- Behavioral Intention
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: OTHER
### Interventions
- Black Health Block Culturally Tailored training
- Health Disparities and Lung Cancer Screening training
### Outcomes
**Primary Outcomes**
- Familiarity with treatment guidelines for tobacco and nicotine treatment
- Weaver et al. 2012 Provider Attitudes and Perceptions about smoking cessation
- Weaver et al. 2012 Provider Perceptions about provider barriers to providing smoking cessation interventions to patients
- Provider Perceptions about patient barriers to smoking cessation
- Behavioral intentions to screen and advise patients about smoking cessation
- Familiarity with lung cancer screening guidelines
- Knowledge about low dose computed tomography for lung cancer screening
- Perceptions about shared decision-making for low dose computed tomography for lung cancer screening
- Perceptions about provider barriers to referring patients to low dose computed tomography for lung cancer screening
- Provider Perceptions about patient barriers to get screened for lung cancer
- Behavioral intentions to advise patients to get screened for lung cancer via low dose computed tomography
**Secondary Outcomes**
- Diversity of enrolled healthcare providers
- Retention: Percent of providers complete the training after enrolling
- Adherence to completing training modules: Percent of modules completed
- Preferences regarding training
- Satisfaction with training
### Location
- **Facility**: Virginia Commonwealth Univesity, Richmond, Virginia, 23284, United States
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## Therapeutic Effect of Hydroxychloroquine on Immunoglobulin A (IgA) Nephropathy Course QUIgAN Study
- **NCT ID**: NCT06350630
- **Study ID**: 20PH284
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-05-01
- **Completion Date**: 2030-12-31
- **Lead Sponsor**: Centre Hospitalier Universitaire de Saint Etienne
### Study Description
immunoglobulin A (IgA) nephropathy (Berger disease) is the most frequent primary glomerulonephritis worldwide. This disease accounts for about 5% of the causes of end stage renal disease in France, representing a major public health issue. Its pathophysiology seems to be triggered by mucosal immunity abnormalities leading to the systemic misaddressing of mucosal IgA, generation of circulating immunoglobulin A1 (IgA1) immune complexes finally deposited in renal glomeruli leading to renal tissue inflammation and scarring processes. Among this pathogeny, innate immunity is involved at several steps, including mucosal immunity.In this regard, hydroxychloroquine has been shown to generate a global anti-inflammatory effect, particularly through its action on Toll like receptors and dendritic cells. This drug is well tolerated, widely used for other auto-immune diseases (e.g. Systemic Lupus Erythematosus) and very low priced.One randomized controlled study conducted in China has recently shown a significant drop in proteinuria of IgA nephropathy patients treated with hydroxychloroquine (-48.4%) compared to the placebo group (+10.0%), after a quite short-term follow-up (6 months) and a moderate statistical power (30 patients in each group).Considering (i) the potential mechanism of therapeutic effect on this disease, (ii) the well documented safety profile of the drug for rheumatologic indications and posologies, and its low cost (iii) its efficacy in reducing proteinuria in IgA nephropathy patients in a preliminary Chinese randomized control study, the investigators aim in this study at establishing the beneficial impact of hydroxychloroquine on IgA nephropathy in a double blind randomized controlled trial on a Caucasian French population with harder outcomes and a longer follow-up compared to the Chinese preliminary study.
### Conditions
- IgA Nephropathy
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- Hydroxychloroquine Oral Tablet
- Placebo oral tablet
### Outcomes
**Primary Outcomes**
- Absolute difference in estimate Glomerular Filtration Rate (GFR) between hydroxychloroquine group and control group evolution
**Secondary Outcomes**
- nephrological follow-up: proteinuria
- nephrological follow-up: albuminuria
- nephrological follow-up: GFR
- nephrological follow-up: hematuria
- nephrological follow-up: systolic and diastolic blood pressure
- nephrological follow-up: proteinuria
- nephrological follow-up: albuminuria
- nephrological follow-up: GFR
- nephrological follow-up: hematuria
- nephrological follow-up: systolic and diastolic blood pressure
- nephrological follow-up: proteinuria
- nephrological follow-up: albuminuria
- nephrological follow-up: hematuria
- nephrological follow-up: systolic and diastolic blood pressure
- end stage renal disease (GFR< 15mL/min/1.73m²)
- death
- adverse events (pruritus, gastro-intestinal disorders) and serious adverse events (QT enlargement, cardiomyopathy, ophthalmologic disorders, neuromyopathy, cytopenia)
### Location
- **Facility**: CHU Gabriel Montpied, Clermont-Ferrand, N/A, 63000, France
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## Personalized rTMS Protocol Based on Functional Reserve to Enhance Ambulatory Function in PD Patients
- **NCT ID**: NCT06350617
- **Study ID**: 2023-12-028
- **Status**: RECRUITING
- **Start Date**: 2024-02-20
- **Completion Date**: 2025-09-30
- **Lead Sponsor**: Samsung Medical Center
### Study Description
The objective of this study was to determine the effects of protocols of repetitive transcranial magnetic stimulation (rTMS) therapy based on the functional reserve of each patient with Parkinson's disease, compared to conventional high-frequency rTMS therapy on bilateral primary motor cortex (M1). Investigators hypothesized that the functional reserve of each patient with Parkinson's disease will be different, and therefore an appropriate simulating target for rTMS therapy is needed. In addition, this approach could be more effective compared to conventional protocols applied to patient with Parkinson's disease regardless of their severity, predicted mechanism of motor function recovery, or functional reserves.
### Conditions
- Parkinson's Disease and Parkinsonism
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- High-Frequency, ipsilateral M1
- High-Frequency, bilateral M1
- High-Frequency, Lt. DLPFC
- High-Frequency, bilateral M1
### Outcomes
**Primary Outcomes**
- Differences of Timed Up and Go Test (TUG)
**Secondary Outcomes**
- Differences of Timed Up and Go Test (TUG)
- Differences of Timed Up and Go Test (TUG)
- Differences of Timed Up and Go Test-Cognitive (TUG-Cog)
- Differences of Timed Up and Go Test-Cognitive (TUG-Cog)
- Differences of Timed Up and Go Test-Cognitive (TUG-Cog)
- Differences of Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS), Part III
- Differences of MDS-UPDRS, Part III
- Differences of New Freezing of Gait Questionnaire (FoG-Q)
- Differences of New Freezing of Gait Questionnaire (FoG-Q)
- Differences of Digit span Test
- Differences of Digit span Test
- Differences of Trail making Test
- Differences of Trail making Test
- Differences of Gait lab parameter (Gait speed)
- Differences of Gait lab parameter (Gait speed)
- Differences of Gait lab parameter (Stride length)
- Differences of Gait lab parameter (Stride length)
- Differences of Gait lab parameter (Step count)
- Differences of Gait lab parameter (Step count)
- Differences of Gait lab parameter (Cadence)
- Differences of Gait lab parameter (Cadence)
- Differences of Gait lab parameter (Swing ratio)
- Differences of Gait lab parameter (Swing ratio)
- Differences of Gait lab parameter (Stride time)
- Differences of Gait lab parameter (Stride time)
- Differences of Gait lab parameter (Pressure distribution)
- Differences of Gait lab parameter (Pressure distribution)
### Location
- **Facility**: Samsung Medical Center, Seoul, N/A, 06351, Korea, Republic of
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## Project WHADE: A Partner-Based Physical Activity Program for Women
- **NCT ID**: NCT06350604
- **Study ID**: PRO-2023-355
- **Status**: RECRUITING
- **Start Date**: 2024-01-02
- **Completion Date**: 2024-07
- **Lead Sponsor**: Rowan University
### Study Description
This study is designed to test the feasibility and acceptability of a new method for supporting physical activity among women ages 40-65 who have risk factors for cardiovascular disease. Each participant receives a trained physical activity coach and a physical activity partner; the partner is another woman in the program. Partners communicate with each other between weekly coaching sessions to provide support for physical activity behavior change.
### Conditions
- Hypertension
- Type 2 Diabetes
- Metabolic Syndrome
- Smoking
- High Cholesterol
- PreDiabetes
- Prehypertension
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: NA
- **Intervention Model**: SINGLE_GROUP
- **Primary Purpose**: PREVENTION
### Interventions
- Project WHADE: A Partner-Based Physical Activity Program for Women
### Outcomes
**Primary Outcomes**
- Frequency of partner communication
- Satisfaction with partner communication
**Secondary Outcomes**
- Physical activity behavior - steps
- Physical activity behavior - active minutes
### Location
- **Facility**: Rowan University, Glassboro, New Jersey, 08028, United States
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## Evaluating Changes in Skeletal Muscle Proteins Following Resistance Exercise and Single-Leg Disuse
- **NCT ID**: NCT06350591
- **Study ID**: 6038674
- **Status**: RECRUITING
- **Start Date**: 2024-04-01
- **Completion Date**: 2024-08
- **Lead Sponsor**: Queen's University
### Study Description
Skeletal muscle plays a critical role in supporting human health. Beyond its role in providing the force to move, skeletal muscle accounts for a large proportion of metabolic rate, glucose disposal, and amino acid storage. Skeletal muscle is dynamically regulated by environmental stimuli, such as loading (i.e., resistance training\]) and unloading (i.e., disuse atrophy) as well as the intake of essential amino acids (EAAs). However, the precise mechanisms that regulate skeletal muscle mass in response to various conditions (e.g., EAA supplementation, resistance training, and unloading) are not completely understood. Therefore, concerted efforts to better understand the mechanisms regulating skeletal muscle size are needed that aid in the development of therapeutic interventions to combat age, disease, and disuse related muscular atrophy.
### Conditions
- Healthy
- Skeletal Muscle Atrophy
- Skeletal Muscle Hypertrophy
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: BASIC_SCIENCE
### Interventions
- Immobilization
- Resistance training
### Outcomes
**Primary Outcomes**
- Changes in average rates of muscle synthesis
- Dynamic proteomic profiling
**Secondary Outcomes**
- Protein expression (phosphorylation and content) of novel and known targets implicated in protein translation and mitochondrial-related protein expression
- Muscle torque
- Quadriceps skeletal muscle volume
### Location
- **Facility**: School of Kinesiology and Health Studies, Kingston, Ontario, K7L 3N6, Canada
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## A Randomized Clinical Trial Comparing Hall vs. Conventional Technique in Primary Molars.
- **NCT ID**: NCT06350578
- **Study ID**: BUHOOTH-D-23-00073
- **Status**: RECRUITING
- **Start Date**: 2023-12-06
- **Completion Date**: 2025-06
- **Lead Sponsor**: Primary Health Care Corporation, Qatar
### Study Description
This study aims to assess the comparative effectiveness of the Hall technique (HT) and the conventional technique (CT) for placing Stainless Steel Crowns (SSCs) in primary molars with approximal caries.
### Conditions
- Dental Caries
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- Hall Crown Technique
- Conventional SSC Technique
### Outcomes
**Primary Outcomes**
- Restoration survival at 12 months
- Occlusal vertical dimension (OVD) resolution
- Tooth survival
- Procedural time
**Secondary Outcomes**
- Participant's cooperation
- Participant's pain perception
- Treatment perceptions and opinions of the parents
### Location
- **Facility**: Primary Healthcare Corporation, Doha, N/A, N/A, Qatar
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## A Clinical Pharmacological Study of Dose Halving of Dexamethasone in Pregnant Women With Preterm Labour With Preterm Birth at Greater Than or Equal to 34 Gestational Weeks (34GW+)
- **NCT ID**: NCT06350565
- **Study ID**: DEX20240104
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-04-30
- **Completion Date**: 2025-12-31
- **Lead Sponsor**: Peking University Third Hospital
### Study Description
This study plans to conduct a DEX dose halving study and a normal dose study in 34+0-35+6 GW women with preterm preterm labour. In addition, this study plans to conduct a DEX dose halving study and a normal dose study in 34-38+6 GW preterm pregnant women with GDM or diabetic co-pregnancy to explore the feasibility of dose halving in pregnant women with diabetes mellitus.
### Conditions
- Respiratory Distress Syndrome of Newborn
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- Dexamethasone
### Outcomes
**Primary Outcomes**
- Respiratory distress syndrome
- PK parameters (analysed in conjunction with population pharmacokinetic (PPK) modelling): area under the blood concentration curve, Cmax, Tmax, Kel, t1/2, CL, VZ
- Pharmacodynamics
- Measurability indicators
- Blood biochemistry findings in newborns
- DEX potential safety marker test
**Secondary Outcomes**
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
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## Prevalence of Postural Abnormalities in Dialysis Patients
- **NCT ID**: NCT06350552
- **Study ID**: PA224ES-1-03
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-04
- **Completion Date**: 2024-04
- **Lead Sponsor**: Pardis Specialized Wellness Institute
### Study Description
The goal of this observational study is to investigate and compare the prevalence of forward head , hyper kyphosis and balance in hemodialysis and peritoneal dialysis patients. The main questions it mains to answer are:What is the prevalence of forward head posture in hemodialysis and peritoneal dialysis patients? What is the prevalence of hyper kyphosis in hemodialysis and peritoneal dialysis patients? Is there any relation between postural abnormalities and physical function in hemodialysis and peritoneal dialysis patients?Participants will answer 2 questionnaires and will do some functional tests.
### Conditions
- End Stage Renal Disease
- Hemodialysis Complication
- Peritoneal Dialysis Complication
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
### Outcomes
**Primary Outcomes**
- Prevalence of thoracic hyper kyphosis
- Prevalence of forward head
**Secondary Outcomes**
- Balance level
- Cardiopulmonary function's level
- Fall risk level
### Location
- **Facility**: Khorshid Dialysis Center, Isfahan, N/A, N/A, Iran, Islamic Republic of
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## Personalized Models for Cancer Research
- **NCT ID**: NCT06350539
- **Study ID**: 10-007
- **Status**: RECRUITING
- **Start Date**: 2024-02-15
- **Completion Date**: 2034-02-15
- **Lead Sponsor**: New York Stem Cell Foundation Research Institute
### Study Description
The New York Stem Cell Foundation (NYSCF) Research Institute is performing this research to accelerate cancer research ranging from disease mechanisms to personalized medicine approaches that will help to realize the promise of precision medicine for oncology.
### Conditions
- Solid Tumor, Adult
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
- Biological Sample Collection
### Outcomes
**Primary Outcomes**
- Implement organoid culture technologies.
- Validate genotypic and phenotypic relevance of tumor-derived organoids for biobanking.
- Establish functional testing using organoid cultures alone or in combination with additional cell types.
- Perform drug testing and screens to identify new targets and/or new therapeutic strategies to effectively treat cancer.
- Develop a Laboratory Developed Test (LDT) for CLEP/FDA approval that will inform clinicians of each patient's tumor responses to FDA approved drugs.
- Develop stem cells from individual patient samples to study tumor evolution.
**Secondary Outcomes**
### Location
- **Facility**: New York Stem Cell Foundation Research Institute, New York, New York, 10019, United States
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## Radiological Characterization of Pulmonary Involvement in Patients With Hematological Diseases
- **NCT ID**: NCT06350526
- **Study ID**: PULMHEMA
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-05-01
- **Completion Date**: 2025-06-01
- **Lead Sponsor**: New Valley University
### Study Description
Hematologic malignancies are heterogeneous groups of neoplasia, with frequent pulmonary complications. These complications may be secondary to the patient's comorbidities, to the hemopathy itself, or its treatments. Divided into infectious and non-infectious complications, the etiologies are numerous and varied. This makes the diagnostic approach complex for the clinicians
### Conditions
- Hematologic Diseases
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
- Complete Blood Count
- C-reactive protein
- O2 saturation
- Serum ferritin and D-dimer
- Liver and renal function tests
- Lactate dehydrogenase
- coronavirus (SARS-CoV-2) swab
- CT chest
### Outcomes
**Primary Outcomes**
- Number of patients who had certain radiological patterns associated with pulmonary complications in patients diagnosed with various hematological diseases
**Secondary Outcomes**
- Number of patients who developed complications
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
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## The Effect of Animated Movies and Storybooks on Fear and Anxiety Levels in Children With Type 1 Diabetes
- **NCT ID**: NCT06350513
- **Study ID**: NecmettinE
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-03-25
- **Completion Date**: 2025-02-25
- **Lead Sponsor**: Selverhan Yurttutan
### Study Description
This study aims to evaluate the effects of animated films and story books on the fear and anxiety levels of children with newly diagnosed type 1 diabetes.
### Conditions
- Diabetes Mellitus, Type 1
- Child, Only
- Anxiety
- Fear
- Nurse
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: SUPPORTIVE_CARE
### Interventions
- Animation movie, story book
### Outcomes
**Primary Outcomes**
- State Anxiety Inventory for Children (STAI-C)
- State Anxiety Inventory for Children (STAI-C)
- State Anxiety Inventory for Children (STAI-C)
**Secondary Outcomes**
- Children's Fear Scale
- Children's Fear Scale
- Children's Fear Scale
### Location
- **Facility**: Semra Köse, Konya, Meram, N/A, Turkey
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## A Patient Navigation Program for Addressing Disparities in Breast Cancer Care
- **NCT ID**: NCT06350500
- **Study ID**: I-3858823
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-05-01
- **Completion Date**: 2026-01-01
- **Lead Sponsor**: Roswell Park Cancer Institute
### Study Description
This clinical trial evaluates a patient navigation program for addressing disparities in breast cancer care. The navigation program is designed to help improve patient knowledge about clinical and supportive care services, navigate to existing services, help manage barriers to care, and enhance patient skills related to management of cancer treatment. Offering a patient navigation program may increase health equity and improve social needs and quality of life over time for newly diagnosed breast cancer patients.
### Conditions
- Breast Carcinoma
- Breast Ductal Carcinoma in Situ
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: NA
- **Intervention Model**: SINGLE_GROUP
- **Primary Purpose**: HEALTH_SERVICES_RESEARCH
### Interventions
- Patient Navigation
- Questionnaire
### Outcomes
**Primary Outcomes**
- Enrollment rate
- Reasons for refusal
- Retention Rate
- Reasons for discontinuation
**Secondary Outcomes**
- European Organization for Research and Treatment of Cancer Quality of Life Scale (EORTC QLQ-C30)
- Social Determinates of health
- Barriers to care
- Use of supportive services
- Patient Satisfaction survey
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
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## The Efficacy of Enavogliflozin in Heart Failure With Preserved Ejection Fraction
- **NCT ID**: NCT06350487
- **Study ID**: SMC2024-01-089-003
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-05-01
- **Completion Date**: 2026-06-30
- **Lead Sponsor**: Samsung Medical Center
### Study Description
The aim of prospective, open label, single center, randomized controlled trial is to investigate the efficacy of enavogliflozin on exercise performance, diastolic dysfunction, and quality of life in patients with heart failure with preserved ejection fraction (HFpEF).
### Conditions
- Heart Failure, Preserved Ejection Fraction
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- SGLT2 inhibitor
### Outcomes
**Primary Outcomes**
- Change in peak oxygen consumption (VO2)
**Secondary Outcomes**
- Change in minute ventilation to carbon dioxide output ratio (VE/VCO2 slope)
- Change in Left atrial volume index (LAVI) before and after maximal exercise
- Change in Lateral Early diastolic transmitral filling velocity over early diastolic relaxation velocity at mitral annulus (E/e') before and after maximal exercise
- Change in Left ventricular mass index (LVMI) before and after maximal exercise
- Change in LV wall thickness before and after maximal exercise
- Change in LV global longitudinal strain before and after maximal exercise
- Change in LA strain before and after maximal exercise
- Change in right ventricular (RV) free wall strain before and after maximal exercise
- Change in health-related quality of life assessed by the Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CS)
- Change in N-Terminal pro-B-type Natriuretic Peptide (NT-proBNP) level
- Change in chronotropic response reserve assessed by change in heart rate from rest to peak exercise
- Change in serum iron
- Change in ferritin
- Change in total iron binding capacity
- Change in hemoglobin
- All-cause death
- Hospitalization for heart failure
### Location
- **Facility**: Samsung Medical Center, Seoul, N/A, 06351, Korea, Republic of
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## Impact of Discontinuing Dornase Alfa in People With CF on Highly Effective CFTR Modulator Therapy-A SIMPLIFY Sub-Study
- **NCT ID**: NCT06350474
- **Study ID**: SIMPLIFY-IP-19 Dnase
- **Status**: COMPLETED
- **Start Date**: 2020-08-25
- **Completion Date**: 2022-07-11
- **Lead Sponsor**: Nicole Hamblett
### Study Description
Despite the increasingly common use of cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapies in treating cystic fibrosis (CF), it is still largely unknown whether or not other chronic therapies can be safely stopped. This SIMPLIFY sub-study is being done to test whether or not it is safe to stop taking dornase alfa (Dnase) in those people that are also taking elexacaftor/tezacaftor/ivacaftor (ETI).ETI is a combination CFTR modulator therapy that was approved by the Food and Drug Administration for people with CF who have at least one F508del mutation. The three drugs that make up ETI work together to allow many more chloride ions to move into and out of the cells, improving the balance of salt and water in the lungs. These changes result in better clearance of mucus from the lungs and improvements in lung function.Dornase alfa (Dnase) also improves clearance of mucus from the lungs to support lung function and has been available to people with CF for many years. Dnase is considered to be relatively burdensome and it is not known whether Dnase can improve or maintain lung function above what is already gained through ETI use.The goal of this SIMPLIFY sub-study is to get information about whether or not it is safe to stop Dnase by testing if there is a change in lung function in participants with cystic fibrosis (CF) who are assigned to stop taking Dnase as compared to those who are assigned to keep taking Dnase while continuing to take ETI.This is a sub study of master protocol SIMPLIFY-IP-19, NCT04378153.The sub study investigating the impact of discontinuing and continuing hypertonic saline is registered under NCTXXXXXXX (will add once available).
### Conditions
- Cystic Fibrosis
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: OTHER
### Interventions
- Discontinuation of dornase alfa (Dnase)
- Continuation of dornase alfa (Dnase)
### Outcomes
**Primary Outcomes**
- Absolute Change in FEV1 % Predicted From Week 0 to Week 6
**Secondary Outcomes**
- Absolute Change in LCI 2.5 From Baseline to Week 6
- Absolute Change in Respiratory Symptoms, as Measured by the CF Respiratory Symptoms Diary-Chronic Respiratory Infection Symptom Severity Score (CRISS) From Week 0 to Week 6
- Absolute Change in Respiratory Symptoms, as Measured by CFQ-R Respiratory Domain From Week 0 to Week 6
- Absolute Change in FEV1 % Predicted From Week -2 to Week 0
- Absolute Change in FEV1 % Predicted From Week 0 to Week 2
- Number and Percent of Participants Initiating Acute Antibiotics From Week 0 to Week 6
- Number and Percent of Participants Hospitalized From Week 0 to Week 6
- Number and percent of participants Experiencing Pulmonary Exacerbations from Week 0 to Week 6
- Number and Percent of Participants Experiencing Adverse Events (AEs) From Week 0 to Week 6
- Rate of Adverse Events (AEs) From Week 0 to Week 6 Therapy Arms
- Number and Percent of Participants with Temporary or Permanent Changes From Assigned Therapy Regimen Due to Adverse Event From Week 0 to Week 6
### Location
- **Facility**: University of Alabama at Birmingham, Birmingham, Alabama, 35294, United States
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## Impact of Discontinuing Hypertonic Saline in People With CF on Highly Effective CFTR Modulators- A SIMPLIFY Sub-Study
- **NCT ID**: NCT06350461
- **Study ID**: SIMPLIFY-IP-19 HS
- **Status**: COMPLETED
- **Start Date**: 2020-08-25
- **Completion Date**: 2022-07-11
- **Lead Sponsor**: Nicole Hamblett
### Study Description
Despite the increasingly common use of cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapies in treating cystic fibrosis (CF), it is still largely unknown whether or not other chronic therapies can be safely stopped. This SIMPLIFY sub-study is being done to test whether or not it is safe to stop taking inhaled hypertonic saline in those people that are also taking elexacaftor/tezacaftor/ivacaftor (ETI).ETI is a combination CFTR modulator therapy that was approved by the Food and Drug Administration for people with CF who have at least one F508del mutation. The three drugs that make up ETI work together to allow many more chloride ions to move into and out of the cells, improving the balance of salt and water in the lungs. These changes result in better clearance of mucus from the lungs and improvements in lung function.Inhaled hypertonic saline (HS) also improves clearance of mucus from the lungs to support lung function and has been available to people with CF for many years. HS is considered to be relatively burdensome and it is not known whether HS can improve or maintain lung function above what is already gained through ETI use.The goal of this SIMPLIFY sub-study is to get information about whether or not it is safe to stop hypertonic saline by testing if there is a change in lung function in participants with cystic fibrosis (CF) who are assigned to stop taking HS as compared to those who are assigned to keep taking HS while continuing to take ETI.This is a sub study of master protocol SIMPLIFY-IP-19, NCT04378153.The sub study investigating the impact of discontinuing and continuing dornase alfa is registered under NCTXXXXXXX (will add once available).
### Conditions
- Cystic Fibrosis
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: OTHER
### Interventions
- Discontinuation of hypertonic saline (HS)
- Continuation of hypertonic saline (HS)
### Outcomes
**Primary Outcomes**
- Absolute Change in FEV1 % Predicted From Week 0 to Week 6
**Secondary Outcomes**
- Absolute Change in LCI 2.5 From Baseline to Week 6
- Absolute Change in Respiratory Symptoms, as Measured by the CF Respiratory Symptoms Diary-Chronic Respiratory Infection Symptom Severity Score (CRISS) From Week 0 to Week 6
- Absolute Change in Respiratory Symptoms, as Measured by CFQ-R Respiratory Domain From Week 0 to Week 6
- Absolute Change in FEV1 % Predicted From Week -2 to Week 0
- Absolute Change in FEV1 % Predicted From Week 0 to Week 2
- Number and Percent of Participants Initiating Acute Antibiotics From Week 0 to Week 6
- Number and Percent of Participants Hospitalized From Week 0 to Week 6
- Number and percent of participants Experiencing Pulmonary Exacerbations from Week 0 to Week 6
- Number and Percent of Participants Experiencing Adverse Events (AEs) From Week 0 to Week 6
- Rate of Adverse Events (AEs) From Week 0 to Week 6 Therapy Arms
- Number and Percent of Participants with Temporary or Permanent Changes From Assigned Therapy Regimen Due to Adverse Event From Week 0 to Week 6
### Location
- **Facility**: University of Alabama at Birmingham, Birmingham, Alabama, 35294, United States
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## Washed Microbiota Transplantation for Rhinitis
- **NCT ID**: NCT06350448
- **Study ID**: WMT-CN-RH
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-05-01
- **Completion Date**: 2029-08-01
- **Lead Sponsor**: The Second Hospital of Nanjing Medical University
### Study Description
The common symptoms of rhinitis include nasal itching, sneezing, anterior or posterior nasal leakage, and nasal congestion. Rhinitis can be classified as allergic rhinitis (AR) and non-allergic rhinitis (NAR) based on the presence of a specific allergen. Increasing evidence showed that gut microbiota can influence the development of AR. Although few studies have reported the association between NAR and gut microbiota, we found that washed microbiota transplantation (WMT) could improve nasal symptoms, whether it is AR or NAR. This clinical trial aims to evaluate the efficacy and safety of WMT for rhinitis.
### Conditions
- Rhinitis
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: NA
- **Intervention Model**: SINGLE_GROUP
- **Primary Purpose**: TREATMENT
### Interventions
- Washed Microbiota Transplantation
### Outcomes
**Primary Outcomes**
- Changes in the reflective total nasal symptom score (rTNSS)
**Secondary Outcomes**
- Changes in the combined symptoms and medication score (CSMS)
- Changes in the rhinoconjunctivitis quality of life questionnaire (RQLQ) score
- Changes in the single reflective nasal symptoms score
- Specific IgE
- Inflammatory factors
- Flow cytometric analysis of lymphocyte clusters
- The incidence of treatment-related adverse events (AE) assessed by CTCAE, Version 5.0
### Location
- **Facility**: Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, 210011, China
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## Effects of Prefabricated Foot Orthoses With and Without Metatarsal Pads on Central Metatarsalgia
- **NCT ID**: NCT06350435
- **Study ID**: CUHK 2023.569
- **Status**: ACTIVE_NOT_RECRUITING
- **Start Date**: 2023-12-18
- **Completion Date**: 2024-05-31
- **Lead Sponsor**: Chinese University of Hong Kong
### Study Description
Compare the effects of prefabricated foot orthoses with and without metatarsal pads on pain intensity in the 2nd to 4th metatarsophalangeal joints, foot and ankle functional abilities as well as the occurrence of plantar callosities among patients with central metatarsalgia.
### Conditions
- Metatarsalgia
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- Prefabricated foot orthoses (PFO) with metatarsal pads
- Prefabricated foot orthoses (PFO) without metatarsal pads
### Outcomes
**Primary Outcomes**
- Pain intensity at the 2nd to 4th metatarsophalangeal joints during walking in shoes on Visual Analogue Scale
**Secondary Outcomes**
- Foot and Ankle Outcome Score
- Size of callosities and corns on the plantar area of the 2nd to 4th metatarsophalangeal joints
### Location
- **Facility**: Pamela Youde Nethersole Eastern Hospital, Hong Kong, N/A, N/A, Hong Kong
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## Neuroimage Genome Study of Neuroplasticity Associated With Microgravity
- **NCT ID**: NCT06350422
- **Study ID**: Microgravity-ChinaPLAGH
- **Status**: ACTIVE_NOT_RECRUITING
- **Start Date**: 2022-01-01
- **Completion Date**: 2024-12-31
- **Lead Sponsor**: Chinese PLA General Hospital
### Study Description
This clinical trial investigates the neuroplasticity and cognitive status changes of the human brain in microgravity. To explore the relationship between cognitive status changes and brain functional activities, gray matter and white matter changes under microgravity exposure, screen and identify representative image markers, so as to provide decision-making information for the cognitive status changes of relevant personnel under microgravity environment.
### Conditions
- Microgravity
- Neuroplasticity
- MRI
- Repeatable Battery for the Assessment of Neuropsychological Status
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
- Head-Down tilt Bed Rest test
### Outcomes
**Primary Outcomes**
- Local brain functional activity
- Brain functional connectivity
- Brain structure - Morphology
- Brain fiber bundle and brain Diffusion index
- Brain blood flow
- Imaging indexes and clinical scale scores
**Secondary Outcomes**
### Location
- **Facility**: Chinese PLA General Hospital, Beijing, N/A, N/A, China
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## Adolescent Outcomes of Post-operative Opioid EXposure
- **NCT ID**: NCT06350409
- **Study ID**: CTN-0146
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-08-10
- **Completion Date**: 2026-10-10
- **Lead Sponsor**: Sharon Levy
### Study Description
The goal of this observational study is to examine the factors associated with the transition from medical exposure to opioids with "signposts" of future opioid use disorder among adolescent surgical patients. The main question aims to identify factors (moderators, mediators, and covariates) associated with risk factors for opioid use disorder (ROUD) in the 12 months following major surgery with opioid exposure among adolescents aged 12-17. Participants will be asked to complete electronic surveys pre- and post-operatively and approve the collection of peri-operative data from the Electronic Medical Record to assess correlations.
### Conditions
- Opioid Use Disorder
- Pain, Chronic
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
### Outcomes
**Primary Outcomes**
- Risk of opioid use disorder due to prolonged pain that develops within the first year after surgery.
- Risk of opioid use disorder due to prolonged opioid use that develops within the first year after surgery.
- Risk of opioid use disorder due to postoperative non-medical use of prescription opioids (NMUPO) that develops within the first year after surgery.
- Risk of opioid use disorder due to increased rate of change in substance use that develops within the first year after surgery.
- Risk of opioid use disorder due to post-surgical trauma that develops within the first year after surgery.
**Secondary Outcomes**
### Location
- **Facility**: Boston Childrens Hopsital - Division of Addiction Medicine, Boston, Massachusetts, 02115, United States
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## pBFS-guided rTMS Over DMPFC for Treatment-Resistant Depression
- **NCT ID**: NCT06350396
- **Study ID**: CPLTRDDM2024
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-04
- **Completion Date**: 2025-06-30
- **Lead Sponsor**: Changping Laboratory
### Study Description
This study is a multicenter, randomized, double-blind, placebo-controlled trial aimed at exploring the effectiveness and safety of rTMS intervention with DMPFC targets guided by pBFS in patients with treatment-resistant depression.
### Conditions
- Treatment Resistant Depression
- Major Depressive Disorder
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- active rTMS treatment
- sham rTMS treatment
### Outcomes
**Primary Outcomes**
- Change in Montgomery-Asberg Depression Rating Scale (MADRS) scores from baseline to Immediate Post-treatment
**Secondary Outcomes**
- Remission and response rates were estimated using Montgomery-Asberg Depression Rating Scale(MADRS)
- Remission and response rates were estimated using Hamilton Depression Rating Scale (HAMD-17)
- Changes in the MADRS from baseline to each visit
- Changes in the HAMD-17 from baseline to each visit
- cognitive change in Digit Symbol Substitution Test (DSST)
- cognitive change in continuous performance test (CPT)
- cognitive change in Trail-Making Test (TMT)
- cognitive change in Digit Span Test (DST)
### Location
- **Facility**: Hebei Mental Health Center, Hebei, Baoding, N/A, China
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## Adapting a Low-cost Intimate Partner Violence and Mental Health Response Intervention
- **NCT ID**: NCT06350383
- **Study ID**: K01TW011775
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-05-06
- **Completion Date**: 2025-01-06
- **Lead Sponsor**: Columbia University
### Study Description
The goal of this feasibility study (clinical trial) is to test a low-cost, combined, adapted intimate partner violence (IPV) and mental health intervention (Wings of Hope: WINGS + Problem Management Plus: PM+) that can be carried out by lay community health workers as a foundation for a potential low-cost essential services package for women experiencing IPV and related mental health challenges in informal settlements in Kenya. The main aims of the study are to (1) assess the safety, feasibility, and acceptability of WINGS+PM+ among women experiencing IPV in informal settlements in Kenya; (2) to test preliminary efficacy of program mediating outcomes in addition to the distal outcome (incidence/severity of IPV), while closely monitoring fidelity or process measures, including attendance/retention, adherence, quality of delivery, participant satisfaction, safety and quality improvement and adaptation modifications; and (3) generate data on distributions of study outcomes to calculate the power to detect a meaningful effect size in a future efficacy trial. Women experiencing IPV (n=260) will be recruited from the outpatient walk-in departments at the Kianda 42 Hospital in Kibera informal settlement (n=130) and Upendo Clinic in Mathare informal settlement (n=130). Consenting women will be screened for experiences of recent IPV (last 3 months). Subsequently 130 eligible IPV survivors from the Kianda 42 Hospital and 130 from the Upendo Clinic will be randomized to either receive the combined WINGS+PM+ intervention (n=65) or the PM+-only intervention (control/comparison arm) (n=65) at each clinic.
### Conditions
- Violence, Domestic
- Psychological Distress
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: SUPPORTIVE_CARE
### Interventions
- WINGS+PM+
- PM+-only
### Outcomes
**Primary Outcomes**
- World Health Organization (WHO) Violence Against Women (VAW) diagnostic instrument
**Secondary Outcomes**
- Receipt of violence services
- Domestic Violence Coping Self-efficacy Scale (DVCSE)
- Multidimensional Scale of Perceived Social Support (MSPSS)
- Safety Behavior Checklist
- Psychological distress (GHQ-12)
- Functioning (WHODAS 2.0)
- Short form of the Posttraumatic Stress Disorder Checklist (PCL-5)
- Personalized outcomes (PSYCHLOPS)
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
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## Short-term and Long-term Outcomes of Colorectal Cancer Treated With Natural Orifice Specimen Extraction Surgery : a National Registry-based Study
- **NCT ID**: NCT06350370
- **Study ID**: NCC3489
- **Status**: RECRUITING
- **Start Date**: 2019-01-01
- **Completion Date**: 2028-01-01
- **Lead Sponsor**: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
### Study Description
Natural orifice specimen extraction surgery (NOSES) has gained widespread recognition among scholars and has gradually been promoted and popularized around the world. However, the development of NOSES is still in the exploratory stage and there is a lack of strong evidence from evidence-based medicine to support its feasibility and safety, which has greatly affected its clinical application and development. Based on this, at the call of Professor Xishan Wang, the Chinese NOSES Alliance conducted a large retrospective clinical study involving multiple centers. By summarizing the NOSES cases of nearly 100 centers in China, the study aims to clarify the current status of NOSES surgery in China. Additionally, a comprehensive analysis and summary was conducted by combining the basic information of NOSES patients, perioperative data, postoperative pathological data, and follow-up information to further demonstrate the safety and feasibility of NOSES in the treatment of colorectal cancer. This study also provides more real and objective evidence-based medicine support for the promotion and development of NOSES surgery.
### Conditions
- Colorectal Cancer
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: NA
- **Intervention Model**: SINGLE_GROUP
- **Primary Purpose**: TREATMENT
### Interventions
- Natural orifice specimen extraction
### Outcomes
**Primary Outcomes**
- Rate of short-term complication
**Secondary Outcomes**
- Operative duration
- Intraoperative blood loss
- Time to first flatus after surgery
- Time to first stool after surgery
- Length of stay after surgery
- 3-year disease free survival
- 3-year overall survival
### Location
- **Facility**: Cancer Hospital Chinese Academy of Medical Sciences, Beijing, Beijing, 100021, China
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## Conventional Clipping Versus Punching Closure
- **NCT ID**: NCT06350357
- **Study ID**: 2024B014
- **Status**: RECRUITING
- **Start Date**: 2024-04-01
- **Completion Date**: 2025-12-31
- **Lead Sponsor**: Ningbo No. 1 Hospital
### Study Description
Endoscopic submucosal dissection (ESD) is an important minimally invasive treatment method for early digestive tract tumors, with a high cure rate, and it is widely used in clinical practice. And wound closure after ESD is a great challenge, which is closely related to postoperative perforation bleeding. Clip closure is one of the most commonly used closure methods. However, when the wound is large or when the wound is located more difficult to operate, conventional closure may lead to delayed perforation, and postoperative clips may be prone to early spontaneous shedding. The authors have recently reported a method that may be able to close larger and difficult wounds because the grooves can better fix the metal clips. The latest study suggests that this approach may be safe and effective, but the study has a small sample size and has no controls. Therefore, high-quality clinical study evidence related to punch closure is required in the strategy of defect closure after ESD, in order to better evaluate the feasibility and safety of this new endoscopic closure method.
### Conditions
- the Rate of Complete Closure
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- punching closure
- Conventional clipping
### Outcomes
**Primary Outcomes**
- Completely closed
**Secondary Outcomes**
- delayed hemorrhage
### Location
- **Facility**: Ningbo first hospital, Ningbo, Zhejiang, N/A, China
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## Smart Technology Facilitated Patient-centered Venous Thromboembolism Management
- **NCT ID**: NCT06350344
- **Study ID**: HZKY-PJ-2024-8-2
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-11-01
- **Completion Date**: 2027-10-31
- **Lead Sponsor**: Navy General Hospital, Beijing
### Study Description
Smart technologies, such as wearable devices, mobile technologies, and artificial intelligence, are being investigated for use in health management. These technologies have the potential to be applied in disease pre-warning, decision-making support, health education, and healthcare maintenance. They are expected to address the challenges in managing thrombosis, improve access to high-quality medical resources in various regions, and enhance the development of a network for thrombosis rescue and treatment prevention.The objective of this study is to observe the long-term effect of mobile venous thromboembolism application (mVTEA) based patient-centered management of venous thromboembolism (VTE) on thromboprophylaxis, and establish a foundation of evidence for managing patients with high-risk VTE.
### Conditions
- Venous Thromboembolism
- Digital Health
- Health Education
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: NA
- **Intervention Model**: SINGLE_GROUP
- **Primary Purpose**: PREVENTION
### Interventions
- mobile venous thromboembolism application (mVTEA)
### Outcomes
**Primary Outcomes**
- VTE-related composite event
**Secondary Outcomes**
- VTE-KAP questionnaire score
- Generic quality of life
- VTE events
- Major bleeding
- VTE-related hospitalization
- New-onset of atrial fibrillation or atrial flutter
- Death
### Location
- **Facility**: Sixth Medical Center of Chinese PLA General Hospital, Beijing, Beijing, 100048, China
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## Smart Technology Facilitated Patient-centered Venous Thromboembolism Management
- **NCT ID**: NCT06350331
- **Study ID**: HZKY-PJ-2024-8-1
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-05-01
- **Completion Date**: 2024-10-31
- **Lead Sponsor**: Navy General Hospital, Beijing
### Study Description
Smart technologies, such as wearable devices, mobile technologies, and artificial intelligence, are being investigated for use in health management. These technologies have the potential to be applied in disease pre-warning, decision-making support, health education, and healthcare maintenance. They are expected to address the challenges in managing thrombosis, improve access to high-quality medical resources in various regions, and enhance the development of a network for thrombosis rescue and treatment prevention.The objective of this study is to evaluate the impact of mobile venous thromboembolism application (mVTEA) based patient-centered management of venous thromboembolism (VTE) on patients' perceptions of thromboprophylaxis, in order to enhance clinical practice and establish a foundation of evidence for managing patients with VTE.
### Conditions
- Venous Thromboembolism
- Digital Health
- Health Education
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: PREVENTION
### Interventions
- mobile venous thromboembolism application (mVTEA)
### Outcomes
**Primary Outcomes**
- VTE-KAP questionnaire score
**Secondary Outcomes**
- Knowledge, attitude, and practice scores in the VTE-KAP questionnaire
- Generic quality of life
- VTE events
- Chronic thromboembolic pulmonary hypertension (CTEPH)
- Chronic thromboembolic pulmonary disease (CTEPD)
- Post-pulmonary embolism syndrome (PPES)
- Major bleeding
- VTE-related hospitalization
- VTE-related rehospitalization
- New-onset of atrial fibrillation or atrial flutter
- Death
### Location
- **Facility**: Sixth Medical Center of Chinese PLA General Hospital, Beijing, Beijing, 100048, China
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## Rituximab and Zanubrutinib in Patients With Indolent B-cell Lymphomas
- **NCT ID**: NCT06350318
- **Study ID**: MCC-22005
- **Status**: RECRUITING
- **Start Date**: 2024-03-13
- **Completion Date**: 2029-03
- **Lead Sponsor**: H. Lee Moffitt Cancer Center and Research Institute
### Study Description
The purpose of the study is to establish the safety and efficacy of zanubrutinib in combination with rituximab for people with untreated B-cell lymphomas (marginal zone lymphoma and follicular lymphomas).
### Conditions
- Follicular Lymphoma
- Marginal Zone Lymphoma
- B-Cell Lymphoma
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: NON_RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- Zanubrutinib
- Rituximab
### Outcomes
**Primary Outcomes**
- Overall Response Rate: Cohort A
- Overall Response Rate: Cohort B
**Secondary Outcomes**
- Efficacy of Zanubrutinib and Rituximab
- Safety and tolerability of combination Zanubrutinib and Rituximab
### Location
- **Facility**: Moffitt Cancer Center, Tampa, Florida, 33612, United States
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## Screening for High-risk Chronic Obstructive Pulmonary Disease
- **NCT ID**: NCT06350305
- **Study ID**: Screening for high-risk COPD
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-05-01
- **Completion Date**: 2027-10-31
- **Lead Sponsor**: Henan University of Traditional Chinese Medicine
### Study Description
This study is a multicenter cross-sectional study design aimed at screening risk factors for the combination of disease and syndrome in high-risk individuals with chronic obstructive pulmonary disease (COPD).
### Conditions
- High-risk COPD
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
- questionnaire survey
### Outcomes
**Primary Outcomes**
- COPD screening questionnaire from Terrassa (EGARPOC)
- COPD assessment in primary care to identify undiagnosed respiratory disease and exacerbation risk questionnaire (CAPTURE)
- COPD Assessment Test (CAT)
- COPD screening questionnaire (COPD-Q)
- chronic obstructive pulmonary disease diagnostic questionnaire (CDQ)
- modified chronic obstructive pulmonary disease diagnostic questionnaire (mCDQ)
- Simple screening questionnaire
- lung function questionnaire (LFQ)
- chronic obstructive pulmonary disease screening questionnaire (COPD-SQ)
- chronic obstructive pulmonary disease population screener questionnaire (COPD-PS)
- Chronic Obstructive Pulmonary Disease Risk Scale (COPDRS)
- Standardised Scale of Physical Fitness in Chinese Medicine
- Syndrome therapeutic evaluation scale of chronic obstructive pulmonary disease (COPD-STES)
**Secondary Outcomes**
### Location
- **Facility**: The First Affiliated Hospital of Henan University of Chinese Medicine, Zhengzhou, Henan, 450000, China
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## SLEEP-COPE: Sleep Intervention for Oppositional Children
- **NCT ID**: NCT06350292
- **Study ID**: 0161464
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-04-01
- **Completion Date**: 2025-02-01
- **Lead Sponsor**: University of South Florida
### Study Description
Children with Oppositional Defiant Disorder (ODD) are at risk for insomnia, arousal dysfunction, mood problems, and noncompliance. Cognitive behavioral treatment for insomnia (CBT-I) holds promise for improving insomnia and related concerns. Telehealth delivery will reduce the burden of in-person sessions, particularly in areas where there is low mental healthcare access. Telehealth CBT-I is efficacious in adults and children but has not been tested in children with ODD. The proposed trial is the next logical step - development and iterative testing of SLEEP-COPE, a brief dyadic telehealth CBT-I for children with ODD and their parents.
### Conditions
- Insomnia Chronic
- Oppositional Defiant Disorder
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: NA
- **Intervention Model**: SINGLE_GROUP
- **Primary Purpose**: TREATMENT
### Interventions
- SLEEP: COPE
### Outcomes
**Primary Outcomes**
- Child Daily Sleep Diaries
- Parent Daily Sleep Diaries
**Secondary Outcomes**
- Child Actigraphy
- Parent Actigraphy
- Child Salivary Cortisol
- Child Hair Cortisol
- The Revised Childhood Anxiety and Depression Scale
- PROMIS Child Sleep Disturbance
- Alabama Parenting Questionnaire
- Perceived Stress Scale
- Child Disruptive Behavior Disorders Checklist
- Beck Depression Inventory-II
- State-Trait Anxiety Inventory
- PROMIS Adult Sleep Disturbance
- Pediatric Sleep Questionnaire
- Epworth Sleepiness Scale
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
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## A Phase I Study to Assess the Safety,Tolerability, PK, PD, and Food Effect of HSK39297 in Healthy Subjects
- **NCT ID**: NCT06350279
- **Study ID**: HSK39297-101
- **Status**: RECRUITING
- **Start Date**: 2023-12-25
- **Completion Date**: 2024-07-31
- **Lead Sponsor**: Haisco Pharmaceutical Group Co., Ltd.
### Study Description
This is a Phase I, randomized, subject-blinded, placebo controlled study to assess the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD),and food effect (FE) of HSK39297 following (1) a single ascending dose (part 1), (2) 10 days of multiple ascending dose (part 2), and (3) a single dose two-period crossover FE cohort.
### Conditions
- Healthy
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: OTHER
### Interventions
- HSK39297
### Outcomes
**Primary Outcomes**
- The number and severity of treatment emergent adverse events (TEAEs) .
**Secondary Outcomes**
- AUC
- Cmax
- Tmax
- t1/2
- AP change
- Bb
### Location
- **Facility**: Beijing Tongren Hospital, Beijing, N/A, N/A, China
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## Informing Low-acuity Emergency Department Patients of Non-emergent Resources
- **NCT ID**: NCT06350266
- **Study ID**: 2024-0183
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-04-22
- **Completion Date**: 2024-12
- **Lead Sponsor**: Geisinger Clinic
### Study Description
The goal of this campaign is to reduce unnecessary ED visits/encourage patients with low acuity visits to follow up with an appropriate provider and/or to seek care outside of the ED in the future. In this campaign, patients will be assigned to receive or not receive outreach following ED discharge that is aligned with the goal. Outreach will occur via a text message, as well as information added to the patient's after visit summary, and will include one or more calls to action that make patients aware of other Geisinger resources and avenues through which they can seek care outside of the ED. These may include, but are not limited to, walk-in urgent care, virtual urgent care, PCP appointments, and/or other ways in which to contact Geisinger. We will measure whether ED use differs across patients in different outreach conditions. We will also examine whether patients followed through on the message-specific calls to action in the messages differently across conditions.
### Conditions
- Emergency Service, Hospital
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: HEALTH_SERVICES_RESEARCH
### Interventions
- Information about healthcare resources
### Outcomes
**Primary Outcomes**
- Return to ED
**Secondary Outcomes**
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
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## Comparison Of Measured To Predicted Resting Metabolism
- **NCT ID**: NCT06350253
- **Study ID**: 22-X-187
- **Status**: RECRUITING
- **Start Date**: 2023-03-14
- **Completion Date**: 2025-12-31
- **Lead Sponsor**: Ohio University
### Study Description
The purpose of this study is to compare RMR values from the BIA, predicted equations, and indirect calorimetry.
### Conditions
- Body Weight
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
- Metabolic cart
- MedGem
- BIA
### Outcomes
**Primary Outcomes**
- Resting metabolic rate
**Secondary Outcomes**
### Location
- **Facility**: Ohio University Exercise Physiology Lab, Athens, Ohio, 45701, United States
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## Effects of Textured Insoles and Exercise in Children With Joint Hypermobility
- **NCT ID**: NCT06350240
- **Study ID**: KUzunAkkaya
- **Status**: RECRUITING
- **Start Date**: 2023-11-01
- **Completion Date**: 2024-11-30
- **Lead Sponsor**: Gazi University
### Study Description
Joint hypermobility is the condition that the joints have a greater range of motion than normal and can be observed frequently in children. In children with joint hypermobility, motor problems, tactile and proprioceptive sensory disorders can be observed. It is very important to support children with joint hypermobility with intervention programs that are rich in both motor and sensory aspects. The aim of this project is to create an exercise protocol rich in tactile, proprioceptive senses for children with joint hypermobility and to examine the effects of using textured insoles in addition to exercise on tactile sense, balance, foot load distribution and quality of life in children.
### Conditions
- Child, Only
- Joint Laxity
- Exercise
- Textured Insoles
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- Exercise
- Exercise+texture insoles
### Outcomes
**Primary Outcomes**
- Tactile sense
- Foot load distribution
- Balance
**Secondary Outcomes**
- Foot posture
- Quality of life assessment
### Location
- **Facility**: Gazi University, Ankara, N/A, N/A, Turkey
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## Impact of Different Hemostasis Methods on Ovarian Function and Fertility During Laparoscopic Ovarian Cystectomy of Benign Ovarian Cyst
- **NCT ID**: NCT06350227
- **Study ID**: WestChinaSU
- **Status**: RECRUITING
- **Start Date**: 2024-01-04
- **Completion Date**: 2026-06
- **Lead Sponsor**: West China Second University Hospital
### Study Description
The purpose of this study is to compare the impact of different hemostasis methods during laparoscopic ovarian cystectomy on ovarian function and fertility in women with benign ovarian cysts.
### Conditions
- Ovarian Cyst Benign
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- the absorbable hemostat and suture
- electrocoagulation and suture
- suture
### Outcomes
**Primary Outcomes**
- Antral Follicle Count (AFC)
**Secondary Outcomes**
- Anti-Mullerian hormone (AMH)
### Location
- **Facility**: West China Second University Hospital, Sichuan University, Chengdu, Sichuan, N/A, China
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## Physical Activity and Nutrition in Cancer Survivors
- **NCT ID**: NCT06350214
- **Study ID**: #2005-06; #2011-17; #2018-01
- **Status**: COMPLETED
- **Start Date**: 2007-01-01
- **Completion Date**: 2018-12-31
- **Lead Sponsor**: West China Hospital
### Study Description
This study aims to investigate the independent and combined associations between physical activity and nutrition condition with mortality among cancer survivors.
### Conditions
- Cancer
- Nutrition, Healthy
- Physical Inactivity
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
- physical activity and nutrition assessment
### Outcomes
**Primary Outcomes**
- All-cause mortality
- Cause-specific mortality
**Secondary Outcomes**
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
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## Machine Learning-based Classification of Symptom Clusters and Online CBT
- **NCT ID**: NCT06350201
- **Study ID**: KY2024.0124.02
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-05-01
- **Completion Date**: 2024-12-01
- **Lead Sponsor**: Wuhan Mental Health Centre
### Study Description
To breakthrough the bottleneck identified, we will conduct a cross-sectional study to develop a symptom clustering model for depression and anxiety. A wide range of statistical methods as well as machine learning approaches were explored, and a cohesive hierarchical clustering algorithm will be used. After developing the model, a symptom-matched intervention program based on problem solving therapy will be formulated. We are supposed to examine whether its use for personalizing symptom-matched psychological treatment can lead to improved patient outcomes, compared with usual care. This project is expected to provide a new and precise method for the emotion management, which will provide a standardized intervention pathway combining screening with treatment for the management of depression symptom and anxiety symptom. A preciser intervention matched to individual symptoms may provide important insight in improving patient outcome as well as a standardized mood management pathway targeting to the early detection and intervention for community residents.
### Conditions
- Depression and Anxiety Symptom
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: SUPPORTIVE_CARE
### Interventions
- cognitive behavior therapy
- control group
### Outcomes
**Primary Outcomes**
- The Patient Health Questionnaire (PHQ-9)
**Secondary Outcomes**
- 7-tiem Generalized Anxiety Disorder Scale,GAD-.7
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
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## Efficacy of Kinesiotape on Treatment of Nonspecific Cardiac Chest Pain
- **NCT ID**: NCT06350188
- **Study ID**: ECM#2024-506
- **Status**: ACTIVE_NOT_RECRUITING
- **Start Date**: 2024-03-22
- **Completion Date**: 2024-07-22
- **Lead Sponsor**: Cairo University
### Study Description
purpose of the study To investigate the effect of Kinesio-tape on treatment of nonspecific cardiac chest pain
### Conditions
- Nonspecific Cardiac Chest Pain
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- experimental
- traditional
### Outcomes
**Primary Outcomes**
- PAIN USING VIISUSL ANALOGE SCALE
**Secondary Outcomes**
- PERSSURE PAIN THRESHOLD
### Location
- **Facility**: Huda Badr Abd Elhamed, Cairo, N/A, N/A, Egypt
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## Emergency Department Management of Tobacco Use Disorder
- **NCT ID**: NCT06350175
- **Study ID**: 2212697123
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-04
- **Completion Date**: 2025-06
- **Lead Sponsor**: West Virginia University
### Study Description
The objective of this study is to determine the effectiveness of ED initiated NRT on tobacco cessation point abstinence rates as reported by patients at 2 weeks and 1 month post randomization, and continued abstinence rates at 3 months compared to standard of care therapy.
### Conditions
- Tobacco Use Disorder
- Tobacco Use Cessation
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- Nicotine Replacement Therapy Agent
- West Virginia Quit Line
### Outcomes
**Primary Outcomes**
- Percentage of Continued Abstinence Rate (2 weeks)
- Percentage of Continued Abstinence Rate (1 month)
- Percentage of Continued Abstinence Rate (3 months)
- Patient Health Questionnaire 2 (Baseline)
- Patient Health Questionnaire 2 (3 months from baseline)
- Heaviness of Smoking Index (Baseline)
- Heaviness of Smoking Index (3 months from baseline)
- Richmond Test (Baseline)
- Richmond Test (3 months from baseline)
**Secondary Outcomes**
### Location
- **Facility**: West Virginia University, Morgantown, West Virginia, 26505, United States
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## Testing the Addition of Radiation Therapy to the Immune Therapy Treatment for ES-SCLC
- **NCT ID**: NCT06350162
- **Study ID**: ASTRUM-LC12
- **Status**: RECRUITING
- **Start Date**: 2023-10-18
- **Completion Date**: 2025-12-31
- **Lead Sponsor**: Zhejiang Cancer Hospital
### Study Description
This phase II trial compares the effect of adding radiation therapy to the usual maintenance therapy with Serplulimab versus Serplulimab alone in patients who have already received Serplulimab plus chemotherapy for the treatment of extensive stage small cell lung cancer .
### Conditions
- Extensive Stage Lung Small Cell Cancer
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- Serplulimab
- Chest Radiation
### Outcomes
**Primary Outcomes**
- 1-year Progression-free survival rate
**Secondary Outcomes**
- Progression-free survival (PFS)
- Overall survival (OS)
- Duration of response (DOR)
- Disease control rate (DCR)
### Location
- **Facility**: Zhejiang Cancer Hospital, Hangzhou, N/A, N/A, China
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## A Pilot and Feasibility Study to Evaluate High vs Low Glycemic Index Mixed Meal Tolerance Test in Adolescents and Young Adults With Cystic Fibrosis
- **NCT ID**: NCT06350149
- **Study ID**: STUDY00004637
- **Status**: RECRUITING
- **Start Date**: 2024-03-22
- **Completion Date**: 2025-09
- **Lead Sponsor**: Emory University
### Study Description
The goal of this study is to determine the extent to which excess dietary simple sugars serve as a secondary mediating factor in Cystic fibrosis-related diabetes (CFRD) development. The main questions it aims to answer are:* Whether conducting a randomized 2x2 factorial design that evaluates acute postprandial changes in glucose over 2 hours following ingestion of a mixed meal challenge that varies by glycemic index and consumption of a sugar-sweetened beverage is acceptable and feasible.* What are the preliminary changes in postprandial hyperglycemia, islet cell function, and incretin response to a high or low Glycemic Index mixed meal tolerance test (MMTT) with and without Sugar-Sweetened Beverages (SSB) in adolescents and young adults with CFParticipants will be randomized to a mixed diet and blood will be drawn before and after the mixed meal challenge.
### Conditions
- Cystic Fibrosis
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: FACTORIAL
- **Primary Purpose**: OTHER
### Interventions
- Sugar Sweetened Beverages (SSB)
- Hi GI
- Lo GI
### Outcomes
**Primary Outcomes**
- Recruitment Rate
- Refusal Rate
- Investigator Fidelity
- Participant Fidelity
- Acceptability
- Retention Rates
- Recruitment
**Secondary Outcomes**
- Change in plasma Cysteine (Cys)
- Change in plasma Cystine (CySS)
- Change in plasma Glutathione (GSH)
- Change in plasma Glutathione Disulfide (GSSG)
- Change in redox potentials (EhCys/ CySS and EhGSH/GSSG)
- Insulinogenic index
- Whole body insulin sensitivity index (WBISI-Matsuda)
- Disposition Index
- Change in plasma Eh Cys/CySS
- Change in incremental glucose AUC
- Changes in Plasma insulin
- Changes in Plasma C-peptide
- Changes in Plasma Glucagon
- Changes in Plasma Incretins: glucagon-like peptide-1 (GLP-1)
- Changes in Plasma Incretins: total glucose-dependent insulinotropic polypeptide (GIP)
### Location
- **Facility**: Center for Advanced Pediatrics: Emory Healthcare, Atlanta, Georgia, 30329, United States
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## The Effect of Self-Management Support Provided to Hypertension Patients Affected by the Earthquake Via Tele-Nursing on Patients' Treatment Compliance and Self-Care Management
- **NCT ID**: NCT06350136
- **Study ID**: 2024/05-37
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-06-01
- **Completion Date**: 2025-06-01
- **Lead Sponsor**: Firat University
### Study Description
This important research includes a randomized controlled trial evaluating the potential of self-management support provided via telenursing to earthquake-affected hypertension patients to improve patients' treatment adherence and overall self-care management. This study will be carried out at Fırat University Hospital and will cover a wide range of effects on health outcomes in individuals receiving hypertension treatment. The sample selected from hypertension patients, which constitute the population of the research, was based on predetermined power analysis criteria. It has been determined that at least 51 hypertension patients should be included in each of the intervention and control groups, and accordingly, a total of 150 hypertension patients will be included in the study.. The results obtained within this framework may provide guidance in the development and implementation of Turkey's health policies, and may also shed light on strategies for the management of other similar health problems. On the other hand, strengthening the digital health infrastructure and effective management of chronic diseases, which are among the health-related targets of the Development Plan, further emphasize the importance of this research. The success of the self-management model supported by tele-nursing can serve as an example in the integration of digital health technologies into Turkey's healthcare system and be an important step towards achieving strategic goals in this field.
### Conditions
- With Tele-Nursing
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: SUPPORTIVE_CARE
### Interventions
- With Tele-Nursing
### Outcomes
**Primary Outcomes**
- Hill-Bone Hypertension Treatment Compliance Scale
- Self-Care Management Scale in Chronic Diseases;
- Psychological Impact of Earthquake Scale:
- Earthquake Stress Coping Strategies Scale
**Secondary Outcomes**
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
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## Efficacy, Safety and Tolerability of Balcinrenone/Dapagliflozin Compared to Dapagliflozin in Adults With Chronic Kidney Disease.
- **NCT ID**: NCT06350123
- **Study ID**: D6405C00002
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-05-06
- **Completion Date**: 2026-01-13
- **Lead Sponsor**: AstraZeneca
### Study Description
The purpose of the study is to evaluate the efficacy, safety and tolerability of balcinrenone/dapagliflozin compared with dapagliflozin alone on patients with chronic kidney disease (CKD) and albuminuria. This study will evaluate the effect of the balcinrenone/dapagliflozin on urinary albumin-to-creatinine ratio (UACR), compared with dapagliflozin in patients with CKD. This is a dose-finding study aiming to identify an optimal dose of balcinrenone/dapagliflozin for a future Phase III study in patients with CKD.
### Conditions
- Chronic Kidney Disease
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- Balcinrenone/dapagliflozin 15 mg/10 mg and matching placebo for dapagliflozin 10 mg
- Balcinrenone/dapagliflozin 40 mg/10 mg and matching placebo for dapagliflozin 10 mg
- Dapagliflozin 10 mg and matching placebo for balcinrenone/dapa gliflozin
### Outcomes
**Primary Outcomes**
- Relative change in UACR from baseline to Week 12
**Secondary Outcomes**
### Location
- **Facility**: Research Site, San Carlos, California, 94070, United States
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## Fourth-gen CAR T Cells Targeting BCMA/CD19 for Refractory Systemic Lupus Erythematosus (SLE)
- **NCT ID**: NCT06350110
- **Study ID**: ESBI202492
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-11-10
- **Completion Date**: 2025-12-28
- **Lead Sponsor**: Essen Biotech
### Study Description
This study is a preliminary investigation, with a single-group design, not randomized and transparent, focusing on treatment. Its purpose is to identify the highest dose of BH002 injection (CD19-BCMA CAR-T cells) that patients suffering from resistant systemic lupus erythematosus can tolerate.
### Conditions
- Systemic Lupus Erythematosus
- Lupus Nephritis
- Autoimmune Diseases
- Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
- Granulomatous Polyangiitis
- Microscopic Polyangiitis
- Systemic Sclerosis
- Idiopathic Inflammatory Myopathies
- Sjogren's Syndrome
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: NA
- **Intervention Model**: SINGLE_GROUP
- **Primary Purpose**: TREATMENT
### Interventions
- CD19- BCMA CAR-T cells
### Outcomes
**Primary Outcomes**
- Incidence and severity of dose limiting toxicities (DLTs) following chemotherapy preparative regimen and infusion of CD19/BCMA chimeric antigen receptor (CAR) T cells
**Secondary Outcomes**
- Rate of successful manufacture and expansion of the CD19/BCMA chimeric antigen receptor (CAR) T cells
### Location
- **Facility**: District one hospital, Shanghai, N/A, N/A, China
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## Phase III, Open-label Study of First-line Osimertinib With or Without Datopotamab Deruxtecan for EGFRm Locally Advanced or Metastatic Non-small Cell Lung Cancer
- **NCT ID**: NCT06350097
- **Study ID**: D516NC00001
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-05-16
- **Completion Date**: 2032-05-25
- **Lead Sponsor**: AstraZeneca
### Study Description
The purpose of this study is to evaluate efficacy and safety of osimertinib (tablet) in combination with Datopotamab Deruxtecan (i.v. infusion) compared with osimertinib (tablet) monotherapy as a first-line therapy in participants with locally advanced or metastatic EGFRm (Ex19del and/or L858R) NSCLC.Study details include:1. The study duration will be event-driven, with an estimated duration of approximately 9 years.2. Participants may receive study treatment until disease progression, unacceptable toxicity, or other specific discontinuation criteria are met.3. The visit frequency will be every 3 weeks during the treatment period.Note: Participants on osimertinib treatment (osimertinib only arm or who have discontinued Datopotamab Deruxtecan while are still receiving osimertinib) are required to attend visits to perform assessments every 6 weeks from Cycle 7 until Cycle 17 and then visits every 12 weeks until disease progression, IP discontinuation or primary PFS DCO. Participants who are receiving osimertinib + Datopotamab Deruxtecan are still required to attend visit to perform assessment every 3 weeks (q3w) per SoA.
### Conditions
- Non-small Cell Lung Cancer
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- Osimertinib
- Datopotamab Deruxtecan
### Outcomes
**Primary Outcomes**
- To demonstrate the superiority of osimertinib in combination with Datopotamab Deruxtecan relative to osimertinib by assessment of PFS by BICR in all randomised participants.
**Secondary Outcomes**
- To demonstrate the superiority of osimertinib in combination with Datopotamab Deruxtecan relative to osimertinib by assessment of OS in all randomised participants.
- To demonstrate the effectiveness of osimertinib in combination with Datopotamab Deruxtecan relative to osimertinib by assessment of PFS on CNS metastases in participants with CNS metastases at baseline
- To demonstrate the effectiveness of osimertinib in combination with Datopotamab Deruxtecan relative to osimertinib by assessment of PFS by investigator in all randomised participants.
- To demonstrate the effectiveness of osimertinib in combination with Datopotamab Deruxtecan relative to osimertinib by assessment of ORR in all randomised participants with measurable disease at baseline.
- To demonstrate the effectiveness of osimertinib in combination with Datopotamab Deruxtecan relative to osimertinib by assessment of DoR in all randomised participants with measurable disease at baseline.
- To demonstrate the effectiveness of osimertinib in combination with Datopotamab Deruxtecan relative to osimertinib on the prevention of CNS metastases
- To demonstrate the effectiveness of osimertinib in combination with Datopotamab Deruxtecan relative to osimertinib by assessment of PFS2 in all randomised participants
- To assess the PK of osimertinib and Datopotamab Deruxtecan
- To investigate the immunogenicity of Datopotamab Deruxtecan
- To compare the local EGFR mutation test result used for patient selection with the retrospective central cobas® EGFR Mutation Test v2 results from baseline tumour samples
- To demonstrate the effectiveness of osimertinib in combination with Datopotamab Deruxtecan vs. osimertinib monotherapy based on the cobas® EGFR Mutation Test v2 plasma screening test result for Ex19del or L858R EGFR mutations
### Location
- **Facility**: Research Site, Clayton, N/A, 3168, Australia
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## Effect of Mother's Touch and Nurse's Therapeutic Touch on Pain Level and Crying Time During Heel Blood Collection
- **NCT ID**: NCT06350084
- **Study ID**: 2023/381
- **Status**: RECRUITING
- **Start Date**: 2023-09-04
- **Completion Date**: 2024-12-31
- **Lead Sponsor**: Burdur Mehmet Akif Ersoy University
### Study Description
This prospective study is planned as a randomized controlled study with the purpose of determining the effect of Mother's Touch and Nurse's Therapeutic Touch on pain levels and crying times by newborns during heel blood collection.
### Conditions
- Pain, Acute
- Newborn
- Crying
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: SUPPORTIVE_CARE
### Interventions
- Mother's Touch
- Nurse's Therapeutic Touch
### Outcomes
**Primary Outcomes**
- NIPS (Neonatal Infant Pain Scale)
**Secondary Outcomes**
- Crying times
- Processing time
### Location
- **Facility**: Burdur Bucak State Hospital, Burdur, Bucak, 15030, Turkey
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## Effect of Kangaroo Care and Swaddling Methods on Pain Level and Crying Time During Heel Blood Collection
- **NCT ID**: NCT06350071
- **Study ID**: 2023/06
- **Status**: RECRUITING
- **Start Date**: 2023-06-19
- **Completion Date**: 2024-12-31
- **Lead Sponsor**: Burdur Mehmet Akif Ersoy University
### Study Description
This prospective study is planned as a randomized controlled study with the purpose of determining the effect of kangaroo care and swaddling methods on pain levels and crying times by newborns during heel blood collection.
### Conditions
- Pain, Acute
- Newborns
- Crying
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: SUPPORTIVE_CARE
### Interventions
- Kangaroo Care
- Swaddling
### Outcomes
**Primary Outcomes**
- NIPS (Neonatal Infant Pain Scale)
**Secondary Outcomes**
- Crying times
- Processing time
### Location
- **Facility**: Burdur Bucak State Hospital, Burdur, Bucak, 15030, Turkey
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## Phase I Clinical Trial of Inactivated Rotavirus Vaccine in a Population Aged 6 Weeks-49 Years Old
- **NCT ID**: NCT06350058
- **Study ID**: 202012005
- **Status**: ACTIVE_NOT_RECRUITING
- **Start Date**: 2021-08-03
- **Completion Date**: 2024-10-31
- **Lead Sponsor**: Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
### Study Description
The research objective is to evaluate the safety and tolerability of the inactivated rotavirus vaccine and explore its preliminary immunogenicity.
### Conditions
- Healthy Volunteers
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: PREVENTION
### Interventions
- Inactivated rotavirus vaccine (low dose)
- Inactivated rotavirus vaccine (high dose)
- Placebo
### Outcomes
**Primary Outcomes**
- Incidence rate of AE
- Incidence rate of SAE
**Secondary Outcomes**
### Location
- **Facility**: Hebei Provincial Center for Disease Control and Prevention, Shijiangzhuang, Hebei, 050021, China
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## High Supracostal Versus Subcostal Puncture in Adult PCNL
- **NCT ID**: NCT06350045
- **Study ID**: supra 11th puncture PCNL
- **Status**: ACTIVE_NOT_RECRUITING
- **Start Date**: 2024-03-01
- **Completion Date**: 2028-04-01
- **Lead Sponsor**: Assiut University
### Study Description
as the supra eleventh puncture PCNL is not well investigated in the literature we will conduct that randomised trial in comparison to the subcostal one
### Conditions
- Urolithiasis
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- PCNL
### Outcomes
**Primary Outcomes**
- Rate of complications
- Stone free rate
**Secondary Outcomes**
- duration of Hospital stay.
- Operative time
### Location
- **Facility**: Assiut University Hospital, Assiut, N/A, 11751, Egypt
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## Investigational Trial to Evaluate Safety and Tolerability of Treprostinil in Children Diagnosed With PAH
- **NCT ID**: NCT06350032
- **Study ID**: TREPaed
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-05
- **Completion Date**: 2028-11
- **Lead Sponsor**: AOP Orphan Pharmaceuticals AG
### Study Description
The goal of this clinical trial is to evaluate safety and tolerability of preservative-free parenteral treprostinil in paediatric patients with PAH (PH Group 1) who are below 18 years of age. The main question it aims to answer is:• if preservative-free parenteral treprostinil is safe and tolerable in the treatment of paediatric PAH in patients who are either treatment-naïve or have been previously treated with commercially available parenteral treprostinil formulations.Participants will receive either subcutaneous (SC) or intravenous (IV) preservative-free treprostinil and will be observed for 5 months (20 weeks ± 1 week).
### Conditions
- Pulmonary Arterial Hypertension
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: NA
- **Intervention Model**: SINGLE_GROUP
- **Primary Purpose**: TREATMENT
### Interventions
- preservative-free parenteral treprostinil
### Outcomes
**Primary Outcomes**
- Frequency and seriousness of adverse events and adverse drug reactions
**Secondary Outcomes**
### Location
- **Facility**: Medizinische Universität Wien, Vienna, N/A, 1090, Austria
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## Vascular Effects of Penil revascularızatıon
- **NCT ID**: NCT06350019
- **Study ID**: 26379996/91
- **Status**: COMPLETED
- **Start Date**: 2013-01-01
- **Completion Date**: 2014-12-25
- **Lead Sponsor**: Ankara Yildirim Beyazıt University
### Study Description
Purpose: The aim of this study is to measure the effects of penile revascularization surgery performed in vascular origin erectile dysfunction (ED) on penile vascular hemodynamic and to determine the importance of vascular parameters in postoperative patient follow-up.Methods: A total of 35 participants who underwent penile revascularization surgery due to vascular ED were included in this study. In the preoperative period and at the 3rd postoperative month, penile color doppler ultrasonography (PCDU) was performed to evaluate cavernosal arteries, dorsal arteries, deep dorsal vein and inferior epigastric artery (IEA) separately. During this evaluation, peak systolic velocity (PSV), end diastolic velocity (EDV), and resistive index (RI) were measured. The International Index of Erectile Function questionnaire (IIEF) was applied to all patients in the preoperative period and at the 3rd postoperative month. The relationship between changes in (IIEF) questionnaire score and penile vascular hemodynamic changes in the postoperative period was evaluated.
### Conditions
- Erectile Dysfunction
- Erectile Dysfunction Due to Arterial Disease
- Erectile Dysfunction Due to Venous Disorder
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: NA
- **Intervention Model**: SINGLE_GROUP
- **Primary Purpose**: TREATMENT
### Interventions
- Penile revascularızation
### Outcomes
**Primary Outcomes**
- The importance of resistive index in evaluating the postoperative success of penile revascularization
**Secondary Outcomes**
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
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## SHR-A1904 Combinations in CLDN18.2-Positive Advanced Solid Tumor
- **NCT ID**: NCT06350006
- **Study ID**: SHR-A1904-301
- **Status**: RECRUITING
- **Start Date**: 2024-05-30
- **Completion Date**: 2028-12-30
- **Lead Sponsor**: Shanghai Hengrui Pharmaceutical Co., Ltd.
### Study Description
This study consists of two research phases:Phase Ib (includes dose escalation phase and efficacy extension phase): To explore the safety, tolerability and initial efficacy of SHR-A1904 in the treatment of CLDN18.2-positive advanced solid tumors, and to determine the recommended dose and recommended population for the Phase III combination study.Phase III: A randomized, double-blind, multicenter clinical study of SHR-1904 combined with chemotherapy and immunotherapy Versus chemotherapy combined with immunotherapy for CLDN18.2-positive advanced solid tumors.
### Conditions
- Cldn18.2-positive Advanced Solid Tumor
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: NON_RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- SHR-A1904; Adebrelimab
- SHR-A1904; CAPOX; Adebrelimab
### Outcomes
**Primary Outcomes**
- Incidence and severity of AE
- Dose Limiting Toxicity (DLT)
- Maximal Tolerable Dose (MTD)
- Phase III Recommended Dose (RP3D)
- Progression-free survival (PFS) assessed by blind Independent Center Review (BICR) based on RECIST 1.1 criteria
**Secondary Outcomes**
- SHR-A1904 toxin binding antibody
- SHR-A1904 Total antibody
- Immunogenicity indicators of SHR-A1904: drug resistant antibody (ADA) and neutralizing antibody (NAb)
- Expression level of CLDN18.2 in tumor tissues
- Overall survival (OS)
- Incidence and severity of AE
### Location
- **Facility**: Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, 510060, China
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## Digital Intervention for Depression and Anxiety in Adolescents
- **NCT ID**: NCT06349993
- **Study ID**: pd003
- **Status**: RECRUITING
- **Start Date**: 2024-04-17
- **Completion Date**: 2025-07-01
- **Lead Sponsor**: Adai Technology (Beijing) Co., Ltd.
### Study Description
The goal of this clinical trial is to evaluate the effectiveness of digital interventions in treating depression and anxiety in adolescents. The main question it aims to answer is: Can digital interventions effectively alleviate symptoms of depression and anxiety in adolescents? The trial will include a comparison group where researchers will compare the effects of the digital intervention to traditional health education methods to assess their relative efficacy.Participants will be asked to engage with the digital intervention platform for a period of two months.
### Conditions
- Depression
- Anxiety
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- Digital Intervention
- Health Education
### Outcomes
**Primary Outcomes**
- Hamilton Depression Rating Scale
- Hamilton Anxiety Rating Scale
**Secondary Outcomes**
- ADHD(attention deficit hyperactivity disorder) Rating Scale-IV
- PHQ-9 (Patient Health Questionnaire-9)
- GAD-7 (Generalized Anxiety Disorder-7)
### Location
- **Facility**: West China Hospital, Chengdu, Sichuang, N/A, China
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## A Study to Explore the Reasonable Dosage and Evaluate the Efficacy, Safety and Tolerability of HLX10 and HLX04 With or Without HLX53 in Untreated, Locally Advanced or Metastatic Hepatocellular Carcinoma Patients.
- **NCT ID**: NCT06349980
- **Study ID**: HLX53-HCC201
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-05-10
- **Completion Date**: 2027-02-10
- **Lead Sponsor**: Shanghai Henlius Biotech
### Study Description
The study is being conducted to to explore the reasonable dosage and evaluate the efficacy, safety and tolerability of Serplulimab Injection (HLX10, a Recombinant Anti-PD-1 Antibody) and HLX04 (a Biosimilar to Bevacizumab) With or Without HLX53 (an Anti-TIGIT Fc Fusion Protein) in Untreated, Locally Advanced or Metastatic Hepatocellular Carcinoma Patients.
### Conditions
- Carcinoma, Hepatocellular
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- HLX53 (1000mg)
- HLX53 (2000mg)
- HLX10
- HLX04
- Placebo
### Outcomes
**Primary Outcomes**
- ORR
- PFS
**Secondary Outcomes**
- ORR
- PFS
- OS
- Incidence and severity of adverse events (AEs)
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
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## Nab-paclitaxel Combined With Cadonilimab (AK104) for the Second-line Treatment of Advanced Gastric Cancer
- **NCT ID**: NCT06349967
- **Study ID**: WCH-2023-1592
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-04-30
- **Completion Date**: 2027-05-30
- **Lead Sponsor**: West China Hospital
### Study Description
Currently, standard treatment options for gastric cancer failed to first-line treatment include monotherapy with paclitaxel/irinotecan/docetaxel/albumin paclitaxel, or paclitaxel combined with ramucirumab. However, the efficacy of these regimens is still far from satisfactory. The aim of the study is to evaluate the efficacy and safety of nab-paclitaxel combined with cadonilimab for the second-line treatment of advanced gastric cancer.
### Conditions
- Gastric Cancer
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: NA
- **Intervention Model**: SINGLE_GROUP
- **Primary Purpose**: TREATMENT
### Interventions
- Nab-paclitaxel Combined With Cadonilimab (AK104)
### Outcomes
**Primary Outcomes**
- overall response rate (ORR)
**Secondary Outcomes**
- disease control rate (DCR)
- overall survival (OS)
- progression-free survival (PFS)
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
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## Effectiveness and Safety of Single-session Endoscopic Stone Extraction
- **NCT ID**: NCT06349954
- **Study ID**: BFHHZS20240064
- **Status**: RECRUITING
- **Start Date**: 2024-04-15
- **Completion Date**: 2024-12-01
- **Lead Sponsor**: Beijing Friendship Hospital
### Study Description
This is a prospective study, including approximately 64 patients with acute cholangitis accompanied with choledocholithiasis at Beijing Friendship Hospital. All patients will be randomly allocate into single-session or two-session endoscopic stone extraction. The investigators assessed the outcomes of single-session and two-session endoscopic stone extraction.
### Conditions
- Choledocholithiasis With Acute Cholangitis
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- single-session ERCP
- two-session ERCP
### Outcomes
**Primary Outcomes**
- Success rate of complete stone removal
- ERCP-related complication rate
**Secondary Outcomes**
- Length of stay
- Hospital expenses
### Location
- **Facility**: Beijing Friendship Hospital, Beijing, Beijing, 100050, China
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## Telemedicine in Rural Patients With Heart Failure
- **NCT ID**: NCT06349941
- **Study ID**: STU-2023-0745
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-07-01
- **Completion Date**: 2024-12-01
- **Lead Sponsor**: University of Texas Southwestern Medical Center
### Study Description
We propose a pilot trial examining the effectiveness of a mHealth-based home cardiac rehabilitation program using a telemedicine platform for the identification, recruitment, and retention of an underserved rural population with heart failure with reduced ejection fraction.(HFrEF). The goal of the pilot trial will be to demonstrate the feasibility of a telemedicine platform for the recruitment and retention of underserved rural patients in clinical trials. Participants will participate in a cardiac rehabilitation program delivered through a smartphone application called Movn. They will be monitored for 14 weeks.
### Conditions
- Heart Failure
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: NA
- **Intervention Model**: SINGLE_GROUP
- **Primary Purpose**: OTHER
### Interventions
- Movn app
### Outcomes
**Primary Outcomes**
- Physical activity levels
- Quality of life using KCCQ score
**Secondary Outcomes**
- Enrollment rate
- Loss to follow up
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
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## "The Show Must go on" : The Experience of Injuries Among Dancers: Fears, Thoughts, and Beliefs. A Qualitative Study
- **NCT ID**: NCT06349928
- **Study ID**: MASF_Dancers01
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-04-01
- **Completion Date**: 2025-04-01
- **Lead Sponsor**: University of Siena
### Study Description
This qualitative, cross-sectional study aims at describing the experience of Italian dancers with injury.Dancers face a high risk of sustaining one or more injuries during their career (87-94%), which may lead to physical, psychological, and socioeconomic consequences affecting dancer's lives and careers both short and long-term.Dancers report fearing injury and its consequences and believing in the existence of a stigma around injury and injured colleagues; many of them also try to self-manage pain and delay reporting injuries to healthcare professionals, possibly making its outcomes worse.This study will collect data from dancers via focus groups and individual interviews, investigating dancers' experiences, thoughts, and beliefs about injury. Records from the interviews will be transcribed ad verbatim and analyzed using the framework method to synthetize the data and highlight the most meaningful content.Understanding dancers' thoughts and behaviors regarding past or possible future injuries may be beneficial in improving treatment efficacy and designing adequate education and prevention strategies. It may also help raise awareness of dancers' complex and unique needs, and the importance of having accessible, specialized professionals around dance companies and schools.
### Conditions
- Injuries
- Dancing
- Injury;Sports
- Stress, Psychological
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
- Focus group or interview
### Outcomes
**Primary Outcomes**
- Experience and perception of injury amongst dancers
**Secondary Outcomes**
- Understanding of injury prevention and pain management amongst dancers
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
@@
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## A Pilot Evaluation of a Digital Peer Support Intervention for Suicidal Adolescents
- **NCT ID**: NCT06349915
- **Study ID**: 2023-15217
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-09
- **Completion Date**: 2026-04
- **Lead Sponsor**: Albert Einstein College of Medicine
### Study Description
Suicide risk has increased among youth in underserved communities, where access to mental healthcare is limited. To address this need, the investigator team plans to evaluate the preliminary efficacy of a brief, low-cost, culturally responsive digital intervention for ethnically diverse youth at risk for suicide in The Bronx, NY. In collaboration with community stakeholders, suicide recovery narratives, featuring adolescents' experiences related to recovery from suicidal thoughts will be developed. A smartphone ecological momentary assessment app will be used to evaluate whether a curriculum of these narratives provides anti-suicidal benefits to at-risk adolescents.
### Conditions
- Suicide
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: NA
- **Intervention Model**: SINGLE_GROUP
- **Primary Purpose**: PREVENTION
### Interventions
- Supporting Wellbeing with Everyday Experiences of Peers (SWEEP)
### Outcomes
**Primary Outcomes**
- Suicidal Thoughts
**Secondary Outcomes**
- Suicidal Urge Resistance
- Social Connectedness
- Optimism
- Social Support
- Intervention Acceptability
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
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## Re-link HCV in Substance-Use Telemedicine Program
- **NCT ID**: NCT06349902
- **Study ID**: Pro00077561
- **Status**: RECRUITING
- **Start Date**: 2024-03-12
- **Completion Date**: 2024-12-31
- **Lead Sponsor**: trueNorth Medical Centres
### Study Description
This is an observational, retrospective \& prospective cohort study. The retrospective element of the study is a chart review to identify people with diagnosed but untreated HCV and re-link them to care. The observational prospective cohort element of the study will examine the HCV linkage to care, treatment initiation, treatment completion \& cure rates of these HCV clients achieved through this chart review and re-linking approach.
### Conditions
- Hepatitis C
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
- Re-Link
### Outcomes
**Primary Outcomes**
- number of patients identified as having diagnosed but untreated HCV
- percentage of patients identified as having diagnosed but untreated HCV that are re-linked to HCV care
**Secondary Outcomes**
- treatment initiation rates
- treatment completion dates
- cure rates
### Location
- **Facility**: trueNorth Medical Centre, Toronto, Ontario, M5B 2A5, Canada
@@
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## Adebrelimab and Chemoradiotherapy in High-risk Locoregionally Advanced Nasopharyngeal Carcinoma
- **NCT ID**: NCT06349889
- **Study ID**: MA-NPC-II-004
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-05-01
- **Completion Date**: 2028-05-01
- **Lead Sponsor**: Sun Yat-sen University
### Study Description
This trial aims to study the role of Adebrelimab combined with induction chemotherapy plus concurrent chemoradiotherapy (IC+CCRT) for high-risk locoregionally advanced nasopharyngeal carcinoma(LANPC).
### Conditions
- Nasopharyngeal Carcinoma
- Nasopharyngeal Cancer
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: NA
- **Intervention Model**: SINGLE_GROUP
- **Primary Purpose**: TREATMENT
### Interventions
- Adebrelimab
### Outcomes
**Primary Outcomes**
- Failure-free survival (FFS)
**Secondary Outcomes**
- Overall survival (OS)
- Distant metastasis-free survival (DMFS)
- Locoregional recurrence-free survival (LRRFS)
- Adverse events (AEs) and serious adverse events (SAEs)
- Quality of life (QoL)
- Failure-free survival (FFS) within different subgroups
### Location
- **Facility**: Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, 510000, China
@@
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## Cholecystectomy in Patients With Silent Common Bile Duct Stones
- **NCT ID**: NCT06349876
- **Study ID**: SUEZ MED - IRB Approval NO: 6
- **Status**: COMPLETED
- **Start Date**: 2023-02-15
- **Completion Date**: 2024-01-15
- **Lead Sponsor**: Suez University
### Study Description
Aim of this study is to evaluate the efficacy of performing only cholecystectomy in patients with asymptomatic common bile duct stones without dealing with common bile duct stones
### Conditions
- Performing Cholecystectomy in Patients With Chronic Calcular Choleycystits
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
- laparoscopic cholecystectomy
### Outcomes
**Primary Outcomes**
- number of patients developed jaundice post cholecystectomy
**Secondary Outcomes**
### Location
- **Facility**: Qeft Teatching Hospital, Qinā, N/A, N/A, Egypt
@@
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## Dutch CHolEcystitis Snapshot Study
- **NCT ID**: NCT06349863
- **Study ID**: W23.225
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-04-01
- **Completion Date**: 2025-04-30
- **Lead Sponsor**: St. Antonius Hospital
### Study Description
Background: Cholecystitis is treated by in various types of hospitals by different specialists, and treatment strategy is influenced by logistical and medical reasons and personal preference. This may significantly impact hospital stay and other outcomes.Purpose: To determine the variation in treatment of cholecystitis in the Netherlands and its impact on outcome.Methods: Nation-wide cohort study of all patients diagnosed and treated for cholecystitis during a 6 month period. The primary outcome will be the proportion of patients with an acute cholecystitis in which the guideline is followed. This group will be compared to those in which the guideline is not followed, focussing on total hospital stay and complications. Secondary aims are to determine: factors related to guideline compliance; the best method of cystic duct closure; the best treatment strategy for a \>7-day existing cholecystitis; factors predictive for concomitant common bile duct stones; strategies following gallbladder drainage. Multivariable analysis and propensity score matching will be used when appropriate for the etiological study aims. The TRIPOD guideline for prediction modelling will be used for the predictive study aims. Hospitals will receive their own results, set out against the national average and best practices, thereafter subsequent changes in hospital practice will be recorded.Conclusion: This study will determine the variation in treatment of cholecystitis in the Netherlands and its impact on clinical outcome. Its results will serve as an important incentive to create optimal, uniform cholecystitis treatment in the Netherlands.
### Conditions
- Cholecystitis
- Cholecystitis; Gallstone
- Cholecystitis; Choledocholithiasis
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
### Outcomes
**Primary Outcomes**
- Total hospital stay
**Secondary Outcomes**
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
@@
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## Predictive Value of Serum Uric Acid to High Density Lipoprotein Cholesterol Ratio for Diabetic Kidney Injury in Type 2 Diabetes
- **NCT ID**: NCT06349850
- **Study ID**: Soh-Med-24-03-06MS
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-04
- **Completion Date**: 2024-09
- **Lead Sponsor**: Sohag University
### Study Description
An prospective observetional study to asses the predictive value of serum uric acid to high density lipoprotein cholesterol ratio for diabetic kidney injury in type 2 diabetes
### Conditions
- Diabetic Kidney Disease
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
- serum uric acid level to plasma HDL-c level ratio (UHR)
### Outcomes
**Primary Outcomes**
- Uric acid to HDL-c ratio (UHR)
**Secondary Outcomes**
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
@@
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## Safety and Tolerability of LDRT Plus Concurrent Partial SBRT and Tislelizumab in Patients With Bulky Tumors
- **NCT ID**: NCT06349837
- **Study ID**: ECLIPSE-02
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-04-15
- **Completion Date**: 2026-03-31
- **Lead Sponsor**: Sichuan University
### Study Description
This is a 3+3 dose escalation phase I study which aims to evaluate the safety and tolerability of low dose radiotherapy (LDRT) plus concurrent partial Stereotactic Ablative Radiotherapy (SBRT) and Tislelizumab in Patients with bulky tumors who have failed standard therapy. At least 9 participants will be enrolled in this study.
### Conditions
- Solid Tumor
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: NA
- **Intervention Model**: SINGLE_GROUP
- **Primary Purpose**: TREATMENT
### Interventions
- Tislelizumab
- Low Dose Radiotherapy
- Stereotactic Ablative Radiotherapy
### Outcomes
**Primary Outcomes**
- Dose Limiting Toxicities
**Secondary Outcomes**
- Objective Response Rate (ORR)
- Progression Free Survival (PFS)
- Overall Survival (OS)
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
@@
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## Dextrose, Steroid, PRP: Choosing the Right Injection for CRS Relief; a RCT
- **NCT ID**: NCT06349824
- **Study ID**: 004AEstb/EC/01/2022
- **Status**: COMPLETED
- **Start Date**: 2023-10-10
- **Completion Date**: 2024-03-30
- **Lead Sponsor**: Sheikh Zayed Medical College
### Study Description
USG guided injections to relieve carpal tunnel syndrome with dextrose water or steroid or PRP
### Conditions
- Carpal Tunnel Syndrome
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- injection Dextrose water
- USG machine
### Outcomes
**Primary Outcomes**
- VAS
**Secondary Outcomes**
### Location
- **Facility**: Sheikh Zayed Medical College, Rahim yar khan, Punjab, 64200, Pakistan
@@
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## A Study of BL-M05D1 in Patients With Locally Advanced or Metastatic Solid Tumors
- **NCT ID**: NCT06349811
- **Study ID**: BL-M05D1-101
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-05
- **Completion Date**: 2026-05
- **Lead Sponsor**: Sichuan Baili Pharmaceutical Co., Ltd.
### Study Description
This study is an open-label, multicenter, dose-escalation, and extended-enrollment nonrandomized phase I study to evaluate the safety, tolerability, pharmacokinetic characteristics, and preliminary efficacy of BL-M05D1 in patients with locally advanced or metastatic solid tumors.
### Conditions
- Locally Advanced or Metastatic Solid Tumors
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: NA
- **Intervention Model**: SINGLE_GROUP
- **Primary Purpose**: TREATMENT
### Interventions
- BL-M05D1
### Outcomes
**Primary Outcomes**
- Phase Ia: Dose limiting toxicity (DLT)
- Phase Ia: Maximum tolerated dose (MTD)
- Phase Ib: Recommended Phase II Dose (RP2D)
**Secondary Outcomes**
- Treatment-Emergent Adverse Event (TEAE)
- Cmax
- Tmax
- T1/2
- AUC0-t
- CL (Clearance)
- Ctrough
- ADA (anti-drug antibody)
- Phase Ib: Objective Response Rate (ORR)
- Phase Ib: Disease Control Rate (DCR)
- Phase Ib: Duration of Response (DOR)
### Location
- **Facility**: Beijing Cancer Hospital, Beijing, Beijing, N/A, China
@@
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## Early and Late Effects of Nefopam in Multimodal Analgesia After Total Hip Arthroplasty (NEFARTHRO)
- **NCT ID**: NCT06349798
- **Study ID**: DR200177
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-04
- **Completion Date**: 2027-04
- **Lead Sponsor**: University Hospital, Tours
### Study Description
NEFARTHRO is a multicentric randomized controlled trial comparing the effects of discontinuous infusions of nefopam (bolus) versus continuous infusion of intravenous nefopam (via an infusion pump) versus placebo on the opioid-request during the first 24 hours following a Total Hip arthroplasty, as part of multimodal analgesia including at least paracetamol and a Non-Steroidal Anti-Inflammatory Drug (NSAID).The primary endpoint is cumulative morphine consumption for the first postoperative 24 hours, expressed in mg of iv equivalent morphine, including titration in the Post Anesthesia Care Unit (PACU).Patients will be followed during 6 months.
### Conditions
- Total Hip Arthroplasty
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- Nefopam
- Nefopam
- NaCl 0.9%
### Outcomes
**Primary Outcomes**
- Cumulative morphine consumption from the end of surgery (Day 0 - Hour 0) to the first 24 hours after surgery, expressed in mg of intravenous morphine (including titration in the Post-Anesthesia care Unit PACU).
**Secondary Outcomes**
- Maximum self-assessed pain using the Numeric Rating Scale ranging from 0 (no pain) to 10 (maximum pain) at rest in the PACU, at rest and on walking between PACU discharge and Hour 24, at Hour 24, and at hospital discharge.
- Time to return to walking.
- Time to leave room.
- Time to climb stairs.
- Length of stay.
- Time to abandon canes/crutches.
- Opioid analgesic consumption between days 1 and 5 or at hospital discharge
- Chronic pain at 6 months (at rest and walking) using a standardized phone questionnaire.
- Neuropathic pain score (DN2)The DN2 is a simplified version of the DN4, with 7 items: burning, painful cold, electric shocks, tingling, pins and needles, numbness, itching (scored 0=absent, 1=present).
- Incidence of all serious AEs during patient follow-up and non-serious AEs.
- Incidence of patients with morphine side effects
- Financial impact of spreading the recommended strategy following the results of the clinical study, estimated per year and over a 5-year period, from the point of view of the French Health Insurance and from the hospital perspective.
### Location
- **Facility**: Anaesthesia - Intensive care, Angers, N/A, 49933, France
@@
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## Manual Hyperinflation and Physical Therapy Program on Lung Recruitment Mechanically Ventilated Pediatric Patients
- **NCT ID**: NCT06349785
- **Study ID**: P.T.REC/012/003858
- **Status**: COMPLETED
- **Start Date**: 2023-12-20
- **Completion Date**: 2024-03-29
- **Lead Sponsor**: New Ismailia National University
### Study Description
The purpose of this study is to investigate the immediate combined effects of Manual Hyperinflation and standard Physical therapy program on lung recruitment and secretion mass in mechanically ventilated pediatric patients aged between 10-15 years 'old
### Conditions
- Mechanical Ventilation Complication
- Physical Disability
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: SUPPORTIVE_CARE
### Interventions
- rehabilitation of mechanically ventilated patients
- supportive care
### Outcomes
**Primary Outcomes**
- change the respiratory functions
- change the respiratory mechanics
- change the bronchospasm
- change the amount of ventilation
**Secondary Outcomes**
- decreasing the amount of secretions
- weaning from mechanical ventilator
### Location
- **Facility**: College of Medicine, Ismailia, N/A, 41522, Egypt
@@
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## Zynrelef vs Exparel: The Battle of Postoperative Pain Control After Robotic Sleeve Gastrectomy
- **NCT ID**: NCT06349772
- **Study ID**: FY2024-203
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-04-01
- **Completion Date**: 2025-04-01
- **Lead Sponsor**: Texas Tech University Health Sciences Center
### Study Description
The purpose of this study is to evaluate the use of an injectable combination of bupivacaine and meloxicam (Zynrelef) vs injectable liposomal bupivacaine (Exparel), two extended local anesthesia strategies currently approved by FDA and on the market for post-surgical pain control. The investigators plan on randomizing study participants to either Exparel or Zynrelef at the closure site of robotic sleeve gastrectomy and assessing their pain control postoperatively both in the hospital and at home. The investigators will measure the outcome of two drugs, Zynrelief, and Exparel on postoperative pain score -using the NRS pin score up to 72 hours after surgery. The total opioid use will be recorded in forms that will be used to measure pain score and total opioid use and will be collected to the Excel sheet. The cost of the drug will be calculated for internal use for Hospital purpose only.
### Conditions
- Post Operative Pain
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- Zynrelef
- Exparel
### Outcomes
**Primary Outcomes**
- postoperative pain score
**Secondary Outcomes**
- Total postoperative opioid use
- Proportion of total rescue medication use
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
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