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## Safety and Efficacy of 0.75% Phentolamine Ophthalmic Solution in Subjects With Post-refractive Surgery Visual Disturbances
- **NCT ID**: NCT06349759
- **Study ID**: OPI-NYXDLD-302
- **Status**: RECRUITING
- **Start Date**: 2024-04-01
- **Completion Date**: 2025-11
- **Lead Sponsor**: Ocuphire Pharma, Inc.
### Study Description
Safety and efficacy of 0.75% Phentolamine Ophthalmic Solution to improve mesopic low contrast visual acuity in subjects with post-refractive surgery visual disturbances.
### Conditions
- Mesopic Vision
- Night Vision Loss
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- phentolamine ophthalmic solution 0.75%, a non-selective alpha-1 and alpha-2 adrenergic antagonist
- Placebo
### Outcomes
**Primary Outcomes**
- Percent of subjects with an increase of at least 15 ETDRS letters read (≥ 3 lines) in the study eye in mLCVA compared to Baseline (Day 1 pre-dose) at Day 15
**Secondary Outcomes**
### Location
- **Facility**: United States, California, Newport Beach, California, 92663, United States
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## Cervical Unilateral Antero-posterior Mobilization and Thoracic Central Postro-anterior Mobilization in Treatment of Shoulder Impingement Syndrome
- **NCT ID**: NCT06349746
- **Study ID**: collage of physical therapy
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-04-15
- **Completion Date**: 2024-06
- **Lead Sponsor**: Egyptian Chinese University
### Study Description
Shoulder impingement syndrome (SIS) is a complex, multi-factorial problem that is treated with a variety of different conservative options. The conservative option that has shown effectiveness is manual therapy of the cervical and thoracic spine
### Conditions
- Shoulder Impingement
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- therapeutic exercises
- mobilization exercise
### Outcomes
**Primary Outcomes**
- pain intensity
- shoulder flexion and abduction range of motion
- muscle strength
**Secondary Outcomes**
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
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## Effectiveness of Botulinum Toxin A in Preventing Scar Formation and Initial Exploration of "Optimal Concentration"
- **NCT ID**: NCT06349733
- **Study ID**: MR-37-23-008382
- **Status**: ACTIVE_NOT_RECRUITING
- **Start Date**: 2023-03-23
- **Completion Date**: 2024-04-10
- **Lead Sponsor**: Qilu Hospital of Shandong University
### Study Description
Each year, millions of burn, trauma, or surgical patients worldwide suffer from scarring that severely affects their quality of life and social functioning. In order to prevent and treat diseases related to abnormal scar hyperplasia, clinicians and researchers have adopted various methods, such as scar grinding, surgical resection, drug injection in scar tissue, cryotherapy, laser and so on. However, these methods can not effectively inhibit the abnormal proliferation of scars and improve the adverse effects of existing scars on patients. To date, there is no accepted gold standard for the effective treatment and improvement of abnormal scar tissue.
### Conditions
- Scar
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: PREVENTION
### Interventions
- Botulinum toxin type A
### Outcomes
**Primary Outcomes**
- The modified Stony Brook Scar Evaluation Scale
**Secondary Outcomes**
- Patient satisfaction
### Location
- **Facility**: Qilu Hospital of Shandong University Dezhou Hospital, Dezhou, Shandong, 253000, China
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## Investigating Long-term Health Effects and Complications in COVID-19 Recoveries
- **NCT ID**: NCT06349720
- **Study ID**: KF-2023-355
- **Status**: RECRUITING
- **Start Date**: 2023-06-07
- **Completion Date**: 2024-06-07
- **Lead Sponsor**: Zhaohui Tong
### Study Description
Clarify the incidence of functional impairments in cured COVID-19 patients and identify influencing factors. Build a multi-omics database for COVID-19 patients in the recovery period to elucidate the biological biomarkers and targets associated with functional impairments. Comprehensive exploration of the long-term prognosis, complications, sequelae, and risk factors of COVID-19 patients after Omicron infection, as well as their immune characteristics. Compare the impact of different strains of the COVID-19 virus on prognosis and immune response. Develop comprehensive rehabilitation intervention strategies for COVID-19 patients with functional impairments and evaluate the impact of different intervention methods on their prognosis. Based on clinical data, multi-omics data, and precise rehabilitation assessment data, construct predictive models for prognosis and rehabilitation effectiveness in COVID-19, providing scientific evidence for the implementation of effective COVID-19 rehabilitation measures.
### Conditions
- COVID-19 Patients
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
- respiratory rehabilitation
### Outcomes
**Primary Outcomes**
- Immunological characteristics associated with functional impairments in COVID-19 convalescent patients
- Changes in laboratory examination indicators
- High-resolution CT of the chest
- Pulmonary function test
- Multi-omics changes and characteristics associated with functional impairments in COVID-19 convalescent patients
- Inflammatory factors related to body dysfunction in COVID-19 rehabilitation patients
- Regular rehabilitation assessment following respiratory rehabilitation intervention in COVID-19 patients
**Secondary Outcomes**
### Location
- **Facility**: Beijing Institute of Respiratory Medicine, Beijing, Beijing, 100027, China
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## Multiplex PCR for Severe Respiratory Infections During the COVID-19 Pandemic
- **NCT ID**: NCT06349707
- **Study ID**: 2023PI112
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-04
- **Completion Date**: 2024-06
- **Lead Sponsor**: Central Hospital, Nancy, France
### Study Description
The hypothesis was that a retrospective investigation of the molecular virological tests in a University hospital could be informative, with the aim to identify non-COVID-19 respiratory viruses during the circulation of SARS-CoV-2, according to systematic population data for public health knowledge.
### Conditions
- Viral Pneumonia
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
- other: Observational
### Outcomes
**Primary Outcomes**
- Occurrence of positive viral PCR assays (not COVID-19) from hospitalizations for respiratory infections.
**Secondary Outcomes**
- Real-life features of patients in Intensive care (from the whole population - Outcome 1) with positive viral PCR during infectious pneumonia.
### Location
- **Facility**: Schvoerer, Vandoeuvre Les Nancy, N/A, 54511, France
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## Comparison of the Efficacy of Transcutaneos Nerve Stimulations in Women With Idiopathic Overactive Bladder
- **NCT ID**: NCT06349694
- **Study ID**: PamukkaleU.ftr-NYıldız-001
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-04-22
- **Completion Date**: 2025-02-28
- **Lead Sponsor**: Pamukkale University
### Study Description
Our study is the first prospective randomized controlled trial that compares the effectiveness of transcutaneous medial plantar nerve stimulation (T-MPNS) and transcutaneous tibial nerve stimulation (TTNS) added to bladder training (BT) in women with idiopathic overactive bladder (OAB). İn this study, we aimed to assess the efficacy of T-MPNS and TTNS added to BT on quality of life (QoL) and clinical parameters asssociated with idiopathic OAB. In addition, preparation time for stimulation, treatment satisfaction and discomfort levels of the patients were evaluated.The main questions we aim to answer are:Is T-MPNS as effective as TTNS in the treatment of idiopathic OAB? For this purpose, we planned to compare transcutaneous applications of the tibial and plantar medial nerve in women with idiopathic OAB. 60 women with OAB will be randomized to 3 groups by using random number generator: BT program alone to Group 1 (n=20), BT plus T-MPNS to Group 2 (n=20), BT plus TTNS to Group 3 (n=20) will be applied.
### Conditions
- Urinary Bladder, Overactive
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: OTHER
### Interventions
- Transcutaneous MPN stimulation (T-MPNS)
- Transcutaneous tibial nerve stimulation (TTNS)
- BT (Control group)
### Outcomes
**Primary Outcomes**
- Improvement in incontinence episodes (positive response rate)
**Secondary Outcomes**
- The severity of incontinence
- Symptom severity
- Frequency of voiding, nocturia, number of pads
- Quality of life (IIQ7)
- The Hospital Anxiety and Depression Scale (HAD)
- FSFI
- Cure-improvement rates
- Treatment satisfaction
### Location
- **Facility**: Pamukkale University, Denizli, N/A, N/A, Turkey
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## Describe Relations Between qCON and qNOX Indicies During Propofol-Remifentanil General Anesthesia
- **NCT ID**: NCT06349681
- **Study ID**: CONOXBird
- **Status**: RECRUITING
- **Start Date**: 2024-04-01
- **Completion Date**: 2024-10-01
- **Lead Sponsor**: University of Padova
### Study Description
CONOX is a neuromonitoring EEG- device for sedation (qCON) and analgesia (qNOX) monitoring during general anesthesia.It is unknown on how the indicies can differentiate themselves so aim of this study is to determine the relationship bewtween the 2 indicies.
### Conditions
- Anesthesia Brain Monitoring
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
### Outcomes
**Primary Outcomes**
- Correlation between qCON and qNOX
**Secondary Outcomes**
- Correlation between qCON and concentrations of Propofol(CeP)
- Correlation between qNOX and concentrations of Remifentanil (CeR)
### Location
- **Facility**: Treviso Regional Hospital, Treviso, TV, 31100, Italy
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## Spinal Morphine or Intravenous Lidocaine in Robot-assisted Upper Urologic Surgery
- **NCT ID**: NCT06349668
- **Study ID**: 2023-505941-21-00
- **Status**: RECRUITING
- **Start Date**: 2024-04-09
- **Completion Date**: 2026-12-01
- **Lead Sponsor**: Hans Bahlmann
### Study Description
The goal of this clinical trial is to learn whether the addition of spinal analgesia leads to superior recovery in patients undergoing robotic-assisted laparoscopic upper urinary tract surgery under general anesthesia. The main questions it aims to answer are:* Is the decrease in wellbeing as quantified by the patient-centered outcome scale "Quality of Recovery 15" (QoR-15), from baseline to the first day after surgery (POD 1), at least 8.0 points less in patients receiving spinal analgesia in addition to general anesthesia?* Does spinal analgesia result in improved recovery as quantified by QoR-15 at POD 7, the incidence of postoperative pain at rest and at mobilization, nausea and vomiting, the need for opioid analgesics, time out-of-bed, length of stay and the incidence of complications?* Does spinal analgesia increase workload in the OR, as quantified by time from arrival in the OR to start of surgery?* Does spinal analgesia result in an increased incidence of hypotension and cardiac dysfunction during surgery, as well as an increased incidence of pruritus after surgery?Participants will be randomized to receive either spinal analgesia with bupivacaine and morphine preoperatively or an intravenous infusion with lidocaine intraoperatively.QoR-15 and other markers of recovery will be registered using structured interviews preoperatively, at POD1 and POD7. In addition, patients will record pain at rest and at mobilization three times daily in a diary.In a subgroup of patients advanced hemodynamic parameters will be recorded using pulse-contour analysis before, during and after surgery. Blood samples will also be collected in these patients at fixed intervals and analyzed for amongst others inflammation and cardiac dysfunction.
### Conditions
- Other Specified Disorders of Kidney and Ureter
- Benign Neoplasm of Ureter
- Calculus of Kidney and Ureter
- Ureter Cancer
- Ureteric Reflux
- Congenital Ureteric Anomaly
- Benign Renal Neoplasm
- Renal Cancer
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- spinal analgesia with morphine and bupivacaine
- lidocaine infusion
### Outcomes
**Primary Outcomes**
- QoR-15 score at postoperative day 1
**Secondary Outcomes**
- QoR-15 score preoperatively
- QoR-15 score at postoperative day 7
- Pain (NRS) in rest and during motion 2hrs after arrival to the PACU
- Pain (NRS) on POD 1-3
- Pain (NRS) in rest and during motion at POD 7
- Time from arrival in the OR to start of surgery
- Time from end of surgery until leaving the OR
- Incidence of unplanned termination of the lidocaine infusion
- Amount of remifentanil in patients given remifentanil
- Amount of intraoperative opioids in patients not receiving remifentanil
- Length of stay at the PACU
- Amount of opioids administred at the PACU
- Percentage of patients with PONV requiring treatment at 0-6 hours and 6-24 hours postoperatively as well as during the whole postoperative stay
- "Time out-of-bed" on POD 1-3
- Amount of opioids administered during the first 24 hours at the ward
- First POD passing gases
- First POD passing stool
- Incidence of pruritus
- Length of stay
- DAOH30
- Postoperative complications untill POD 30
- Requirement for opioids after discharge
- Incidence of respiratory depression leading to the use of a mu-antagonist within 48 hours of induction of anesthesia
- Intraoperative fluid balance
- Time with low blood pressure during anesthesia
- Lowest MAP within 10 minutes after induction of anesthesia
- Highest MAP within 10 minutes of abdominal insufflation
- Fraction of patients needing norepinephrine before start of surgery
- Fraction of patients needing norepinephrine intraoperatively (later than 15 minutes after start of surgery)
- Average infusion rate of norepinephrine, in patients receiving norepinephrine, before start of surgery
- Average infusion rate of norepinephrine, in patients receiving norepinephrine, after start of surgery
- Intraoperative Cardiac Index
- Intraoperative Stroke Volume Index
- Intraoperative Cardiac Power Index
- Intraoperative dPmx
- Intraoperative Pulse Pressure Variation
- Intraoperative Stroke Volume Variation
- Intraoperative Systemic Vascular Resistance Index
- Intraoperative heart rate
- Biochemical markers of inflammation
### Location
- **Facility**: University Hospital Linköping, Linköping, N/A, N/A, Sweden
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## The Real-world Clinical Study of Azvudine Tablets in the Treatment of COVID-19
- **NCT ID**: NCT06349655
- **Study ID**: 2023-KY-0865-001
- **Status**: COMPLETED
- **Start Date**: 2023-12-05
- **Completion Date**: 2024-03-10
- **Lead Sponsor**: The First Affiliated Hospital of Zhengzhou University
### Study Description
To establish a real-world clinical cohort and database of Azvudine in the treatment of SARS-CoV-2 infection, and to provide stable and reliable evidence for the clinical efficacy and safety evaluation of azvudine in the treatment of SARS-CoV-2 infection.
### Conditions
- COVID-19
- Azvudine
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
- Azvudine
- Paxlovid
### Outcomes
**Primary Outcomes**
- All-cause death
**Secondary Outcomes**
- Composite disease progression
### Location
- **Facility**: The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, 450052, China
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## Predicting Response to Immune Checkpoint Inhibitors Across Solid Tumors Using a Live Tumor Diagnostic Platform
- **NCT ID**: NCT06349642
- **Study ID**: MC230901
- **Status**: RECRUITING
- **Start Date**: 2024-04-24
- **Completion Date**: 2027-05
- **Lead Sponsor**: Mayo Clinic
### Study Description
The primary purpose of this study is to determine the sensitivity of CYBRID Score for predicting in-vivo clinical response based on surgical response or RECIST 1.1 for neoadjuvant and locally advanced/metastatic patients, respectively. The secondary purposes is to determine the sensitivity of the CYBRID Score for predicting in-vivo clinical response based on surgical response or RECIST 1.1 for neoadjuvant and locally advanced/metastatic patients, respectively.
### Conditions
- Early Stage Triple-Negative Breast Carcinoma
- Locally Advanced Bladder Urothelial Carcinoma
- Locally Advanced Cervical Carcinoma
- Locally Advanced Clear Cell Renal Cell Carcinoma
- Locally Advanced Colorectal Carcinoma
- Locally Advanced Endometrial Carcinoma
- Locally Advanced Esophageal Carcinoma
- Locally Advanced Liver Carcinoma
- Locally Advanced Lung Non-Small Cell Carcinoma
- Locally Advanced Malignant Skin Neoplasm
- Locally Advanced Triple-Negative Breast Carcinoma
- Metastatic Bladder Urothelial Carcinoma
- Metastatic Cervical Carcinoma
- Metastatic Clear Cell Renal Cell Carcinoma
- Metastatic Colorectal Carcinoma
- Metastatic Endometrial Carcinoma
- Metastatic Esophageal Carcinoma
- Metastatic Liver Carcinoma
- Metastatic Lung Non-Small Cell Carcinoma
- Metastatic Malignant Skin Neoplasm
- Metastatic Malignant Solid Neoplasm
- Metastatic Triple-Negative Breast Carcinoma
- Resectable Bladder Urothelial Carcinoma
- Resectable Colorectal Carcinoma
- Resectable Lung Non-Small Cell Carcinoma
- Resectable Malignant Liver Neoplasm
- Resectable Skin Carcinoma
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
- Biospecimen Collection
- Tissue Collection
### Outcomes
**Primary Outcomes**
- Accuracy of cytoplasmic hybrid (Cybrid) Score for predicting in-vivo clinical response
**Secondary Outcomes**
### Location
- **Facility**: Mayo Clinic in Florida, Jacksonville, Florida, 32224, United States
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## The Clinical Study of 3D-printed Magnesium Alloy Prosthesis With Controllable Degradation Rate in the Repair of Periarticular Bone Defects
- **NCT ID**: NCT06349629
- **Study ID**: 20240401
- **Status**: RECRUITING
- **Start Date**: 2023-01-01
- **Completion Date**: 2027-01-01
- **Lead Sponsor**: Peking University Third Hospital
### Study Description
Perimarticular fracture bone defect is a common and complicated clinical disease. The current treatment for this type of injury is anatomical reduction of the fracture, where the bone defect is filled with artificial, autologous or allogeneic bone in granular form, and then fixed with plates and screws. However, these bone filler materials exist in a loose accumulation state and cannot form an effective overall support force for the joint. The applicant realized three dimensional (3D) printing of WE43 magnesium alloy with personalized design and porous overall structure, and developed high-temperature heat treatment technology to slow its degradation, which effectively realized the dual stability of degradation rate of magnesium alloy support body and overall structure during the bone repair period. This project will optimize the design of 3D printed WE43 magnesium alloy full-structure in-bone support, and establish a metamaterial pore structure design platform that regulates the physical properties and degradation behavior of porous implants. Fracture from proximal humerus, distal radius and tibial plateau
### Conditions
- Degradation of Magnesium Alloy Prosthesis and New Bone Regeneration
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: NON_RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- 3D printed WE43 magnesium alloy
### Outcomes
**Primary Outcomes**
- Detection of Magnesium alloy metabolism
- Degradation of 3D printed magnesium alloy prosthesis
- New bone regeneration
- Evaluation of shoulder joint function
- Evaluation of wrist joint function
- Evaluation of knee joint function
**Secondary Outcomes**
### Location
- **Facility**: Peking University Third Hospital, Beijing, Haidian, N/A, China
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## Cooling Strategies for Older Adults in the Heat
- **NCT ID**: NCT06349616
- **Study ID**: STUDY24458
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-04
- **Completion Date**: 2026-12
- **Lead Sponsor**: Penn State University
### Study Description
The earth's climate is warming, and the number of heat waves has increased in recent years. At the same time, the number of adults over the age of 65 is growing. Humans sweat and increase blood flow to the skin to cool their body when they get hot. Older adults do not do this as well as young adults. This makes it harder to safely be in warm and/or humid conditions. It is important to learn about cooling strategies for older adults to safely be in warm and/or humid conditions.There is compelling evidence that intermittent hand and forearm cold-water immersion effectively reduces the rise of core temperature during heat stress in older adults. However, it is still unknown if this is an effective cooling strategy for older adults. Furthermore, our laboratory has shown that folic acid supplementation improves blood flow responses in older adults. This may be beneficial to older adults during heat stress.
### Conditions
- Aging
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: CROSSOVER
- **Primary Purpose**: BASIC_SCIENCE
### Interventions
- Intermittent cold-water hand and forearm immersion
- No intermittent cold-water hand and forearm immersion
### Outcomes
**Primary Outcomes**
- Core temperature
- Heart rate
- Blood Pressure
**Secondary Outcomes**
- Body Mass
- Skin Temperature
### Location
- **Facility**: Noll Laboratory, University Park, Pennsylvania, 16802, United States
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## Physiotherapy Approach for Susac Syndrome
- **NCT ID**: NCT06349603
- **Study ID**: S2023
- **Status**: COMPLETED
- **Start Date**: 2023-02-13
- **Completion Date**: 2023-04-06
- **Lead Sponsor**: Rehabilitation Centre Zivot
### Study Description
Susac's syndrome is a rare autoimmune disorder characterised by a triad of encephalopathy (brain dysfunction), branch retinal artery occlusion (loss of vision) and sensorineural hearing loss. This study presents the case of a patient undergoing intensive physiotherapy intervention following an injury, focusing on assessments such as volume and range of motion measurements, manual muscle tests, and pain intensity evaluations using various scales.
### Conditions
- Susac Syndrome
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
### Outcomes
**Primary Outcomes**
- Mobility and Muscle Strength Improvement
- Muscle Strength Improvement Outcome Measure
- Pain Intensity Outcome Measure
**Secondary Outcomes**
### Location
- **Facility**: Rehabilitation centre Život, Mostar, N/A, 88000, Bosnia and Herzegovina
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## Manipulation of the Gut Microbiome by a Standardized Preoperative Diet to Prevent Colorectal Cancer Recurrence and Metastasis Following Surgery
- **NCT ID**: NCT06349590
- **Study ID**: IRB24-0373
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-04
- **Completion Date**: 2029-04
- **Lead Sponsor**: University of Chicago
### Study Description
A single arm, prospective, single center Phase1/2 Dietary intervention trial for subjects diagnosed with colorectal cancer and scheduled for tumor resection more than 21 days from informed consent. Subjects will be provided 21 days of standardized plant-based low fat/ high-fiber meals and complete a food diary up until lunch on the day prior to surgery. Blood samples will be collected at baseline and on the day of surgery. Stool samples will be collected throughout the dietary intervention period at specific timepoints, on the day of surgery, and 30 days post-surgery. Tissue from the tumor resection will be isolated for organoid cultures. Subjects will be followed per standard of care for up to 5 years or disease recurrence, whichever comes first. Subject may be treated for their cancer prior to surgery and/or during the follow-up period.
### Conditions
- Colorectal Cancer
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: NA
- **Intervention Model**: SINGLE_GROUP
- **Primary Purpose**: PREVENTION
### Interventions
- Plant-Based Meals
### Outcomes
**Primary Outcomes**
- Change of the presence of active-urokinase-type plasminogen activation (uPA) stool samples before and after diet intervention using western blot and zymography.
**Secondary Outcomes**
- Change of the presence of active- Matrix Metalloproteinase-9 (MMP9) in stool samples before and after diet intervention using western blot and zymography.
- Change of the presence of plasminogen in stool samples before and after diet intervention using western blot and zymography.
- Change of the stool associated metagenomics in subjects before and after intervention.
- Change of the levels of short-chain fatty acids and bile acids between pre- and post- intervention stool samples.
### Location
- **Facility**: University of Chicago, Chicago, Illinois, 60637, United States
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## Optimizing Pulsatility During Cardiopulmonary Bypass to Reduce Acute Kidney Injury
- **NCT ID**: NCT06349577
- **Study ID**: 23-0921
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-04
- **Completion Date**: 2028-10
- **Lead Sponsor**: University of Colorado, Denver
### Study Description
The objective is to determine the effectiveness of pulsatile flow during cardiopulmonary bypass to reduce the incidence of acute kidney injury after cardiac surgery. Investigators will also evaluate the safety and impact of pulsatile flow on clinical outcomes compared to non-pulsatile flow during cardiopulmonary bypass.
### Conditions
- Acute Kidney Injury
- Hemolysis
- Thrombocytopenia
- Surgery
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: PREVENTION
### Interventions
- Non-pulsatile blood flow
- Pulsatile blood flow
### Outcomes
**Primary Outcomes**
- Acute kidney injury
**Secondary Outcomes**
- Acute kidney injury risk score
- Red blood cell units transfused
- Platelet nadir
- Discontinuation rate of cardiopulmonary bypass mode
- 30-day mortality
### Location
- **Facility**: University of Colorado Hospital, Aurora, Colorado, 80045, United States
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## Implementing Virtual Reality (VR) to Reduce Sedation
- **NCT ID**: NCT06349564
- **Study ID**: 23-01443
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-04
- **Completion Date**: 2025-04
- **Lead Sponsor**: NYU Langone Health
### Study Description
The study is a prospective pilot patients aged 21 to 65 undergoing screening colonoscopy or diagnostic upper endoscopy. Patients are administered minimal sedation (2 mg of Versed and 25 mg of Fentanyl) and are given Virtual Reality (VR) goggles to wear for the duration of the procedure. The purpose of this study is to assess the feasibility, effect, and safety of using VR goggles during endoscopic procedures to decrease sedation requirements, enhance patient satisfaction, and reduce recovery time.
### Conditions
- Sedative During Endoscopy
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: NON_RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: SUPPORTIVE_CARE
### Interventions
- Pico 4 Enterprise headset with noise cancelling headphones
### Outcomes
**Primary Outcomes**
- Total amount of sedative drugs administered during the procedure
**Secondary Outcomes**
- Patient-reported discomfort or pain (using 0-10 pain scale)
- Duration of the procedure
- Overall patient satisfaction scores
- Number of events of complications from VR
- Number of technical failures
- Troubleshooting time
- PACU length of stay
### Location
- **Facility**: NYU Langone Brooklyn, Brooklyn, New York, 11220, United States
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## Clot Formation and Coagulation Factors Consumption in the Clearing Fluid After Arterial Catheter Blood Sampling.
- **NCT ID**: NCT06349551
- **Study ID**: RC23_0586
- **Status**: RECRUITING
- **Start Date**: 2024-04-17
- **Completion Date**: 2025-03-20
- **Lead Sponsor**: Nantes University Hospital
### Study Description
After blood sampling from an arterial catheter, the reinjection of the clearing fluid (a mixture of saline solution and blood) is proposed to limit blood loss. However, the status of coagulation in this clearing liquid remains poorly documented.
### Conditions
- Intensive Care Units
- Arterial Lines
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
- Patients of intensive care unit
### Outcomes
**Primary Outcomes**
- Composite score of the coagulation activation over time in the clearing fluid during blood sampling from an arterial catheter
**Secondary Outcomes**
- Concentration of prothrombin over time in the clearing fluid during blood sampling from an arterial catheter
- Concentration of factor II over time in the clearing fluid during blood sampling from an arterial catheter
- Concentration of factor V over time in the clearing fluid during blood sampling from an arterial catheter
- Concentration of fibrin monomer over time in the clearing fluid during blood sampling from an arterial catheter
### Location
- **Facility**: Nantes university hospital, Nantes, Loire-atlantique, 44093, France
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## Identifying Markers of Disease Subtypes and Disease Progression in the Syndrome of Essential Tremor
- **NCT ID**: NCT06349538
- **Study ID**: 35-435 ex 22/23
- **Status**: ENROLLING_BY_INVITATION
- **Start Date**: 2024-04-04
- **Completion Date**: 2034-04-30
- **Lead Sponsor**: Medical University of Graz
### Study Description
The goal of this observational study is to learn about epidemiology, biologic markers, disease subtypes and possible prognostic factors in essential tremor (ET) patients. The main question\[s\] it aims to answer are:* The prevalence of ET-plus compared to ET in a prospectively collected ET population.* To assess in detail the heterogenous group of ET patients using comprehensive clinical (motor and non-motor scales, questionnaires), imaging \[magnetic resonance imaging (MRI), sonography of substantia nigra and cerebral vessels\], neurophysiological (tremor analysis, digital spiral drawing) and laboratory markers (sGFAP, sNfL, routine laboratory parameters).* To assess possible non-invasive markers of neurodegeneration in ET patients (optic coherence tomography, alpha-synuclein in olfactory mucosa)Participants will be asked to undergo the above mention evaluation at baseline and at follow-up approx. 5 years later.Researchers will compare the findings within the ET group to independently existing cohorts of healthy controls and/or patients with other movement disorders like Parkinson's disease.
### Conditions
- Essential Tremor
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
- Clinical examination, blood draw, cerebral MRI, sonography, tremor analysis, OCT, olfactory mucosa swab.
### Outcomes
**Primary Outcomes**
- Prevalence of ET-plus
**Secondary Outcomes**
- Age of ET patients
- Sex of ET patients
- Family history
- Symptom leading to ET-plus classification
- current and former medication for essential tremor
- subjective disease course of ET
- responsivity to alcohol
- presence of cardiovascular risk factors
- MDS-UPDRS (Movement Disorder Society Unified Parkinson's Disease Rating Scale) parts I-IV
- modified Essential Tremor Rating Assessment Scale (mTETRAS)
- Scale for the assessment and rating of ataxia (SARA)
- Verbal fluency animals (part of the CERAD-plus test battery)
- Boston Naming Test (part of the CERAD-plus test battery)
- Mini Mental State Examination Test (MMSE; part of the CERAD-plus test battery)
- word list learning (part of the CERAD-plus test battery)
- constructive praxis (part of the CERAD-plus test battery)
- word list recall (part of the CERAD-plus test battery)
- word list recognition (part of the CERAD-plus test battery)
- constructive praxis recall (part of the CERAD-plus test battery)
- Trail Making Test A (part of the CERAD-plus test battery)
- Trail Making Test B (part of the CERAD-plus test battery)
- s-words (part of the CERAD-plus test battery)
- Frontal Assessment Battery (FAB)
- Geriatric Depression Scale (GDS)
- Hospital Anxiety and Depression Scale (HADS)
- Non-Motor Symptoms Scale for Parkinson's Disease (NMSS)
- RBD Screening Questionnaire
- Global Physical Activity Questionnaire (GPAQ)
- Quality of Life in Essential Tremor Questionnaire (QUEST)
- University of Pennsylvania Smell Identification Test (UPSIT)
- Montreal Cognitive Assessment (MOCA)
- Auditory verbal learning test
- Symbol Digit Modalities Test (SDMT)
- Brief Visuospatial Memory Test
- Comprehensive trail making test 4
- Comprehensive trail making test 5
- Regensburg word fluency test
- EQ-5D
- resilience scale (RS-13)
- Pittsburgh Sleep Quality Index (PSQI)
- Digital Spiral Drawing
- Schellong Test
- serum glial fibrillary acidic protein (sGFAP)
- serum neurofilament light (sNfL)
- Transcranial sonography
- tremor analysis
- cerebral MRI
- cerebral MRI
- cerebral MRI
- cerebral MRI
- cerebral MRI
- cerebral MRI
- optic coherence tomography (OCT)
- optic coherence tomography (OCT)
- optic coherence tomography (OCT)
- optic coherence tomography (OCT)
- Olfactory mucosa swab
### Location
- **Facility**: Medical University of Graz, Graz, N/A, 8036, Austria
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## Retention of Telescopic Versus Locator Attachments
- **NCT ID**: NCT06349525
- **Study ID**: DU-2021-00103
- **Status**: COMPLETED
- **Start Date**: 2021-04-01
- **Completion Date**: 2023-10-01
- **Lead Sponsor**: Delta University for Science and Technology
### Study Description
Forty patients ( 24female and16 male )with completely edentulous maxilla and mandible . All patients received implant supported mandibular and maxillary overdentures. The patients were randomly divided into two groups according to attachments retaining Max IOD that supported by four axial implants in maxilla . The TA was used to retain group I (GrI) MaxIOD , while that of group II (Gr II) was retained by LA. MaxIOD retention and MBL(vertical and horizontal) around implants of both groups was recorded at time of insertion (R0) ,then twelve(R12)and (R24) months following insertion of the prosthesis.
### Conditions
- Jaw, Edentulous
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- telescopic overdenture
- Locator overdenture
### Outcomes
**Primary Outcomes**
- Retention
**Secondary Outcomes**
- Marginal bone loss
### Location
- **Facility**: Delta University for Science & Technology, Mansoura, N/A, N/A, Egypt
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## 68Ga-FAPI-46 PET/CT for Predicting Histological Response in Triple-negative Breast Cancer (FAP-IT)
- **NCT ID**: NCT06349512
- **Study ID**: IC 2022-07
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-06-15
- **Completion Date**: 2027-07-30
- **Lead Sponsor**: Institut Curie
### Study Description
Prospective multicenter study evaluating the prediction of histological response after neoadjuvant pembrolizumab in combination with chemotherapy by pre-treatment 68Ga-FAPI-46 PET/CT imaging in patients with early-stage high-risk TNBC.
### Conditions
- Triple Negative Breast Cancer
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: NA
- **Intervention Model**: SINGLE_GROUP
- **Primary Purpose**: DIAGNOSTIC
### Interventions
- 68Ga-FAPI-46 PET/CT imaging
### Outcomes
**Primary Outcomes**
- Area under the ROC curve
**Secondary Outcomes**
- Comparison of 68Ga-FAPI-46 PET/CT and 18F-FDG PET/CT performances
- Comparison of 68Ga-FAPI-46 PET/CT and 18F-FDG PET/CT performances
- Comparison of 68Ga-FAPI-46 PET/CT and 18F-FDG PET/CT predictive performances
- Evaluation of predictive model performance combining 68Ga-FAPI-46 PET/CT and 18F-FDG PET/CT
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
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## [Trial of device that is not approved or cleared by the U.S. FDA]
- **NCT ID**: NCT06349499
- **Study ID**: CIIPCL-AMD-MAG-23
- **Status**: WITHHELD
- **Start Date**: N/A
- **Completion Date**: N/A
- **Lead Sponsor**: [Redacted]
### Study Description
No description available.
### Conditions
- No conditions listed.
### Study Design
- **Type**: N/A
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
### Outcomes
**Primary Outcomes**
**Secondary Outcomes**
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
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## Efficacies of Bismuth-amoxicillin-vonoprazan Triple Therapy, Vonoprazan-amoxicillin Dual Therapy and Proton Pump Inhibitor-based Standard Triple Therapy for Hp Eradication
- **NCT ID**: NCT06349486
- **Study ID**: KMUHIRB-F(II)-20230179
- **Status**: RECRUITING
- **Start Date**: 2023-11-28
- **Completion Date**: 2026-12-31
- **Lead Sponsor**: Kaohsiung Medical University
### Study Description
1. Compare the efficacies and safety of 14-day bismuth-amoxicillin-vonoprazan tiple therapy, 14-day vonoprazan dual therapy and 14-day rabeprazole triple therapy in the first-line treatment of H. pylori infection.2. To investigate the impacts of antibiotic resistance of H. pylori as well as CYP3A4, CYP2C19 and IL-1B -511 genotypes of host on the eradication efficacies of anti-H. pylori treatments.
### Conditions
- Helicobacter Pylori Eradication
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- vonoprazan, amoxicillin, tripotassium dicitrate bismuthate
- vonoprazan, amoxicillin
- rabeprazole, amoxicillin, clarithromycin
### Outcomes
**Primary Outcomes**
- the eradication rate of Helicobacter pylori
**Secondary Outcomes**
- genotype analysis
### Location
- **Facility**: Kaohsiung Medical University Hospital, Kaohsiung, N/A, 807, Taiwan
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## A Study of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SR604 in Two Participants Groups (Part A: Healthy Participants, and Part B: Participants With Hemophilia A or Hemophilia B)
- **NCT ID**: NCT06349473
- **Study ID**: SR604-1
- **Status**: RECRUITING
- **Start Date**: 2024-04-15
- **Completion Date**: 2025-09-27
- **Lead Sponsor**: Equilibra Bioscience LLC
### Study Description
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamic (PD) of SR604 in healthy participants (Part A) and to evaluate the safety, tolerability, PK, PD, and efficacy of SR604 in participants with severe Hemophilia A or Hemophilia B, with or without inhibitors (Part B).
### Conditions
- Healthy Participants
- Hemophilia A
- Hemophilia B
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: SEQUENTIAL
- **Primary Purpose**: TREATMENT
### Interventions
- SR604
- Placebo
### Outcomes
**Primary Outcomes**
- Parts A and B: Number of Participants with Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
- Parts A and B: Number of Participants with Clinical Abnormal Changes in Coagulations Markers
**Secondary Outcomes**
- Part A: Area Under the Serum Concentration-time Curve from time Zero to the Last Quantifiable Time Point (AUC[0-t])
- Part A: Area Under the Serum Concentration-time Curve from time Zero Extrapolated to Infinity (AUC[0-inf])
- Parts A and B: Maximum Concentration (Cmax) of SR604
- Parts A and B: Time to Maximum Concentration (tmax) of SR604
- Parts A and B: Terminal Half-life (T1/2) of SR604
- Part A: Clearance Following Extravascular Administration (CL/F) of SR604
- Part A: Volume of Distribution in Terminal Phase Following Extravascular Administration (Vz/F) of SR604
- Parts B: Concentration before the next dose administration (Ctrough)
- Parts B: Area Under the Serum Concentration-time Curve within One Dosing Interval (AUCtau)
- Parts B: Accumulation Ratio (R) of SR604
- Parts B: Number of Bleeding Events
- Parts B: Annualized Bleeding Rate (ABR) in Body and Targeted Joints
- Parts A and B: Number of Participants with Positive Antidrug Antibodies (ADAs)
### Location
- **Facility**: California Clinical Trials Medical Group (CCTMG), Glendale, California, 91206, United States
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## A Micro-Randomized Trial to Optimize Just-in-Time Adaptive Intervention for Binge Eating & Weight-related Behaviors
- **NCT ID**: NCT06349460
- **Study ID**: STU00216998
- **Status**: RECRUITING
- **Start Date**: 2024-03-21
- **Completion Date**: 2026-12-31
- **Lead Sponsor**: Northwestern University
### Study Description
The purpose of this study is to conduct a micro-randomized trial to learn which evidence-based targets within a mobile intervention for binge eating and weight-related behaviors are most impactful for which people and in what sequence.
### Conditions
- Binge Eating
- Obesity
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: SEQUENTIAL
- **Primary Purpose**: TREATMENT
### Interventions
- FoodSteps behavioral intervention
### Outcomes
**Primary Outcomes**
- Weekly change in binge eating
**Secondary Outcomes**
### Location
- **Facility**: Northwestern University Feinberg School of Medicine, Chicago, Illinois, 60611, United States
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## Pilot Study of LED for PIE and PIH
- **NCT ID**: NCT06349447
- **Study ID**: KY2021-771
- **Status**: RECRUITING
- **Start Date**: 2024-04-10
- **Completion Date**: 2024-06-01
- **Lead Sponsor**: Yanjun Dan
### Study Description
The aim of this study is to explore the effect of medical LEDs (830 nm and 590 nm) in the prevention and treatment of PIE and PIH.
### Conditions
- Hyperpigmentation
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- LED
- without any LED exposition
### Outcomes
**Primary Outcomes**
- melanin index
- erythema index
**Secondary Outcomes**
- transepidermal water loss (TEWL)
- elasticity
### Location
- **Facility**: Huashan Hospital, Shanghai, N/A, N/A, China
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## The Utilization Effects of Powered Wearable Orthotics in Improving Upper Extremity Function and ADL in Persons With SCI
- **NCT ID**: NCT06349434
- **Study ID**: R-1215-23
- **Status**: RECRUITING
- **Start Date**: 2023-10-15
- **Completion Date**: 2028-10-01
- **Lead Sponsor**: Kessler Foundation
### Study Description
To evaluate the usefulness of an upper extremity assistive device, called (MyoPro) in improving upper extremity activities in people with incomplete spinal cord injury. The Department of Defense is supporting this study.
### Conditions
- SCI - Spinal Cord Injury
- Upper Extremity Dysfunction
- Upper Extremity Problem
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: SINGLE_GROUP
- **Primary Purpose**: TREATMENT
### Interventions
- MyoMo
- conventional therapy
### Outcomes
**Primary Outcomes**
- GRASSP
- Range of motion of hands and arms
- Muscle strength measurement
**Secondary Outcomes**
- Spasticity measurement
- Brain signals measurement
- CUE-Q
### Location
- **Facility**: Kessler Foundation, West Orange, New Jersey, 07052, United States
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## Exploring the Impact of Fully Guided Implant Placement on Classifying Bone Quality Through Tactile Sensation
- **NCT ID**: NCT06349421
- **Study ID**: 202401078RINE
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-03-31
- **Completion Date**: 2024-10-31
- **Lead Sponsor**: National Taiwan University Hospital
### Study Description
Bone quality stands as a crucial determinant impacting the success rate of dental implants, exerting influence on both implant primary stability and the efficacy of osseointegration. While radiographic images can partially reveal bone quality, experienced surgeons often rely on tactile sensation during bone drilling to assess it. Subsequently, based on the diagnosed bone quality, distinct implant designs and surgical protocols have been invented to enhance survival rates.Technological advancements now enable the preoperative design of implant placement through a comprehensive guide, merging CBCT DICOM files with digital oral scanning data. This "fully guided" approach enhances the precision, stability, and safety of implant placement surgery. However, the use of a fully guided surgical guide introduces an additional factor-the friction between the drill and guide-potentially impacting the surgeon's tactile feedback.This study aims to assess the difference in bone quality evaluation by tactile sensation between freehand drilling and drilling with a fully guided surgical guide, using test blocks of different bone density. The discussion will explore the pros and cons of employing a fully guided guide to optimize outcomes in implant treatment.
### Conditions
- Dentistry
- Education
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
### Outcomes
**Primary Outcomes**
- VAS scale at the same density of sawbone
**Secondary Outcomes**
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
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## IBI3001 in Participants With Unresectable, Locally Advanced or Metastatic Solid Tumors
- **NCT ID**: NCT06349408
- **Study ID**: CIBI3001A101
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-05-30
- **Completion Date**: 2027-05-30
- **Lead Sponsor**: Innovent Biologics (Suzhou) Co. Ltd.
### Study Description
This is a Phase 1/2 multicenter, multi-regional, open-label, first-in-human study of IBI3001 in participants with unresectable, locally advanced or metastatic solid tumors. It includes a Phase 1 section to identify Maximum Tolerated Dose (MTD)/Recommended Phase 2 Dose (RP2D) of IBI3001, and a Phase 2 section to explore and confirm the efficacy, safety and tolerability of IBI3001 at its RP2D.
### Conditions
- Locally Advanced Solid Tumor
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: NA
- **Intervention Model**: SINGLE_GROUP
- **Primary Purpose**: TREATMENT
### Interventions
- IBI3001
### Outcomes
**Primary Outcomes**
- Number of subjects with adverse events
- Number of subjects with clinically significant changes in physical examination results
- Number of subjects with clinically significant changes in vital signs
- MTD or RP2D of IBI3001 Number of subjects with dose-limiting toxicities (DLTs)
**Secondary Outcomes**
- Plasma concentration (Cmax) of IBI3001
- Area under the curve (AUC) of IBI3001
- Time to maximum concentration (Tmax) of IBI3001
- Clearance (CL) of IBI3001
- Volume of distribution (V) of IBI3001
- Half-life (T1/2) of IBI3001
- Immunogenicity of IBI3001
- Objective response rate (ORR)
- Duration of response (DoR)
- Disease control rate (DCR)
- Time to response (TTR)
- Progression free survival (PFS)
- Overall survival (OS)
### Location
- **Facility**: Wollongong Public, Wollongong, New South Wales, 2500, Australia
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## The Effect of Mindfulness-Based Stress Reduction Training Before Mastectomy on Postoperative Pain in Early Period
- **NCT ID**: NCT06349395
- **Study ID**: NisantasiU
- **Status**: RECRUITING
- **Start Date**: 2023-05-01
- **Completion Date**: 2024-07-29
- **Lead Sponsor**: Istanbul Nisantasi University
### Study Description
This research aims to investigate the effect of mindfulness-based stress reduction training given before mastectomy on postoperative early period pain and the fear of movement caused by pain. According to the World Health Organization, 18.1 million new cancer diagnoses are made each year, with breast cancer being the most common type among women, accounting for 24.2% of all cancers diagnosed. In Turkey, the incidence of breast cancer was determined as 22,345 in 2018. Breast cancer significantly affects women's quality and length of life. Surgical intervention is the most commonly chosen treatment method for cases of localized breast cancer. Pain and limited movement are among the most common problems encountered after surgery. Non-pharmacological methods have been shown to be effective in pain management, with the mindfulness-based stress reduction technique being one of these methods. This technique is described as an effective treatment for conditions such as pain, depression, and addiction, with high levels of mindfulness being associated with greater self-esteem, optimism, and empathy, whereas low levels of mindfulness are linked to depression, anxiety, chronic pain, and acute pain.
### Conditions
- Pain Management
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: SUPPORTIVE_CARE
### Interventions
- MBSR surgical nursing care
### Outcomes
**Primary Outcomes**
- Visual analog scale
- The Tampa Scale of Kinesiophobia
**Secondary Outcomes**
### Location
- **Facility**: Istanbul University - Cerrahpasa, Istanbul, N/A, 34160, Turkey
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## CArbohydrate Loading in Aortic Surgery
- **NCT ID**: NCT06349382
- **Study ID**: CALAS
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-04-01
- **Completion Date**: 2024-11-01
- **Lead Sponsor**: University of Belgrade
### Study Description
The adverse effects of overnight fasting before surgery have been well-documented in the contemporary literature. Still, due to the possibility of pulmonary aspiration of gastric contents, many clinicians worldwide still employ this practice. On the other hand, the benefits of preoperative oral carbohydrate loading (OCHL) have been shown in various patient groups. Studies examining the usefulness of preoperative OCHL in aortic surgery are lacking. In particular, no randomized control trials have specifically examined the impact of preoperative OCHL on the postoperative course in patients undergoing open abdominal aortic surgery.
### Conditions
- Abdominal Aortic Aneurysm
- Leriche Syndrome
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: PREVENTION
### Interventions
- carbohydrate-rich beverage
### Outcomes
**Primary Outcomes**
- The ICU length of stay
- Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
- Insulin sensitivity index (HOMA-ISI)
- Homeostasis model assessment of β-cell function (HOMA-β)
- Six aspects of subjective well-being according to the visual analog scale
**Secondary Outcomes**
- Length of hospital stay
- 30-day mortality rate
- The incidence of local wound infections
- The incidence of postoperative surgical complications
- The incidence of postoperative non-surgical complications
### Location
- **Facility**: Clinic for Vascular and Endovascular Surgery, University Clinical Center of Serbia, Belgrade, N/A, 11000, Serbia
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## Effect of tDCS on Inflammatory Biomarkers in Chronic Schizophrenia
- **NCT ID**: NCT06349369
- **Study ID**: PG Thesis/2023-24/105
- **Status**: RECRUITING
- **Start Date**: 2024-04-08
- **Completion Date**: 2026-04-09
- **Lead Sponsor**: All India Institute of Medical Sciences, Bhubaneswar
### Study Description
The study is a randomized, double-blind, parallel-arm, sham-controlled trial that aims to compare the effects of transcranial direct current stimulation (tDCS) versus sham stimulation on inflammatory markers (IL-6 and TNF-alpha) and clinical outcomes (PANSS, AHRS, CGI-SCH, GAF) in patients with chronic schizophrenia over 10 days of treatment. The primary objective is to assess changes in IL-6 levels, while secondary objectives include evaluating changes in TNF-alpha, symptom scales, and adverse events. The study will be conducted at the psychiatry department of AIIMS Bhubaneswar, with 60 patients aged 18-60 years with moderate-to-severe schizophrenia symptoms randomized to receive either active tDCS (cathode over left temporo-parietal junction, anode over left dorsolateral prefrontal cortex) or sham stimulation. The researchers hope to elucidate the potential immunomodulatory effects of tDCS and its impact on symptoms in chronic schizophrenia, which may lead to more targeted, multifaceted interventions to improve patient outcomes.
### Conditions
- Chronic Schizophrenia
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- transcranial direct current stimulation
### Outcomes
**Primary Outcomes**
- Change in the IL-6 levels
**Secondary Outcomes**
- Change in the TNF alpha levels.
- Change in the Positive and Negative syndrome Scale
- Change in the Auditory hallucination rating scale
- Change in the Clinical global impression- Schizophrenia scale
- Change in the Global Assessment of Functioning scale
- To compare the adverse events reported in both control and intervention groups.
### Location
- **Facility**: AIIMS Bhubaneswar, Bhubaneswar, Odisha, 751019, India
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## Prospective Evaluation of Efficacy and Safety of an Intense Pulsed Light Device to Treat Dry Eye Disease"
- **NCT ID**: NCT06349356
- **Study ID**: FDACSTIM0012023
- **Status**: RECRUITING
- **Start Date**: 2023-03-28
- **Completion Date**: 2024-12-31
- **Lead Sponsor**: Quantel Medical
### Study Description
The goal of this clinical trial is to evaluate the efficacy and safety of C.STIM, an intense pulsed light device to treat signs and symptoms of dry eye disease. The main question it aims to answer is:• Difference of the evolution of Tear Break-Up time (TBUT) between the 2 arms of the study (placebo and treated).Researchers will compare treated group and placebo to respond to the main question.Participants will assess to an inclusion visit (disease evaluation purpose) and then four IPL treatment visit to finish with the last visit (disease evaluation purpose).
### Conditions
- Dry Eye Disease
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- Intense pulsed light with C.STIM device
### Outcomes
**Primary Outcomes**
- Tear Break-Up Time evolution
**Secondary Outcomes**
- dry eye signs and symptoms
- dry eye signs and symptoms
- dry eye signs and symptoms
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
- Meibum quality
- Meibum Expressibility
- Use of artificial tear drops
- Use of artificial tear drops
- Glaucoma
### Location
- **Facility**: Visionary Consultants Inc., Lexington, Kentucky, 40517, United States
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## CD19/BCMA HLA-independent TCR-T Cell Therapy for Refractory/Moderate-to-severe Systemic Lupus Erythematosus
- **NCT ID**: NCT06349343
- **Study ID**: UHCT230949
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-04
- **Completion Date**: 2026-01
- **Lead Sponsor**: Wuhan Union Hospital, China
### Study Description
The purpose of the study is to explore the safety and efficacy of cluster of differentiation 19 (CD19)/B cell maturation antigen (BCMA) human leukocyte antigen (HLA)-independent T cell receptor (TCR) -T therapy in refractory/moderate-to-severe systemic lupus erythematosus(SLE).
### Conditions
- Systemic Lupus Erythematosus
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: NA
- **Intervention Model**: SINGLE_GROUP
- **Primary Purpose**: TREATMENT
### Interventions
- CD19/BCMA Hi-TCR-T cell therapy
### Outcomes
**Primary Outcomes**
- Safety and tolerability
**Secondary Outcomes**
- Proportion of subjects with SRI-4 response
- Changes in the Safety of Estrogens in Lupus Erythematosus National Assessment - Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) score from baseline
- Changes in the BILAG-2004 score from baseline
- Changes in the Physician Global Assessment (PGA) score from baseline
- Pharmacokinetics (PK)
- Pharmacodynamics (PD)
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
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## The Immediate Effectiveness of a 3D Intraoral Scanner as an Oral Hygiene Educational Tool
- **NCT ID**: NCT06349330
- **Study ID**: 2022/00908
- **Status**: RECRUITING
- **Start Date**: 2023-11-07
- **Completion Date**: 2024-07-31
- **Lead Sponsor**: National University Hospital, Singapore
### Study Description
The goal of this randomized controlled clinical trial is to compare the immediate effectiveness of 3D intra-oral scanners and standard oral hygiene instructions in improving the oral hygiene of 52 subjects. The main question\[s\] it aims to answer are:* Does a 3D intra-oral scanner facilitate the improvement of oral hygiene in subjects?* Does a 3D-rendered image of plaque-stained teeth confer better visualization to subjects?Prospective Open Cohort study: Patients referred to NUCOHS Periodontology Department will be invited to participate in the study. Included participants will be randomized into the 3D scanner (test) and standard oral hygiene (control) group. Subsequently, both groups will receive personalized oral hygiene instructions before brushing their teeth. The participants will receive plaque disclosing again to compare the differences between baseline and post-intervention.Routine periodontal parameters will be recorded at baseline and researchers will compare the percentage improvement in full mouth plaque scores to see if the test group performed better than the control group.A questionnaire will be given to subjects in the test and control group for qualitative analysis.The study will require 1 visit.
### Conditions
- Periodontal Diseases
- Plaque Induced Gingival Disease
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: PREVENTION
### Interventions
- Test: 3D intra-oral scanner
- Control: Standard oral hygiene
### Outcomes
**Primary Outcomes**
- Full mouth plaque score (%)
**Secondary Outcomes**
- Patient's satisfaction of 3D scanner and standard oral hygiene group based on 5-point Likert Scale
### Location
- **Facility**: National University Hospital, Singapore, Singapore, N/A, N/A, Singapore
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## Neoadjuvant IMRT Combined With Camrelizumab and Apatinib for Resectable HCC With PVTT
- **NCT ID**: NCT06349317
- **Study ID**: 2024-005
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-05
- **Completion Date**: 2026-06
- **Lead Sponsor**: Yongyi Zeng
### Study Description
This study is an open-label, single-arm prospective clinical trial that evaluates the efficacy and safety of neoadjuvant intensity-modulated radiotherapy combined with perioperative camrelizumab and apatinib in the treatment of resectable hepatocellular carcinoma with portal vein tumor thrombus.
### Conditions
- Hepatocellular Carcinoma
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: NA
- **Intervention Model**: SINGLE_GROUP
- **Primary Purpose**: TREATMENT
### Interventions
- Neoadjuvant intensity-modulated radiotherapy combined with perioperative camrelizumab and apatinib
### Outcomes
**Primary Outcomes**
- 1-year Event-Free Survival (EFS) rate
**Secondary Outcomes**
- Event-Free Survival (EFS)
- Overall Survival (OS)
- Disease-Free Survival (DFS)
- R0 resection rate
- Overall Objective Response of primary liver tumor and PVTT
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
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## Impact of Grape Powder Consumption on Eye Health and Glycemic Status in Singapore Older Adults
- **NCT ID**: NCT06349304
- **Study ID**: S25
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-05-01
- **Completion Date**: 2025-08-01
- **Lead Sponsor**: National University of Singapore
### Study Description
The purpose of this study is to understand the impacts of regular consumption of freeze-dried table grape powder on eye health and regulation of advanced glycation end products in Singapore older adults. The investigators hypothesize that regular consumption of freeze-dried table grape powder will promote improvements in eye health and lower levels of advanced glycation end products when compared to the placebo group.
### Conditions
- Macula; Degeneration
- Aging
- Advanced Glycation End Products
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: PREVENTION
### Interventions
- Freeze-dried table grape powder
- Placebo grape powder
### Outcomes
**Primary Outcomes**
- Macular pigment optical density
- Visual acuity
- Photostress recovery time
- Visual function questionnaire 25
- Skin advanced glycation end products levels
- Dietary advanced glycation end products level
- Blood advanced glycation end products levels
- Contrast sensitivity
**Secondary Outcomes**
- Concentration of tumour necrosis factor-α
- Concentration of interleukin-6
- Concentration of high-sensitivity C-reactive protein
- Concentration of fasting blood glucose
- Concentration of malondialdehyde
- Concentration of 8-isoprostaglandin-F2α
- Skin carotenoid status
- Concentration of insulin
- Percentage of glycated hemoglobin
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
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## Venous Thrombosis After Removal of Central Venous Catheter
- **NCT ID**: NCT06349291
- **Study ID**: 0074-24-MMC
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-08-01
- **Completion Date**: 2025-08-01
- **Lead Sponsor**: Meir Medical Center
### Study Description
Insertion of intravenous catheter is a very common operation in patients in the general intensive care unit. These catheters are used for a variety of purposes - administration of inotropics/pressors, intravenous nutrition, concentrated electrolytes and performing dialysis.There are several known complications of central venous catheter insertion, such as thrombosis and pulmonary embolism. In a literature review, there are no clear data regarding the rate of intravenous thrombosis in patients after removal of a central venous catheter. These findings are often discovered randomly, when the patient undergoes imaging for a different indication. There is no recommendation for an active search for intravenous thrombi at the catheter insertion sites in these patients, and it is not entirely clear whether it is mandatory to administer anticoagulant treatment in these patients if thrombi are randomly discovered at the catheter insertion sites.In this study, we aim to check the proportion of patients who developed thrombosis at the central catheter insertion sites after its removal, to check whether there are catheter insertion sites that are at a higher risk of developing thrombosis than other sites, and to check whether there are predictive characteristics for the development of this type of thrombosis.
### Conditions
- Thrombosis, Venous
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
- Detection of venous thrombosis via US
### Outcomes
**Primary Outcomes**
- Rate of DVT after removal of central venous catheter
**Secondary Outcomes**
### Location
- **Facility**: Meir Medical Center, Kfar Saba, N/A, N/A, Israel
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## Pancreatic Cancer and Synchronous Liver Metastases Resection Following Neoadjuvant FOLFIRINOX
- **NCT ID**: NCT06349278
- **Study ID**: 2024-7276
- **Status**: RECRUITING
- **Start Date**: 2024-01-16
- **Completion Date**: 2029-01-16
- **Lead Sponsor**: Laval University
### Study Description
This is a prospective, pilot study from a single center. Patients will be evaluated and operated on by one of five surgeons with a subspeciality in hepato-biliary and pancreatic surgery. After thorough, standard of care assessment for both pancreatic primary and liver metastases resectability with blood tumor markers (CEA, CA 19-9 and CA-125), triphasic CT-scan and liver magnetic resonance imaging (MRI), patients with resectable pancreatic ductal adenocarcinoma primary and three or less resectable liver metastases will be prospectively included in the study. PET-scan may be added to the investigation depending on CT-scan or MRI results to prove metastatic disease or rule out extrahepatic metastases. Patients will receive a total of 12 cycles of perioperative FOLFIRINOX (FFX), with first reassessment with triphasic CT-scan to monitor tumor response after the first six cycles. Every patient will receive at least 6 cycles of FFX before surgery. The remaining six cycles will be received either preoperatively or postoperatively, depending on patient tolerance and tumor response at reassessment. Patients with liver metastases only visible on MRI will also have liver MRI at reassessment, which is also standard of care. Patients with evidence of tumor response on both imaging using RECIST V.1.1 criteria (stable disease or partial response), and blood tumor markers (≥ 80% decrease and/or normalization of all tumor markers) will then undergo pancreatic resection, either distal pancreatectomy or pancreatoduodenectomy depending on tumor side, with liver metastases excision. Each case will be followed with blood tumor markers and CT-scan every three months for two years, and every four months afterwards or until recurrence, which is standard of care for patients with metastatic PDAC. For patients without evidence of tumor response on imaging, or \< 80% decrease of all tumor markers, the standard palliative systemic treatment will be continued.
### Conditions
- Pancreas Adenocarcinoma
- Pancreas Metastases
- Pancreas Cancer
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: NA
- **Intervention Model**: SINGLE_GROUP
- **Primary Purpose**: TREATMENT
### Interventions
- Pancreatic resection and non-anatomic liver resections.
### Outcomes
**Primary Outcomes**
- Morbidity and mortality
**Secondary Outcomes**
- Overall survival
### Location
- **Facility**: CHU de Québec, Quebec City, Quebec, G1R 2J6, Canada
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## Ultrasound-Guided 5% Dextrose Injection for Carpal Tunnel Syndrome
- **NCT ID**: NCT06349265
- **Study ID**: 02
- **Status**: COMPLETED
- **Start Date**: 2023-10-02
- **Completion Date**: 2024-03-02
- **Lead Sponsor**: Kastamonu University
### Study Description
This study was a prospective randomized double-blind clinical trial conducted at the Physical Medicine and Rehabilitation Clinic of a local research and training hospital in Turkey from October 2023 and May 2024. Patients diagnosed with CTS were classified into three groups: severe, mild, and moderate CTS, based on the results of electrophysiological tests. An ultrasound-guided 5% Dextrose in Water injection was performed. The primary outcome measurement was the Visual Analog Scale (VAS), while secondary measurements were the Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) and the Dolour Neuropathic en 4 Questions (DN4) questionnaire. The measurements were performed before the injection and at the first week, first month and third month follow-up times. The distribution of data within groups was examined using the Shapiro-Wilk test and Q-Q plots. The study also analyzed temporal changes, group differences, and intergroup changes using repeated measures ANOVA models.
### Conditions
- Carpal Tunnel Syndrome
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- Carpal Tunnel Hydrodissection with %5 dextrose in water injection
### Outcomes
**Primary Outcomes**
- Visual Analogue Scale(VAS)
**Secondary Outcomes**
- Boston Carpal Tunnel Syndrome Questionnaire (BCTQ)
- Dolour Neuropathique en 4 Questions (DN4) questionnaire
### Location
- **Facility**: Gamze Gül Güleç, Kastamonu, N/A, 37150, Turkey
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## Survival Validation and Gene Mutations of N Descriptors in the Ninth Edition of the TNM Classification for Lung Cancer
- **NCT ID**: NCT06349252
- **Study ID**: LUNGTNM
- **Status**: RECRUITING
- **Start Date**: 2021-01-01
- **Completion Date**: 2025-01-01
- **Lead Sponsor**: Fudan University
### Study Description
The International Association for the Study of Lung Cancer Staging Committee recently unveiled the ninth edition of TNM staging system for lung cancer. This study aims to explore survival outcomes, stage grouping, and gene mutations in N descriptors of this new classification system.
### Conditions
- Non-small Cell Lung Cancer
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
- Radical resection
### Outcomes
**Primary Outcomes**
- Overall Survival
**Secondary Outcomes**
### Location
- **Facility**: Fudan University Cancer Center, Shanghai, Shanghai, 200032, China
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## Oral Azacitidine Maintenance Post-CPX 351
- **NCT ID**: NCT06349239
- **Study ID**: 24Hemato01
- **Status**: RECRUITING
- **Start Date**: 2020-01-01
- **Completion Date**: 2025-01-01
- **Lead Sponsor**: Centre Hospitalier Universitaire de Nice
### Study Description
Approximately 10% of patient develop AML after chemotherapy or radiation for unrelated disease (t-AML) and 20% have AML with an antecedent hematologic disorder (AML-MRC). CPX-351 (Vyxeos), a liposomal formulation of a fixed molar ratio (1:5) daunorubicin and cytarabine, has been approved for treatment of adults with newly diagnosed t-AML or AML-MRC. CPX-351 significantly improved median overall survival.Although induction chemotherapy results in remission in many older patients with AML, relapse is common and overall survival is poor. For patients not eligible for HSCT, maintenance therapies are needed to reduce the risk of relapse and prolong overall survival without causing undue adverse effects or compromising health-related quality of life. Oral azacitidine (ONUREG) has been approved by FDA on September, 2020, to treat adult patients with AML who achieved CR or CRi following intensive induction chemotherapy with or without consolidation and who are not able to complete intensive curative therapy (not candidate to HSCT).The use of oral azacitidine maintenance is an integral part of clinical practice for AML patients who have achieved a first complete remission (CR) or complete remission with incomplete blood count recovery (CRi) after intensive ""3+7"" induction chemotherapy and who are unable to complete intensive curative therapy.But there are few data on its efficacy as a post-CPX-351 maintenance agent in patients with newly diagnosed t-AML or AML-MRC or de novo AML.THe aim of this study is to show the improvement of overall survival with use of oral Azacitidine as maintenance for patients with de novo AML including t-AML or AML-MRC who achieved complete remission or complete remission with incomplete blood count recovery after CPX-351. Long-term product safety is also being studied
### Conditions
- Acute Myeloid Leukemia
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
- No intervention
### Outcomes
**Primary Outcomes**
- overall survival
**Secondary Outcomes**
- Safety and tolerance
### Location
- **Facility**: CHU de Nice, Nice, N/A, N/A, France
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## Identification of Biomarkers and Molecular Targets Involved on Intervertebral Disc Degeneration and Discogenic Pain
- **NCT ID**: NCT06349226
- **Study ID**: DISCOLAB
- **Status**: RECRUITING
- **Start Date**: 2018-05-22
- **Completion Date**: 2025-05-21
- **Lead Sponsor**: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
### Study Description
Low back pain, associated with intrinsic disorders of the spine, is a very frequent clinical condition that is accompanied by high morbidity with effects both on psychosocial aspects, and health care system. It occurs in approximately 80% of the population throughout their lives. Most low back pain is associated with intervertebral disc degeneration (IDD) associated with neuroinflammation and pain. In this context, the study of sphingolipid metabolism can play an important role in the identification of new molecules responsible for the degenerative process. Sphingolipids, in fact, are a class of molecules that are implicated in multiple signal pathways, such as proliferation, degradation of the extracellular matrix, inflammatory state, apoptosis and migration. In particular, sphingosine-1-phosphate (S1P), an intermediate of sphingolipid metabolism, acts as a pro-inflammatory mediator, predominantly in the extracellular environment, regulating important cellular properties related to inflammatory potential and pain. The objective of this study is to characterize the degenerative process in cells isolated from degenerated human intervertebral discs from both at cellular and molecular levels in order to identify new targets implicated in degenerative processes, including sphingolipid signaling pathway.
### Conditions
- Intervertebral Disc Degeneration
- Discogenic Pain
- Discogenic Disease
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
- cell isolation from intervertebral disc tissue and biomarker investigation
### Outcomes
**Primary Outcomes**
- Characterization of degenerated intervertebral disc cells
**Secondary Outcomes**
- Development of cellular model platform
### Location
- **Facility**: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, N/A, 20122, Italy
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## Uncovering the Cognitive and Neural Mechanisms Underlying Cognitive Time
- **NCT ID**: NCT06349213
- **Study ID**: C23-19
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-05-02
- **Completion Date**: 2030-11-01
- **Lead Sponsor**: Institut National de la Santé Et de la Recherche Médicale, France
### Study Description
Time processing, the ability to process and encode temporal information, is essential for cognitive functioning and for a large number of daily life activities. In particular, the processing of durations of several seconds is central to cognition, impaired in several pathologies, and has been associated with cognitive changes with advancing age. While behavioral studies have been conducted to specify the neural bases of temporal cognition and their association with other cognitive functions, the mechanisms underlying age-related changes, and individual differences, remain unknown. The project will characterize ageing effects on timing mechanisms and their neural underpinnings. Building on recent advances from neuroscience and age-related cognitive changes, the project focuses on the precision of duration processing, that declines with age, and the associated neural bases. Participants will perform a duration judgement task while (a) electroencephalography, and (b) functional magnetic resonance imaging activity are simultaneously recorded to investigate age effects on structural and functional network connectivity. In addition, striatal dopamine will be measured using a FDOPA PETscan. Evaluation of other temporal cognition processes and general cognition will also be performed. This combination offers a unique opportunity to accurately specifying the neurophysiological underpinning of aging effects on time processing changes. This project will further our understanding of the variability of cognitive performance with advancing age, and contribute to identifying new measures of temporal impairments.
### Conditions
- Healthy Aging
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
- FDOPA injection before PET imaging
- Time perception tasks
- fMRI imaging
- EEG imaging
- 3 year follow-up
### Outcomes
**Primary Outcomes**
- EEG phase lag index differences between group
**Secondary Outcomes**
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
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## Comparing Binaural Beats and 432Hz Music for Reduction of Preoperative Anxiety in Root Canal Patients
- **NCT ID**: NCT06349200
- **Study ID**: 3197
- **Status**: RECRUITING
- **Start Date**: 2024-03-27
- **Completion Date**: 2024-07
- **Lead Sponsor**: Dow University of Health Sciences
### Study Description
Many patients suffer from dental anxiety and don't go to dentists for regular checkups. This can lead to the initiation and progression of dental caries, which, if not controlled at the right time, can lead to the loss of the tooth itself. Many forms of distraction have been used to overcome this; music is also one of them. The main objective of this study is to compare the effectiveness of binaural beats and 432 Hz music in reducing preoperative dental unease and anxiety among adult patients undergoing root canal treatment in a dental teaching hospital. The null hypothesis is that both binaural beats and 432 Hz-frequency music are not effective in reducing preoperative dental anxiety among patients undergoing routine endodontic therapy in a dental teaching hospital. A total of three groups will be a part of this study, with a total sample size of 99 participants (33 participants in each group). Group A will listen to 432 Hz music for 10 minutes before the procedure, Group B will listen to binaural beats for 10 minutes before the procedure; and Group C (active control group) will listen to white noise for 10 minutes before the procedure. The Visual Analog Scale for Anxiety will be used to assess the anxiety levels before local anesthesia administration, after local anesthesia administration, and 10 minutes after listening to sounds. Then root canal treatment will be completed as a routine procedure.
### Conditions
- Dental Anxiety
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- 432 Hz music
- Binaural beats
- White noise
### Outcomes
**Primary Outcomes**
- Change in Pre-operative Dental Anxiety score using Visual Analog Scale for Anxiety
**Secondary Outcomes**
### Location
- **Facility**: Dow University of Health Sciences, Karachi, Sindh, 74200, Pakistan
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## Digital Competencies of the Doctors
- **NCT ID**: NCT06349187
- **Study ID**: dsc002
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-04-10
- **Completion Date**: 2024-06-10
- **Lead Sponsor**: Limited Liability Company "Docstarclub"
### Study Description
The role of digital technologies in healthcare is growing. Therefore, the roles and responsibilities of medical professionals are constantly changing and there is a need for continuous professional development. However, according to some authors, today's generation of doctors can be considered as "digital aborigines" \[Aungst, Patel, 2020\]. Low literacy in the field of e-health has become a major obstacle to digital transformation in developed countries, so digital skills training for healthcare professionals has gradually been introduced in the USA \[Adler-Milstein, et al., 2014\], Europe \[Schreiweis, et al., 2019\], Australia \[Evolution of eHealth in Australia, 2016\].The most common methodologies for determining a doctor's digital literacy level are HITCOMP and TIGER. In particular, HITCOMP includes 5 areas of expertise: administration, research/biomedicine, direct patient care, computer science, engineering/information systems/information and communication technologies, as well as several levels: basic, basic, intermediate, advanced, expert \[EU\*US eHealth Work Project, 2020\].However, in our opinion, the digital competence of a doctor is not only the ability to work at a computer and use software. The successful development of the digital world is preceded by some psychological and emotional processes.It all starts with digital trust, that is, with people's confidence in the reliability and security of digital systems, processes and technologies. Without the conviction that the implementation and active use of certain IT services will be useful and will not bring harm, the successful launch of such technologies will be impossible.Provided that there is digital trust, a person in his daily life gradually gets experience using various technologies: payments, appointments with specialists, purchases, etc. Thus, basic digital literacy appears in conjunction with the rules of behavior in the online space (digital culture). And only after that, having skills positively supported by experience, the doctor begins to master digital competencies in his workplace.Computerization and automation of the healthcare system began relatively recently, traditional (paper) document management in medicine is familiar to everyone, but not optimal from the point of view of system management. Therefore, universal digitalization is perceived as something artificially imposed, increasing the workload of doctors, distracting from their main work and shifting the focus from truly therapeutic activities to filling out documentation. As a result, doctors have a range of negative emotions: fear, annoyance, anxiety, despondency, refusal of further contacts, etc., which lead to an aggravation of emotional burnout. The ability to recognize and live through these states, to come to an inner balance, to accumulate an internal resource for further development of new technologies - all this is possible under the condition of the development of emotional intelligence. By developing so-called soft skills, the doctor will be emotionally stable, capable of further advancement and learning new skills, and will easily cope with temporary difficulties and setbacks.And the final stage, having gained the opportunity to overcome internal obstacles, the doctor is ready to begin mastering specialized digital skills directly related to medical activities: work in medical information systems, remote monitoring, artificial intelligence, medical decision support systems.The result of the development of a doctor within this model will be not only digital literacy, but also the development of an internally stable personality that easily overcomes any obstacles not only in training, but also in communication with patients and colleagues.
### Conditions
- Digital Competences
- Emotional Intelligence
- Emotional Burnout
- Doctor Patient Relation
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
- Interview
### Outcomes
**Primary Outcomes**
- Completing the survey
**Secondary Outcomes**
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
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## Safety and Efficacy of Endobronchial Valve for Bronchoscopic Lung Volume Reduction Surgery: A Prospective Pilot Study
- **NCT ID**: NCT06349174
- **Study ID**: 2024-valve-1
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-04-11
- **Completion Date**: 2025-03-31
- **Lead Sponsor**: China-Japan Friendship Hospital
### Study Description
The goal of this pliot study al is to preliminarily evaluate the effectiveness and safety of transbronchial lung volume reduction surgery using the self-devloped endobronchial valves for chronic obstructive pulmonary disease patients with emphysema phenotype . The main questions it aims to answer are:Does self-devloped endobronchial valves improve the lung function、exercise capacity and symptons of participants? What surgery-related adverse events do participants have after transbronchial lung volume reduction surgery using the self-devloped endobronchial valves?Participants will:undergo transbronchial lung volume reduction surgery using the self-devloped endobronchial valves.receive follow-up before surgery (baseline) and 3 days, 4 weeks, 12weeks after surgery.
### Conditions
- Emphysema
- Chronic Obstructive Pulmonary Disease
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: NA
- **Intervention Model**: SINGLE_GROUP
- **Primary Purpose**: TREATMENT
### Interventions
- bronchoscopic lung volume reduction surgery using endobronchial valve
### Outcomes
**Primary Outcomes**
- Percentage change in FEV1 relative to baseline
**Secondary Outcomes**
- Percentage of subjects with FEV1 improvement ≥ 12% after bronchodilators
- Percentage change in RV relative to baseline
- Percentage change in TLC relative to baseline
- Percentage change in DLCO relative to baseline
- Percentage change in SGRQ score relative to baseline
- Percentage change in mMRC grade relative to baseline
- Percentage change in 6MWD relative to baseline
- the incidence of surgical-related adverse events
### Location
- **Facility**: China-Japan Friendship Hospital, BeiJing, Beijing, 100029, China
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## Long-term Outcome of Retroperitoneoscopic One-trocar-assisted Pyeloplasty: A Single-center and Single-surgeon Experience
- **NCT ID**: NCT06349161
- **Study ID**: 1451_02/BVNTW-VNCSKTE
- **Status**: COMPLETED
- **Start Date**: 2011-05
- **Completion Date**: 2024-03
- **Lead Sponsor**: National Children's Hospital, Vietnam
### Study Description
Open surgical dismembered pyeloplasty has traditionally been the preferred method for treating ureteropelvic junction obstruction (UPJO), with a success rate exceeding 94%. However, it is associated with drawbacks such as increased postoperative pain, extended hospital stays, and visible scarring. Minimally invasive alternatives, including laparoscopic pyeloplasty (LP) and robot-assisted laparoscopic pyeloplasty (RALP), have gained popularity since their introduction in 1993, offering comparable success rates to open surgery while providing cosmetic benefits and shorter hospital stays. Nevertheless, these techniques present challenges in pediatric patients, including limited working space, technical complexities, and prolonged operative times. The retroperitoneoscopic one-trocar-assisted pyeloplasty (OTAP) method, introduced in 2007, combines the advantages of minimally invasive surgery with the success rates of standard dismembered pyeloplasty. Despite favorable outcomes reported by several researchers, comprehensive studies regarding long-term follow-up and clinical outcomes are lacking. This study aims to evaluate the long-term outcomes of OTAP, addressing this gap in the medical literature.
### Conditions
- Ureteropelvic Junction Obstruction
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
- One-trocar-assisted pyeloplasty
### Outcomes
**Primary Outcomes**
- Operative time
- Conversion to open
- Extension of skin incision
- Postoperative complications
- Median length of hospital stays
- Median follow up length
- Post-operative mean APD
- Post-operative mean DRF
- Mean incision length
- Recurrence
**Secondary Outcomes**
### Location
- **Facility**: The National Hospital of Pediatrics, Hanoi, N/A, N/A, Vietnam
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## The Effects of Immunonutrition Therapy on Locally Advanced Cervical Cancer Patients
- **NCT ID**: NCT06349148
- **Study ID**: NESTLE2022QN-0007
- **Status**: RECRUITING
- **Start Date**: 2024-01-01
- **Completion Date**: 2025-12
- **Lead Sponsor**: SHUANGZHENGJIA
### Study Description
The goal of this open-label randomized control trial is to study the effect of immunonutrition in locally advanced cervical cancer (LACC) with standard concurrent chemoradiotherapy. LACC patients undergoing radical synchronous chemoradiotherapy will be randomized into the experimental group receiving enteral immunonutrition therapy and the control group receiving standard enteral nutrition support.The main purpose it aims to answer are:1）Can immunonutrition therapy improve patients' dose-limiting toxicity(DLT) and DLT-free survival? 2）Can immunonutrition therapy improve patients' nutritional status and quality of life?
### Conditions
- Cervical Cancers
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: SUPPORTIVE_CARE
### Interventions
- enteral immunonutrition
- standard oral enteral nutrition
### Outcomes
**Primary Outcomes**
- Dose-limiting toxicity
- DLT-free survival
**Secondary Outcomes**
- compliance
- Prevalence of malnutrition
- Prevalence of sarcopenia
- QoL (Quality of life)
- Objective response rate (ORR)
- laboratory tests
- 2-year overall survival
- 2-year progression-free survival
### Location
- **Facility**: Cancer Hospital, Chinese Academy of Medical Sciences, Beijing, N/A, 100021, China
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## Assessment of Serum Concentration of Interleukin-17 and Osteoprotegerin in Response to Surgical Trauma Induced by Management of Mandibular Fractures Via Intraoral Versus Extraoral Approaches: Prospective Cohort Study
- **NCT ID**: NCT06349135
- **Study ID**: A.Ayman OMFS
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-04-15
- **Completion Date**: 2025-12-15
- **Lead Sponsor**: Aya Ayman Ahmed
### Study Description
Assessment of Serum Concentration of Interleukin-17 and Osteoprotegerin in Response to Surgical Trauma Induced by Management of Mandibular Fractures via Intraoral Versus Extraoral Approaches: Prospective Cohort Study
### Conditions
- Mandibular Fractures
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
- Open Reduction & Internal Fixation
### Outcomes
**Primary Outcomes**
- IL-17
- OPG
**Secondary Outcomes**
- Blood Loss
- Operative time
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
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## Screen-and-treat Strategy for Vaginal Flora Abnormalities in Pregnant Women at High Risk of Preterm Birth
- **NCT ID**: NCT06349122
- **Study ID**: 2023-509421-41-00
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-08
- **Completion Date**: 2028-01
- **Lead Sponsor**: Assistance Publique Hopitaux De Marseille
### Study Description
Preterm birth is an important cause of death and disabilities. Bacterial vaginosis (BV) is a common vaginal dysbiosis or abnormal microbiota, with a predominance of anaerobic bacteria with a lack of Lactobacillus, with various diagnosis methods. Often asymptomatic, BV increases the risk of preterm birth according to the gestational age at diagnosis. BV is usually diagnosed by conventional diagnosis such as Nugent score. Molecular diagnosis of BV has been demonstrated to be more reproducible, more accurate and to better define dysbiosis.The main objective of the study is to evaluate the effectiveness of an innovative screen-and-treat strategy for vaginal flora abnormalities by molecular biology using a Point of Care multiplex technology before 18 weeks' gestation to reduce the rate of preterm birth in a population of pregnant women at high risk of preterm birth.The hypothesis is that a strategy for screening and treating vaginal flora abnormalities and their recurrences using molecular biology in women with a history of prematurity or late-term abortion could be effective in reducing premature births by 40%.
### Conditions
- Bacterial Vaginosis
- Vaginal Dysbiosis
- Premature Delivery
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- Vaginal flora abnormalities screening and quantification using molecular biology technique
- Azithromycine
- Ceftriaxone
- Metronidazole
- Clotrimazole, Vaginal
- Usual Care
### Outcomes
**Primary Outcomes**
- The rate of preterm birth
**Secondary Outcomes**
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
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## Physical Activity in Children With Wolff-Parkinson-White Syndrome
- **NCT ID**: NCT06349109
- **Study ID**: PA-WPW
- **Status**: RECRUITING
- **Start Date**: 2024-03-01
- **Completion Date**: 2025-05-01
- **Lead Sponsor**: Karamanoğlu Mehmetbey University
### Study Description
The aim of this study was to investigate the level of physical activity and its determinants in children with WPW.
### Conditions
- Wolff-Parkinson-White Syndrome
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
- Cardiopulmonary exercise test
- Atrial-Ventricular Strain Analysis
- Arterial Stiffness Measurement
- Physical Activity Level
- Physical Activity Barriers Assesment
### Outcomes
**Primary Outcomes**
- The Physical Activity Questionnaire for Older Children Score
**Secondary Outcomes**
- VO2peak
- aPWV
- GLS
- LASr
- LASct
- LAScd
- Physical activity barriers (Parent) scale score
- Physical Activity Outcome Expectancies (Child) scale score
- Physical Activity Home Environment (Child) scale score
### Location
- **Facility**: Hacettepe University, Ankara, N/A, N/A, Turkey
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## Safety And Efficacy Investigation Of The Effects Of ClearLift Q-Switched Nd:Yag 1064nm Laser Module In The Treatment Of Facial Skin Wrinkles
- **NCT ID**: NCT06349096
- **Study ID**: ALM-HAR-CLL-23-01
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-03-26
- **Completion Date**: 2024-10
- **Lead Sponsor**: Alma Lasers
### Study Description
Alma Lasers ClearLift is a fractional non-ablative Q-Switched laser, allowing practitioners to use the benefits of a high intensity QS laser for the treatment of aged skin. Alma Harmony ClearLift uses a fractional QS laser to achieve a deep mechanical effect beneath the epidermis via a photoacustic effect. This creates a controlled dermal wound while leaving the epidermis intact. The wound healing process stimulates growth of new collagen, skin contracture and tightening. This procedure is virtually painless with no downtime and is safe for all skin types.Based on this background, we have considered an interest to design a study aimed at assessing the efficacy and safety of a treatment course with ClearLift Module in patients with facial skin wrinkles
### Conditions
- Facial Skin Wrinkles
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: NA
- **Intervention Model**: SINGLE_GROUP
- **Primary Purpose**: TREATMENT
### Interventions
- Alma Harmony
### Outcomes
**Primary Outcomes**
- Primary endpoint
**Secondary Outcomes**
- Secondary endpoint
- Secondary endpoint
- Secondary endpoint
### Location
- **Facility**: San Luca Medical Clinic, Tirana, N/A, N/A, Albania
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## Neurobehavioral Mechanisms of Psilocybin-assisted Treatment for AUD
- **NCT ID**: NCT06349083
- **Study ID**: 23-01227
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-07
- **Completion Date**: 2029-01
- **Lead Sponsor**: NYU Langone Health
### Study Description
This is a double-blind, randomized, placebo-controlled Phase 2 mechanistic clinical trial designed to evaluate the therapeutic neural mechanisms of psilocybin in patients with alcohol use disorder (AUD), and to determine whether further studies are warranted to study the relationship of any such effects to clinical improvement in AUD symptoms. The primary aims are to evaluate the effects of psilocybin on AUD; measures will include 1) fMRI neural activation and functional connectivity, using a well-validated task to characterize neural and subjective response to negative affective and alcohol visual stimuli; 2) alcohol use data (self-report and blood biomarkers); and 3) self-report measures related the NE, IS, and EF domains.
### Conditions
- Alcohol Use Disorder
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- Psilocybin
- Inactive Placebo
- Supportive therapy sessions
### Outcomes
**Primary Outcomes**
- Percent change in the alcohol cue-induced Blood-oxygen-level dependent (BOLD) signal in the lateral prefrontal cortex (PFC)
- Percent change in the alcohol cue-induced BOLD signal change in the caudate
- Percent change in alcohol cue-induced BOLD signal change in the ventromedial PFC (vmPFC)
- Percent change in alcohol cue-induced BOLD signal change in the insula
- Percent change in negative affective cue-induced BOLD signal change in the dorsomedial PFC (dmPFC)
- Percent change in negative affective cue-induced BOLD signal change in the supramarginal gyrus
- Percent change in negative affective cue-induced BOLD signal change in the amygdala
- Percent change in negative affective cue-induced BOLD signal change in the insula
- Percent change in alcohol cue-induced functional connectivity in prespecified regions of interest (ROI)
- Percent change in negative affective cue-induced functional connectivity in prespecified regions of interest (ROI)
- Percent change in the frequency of failed response inhibition
- Change in discounting rate (log(k))
- Change in number of set-shifting errors
- Average number of no heavy drinking days
- Change in phosphatidyl ethanol (PEth) blood levels
- Change in carbohydrate-deficient transferrin (CDT) blood levels
- Change in the Drinker Inventory of Consequences questionnaire (DrInC-2R) total score
- Change in PSQI global score
- Change in patient's self-assessed quality of life (by the SF-36 Questionnaire)
- Change in Alcohol craving score
- Change in negative affect score
- Change in impulsivity score (Barratt impulsivity scale by the subscales and by the total score)
**Secondary Outcomes**
- Average number of no drinking days
- Percentage of heavy drinking days
- Average number of drinks per day
- Percentage of abstinent days
### Location
- **Facility**: NYU Langone Health, New York, New York, 10016, United States
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## RESTORE - Phase II
- **NCT ID**: NCT06349070
- **Study ID**: 23-00404
- **Status**: RECRUITING
- **Start Date**: 2024-01-26
- **Completion Date**: 2027-03-30
- **Lead Sponsor**: NYU Langone Health
### Study Description
The study will apply the principles of Community Based Participatory Research to evaluate implementation strategies, designed to assist in the delivery of an evidence-based lifestyle counseling intervention for pregnant participants. The primary strategies include a technology supported strategy (low touch) in which text messaging and online videos are used for asynchronous viewing compared to a Community Health Worker-led synchronous (group and individual) strategy (high touch). Prior to implementation, one-time interview and focus groups will be conducted with clinic providers and staff. In addition, a subsample of subjects will be enrolled into a prospective cohort to complete a survey during pregnancy and a survey postpartum. The aims of the study are 1) to evaluate and compare adoption of the program delivery with text technology messaging vs. delivery by Community Health Workers (CHW), 2) to examine implementation fidelity , 3) to evaluate and compare the impact of the strategies on key clinical outcomes, 4) to examine sustainability (continued adoption) following the CHW-led strategy implementation period and conduct an economic evaluation of the two-implementation strategies.
### Conditions
- Maternal Health
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: SEQUENTIAL
- **Primary Purpose**: HEALTH_SERVICES_RESEARCH
### Interventions
- Low Touch - Text Messaging Implementation Strategy
- High Touch - Community Health Worker (CHW) Implementation Strategy
### Outcomes
**Primary Outcomes**
- Percent adoption of the program
**Secondary Outcomes**
- Mean number of videos viewed
- Mean number of sessions completed
- Level of adherence
- Adequacy of Prenatal Care Utilization Index Score
- Number of postpartum follow-up visits attended
- Number of subjects who had a pre-term delivery
- Number of subjects with post-partum depression
- Mean gestational weight gain
- Percent sustainability (continued adoption) following the M-CHW implementation period
- Program Costs
### Location
- **Facility**: NYC Health + Hospitals/Bellevue, New York, New York, 10016, United States
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## The Effect of the Anticholinergic Burden Following Elective Coronary Artery Surgery
- **NCT ID**: NCT06349057
- **Study ID**: AnkaraCHBilkent.1
- **Status**: RECRUITING
- **Start Date**: 2024-01-01
- **Completion Date**: 2024-12-30
- **Lead Sponsor**: Ankara City Hospital Bilkent
### Study Description
Many drugs have anticholinergic activity. This means that it blocks the muscarinic binding of the neurotransmitter acetylcholine.In this study, the anticholinergic burden of the patients in the perioperative period will be calculated with the Anticholinergic Cognitive Burden Scale (ACBS) and patients with a score of 1 or above will be included in the study. Anticholinergic load of drugs used in the intraoperative period; Its effect on postoperative hospital stay, morbidity and mortality following elective heart surgery will be investigated.
### Conditions
- Mortality
- Postoperative Complications
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- reducing anticholinergic burden
### Outcomes
**Primary Outcomes**
- Mortality
**Secondary Outcomes**
- Effects on postoperative recovery
- Effects on postoperative recovery
- Postoperative complication
### Location
- **Facility**: Seda Kurtbeyoğlu, Çankaya, Ankara, 06800, Turkey
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## A Randomized, Multicenter Phase II Basket Study of Hypofractionated Radiotherapy/Stereotactic Body Radiotherapy Followed by Immunotherapy-Based Systemic Therapy +/- L. Rhamnosus M9 for the First-Line Treatment of Advanced Digestive System Malignancies.
- **NCT ID**: NCT06349044
- **Study ID**: BASIMA
- **Status**: RECRUITING
- **Start Date**: 2024-03-20
- **Completion Date**: 2025-12-31
- **Lead Sponsor**: Zhejiang Cancer Hospital
### Study Description
Based on the interaction between radiation therapy and immunotherapy and the potential potentiation of Probio-M9 for the treatment of ICIs, this study is planned to design an integrated treatment protocol for the first-line treatment of advanced gastrointestinal tumors through the use of macrofractionated radiotherapy as a means of immune activation, combined with the synergistic effect of Probio-M9 microbial agents and PD-1 inhibitors.
### Conditions
- Gastroesophageal Junction Adenocarcinoma
- Liver Cancer Stage IV
- Biliary Tract Cancer
- Pancreatic Adenocarcinoma
- Colorectal Cancer
- Gastric Cancer
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- Hypofractionated radiotherapy/SBRT（5-8 Gy/fx，3-5 fx）
- Anti-PD-1 monoclonal antibody
- Oxaliplatin and Capecitabine
- Anti-VEGF 15mg/kg
- Anti-VEGF 7.5mg/kg
- Gemcitabine and Cisplatin
- Gemcitabine and Albumin paclitaxel
### Outcomes
**Primary Outcomes**
- ORR
**Secondary Outcomes**
- ORR
- adverse effects rate
- Qol
- PFS
- OS
- Qol
### Location
- **Facility**: Zhengjiang Cancer Hospital, Hangzhou, Zhejiang, N/A, China
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## Comparison of Efficacy & Tolerability Of PEG 4000 Versus PEG 3350+ Electrolytes for Pediatric Fecal Disimpaction
- **NCT ID**: NCT06349031
- **Study ID**: IEC/IMS.SH/SOA/2024/683
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-04-15
- **Completion Date**: 2024-09-15
- **Lead Sponsor**: Institute of Medical Sciences and SUM Hospital
### Study Description
Childhood constipation is a common but serious gastrointestinal disorder prevalent worldwide. In 90-95% of children, it is of functional origin. Thirty to seventy-five percent of children with functional constipation also have fecal impaction. The treatment strategy for functional constipation includes fecal disimpaction and maintenance therapy to ensure regular bowel movements.Polyethylene glycol (PEG) based laxatives have been recommended as the first-line therapeutic agents. The commonly used formulations are PEG 3350 with a molecular weight between 3200- 3700 g/mol and PEG 4000 with molecular weight of 4000 g/mol. Both are shown to be effective in pediatric constipation management in placebo-controlled trials. PEG 3350 + Electrolyte (E) is more widely used than PEG 4000 for the management of constipation. This might be because of the perception that PEG 3350 + E is safer in terms of preventing electrolyte imbalance. However, because of the inclusion of electrolytes, PEG 3350+ E solution taste saltier than PEG 4000. Many patients struggle to tolerate the unpleasant taste resulting in the high incidence of non-compliance. To date, no pediatric trials have compared PEG 4000 versus PEG 3350+E for management of Fecal disimpaction.Present study has been planned to evaluate the efficacy \& tolerability of PEG 4000 versus PEG 3350+ E for fecal disimpaction in pediatric functional constipation. Patients between age 1-16 years having functional constipation (as per ROME IV criteria) with fecal impaction will be included. Subjects will be randomly assigned to either PEG 4000 or PEG 3350+E at a ratio of 1:1. They will be stratified into 3 different age groups: 1-5 years, 6-11 years, and 12-16 years. They will receive either of the PEG solutions (as per allocation) at a dose of 1.5 gm/kg/day for 6 consecutive days or till the resolution of fecal impaction whichever is earlier. The resolution of fecal impaction is defined as the passage of clear liquid stool and the disappearance of palpable abdominal fecolith.Primary outcome is defined as the proportion of subjects achieving fecal disimpaction in each arm.Secondary outcomes are defined as follows:1. Total no of Days required to achieve fecal disimpaction in each arm2. Cumulative dose of PEG required for fecal disimpaction in each arm3. Proportion of subjects (\> 5 years age) reporting palatability issues in each arm4. Proportion of subjects discontinuing the treatment due to palatability issues in each arm
### Conditions
- Functional Constipation
- Fecal Impaction
- Constipation - Functional
- Constipation Chronic Idiopathic
- Pediatric Functional Constipation
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- Administration of Polyethylene Glycol (PEG) 4000 as per treatment allocation to participants
- Administration of Polyethylene Glycol (PEG) 3350 + Electrolyte as per treatment allocation to participants
### Outcomes
**Primary Outcomes**
- Proportion of subjects achieving fecal disimpaction in Each Arm
**Secondary Outcomes**
- Total no of Days required to achieve fecal disimpaction in each arm
- Cumulative PEG dose required for fecal disimpaction in each arm
- Proportion of subjects reporting palatability issues in each arm
- Proportion of subjects discontinuing the treatment due to palatability issues in each arm
### Location
- **Facility**: Institute of Medical Sciences (IMS) and SUM Hospital, Bhubaneswar, Odisha, 751003, India
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## Effects of Isotonic Beetroot Supplementation on Sprint Interval Exercise Performance
- **NCT ID**: NCT06349018
- **Study ID**: IRB-2023-972
- **Status**: RECRUITING
- **Start Date**: 2024-02-20
- **Completion Date**: 2025-02-28
- **Lead Sponsor**: Nanyang Technological University
### Study Description
This study aims to examine the effects of dietary nitrate supplementation via beetroot juice on sprint interval cycling exercise performance. Twenty-four participants (male or female) will undertake a randomized, crossover trial where they consume either (i) an isotonic beetroot juice drink containing nitrate (12.9 mmol) for 5 days or (ii) an isotonic sports drink (no nitrate) for 5 days. On Day 5 of each trial, participants will come to the laboratory and 2 hours after consuming their allocated drink will complete a 6 bouts of sprint interval exercise. Power output during cycling will be measured as the primary outcome measure. Salivary and plasma measures of nitrate and nitrite will be taken over the course of the morning on Day 5. After a 5-day washout period participants will crossover and begin their second trial.
### Conditions
- Exercise Performance
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: CROSSOVER
- **Primary Purpose**: OTHER
### Interventions
- Dietary Supplement: High nitrate isotonic drink
- Dietary Supplement: No nitrate isotonic drink
### Outcomes
**Primary Outcomes**
- Power output during maximal sprint cycling
**Secondary Outcomes**
- Salivary nitrate
- Plasma nitrate and nitrite
- Muscle oxygenation
- Sensory evaluation (Acceptance and Preference Test Evaluation by Meilgaard et al 2007)
- Stroop test
### Location
- **Facility**: Human Bioenergetics Laboratory, National Institute of Education, Nanyang Technological University, Singapore, N/A, 637616, Singapore
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## Laryngoscopy and Coronary Artery Bypass Graft Surgery
- **NCT ID**: NCT06349005
- **Study ID**: 111
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-04-10
- **Completion Date**: 2024-09-01
- **Lead Sponsor**: Konya Meram State Hospital
### Study Description
In this prospective, randomized, controlled trial, the purpose is to compare Macintosh laryngoscope, EzVision® video laryngoscope, McGrath® video laryngoscope and Storz® video laryngoscope in terms of hemodynamic response associated with intubation in adult patients undergoing Coronary Artery Bypass Surgery (CABG).
### Conditions
- Videolaryngoscopy
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- Tracheal intubation using Storz VL
- Tracheal intubation using Macintosh laryngoscopy
- Tracheal intubation using MacGrath VL
- Tracheal intubation using EzVision VL
### Outcomes
**Primary Outcomes**
- Hemodynamic response
- Hemodynamic response
**Secondary Outcomes**
- Intubation time
- Visualization of the glottis
### Location
- **Facility**: Betul Kozanhan, Konya, N/A, 42005, Turkey
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## ACT Combined Yoga for Parental Burnout in Parents With Autistic Children
- **NCT ID**: NCT06348992
- **Study ID**: HMUDQ20240318001
- **Status**: RECRUITING
- **Start Date**: 2023-09-01
- **Completion Date**: 2024-12-31
- **Lead Sponsor**: Harbin Medical University
### Study Description
OBJECTIVE: To explore the intervention effect of ACT combined with a yoga intervention program on parenting burnout in parents with ASD.METHODS: This study used a combination of qualitative research and quantitative analysis to examine the intervention effects of an ACT-centered intervention program on parenting burnout in parents of children with ASD, and to clarify the evaluations and perceptions of parents with ASD about the research program through qualitative research.RESULTS AND CONCLUSION: To clarify the intervention effect of ACT combined with yoga intervention program on parenting burnout of ASD parents.
### Conditions
- Autism Spectrum Disorder
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: SUPPORTIVE_CARE
### Interventions
- Acceptance commitment therapy and yoga
- Active Comparator: Mental Health Education Group
### Outcomes
**Primary Outcomes**
- Measuring parental Burnout Levels
- Measuring parenting stress Levels
**Secondary Outcomes**
- Patient-Reported Outcomes Measurement Information System adult profile-57, PROMIS-57
- Medical Outcomes Study 36-Item Short-Form Health Survey, MOS SF-36
- Acceptance and Action Questionnaire-II, AAQ-II
- Cognitive Fusion Questionnaire，CFQ-F
### Location
- **Facility**: Harbin Medical University Hospital, Daqing, None Selected, 043300, China
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## Clinical Performance of Fiber Reinforced FRC Base and Bonded CAD/CAM Resin Composite Endocrowns
- **NCT ID**: NCT06348979
- **Study ID**: CEBD 5/2021
- **Status**: COMPLETED
- **Start Date**: 2022-01-01
- **Completion Date**: 2024-01-30
- **Lead Sponsor**: Cairo University
### Study Description
This research proposal is introduced to clinically test short fiber reinforced flowable resin composite material (everX Flow, GC Europe) as a supporting base under CAD/CAM resin composite endocrowns due to gap of knowledge present in this area.
### Conditions
- Dental Caries
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- Fiber flowable (SFRC) support below hybrid nanoceramic endocrowns
- all ceramic Endocrowns (emax)
### Outcomes
**Primary Outcomes**
- clinical Fracture
**Secondary Outcomes**
- clinical performance marginal adaptation
### Location
- **Facility**: Cairo University, Cairo, N/A, N/A, Egypt
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## Predictors of Hospital Readmission for Chronic Obstructive Pulmonary Disease Patients
- **NCT ID**: NCT06348966
- **Study ID**: predictors of readmission
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-05-01
- **Completion Date**: 2026-06
- **Lead Sponsor**: Assiut University
### Study Description
This study is aimed to determine the risk factors for hospital readmission within 6 months in COPD patients
### Conditions
- Hospital Radmission for COPD Patients
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
### Outcomes
**Primary Outcomes**
- assessment of potential predictors of readmission among COPD patients
**Secondary Outcomes**
- development of early warning model for hospital readmission in COPD patients
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
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## Bioactive Versus Non-Bioactive Restorative System in Deep Carious Molars
- **NCT ID**: NCT06348953
- **Study ID**: Bioactive restorative system
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-04
- **Completion Date**: 2025-11
- **Lead Sponsor**: Cairo University
### Study Description
This research study delves into the effectiveness of bioactive and non-bioactive restorative systems in deep carious permanent molars treated with selective caries removal. Selective caries removal techniques aim to preserve as much healthy tooth structure as possible while effectively eliminating carious tissue. The study investigates how the choice of restorative material influences the outcomes of selective caries removal procedures in deep carious lesions. By assessing factors such as restoration integrity, pulpal response, and long-term success rates, the research seeks to provide evidence-based insights into the comparative performance of bioactive and non-bioactive restorative systems in this clinical context.
### Conditions
- Dental Caries
- Dental Diseases
- Deep Caries
- Tooth Diseases
- Tooth Decay
- Teeth; Lesion
- Caries; Dentin
- Dental Restoration Failure of Marginal Integrity
- Tooth Demineralization
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- selective caries removal and conventional non-bioactive restorative system
- selective caries removal and bioactive restorative system
### Outcomes
**Primary Outcomes**
- Biological properties - Post Operative Hypersensitivity and Vitality-Success rate%-Scoring system:Ordinal1-5
**Secondary Outcomes**
- Functional properties - fracture&retention-marginal adaptation-Radiographic Examination"when applicable"-Scoring system Ordinal 1-5
- Biological properties (Recurrence of caries (CAR), erosion, abfraction- Scoring system Ordinal 1-5)
- Success or Failure
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
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## Effects of Behavioral Activation on Negative Emotions, Cancer-related Symptoms and Clinical Indicators in Cancer Patients
- **NCT ID**: NCT06348940
- **Study ID**: 83242392
- **Status**: ACTIVE_NOT_RECRUITING
- **Start Date**: 2023-03-12
- **Completion Date**: 2024-06-12
- **Lead Sponsor**: Anhui Medical University
### Study Description
The majority of cancer patients experience varying degrees of psychological distress and physical symptoms due to the presence of cancer or the process of treatment. These symptoms are closely associated with inflammatory markers and patient prognosis, highlighting the urgent need for effective psychological intervention methods. Behavioral activation, an emerging psychological intervention approach, requires further investigation regarding its potential in alleviating negative emotions among cancer patients. Therefore, the investigators conducted a randomized controlled trial (RCT) to investigate whether (1) behavioral activation can ameliorate negative emotions and physical symptoms in cancer patients; (2) behavioral activation can contribute to improved survival outcomes for these patients; and (3) behavioral activation can enhance NLR levels and other clinical indicators among individuals with cancer.The investigators aimed to recruit a total of 390 cancer patients, comprising 170 individuals diagnosed with esophageal and gastric cancer, 100 individuals with colorectal cancer, and 120 individuals with lung cancer. These patients were recruited from the Department of Oncology at the Second Affiliated Hospital of Anhui Medical University between March 2023 and November 2023. They were randomly allocated into two groups: an intervention group (behavioral activation+care as usual, BA+CAU) and a control group (care as usual, CAU). The intervention group underwent an eight-week behavioral activation program (see Detailed Description) designed to promote engagement in meaningful activities that are physically and emotionally rewarding while reducing involvement in maladaptive emotional cycles. Both the intervention group and the control group received standard care along with conventional treatment for their respective cancers.This study aims to demonstrate the significant efficacy of behavioral activation in improving negative emotions, somatic symptoms, quality of life, and clinical inflammatory indicators among cancer patients. Furthermore, it may potentially enhance patient survival rates, thereby offering a novel approach for psychological intervention in cancer patients and contributing to multidisciplinary treatment and management strategies. The intervention measures employed in this study do not involve any pharmacological treatments or hazardous activities. For illiterate or less educated patients, the informed consent process and questionnaire collection will be conducted using methods that ensure their full comprehension (e.g., verbal explanations, visual aids). Additionally, patients with evident cognitive impairments were excluded from the study.The investigators have implemented a questionnaire system on the WJX website (https://www.wjx.cn/) to collect patient information through both paper and electronic questionnaires. The psychological measurement questionnaires are stored electronically, while socio-demographic data and clinical indicators are collected in the hospital's medical record management system. Subsequently, all data is summarized and saved in local Excel files and SPSS files for specialized analysis by data analysts. Patient names are anonymized within the database, ensuring strict confidentiality of personal information such as contact details and home address.Possible statistical methods include descriptive statistical analysis, generalized estimating equation or repeated measures analysis of variance, structural equation modeling, correlation analysis and regression, survival analysis, etc.
### Conditions
- Cancer Patients
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- behavioral activation
### Outcomes
**Primary Outcomes**
- Sociodemographic data
- Status of Tumor
- Body Mass Index, BMI
- Biochemical index
- Blood Pressure, BP
- Nutritional Risk Screening, NRS
- Visual Analogue Scale, VAS
- Karnofsky Performance Status Scale, KPS
- Psychological Distress Thermometer (DT)
- Hospital anxiety and depression scale (HADS)
- European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
- Pittsburgh sleep quality index (PSQI)
- Revised Piper Fatigue Scale (PFS-R)
- International physical activity questionnaire (IPAQ)
- Brief Resilient Coping Scale (BRCS)
- Multidimensional Scale of Perceived Social Support (MSPSS)
- General Self-Efficacy Scale (GSES)
- The activation subscale of Behavioral Activation for Depression Scale (BADS-A)
- Social Impact Scale (SIS)
- Fear of Cancer Recurrence Inventory- Short Form (FCRI-SF)
- The Functional Assessment of Cancer Therapy-Cognitive (FACT-Cog)
- Time of Progression-free survival (PFS)
- Time of Time to progression (TTP)
- Concentration of C-reactive protein (CRP)
- Value of Neutrophils to lymphocytes ratio (NLR)
- Value of Platelet-lymphocyte ratio (PLR)
- Value of Monocyte-lymphocyte ratio (MLR)
- Value of Systemic immune inflammation index (SII)
- Value of Pan-immune inflammation value (PIV)
- Concentration of Carcinoembryonic antigen (CEA)
- Concentration of Carbohydrate antigen 19-9 (CA19-9)
- Concentration of Carbohydrate antigen 72-4 (CA72-4)
- Concentration of Neuron-specific enolase (NSE)
- Concentration of Squamous cell carcinoma associated antigen (SCC)
**Secondary Outcomes**
### Location
- **Facility**: Second Affiliated Hospital of Anhui Medical University, Hefei, Anhui, N/A, China
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## Sunvozertinib Plus Anlotinib as 1L Treatment in EGFR-Sensitive Mutations Combined With Co-Mutations Advanced NSCLC
- **NCT ID**: NCT06348927
- **Study ID**: DZ2023EI004
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-04-30
- **Completion Date**: 2027-04-30
- **Lead Sponsor**: Hunan Province Tumor Hospital
### Study Description
This is a phase II, open-label, single-arm, single-center clinical study to evaluate the preliminary efficacy of sunvozertinib in combination with anlotinib in patients with EGFR-sensitive mutations and co-mutations in locally advanced or metastatic treatment-naive non-small cell lung cancer.Condition or disease Intervention/treatment Phase Non-Small Cell Lung Cancer Drug: sunvozertinib Drug: anlotinib Phase 2
### Conditions
- Non-Small Cell Lung Cancer
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: NA
- **Intervention Model**: SINGLE_GROUP
- **Primary Purpose**: TREATMENT
### Interventions
- sunvozertinib in combination with Anlotinib
### Outcomes
**Primary Outcomes**
- Progression-free survival (PFS)
**Secondary Outcomes**
- Objective Response Rate (ORR)
- Overall survival (OS)
- Duration of Response (DoR)
- Adverse events (AEs) according to CTCAE 5.0
### Location
- **Facility**: Hunan Cancer Hospital, Changsha, Hunan, 410013, China
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## Knowledge of Vital Pulp Therapy in Permanent Teeth Among a Group of Dental Students in Egypt
- **NCT ID**: NCT06348914
- **Study ID**: 6991
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-09-10
- **Completion Date**: 2024-12-30
- **Lead Sponsor**: Cairo University
### Study Description
Conducting this questionnaire will help in collecting information about the extent of knowledge of vital pulp therapy in permanent teeth among dental students in Egypt. This will aid in identifying the knowledge gap, interest, and challenges regarding utilization of vital pulp therapy in permanent teeth.
### Conditions
- Vital Pulp Therapy
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
- Knowledge assessment
- Educational Material
### Outcomes
**Primary Outcomes**
- Knowledge of vital pulp therapy
**Secondary Outcomes**
- Knowledge after awareness about vital pulp therapy
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
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## Clinical Utility of Oxford Cognitive Screen Test to Screen Cognitive Impairment in Post Stroke Patients
- **NCT ID**: NCT06348901
- **Study ID**: 2021-09-001
- **Status**: RECRUITING
- **Start Date**: 2021-09-01
- **Completion Date**: 2025-02-28
- **Lead Sponsor**: Bundang CHA Hospital
### Study Description
The goal of this type of study: clinical trial is to assess K-OCS clinical utility in participant population. The main aims:validate the reliability and validity of the Korean version of the Oxford Cognitive Screen (K-OCS) analyze its sensitivity, specificity, and diagnostic accuracy, and compare its examination participation rates with existing assessment tools to determine the effectiveness of K-OCS in detecting post-stroke cognitive impairment.
### Conditions
- Stroke
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
### Outcomes
**Primary Outcomes**
- Measurement of K-OCS
**Secondary Outcomes**
- Measurement of Korean version of mini-mental state examination (K-MMSE)
- Measurement Korean Version of the Oxford cognitive screen (K-OCS)
- Measurement of national institute of health care stroke scale (NIHSS)
- Measurement of fuctional independence meausure (FIM)
### Location
- **Facility**: Department of Rehabilitation Medicine, CHA Bundang Medical Center, Seongnam-si, Gyeonggi-do, 13496, Korea, Republic of
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## A Study to Learn About How Itraconazole and Carbamazepine Affect the Level of BAY2927088 in the Blood When These Drugs Are Taken Together by Healthy Participants
- **NCT ID**: NCT06348888
- **Study ID**: 22250
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-04-10
- **Completion Date**: 2024-05-30
- **Lead Sponsor**: Bayer
### Study Description
Researchers are looking for a better way to treat people who have advanced non-small cell lung cancer (NSCLC) with specific genetic changes called EGFR and HER2 mutations.Advanced NSCLC refers to a type of lung cancer that has spread from the lungs to nearby tissues or other body parts. People with advanced NSCLC may have changes in certain proteins like EGFR and HER2, that cause uncontrolled cell growth and increased spread of cancer.In this study, participants will be healthy and will not benefit from taking the study treatment, BAY2927088. However, the study will provide information about how to test BAY2927088 in future studies with people who have advanced NSCLC with EGFR or HER2 mutations.BAY2927088 is under development for the treatment of advanced NSCLC with EGFR or HER2 mutations. It is expected to work against these changed proteins, which might slow down the spread of cancer.BAY2927088 is broken down by an enzyme called CYP3A4 inside the body. Itraconazole is a drug that inhibits the activity of CYP3A4 while carbamazepine is a drug that enhances the activity of CYP3A4. Giving these drugs together will allow researchers to learn how the blood levels of BAY2927088 change when the CYP3A4 activity is inhibited or enhanced.The main purpose of this study is to find out how itraconazole and carbamazepine may affect the blood levels of BAY2927088. For this, researchers will measure the following for BAY2927088 when it is given with and without itraconazole and carbamazepine* Area under the curve (AUC): a measure of the total amount of BAY2927088 in participants' blood over time* Maximum observed concentration (Cmax): the highest amount of BAY2927088 in participants' bloodThe study will have 2 treatment groups.In Group 1, participants will take:* BAY2927088 as a single dose on Days 1 and 8.* Itraconazole once daily on Days 5 to 11.In Group 2, participants will take:* BAY2927088 as a single dose on Days 1 and 14.* Different doses of carbamazepine two times a day on Days 3 to 15. Participants will be in this study for about 7 weeks in Group 1 and 8 weeks in Group 2.Participants will visit the study clinic:* at least once, 2 to 28 days before the treatment starts in both groups, to confirm they can take part in this study* on Day 1, and will stay at the clinic until Day 12 in Group 1 and Day 16 in Group 2* once, 7 to 10 days later from last dose of BAY2927088 in both groups, for a health check upDuring the study, the doctors and their study team will:* perform physical examinations* collect blood samples from the participants to measure the levels of BAY2927088* check participants' health by performing tests such as blood and urine tests, and checking heart health using an electrocardiogram (ECG)* ask the participants questions about how they are feeling and what adverse events they are having An adverse event is any medical problem that a participant has during a study. The study doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatment.
### Conditions
- Advanced Non-small Cell Lung Cancer
- EGFR Mutation
- HER2 Mutation
- Healthy Volunteers
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: NON_RANDOMIZED
- **Intervention Model**: CROSSOVER
- **Primary Purpose**: OTHER
### Interventions
- BAY2927088
- Itraconazole
- Carbamazepine
### Outcomes
**Primary Outcomes**
- AUC of BAY2927088 with and without itraconazole
- Cmax of BAY2927088 with and without itraconazole
- AUC of BAY2927088 with and without carbamazepine
- Cmax of BAY2927088 with and without carbamazepine
**Secondary Outcomes**
- Number of participants with TEAEs
- Severity of TEAEs
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
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## Clinical Evaluation of Radiation Reduction for Optimized Safety
- **NCT ID**: NCT06348875
- **Study ID**: CLN-PLAN-102v1
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-06-15
- **Completion Date**: 2024-07-31
- **Lead Sponsor**: Angiowave Imaging
### Study Description
The primary objective of this study is to determine whether a reduced radiation protocol (RRP) in which angiograms are acquired at ultralow radiation doses and then processed using spatiotemporal enhancement software can produce similar quality angiographic images as compared with standard techniques.
### Conditions
- Coronary Artery Disease
- Myocardial Infarction
- Coronary Disease
- Coronary Stenosis
- Angina Pectoris
- Chest Pain
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
### Outcomes
**Primary Outcomes**
- Segment-level percent diameter stenosis (%DS)
**Secondary Outcomes**
- Stenosis severity
- Diagnostic quality
- Radiation dose - SOC
### Location
- **Facility**: Corewell Health West, Grand Rapids, Michigan, 49503, United States
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## Assessment of Stress and Anxiety for Patients Undergoing MRI Using, Holy Quran, Music, and Natural Sounds
- **NCT ID**: NCT06348862
- **Study ID**: 323/REC/2023
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-03-31
- **Completion Date**: 2024-06-30
- **Lead Sponsor**: Al-Quds University
### Study Description
The aim of the current study is to analyze the effect of listening to Quran or music or natural sounds on anxiety and stress level among patients undergoing MRI.
### Conditions
- Anxiety
- Stress
- MRI Contrast Media Adverse Reaction
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: SUPPORTIVE_CARE
### Interventions
- Listening to either Quran, Music, and or Natural sound
### Outcomes
**Primary Outcomes**
- Level of Anxiety among patients who underwent MRI
- Level of Stress
**Secondary Outcomes**
- Sociodemographic
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
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## The Desensitising Effect of Nanosilver Fluoride in Molar-Incisor Hypomineralisation
- **NCT ID**: NCT06348849
- **Study ID**: 0797-11/2023
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-04
- **Completion Date**: 2024-07
- **Lead Sponsor**: Alexandria University
### Study Description
The aim of the current study is to assess the desensitising effect of nanosilver fluoride on first permanent molars (FPMs) in patients with MIH in comparison to low-level laser therapy.
### Conditions
- Molar Incisor Hypomineralization
- Hypersensitivity
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
### Outcomes
**Primary Outcomes**
- Desensitising effect in hypersensitive MIH molars
**Secondary Outcomes**
- Change in the plaque index scores
- Change in children's frequency of toothbrushing
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
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## The Effects of Open Chain Versus Closed Chain Strengthening on Dynamic Valgus During a Step Down Test
- **NCT ID**: NCT06348836
- **Study ID**: 2123624-1/2
- **Status**: RECRUITING
- **Start Date**: 2024-03-22
- **Completion Date**: 2025-02-28
- **Lead Sponsor**: Alvernia University
### Study Description
The goal of this clinical trial is to compare the effects of different exercises programs in individuals with abnormal knee motion. The main question it aims to answer are:* In individuals with abnormal knee motion and without knee pain, does a weight-bearing exercise program reduce abnormal knee motion during a step-down test better than a non weight-bearing exercise program? Participants will* Perform a stepdown test while undergoing motion analysis and electromyograph (EMG) recording.* Participants will then be placed either into a weight-bearing or non weight-bearing exercise group. Exercises will be performed 3 times per week for 6 weeks.* Further motion analysis and EMG data will be collected to test for differences. Researchers will compare individual results before and after exercise, and between-group results before and after exercise to see if one exercise program helps improved abnormal knee motion more than the other.
### Conditions
- Dynamic Knee Valgus
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- Exercise
### Outcomes
**Primary Outcomes**
- Electromyographic activity of gluteus medius muscle during step-down test
- Electromyographic activity of quadriceps muscle during step-down test
- Electromyographic activity of hamstring muscles during step-down test
**Secondary Outcomes**
- Amount of dynamic knee valgus during step-down test measured with motion analysis
### Location
- **Facility**: Alvernia University, Reading, Pennsylvania, 19607, United States
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## Relationship Between Soft Tissue Volume and Gingival Phenotype: A Novel Classification System
- **NCT ID**: NCT06348823
- **Study ID**: BritishUE
- **Status**: RECRUITING
- **Start Date**: 2024-02-25
- **Completion Date**: 2024-10
- **Lead Sponsor**: Ain Shams University
### Study Description
Different classifications to describe alveolar ridge defects have been published over the past years but no single classification has been developed concerning soft tissue volume around teeth or dental implants. Moreover, while several studies investigated the effect of various augmentation techniques and materials on soft tissue volume change and volume stability there is a real gap of knowledge regarding how to evaluate the available soft tissue volume and when to consider it sufficient or deficient which would definitely improve clinical decision making and treatment planing. Therefore, our primary aim was to assess the application of a novel classification system based on the correlation between buccal soft tissue volume and gingival biotypes and, also to assess the sensitivity of such novel method.
### Conditions
- Gingival Biotype
- Soft Tissue
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
- volume survey
### Outcomes
**Primary Outcomes**
- soft tissue volume - biotype correlation
**Secondary Outcomes**
### Location
- **Facility**: Ahmed Hamdy, Cairo, N/A, 11234, Egypt
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## Dual-Task Training for People With Mild Cognitive Impairment and Mild Dementia
- **NCT ID**: NCT06348810
- **Study ID**: DTT2024
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-05-01
- **Completion Date**: 2025-01-15
- **Lead Sponsor**: Taipei Medical University
### Study Description
Evidence shows that people with dementia have a higher prevalence of sleep disturbance, cognitive decline, behavioral disturbance, and experience motor dysfunction. These symptoms are interrelated. However, few randomized controlled trial (RCT) studies implement dual-task training for mild cognitive impairment and mild dementia, especially for those who experience sleep problems and behavioral disturbances.Therefore, this study aims to analyze the effect of dual-task training in improving global cognitive function, executive function, working memory, sleep, behavioral disturbances, balance, and flexibility among people with mild cognitive impairment and mild dementia.The main questions it aims to answer are:1. . Does dual-task training affect primary outcomes (global cognitive function, executive function, and working memory)2. . Does dual-task training affect secondary outcomes (including sleep quality, behavioral disturbances, balance, and flexibility) for people with mild cognitive impairment and mild dementia?"The length of dual-task training is 6 weeks; sessions are 3 times per week, each session lasts 45 minutes, and total sessions are 18. While the control group receives the usual care. Researchers will compare the experiment and control groups to see the effect of the dual-task training.
### Conditions
- Dementia
- Mild Cognitive Impairment
- Older Adult
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: SUPPORTIVE_CARE
### Interventions
- Dual-task training
- Usual care
### Outcomes
**Primary Outcomes**
- Global cognitive function
- Executive function
- Working memory
**Secondary Outcomes**
- Sleep Quality
- Behavioral disturbance
- Balance
- Flexibility
### Location
- **Facility**: Nursing Home, Malang, Jawa Timur, 65216, Indonesia
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## Phase I Clinical Study of α-PD-L1/DLL3 CAR-T in Patients With R/R SCLC
- **NCT ID**: NCT06348797
- **Study ID**: BHP01-01
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-06-01
- **Completion Date**: 2026-12-31
- **Lead Sponsor**: Sichuan University
### Study Description
A study to evaluate the safety and feasibility of α-PD-L1/4-1BB DLL3 Chimeric Antigen Receptor (CAR)-T (BHP01) in patients with Relapsed/Refractory Small Cell Lung Cancer (SCLC) and determine the appropriate CAR-T cell dose. Next, In dose expansion phase, patients were assign two groups with/without bridge radiotherapy.
### Conditions
- Small Cell Lung Cancer Extensive Stage
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: NA
- **Intervention Model**: SINGLE_GROUP
- **Primary Purpose**: TREATMENT
### Interventions
- α-PD-L1/4-1BB DLL3 CAR-T (BHP01)
### Outcomes
**Primary Outcomes**
- Dose-limiting toxicity (DLT)
**Secondary Outcomes**
- Objective Response Rate (ORR)
- Progression-free survival (PFS)
- Disease control rate (DCR)
- Duration of response (DOR)
- Overall-Survival (OS)
- CAR-T cell numbers
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
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## Screening for Ovarian Malignancy
- **NCT ID**: NCT06348784
- **Study ID**: 11
- **Status**: COMPLETED
- **Start Date**: 2022-01-01
- **Completion Date**: 2023-01-01
- **Lead Sponsor**: Ain Shams Maternity Hospital
### Study Description
Ovarian cancer is the second most common gynecologic malignancy. In 2008, it was the seventh leading cause of cancer deaths in women worldwide. Estimating the risk of malignancy is essential in the management of adnexal masses and several mathematical models and scoring systems have been developed to be used for discrimination between benign and malignant adnexal masses. Knowledge of the specific type of adnexal pathology before surgery is likely to improve patient triage with high accuracy, and it also makes it possible to optimize treatment. The correct identification of stage I cancer is particularly important
### Conditions
- Early Detection of Ovarian Cancer
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
- Assesment of Different NEoplasias in the adenexa model
- Risk of malignancy index
- Histopathologic examination
### Outcomes
**Primary Outcomes**
- Sensitivity, specificity, positive predictive, and negative predictive value of Assessment of Different NEoplasias in the adneXa model for differentiating between benign and malignant ovarian tumors
**Secondary Outcomes**
### Location
- **Facility**: AinShams university maternity hospital, Cairo, N/A, N/A, Egypt
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## Postprandial Inflammation and Nuts (PIN) in Older Adults
- **NCT ID**: NCT06348771
- **Study ID**: Pro2023001579
- **Status**: RECRUITING
- **Start Date**: 2024-03-25
- **Completion Date**: 2025-01-30
- **Lead Sponsor**: Rutgers, The State University of New Jersey
### Study Description
The aging population is rapidly increasing, and it is important to identify dietary factors that can prevent disease and promote health in this group. Legumes, such as peanuts, are a plant-based food high in protein and unsaturated fat making this a healthy choice, but are not consumed frequently enough in older adults. Studies have shown that regular nut consumption is associated with lower adiposity and reduced weight gain and inflammation. Given these findings, this study will examine the postprandial effects of meals with 2 levels of saturated fatty acids (SFA) on metabolic endotoxemia, inflammation and satiety, using a randomized cross-over design. The low SFA meal includes peanuts that are high in monounsaturated fatty acids (MUFA) and this will be compared to a high SFA meal. The results of this study have the potential to provide valuable insights into the role of peanuts in promoting health and preventing disease in at-risk older adults.
### Conditions
- Healthy Aging
- Overweight and Obesity
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: CROSSOVER
- **Primary Purpose**: PREVENTION
### Interventions
- monounsaturated fatty acids (MUFA) peanut meal
### Outcomes
**Primary Outcomes**
- Concentration of Endotoxin
- Concentration of Interleukin-6
**Secondary Outcomes**
- Concentration of Glucose and Insulin
- Concentration of Triglyceride
- Appetite
- Concentration of Inflammatory markers
### Location
- **Facility**: Foran Hall, New Brunswick, New Jersey, 08901, United States
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## Knowledge, Attitudes, And Perceptions of a Group of Egyptian Dental Students Towards Artificial Intelligence
- **NCT ID**: NCT06348758
- **Study ID**: KAP towards AI
- **Status**: ENROLLING_BY_INVITATION
- **Start Date**: 2024-02-11
- **Completion Date**: 2024-08-07
- **Lead Sponsor**: Cairo University
### Study Description
In the context of this ongoing AI revolution, it is essential to ensure that current and future clinical practitioners are up to date regarding this technology's current state and potential. It is valuable to assess the current attitude of clinical dentists and undergraduate students in dentistry regarding the future role of AI.To the best of the author's knowledge, there is no study about Egyptian dental students' views and attitudes regarding the application of AI in dental practice. Therefore, this study aimed to evaluate the attitudes and perceptions of a group of dental students in Egypt towards AI.
### Conditions
- Health Knowledge, Attitudes, Practice
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
- questionnaire
### Outcomes
**Primary Outcomes**
- knowledge, attitudes, and perceptions about artificial intelligence in Dentistry
**Secondary Outcomes**
### Location
- **Facility**: Cairo University- Faculty of Dentistry, Cairo, N/A, N/A, Egypt
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## Trans Thoracic Ultrasound to Assess Diaphragmatic Function in Stable COPD Versus Bronchial Asthma.
- **NCT ID**: NCT06348745
- **Study ID**: diaphragmatic ultrasound
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-04-01
- **Completion Date**: 2026-05-01
- **Lead Sponsor**: Assiut University
### Study Description
* Assessment of diaphragmatic function (excursion, thickness variation, thickness ratio) in COPD and bronchial asthma patients.* Assessment of presence of correlation between diaphragmatic dysfunction and pulmonary function.* Assessment of possible association between diaphragmatic dysfunction and presence of reversibility in pulmonary function post bronchodilator.
### Conditions
- Diaphragm
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: SCREENING
### Interventions
- ultrasound
### Outcomes
**Primary Outcomes**
- diaphragmatic function
**Secondary Outcomes**
- pulmonary function .
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
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## Diagnostic and Prognostic Role of Troponin and Brain Natriuretic Peptide in Pediatric Patients With Cardiomyopathy in Correlation to Echocardiography Findings
- **NCT ID**: NCT06348732
- **Study ID**: biomarkers in cardiomyopathy
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-09-01
- **Completion Date**: 2025-11
- **Lead Sponsor**: Assiut University
### Study Description
This study aims to assess the the role of cardiac biomarkers (troponin and ProBNP) in pediatric Patients with all types of cardiomyopathy in correlation with echocardiography findings .
### Conditions
- Cardiomyopathies
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
### Outcomes
**Primary Outcomes**
- Diagnostic and Prognostic Role of Troponin and Pro BNP in Pediatric Patients with Cardiomyopathy in correlation to Echocardiography findings .
**Secondary Outcomes**
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
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## Medico-economic Evaluation of Robot-assisted Laparoscopy Compared With Conventional Laparoscopy in Hysterectomy for Endometrial Cancer.
- **NCT ID**: NCT06348719
- **Study ID**: 35RC21_9732_ROBOT-ECO-GYN
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-04
- **Completion Date**: 2027-10
- **Lead Sponsor**: Rennes University Hospital
### Study Description
The standard treatment for endometrial cancer is surgery, as long as the stage of the disease and the patient's condition allow. It consists of hysterectomy (TSH) with bilateral adnexectomy. The recommended surgical approach is the minimally invasive or laparoscopic route, whose oncological safety has been demonstrated by the LAP2 study.Since 2010 and the arrival of robotic surgery in gynaecology, the robot-assisted laparoscopic approach has gradually been used for endometrial cancer Hysterectomy.Several studies have suggested that the cost and effectiveness of laparoscopy may vary according to the age and body mass index of the patient.The investigators therefore hypothesise that robot-assisted laparoscopy may be more efficient than conventional laparoscopy for endometrial cancer hysterectomy in the context of an advanced learning curve in France.The investigators therefore hypothesise that robot-assisted laparoscopy could be more efficient than conventional laparoscopy for endometrial cancer hysterectomy in the context of an advanced learning curve in France. The investigators will also test the efficiency of the surgical technique as a function of age and Body mass Index.
### Conditions
- Hysterectomies for Low- or Intermediate-risk Endometrial Carcinoma
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: OTHER
### Interventions
- Robot-assisted laparoscopy
- conventional laparoscopy
- Prospective cohort study
- Retrospective cohort study
- information and consent
- randomization
- Collection of socio-demographic, clinical, biological, imaging and histopathological data, treatment decision, recurrence
- Surgical data collection
- Biological data collection
- Collection of histological data from the surgical specimen
- Phone calls
- Pain assessment
- Collect of data on non-reimbursed transport
- Collect of everyday help
- Collection of the business resumption date
- SF36 questionnaire
- Questionnaire EQ5D-5L
- FIGO Stadium
- Collection of treatments (analgesics and anticoagulants up to J42, complication-related treatments, etc.)
- Collection of adjuvant treatments
- Recording of any complications, emergency room visits/unscheduled consultations, additional work stoppages to the initial one
- Collection of data
### Outcomes
**Primary Outcomes**
- Cost-utility ratio expressed in terms of costs / QALY
**Secondary Outcomes**
- Operating time
- Conversion rate
- Rate and nature of intraoperative complications
- Post-operative complication rate and nature at D42 (Clavien-Dindo classification)
- Post-operative complication rate and nature at M6 (Clavien-Dindo classification)
- Volume of intraoperative blood loss
- Number of RBC, FFP, PC transfused during hospital stay
- Visual analogue scale (VAS) of pain 6h after surgery
- Visual analogue scale (VAS) of pain 24h after surgery
- Visual analogue scale (VAS) of pain D3 after surgery
- Analgesic consumption at D1 after surgery
- Analgesic consumption at D3 after surgery
- Analgesic consumption at D7 after surgery
- Analgesic consumption at D42 after surgery
- EQ-5D-5L at inclusion after surgery
- EQ-5D-5L at D1 after surgery
- EQ-5D-5L at D3 after surgery
- EQ-5D-5L at D7 after surgery
- EQ-5D-5L at D14 after surgery
- EQ-5D-5L at D21 after surgery
- EQ-5D-5L at D42 after surgery
- EQ-5D-5L at M3 after surgery
- EQ-5D-5L at M6 after surgery
- SF-36 at baseline after surgery
- SF-36 at D3 after surgery
- SF-36 at D7 after surgery
- SF-36 at D42 after surgery
- SF-36 at M6 after surgery
- Consumption of care: average length of hospital stay
- Consumption of care: average of number of re-hospitalizations,
- Consumption of care: average of emergency room visits
- Consumption of care: average of number of gynecologist consultations
- Consumption of care: quantity of analgesic(s)
- Consumption of care:
- Consumption of care: average of number of work stoppage(s).
- Time to initiate adjuvant treatment when indicated
- Vital status at 6 months
- Gas recovery time
- QALYs from a collective perspective at D42
- QALYs from a collective perspective at M6.
- Number of patients who underwent each approach
- QALYs and average costs in relation to care consumption of patients included in the prospective cohort and in the randomized controlled trial according to the approach used and subgroups defined by age (<or> to 75 years) and BMI <or> to 30 kg/m2).
- Surgical teams' perception of the benefits and limitations of robotic surgery in this indication, as well as perceived barriers and levers to the deployment of robot-assisted surgery in low- or intermediate-risk endometrial cancer.
- Assessment of the surgeon's physical stress during and at the end of the operation using the Borg scale
- Assessment of the surgeon's physical stress during and at the end of the operation using the NASA-TLX
- Total annual costs of the foreseeable spread of robot-assisted surgery
### Location
- **Facility**: CHU de Lille, Hôpital Jeanne de Flandre, Lille, N/A, 59000, France
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## Effect of Dipeptidyl Peptidase- 4 Inhibitors on Non-Alcoholic Steatohepatitis and Type 1 Diabetes
- **NCT ID**: NCT06348706
- **Study ID**: Ain Shams University25032024
- **Status**: COMPLETED
- **Start Date**: 2022-11-10
- **Completion Date**: 2024-01-15
- **Lead Sponsor**: Ain Shams University
### Study Description
Background: Non-alcoholic steatohepatitis (NASH) is an advanced form of non-alcoholic fatty liver disease (NAFLD) that can precipitate to advanced fibrosis and leads to cardiovascular morbidity and mortality. Many patients with type 1 diabetes mellitus (T1DM) had histological evidence of steatosis and met the histological criteria for NASH. Matrix metalloproteinase-14 (MMP-14) is a type 1 transmembrane proteinase expressed in liver fibrosis and is involved in the development of atherosclerosis and cardiovascular disease. Hepatic dipeptidyl peptidase-4 (DPP-4) expression in NAFLD may be directly associated with hepatic lipogenesis and liver injury. Some studies showed the beneficial effect of dipeptidyl peptidase-4 (DDP-4) inhibitors in NAFLD/NASH for their role in improving hepatic glucose metabolism. Vildagliptin, a DPP-4 inhibitor, could be promising therapeutic agents for NAFLD/NASH.To the best of our knowledge, no previous study assessed the role of DPP-4 inhibitors in adolescent patients with T1DM and NASH.Objectives: This randomized-controlled clinical trial assessed the impact of the oral DPP-4 inhibitor, vildagliptin, as an add-on therapy on NASH in adolescents with T1DM as well as its effect on glycemic control, lipid profile, MMP-14 levels and CIMT as a marker for subclinical atherosclerosis.Methods: This study included 60 adolescents with T1DM and NASH with a mean age 15.6 ± 2.08 years and disease duration ≥ 5 years. Forty age- and sex-matched healthy subjects with a mean age 14.9 ± 3.2 years were enrolled as healthy controls to compare MMP-14 levels. T1DM patients were randomly assigned to receive oral vildagliptin (50 mg daily) with lunch meal for six months or not. Fasting and 2 hours post-prandial blood glucose levels, HbA1c, liver function tests, fasting lipid profile, hepatic steatosis index and triglyceride glucose (TyG) index were assessed. MMP-14 levels were measured by enzyme-linked immunosorbent assay among all patients and healthy controls. CIMT was assessed using Doppler ultrasound and transient elastography with controlled attenuation parameter (CAP) was performed to assess liver stiffness and steatosis stage.
### Conditions
- Diabetes Mellitus, Type 1
- NASH
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- Dipeptidyl peptidase 4 (DPP-4) inhibitor
### Outcomes
**Primary Outcomes**
- Number of participants with treatment-related effect on NASH status in adolescents with type 1 diabetes mellitus
**Secondary Outcomes**
- Number of participants with treatment-related Matrix metalloproteinase-14 (MMP-14) level change
- Number of participants with treatment-related Glycemic control (HbA1c%) level change
### Location
- **Facility**: Nancy Elbarbary, Cairo, N/A, 11361, Egypt
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## Development of Therapeutic Approaches Modulating Molecular Targets Implicated on Cancer Stem Cell-related Aggressiveness
- **NCT ID**: NCT06348693
- **Study ID**: Gliotherapy
- **Status**: RECRUITING
- **Start Date**: 2017-04-19
- **Completion Date**: 2025-11-21
- **Lead Sponsor**: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
### Study Description
Tumors of the central nervous system affect 21 people per 100,000 every year, a figure that refers to countries with advanced economies, with an increase in incidence over time. Experimental evidence suggests that cancer stem cells (CSCs) may play a key role in the malignancy of these tumors. In fact, due to the hypoxic tumor microenvironment, these cells are able to create compensatory pathways that confer stem-like, angiogenic and pro-tumoral functions. Furthermore, it has been demonstrated that brain tumor stem cells are radio- and chemo-resistant and therefore not treatable with the therapeutic protocols currently in use. To date, in fact, there are no definitive treatments for the eradication of brain tumors. In this scenario, sphingolips, a class of lipid deputized to several physiological functions, are also involved in tumor onset, progression, drug resistance, and aggressiveness. In hypoxic tumor microenvironment, CSCs present a modified rheostat in the metabolism of sphingolipid, in favor of Sphingosine-1-phosphate (S1P).S1P is an intermediate of sphingolipid metabolism, formed from sphingosine through the action of sphingosine kinases (SK). Increasing evidence suggests that S1P acts as a tumor-promoting signal, predominantly in the extracellular environment, regulating important cellular properties correlated with tumor potential.The project aims to identify new molecular and metabolic targets involved in the survival and chemo-resistance of tumor stem cells in relation to the tumor microenvironment.
### Conditions
- Glioblastoma
- Glioma
- Glioma Glioblastoma Multiforme
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
- cell isolation from tumor biopsies and biomarker investigation
### Outcomes
**Primary Outcomes**
- Investigation of molecular and metabolic signature of cancer stem cells to assess specific markers related to gliomagenesis and cancerogenesis.
**Secondary Outcomes**
- Biomarker investigation
- Cellular response to pharmacological treatments
### Location
- **Facility**: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, N/A, 20122, Italy
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## The Effect of Video-assisted Episiotomy Repair Training on Anxiety and Self-efficacy Levels in Midwifery Students
- **NCT ID**: NCT06348680
- **Study ID**: AmasyaU-betuluzun-004
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-03-25
- **Completion Date**: 2024-05-15
- **Lead Sponsor**: Amasya University
### Study Description
The goal of midwifery undergraduate education is; To provide students with basic professional knowledge, skills and attitudes in cognitive, affective and psychomotor dimensions. Various practices are used to provide students with midwifery skills. Case studies, maintenance processes, laboratory applications, field studies, simulation application and video monitoring are some of these applications. Each of these approaches, which are especially preferred in applied courses, has an important place in increasing students' self-efficacy and reducing their anxiety. Episiotomy is one of the obstetric interventions that negatively affects the self-efficacy of midwifery students and causes anxiety. Midwives are responsible for performing and caring for episiotomy. In many countries, episiotomy repair training is given to midwifery students using sponges or models. However, today the use of calf tongue, which is very similar to perineal tissue, has become widespread. There are a limited number of studies in the literature using calf tongue simulation. These studies suggested that the practice improved the skills of midwifery students. No study has been found in the literature using video-assisted episiotomy repair training.
### Conditions
- Episiotomy Wound
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: HEALTH_SERVICES_RESEARCH
### Interventions
- Video assisted episiotomy repair training
### Outcomes
**Primary Outcomes**
- State Anxiety Scale
- Episiotomy Skills Self-Efficacy Scale
**Secondary Outcomes**
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
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## Effects of a Short- and Long-term 'Blackboard' Intervention on Ankle Stability in Older Adults
- **NCT ID**: NCT06348667
- **Study ID**: 3184794
- **Status**: RECRUITING
- **Start Date**: 2024-03-07
- **Completion Date**: 2024-06-10
- **Lead Sponsor**: University of Valencia
### Study Description
The goal of this clinical trial is to assess the effectiveness of adding specific Blackboard Training (BB) exercises to conventional physiotherapy in improving foot and ankle parameters essential for fall prevention among older adults.The main questions it aims to answer are:1. Can the addition of BB exercises improve ankle dorsiflexion mobility?2. Can the addition of BB exercises enhance single-leg stability and control of mediolateral displacement of the center of pressure?Participants will be divided into control and intervention groups. Both groups will receive their usual conventional physiotherapy exercises. The intervention group will undergo a 5-week program comprising 10 sessions of BB exercises targeting ankle mobility and balance.Participants will be asked to:* Perform 3 sets of 15 repetitions for assisted ankle dorsiflexion mobility.* Engage in 5 rounds of 40-second balance exercises using the BB.Researchers will compare the intervention group's outcomes with those of the control group to determine the effectiveness of adding BB exercises in improving foot and ankle parameters related to fall prevention.
### Conditions
- Fall
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: PREVENTION
### Interventions
- Specific ankle stability exercises
- Conventional physiotherapy exercises program
### Outcomes
**Primary Outcomes**
- Foot and ankle pain
- Foot and ankle strength
- Foot and ankle ROM
- Ankle dorsiflexion under load
- Center of pressures variations (anteroposterior and mediolateral center of pressure displacement, velocity, and total surface)
- Monopodal stability
- Functional stability
**Secondary Outcomes**
### Location
- **Facility**: Rodrigo Martin-San Agustin, Valencia, N/A, N/A, Spain
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## New Digital Person-based Care Model in Patients With HER2-negative Advanced Breast Cancer
- **NCT ID**: NCT06348654
- **Study ID**: 6392
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-03-30
- **Completion Date**: 2025-01-01
- **Lead Sponsor**: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
### Study Description
The goal of the InPerson study is to employ all resources in a digital listening platform to benefit the quality of life of patients (QoL) with advanced HER2-negative breast cancer.The care pathway of patients with this type of disease represents an optimal setting for the implementation of an innovative narrative medicine pathway that, aided by integrative therapies, aims to support and accompain them in their treatment journey with a continuum of care. Moreover, the narrative medicine platform will implement the actual "static" way to define QoL with the classic Patient-Reported Outcomes (PROs) questionnaires, that reflect the patient status at a certain time point and not as a dinamic entity. It is on the basis of these assumptions that the present application project on the use of the DNMLAB digital narrative diary in the oncology department of the Fondazione Policlinico Gemelli was born.
### Conditions
- Breast Cancer
- Narrative Medicine
- HER2-negative Breast Cancer
- Patient Satisfaction
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
- introduction of digital listening may improve the quality of life of patients withe breast cancer
### Outcomes
**Primary Outcomes**
- Standardized quality-of-life measurement
- Perceived quality of life
- Personalization of the care pathway
- Quality of the patient-physician relationship.
**Secondary Outcomes**
- Interaction between multidisciplinary teams
- Patient involvement and compliance in the care pathway
- lifestyles best suited to positively affect quality of life
- Awareness of disease condition
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
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## Reducing Pain and Increasing Comfort During a Retinopathy of Prematurity Examination
- **NCT ID**: NCT06348641
- **Study ID**: 2011-KAEK-25 2022/12-11
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-04-20
- **Completion Date**: 2025-04-20
- **Lead Sponsor**: Nurgül Tekin
### Study Description
The aim of this study is to investigate the effect of baby massage applied to babies with retinopathy of prematurity on the pain and comfort of the newborn.This was randomised-controlled study in the NICU at the Health Sciences University Bursa High Specialization Training and Research Hospital, Bursa, Turkey. The population of the study will consist of preterms hospitalized in the neonatal intensive care unit during the time period of the study. In the calculation of the sample size, the power level was 80% and the significance level was 5%. When the effect size was determined as 0.8 in the examination of the difference between the experimental and control groups in terms of the premature infant pain profile (PIPP) variable, it was determined by the statistical expert that the number of babies to be included in each group was 26 and 52 babies in total should be included in the study. Based on this, the study sample was determined as 60 preterm infants in 30 experimental and 30 control groups. Block randomization method will be applied in the randomization of the groups.Case report form, PIPP=Premature Infant Pain Scale and Premature Infant Comfort Scale (PBIQ) will be used to collect the study data. Patients included in the study will be examined by the same ophthalmologist.The infant massage to be applied before the examination will be applied by a single nurse=researcher. Video recordings will be taken before and during the ROP examination and evaluations will be made by two neonatal nurses other than the researcher.Infants will be massaged by the researcher in accordance with IAIM guidelines and massage techniques. Total massage time will be equal for each infant.The researcher has an IAIM infant massage certificate. Before starting the infant massage, jewelry will be removed and hands will be washed. In the study, leg and face massage will be applied among the massage techniques in the IAIM guidelines.
### Conditions
- Pain
- Retinopathy of Prematurity
- Premature Baby 26 to 32 Weeks
- Premature Baby 33 to 36 Weeks
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: SUPPORTIVE_CARE
### Interventions
- baby massage
### Outcomes
**Primary Outcomes**
- Pain during examination for retinopathy of prematurity
**Secondary Outcomes**
- Comfort during retinopathy of prematurity examination
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
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## Motivational Interviewing in the Management of Non Alcoholic Fatty Liver Disease
- **NCT ID**: NCT06348628
- **Study ID**: P/38/04/2021
- **Status**: ACTIVE_NOT_RECRUITING
- **Start Date**: 2022-05-31
- **Completion Date**: 2025-07
- **Lead Sponsor**: Madunil Anuk Niriella
### Study Description
The goal of this study is to assess if motivational counselling works to reduce the weight in participants with Non Alcoholic Fatty Liver Disease (NAFLD).
### Conditions
- Non-Alcoholic Fatty Liver Disease
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- Motivational Interview
- Placebo
### Outcomes
**Primary Outcomes**
- Change in weight after 1 year compared to baseline
- Change in Aspartate aminotransferase (AST) level and Alanine aminotransferase (ALT) level after 1 year compared to baseline
- Change in platelet count after 1 year compared to baseline
- Change in waist circumference and hip circumference after 1 year compared to baseline
- Change in total fat percentage and visceral fat percentage after 1 year compared to baseline
**Secondary Outcomes**
- Change in motivation for weight loss after 1 year compared to baseline
- Change in depression, anxiety and stress after 1 year compared to baseline
- Change in quality of life after 1 year compared to baseline
### Location
- **Facility**: Faculty of Medicine, University of Kelaniya, Ragama, Western Province, 11010, Sri Lanka
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## Study Aimed at Evaluation of the Effectiveness and Tolerability of an Anti-cellulite Cream Medical Device
- **NCT ID**: NCT06348615
- **Study ID**: DEFBODY
- **Status**: RECRUITING
- **Start Date**: 2024-01-23
- **Completion Date**: 2024-06-07
- **Lead Sponsor**: ICIM International S.r.l. a socio unico
### Study Description
Post-marketing clinical study conducted on a CE medical device, named Defense Body, cellulite treatment, edematous fibrosclerotic panniculopathy (2nd and 3rd stage pathology), reducing draining cream-gel, to verify its effectiveness and tolerability on a panel of 56 subjects females affected by 2nd and 3rd degree PEF. The effectiveness of the device is measured in terms of reduction in thigh circumference, improvement in the appearance of the skin with reduction of the orange peel appearance and improvement in skin smoothness.
### Conditions
- Cellulite
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: NA
- **Intervention Model**: SINGLE_GROUP
- **Primary Purpose**: TREATMENT
### Interventions
- Anti-cellulite cream-gel Medical Device (DEFBODY)
### Outcomes
**Primary Outcomes**
- First day of study initiation: clinical history; personal and demographic data and previous or concomitant treatments
- First day of study initiation: BMI
- First day of study initiation: Measurement of waist circumference, hip circumference and thigh circumference
- First day of study initiation: digital photographs of the area to be treated
- First day of study initiation: skin profilemetry of the thigh
- First day of study initiation: pinch test
**Secondary Outcomes**
- After 28 days of treatment: recording of any concomitant pharmacological treatments that have occurred.
- After 28 days of treatment: BMI
- After 28 days of treatment: Measurement of waist circumference, hip circumference and thigh circumference
- After 28 days of treatment: digital photographs of the area to be treated
- After 28 days of treatment: skin profilemetry of the thigh
- After 28 days of treatment: pinch test
- After 28 days of treatment: AE or AED or Drop-off
- After 28 days of treatment: satisfaction evaluation and compliance
- After 56 days of treatment: recording of any concomitant pharmacological treatments that have occurred.
- After 56 days of treatment: BMI
- After 56 days of treatment: Measurement of waist circumference, hip circumference and thigh circumference
- After 56 days of treatment: digital photographs of the area to be treated
- After 56 days of treatment: skin profilemetry of the thigh
- After 56 days of treatment: pinch test
- After 56 days of treatment: AE or AED or Drop-off
- After 56 days of treatment: evaluation of compliance
- After 56 days of treatment: overall rating of product satisfaction
### Location
- **Facility**: Dermatology Unit - I.R.C.C.S. Ospedale San Raffaele, Milano, N/A, N/A, Italy
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## Evaluation of Safety & Efficacy for the Prevention of Ocular GVHD With Ophthalmic Tacrolimus vs Cyclosporine in Allo-HSCT
- **NCT ID**: NCT06348602
- **Study ID**: PI23-00201
- **Status**: RECRUITING
- **Start Date**: 2023-08-01
- **Completion Date**: 2025-12-31
- **Lead Sponsor**: Hospital Universitario Dr. Jose E. Gonzalez
### Study Description
Chronic GVHD (cGVHD) is a predominant cause of mortality and disability not related to relapse; it occurs in 30 to 70% of patients. The majority of patients with cGVHD present with ocular involvement with a reported incidence of 40-60%. Symptoms can range from mild dry eye syndrome to severe epithelial defects that can generate corneal perforation and loss of vision. The most accepted pharmacological modality is the topical application of cyclosporine A; on the other hand, tacrolimus has shown greater immunosuppressive power when used in ocular GVHD. However, this effectiveness is limited since by the time the manifestations appear, there is already permanent damage to the lacrimal gland due to the lymphocytic infiltration; so it is necessary to use a prevention strategy before these manifestations appear. Previously, the employment of ocular cyclosporine drops as ocular GVHD prophylaxis was assessed to evaluate safety and effectiveness, showing that it is well tolerated and can limit the appearance of severe dry eye manifestations in a small group of patients. The purpose of this work is to compare the two modalities currently accepted for the treatment of the disease, but in a prophylactic way; topical ciclosporin A against topical tacrolimus, to determine the safety and efficiency of each of them as a preventive measure to limit the risk of developing the appearance of ocular cGVHD and the permanent consequences that this generates.
### Conditions
- Ocular Graft-versus-host Disease
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: PREVENTION
### Interventions
- Cyclosporine ophthalmic solution 0.1%
- Tacrolimus ophthalmic ointment 0.03%
### Outcomes
**Primary Outcomes**
- Incidence of ocular graft-versus-host disease in patients undergoing allo-HSCT receiving topical prophylaxis with Cyclosporine A or Tacrolimus as assessed by the International Consensus Criteria on chronic ocular graft-versus-host disease.
**Secondary Outcomes**
- Incidence of ocular graft-versus-host disease in patients undergoing allo-HSCT receiving topical prophylaxis with Cyclosporine A or Tacrolimus as assessed by the National Institutes of Health Consensus Development Projects on Chronic GVHD scoring system.
- Prevalence of ocular GVHD based on historical records in the hematology service of the University Hospital U.A.N.L. in patients without prophylactic treatment as assessed by the International Consensus Criteria on chronic ocular graft-versus-host disease
- Severity of ocular GVHD based on historical records in the hematology service of the University Hospital U.A.N.L. in patients without prophylactic treatment, as assessed by the International Consensus Criteria on chronic ocular graft-versus-host disease.
- Prevalence of ocular GVHD based on historical records in the hematology service of the University Hospital U.A.N.L. in patients without prophylactic treatment, as assessed by the National Institutes of Health Consensus on Chronic GVHD scoring system.
- Severity of ocular GVHD based on historical records in the hematology service of the University Hospital U.A.N.L. in patients without prophylactic treatment, as assessed by the National Institutes of Health Consensus on Chronic GVHD scoring system.
- Number of participants requiring adjuvant treatment for ocular GVHD in patients receiving prophylactic tacrolimus or cyclosporine for ocular GVHD.
- Prevalence of Dry Eye Disease prior to the HSCT.
- Subtypes of Dry Eye Disease prior to the HSCT
- Number of participants requiring adjuvant treatments for the Dry Eye Disease
- Incidence of other manifestations of acute and chronic GVHD, local or systemic, in patients receiving prophylactic treatment for ocular GVHD.
- Number of participants with topical tacrolimus related adverse events as assessed by a questionnaire for evaluation of adverse drug events
- Number of participants with topical cyclosporine related adverse events as assessed by a questionnaire for evaluation of adverse drug events
### Location
- **Facility**: Hospital Universitario de la U.A.N.L., Nuevo León, Monterrey, 66640, Mexico
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## Orthostatic Hypotension and Blood Pressure Variability in Persons Undergoing Hemodialysis
- **NCT ID**: NCT06348589
- **Study ID**: 2023-05959-01
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-04
- **Completion Date**: 2024-09
- **Lead Sponsor**: Vrinnevi Hospital
### Study Description
High blood pressure is a risk factor for end-stage renal disease and is common in patients undergoing maintenance hemodialysis. Intradialytic hypotension is associated with an adverse prognosis. More knowledge is needed to identify patients at high risk for intradialytic hypotension and dialysis-associated hypotensive episodes. The aim of this observational single-center pilot study is to evaluate whether point-of-care ultrasound measurements may predict intradialytic hypotension and orthostatic blood pressure falls, in patients with chronic kidney disease who undergo maintenance hemodialysis.
### Conditions
- Chronic Kidney Disease Requiring Chronic Dialysis
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
### Outcomes
**Primary Outcomes**
- Intra-dialytic systolic blood pressure fall of 20 mmHg or larger
- Post-dialytic orthostatic systolic blood pressure fall of 20 mmHg or larger
**Secondary Outcomes**
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
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## Phase III Study to Evaluate the Efficacy and Safety of AD-209
- **NCT ID**: NCT06348576
- **Study ID**: AD-209P3
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-04
- **Completion Date**: 2025-02
- **Lead Sponsor**: Addpharma Inc.
### Study Description
The purpose of this study is to evaluate the efficacy and safety of AD-209
### Conditions
- Hypertension,Essential
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- AD-209
- AD-2091
- AD-209 Placebo
- AD-2091 Placebo
### Outcomes
**Primary Outcomes**
- Change rate of MSSBP
**Secondary Outcomes**
### Location
- **Facility**: Korea University Guro Hospital, Seoul, N/A, N/A, Korea, Republic of
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## AGED Diagnostics Liver Disease Assessment
- **NCT ID**: NCT06348563
- **Study ID**: 7437787981
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-05-15
- **Completion Date**: 2025-09-15
- **Lead Sponsor**: Active Genomes Expressed Diagnostics, Corp
### Study Description
Continue development of previously established methods to further validate candidate biomarkers that can discriminate steatosis from NASH and separately stage fibrosis from blood. The first assessment is to conduct test method verification to expand sample size to several hundred samples through whole genome sequencing methods. The second assessment is focused on biomarker validation by comparing targeted sequencing from patient plasma. Several sub- assessments will be conducted to support overall biomarker development efforts.
### Conditions
- NASH With Fibrosis
- NAFLD
- Healthy
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: NON_RANDOMIZED
- **Intervention Model**: SINGLE_GROUP
- **Primary Purpose**: DIAGNOSTIC
### Interventions
- AGED Multiple Target Assay in Healthy Controls
- AGED Multiple Target Assay in NAFLD Participants
- AGED Multiple Target Assay in Fibrosis Participants
### Outcomes
**Primary Outcomes**
- Test Method Verification, Whole genome bisulfite sequencing assessment for liver tissue and plasma
**Secondary Outcomes**
- Biomarker Validation, Targeted Epigenetic Sequencing Assessment
### Location
- **Facility**: AGED Diagnostics, Bethesda, Maryland, 20002, United States
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## Effect of the Association of Berberine Fitosoma® and Monacolin K MonaKoPure® on Glyco-metabolic Parameters in Dysglycemic and Dyslipidemic Patients.
- **NCT ID**: NCT06348550
- **Study ID**: BFMKP 01
- **Status**: RECRUITING
- **Start Date**: 2023-11-30
- **Completion Date**: 2024-09
- **Lead Sponsor**: University of Pavia
### Study Description
The objective of this study is to evaluate the effectiveness of the association Berberina Fitosoma® and monacolin K MonaKoPure® (Berberol® K supplement) compared to placebo on glucidic and lipid parameters in subjects with fasting blood glucose (FPG) values between 100 and 125 mg/dl and with total cholesterol (TC) values ≥ 200 mg/dl.
### Conditions
- Dyslipidemias
- Dysglycemia
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- Berberol® K
- Placebo
### Outcomes
**Primary Outcomes**
- Variation of LDL cholesterol
**Secondary Outcomes**
- Variation of lipid profile
- Change in glycemic status
### Location
- **Facility**: IRCCS Policlinico S. Matteo Foundation, Pavia, N/A, 27100, Italy
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## Effects of Olive Polyphenols in Fibromyalgia Patients
- **NCT ID**: NCT06348537
- **Study ID**: Polyphenol-Fibromyalgia
- **Status**: COMPLETED
- **Start Date**: 2021-01-20
- **Completion Date**: 2023-09-01
- **Lead Sponsor**: Universidad de Granada
### Study Description
To study the effects of a nutritional intervention with an olive (poly)phenol preparation in female patients with FM.
### Conditions
- Fibromyalgia
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- Olive Polyphenols
- Placebo
### Outcomes
**Primary Outcomes**
- Plasma proteome
- Lipid peroxidation
**Secondary Outcomes**
- Aldolase
- C-reactive protein (CRP)
- Impact of fibromyalgia
- Quality of Life
- Red blood cells
- Haemoglobin
- Fibrinogen
- Total cholesterol
- Cholesterol ratio
- LDL cholesterol
- Cortisol
### Location
- **Facility**: University of Jaén, Jaén, N/A, 23071, Spain
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## Ferumoxytol-enhanced Magnetic Resonance Imaging
- **NCT ID**: NCT06348524
- **Study ID**: ferumoxytol_2015
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-08-03
- **Completion Date**: 2025-12-30
- **Lead Sponsor**: Transmed Solutions
### Study Description
There are no current alternatives to diagnostic contrast-requiring imaging for patients with an eGFR \<30mL/min due to the association of gadolinium-based imaging modalities to nephrogenic systemic fibrosis and iodinated contrast-induced kidney injury. Ferumoxytol-enhanced imaging may offer an alternative approach.
### Conditions
- Coronary Artery Disease
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: NA
- **Intervention Model**: SINGLE_GROUP
- **Primary Purpose**: DIAGNOSTIC
### Interventions
- Ferumoxytol injection
### Outcomes
**Primary Outcomes**
- Detect the absence of ≥50% stenosis in the coronary artery tree
**Secondary Outcomes**
- Detect stenosis in proximal and distal segments of the coronary artery tree
- Compare ferumoxtyol enhanced magnetic resonance angiography with stress echocardiography
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
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## XTics - A Gamified Enhancer of Non-Pharmacological Interventions in Tic Disorders
- **NCT ID**: NCT06348511
- **Study ID**: 0165-22-TLV
- **Status**: COMPLETED
- **Start Date**: 2022-07-01
- **Completion Date**: 2022-12-31
- **Lead Sponsor**: Tel-Aviv Sourasky Medical Center
### Study Description
The investigators developed a neuroscientifically-informed gamified tic-therapy platform. The investigators previously identified tic-triggering elements in movies and video games. Next, the investigators employed these elements to generate and validate a gamified intervention protocol, which is based on a video game the investigators designed (called XTics). The study tests the efficacy of the gamified tool integrated in an exposure and response prevention (ERP) protocol to enhance both patient's compliance and clinical outcome.
### Conditions
- Tic Disorders
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: CROSSOVER
- **Primary Purpose**: DIAGNOSTIC
### Interventions
- XTics
### Outcomes
**Primary Outcomes**
- The Tic Yale Global Tic Severity Scale (YGTSS)
- The Parent Tic Questionnaire (PTQ)
- Premonitory Urge for Tic Scale (PUTS)
- The Subjective Units of Distress Scale (SUDS)
- The "Urge Thermometer"
- Rush Videotape Protocol
- Tic-to-tic interval
**Secondary Outcomes**
- The Screen for Child Anxiety Related Emotional Disorders (SCARED)
- The Children Depression Inventory (CDI)
- The Conners' Parent Rating Scale-Revised Long Form (CRS:RL)
- Obsessive Compulsive Inventory-Child Version (OCI-CV)
- The Behavior Rating Inventory of Executive Function (BRIEF)
- The Emotion Regulation Questionnaire (ERQ)
- User Engagement Scale (UES)
### Location
- **Facility**: Sagol Brain Institute, Tel Aviv Sourasky Medical Center, Tel Aviv, N/A, N/A, Israel
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## Pharmacokinetic and Pharmacodynamic of Jia Shen Tablets in Chronic Heart Failure
- **NCT ID**: NCT06348498
- **Study ID**: TSL-TCM-JSP-Ⅰb
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-03-31
- **Completion Date**: 2026-06-30
- **Lead Sponsor**: Tasly Pharmaceutical Group Co., Ltd
### Study Description
Evaluate the pharmacokinetic and pharmacodynamic characteristics of Jia Shen Tablets in patients with Chronic Heart Failure.
### Conditions
- Heart Failure
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: NA
- **Intervention Model**: SINGLE_GROUP
- **Primary Purpose**: TREATMENT
### Interventions
- Jia Shen Tablet
### Outcomes
**Primary Outcomes**
- Pharmacokinetic characteristic evaluation：Maximum observed plasma concentration (Cmax)
- Plasma PK analysis: Time to reach peak or maximum observed concentration following drug administration (Tmax)
- Plasma PK analysis: Area under curve at steady state (AUCss)
**Secondary Outcomes**
- NT-proBNP
- 6-Minutes-Walking-Test (6MWT)
- Echocardiogram results
- NYHA classification
- AEs
### Location
- **Facility**: The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, Tianjin, N/A, China
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## Massive Nasal Bleeding in Patients With NPC Received Curative RT
- **NCT ID**: NCT06348485
- **Study ID**: VGHTCCTC_NPCbleeding001
- **Status**: COMPLETED
- **Start Date**: 1994-12-01
- **Completion Date**: 2024-02-29
- **Lead Sponsor**: Taichung Veterans General Hospital
### Study Description
To investigate the incidence, predictive markers, and survival impact of massive nasal bleeding in nasopharyngeal carcinoma (NPC) patients who received curative radiotherapy (RT) with/without chemotherapy. A total of 1327 patients with previously untreated, biopsy-proven NPC, and no distant metastasis were retrospective reviewed. Investigators analyzed the occurrence rates of massive nasal bleeding between different characteristics and tried to identify important predictive factors. Investigators compared overall survival between patients with and without massive nasal bleeding by Kaplan-Meier method.
### Conditions
- Nasopharyngeal Carcinoma Patients Treated With Curative Radiotherapy
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
- Patients without massive nasal bleeding
- Patients with massive nasal bleeding
### Outcomes
**Primary Outcomes**
- Massive Nasal Bleeding Rate
**Secondary Outcomes**
- Overall Survival
### Location
- **Facility**: Taichung Veterans General Hospital, Taichung, N/A, 407, Taiwan
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## The Predictive Role of Immune-inflammatory Biomarkers and Their Interaction With the Oxytocin System in Trauma-related Psychotherapy Responsiveness
- **NCT ID**: NCT06348472
- **Study ID**: 0004-24-SHA
- **Status**: RECRUITING
- **Start Date**: 2024-03-14
- **Completion Date**: 2028-03-01
- **Lead Sponsor**: Shalvata Mental Health Center
### Study Description
Despite a range of treatments for posttraumatic stress disorder (PTSD), only a small proportion of patients reach full symptomatic remission. Recent developments in the field of neuroscience have been providing compelling evidence to suggest that neurobiological determinants might influence not only the emergence of PTSD, but also its resistance to treatment. Immune-inflammation regulatory processes were found to be active during recovery from PTSD, potentially through interactive relationship with the oxytocin secretion system. This innovative longitudinal study aims to examine the role of inflammatory biomarkers and their interactive effect with the oxytocin (OT) system on the development of PTSD and on treatment response among patients with PTSD symptoms undergoing psychotherapy treatment. Patients (N = 100) suffering from trauma-related distress will be recruited from the trauma clinic in Shalvata Mental Health Center. Participants will be followed for 12 weeks of once-a-week psychotherapy sessions. They will be measured for endogenous OT level and cytokines levels in saliva before and after sessions 1, 6, and 12, and will complete psychotherapy outcome self-report questionnaires following each of these sessions.
### Conditions
- Posttraumatic Stress Disorder
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
### Outcomes
**Primary Outcomes**
- Oxytocin Secretion
- Inflammatory Response: IL-1β
- Inflammatory Response: IL-6
- Inflammatory Response: TNF-α
- Posttraumatic stress disorder symptoms
- Depression severity
- General anxiety symptoms
**Secondary Outcomes**
- Psychological resilience
- Working Alliance
### Location
- **Facility**: Shalvata Mental health Center, Hod HaSharon, N/A, N/A, Israel
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