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## The Impact of Different Feeding Modes on Patients With Intracerebral Hemorrhage
- **NCT ID**: NCT06328946
- **Study ID**: IOE intracerebral hemorrhage
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-03
- **Completion Date**: 2024-12
- **Lead Sponsor**: Copka Sonpashan
### Study Description
This was a multicenter, prospective, randomized controlled clinical trail involved tracheostomized patients with Intracerebral Hemorrhage.The goal of this clinical trial is to compare the clinical effect of Intermittent Oro-esophageal Tube Feeding vs Nasogastric Tube Feeding in Tracheostomized Patients with Intracerebral Hemorrhage. The main questions it aims to answer are:Compared to Nasogastric Tube Feeding, can the Intermittent Oro-esophageal Tube Feeding better improve the nutritional status, extubation of tracheostomy tube, pulmonary infection, neurological deficit of Patients with Intracerebral Hemorrhage Compared to Nasogastric Tube Feeding, is the Intermittent Oro-esophageal Tube Feeding safer.Participants will be divided into two groups randomly, with different nutritional support respectively.
### Conditions
- Intracerebral Hemorrhage
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- Basic treatment
- Intermittent Oro-esophageal Tube Feeding
- Nasogastric Tube Feeding
### Outcomes
**Primary Outcomes**
- Number of cases of successful extubation
**Secondary Outcomes**
- Body mass index
- Concentration of Serum albumin
- Concentration of Hemoglobin
- Clinical Pulmonary Infection Score
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
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## Intermittent Oral Tube on Feeding Amount
- **NCT ID**: NCT06328933
- **Study ID**: IOE feeding amount
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-03
- **Completion Date**: 2024-12
- **Lead Sponsor**: Copka Sonpashan
### Study Description
The goal of this clinical trial is to compare the differences in feeding amount and nutritional status between ischemic stroke patients using Intermittent Oro-esophageal Tube and Nasogastric Tube. Patients will be randomly divided into an observation group and a control group, all receiving routine rehabilitation treatment. On this basis, the observation group will use Intermittent Oro esophageal Tube for enteral nutrition support, while the control group will use Nasogastric Tube. Researchers will compare changes in daily intake and nutritional status of two groups of patients before and after the study to see if Intermittent Oro-esophageal Tube can improve the feeding amount and nutritional status between ischemic stroke patients compared to Nasogastric Tube
### Conditions
- Stroke
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- Nasogastric Tube Feeding
- Intermittent Oro-esophageal Tube Feeding
- comprehensive rehabilitation therapy
### Outcomes
**Primary Outcomes**
- Nutritional status-total protein
- Nutritional status-hemoglobin
- Nutritional status-albumin
- Nutritional status-prealbumin
**Secondary Outcomes**
- Feeding Amount
- Body weight
- Functional Oral Intake Scale
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
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## Intermittent Oro-esophageal Tube on Rehabilitation Therapy Compliance for Stroke
- **NCT ID**: NCT06328920
- **Study ID**: IOE Yicongxing
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-03
- **Completion Date**: 2024-12
- **Lead Sponsor**: Copka Sonpashan
### Study Description
The aim of this clinical trial is to compare Rehabilitation Therapy Compliance of ischemic stroke patients who receive enteral nutrition support through either Intermittent Oro-esophageal Tube or Nasogastric Tube. Patients will be randomly assigned to either an observation group or a control group, with both groups receiving routine rehabilitation treatment. The observation group will receive enteral nutrition support through Intermittent Oro-esophageal Tube, while the control group will receive it through Nasogastric Tube. Researchers will then compare Rehabilitation Therapy Compliance of the two groups.
### Conditions
- Stroke
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- Intermittent Oro-esophageal Tube Feeding
- Nasogastric Tube Feeding
### Outcomes
**Primary Outcomes**
- Rehabilitation Treatment Compliance Questionnaire
**Secondary Outcomes**
- Patient Health Questionnaire-9
- Swallowing Quality of Life questionnaire
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
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## Multifunctional Nutrition Tube on Social Condition and Experience in Cerebralvascular Accident
- **NCT ID**: NCT06328907
- **Study ID**: IOE Social Condition
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-03
- **Completion Date**: 2024-12
- **Lead Sponsor**: Copka Sonpashan
### Study Description
The aim of this clinical trial is to compare the psychological condition and experience of ischemic stroke patients who receive enteral nutrition support through either Intermittent Oro-esophageal Tube or Nasogastric Tube. Patients will be randomly assigned to either an observation group or a control group, with both groups receiving routine rehabilitation treatment. The observation group will receive enteral nutrition support through Intermittent Oro-esophageal Tube, while the control group will receive it through Nasogastric Tube. Researchers will then compare the Social Condition and experience of the two groups.
### Conditions
- Stroke
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- comprehensive rehabilitation therapy
- Intermittent Oro-esophageal Tube Feeding
- Nasogastric Tube Feeding
### Outcomes
**Primary Outcomes**
- Swallowing-Quality of Life questionnaire
**Secondary Outcomes**
- The Reintegration to Normal Living Index
- Functional Oral Intake Scale
- Patient Health Questionnaire-9
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
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## Effect of Different Feeding Modes on Psychological Condition and Experience in Stroke Patients
- **NCT ID**: NCT06328894
- **Study ID**: IOE Psychological
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-03
- **Completion Date**: 2024-12
- **Lead Sponsor**: Copka Sonpashan
### Study Description
The goal of this clinical trial is to compare the differences on Psychological Condition and Experience in ischemic stroke patients using Intermittent Oro-esophageal Tube and Nasogastric Tube. Patients will be randomly divided into an observation group and a control group, all receiving routine rehabilitation treatment. On this basis, the observation group will use Intermittent Oro esophageal Tube for enteral nutrition support, while the control group will use Nasogastric Tube. Researchers will compare Psychological Condition and Experience of two groups.
### Conditions
- Ischemic Stroke
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: SUPPORTIVE_CARE
### Interventions
- Nasogastric Tube Feeding
- Intermittent Oro-esophageal Tube Feeding
- comprehensive rehabilitation therapy
### Outcomes
**Primary Outcomes**
- Generalized Anxiety Disorder 7
**Secondary Outcomes**
- Patient Health Questionnaire-9
- Self-made questionnaire
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
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## Effect of Intermittent Oral Tube on Dysphagia in Parkinson's Disease Patients
- **NCT ID**: NCT06328881
- **Study ID**: IOE Parkinson
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-03
- **Completion Date**: 2024-12
- **Lead Sponsor**: Copka Sonpashan
### Study Description
The goal of this or clinical trial is to explore Intermittent Oro-esophageal Tube Feeding vs. Nasogastric Tube Feeding on nutritional status, dysphagia, and activities of daily living in patients with Parkinson's disease. The main question it aims to answer are:• Can stellate ganglion block improve the nutritional status, dysphagia, and activities of daily living in patients with Parkinson's disease, better than Nasogastric Tube Feeding.Participants will be divided into the control group and observation group evenly. All the patients were provided with routine therapy and given nutritional support by Intermittent Oro-esophageal Tube Feeding and Nasogastric Tube Feeding respectively. The nutritional status, swallowing function, and activities of daily living of the two groups of patients before and after treatment were evaluated.
### Conditions
- Parkinson Disease
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- Comprehensive rehabilitation training
- Intermittent Oro-esophageal Tube
- Nasogastric tube
### Outcomes
**Primary Outcomes**
- Concentration of Serum albumin
- Concentration of Hemoglobin
**Secondary Outcomes**
- Modified Barthel Index
- Functional Oral Intake Scale
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
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## Multifunctional Nutrition Tube in Dysphagia for Nasopharyngeal Carcinoma
- **NCT ID**: NCT06328868
- **Study ID**: IOE Nasopharyngeal Carcinoma
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-03
- **Completion Date**: 2024-12
- **Lead Sponsor**: Copka Sonpashan
### Study Description
Baseline information (demographics, medical history, etc.), nutritional status at admission and after treatment, depression, dysphagia, and quality of life (QOL) after treatment as well as adverse events are compared.Palliation to delayed dysphagia after radiotherapy for nasopharyngeal carcinoma (NPC) continues to be a challenge. Although nasogastric tube feeding (NGT) has been adopted widely, the weaknesses have yet to be improved by another enteral nutrition support mode. This study aims to observe the clinical efficacy of intermittent oro-esophageal tube feeding (IOE) in the treatment of delayed dysphagia after radiotherapy for (NPC). This is a prospective multicenter study with patients with delayed dysphagia after radiotherapy for NPC. Patients enrolled are randomly divided equally into the observation group and the control group. All patients receive conventional care, and the observation group received IOE while the control group received NGT for enteral nutrition support.
### Conditions
- Dysphagia
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- Intermittent Oral-esophageal Tube Feeding
- Nasogastric Tube Feeding
- comprehensive rehabilitation therapy
### Outcomes
**Primary Outcomes**
- Concentration of Hemoglobin
- Concentration of Serum albumin
- Body Mass Index
- Concentration of Serum prealbumin
**Secondary Outcomes**
- Depression
- Functional Oral Intake Scale
- Penetration-Aspiration Scale
- Swallowing-Quality of Life questionnaire
- Feeding amount
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
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## Intermittent Oro-esophageal Tube Feeding on Dysphagia in Stroke Survivor
- **NCT ID**: NCT06328855
- **Study ID**: IOE Dysphagia in Stroke
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-03
- **Completion Date**: 2024-12
- **Lead Sponsor**: Copka Sonpashan
### Study Description
This was a prospective multicenter study. the patients after stroke with were randomly divided into the observation group and the control group. All patients were given comprehensive rehabilitation therapy. During the treatment, enteral nutrition support was provided for the two groups by Intermittent Oro-esophageal tube feeding and nasogastric tube feeding, respectively. Nutritional status, dysphagia, quality of life and depression before and after treatment were compared.
### Conditions
- Stroke
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- Intermittent Oro-esophageal Tube Feeding
- comprehensive rehabilitation therapy
- Nasogastric Tube Feeding
### Outcomes
**Primary Outcomes**
- Penetration-Aspiration Scale
**Secondary Outcomes**
- Body weight
- Nutritional status-total protein
- Nutritional status-albumin
- Yale pharyngeal residue severity rating scale
- Patient health questionnaire-9
- Swallowing Quality of Life questionnaire
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
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## Effect of Multifunctional Nutrition Tube on Cerebral Small Vessel Disease Patients
- **NCT ID**: NCT06328842
- **Study ID**: IOE Cerebral Small Vessel
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-03
- **Completion Date**: 2024-12
- **Lead Sponsor**: Copka Sonpashan
### Study Description
Nasogastric tube feeding (NGT) has been widely used in cerebral small vessel disease (CSVD) patients with dysphagia but has a significant risk of complications. Intermittent Oro-esophageal Tube Feeding (IOE) is an established enteral nutrition approach that can be used with comprehensive rehabilitation therapy. This study aims to explore the clinical effect of IOE vs. NGT on CSVD Patients with Dysphagia. Compared to NGT, IOE, as an enteral nutrition support mode, in CSVD Patients with Dysphagia who received comprehensive rehabilitation therapy, showed advantages in improvement in dysphagia, nutritional status, ADL, QOL, pneumonia, and adverse events, which should be considered as the preferred approach.
### Conditions
- Cerebral Small Vessel Diseases
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- Intermittent Oro-esophageal Tube Feeding
- Nasogastric Tube Feeding
### Outcomes
**Primary Outcomes**
- Video Fluoroscopic Swallowing Study
**Secondary Outcomes**
- Functional Oral Intake Scale
- Body mass index
- Pneumonia
- Activities of daily living
- World Health Organization Quality of Life Assessment Instrument Brief Version
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
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## Intermittent Oral Tube in Alzheimer's Patients
- **NCT ID**: NCT06328829
- **Study ID**: IOE Alzheimer
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-03
- **Completion Date**: 2024-12
- **Lead Sponsor**: Copka Sonpashan
### Study Description
This is a prospective multicenter study with Alzheimer's patients with dysphagia. Patients enrolled are randomly divided equally into the observation group and the control group. All patients receive conventional care, and the observation group received Intermittent Oral-esophageal Tube Feeding while the control group received Nasogastric Tube Feeding for enteral nutrition support. Baseline information (demographics, medical history, etc.), nutritional status at admission and after treatment, depression, dysphagia, and quality of life after treatment are compared.
### Conditions
- Alzheimer Disease
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- Conventional Care
- Intermittent Oral-esophageal Tube Feeding
- Nasogastric tube
### Outcomes
**Primary Outcomes**
- Concentration of Hemoglobin
- Concentration of Serum albumin
- Concentration of Total serum protein
- Concentration of Serum prealbumin
- Body Mass Index
**Secondary Outcomes**
- Pulmonary Infections
- Mini Nutritional Assessment
- Standardized Swallowing Assessment
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
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## Computer-based Training on Cognitive Dysphagia in Stroke Survivors
- **NCT ID**: NCT06328816
- **Study ID**: Computer-based Training
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-03
- **Completion Date**: 2024-12
- **Lead Sponsor**: Copka Sonpashan
### Study Description
This is a multicenter randomized controlled study. The study recruited stroke patients with mild cognitive impairment and dysphagia who were undergoing inpatient rehabilitation treatment in three hospitals in mainland China as the participants (study subjects). The study duration for each participant was 15 days. The subjects were randomly divided into an experimental group and a control group. During the treatment, all patients received routine rehabilitation treatment. In addition, patients in the control group received conventional cognitive training, while patients in the experimental group received computer-assisted cognitive training.
### Conditions
- Dysphagia
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- routine rehabilitation treatment
- Computer-assisted Cognitive Function Training
### Outcomes
**Primary Outcomes**
- Montreal Cognitive Assessment
**Secondary Outcomes**
- The coordination of swallowing
- Penetration-Aspiration Scale
- Swallowing reflex
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
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## Impact of Active Breathing Exercises on Respiratory Rhythm Disorders in Stroke Patients
- **NCT ID**: NCT06328803
- **Study ID**: Active Breathing Exercises
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-03
- **Completion Date**: 2024-12
- **Lead Sponsor**: Copka Sonpashan
### Study Description
The goal of this clinical trial is to explore The Effect of Active Breathing Exercises in Stroke Patients With Respiratory Rhythm Disorder. Patients will be randomly divided into an observation group and a control group, all receiving routine rehabilitation treatment. On this basis, the observation group will be given Active Breathing Exercises. Researchers will compare dysphagia of two groups.
### Conditions
- Stroke
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: SUPPORTIVE_CARE
### Interventions
- Rehabilitation training
- Active Breathing Exercises
### Outcomes
**Primary Outcomes**
- Penetration-Aspiration Scale
**Secondary Outcomes**
- Functional Oral Intake Scale
- Yale Pharyngeal Residue Severity Rating Scale
- Fiberoptic Endoscopic Dysphagia Severity Scale
- Murray Secretion Scale
- Swallowing Quality of Life
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
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## Study of Biomorkers and Rehabilitation Strategies in Functional Motor Disorders (FMD)
- **NCT ID**: NCT06328790
- **Study ID**: PNRR-MAD-2022-12376826
- **Status**: RECRUITING
- **Start Date**: 2023-05-31
- **Completion Date**: 2025-05
- **Lead Sponsor**: Michele Tinazzi, MD, PhD
### Study Description
Functional motor disorders (FMD) are prevalent and highly disabling conditions characterized by abnormal movements (functional weakness, tremor, dystonia) significantly altered by distractive manoeuvres and incongruent with movement disorders seen in specific neurological diseases. FMDs are still misunderstood, diagnosed with delay, and not adequately treated, leading to reduced independence and high healthcare costs. Symptoms are physiologically associated with voluntary movement (distractibility, resolution with placebo) but are reported as involuntary. How this happens is yet a matter of debate. Identifying diagnostic and prognostic disease-specific biomarkers is an unmet need. The investigators will investigate motor, exteroceptive and interoceptive domains in a large cohort of FMD patients by a comprehensive set of behavioural, neurophysiological, and MRI tests. Ad-hoc eXplainable Artificial Intelligence (XAI) methods will develop disease-specific diagnostic and prognostic biomarker algorithms.
### Conditions
- Functional Motor Disorders
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
- Multidisciplinary Rehabilitation Training
- Cross-sectional study on patients with FMD and patients with structural/organic diseases
- Cross-sectional study on patients with FMD and healthy controls (HC)
### Outcomes
**Primary Outcomes**
- Simplified Functional Movement Disorders Rating Scale (S-FMDRS) score
- Multidimensional Fatigue Inventory Scale (MFI-20) score
- Brief Pain Inventory (BPI) score
- Beck Anxiety Inventory (BAI) score
- Beck Depression Inventory (BDI-II) score
- 12-item Short-Form Health Survey (SF-12) score
- Toronto Alexithymia Scale (TAS-20) score
- Direct adn indirect index of Sensory Attenuation (SA)
- Joint angle at the elbow vibrated and reproduced
- N2/P2 amplitude
- Objective/Subjective heart rate ratio
- Cortical thickness and gray matter volumes
- Clinical Global Impression (CGI) score
- Gait speed (cm/sec)
- Swing time (%)
- Stride time (s)
- Stride length (cm)
- Sway area (mm2)
- Stance time (sec)
- Total excursion path (mm)
- Velocity of Cop displacement in the anteroposterior directions (mm/s)
- Velocity of Cop displacement in the mediolateral directions (mm/s)
- Autism spectrum Quotient (AQ)
- Schizotypal Personality Questionnaire (SPQ)
**Secondary Outcomes**
### Location
- **Facility**: Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona, Salerno, Campania, 84131, Italy
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## RESET-SSc: An Open-Label Study to Evaluate the Safety and Efficacy of CABA-201, a CD19-CAR T Cell Therapy, in Subjects With Systemic Sclerosis
- **NCT ID**: NCT06328777
- **Study ID**: CAB-201-003
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-06
- **Completion Date**: 2029-07
- **Lead Sponsor**: Cabaletta Bio
### Study Description
RESET-SSc: A Phase 1/2 Open-Label Study to Evaluate the Safety and Efficacy of CABA-201, a CD19-CAR T cell therapy, in Subjects with Systemic Sclerosis
### Conditions
- Systemic Sclerosis
- Scleroderma
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: NA
- **Intervention Model**: SINGLE_GROUP
- **Primary Purpose**: TREATMENT
### Interventions
- CABA-201
### Outcomes
**Primary Outcomes**
- To evaluate incidence of adverse events
**Secondary Outcomes**
- To evaluate adverse events and laboratory abnormalities
- To characterize the pharmacodynamics (PD)
- To characterize the pharmacokinetics (PK)
- To evaluate efficacy
### Location
- **Facility**: University of Michigan, Ann Arbor, Michigan, 48109, United States
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## A Clinical Trial Evaluating the Safety and Efficacy of CS-101 in Treating Subjects With β-thalassemia
- **NCT ID**: NCT06328764
- **Study ID**: CS-101-11
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-03-20
- **Completion Date**: 2026-01-30
- **Lead Sponsor**: CorrectSequence Therapeutics Co., Ltd
### Study Description
The goal of this open label, single-arm clinical study is to learn about the safety and efficacy of CS-101 in treating β-thalassemia.
### Conditions
- Beta-Thalassemia
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: NA
- **Intervention Model**: SINGLE_GROUP
- **Primary Purpose**: TREATMENT
### Interventions
- CS-101
### Outcomes
**Primary Outcomes**
- Frequency and severity of adverse events(AEs）as assessed by CTCAE v5.0
- Time to neutrophil and platelet engraftment
- Proportion of subjects with engraftment
- Incidence of transplant-related mortality
- All-cause mortality
- Proportion of subjects achieving transfusion independence for at least 6 consecutive months
- Time to last red blood cell(RBC) transfusion
**Secondary Outcomes**
- Change in total hemoglobin(Hb) concentration over time
- Change in fetal hemoglobin(HbF) concentration over time
- Chimerism level in Peripheral blood and bone marrow
### Location
- **Facility**: The First Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi, N/A, China
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## Meditation With Virtual Reality for Cancer Pain Relief in the Pain Therapy and Palliative Care Service
- **NCT ID**: NCT06328751
- **Study ID**: 76043823.0.0000.0004
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-03-31
- **Completion Date**: 2025-08-30
- **Lead Sponsor**: Emily Santos Montarroyos
### Study Description
Cancer is a disabling, challenging and growing global disease. Although early diagnosis and adequate treatment of oncological disease have been developing rapidly, a large part of the population remains without access to specialized services and routinely evolve to symptoms and sequelae with uncontrolled pain, worse quality of life and suffering. Complementary therapies to control pain and improve the well-being of cancer patients are fundamental tools of integrative oncology medicine. This study proposes to use immersive virtual reality to encourage cancer patients to carry out the regular practice of meditation, as an effective tool in pain management and in the search for a better quality of life, based on a structured intervention that encourages autonomy as important part of your treatment. Two studies will be carried out at the Pain Therapy and Palliative Care Service of the Amazonas State Oncology Control Center Foundation (FCECON). Study 1 will be a cross-sectional study to describe the variables associated with the diagnosis and treatment of patients' pain and Study 2 will be a Randomized Controlled Trial that will analyze the impact of an intervention performed with meditation through immersive virtual reality for pain relief. pain in these patients. It is expected that the regular practice of meditation through immersive virtual reality will promote pain relief and improve the quality of life of cancer pain patients.
### Conditions
- Cancer Pain
- Quality of Life
- Palliative Medicine
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- Case group
- Active control group
- Passive control group
### Outcomes
**Primary Outcomes**
- Brief Pain Inventory (Reduced version)
- McGill Quality of Life Questionnaire
**Secondary Outcomes**
- Hospital Anxiety and Depression Scale (HADS)
- The Edmonton Symptom Assessment Scale (ESAS)
- The National Comprehensive Cancer Network® (NCCN) Distress Thermometer
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
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## ELVN-002 With Trastuzumab +/- Chemotherapy in HER2+ Solid Tumors, Colorectal and Breast Cancer
- **NCT ID**: NCT06328738
- **Study ID**: ELVN-002-003
- **Status**: RECRUITING
- **Start Date**: 2024-06-01
- **Completion Date**: 2028-07
- **Lead Sponsor**: Enliven Therapeutics
### Study Description
The purpose of this study is to determine the safety, tolerability, and recommended dose of ELVN-002 in combination with trastuzumab in participants with advanced-stage HER2-positive tumors and in combination with trastuzumab, and chemotherapy in participants with advanced-stage HER2-positive colorectal cancer and breast cancer.
### Conditions
- HER2-positive Breast Cancer
- HER2-positive Gastric Cancer
- HER2 Positive Solid Tumors
- HER2 Amplification
- Colorectal Cancer
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: NON_RANDOMIZED
- **Intervention Model**: SEQUENTIAL
- **Primary Purpose**: TREATMENT
### Interventions
- ELVN-002
- Trastuzumab
- 5-Fluorouracil
- Oxaliplatin
- Capecitabine
- Eribulin
- paclitaxel
- Leucovorin
### Outcomes
**Primary Outcomes**
- Incidence of dose limiting toxicities (DLTs; Phase 1a only)
- Incidence of adverse events (AEs)
- Incidence of laboratory abnormalities
- Incidence of electrocardiogram abnormalities
**Secondary Outcomes**
- PK parameter of area under the curve of ELVN-002 (Phase 1a only)
- PK parameter of maximum concentration of ELVN-002 (Phase 1a only)
- PK parameter of minimum concentration of ELVN-002 (Phase 1a only)
- PK parameter of terminal half life of ELVN-002 (Phase 1a only)
- Confirmed objective response rate (ORR)
- Duration of response (DOR; Phase 1b only)
- Brain metastases response (Phase 1b only)
### Location
- **Facility**: NEXT Virginia, Fairfax, Virginia, 22031, United States
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## Evaluate the Efficacy and Safety of EN001 in Patients With Duchenne Muscular Dystrophy
- **NCT ID**: NCT06328725
- **Study ID**: EN001_POWER
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-03
- **Completion Date**: 2025-11
- **Lead Sponsor**: ENCell
### Study Description
A Multi-center, Randomized, Double-blind, Placebo-controlled, Phase 1/2 Trial to Evaluate the Efficacy and Safety of EN001 in Patients with Duchenne Muscular Dystrophy
### Conditions
- Duchenne Muscular Dystrophy
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- EN001
### Outcomes
**Primary Outcomes**
- <Phase 1> Adverse drug reactions related to dose limiting toxicity (DLT)
- <Phase 1> Adverse drug reactions related to discontinuation of clinical trial drug administration
- <Phase 2> Change in time to stand test (TTSTAND)
**Secondary Outcomes**
- <Phase 1> Time to stand test (TTSTAND) change amount
- <Phase 1> TTSTAND velocity (1/TTSTAND) change amount
- <Phase 1> Time to run/walk 10 meters test (TTRW) change amount
- <Phase 1> TTRW velocity (1/TTRW) change amount
- <Phase 1> North Star Ambulatory Assessment (NSAA) change amount
- <Phase 1> Time to climb 4 steps test (TTCLIMB) change amount
- <Phase 1> TTCLIMB velocity (1/TTCLIMB) change amount
- <Phase 1> 6-minute walk test (6MWT) change amount
- <Phase 1> Changes amount in muscle strength by region
- <Phase 1> Changes amount in parameters related to pulmonary function
- <Phase 1> Changes amount in parameters related to cardiac function
- <Phase 1> Change rate of creatine kinase (CK) at each visit after administration of investigational product compared to baseline (Visit 2)
- <Phase 2> Time to stand test (TTSTAND) change amount
- <Phase 2> TTSTAND velocity (1/TTSTAND) change amount
- <Phase 2> Time to run/walk 10 meters test (TTRW) change amount
- <Phase 2> TTRW velocity (1/TTRW) change amount
- <Phase 2> North Star Ambulatory Assessment (NSAA) change amount
- <Phase 2> Time to climb 4 steps test (TTCLIMB) change
- <Phase 2> TTCLIMB velocity (1/TTCLIMB) change amount
- <Phase 2> 6-minute walk test (6MWT) change amount
- <Phase 2> Changes amount in muscle strength by region
- <Phase 2> Changes amount and rate of change in whole thigh muscle volume and index assessed by MRI
- <Phase 2> Changes amount in parameters related to pulmonary function
- <Phase 2> Changes amount in parameters related to cardiac function
- <Phase 2> Change rate of creatine kinase (CK) at each visit after administration of investigational product compared to baseline (Visit 2)
- <Phase 2> Pediatric Outcomes Data Collection Instrument (PODCI) item score and total score change
- <Phase 2> Pediatric Quality of Life inventory™ (PedsQL™) item scores and total score change
- <Phase 1> Adverse Event
- <Phase 1> Laboratory examination
- <Phase 1> Vital sign
- <Phase 2> Adverse Event
- <Phase 2> Laboratory examination
- <Phase 2> Vital sign
### Location
- **Facility**: Samsung Medical Center, Seoul, N/A, N/A, Korea, Republic of
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## Evaluate the Safety and Efficacy of EN001 in Patients With Charcot-Marie-Tooth Disease Type 1A
- **NCT ID**: NCT06328712
- **Study ID**: EN001_MIRACLE1
- **Status**: RECRUITING
- **Start Date**: 2024-03
- **Completion Date**: 2024-10
- **Lead Sponsor**: ENCell
### Study Description
An Open, Dose-escalation, Phase 1b Clinical Trial to Evaluate the Safety and Efficacy of EN001 in Patients with Charcot-Marie-Tooth Disease type 1A (CMT1A)
### Conditions
- Charcot-Marie-Tooth Disease Type 1A
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: NON_RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- EN001
### Outcomes
**Primary Outcomes**
- Dose limiting toxicity (DLT) and adverse drug reactions related to discontinuation of investigational product administration
**Secondary Outcomes**
- CMTNSv2 score change
- CMT examination score change
- Rasch-modified CMTNSv2 score change
- Rasch-modified CMTES score change
- FDS score change
- ONLS score change
- 10MWT score change
- Change in grade of fatty infiltration in the proximal lower extremities (According to Goutallier classification scale)
- Change in Motor Nerve Conduction Velocity (Unit: m/s)
- Change in Compound Muscle Action Potential (Unit: ㎷)
- Change in Sensory Nerve Action Potential (Unit: ㎶)
- Change in Sensory Nerve Conduction Velocity (Unit: m/s)
- SF-36v2 score change
- Adverse Event
- Vital sign
- Laboratory examination
- electrocardiography
- X-ray
- Physical Examinations
### Location
- **Facility**: Samsung Medical Center, Seoul, N/A, N/A, Korea, Republic of
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## Chaplain-Delivered Compassion Meditation to Improve Spiritual Care of Patients Receiving Stem Cell Transplantation
- **NCT ID**: NCT06328699
- **Study ID**: STUDY00006456
- **Status**: RECRUITING
- **Start Date**: 2023-10-30
- **Completion Date**: 2024-11-15
- **Lead Sponsor**: Emory University
### Study Description
This clinical trial tests the feasibility, implementation and acceptability of chaplain delivered compassion meditation in order to improve spiritual care for patients receiving stem cell transplantation. Hospital chaplains play a vital role in delivering emotional and spiritual care to a broad range of both religious and non-religious patients for a wide variety of stressors, and extensive research indicates that spiritual consults impact patient outcomes and satisfaction. Compassion meditation is a secularized, research-based mindfulness and compassion meditation program designed to expand and strengthen compassion for self and others. Practices include training in attentional stability and increased emotional awareness, as well as targeted reflections to appreciate one's relationship with self and others. By centering the mind, controlling debilitating ruminative thoughts, and cultivating personal resiliency and an inclusive and more accurate understanding of others. Engaging in chaplain delivered compassion meditation may improve the spiritual care for patients receiving stem cell transplantation.
### Conditions
- Lymphoma
- Multiple Myeloma
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: SUPPORTIVE_CARE
### Interventions
- Spiritual Therapy
- Best Practice
### Outcomes
**Primary Outcomes**
- Feasibility - patient enrollment and treatment-specific retention rates
**Secondary Outcomes**
- Patient Characteristics Affecting Acceptability - Chaplain Satisfaction Survey
- Functional Assessment of Cancer Therapy-Bone Marrow Transplant [FACT-BMT]
- Acceptability - Chaplain Satisfaction Survey
### Location
- **Facility**: Emory University Hospital/Winship Cancer Institute, Atlanta, Georgia, 30322, United States
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## Arginine and Whole Brain Radiation Therapy for the Treatment of Patients With Brain Metastases
- **NCT ID**: NCT06328686
- **Study ID**: STUDY00005787
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-05-31
- **Completion Date**: 2026-12-31
- **Lead Sponsor**: Emory University
### Study Description
This early phase I trial evaluates different administration techniques (oral or intravenous) for arginine and tests the safety of giving arginine with whole brain radiation therapy in patients who have cancer that has spread from where it first started (primary site) to the brain (brain metastases). Arginine is an essential amino acid. Amino acids are the molecules that join together to form proteins in the body. Arginine supplementation has been shown to improve how brain metastases respond to radiation therapy. The optimal dosing of arginine for this purpose has not been determined. This study measures the level of arginine in the blood with oral and intravenous dosing at specific time intervals before and after drug administration to determine the best dosing strategy.
### Conditions
- Metastatic Malignant Neoplasm in the Brain
- Metastatic Malignant Solid Neoplasm
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- Arginine
- Biospecimen Collection
- Computed Tomography
- Magnetic Resonance Imaging
- Spectroscopy
- Whole-Brain Radiotherapy
### Outcomes
**Primary Outcomes**
- Peak plasma L-arginine (arginine) and arginine metabolite concentration
**Secondary Outcomes**
- Incidence of adverse events associated with delivering L-arginine with standard fractionation whole brain radiation therapy
- Side effect profile of oral and IV arginine
- Frontal cortex blood volume/flow changes with L-arginine administration
- Describe The Immunological Effects of Oral versus IV Arginine
- Describe The Metabolic Effects of Oral versus IV Arginine
### Location
- **Facility**: Emory University Hospital/Winship Cancer Institute, Atlanta, Georgia, 30322, United States
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## A Study of DM919 Alone and in Combination With Pembrolizumab in Advanced Solid Tumors
- **NCT ID**: NCT06328673
- **Study ID**: DM919-001
- **Status**: RECRUITING
- **Start Date**: 2024-03-01
- **Completion Date**: 2026-03-01
- **Lead Sponsor**: D2M Biotherapeutics Inc.
### Study Description
The goal of this clinical trial is to define a safe and effective dose of DM919 for participants with solid tumorsThe main questions it aims to answer are:What is the safe and effective dose of DM919 when used alone or in combination with pembrolizumab? What cancers can be treated effectively with DM919 alone or in combination with pembrolizumab??Participants will be asked to attend clinic and be given a intravenous infusion of DM919 or DM-919 in combination with pembrolizumab. They will have blood tests and other assessments to measure whether DM-919 will have the effect on tumors.
### Conditions
- Advanced Solid Tumor
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: NON_RANDOMIZED
- **Intervention Model**: SEQUENTIAL
- **Primary Purpose**: TREATMENT
### Interventions
- DM919
- Pembrolizumab
### Outcomes
**Primary Outcomes**
- Number of treatment-emergent events (TEAEs) in Dose Escalation
- RDEs or RP2Ds of DM919 alone and in combination with pembrolizumab
**Secondary Outcomes**
- All cohorts
- All cohorts
- All cohorts
- All cohorts
### Location
- **Facility**: NEXT Oncology, San Antonio, Texas, 78216, United States
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## Refitting Multifocal Contact Lens Wearers With a Different Multifocal Contact Lens
- **NCT ID**: NCT06328660
- **Study ID**: EX-MKTG-155
- **Status**: ACTIVE_NOT_RECRUITING
- **Start Date**: 2024-02-15
- **Completion Date**: 2024-06-18
- **Lead Sponsor**: Coopervision, Inc.
### Study Description
The purpose of this study is to compare ease of handling and vision acuity of two multifocal contact lenses to correct presbyopia that are currently CE marked and on the UK market.
### Conditions
- Presbyopia
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: NON_RANDOMIZED
- **Intervention Model**: SEQUENTIAL
- **Primary Purpose**: TREATMENT
### Interventions
- Lens 1
- Lens 2
### Outcomes
**Primary Outcomes**
- Overall Lens Handling
**Secondary Outcomes**
- Overall logMAR Visual Acuity
### Location
- **Facility**: Ocular Technology Group, London, N/A, SW1E6AU, United Kingdom
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## Quantra Point-of-Care Hemostasis Monitoring
- **NCT ID**: NCT06328647
- **Study ID**: 24-010
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-05-01
- **Completion Date**: 2026-12-31
- **Lead Sponsor**: The Cleveland Clinic
### Study Description
The investigators will test the hypothesis that utilization of a blood and blood component transfusion algorithm guided by the POC Quantra QPlus System in patients undergoing complex cardiac surgery will reduce RBC, plasma, cryoprecipitate, and platelet transfusion during surgery and the first 12 postoperative hours, compared to standard of care (central laboratory transfusion monitoring at the primary anesthesia provider's discretion).
### Conditions
- Bleeding
- Hemostatic Disorder
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- POC Quantra QPlus System
- Routine care
### Outcomes
**Primary Outcomes**
- Blood and blood component transfusions
**Secondary Outcomes**
- Bleeding
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
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## Bacillus Cereus Infection of Patients Diagnosed at Nîmes University Hospital
- **NCT ID**: NCT06328634
- **Study ID**: LOCAL/2014/FV-01
- **Status**: COMPLETED
- **Start Date**: 2008-01-01
- **Completion Date**: 2012-12-31
- **Lead Sponsor**: Centre Hospitalier Universitaire de Nīmes
### Study Description
OBJECTIVES:We aimed to study the characteristics of patients presenting with a Bacillus cereus infection in a university hospital.METHODS:We performed a retrospective analysis of the clinical, biological, and treatment-related data of patients hospitalized in our university hospital between January 1st, 2008 and December 31st, 2012 and diagnosed with a B. cereus infection. We identified a subgroup of patients presenting with bacteremia and looked for risk factors for death within that group of patients.
### Conditions
- Bacillus Cereus Infection
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
### Outcomes
**Primary Outcomes**
- descriptive analysis of patients' characteristics and B. cereus infection or colonization.
**Secondary Outcomes**
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
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## Lung Cancer Risk Assessment and Etiology
- **NCT ID**: NCT06328621
- **Study ID**: 19594
- **Status**: RECRUITING
- **Start Date**: 2021-07-02
- **Completion Date**: 2029-06-15
- **Lead Sponsor**: City of Hope Medical Center
### Study Description
This study examines the biological and social determinants that may increase the risk for lung cancer in patients and never-smoking individuals. Biological characteristics of a person can include their genetics and social determinants of a person can include their education, income, and environment, all of which can impact their health. Information collected in this study may help increase early detection of lung cancer.
### Conditions
- Lung Carcinoma
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
- Biospecimen Collection
- Computed Tomography
- Electronic Health Record Review
- Survey Administration
### Outcomes
**Primary Outcomes**
- Frequency of germline alterations
**Secondary Outcomes**
### Location
- **Facility**: City of Hope Medical Center, Duarte, California, 91010, United States
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## A Study to Learn About the Safety and Effects of the Study Drug PRX-102 in Children and Adolescents With Fabry Disease
- **NCT ID**: NCT06328608
- **Study ID**: CLI-06657AA1-01
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-10
- **Completion Date**: 2028-03
- **Lead Sponsor**: Chiesi Farmaceutici S.p.A.
### Study Description
A Study to Learn About the Safety and Effects of the Study Drug PRX-102 in Children and Adolescents with Fabry Disease.
### Conditions
- Fabry Disease
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: NA
- **Intervention Model**: SINGLE_GROUP
- **Primary Purpose**: TREATMENT
### Interventions
- PRX-102 1 mg/kg every two weeks
### Outcomes
**Primary Outcomes**
- Incidence of Treatment Emergent Adverse Events (TEAEs)
- Incidence of Infusion Related Reactions (IRRs)
- Incidence of Injection site reactions (ISRs)
- Change in Tanner stage
- Change from baseline of 12-lead ECG quantitative parameters: Mean Heart Rate
- Change from baseline of 12-lead ECG quantitative parameters: PR Interval
- Change from baseline of 12-lead ECG quantitative parameters: QRS Duration
- Change from baseline of 12-lead ECG quantitative parameters: QT Interval
- Change from baseline of 12-lead ECG quantitative parameters: QTc Interval
- Change from baseline of 12-lead ECG quantitative parameters: ST Segment
- Incidence of treatment-emergent Anti-Drug Antibodies (ADAs)
- Incidence of premedication use at each visit and change of infusion premedications from baseline
- Pharmacokinetics: Time to maximum plasma concentration (tmax)
- Pharmacokinetic : Area under the plasma concentration-time curve from time 0 to time t (AUC0 t)
- Pharmacokinetics: Area under the curve from time 0 to 2 weeks (AUC0-2wk)
- Pharmacokinetics: Area under the curve from time 0 to infinity (AUC0-∞)
- Pharmacokinetics: Terminal half-life (t1/2)
- Pharmacokinetics: Area under the curve over a dosing interval (AUCτ)
- Pharmacokinetics: Observed drug concentration at the end of the dosing interval (Cτ)
- Pharmacokinetics: Clearance (Cl)
- Pharmacokinetics: Volume of distribution (Vz)
- Change in eGFR
- Change in annualized eGFR slope
- Change in urine albumin levels
- Change in urine protein levels
- Change from baseline in LVMi as assessed by echocardiogram
- Change from baseline in LVMi as assessed by echocardiogram
- Change from baseline in LVMi as assessed by echocardiogram
- Change from baseline in LVMi as assessed by echocardiogram
- Change from baseline in LVMi as assessed by echocardiogram
- Incidence of any cardiac arrythmias as assessed by Holter ECG
- Change in plasma levels of cardiac biomarkers
- Change in plasma level of Gb3 concentration (nM)
- Change in plasma level of lyso-Gb3 (nM)
- Change in urine level of lyso-Gb3 (nM)
- Incidence of change from baseline in the number of different pain medications
- Incidence of Fabry Clinical Events
- Change from baseline of Mainz Severity Score Index (MSSI) scores
- Change from baseline of PedsQL-GI (or GSRS for subjects who reaches 18 yrs of age) scores
- Change from baseline of FPHPQ scores
- Change from baseline of PedsQL-PPQ (or BPI-SF for subjects who reaches 18 yrs of age) scores
- Change from baseline of EQ-5D-Y (or EQ-5D-5L for subjects who reaches 18 yrs of age) scores
**Secondary Outcomes**
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
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## Muscular and Joint Symptoms in COVID-19 Patients: Insights From Syria
- **NCT ID**: NCT06328595
- **Study ID**: Cross sectional
- **Status**: COMPLETED
- **Start Date**: 2022-04-22
- **Completion Date**: 2023-08-20
- **Lead Sponsor**: Syrian Private University
### Study Description
Observation study, shows the relation between musckeloskeletal symptoms with during and post Covid-19 infection, by asking participants questions about there age,job,which vaccination covid participants took, residual area, social status, number of time of covid-19 infection, number of joint affected and duration of joint pain and asking if there any malaise or fatigue
### Conditions
- Musculoskeletal Pain
- COVID-19
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
### Outcomes
**Primary Outcomes**
- The Demographic characteristics were classified into four groups: Gender, Residual area, education level.
**Secondary Outcomes**
### Location
- **Facility**: Mohamad Zaid Ahmad Abdalla, Damascus, N/A, N/A, Syrian Arab Republic
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## Acupuncture Technique for Restoring Consciousness on Post-stroke Dysphagia
- **NCT ID**: NCT06328582
- **Study ID**: Zhenjiu Post-stroke dysphagia
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-03
- **Completion Date**: 2024-12
- **Lead Sponsor**: Copka Sonpashan
### Study Description
This is a randomized controlled study, including post-stroke dysphagic patients. The participants were divided randomly into the experimental group and the control group. Both two groups were given routine treatment and swallowing rehabilitation training. Moreover, the experimental group was given Acupuncture Technique for Restoring Consciousness. Swallowing function will be compared before and after treatment.
### Conditions
- Dysphagia
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: SUPPORTIVE_CARE
### Interventions
- Routine rehabilitation training
- Acupuncture Technique for Restoring Consciousness combined with Scalp Acupuncture
### Outcomes
**Primary Outcomes**
- Penetration-Aspiration Scale
**Secondary Outcomes**
- Functional Oral Intake Scale
- Gugging Swallowing Screen
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
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## Virtual Reality Therapy on Dysphagia in Wallenberg Syndrome
- **NCT ID**: NCT06328569
- **Study ID**: VR Wallenberg Syndrome
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-03
- **Completion Date**: 2024-12
- **Lead Sponsor**: Copka Sonpashan
### Study Description
The goal of this clinical trial is to learn about on dysphagia in wallenberg syndrome. The main questions it aims to answer are:the efficacy of Virtual Reality Therapy in the rehabilitation of patients with dysphagia in Wallenberg syndrome.Participants received conventional dysphagia treatment and Virtual Reality Therapy once a day for 14 days. Researchers compared the control group to see the effect and mechanism of Virtual Reality Therapy.
### Conditions
- Wallenberg Syndrome
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: SUPPORTIVE_CARE
### Interventions
- Virtual Reality Therapy
- Conventional dysphagia treatment
### Outcomes
**Primary Outcomes**
- standardized swallowing assessment
**Secondary Outcomes**
- Murray secretion scale
- penetration-aspiration scale
- swallowing-quality of life
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
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## Ultrasound-guided Botulinum Toxin Injection on Cricopharyngeal Muscle Dysfunction
- **NCT ID**: NCT06328556
- **Study ID**: Ultrasound-guided Botulinum
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-03
- **Completion Date**: 2024-12
- **Lead Sponsor**: Copka Sonpashan
### Study Description
Ultrasound-guided injection is a visual, convenient, and radiation-free technique that allows real-time observation of the needle insertion process and drug injection location. The combination with a balloon for fixation further enhances the precision of the injection. In this study, the investigators employed ultrasound-guided injection combined with balloon localization for cricopharyngeal muscle botulinum toxin injection treatment and conducted clinical observations.
### Conditions
- Cricopharyngeal Achalasia
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: NA
- **Intervention Model**: SINGLE_GROUP
- **Primary Purpose**: TREATMENT
### Interventions
- botulinum toxin type A
- Injection
### Outcomes
**Primary Outcomes**
- functional oral intake scale
**Secondary Outcomes**
- Penetration-Aspiration Scale
- The Fiberoptic Endoscopic Dysphagia Severity Scale
- Murray secretion scale
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
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## Itch Sensation Induced by Multiple Applications of Pruritogens (Temporal Summation)
- **NCT ID**: NCT06328543
- **Study ID**: N-20210046 4th project
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-04-01
- **Completion Date**: 2026-12-31
- **Lead Sponsor**: Aalborg University
### Study Description
In This experiment, the investigators would like to design a new itch model based on the temporal summation of pruritic stimuli. The hypothesis behind this study (temporal summation) is that two overlapped applications of pruritogens will result in a higher itch sensation compared with a single application.
### Conditions
- Histamine
- Cowhage
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: SINGLE_GROUP
- **Primary Purpose**: BASIC_SCIENCE
### Interventions
- Histamine
- Cowhage
### Outcomes
**Primary Outcomes**
- Assessment of itch
- Assessment of pain
**Secondary Outcomes**
- Microvascular reactivity
- Alloknesis
- Mechanically evoked itch
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
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## Itch Sensation Induced by Simultaneous Application of Pruritogens (Spatial Summation)
- **NCT ID**: NCT06328530
- **Study ID**: N-20210046 3rd project
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-04-01
- **Completion Date**: 2026-12-31
- **Lead Sponsor**: Aalborg University
### Study Description
In This experiment, the investigators would like to design a new itch model based on the spatial summation of pruritic stimuli. The hypothesis behind this study (spatial summation) is that two simultaneous applications of pruritogens will result in higher itch sensation compared with a single application of pruritogen.
### Conditions
- Histamine
- Cowhage
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: SINGLE_GROUP
- **Primary Purpose**: BASIC_SCIENCE
### Interventions
- Cowhage
- Histamine
### Outcomes
**Primary Outcomes**
- Assessment of itch
- Assessment of pain
**Secondary Outcomes**
- Alloknesis
- Mechanically evoked itch
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
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## The Influence of Nutritional Factors on the Prognosis of Liver Cirrhosis Patients and the Exploration of Predictive Models
- **NCT ID**: NCT06328517
- **Study ID**: 2023-305
- **Status**: RECRUITING
- **Start Date**: 2023-11-01
- **Completion Date**: 2026-11-01
- **Lead Sponsor**: Juan Kang
### Study Description
Cirrhosis is a progressive developing liver disease transforming normal hepatocytes into scar tissue with loss of function.The prevalence of cirrhosis has approximately tripled over the past two decades. With the increasing incidence of chronic liver disease, about 2 million people died from cirrhosis worldwide. Currently, D'Amico stage classification and Child-Pugh and Model for End-Stage Liver Disease (MELD) scores constitute the best tools to predict mortality in patients with Cirrhosis; however, one of their main limitations is the lack of evaluation of the nutritional and functional status. Patients with End-Stage Liver Disease (ESLD) have reduced nutritional intake, hypermetabolism, increased energy expenditure, impaired fasting adaptability, decreased hepatic glycogen reserves, and increased consumption of protein as the main energy donor that often lead to malnutrition, therefore, malnutrition is one of the most common complications in patients with Cirrhosis, is closely related to the increase in morbidity and mortality. Moreover, malnutrition is closely related to the high incidence of infection, ascites, hepatic encephalopathy, and hepatorenal syndrome, and is an independent risk factor affecting the survival rate of patients with End-Stage Liver Disease, including liver transplantation.Therefore, malnutrition should be treated as equally important complications such as ascites and hepatic encephalopathy, and accurate screening, evaluation and appropriate nutritional intervention measures should be taken to improve the prognosis of patients with Cirrhosis. This study aims to establish a nomogram model about nutritional factors to predict the prognosis of patients with Cirrhosis, verify and optimize the model, through the establishment of the model, to more comprehensively evaluate and predict the prognosis of patients with Cirrhosis from the perspective of nutrition, to provide sufficient basis and lay a solid foundation for further nutritional intervention and improve patient prognosis.
### Conditions
- Cirrhosis
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
### Outcomes
**Primary Outcomes**
- Death
**Secondary Outcomes**
- complication
### Location
- **Facility**: The Second Affiliated Hospital of Chongqing Medical University, Chongqing, Chongqing, 400000, China
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## Efficacy of Cashew Nut Protein Immunotherapy
- **NCT ID**: NCT06328504
- **Study ID**: Cashew Protocol
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-03
- **Completion Date**: 2027-04-21
- **Lead Sponsor**: Medical University of Warsaw
### Study Description
It is a randomized, sigle-center, controlled trial to evaluate the effectiveness of oral immunotherapy with cashew protein compared with standard treatment (elimination diet) in pediatric patients with cashew allergy.
### Conditions
- Food Allergy
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- Cashew immunotherapy
### Outcomes
**Primary Outcomes**
- Cashew full tolerance
**Secondary Outcomes**
- Cashew partial tolerance
- OIT safety
- Wheal diamater in skin prick tests
- SIgE and IgG 4 levels
- BAT scores
- Quality of life- FAQLQ
- Air condensate
### Location
- **Facility**: Medical University of Warsaw, Warsaw, Mazowieckie, 02-091, Poland
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## Erdafitinib in Metastatic Steroid-cell Ovarian Cancer
- **NCT ID**: NCT06328491
- **Study ID**: OZUHN-014
- **Status**: COMPLETED
- **Start Date**: 2022-05-30
- **Completion Date**: 2022-08-22
- **Lead Sponsor**: University Health Network, Toronto
### Study Description
This is a single participant study of erdafitinib for the treatment of a patient with metastatic steroid-cell tumor of the ovary.
### Conditions
- Ovarian Cancer
- Steroid Cell Tumor, Malignant
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: NA
- **Intervention Model**: SINGLE_GROUP
- **Primary Purpose**: TREATMENT
### Interventions
- Erdafitinib
### Outcomes
**Primary Outcomes**
- Tumor response
- Overall health status
**Secondary Outcomes**
### Location
- **Facility**: Princess Margaret Cancer Centre, Toronto, Ontario, M5G 2M9, Canada
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## Predictors of Acute Kidney Injury in Critically Ill Children Admitted to PICU.
- **NCT ID**: NCT06328478
- **Study ID**: Predictors of AKI in PICU.
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-05-01
- **Completion Date**: 2025-05-01
- **Lead Sponsor**: Assiut University
### Study Description
Predictors of Acute Kidney Injury in critically ill children admitted to PICU during one year.
### Conditions
- Acute Kidney Injury
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
- Observational prospective study.
### Outcomes
**Primary Outcomes**
- Incidence of acute kidney injury and survival to discharge from the PICU.
**Secondary Outcomes**
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
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## fREEDOM: REsonance for Early Detection Of Breast Cancer Metastases
- **NCT ID**: NCT06328465
- **Study ID**: IEO 1108
- **Status**: RECRUITING
- **Start Date**: 2019-11-22
- **Completion Date**: 2028-12-31
- **Lead Sponsor**: European Institute of Oncology
### Study Description
The aim of this study is to understand whether DWB-MRI (Diffusion Whole Body-Magnetic Resonance Imaging) is useful for early detection of locoregional or distant recurrence and whether early diagnosis influences the prognosis in high-risk populations thanks to the possibility of being able to use a more effective treatment. The primary objective is to evaluate 5-year overall survival (OS) in patients with Human Epidermal Growth Factor Receptor 2 positive (HER2+) or high-risk Triple Negative (TN) undergoing surveillance with DWB-MRI.
### Conditions
- Invasive Breast Cancer
- HER2-positive Breast Cancer
- Triple Negative Breast Cancer
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: NA
- **Intervention Model**: SINGLE_GROUP
- **Primary Purpose**: DIAGNOSTIC
### Interventions
- Diffusion whole body MRI
### Outcomes
**Primary Outcomes**
- 5-year overall survival
**Secondary Outcomes**
- Overall survival of patients underwent local treatment
- Breast cancer specific survival
- Safety of local treatment
- Anxiety assessment
- Health state assessment
- Ability to Cope With Trauma assessment
- Personality assessment
- Acceptability and perception of DWB-MRI
### Location
- **Facility**: European Institute of Oncology, Milan, N/A, 20141, Italy
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## Risk Factors and Impact MASLD in Patients With IBD
- **NCT ID**: NCT06328452
- **Study ID**: MASLD
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-04-01
- **Completion Date**: 2025-06-30
- **Lead Sponsor**: Assiut University
### Study Description
Inflammatory bowel disease (IBD) is a chronic disease characterized by remitting and relapsing inflammation of the gastrointestinal tract. Crohn's disease (CD) and ulcerative colitis (UC) are the two main types of IBD and their incidence and prevalence are increasing.In about 5-50% of patients with IBD, there are several extraintestinal manifestations as primary sclerosing cholangitis, autoimmune/granulomatous hepatitis, and non-alcoholic fatty liver disease (NAFLD).Metabolic dysfunction-associated steatotic liver disease "MASLD"(formerly NAFLD) is a spectrum of hepatic diseases associated with metabolic and cardiovascular disorders, such as obesity, insulin resistance (IR), hypertension, dyslipidemia, impaired glucose tolerance and type 2 diabetes mellitus.The risk factors of developing liver steatosis in patients with IBD remain undetermined. Some studies have supported traditional risk factors, such as type 2 Diabetes mellitus (T2DM), weight gain, or obesity, to contribute to MAFLD development in patients with IBD. Other studies have highlighted the involvement of disease activity, duration, drug-induced liver injury and small bowel surgeries in MAFLD progression.Limited data are available on the frequency and risk factors of MASLD in Egyptian patients with IBD, and no published Egyptian study has addressed the clinical utility of serum steatosis markers in MASLD prediction in IBD population. Moreover, the impact of MASLD on IBD course is unclear. Therefore, we will conduct our study to shed some light on this issue.
### Conditions
- Metabolic Dysfunction-associated Steatotic Liver Disease
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
- FibroScan
### Outcomes
**Primary Outcomes**
- Assess the prevalence and risk factors of metabolic dysfunction associated steatotic liver disease among patients attending inflammatory bowel disease outpatient clinic
- Effect of metabolic dysfunction associated steatotic liver disease on inflammatory bowel disease course
**Secondary Outcomes**
- Performance of serum steatosis markers in prediction of steatosis
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
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## A Study to Evaluate ANS014004 in Subjects With Locally Advanced or Metastatic Solid Tumors
- **NCT ID**: NCT06328439
- **Study ID**: ANS014004-I-CN-01
- **Status**: RECRUITING
- **Start Date**: 2024-03-19
- **Completion Date**: 2028-01-31
- **Lead Sponsor**: Avistone Biotechnology Co., Ltd.
### Study Description
Brief Summary: This is a Phase I, first-in-human, open-label, multi-center study designed to explore the safety, tolerability, PK, and anti-tumor antitumor activity of ANS014004 monotherapy in subjects with locally advanced or metastatic solid tumors.* The study consists of two parts: a dose-escalation part (Part 1) and a dose-expansion part (Part 2). For each subject, the study will consist of a screening period (Day -28 to Day -1), a treatment period (until discontinuation of treatment) and a follow-up period (including safety follow-up and survival follow-up).* During the Treatment Period, subjects will receive ANS014004 single-agent oral administration until the subject meets any treatment termination criteria. 1, The dose-escalation part (Part 1) will consist of a single-dose period and a multiple-dose period (28 days per cycle), participants during dose escalation will receive a single dose of ANS014004 on Day 1 of the single-dose period in order to obtain complete PK parameters for the single dose. There will be a 7-day washout period between the single dosing period and the multiple dosing period at the same dose level. If no dose-limiting toxicity (DLT) occurs during the 7-day washout period, participants will begin Cycle 1 (28 days per cycle) multiple dosing treatment on Day 8, receiving ANS014004 once daily (QD). participants in the backfill cohort will enter the multiple dosing period directly. The specific dose which participant receives will depend on the different cohort assignments. The dose-escalation part (Part 1) will use the initial accelerated titration design (ATD) and the traditional "3 + 3" design to determine the MTD of ANS014004 in subjects with locally advanced or metastatic solid tumors. 2. In the Dose Expansion (Part 2), participants, will receive oral administration of ANS014004 QD at each treatment cycle (28 days per cycle). An end-of-treatment (EOT) visit will be conducted within 7 days of the final dose or investigator decision to discontinue.All subjects will undergo imaging evaluations of their tumors every 8 weeks until disease progression is confirmed by the investigator, the subject begins new antitumor therapy, dies, is lost to follow-up, or withdraws from the study, whichever occurs first.
### Conditions
- Locally Advanced or Metastatic Solid Tumors
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: NA
- **Intervention Model**: SEQUENTIAL
- **Primary Purpose**: TREATMENT
### Interventions
- ANS014004
### Outcomes
**Primary Outcomes**
- Incidence of Adverse Events (AEs)
- Incidence of Serious Adverse Events (SAEs)
- Incidence of dose-limiting toxicities (DLT) as defined in the protocol
- Incidence of baseline laboratory finding, ECG and vital signs changes
- Proportion of patients with radiological response (ORR)
**Secondary Outcomes**
- Objective Response Rate (ORR)
- Duration of Response (DoR)
- Disease Control Rate (DCR)
- Progression free Survival (PFS)
- Overall Survival (OS)
- Pharmacokinetics of ANS014004: Plasma PK concentrations
- Pharmacokinetics of ANS014004: Area under the concentration time curve (AUC)
- Pharmacokinetics of ANS014004: Maximum plasma concentration of the study drug (C-max)
- Pharmacokinetics of ANS014004: Time to maximum plasma concentration of the study drug (T-max)
- Pharmacokinetics of ANS014004: Clearance
- Pharmacokinetics of ANS014004: Half-life
### Location
- **Facility**: Shanghai Chest Hospital, Shanghai, N/A, N/A, China
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## Vitamin D With Omega-3 or Metformin in Osteoarthritis
- **NCT ID**: NCT06328426
- **Study ID**: Anti-osteoarthritis
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-08
- **Completion Date**: 2026-12
- **Lead Sponsor**: Assiut University
### Study Description
To determine the efficacy of vitamin D with omega-3 or metformin for reducing knee symptoms and effusion synovitis in patients with symptomatic knee osteoarthritis.
### Conditions
- Osteoarthritis
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- Vitamin D
- Omega-3
- Metformin
- Placebo
### Outcomes
**Primary Outcomes**
- Effusion-synovitis volume on musculoskeletal ultrasound.
**Secondary Outcomes**
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
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## L-PRF vs PBM on Extraction Socket Healing
- **NCT ID**: NCT06328413
- **Study ID**: KAEK-302
- **Status**: COMPLETED
- **Start Date**: 2020-04-20
- **Completion Date**: 2021-09-21
- **Lead Sponsor**: Akdeniz University
### Study Description
The aim of this study is to compare leukocyte and platelet-rich fibrin (L-PRF) and photobiomodulation (PBM) applications, which have been repeatedly reported to be superior to control groups, in terms of pain, soft tissue and bone healing in tooth extraction sockets.
### Conditions
- Healing Surgical Wounds
- Pain
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- photobiomodulation
- Leukocyte and Platelet Rich Fibrin
### Outcomes
**Primary Outcomes**
- Newly formed bone (Healing at extraction sockets)
**Secondary Outcomes**
- Soft tissue healing
- Probing depth
### Location
- **Facility**: Akdeniz University, Antalya, Merkez, 07058, Turkey
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## A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral Deuremidevir Hydrobromide for Suspension
- **NCT ID**: NCT06328400
- **Study ID**: VV116-RSV-02
- **Status**: RECRUITING
- **Start Date**: 2024-03-27
- **Completion Date**: 2024-08-30
- **Lead Sponsor**: Vigonvita Life Sciences
### Study Description
This trial is a multi dose, randomized, double-blind, placebo-controlled, single center Phase I clinical study. The purpose of this study is to evaluate the safety, tolerability, and PK characteristics of Deuteromide Hydrobromide for Suspension administered multiple times in healthy volunteers.
### Conditions
- Respiratory Syncytial Virus Infections
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- Deuremidevir Hydrobromide for Suspension
- Deuremidevir Hydrobromide for Suspension Placebo
### Outcomes
**Primary Outcomes**
- Incidence of Treatment-Emergent Adverse Events
**Secondary Outcomes**
- Cmax
- Tmax
- AUC0- t
- AUC0-∞
- t1/2
### Location
- **Facility**: Hushan Hospital Fudan university, Shanghai, Shanghai, 201900, China
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## HCQ+ADC vs ADC in the Treatment of Advanced Breast Cancer
- **NCT ID**: NCT06328387
- **Study ID**: SYSKY-2024-064-03
- **Status**: RECRUITING
- **Start Date**: 2024-01-29
- **Completion Date**: 2026-03-01
- **Lead Sponsor**: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
### Study Description
Advanced breast cancer is a special subtype of human breast cancer. Conventional guidelines recommend chemotherapy combined with other adjuvant therapies for this subtype of patients. However, the choice of treatment for these patients after treatment progress is a research hotspot in this field. Trastuzumab Deruxtecan (T-DXd) and Sacituzumab Govitecan (SG) are new ADC drugs targeting HER2 or TROP-2 with high efficacy and low toxicity after the progress of first-line treatment. The autophagy agents hydroxychloroquine or chloroquine has become the only FDA (Food and Drug Administration) approved autophagy inhibitor, and hydroxychloroquine and antibody-drug conjugate(ADC) may have synergistic effects based on the previous work results of our research group.Therefore,we envisage that Trastuzumab Deruxtecan(T-DXd) or Sacituzumab Govitecan (SG) combined with hydroxychloroquine(HCQ) in the treatment of advanced breast cancer in clinical practice has the advantages of improving efficacy and survival.To this end, we intend to conduct a prospective,multi-center, phase I/II clinical trial to evaluate the efficacy and safety of T-DXd or SG in combination with HCQ in patients with advacned breast cancer.
### Conditions
- Advanced Breast Cancer
- Metastatic Breast Cancer
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: NON_RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- Hydroxychloroquine
- Sacituzumab Govitecan
- Trastuzumab Deruxtecan
### Outcomes
**Primary Outcomes**
- Dose Limiting Toxicity, DLT
- Adverse event, AE
- Objective Response Rate, ORR
**Secondary Outcomes**
- Progression-Free Survival, PFS
- Overall Survival, OS
- Clinical Benefit Rate, CBR
- Disease Control Rate, DCR
- The rate of adverse events
- Quality of life scale score, QoL
- Exploration of biomarkers
### Location
- **Facility**: Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, Guangdong, 510120, China
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## Voice and Swallowing Disorders in Adults With and Without Alzheimer's Disease
- **NCT ID**: NCT06328374
- **Study ID**: 240420
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-05
- **Completion Date**: 2026-12
- **Lead Sponsor**: Vanderbilt University Medical Center
### Study Description
This research study is investigating whether people with Alzheimer's disease experience more changes to voice and swallowing than their healthy age-matched peers. The prevalence of swallowing impairments in moderate-severe Alzheimer's Disease is high (85-93%) and voice is also often negatively impacted by Alzheimer's disease. The overall objective of this study is to evaluate the voice and swallowing function of adults with and without Alzheimer's disease. The investigators will also be involving the primary caregivers of individuals with Alzheimer's that are enrolled in the study to better understand the impact of voice and swallowing impairments on the primary caregivers of those with Alzheimer's Disease.Healthy adults and individuals with Alzheimer's disease will:* undergo tests of cough, voice, and swallow function* undergo tests of grip and tongue strength* complete questionnairesCaregivers of individuals with Alzheimer's disease will also complete questionnaires.
### Conditions
- Alzheimer Disease
- Caregiver Burden
- Healthy Aging
- Dysphonia
- Dysphagia
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
### Outcomes
**Primary Outcomes**
- Swallowing safety
- Voluntary cough peak expiratory flow
- Vocal fold bowing index
**Secondary Outcomes**
- Swallowing and Eating Related Fatigue Questionnaire (SERF)
- Swallowing Related Quality of Life Questionnaire (SWAL-QOL)
- Voice Handicap Index (VHI)
- Aging Voice Index (AVI)
- Grip Strength
- Tongue strength
- Clinical frailty scale
- Caregiver Analysis of Reported Experiences with Swallowing Disorders (CARES) Questionnaire
- Caregiver Self-Assessment Questionnaire
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
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## Nordic ORgan Preservation Pilot Approach Nonrandomised Single-Arm Trial for Non-Operative Management of Rectal Cancer
- **NCT ID**: NCT06328361
- **Study ID**: R24008
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-05-01
- **Completion Date**: 2032-12-31
- **Lead Sponsor**: Tampere University Hospital
### Study Description
The goal of this one-arm clinical trial is to implement and study the oncological outcomes of nonoperative management of rectal cancer having complete clinical response to neoadjuvant therapy. The main questions to answer are* if the oncological results of nonoperative management after Nordic practice in chemoradiotherapy indications differ from experiences elsewhere* what is the organ preservation rate* what is the local regrowth rate
### Conditions
- Rectal Cancer
- Rectal Adenocarcinoma
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: NA
- **Intervention Model**: SINGLE_GROUP
- **Primary Purpose**: TREATMENT
### Interventions
- Nonoperative surveillance
### Outcomes
**Primary Outcomes**
- Disease-free survival
**Secondary Outcomes**
- Overall survival
- TME-free survival
- ctDNA-free survival
- Post local regrowth disease-free survival
- Post local regrowth overall survival
- Local regrowth-free survival
- Local recurrence-free survival
- Distant metastases-free survival
- Disease-free survival
- Salvage rate after local regrowth
- Quality of life score
- Complication rates
### Location
- **Facility**: East Tallinn Central Hospital, Tallinn, N/A, N/A, Estonia
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## Assessing the Synergistic Effects of Black Cohosh, Soy Isoflavones, and SDG Lignans (Soloways TM) on Menopausal Symptoms
- **NCT ID**: NCT06328348
- **Study ID**: SW010
- **Status**: COMPLETED
- **Start Date**: 2023-07-18
- **Completion Date**: 2023-12-30
- **Lead Sponsor**: S.LAB (SOLOWAYS)
### Study Description
This clinical trial aimed to evaluate the effectiveness of a combination of Black Cohosh, Soy Isoflavones, and SDG Lignans compared to a placebo in reducing menopausal symptoms in postmenopausal women aged 45-60 years. The study was meticulously designed to be a randomized, double-blind, parallel-group trial, ensuring rigorous scientific standards and participant confidentiality. It received ethical approval and adhered to the Declaration of Helsinki guidelines. Participants were carefully selected based on specific inclusion and exclusion criteria to maintain the study's integrity and relevance to the target population.The trial involved 96 eligible women from the Center for New Medical Technologies registry in Novosibirsk, Russia, divided into two groups through a computer-generated random sequence. One group received the active supplements, while the other received a placebo, with both groups and researchers blinded to the assignments. The supplements and placebos were produced to be indistinguishable in appearance, with dosages designed to maximize absorption and efficacy while minimizing side effects. The primary endpoint was the change in Menopause Rating Scale (MRS) scores, with secondary outcomes focusing on adverse symptoms and key hormonal changes.The study's design also included measures to ensure adherence and minimize bias, such as drug container returns and daily reminders. The involvement of S.Lab (Soloways) was limited to manufacturing the supplements, with the research conducted independently to avoid commercial influence. The sample size calculation indicated that 48 participants per group would provide adequate power to detect significant differences in menopausal symptom reduction, aiming for a high level of confidence and statistical power.
### Conditions
- Menopause Symptoms
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- supplementation
- placebo
### Outcomes
**Primary Outcomes**
- Change in the Menopause Rating Scale (MRS) score
**Secondary Outcomes**
- Follicle-Stimulating Hormone (FSH) change
- Estradiol change
- Number of any adverse events
### Location
- **Facility**: Center of New Medical Technologies, Novosibirsk, Novosibisk Region, 630090, Russian Federation
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## The Effect of Rehabilitation Training on Orthostatic Hypotension in Parkinson's Patients
- **NCT ID**: NCT06328335
- **Study ID**: Orthostatic Hypotension
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-04
- **Completion Date**: 2024-12
- **Lead Sponsor**: Copka Sonpashan
### Study Description
The goal of this clinical trial is to explore raise-bed training Orthostatic Hypotension in Parkinson's Patients. The main question it aims to answer is:Can raise-bed training improve Orthostatic Hypotension in Parkinson's Patients. Patients will be randomly allocated into the control group or the experimental group, all under rehabilitation treatment, the experimental group will be given raise-bed training. The study lasts 21 days for each patient. Researchers will compare Orthostatic Hypotension Questionnaire, Orthostatic Grading Scale, Composite Autonomic Symptom Scale 31 to see if raise-bed training can help improve the symptom
### Conditions
- Orthostatic Hypotension
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- Comprehensive rehabilitation training
- Rise-bed Training
### Outcomes
**Primary Outcomes**
- Composite Autonomic Symptom Scale 31
**Secondary Outcomes**
- Orthostatic Hypotension Questionnaire
- Orthostatic Grading Scale
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
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## Study of Percutaneous Coronary Intervention in Left Main Coronary Artery Disease in Patients With Acute Coronary Syndrome at Sohag University Hospitals
- **NCT ID**: NCT06328322
- **Study ID**: Soh-Med-24-03-02MD
- **Status**: RECRUITING
- **Start Date**: 2024-04-01
- **Completion Date**: 2025-04-01
- **Lead Sponsor**: Sohag University
### Study Description
Acute coronary syndromes (ACS) encompass a spectrum of cardiovascular disorders characterized by the sudden onset of myocardial ischemia. They are primarily caused by atherosclerotic plaque rupture or erosion, leading to partial or complete occlusion of the coronary arteries. Among the various coronary arteries affected, left main coronary artery disease (LMCAD) is of particular concern due to its high anatomical significance and potential for adverse outcomesThe left main coronary artery (LMCA) is responsible for supplying a substantial portion of the left ventricular myocardium, including the interventricular septum and the anterior and lateral walls. Any obstruction or compromise in blood flow within this critical artery can have severe consequences, including myocardial infarction, heart failure, or even sudden cardiac death. The management of LMCAD associated with ACS represents a significant clinical challenge, necessitating prompt and optimal treatment strategiesAmong the various coronary arteries affected by atherosclerosis, left main coronary artery disease (LMCAD) holds particular clinical significance due to its anatomical location and the vital role it plays in supplying a substantial portion of the left ventricular myocardium. The left main coronary artery (LMCA) typically bifurcates into the left anterior descending artery (LAD) and the left circumflex artery (LCX), which together provide blood supply to the majority of the left ventricle, including the interventricular septum and the anterior and lateral wallsThe selection of an appropriate treatment strategy for LMCAD associated with ACS is a complex decision that requires careful consideration of multiple factors, including patient characteristics, coronary anatomy, severity of ischemia, and procedural expertise. The emergence of several clinical trials and observational studies exploring the efficacy and safety of different revascularization strategies has further complicated the decision-making process
### Conditions
- Left Main Coronary Artery Disease With Acute Coronary Syndrome
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
- Percutaneous Coronary Intervention in Left Main Artery Disease
### Outcomes
**Primary Outcomes**
- major adverse cardiac events (MACE)
**Secondary Outcomes**
### Location
- **Facility**: Sohag university Hospital, Sohag, N/A, N/A, Egypt
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## Impact of v Release on Dysphagia in Patients With Traumatic Brain Injury
- **NCT ID**: NCT06328309
- **Study ID**: Myofascial Traumatic Brain
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-03
- **Completion Date**: 2024-12
- **Lead Sponsor**: Copka Sonpashan
### Study Description
The goal of this clinical trial is to explore Clinical Effect of Myofascial Release Therapy in Dysphagic Traumatic Brain injured Survivors. The main question it aims to answer is:• Can Myofascial Release Therapy improve swallowing function in Traumatic Brain injured Survivors? Patients will be randomly allocated into the control group or the experimental group, all under rehabilitation treatment, the experimental group will be given Myofascial Release Therapy. The study lasts 21 days for each patient. Researchers will compare the Functional Oral Intake Scale, Penetration-Aspiration Scale, Swallowing Quality of Life to see if the Myofascial Release Therapy can help improve the situation.
### Conditions
- Traumatic Brain Injury
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- Rehabilitation treatment
- Myofascial Release Therapy
### Outcomes
**Primary Outcomes**
- Penetration-Aspiration Scale
**Secondary Outcomes**
- Swallowing Quality of Life questionnaire
- Patient health questionnaire-9
- Functional Oral Intake Scale
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
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## Impact of Myofascial Release on Dysphagia in Parkinson's Disease Patients
- **NCT ID**: NCT06328296
- **Study ID**: Myofascial Parkinson's Dysphag
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-04
- **Completion Date**: 2024-12
- **Lead Sponsor**: Copka Sonpashan
### Study Description
The goal of this clinical trial is to explore Clinical Effect of Myofascial Release Therapy in Dysphagic Parkinson's Patients. The main question it aims to answer is:• Can Myofascial Release Therapy improve swallowing function in Parkinson's Patients? Patients will be randomly allocated into the control group or the experimental group, all under rehabilitation treatment, the experimental group will be given Myofascial Release Therapy. The study lasts 21 days for each patient. Researchers will compare the Functional Oral Intake Scale, Penetration-Aspiration Scale, Swallowing Quality of Life to see if the Myofascial Release Therapy can help improve the situation.
### Conditions
- Parkinson Disease
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: SUPPORTIVE_CARE
### Interventions
- Rehabilitation treatment
- Myofascial Release Therapy
### Outcomes
**Primary Outcomes**
- Penetration-Aspiration Scale
**Secondary Outcomes**
- Swallowing Quality of Life questionnaire
- patient health questionnaire-9
- Functional Oral Intake Scale
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
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## The Diagnostic Efficacy of Glutamine Synthetaseand BCLAF1in Early Diagosis of Hepatocellular Carcinoma in Cirrhotic Patients
- **NCT ID**: NCT06328283
- **Study ID**: Soh-Med-24-02-01MD
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-04-01
- **Completion Date**: 2026-03-01
- **Lead Sponsor**: Sohag University
### Study Description
Hepatocellular carcinoma (HCC) is the most prominent kind of liver cancer, accounting for 85% of primary liver malignancies. It is a very aggressive tumor, having a terrible prognosis and poor survival rate HCC is ranked as the sixth most common type of cancer and the third leading cause of cancer-related mortalities world wide.HCC incidences arise in complications associated with chronic liver disease like cirrhosis, endemic hepatitis B virus (HBV)/hepatitis C virus (HCV) infections, non alcoholic fatty liver disease (NAFLD), and alcohol-related liver disease (Torre, 2015).
### Conditions
- Hepatocellular Carcinoma
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
- measure of Glutamine synthetase and BCLFAF1
### Outcomes
**Primary Outcomes**
- glutamine synthetase
**Secondary Outcomes**
### Location
- **Facility**: Sohag university Hospital, Sohag, Sohagm, N/A, Egypt
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## Comparison of the Therapeutic Effects of Intra-Articular Injection of Ozone and Corticosteroid in Knee Osteoarthritis
- **NCT ID**: NCT06328270
- **Study ID**: 03.09.2019 / 2505
- **Status**: COMPLETED
- **Start Date**: 2020-09-01
- **Completion Date**: 2022-03-30
- **Lead Sponsor**: Sisli Hamidiye Etfal Training and Research Hospital
### Study Description
This clinical trial aimed to involve patients aged 40-85 years who had been experiencing knee pain for at least 6 months and had received a clinical diagnosis of knee osteoarthritis through radiologic imaging. The patients were randomly assigned to two groups. One group received a 3-week intra-articular injection of 15 mg/ml ozone, while the second group received a 1 ml intra-articular injection of betamethasone. All patients were evaluated before treatment, as well as 4 and 12 weeks after the first dose of treatment. The study evaluated treatment efficacy using the Visual Pain Score (VAS) and the Western Ontario and McMaster Universities Arthritis Index (WOMAC).
### Conditions
- Knee Osteoarthritis
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- Ozone - oxygen Therapy
- Corticosteroid
### Outcomes
**Primary Outcomes**
- Visual Pain Score
- Western Ontario and McMaster Universities Arthritis Index
**Secondary Outcomes**
- Visual Pain Score
- Western Ontario and McMaster Universities Arthritis Index
### Location
- **Facility**: University of Health Sciences, Şişli Hamidiye Etfal Training and Research Hospital, Istanbul, N/A, N/A, Turkey
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## Impact of Myofascial Release on Preventing Dysphagia in the Elderly Community
- **NCT ID**: NCT06328257
- **Study ID**: Elderly Community Myofascial
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-05
- **Completion Date**: 2024-08
- **Lead Sponsor**: Copka Sonpashan
### Study Description
The goal of this clinical trial is to explore the impact of Myofascial Release Training on swallowing function and quality of life in community-dwelling elderly individuals (≥60 year old) with swallowing disorders. It primarily aims to address the effects of Myofascial Release Training on swallowing function and quality of life in community-dwelling elderly individuals with swallowing disorders. All participants are required to undergo a continuous three-week (21 days) Myofascial Release Training, with weekends off and training conducted only on weekdays. The training will be conducted two sessions per day, lasting 15-30 minutes each.
### Conditions
- Dysphagia
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: NA
- **Intervention Model**: SINGLE_GROUP
- **Primary Purpose**: PREVENTION
### Interventions
- Myofascial Release Training
### Outcomes
**Primary Outcomes**
- Swallowing-Related Quality of Life Questionnaire
**Secondary Outcomes**
- Time consumed in eating
- Functional Oral Intake Scale
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
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## Community-Based Swallowing Training for Elderly Individuals: Impact and Benefits
- **NCT ID**: NCT06328244
- **Study ID**: Community-Based Swallowing
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-04
- **Completion Date**: 2024-06
- **Lead Sponsor**: Copka Sonpashan
### Study Description
The goal of this clinical trial is to explore the impact of systematic simple swallowing training on swallowing function and quality of life in community-dwelling elderly individuals (≥60 year old) with swallowing disorders. It primarily aims to address two key aspects: 1) the prevalence of dysphagia among community-dwelling elderly individuals, and 2) the effects of systematic simple swallowing training on swallowing function and quality of life in community-dwelling elderly individuals with swallowing disorders. All participants are required to undergo a continuous three-week (21 days) systematic simple swallowing training, with weekends off and training conducted only on weekdays. The training will be conducted two sessions per day, lasting 15-30 minutes each.
### Conditions
- Dysphagia
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- Simple swallowing training
### Outcomes
**Primary Outcomes**
- Eating Assessment Tool-10
**Secondary Outcomes**
- Time consumed in eating
- Swallowing-Related Quality of Life Questionnaire
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
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## The Impact of Swallowing Intervention for Elderly Community Dwellers
- **NCT ID**: NCT06328231
- **Study ID**: Community elderly dysphagia
- **Status**: COMPLETED
- **Start Date**: 2024-03-25
- **Completion Date**: 2024-04-14
- **Lead Sponsor**: Copka Sonpashan
### Study Description
The goal of this clinical trial is to explore the impact of systematic simple swallowing training on swallowing function and quality of life in community-dwelling elderly individuals (≥60 year old) with swallowing disorders. It primarily aims to address two key aspects: 1) the prevalence of dysphagia among community-dwelling elderly individuals, and 2) the effects of systematic simple swallowing training on swallowing function and quality of life in community-dwelling elderly individuals with swallowing disorders. All participants are divided into 2 groups. The intervention group is required to undergo a continuous three-week (21 days) systematic simple swallowing training, with weekends off and training conducted only on weekdays. The training will be conducted two sessions per day, lasting 15-20 minutes each.
### Conditions
- Dysphagia
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: PREVENTION
### Interventions
- Systematic simple swallowing training
### Outcomes
**Primary Outcomes**
- Gugging Swallowing Screen
**Secondary Outcomes**
- Time consumed in eating
- Swallowing-Related Quality of Life Questionnaire
- Eating Assessment Tool-10
### Location
- **Facility**: Railway Commu., Zhenzhou, N/A, N/A, China
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## The Effect of Simple Gymnastics Training for Parkinson's Patients in the Community
- **NCT ID**: NCT06328218
- **Study ID**: Gymnastics ParkinsonCommunity
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-03
- **Completion Date**: 2024-05
- **Lead Sponsor**: Copka Sonpashan
### Study Description
The goal of this clinical trial is to explore the impact of Simple Gymnastics Training on Limb motor function and mental health in Parkinson's Patients in the Community (≥60 year old) with swallowing disorders. It primarily aims to address two key aspects: 1) the prevalence of Parkinson's Diseases among community-dwelling elderly individuals, and 2) the effects of Simple Gymnastics Training on Limb motor function and mental health in community-dwelling Parkinson's Patients. All patients are required to undergo a continuous three-week (21 days) Simple Gymnastics Training, with weekends off and training conducted only on weekdays. The training will be conducted two sessions per day, lasting 30 minutes each.
### Conditions
- Parkinson Disease
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: NA
- **Intervention Model**: SINGLE_GROUP
- **Primary Purpose**: TREATMENT
### Interventions
- Simple Gymnastics Training
### Outcomes
**Primary Outcomes**
- Unified Parkinson's Disease Rating Scale
**Secondary Outcomes**
- The Berg Balance Scale
- Patient Health Questionnaire-9
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
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## Impact of Glossopharyngeal Nerve Block on Swallowing Difficulties Caused by Gastroesophageal Reflux Disease
- **NCT ID**: NCT06328205
- **Study ID**: Glossopharyngeal Nerve Block
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-03
- **Completion Date**: 2024-12
- **Lead Sponsor**: Copka Sonpashan
### Study Description
The goal of this clinical trial is to explore Clinical Effect of Glossopharyngeal Nerve Block on Pharyngeal Dysphagia Induced by Gastroesophageal Reflux Disease. The main question it aims to answer is:• Can Glossopharyngeal Nerve Block improve dysphagia caused by gastroesophageal reflux symptoms on the basis of rehabilitation training? Participants will be randomly allocated into the control group or the experimental group, all under rehabilitation treatment, the experimental group will be given Glossopharyngeal Nerve Block once a day additionally. The study lasts 20 days for each participant. Researchers will compare the Rosenbek penetration-aspiration scale, Gastroesophageal Reflux Disease Questionnaire, Pressure pain threshold, to see if the Glossopharyngeal Nerve Block can help improve the symptom.
### Conditions
- Dysphagia
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- Rehabilitation therapy
- Glossopharyngeal Nerve Block
- Lidocaine Hydrochloride
- placebo injection
### Outcomes
**Primary Outcomes**
- penetration-aspiration scale
**Secondary Outcomes**
- Gastroesophageal Reflux Disease Questionnaire
- Pressure pain threshold
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
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## The Impact of Practicing Active Breathing Exercises on Elderly Individuals Living in the Community
- **NCT ID**: NCT06328192
- **Study ID**: active breathing elderly
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-04
- **Completion Date**: 2024-05
- **Lead Sponsor**: Copka Sonpashan
### Study Description
The goal of this clinical trial is to explore the impact of Active Breathing Exercises on swallowing function and quality of life in community-dwelling elderly individuals (≥60 year old) with swallowing disorders. It primarily aims to address two key aspects: 1) the prevalence of dysphagia among community-dwelling elderly individuals, and 2) the effects of Active Breathing Exercises on swallowing function and quality of life in community-dwelling elderly individuals with swallowing disorders. All participants enrolled are required to undergo a continuous three-week (21 days) Active Breathing Exercises, with weekends off and training conducted only on weekdays. The training will be conducted two sessions per day, lasting 15-30 minutes each.
### Conditions
- Dysphagia
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: NA
- **Intervention Model**: SINGLE_GROUP
- **Primary Purpose**: PREVENTION
### Interventions
- Active Breathing Exercises
### Outcomes
**Primary Outcomes**
- Standardized Swallowing Assessment Scale
**Secondary Outcomes**
- Time consumed in eating
- Swallowing-Related Quality of Life Questionnaire
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
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## Clinical Study Protocol for the Treatment of ND-AML and RR-AML With KMT2A Gene Abnormalities Using VHEA.
- **NCT ID**: NCT06328179
- **Study ID**: KY-2023-058-01
- **Status**: RECRUITING
- **Start Date**: 2022-05-24
- **Completion Date**: 2027-12-30
- **Lead Sponsor**: Huai'an First People's Hospital
### Study Description
This study is a clinical trial aimed at evaluating the efficacy and safety of the VHEA（Venetoclax with Homoharringtonine，Etoposide，Cytarabine）regimen in the treatment of newly diagnosed and relapsed/refractory acute myeloid leukemia (AML) with MLL gene abnormalities.This study includes the induction and consolidation phases of AML treatment.
### Conditions
- Acute Myeloid Leukemia
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: NA
- **Intervention Model**: SINGLE_GROUP
- **Primary Purpose**: TREATMENT
### Interventions
- Venetoclax 100 mg d1，200 mg d2，400 mg d3-14；
### Outcomes
**Primary Outcomes**
- Overall response rate，ORR
**Secondary Outcomes**
- Overall survival, OS
- Event free survival, EFS
- Duration of remission, DOR
### Location
- **Facility**: The Affiliated Huaian No.1 People's Hospital of Nanjing Medical University（Huai'an First People's Hospital）, Huai'an, Jiangsu, 210000, China
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## The Effect and Safety of Recombinant Fibroblast Growth Factor-1 for Carpal Tunnel Syndrome
- **NCT ID**: NCT06328166
- **Study ID**: rFGF-1 for CTS
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-03-22
- **Completion Date**: 2024-12-31
- **Lead Sponsor**: Tri-Service General Hospital
### Study Description
Carpal tunnel syndrome (CTS) is a common peripheral entrapment mononeuropathy of the upper limb, which results from compression of median nerve at level of wrist. In recent years, regenerative medicine has gradually been applied in the treatment of various degenerative conditions such as bones, muscles, and nerves. Human fibroblast growth factor 1 is a single-chain protein , which has been shown to play a crucial regulatory role in the brain and spinal cord and can facilitate nerve cell differentiation and growth. ES135 is a recombinant human fibroblast growth factor 1 (rhFGF1) which is composed of 135 amino acids with a molecular weight of approximately 15.2 kilodalton. Several studies have shown that significant improvement of Functional Independence Measure, motor and sensory function of spinal cord injury patients after ES135 treatment. One study also revealed the muscle strength have significant improvement in brachial plexus injury patients after ES135 therapy. According to above studies, the investigators hypothesized that ES135 may have benefits to CTS patients. Hence, the purpose of this study aim to demonstrate the therapeutic effects and safety of ES135 for CTS.
### Conditions
- Carpal Tunnel Syndrome
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- Sono-guided injection with ES135
- Sono-guided injection with placebo
### Outcomes
**Primary Outcomes**
- Change from baseline of severity of symptoms and functional status on 1st month, 2nd month, 3rd month,4th month, 6th month after injection.
**Secondary Outcomes**
- Change from baseline of pain on 1st month, 2nd month, 3rd month,4th month, 6th month after injection.
- Change from baseline of cross-sectional area of the median nerve on 1st month, 2nd month, 3rd month,4th month, 6th month after injection.
- Change from baseline of conduction velocity, latency of median nerve on 1st month, 2nd month, 3rd month,4th month, 6th month.
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
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## Efficacy and Mechanism of FSN Treatment for Senile Knee Osteoarthritis
- **NCT ID**: NCT06328153
- **Study ID**: BF2022-101
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-03-15
- **Completion Date**: 2026-03-01
- **Lead Sponsor**: Guangdong Provincial Hospital of Traditional Chinese Medicine
### Study Description
The goal of this clinical trial is to compare FSN with oral Nonsteroidal Antiinflammatory Drugs (NSAIDs) in pain relief and improvement in knee function among elder people, the main questions it aims to answer are:Q1: Compared with the positive drug (celecoxib), whether FSN is more or at least as effective for pain relief and improvement in knee function in elder people with knee arthritis.Q2: From the biomechanical point of view, what is the mechanism by which FSN plays a therapeutic role in knee osteoarthritis (KOA)?Participants will:1. Will be randomly assigned to 2 groups. There will be 30 participants in each group.2. A group of patients will receive FSN monotherapy, while the other group will receive oral celecoxib and pantoprazole. Each patient will receive a 2-week course of treatment.3. Visual analogue scale (VAS), WOMAC, knee range of motion (ROM), gait analysis, and musculoskeletal ultrasonography (US) of lower extremity muscles will be assessed during treatment and in the follow-up.Researchers will compare FSN and celecoxib to see if FSN has better, or at least equivalent, efficacy than celecoxib, which is commonly used in clinical practice.
### Conditions
- Osteoarthritis, Knee
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- Fu's Subcutaneous Needling
- Celecoxib
### Outcomes
**Primary Outcomes**
- Change from Baseline in the visual analogue scale (VAS) (0-100 mm) at the 14th day after receiving treatment.
**Secondary Outcomes**
- Change from Baseline in the visual analogue scale (VAS) (0-100 mm) at the 7th day, the 28th day and 42th day after the start of treatment.
- Change from Baseline in The Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index at the 7th day, the 14th day, the 28th day and 42th day after the start of treatment.
- Change from Baseline in the active range of motion (ROM) of the knee at the 7th day,the 14th day,the 28th day and 42th day after the start of treatment.
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
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## Sleep Quality, Cognitive Performance, and Computerized Cognitive Training
- **NCT ID**: NCT06328140
- **Study ID**: Skyland 001
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-04-15
- **Completion Date**: 2026-04-14
- **Lead Sponsor**: George West Mental Health Foundation d/b/a Skyland Trail
### Study Description
Poor sleep quality is common in neuropsychiatric conditions and some of the problems associated with poor sleep at night may be due to medication side effects or reduced efficacy of certain treatments. Poor sleep quality has been implicated in cognitive impairments, with the sleep quality to cognition association so strong that specialized assessments have been developed to examine the subjective association between poor nighttime sleep and daytime cognitive impairment.Computerized cognitive training (CCT) is a training procedure designed to build cognitive skills, with a goal of improvement of functional outcomes. CCT is also a learning-based approach and previous studies have shown that successful CCT interventions lead to changes in brain circuitry. It is also known, however, that many cases who are treated with CCT fail to make treatment-related gains. Recent studies have suggested that this may be associated with failures to engage in the training procedures, which could be related to sleep related impairments.Increased anticholinergic load can also substantially disrupt the process of training related gains directly. Antihistaminergic effects, common to many antidepressant and antipsychotic medications, can lead to daytime sedation and sleepiness, which both interferes with treatment but also interferes with nighttime sleep as wellIn previous clinical trials, Lurasidone was associated with reductions in sleepiness and with cognitive gains that exceeded practice effects. One viable hypothesis is that Lurasidone has both direct beneficial effects on cognition and substantial indirect benefits, due to the lack of histamine receptor occupancy, lack of anticholinergic effects, and direct promotion of positive nighttime sleep outcomes.Thus, a broad-spectrum naturalistic comparison of Lurasidone-treated patients with patients treated with other medications is proposed. This would include examining the level of engagement in CCT treatment, measurement of CCT training gains, and relating engagement and training gains with concurrent sleep quality, measured by actigraphy.
### Conditions
- Bipolar Disorder
- Major Depressive Disorder
- Psychosis
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
- Lurasidone
- FDA Approved antidepressant treatment
### Outcomes
**Primary Outcomes**
- Improvement in Cognitive Performance
**Secondary Outcomes**
- Training Engagement in Cognitive training
- Nighttime sleep measured with actigraphy
### Location
- **Facility**: George West Mental Health Foundation, DBA Skyland Trail, Atlanta, Georgia, 30329, United States
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## Positive Psychology Intervention for Hematopoietic Stem Cell Transplantation Survivors
- **NCT ID**: NCT06328127
- **Study ID**: 23-691
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-06-01
- **Completion Date**: 2029-04-30
- **Lead Sponsor**: Brigham and Women's Hospital
### Study Description
This randomized clinical trial is evaluating the impact of a positive psychology intervention (PATH) on anxiety symptoms, depression symptoms, and quality of life in survivors of hematopoietic stem cell transplant (HSCT) compared to usual care.
### Conditions
- Hematopoietic Stem Cell Transplant
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: SUPPORTIVE_CARE
### Interventions
- PATH
### Outcomes
**Primary Outcomes**
- Anxiety Symptoms based on the Hospital Anxiety and Depression Scale-Anxiety Subscale
**Secondary Outcomes**
- Anxiety Symptoms based on the Hospital Anxiety and Depression Scale-Anxiety Subscale
- Depression Symptoms based on the Hospital Anxiety and Depression Scale-Depression Subscale
- Gratitude based on the Gratitude Questionnaire
- Positive Affect based on the Positive and Negative Affect Schedule Positive Affect Subscale
- Physical function based on the Patient-Reported Outcomes Measurement Information System-Physical Function-20
- Patient-Reported Quality of Life based on the Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT)
### Location
- **Facility**: Moffitt Cancer Center, Tampa, Florida, 33612, United States
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## Accelerating TMS for Cervical Dystonia
- **NCT ID**: NCT06328114
- **Study ID**: Pro00114549
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-07-01
- **Completion Date**: 2029-07-01
- **Lead Sponsor**: Duke University
### Study Description
This study aims to investigate the impact of accelerated transcranial magnetic stimulation (TMS) on brain function and behavior in patients with focal cervical dystonia. Previous research demonstrated that individualized TMS improved writing behavior in focal hand dystonia after one session. In this study, we aim to expand the application on TMS on focal cervical dystonia. The current study administers four TMS sessions in a day. The research involves 9 in-person visits. The effect of TMS will be assessed using functional MRI brain scans and behavioral measurements. The risk of TMS includes seizures; the potential risk of seizures from TMS is mitigated through careful screening, adhering to safety guidelines. The study's main benefit is enhancing dystonic behavior and deepening the understanding of brain changes caused by TMS in cervical dystonia, paving the way for further advancements in clinical therapy for this condition.
### Conditions
- Isolated Cervical Dystonia
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: CROSSOVER
- **Primary Purpose**: TREATMENT
### Interventions
- Transcranial Magnetic Stimulation (TMS)
### Outcomes
**Primary Outcomes**
- Change in Neck Angles as Measured by Neck Sensor Device
**Secondary Outcomes**
- Changes in Brain Activity (bold activity) on Functional Magnetic Resonance Imaging (fMRI)
- Changes in Brain Activity (functional connectivity) on Functional Magnetic Resonance Imaging (fMRI)
- Behavioral Response After Deep Brain Stimulation (DBS), as measured by Neck Angles
### Location
- **Facility**: Duke University Health System, Durham, North Carolina, 27705, United States
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## Autoimmune Pancreatitis, Pancreatic and Extrapancreatic cAnceR (AiPPEAR)
- **NCT ID**: NCT06328101
- **Study ID**: 2023-02558
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-05-01
- **Completion Date**: 2025-04-01
- **Lead Sponsor**: University Medical Center Goettingen
### Study Description
The goal of this observational, retrospective study is to learn about cancer risk in autoimmune pancreatitis (AIP) patients. The main questions it aims to answer are:* Do patients with AIP have higher incidence of cancer in comparison to general population?* What is the overall prevalence of cancer in AIP patients?* What are the characteristics of AIP patients associated with the incidence of cancer?
### Conditions
- Autoimmune Pancreatitis Type 1
- Autoimmune Pancreatitis Type 2
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
### Outcomes
**Primary Outcomes**
- Standardized incidence ratio (SIR) of first invasive cancer
**Secondary Outcomes**
- The prevalence of cancer diagnoses 12 months prior to AIP diagnosis
- Risk factor associated with cancer diagnosis.
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
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## Vegetarian Versus Non Vegetarian Based Diet in the Recurrence of Hepatic Encephalopathy in Patients With Cirrhosis: An Open Label Pilot Study
- **NCT ID**: NCT06328088
- **Study ID**: EC/12/23/2400
- **Status**: RECRUITING
- **Start Date**: 2024-02-16
- **Completion Date**: 2024-10-16
- **Lead Sponsor**: Sir Ganga Ram Hospital
### Study Description
Earlier protein restriction was advocated in the treatment of HE but later this concept was refuted and increase protein intake was advocated in patients with HE. Diet in patients during an episode HE is also not known. It is advisable based on many case reports or case series that vegetable-based diet during the episode of HE is better than animal-based diet as it reduces ammonia level and other false neurotransmitters in brain and helps in early recovery of, HE . However, diet in patients who had recovered from an episode of, HE is not known and what type of protein (vegetarian or non-vegetarian) should be taken to prevent another episode of HE has never been evaluated. In India majority of the patients are vegetarian and patients with cirrhosis are malnourished and lack protein in their diet as per our previous published study
### Conditions
- Hepatic Encephalopathy
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
- Non vegetarian
### Outcomes
**Primary Outcomes**
- Recurrence of overt hepatic encephalopathy
**Secondary Outcomes**
- Hospitalization due to any cause
### Location
- **Facility**: Sir Ganga Ram Hospital, Delhi, N/A, 110060, India
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## Artificial Intelligence to Assist the Echocardiographic Identification of Transthyretin Cardiac Amyloidosis
- **NCT ID**: NCT06328075
- **Study ID**: AI-ATTR-ECHO
- **Status**: RECRUITING
- **Start Date**: 2022-01-01
- **Completion Date**: 2026-01-01
- **Lead Sponsor**: Algalarrondo Vincent
### Study Description
The goal of this study is to develop an algorithm using artificial intelligence (AI) to assist identification of potential ATTR-CM cases using routine transthoracic echocardiography.The main questions it aims to answer are:* is the algorithm able to diagnose ATTR-CM* is the algorithm able to diagnose different types of ATTR-CM (ATTRv, ATTRwt)This is a non interventional study. Participant' echocardiographies will be, after deidentification, used to train, valid and test the algorithm.
### Conditions
- Amyloid Cardiomyopathy
- Transthyretin Amyloid Cardiomyopathy
- Transthyretin Cardiac Amyloidosis
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
- non interventional study
### Outcomes
**Primary Outcomes**
- Building and validating the diagnostic performance metrics curves of the AI algorithm to diagnose ATTR-CM :
- Building and validating the diagnostic performance metrics of the AI algorithm to diagnose ATTR-CM :
**Secondary Outcomes**
- Building and validating the diagnostic performance metrics of the AI algorithm to diagnose ATTRwt-CM :
- Building and validating the diagnostic performance metrics of the AI algorithm to diagnose ATTRv-V122I-CM :
- Building and validating the diagnostic performance metrics of the AI algorithm to diagnose ATTRv-CM :
- Building and validating the diagnostic performance metrics of the AI algorithm to differentiate ATTR-CM from LV hypertrophy (LVH) :
- Building and validating the diagnostic performance metrics curves of the AI algorithm to diagnose ATTRwt-CM :
- Building and validating the diagnostic performance metrics curves of the AI algorithm to diagnose ATTRv-V122I-CM :
- Building and validating the diagnostic performance metrics curves of the AI algorithm to diagnose ATTRv-CM :
- Building and validating the diagnostic performance metrics curves of the AI algorithm to differentiate ATTR-CM from LV hypertrophy (LVH) :
### Location
- **Facility**: Bichat, Paris, N/A, 75018, France
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## Comparing Efficiency of Mirogabalin and Pregabalin in Primary TKA
- **NCT ID**: NCT06328062
- **Study ID**: TUH Mirogabalin TKA
- **Status**: RECRUITING
- **Start Date**: 2024-04-01
- **Completion Date**: 2025-05-31
- **Lead Sponsor**: Thammasat University Hospital
### Study Description
The goal of this RCT is to compare efficacy between mirogabalin and pregabalin in pain reducing after unilateral primary total knee arthroplasty.The main question\[s\] it aims to answer are:• Does mirogabalin have better pain reduction than pregabalin after unilateral primary total knee arthroplasty.Participants will randomized to mirogabalin or pregabalin group and will take the drug for 6 weeks after TKA. Researchers will compare to pregabalin group to see pain and functional outcomes after TKA.
### Conditions
- Pain Postoperative
- Osteoarthritis
- Total Knee Arthroplasty
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- Mirogabalin
- Pregabalin
### Outcomes
**Primary Outcomes**
- Pain score
**Secondary Outcomes**
- Morphine consumption
- Range of motion
- Knee society score
- Knee injury and Osteoarthritis Outcome Score (KOOS)
- Sedation score
- Incidence of Somnolence and dizziness
- Total hospital stay
### Location
- **Facility**: Thammasat University Hospital, Khlong Luang, Pathum Thani, 12120, Thailand
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## A Study of Trilaciclib Combined With Chemotherapy in the Treatment of NSCLC
- **NCT ID**: NCT06328049
- **Study ID**: HSKY-033
- **Status**: RECRUITING
- **Start Date**: 2023-08-10
- **Completion Date**: 2025-08-10
- **Lead Sponsor**: Taixing People's Hospital
### Study Description
The aim of this study is to investigate the safety and efficacy of the prophylactic use of Trilaciclib in patients with non-small cell lung cancer (NSCLC) receiving platinum-based chemotherapy, so as to provide more evidence-based medical evidence for the optimal diagnosis and treatment strategy in this population.
### Conditions
- NSCLC
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: NA
- **Intervention Model**: SINGLE_GROUP
- **Primary Purpose**: PREVENTION
### Interventions
- Trilaciclib Injection
### Outcomes
**Primary Outcomes**
- Incidence of febrile neutropenia (FN)
**Secondary Outcomes**
- Incidence of Treatment-Emergent Adverse Events
- Antibiotic Use rate
- Number of medication delays
- Number of chemotherapy dose reductions
### Location
- **Facility**: Taixing People's Hospital, Taixing, Jiangsu, 225400, China
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## Testing the Combination of Anti-cancer Drugs Tiragolumab and Atezolizumab to Improve Outcomes for Patients With Recurrent Glioblastoma
- **NCT ID**: NCT06328036
- **Study ID**: NCI-2024-02185
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-06-21
- **Completion Date**: 2025-07-01
- **Lead Sponsor**: National Cancer Institute (NCI)
### Study Description
This phase II trial compares the safety, side effects and effectiveness of atezolizumab with tiragolumab to atezolizumab alone in treating patients with glioblastoma that has come back after a period of improvement (recurrent). Glioblastoma is the most common primary brain cancer in adults and despite aggressive treatment, it is nearly always fatal. Currently, there are limited effective treatment options in patients that have recurrence. Immunotherapy has been shown to be effective in other types of cancer and may be an appealing potential treatment option for recurrent glioblastoma. Immunotherapy with monoclonal antibodies, such as atezolizumab and tiragolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Study doctors also want to learn if a tumor infiltrating T lymphocyte (TIL) response is helpful to determine the benefit of the combination of study drugs compared to the usual approach. TILs are a type of immune cell that has moved from the blood into a tumor. TILs can recognize and kill tumor cells. Giving atezolizumab with tiragolumab may be safe, tolerable and/or effective compared to atezolizumab alone in treating patients with recurrent glioblastoma.
### Conditions
- Recurrent Glioblastoma, IDH-Wildtype
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- Atezolizumab
- Biospecimen Collection
- Magnetic Resonance Imaging
- Surgical Procedure
- Tiragolumab
### Outcomes
**Primary Outcomes**
- Progression free survival (PFS)
**Secondary Outcomes**
- Tumor infiltrating T lymphocyte density
- Dose limiting toxicity
- Incidence of adverse events
- Objective response rate (ORR)
- PFS6
- Overall survival
- Tumor mutational burden (TMB)
- Expression of immune checkpoint receptors and ligands
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
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## Impact of Concussion History on Sleep and Physical Performance in Contact Sports Athletes
- **NCT ID**: NCT06328023
- **Study ID**: REC/MS-PT/01831
- **Status**: RECRUITING
- **Start Date**: 2024-03-18
- **Completion Date**: 2024-06-02
- **Lead Sponsor**: Riphah International University
### Study Description
This study investigates the correlation between a history of concussions and its effects on both sleep patterns and physical performance among athletes engaged in contact sports. By examining the relationship between concussion history, sleep quality, and athletic performance, this research aims to provide insights into the potential long-term implications of concussions on the well-being and performance of athletes in contact sports
### Conditions
- Concussion, Mild
- Sleep
- Physical Performance
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
- SCOAT 6 to find association
### Outcomes
**Primary Outcomes**
- Cantu Scale
**Secondary Outcomes**
- Sport Concussion Office Assessment Tool 6
### Location
- **Facility**: HAYATABAD Sports complex, Peshawar, Khyber Pakhtun Khawan, 24730, Pakistan
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## An Observational Clinical Registry to Collect Safety and Efficacy Data on Wound Care in Medical Centers
- **NCT ID**: NCT06328010
- **Study ID**: SIDDXAC02
- **Status**: ENROLLING_BY_INVITATION
- **Start Date**: 2024-04-01
- **Completion Date**: 2030-06-30
- **Lead Sponsor**: Siddhey LLC
### Study Description
Collect data on various wound treatments and their related wound healing process, in real life settings.Analyze the safety and efficacy of wound treatments, including: advanced biological/synthetic grafts and standard of wound care treatments.
### Conditions
- Wounds and Injuries
- Burns
- Mohs Surgery
- Diabetic Foot Ulcer Mixed
- Venous Leg Ulcer
- Non-healing Wound
- Trauma Injury
- Injury and Wounds
- Degloving Injuries
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
- Advanced Treatment Modalities for wound and injuries
### Outcomes
**Primary Outcomes**
- Data collection of 5000 patients
**Secondary Outcomes**
- Different types of wounds/injuries heal rate
### Location
- **Facility**: Comprehensive Medicine, Alpine, California, 91901, United States
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## An Exploratory Study by Fast CAR T Cells
- **NCT ID**: NCT06327997
- **Study ID**: BZE2203-A-01
- **Status**: RECRUITING
- **Start Date**: 2024-03-07
- **Completion Date**: 2027-12-31
- **Lead Sponsor**: Shanghai Cell Therapy Group Co.,Ltd
### Study Description
The main goal of this trial is to evaluate the safety and tolerability of CAR T cell therapy for advanced solid tumors with positive mesothelin and MUC1.Patients were screened, peripheral blood mononuclear cells (PBMC) were isolated from eligible patients, and cells were prepared. Pretreatment was performed within 5 days before infusion, and CAR T cells were infused on day 0 (the dose was determined according to the requirements of climbing/expansion). The safety intensive observation period was 28 days after infusion, and the clinical efficacy after infusion was evaluated on days 28-34. The follow-up observation and evaluation were carried out according to the follow-up visit point, and the follow-up period was 1 year. From the second year, the telephone follow-up period was entered.
### Conditions
- Solid Tumor
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: NA
- **Intervention Model**: SINGLE_GROUP
- **Primary Purpose**: TREATMENT
### Interventions
- Fast CAR T cells
### Outcomes
**Primary Outcomes**
- Dose-limiting toxicity(DLT)
**Secondary Outcomes**
- Maximum tolerated dose (MTD)
- Objective response rate (ORR)
- Progression-free survival (PFS)
- Overall survival (OS)
- Peak Plasma Concentration (Cmax)
- AUC
- Pharmacodynamics (PD)
### Location
- **Facility**: Shanghai Mengchao Cancer Hospital, Shanghai, Shanghai, N/A, China
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## Barts Sex-CAD Database
- **NCT ID**: NCT06327984
- **Study ID**: 157354
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-05
- **Completion Date**: 2027-05
- **Lead Sponsor**: Queen Mary University of London
### Study Description
There is a lack of understanding of how Coronary Artery Disease (CAD) - meaning the blocking or furring up of the arteries of the heart - starts and progresses in women. In both men and women, CAD is the most common cause of heart attacks, which occur when the blood supply in the heart is interrupted (these are also known medically as 'acute coronary syndromes').Before the menopause women appear to be protected from CAD; however, after the menopause that protection is lost. Also, those women who do suffer a heart attack have twice the risk of further heart attacks compared to men despite having the same treatment that works well in men. Biological differences between men and women are probably playing an important role in the way CAD develops. However, due to a lack of research there is currently little understanding of how the female body works in this area.Inflammation is the body's natural response to injury or infection. Importantly it is also involved in the development of CAD. Hormones such as oestrogen and testosterone are also likely to be contributory factors. We think the differences between the way these hormones and inflammation play a part in CAD in both men and women are important, but the role they play is not yet fully understood.In this study we wish to measure the 'markers' of inflammation in the blood of patients attending Barts Heart Centre with chest pain. We will also conduct questionnaires with these patients, to understand their hormone status and how parts of their medical history may be a contributory factor. For patients who have previously attended Barts Heart Centre will will contact them to conduct the questionnaire over the telephone only. We will combine this data with the data that is routinely collected during hospital admission. In this way we hope to understand whether inflammation together with hormone status plays an important role in CAD. Our hope is that through this research we will address an under researched area and find new ways of treating women and men with coronary artery disease.
### Conditions
- Coronary Artery Disease
- Myocardial Infarction
- Acute Coronary Syndrome
- Atherosclerosis
- Inflammation
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
### Outcomes
**Primary Outcomes**
- Mortality
- Re-admission
- MACE
**Secondary Outcomes**
- Relationship with specific MI types
- Relationship with inflammation
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
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## Enhanced Outcome Prediction in Cutaneous Squamous Cell Carcinoma Using Deep-learning and Computational Histopathology
- **NCT ID**: NCT06327971
- **Study ID**: 0000
- **Status**: ACTIVE_NOT_RECRUITING
- **Start Date**: 2023-10-20
- **Completion Date**: 2028-10
- **Lead Sponsor**: Queen Mary University of London
### Study Description
Evaluate a deep-learning model trained on computational histopathology for predicting outcomes in cutaneous squamous cell carcinoma
### Conditions
- Squamous Cell Carcinoma of the Skin
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
### Outcomes
**Primary Outcomes**
- Metastasis
**Secondary Outcomes**
### Location
- **Facility**: Barts Health NHS Trust, London, N/A, N/A, United Kingdom
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## THE EFFECTS OF DIRECT AND INDIRECT LARYNGOSCOPY ON CORMACK-LEHANE AND POGO SCORES
- **NCT ID**: NCT06327958
- **Study ID**: protocol Number: 2021/21
- **Status**: COMPLETED
- **Start Date**: 2021-09-15
- **Completion Date**: 2022-06-30
- **Lead Sponsor**: Zonguldak Bulent Ecevit University
### Study Description
Direct laryngoscopy (DL) is a conventional and highly difficult method that is used in endotracheal intubation (ETI) training. Today, the usage of video-laryngoscopes (VLs) to teach airway management to inexperienced healthcare personnel is a prevalent practice. In ETI training, it is recommended to train students on simulators before allowing them direct access to patients.
### Conditions
- Being a 5th Year Student at the Faculty of Medicine
- No Previous Laryngoscopy Experience
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
- Cormack-Lehane (C&L)
- POGO score
### Outcomes
**Primary Outcomes**
- The percentage of glottic opening (POGO) scores in the airway management training of medical students.
**Secondary Outcomes**
### Location
- **Facility**: Zonguldak Bülent Ecevit University, Zonguldak, Kozlu, 67600, Turkey
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## Transplanting Lungs From Uncontrolled Donation After Circulatory Death
- **NCT ID**: NCT06327945
- **Study ID**: 22-00009
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-07-01
- **Completion Date**: 2028-06-30
- **Lead Sponsor**: NYU Langone Health
### Study Description
The study team developed an uncontrolled donation after circulatory death (uDCD) protocol that preserves lungs for just over 3 hours after death using positive end expiratory pressure (PEEP) and supplemental oxygen. The study will assess lung uDCD program safety by continuous review of operations/clinical records from each case activation and transplantation. Attrition outcomes include rates of initial and continued lung preservation, donation authorization, lung recovery, passing ex-vivo lung perfusion (EVLP) performance testing, and lung transplantation. Planned viability assessments also include macroscopic determination, radiology (X-ray), and fiber optic bronchoscopy before initiating EVLP. We expect \~50% of lungs assessed with EVLP will be transplanted to meet sustainability targets. Safety outcomes include the primary outcome, primary graft dysfunction (PGD) grade III at 72 hours, and secondarily survival one year after transplantation.
### Conditions
- Lung Transplantation
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: NA
- **Intervention Model**: SINGLE_GROUP
- **Primary Purpose**: OTHER
### Interventions
- Lung uDCD Protocol
### Outcomes
**Primary Outcomes**
- Incidence of Primary Graft Dysfunction (PDG) Grade III
**Secondary Outcomes**
- Number of Participants who Required Normothermic Extracorporeal Membrane Oxygenation (nECMO)
- Number of Participants who Required Normothermic Extracorporeal Membrane Oxygenation (nECMO)
- Incidence of Re-Transplantation
- Overall Survival
- Overall Survival
### Location
- **Facility**: NYU Langone Health, New York, New York, 10016, United States
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## HIVEC in Patients With Non-Muscle-Invasive Bladder Cancer
- **NCT ID**: NCT06327932
- **Study ID**: HIVEC(PRG)
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-04-01
- **Completion Date**: 2028-03-31
- **Lead Sponsor**: Affiliated Cancer Hospital & Institute of Guangzhou Medical University
### Study Description
The purpose of this study is to determine the efficacy and safety of Hyperthermic Intravesical Chemotherapy (HIVEC) with Gemcitabine (GEM) after Transurethral Resection of Bladder Tumors (TURBT) in the treatment of medium or high-risk group Non-Muscle-Invasive Bladder Cancer (NMIBC).
### Conditions
- Non-Muscle-Invasive Bladder Cancer
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: PREVENTION
### Interventions
- TURBT
- HIVEC
- Intravesical Chemotherapy
- Gemcitabine
### Outcomes
**Primary Outcomes**
- Recurrence rate
**Secondary Outcomes**
- 1-year recurrence rate
- Recurrence-free survival (RFS) rate
- Time to treatment failure
- Success rate of therapeutic operation
- Quality of international prostate symptom score
- Quality of bother of score
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
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## Effects of Probiotic Supplementation With Weight Reducing Plan in Patients With Food Addiction and Weight Regain After Bariatric Surgery
- **NCT ID**: NCT06327919
- **Study ID**: 62885
- **Status**: COMPLETED
- **Start Date**: 2022-06-01
- **Completion Date**: 2023-09-23
- **Lead Sponsor**: National Nutrition and Food Technology Institute
### Study Description
To study the effects of probiotic supplementation with a weight loss program and cognitive behavioral therapy (CBT) on anthropometric measures, eating behavior, food addiction, and related hormone levels in patients with food addiction and weight regain after bariatric surgery, 50 patients who referred to obesity clinic with weight regain (regaining ≥10% nadir weight) after bariatric surgery (at least 18 months), and food addiction will be randomly allocated to receive a weight loss program and CBT plus either probiotic, or placebo for 12 weeks. At the first and the end of the intervention, anthropometric measurements, eating behavior, food addiction, leptin, serotonin, and oxytocin will be assessed and compared between groups.
### Conditions
- Weight Regain After Bariatric Surgery and Food Addiction
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- Probiotic supplement
- Placebo supplement
### Outcomes
**Primary Outcomes**
- Weight
- BMI
- Waist circumference
- Fat mass
- Food addiction
**Secondary Outcomes**
- Eating behavior
- Leptin
- Serotonin
- Oxytocin
### Location
- **Facility**: Azita Hekmatdoost, Tehran, Middle East, 19835, Iran, Islamic Republic of
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## A Prospective Birth Cohort of Infants With Allergy and Neurodevelopmental Disorders in China
- **NCT ID**: NCT06327906
- **Study ID**: qilu000002
- **Status**: RECRUITING
- **Start Date**: 2023-11-15
- **Completion Date**: 2029-11-15
- **Lead Sponsor**: Qilu Hospital of Shandong University
### Study Description
In this study, a birth cohort was established to demonstrate the causal relationship between allergies and neurodevelopment disorders in infants and young children, and to find out the influencing factors of neurodevelopment disorders in early life.
### Conditions
- Child Allergy
- Neurodevelopmental Disorders
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
### Outcomes
**Primary Outcomes**
- ASD
- ADHD
**Secondary Outcomes**
### Location
- **Facility**: Qilu Hospital of Shandong University, Jinan, Shandong, N/A, China
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## Patients Treated by the Danish Emergency Medical Services Following Non-drowning Water Rescues From 2016 to 2023
- **NCT ID**: NCT06327893
- **Study ID**: AQUATIC_RESCUE
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-05-01
- **Completion Date**: 2025-05-01
- **Lead Sponsor**: Prehospital Center, Region Zealand
### Study Description
Since 2015, all Danish prehospital EMS have used the nationwide Prehospital Electronic Medical Record (PEMR). In 2023, the investigators developed the Danish Drowning Formula (DDF), a text-search algorithm designed to search the unstructured text fields in the electronic medical records with comprehensive search criteria to identify all potential water-related incidents. This protocol describes the first study to analyse the prehospital data from a nationwide Danish cohort of patients treated by the EMS from 2016 to 2023 following non-drowning aquatic rescues.
### Conditions
- Drowning
- Drowning, Near
- Submersion
- Submersion - Accidental
- Submersion or Drowning Due to Being Washed Overboard
- Submersion or Drowning Due to Being Thrown Overboard
- Submersion or Drowning Due to Ship Sinking, Water Skier Injured
- Submersion or Drowning Due to Boat Submerging, Swimmer Injured
- Submersion or Drowning Due to Boat Overturning, Swimmer Injured
- Submersion or Drowning Due to Boat Submerging, Water Skier Injured
- Submersion or Drowning Due to Fall From Gangplank, Swimmer Injured
- Submersion or Drowning Due to Ship Sinking, Docker or Stevedore Injured
- Submersion or Drowning Due to Fall Overboard, Docker or Stevedore Injured
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
- Submersion or immersion in liquid
### Outcomes
**Primary Outcomes**
- The annual incidence.
- The annual incidence rate.
**Secondary Outcomes**
- The spatial distribution of aquatic rescues on a map of Denmark.
### Location
- **Facility**: Prehospital Center, Næstved, Region Zealand, 4700, Denmark
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## A Study to Learn About the Study Medicine Called PF-07054894 in People of Japanese Origin
- **NCT ID**: NCT06327880
- **Study ID**: C4151006
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-05-13
- **Completion Date**: 2024-07-02
- **Lead Sponsor**: Pfizer
### Study Description
The purpose of this clinical study is to learn about the safety and effects of the study medicine (PF-07054894) in healthy Japanese participants.The study is seeking the following participants:* Male or female Japanese participants aged 18 years or older. The participants should be healthy after going through some medical tests.* Have a Body Mass Index (BMI) of 16 to 32 kilogram per meter squared; and a total body weight of more than 45 kilograms (100 pounds).* Are willing and able to follow all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.In research, the participants in clinical studies are assigned by chance to separate groups that are given different treatments. Hence participants will be by chance assigned to receive either PF-07054894 or a harmless treatment that has no medical effect (placebo). Both these will be taken by mouth for 14 days. The total duration of the study is about 11 weeks, with a follow-up via telephone about 6 weeks after first treatment.
### Conditions
- Healthy
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: OTHER
### Interventions
- PF-07054894 or placebo
### Outcomes
**Primary Outcomes**
- Number of participants with adverse events (AE) or serious adverse events (SAE)
- Number of participants with clinically meaningful change from baseline in laboratory tests results
- Number of participants with clinically meaningful change from baseline in vital signs
- Number of participants with clinically meaningful change from baseline in electrocardiogram (ECG) parameters
- Maximal plasma concentration (Cmax)
- Time to Maximum Plasma Concentration (Tmax)
- Area Under the Plasma Concentration-Time Profile From Time Zero (AUCτ) To End of Dosing Interval (AUCt)
- Half-life of PF-07054894
**Secondary Outcomes**
- Observed Accumulation Ratio (Rac)
- Observed Accumulation Ratio Based on Cmax (Rac,Cmax)
- Trough plasma concentrations (Ctrough)
- Apparent Volume of Distribution (Vz/F) as data permits
- Apparent Oral Clearance (CL/F)
### Location
- **Facility**: Pfizer Clinical Research Unit - Brussels, Brussels, Bruxelles-capitale, Région DE, B-1070, Belgium
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## Comparison of Video Laryngoscopy Versus Direct Laryngoscopy for Orotracheal Intubation Among Adults in Emergency Department
- **NCT ID**: NCT06327867
- **Study ID**: drs2402021836
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-05-01
- **Completion Date**: 2025-05-01
- **Lead Sponsor**: Patan Academy of Health Sciences
### Study Description
This is an open-label, single center, prospective, randomized, comparative, intervention study.The goal of this study is to compare the success rate of video laryngoscopy vs direct laryngoscopy for first pass oro tracheal intubation. The other question it aims to answer are:1. To assess the adverse events during video laryngoscopy2. To assess the adverse events during direct Laryngoscopy3. To compare the first pass success rate of DL vs VL according to demographic profile (age and sex)
### Conditions
- To Compare Success Rate of Video Laryngoscopy vs Direct Laryngoscopy
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- Oro Tracheal Intubation by DL
- Oro Tracheal Intubation by VL
### Outcomes
**Primary Outcomes**
- First pass success of direct laryngoscopy in oro tracheal intubation
- First pass success of video laryngoscopy in oro tracheal intubation
**Secondary Outcomes**
- Complications rates between two methods.
- Use of alternative methods for ventilation or oxygenation between two methods
- Better visualization of Cormack-Lehane grading between two methods
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
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## NUtrition and ORal Health in Orthopaedic Surgery
- **NCT ID**: NCT06327854
- **Study ID**: NUOROS (PI: M Briguglio)
- **Status**: RECRUITING
- **Start Date**: 2024-03-18
- **Completion Date**: 2024-12-10
- **Lead Sponsor**: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
### Study Description
This prospective observational study evaluates the relationship between the objective oral health status and the patient reported diet in 64 adult patients undergoing elective major orthopaedic surgery (hip, knee, or spine surgery).
### Conditions
- Orthopedic Disorder
- Metabolism and Nutrition Disorder
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
### Outcomes
**Primary Outcomes**
- Association between pre-operative oral health and diet
**Secondary Outcomes**
### Location
- **Facility**: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio, Milan, N/A, N/A, Italy
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## Plaque Reduction Sesame Oil
- **NCT ID**: NCT06327841
- **Study ID**: EK 1117/2022
- **Status**: COMPLETED
- **Start Date**: 2022-06-21
- **Completion Date**: 2022-08-18
- **Lead Sponsor**: Medical University Innsbruck
### Study Description
The goal of this clinical trials to learn about potential additives in reducing dental plaque. The main questions it aims to answer is:• is there a difference in the plaque reducing effect of oil pulling with sesame oil compared to rinsing with distilled water? Participants will rinse with 15 ml of their allocated liquid for 15 min every morning for 8 weeks.Researchers will compare sesame oil against distilled water to see if there is a difference in the plaque reducing effect.
### Conditions
- Dental Plaque
- Gingivitis
- Oral Microbial Colonization
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- sesame oil
- distilled water
### Outcomes
**Primary Outcomes**
- Rustogi Modified Navy Plaque Index (RMNPI)
**Secondary Outcomes**
- Gingival Index (GI)
- microbial analysis
- Oral Health Impact Profile (OHIP)
- Interview halitosis, xerostomia
### Location
- **Facility**: Medical University, Innsbruck, Tyrol, 6020, Austria
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## Methimazole in Graves' Disease - a Randomised Controlled Trial Comparing the Computer-aided Treatment DigiThy Versus Usual Care
- **NCT ID**: NCT06327828
- **Study ID**: 32-663
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-04-01
- **Completion Date**: 2026-10-01
- **Lead Sponsor**: Medical University of Graz
### Study Description
The goal of this clinical trial is to compare two methods of guiding methimazole therapy in patients with Graves' disease: methimazole dose adjustments based on a new semi-automated computer-guided treatment (based on a mathematical model) or based on the treating physician's decision (i.e. usual care). The main question it aims to answer is whether semi-automated computer-guided treatment is not inferior to usual care in terms of safety, the time it takes to achieve euthyroidism and the methimazole dose required.
### Conditions
- Graves Disease
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- Semi-automated computer-aided treatment (Digital Thyroid, DigiThy)
- Usual care
### Outcomes
**Primary Outcomes**
- The primary aim is to compare semi-automated computer-guided treatment with usual care in terms of their performance indices
**Secondary Outcomes**
- Comparison in terms of dosing and penalties
- Comparison based on free thyroxine (fT4) target range
### Location
- **Facility**: Medical University of Graz, Graz, N/A, 8044, Austria
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## Efficacy of FDC Regimen of Dapagliflozin/Metformin Compared to Co-administered Dual Therapy on Glycemic Control, Satisfaction and Adherence in Chinese Patients With T2DM
- **NCT ID**: NCT06327815
- **Study ID**: D1690L00149
- **Status**: RECRUITING
- **Start Date**: 2024-03-27
- **Completion Date**: 2025-04-30
- **Lead Sponsor**: AstraZeneca
### Study Description
Study D1690L00149 is a 24-week, multicentre, randomized, parallel, interventional, non-inferiority, open-label study designed to compare the FDC Regimen of Dapagliflozin/Metformin XR with the Dapagliflozin co-administered with Metformin XR in glycemic lowering control, satisfaction and adherence in Chinese patients with T2DM.
### Conditions
- Type 2 Diabetes Mellitus (T2DM)
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- Xigduo (Dapagliflozin and Metformin hydrochloride extended-release) tablets
- Dapagliflozin tablets and Metformin HCl extended-release tablets
### Outcomes
**Primary Outcomes**
- Change in HbA1c from baseline
**Secondary Outcomes**
- Proportion of patients achieved HbA1c less than 7.0% from baseline to week 24.
- Absolute change in FPG from baseline to week 24.
- Absolute change in PPG from baseline to week 24.
- The difference in satisfaction scores between 2 groups measured with the Diabetes Treatment Satisfaction Questionnaire (DTSQ) at week 24.
- The difference in quality of life between 2 groups measured with Diabetes Quality of Life (DQOL) questionnaire at week 12 and week 24.
- To evaluate the difference in adherence of FDC versus co-administered dual therapy by Morisky Medication Adherence Scale-8 (MMAS-8) questionnaire in Chinese patients with T2DM.
### Location
- **Facility**: Research Site, Beijing, N/A, 100020, China
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## Improving the Well-being of Caregivers of Cystic Fibrosis Patients During Physiotherapy Treatment
- **NCT ID**: NCT06327802
- **Study ID**: 20240104
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-04-01
- **Completion Date**: 2025-07-31
- **Lead Sponsor**: Pole Sante Grace de Dieu
### Study Description
The main objective of the study is to determine the impact of cystic fibrosis affecting a child on the parents' quality of life, their possible anxiety and depressive symptoms, their general fatigue and the feeling of burden in these caregivers.
### Conditions
- Cystic Fibrosis
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
- Questionnaire
### Outcomes
**Primary Outcomes**
- Zarit Burden Interview
**Secondary Outcomes**
### Location
- **Facility**: PSLA GDD, Caen, N/A, 14000, France
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## Trunk Control and Disability in Persons With Multiple Sclerosis
- **NCT ID**: NCT06327789
- **Study ID**: ZBEU-MS
- **Status**: COMPLETED
- **Start Date**: 2021-12-21
- **Completion Date**: 2022-02-21
- **Lead Sponsor**: Zonguldak Bulent Ecevit University
### Study Description
This study aims to investigate the relationship between physical disability and trunk control, balance, and pedobarographic parameters in persons with Relapsing Remitting Multiple Sclerosis (RRMS) who have a low Expanded Disability Status Scale (EDSS) score. Twenty-three RRMS patients with an age range of 18-50 years, EDSS score ≤ 3 were included in this study. The patients' level of disability (EDSS), trunk control )Trunk Impairment Scale - TIS), lower extremity functionality (Timed 25-Foot Walk Test - T25FW), upper extremity functionality (Nine Hole Peg Test- 9HPT), balance (Biodex Balance System) and gait (Zebris® FDM 2) were evaluated.
### Conditions
- Multiple Sclerosis
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
### Outcomes
**Primary Outcomes**
- Expanded Disability Status Scale (EDSS)
- Trunk Impairment Scale (TIS)
- Biodex Balance System (BBS) (MedicalSystems, Shirley, NY, USA)
- Step Length (cm)
- Stride Length (cm)
- Step Width (cm)
- Cadence (steps/min)
- Velocity (m/s)
- Step time (s)
- Stride time (s)
- Timed 25-Foot Walk Test (T25FW)
- Nine-Hole Peg Test (9HPT)
**Secondary Outcomes**
### Location
- **Facility**: Zonguldak Bülent Ecevit University, Zonguldak, N/A, N/A, Turkey
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## New Protein Biomarkers and Technology for Improving Diagnosis and Outcome Prediction in Mild TBI
- **NCT ID**: NCT06327776
- **Study ID**: 21/709
- **Status**: RECRUITING
- **Start Date**: 2022-03-04
- **Completion Date**: 2025-12-31
- **Lead Sponsor**: Hospital Universitario 12 de Octubre
### Study Description
Mild traumatic brain injury(mTBI) is a common cause of consultation to the emergency rooms worldwide and is the most common form of traumatic brain injury. Though classified as mild, as many as 40% of patients suffering mTBI do not make complete recoveries or present persistent symptoms. The present study is intended to determine long term outcome of patients suffering mTBI and to establish new prognostic models with the use of serum and saliva based biomarkers. For this purpose this study will not exclude patients regarding their comorbidities.
### Conditions
- Mild Traumatic Brain Injury
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
- Serum and saliva biomarkers
### Outcomes
**Primary Outcomes**
- Biomarkers diagnostic performance
**Secondary Outcomes**
- Determination of the potential of the biomarkers in predicting neurological symptoms after TBI
- Determination of the potential of the biomarkers in predicting neurological outcome assessed by the Extended Glasgow Outcome Score (GOSE) after TBI
- Determination of the potential of the biomarkers in predicting quality of life assessed by Qolibri-OS after TBI
- Determination of the potential of the biomarkers in predicting quality of life assessed by EQ-5D-5L after TBI
- Determination of the potential of the biomarkers in predicting quality of sleep assessed by the Epworth and Pittsburgh Scales
### Location
- **Facility**: Hospital Universitario 12 de Octubre, Madrid, N/A, 28041, Spain
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## Prophylactic Ilioinguinal Neurectomy During Open Tension-Free Inguinal Hernia Repair
- **NCT ID**: NCT06327763
- **Study ID**: Ilioinguinal Neurectomy
- **Status**: COMPLETED
- **Start Date**: 2022-01-01
- **Completion Date**: 2023-06-01
- **Lead Sponsor**: Zagazig University
### Study Description
postoperative chronic inguinal pain is a common postoperative complication after open inguinal hernia repair.Chronic inguinal pain is a common complication following open inguinal hernia repair. Ilioinguinal nerve entrapment is a common cause of this chronic pain which may adversely affect the patients' life. Ilioinguinal neurectomy seems to be beneficial in preventing such pain, but it carries the risk for numbness and hypoesthesia.
### Conditions
- Ilioinguinal Nerve Section
- Pain Prevention
- Hernioplasty
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: PREVENTION
### Interventions
- ilioinguinal nerve section
### Outcomes
**Primary Outcomes**
- detect postoperative pain using short form inguinal pain questionnaire
**Secondary Outcomes**
### Location
- **Facility**: yasmine Hegab, Zagazig, N/A, 7120730, Egypt
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## The Microcirculation, Dialysis Modality and Sequestered Salt
- **NCT ID**: NCT06327750
- **Study ID**: NL83566.018.24
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-06
- **Completion Date**: 2027-12
- **Lead Sponsor**: Amsterdam UMC, location VUmc
### Study Description
The aim of this clinical trial is to investigate the effect of 5 different dialysis treatments (combinations of dialysis mode and dialysis fluid sodium content) on the microcirculation (MC) and sequestered sodium content (SSC) in adult prevalent end-stage kidney disease (ESKD) patients treated with hemodialysis (HD) or hemodiafiltration (HDF). The main questions it aims to answer are:1. What are the effects on the sequestered sodium content and microcirculation after 4 weeks of treatment with the following dialysis modes? * HDF with an expected zero diffusive sodium balance (Dialysate sodium concentration (DNa)= Plasma sodium concentration (PNa)) compared to * HDF with an expected diffusive sodium efflux (DNa \< PNa, difference 3 mmol/L) compared to * HD with an expected zero diffusive sodium balance (DNa = PNa) compared to * HD with an expected diffusive sodium efflux (DNa \< PNa, difference 3 mmol/L) compared to * Isolated ultrafiltration for 30 minutes followed by HD with an expected zero diffusive sodium balance (DNa = PNa)2. Are the SSC and MC interrelated in this patient group?This study is a randomized cross-over trial. Participants will be subjected to the abovementioned dialysis treatment modes in random order.
### Conditions
- End-stage Renal Disease
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: CROSSOVER
- **Primary Purpose**: TREATMENT
### Interventions
- Hemodialysis (DNa = PNa)
- Hemodialysis (DNa<PNa)
- Hemodialysis after isolated ultrafiltration (DNa=PNa)
- High volume hemodiafiltration (DNa=PNa)
- High volume hemodiafiltration (DNa<PNa)
### Outcomes
**Primary Outcomes**
- Skin microcirculation
- Sequestered salt content (SSC)
**Secondary Outcomes**
- Intradialytic hypotension
- Change in intradialytic blood pressure
- Peridialytic blood pressure
- Change in CK-MB
- Change in high sensitivity C-reactive protein (hs-CRP)
- Change in interleukin-6 receptor (IL-6R)
- Change in soluble CD163 (sCD163)
- Change in soluble intercellular adhesion molecule-1 (s-ICAM-1)
- Change in serum glycosaminoglycans
- Change in syndecan-1
- Change in vascular endothelial growth factor C (VEGF-C)
- Change in extracellular vesicles (EVs)
- Change in skin microcirculation
- Change in sequestered salt content (SSC)
- modified Dialysis symptom index (mDSI)
- Thirst distress scale (TDS)
- EQ Visual analogue scale (EQ VAS)
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
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## Diabetic Ketoacidosis Diagnosis and Management
- **NCT ID**: NCT06327737
- **Study ID**: AKDENIZ-KAEK-916
- **Status**: COMPLETED
- **Start Date**: 2020-12-15
- **Completion Date**: 2023-03-15
- **Lead Sponsor**: Akdeniz University
### Study Description
This is the first and only study conducted on the use of capnography in children diagnosed with DKA to evaluate the initial clinical grading of DKA, monitor clinical improvement, and predict complications such as brain edema.
### Conditions
- Metabolic Acidosis
- Diabetic Ketoacidosis
- Brain Edema
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
- Capnography
### Outcomes
**Primary Outcomes**
- Correlation between PCO2 and EtCO2
- Correlation between Integrated Pulmonary Index and degree of acidosis
- Prediction of cerebral edema with Integrated Pulmonary Index
**Secondary Outcomes**
### Location
- **Facility**: Akdeniz University, Antalya, N/A, N/A, Turkey
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## Belimumab in SLE Synovial Inflammation and Lymph Nodes
- **NCT ID**: NCT06327724
- **Study ID**: 12434
- **Status**: RECRUITING
- **Start Date**: 2023-09-01
- **Completion Date**: 2025-03-01
- **Lead Sponsor**: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
### Study Description
Systemic lupus erythematosus (SLE)is an immune-mediated inflammatory disease (IMIDs) of which the cellular and molecular alterations of the immune system driving the diseases still remains largely unknown. Accordingly, it remains difficult to predict the individual patient's response to treatment. Moreover, the patient's response to treatment remains heterogeneous and difficult to predict, despite the development of a variety of novel and powerful drugs (including the so-called biologicals). Therefore, there is a clear need for the identification and validation of cellular and molecular biomarkers which can provide useful clinical information for diagnosis, classification, prognosis and treatment, as well as the development of new therapeutic strategies. Biomarkers can be found and analyzed in different body compartments, of which the peripheral blood and the intra-articular synovial fluid or tissue are most easily accessible. However, previous studies in RA and other IMIDs showed that adaptive immune responses in other tissues such as lymph nodes also play an important role. Investigating other immune compartments of the body such as the lymph nodes could result in new insights. To study the early pathogenesis of inflammatory conditions, in 2008 our department initiated core-needle inguinal lymph node biopsy sampling. Since then more than 100 lymph node biopsy procedures were performed. The procedure is well-tolerated and, other than a small hematoma which does not require therapy in most of the cases, no complications were reported.In the current study, the effects of belimumab (anti-BAFF) in SLE will be investigated by studying the immune alterations taking place in lymph nodes in comparison to peripheral blood and immune alterations taking place in the end-organ, e.g. the joint (wrist, knee or ankle) by taking synovial biopsies during a needle- or mini-arthroscopy. This procedure has been performed frequently in our department over the last 15 years. In this way immune alterations in the lymph nodes (secondary lymphoid organ), peripheral blood (systemic) and the joint (end organ for the disease) will be assessed and compared.
### Conditions
- Systemic Lupus Erythematosus
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
- Belimumab
### Outcomes
**Primary Outcomes**
- Differences in lymph node cellular composition as assessed by advanced flow cytometry
**Secondary Outcomes**
- Differences in peripheral blood cellular composition as assessed by advanced flow cytometry
- Differences in synovial tissue cellular composition as assessed by advanced flow cytometry
### Location
- **Facility**: Amsterdam UMC; location Academic Medical Center, Amsterdam, N/A, 1100DD, Netherlands
@@
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## Benefits of Nutritional Ingredients for Type 2 Diabetes
- **NCT ID**: NCT06327711
- **Study ID**: BL77
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-04
- **Completion Date**: 2025-03
- **Lead Sponsor**: Abbott Nutrition
### Study Description
This is a prospective randomized, double-blinded, parallel design study to evaluate the benefits of long-term consumption of two experimental blends of liquid supplements.
### Conditions
- Diabetes type2
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: OTHER
### Interventions
- Control: CHO Blend
- Experimental: CHO Blend plus AN100
### Outcomes
**Primary Outcomes**
- Matsuda Index
- Fasted Glucose
- Fasted Insulin
**Secondary Outcomes**
- Body Weight
- Body Composition Measurements
- Continuous Glucose Monitoring
- Glycated Hemoglobin
- Resting Energy Expenditure (REE)
- Microbiome - Fecal
- Microbiome - Saliva
- Waist Circumference
- Hip Circumference
- Conicity Index
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
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## Cadonilimab in Combination With Anlotinib in the Treatment of Locally Progressive or Metastatic Melanoma With First-Line Therapy Failure
- **NCT ID**: NCT06327698
- **Study ID**: AK104-IIT-C-S-0010
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-05-15
- **Completion Date**: 2027-05-31
- **Lead Sponsor**: Hunan Cancer Hospital
### Study Description
This study is an open-label, multicenter, single-arm Phase II clinical study to evaluate the effectiveness of cadonilimab (AK104) in combination with anlotinib in the treatment of locally advanced or metastatic melanoma.
### Conditions
- Melanoma
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: NA
- **Intervention Model**: SINGLE_GROUP
- **Primary Purpose**: TREATMENT
### Interventions
- Cadonilimab
- anlotinib
### Outcomes
**Primary Outcomes**
- Response Rate
**Secondary Outcomes**
- Progression-free Survival (PFS)
- Disease Control Rate (DCR)
- Safety and tolerability
### Location
- **Facility**: N/A, N/A, N/A, N/A, N/A
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## Avapritinib With Decitabine in Patients With SM-AHN
- **NCT ID**: NCT06327685
- **Study ID**: MCC-22318
- **Status**: RECRUITING
- **Start Date**: 2024-03-13
- **Completion Date**: 2027-03
- **Lead Sponsor**: H. Lee Moffitt Cancer Center and Research Institute
### Study Description
Systemic mastocytosis with an associated hematologic neoplasm (SM-AHN) is a challenging disease to treat. Targeted KIT inhibitors have been approved for this indication based on their ability to control the mastocytosis portion of the disease, but patients frequently experience progression of the concomitant myeloid malignancy (i.e. the AHN). Using a combination approach to treat both aspects of the disease has the potential to provide enhanced disease control; however, overlapping toxicity is a concern. In this study, investigators aim to study the safety and tolerability of combined avapritinib and decitabine for the treatment of SM-AHN.
### Conditions
- Systemic Mastocytosis With an Associated Hematologic Neoplasm
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: NON_RANDOMIZED
- **Intervention Model**: SEQUENTIAL
- **Primary Purpose**: TREATMENT
### Interventions
- Avapritinib
- Decitabine
- Decitabine/Cedazuridine
### Outcomes
**Primary Outcomes**
- Recommended phase 2 dose (RP2D)
**Secondary Outcomes**
- Systemic mastocytosis overall response rate (ORR)
- Overall Responsive Rate
- Incidence and frequency of AEs and changes in vital signs, ECGs, and laboratory tests
### Location
- **Facility**: Mayo Clinic - Arizona, Phoenix, Arizona, 85054, United States
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## INOCA Spanish National Registry
- **NCT ID**: NCT06327672
- **Study ID**: 162023
- **Status**: RECRUITING
- **Start Date**: 2024-03-24
- **Completion Date**: 2026-03
- **Lead Sponsor**: Eva Rumiz González
### Study Description
Coronary atherosclerosis is the most common cause of ischaemic heart disease. About 40-50% of patients with symptoms and documented ischaemia on non-invasive tests do not show obstructive coronary artery disease on coronary angiography. This cause of ischaemic heart disease called INOCA (Ischemic Non-Obstructive Coronary Artery), far from having a benign prognosis, is associated with an increase in major adverse cardiac events (MACE) as well as increased functional limitation. The current European Society of Cardiology clinical practice guidelines for the management of chronic coronary syndrome establish for the first time a IIa recommendation for the invasive analysis of coronary flow reserve (CFR) and microvascular resistance index (MRI) in symptomatic patients with INOCA. The acetylcholine (Ach) test, based on intracoronary (ic) administration, is established as indication IIb for the assessment of micro or macrovascular vasospasm in patients with suspected vasospastic angina (VSA) (4). A national multicentre registry would allow us to determine the prevalence of INOCA and its different endotypes in our setting.
### Conditions
- Non-Obstructive Coronary Atherosclerosis
- Ischemia
- Coronary Disease
### Study Design
- **Type**: OBSERVATIONAL
- **Allocation**: N/A
- **Intervention Model**: N/A
- **Primary Purpose**: N/A
### Interventions
### Outcomes
**Primary Outcomes**
- Prevalence of INOCA endotypes.
**Secondary Outcomes**
- Incidence of combined event: death from all causes, acute myocardial infarction, readmission for heart failure and consultation for chest pain in the emergency department.
- Targeted pharmacological treatment
- Prognostic markers.
- INOCA and risk of heart failure with preserved ejection fraction.
### Location
- **Facility**: Hospital Universitario de la Princesa, Madrid, N/A, N/A, Spain
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## Efficacy of Using 50 ml Syringe Manual Thrombectomy Catheter in Primary PCI With Heavy Thrombus Burden
- **NCT ID**: NCT06327659
- **Study ID**: Thrombectomy by 50 ml syringe
- **Status**: NOT_YET_RECRUITING
- **Start Date**: 2024-04-01
- **Completion Date**: 2025-01-01
- **Lead Sponsor**: Helwan University
### Study Description
In high thrombus burden subgroup of Acute STEMI, manual aspiration thrombectomy was associated with reduced cardiovascular death but increased stroke or transient ischemic attack. The role of aspiration thrombectomy is still a matter of active debate. Manual aspiration suffers from decreasing aspiration force as the syringe fills with fluid and requires the operator to exchange syringes during the procedure to maintain suction.
### Conditions
- STEMI - ST Elevation Myocardial Infarction
- Thrombosis Cardiac
### Study Design
- **Type**: INTERVENTIONAL
- **Allocation**: RANDOMIZED
- **Intervention Model**: PARALLEL
- **Primary Purpose**: TREATMENT
### Interventions
- 30 mL syringe manual thrombectomy catheter
- 50 mL syringe manual thrombectomy catheter
### Outcomes
**Primary Outcomes**
- TIMI flow grade after PCI
- MBG after PCI
**Secondary Outcomes**
- Composite rate of occurrence of MACE
- Rate of cardiovascular death
- Rate of recurrent myocardial infarction
- Rate of stroke
- Rate of cardiogenic shock
- Rate of NYHA IV heart failure
### Location
- **Facility**: Badr University Hospital, Badr, Cairo, N/A, Egypt
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