pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Sildenafil to Reduce Vascular Remodeling During Left Ventricular Assist Device Support
NCT Number: NCT06510322
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: EARLY_PHASE1
Conditions: Vascular Diseases
Interventions: DRUG: Sildenafil|OTHER: Placebo
Sponsor: Montefiore Medical Center
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2025-01
Completion Date: 2029-12
Locations: Montefiore Medical Center, Bronx, New York, 10461, United States

Summary:
Contemporary left ventricular assist device (LVAD) therapy improves survival during advanced heart failure but vascular aging develops rapidly leading to major adverse events including stroke and bleeding in nearly half of patients. In this study, the study team aims to investigate whether sildenafil pharmacotherapy, which has anti-fibrotic effects, can reduce vascular aging during LVAD support.

Primary Outcome Measures: Change in Aortic Pulse Wave Velocity, Pulse wave velocity (PWV) will be measured by vascular ultrasound. PWV will be calculated by dividing the distance between the carotid and femoral artery waveform acquisition sites (in meters) by the carotid-femoral transit time (change in time, in seconds). Change in group mean PWV from baseline will be summarized. Increases in PWV can be an indicator of vascular fibrosis and are associated with increased risk of cardiovascular comorbidities., From Baseline to 180 days
Secondary Outcome Measures: Change in Vascular Reactivity Index, Endothelial function will be determined by the finger vascular reactivity index (VRI) during LVAD support. VRI will be assessed by a non-invasive method using the Endothelix device. VRI is determined by measuring figure tip temperature change before and after cuff deflation. Change in group median VRI values from baseline will be summarized. Positive changes from baseline are associated with improved endothelial function., From Baseline to 180 days|Change in Gastrointestinal Angiodysplasia (GIAD) Foci, Microvascular angiodysplasia will be assessed by video capsule endoscopy (VCE). VCE is a minimally invasive technique used to identify gastrointestinal lesions and diagnose GIAD. Change in the group mean number of GIAD foci/lesions per patient from baseline to 180 days will be determined.

GIAD formation will only be assessed at baseline and at 180 days unless the patient(s) experiences an episode of gastrointestinal bleeding prior to 180 days., From Baseline to 180 days|Change in Urinary Protein to Creatinine Ratio (ACR), Urine samples will be assessed to determine the protein to creatinine ratio. Urinary PCR is calculated by dividing the concentration of protein (mg/dL) in the urine sample by the creatinine concentration (mg/dL). Change in group mean urinary protein to creatine ratios from baseline will be summarized. Elevated ratios of protein to creatinine are associated with increased risk of renal disease and microvascular dysfunction., From Baseline to 180 days
A Phase II Study Using Rituximab Plus Venetoclax in the Front Line Treatment of Marginal Zone Lymphoma
NCT Number: NCT06510309
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Lymphoma|Marginal Zone Lymphoma|MZL
Interventions: DRUG: Venetoclax|DRUG: Rituximab
Sponsor: Gottfried von Keudell, MD PhD
Collaborators: AbbVie
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 33
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2030-02-01
Locations: Beth Israel Deaconess Medical Center, Boston, Massachusetts, 02215, United States

Summary:
The purpose of this study is to see if the combination of rituximab and venetoclax is effective in treating participants with untreated Marginal Zone Lymphoma (MZL).

The names of the study drugs involved in this study are:

* Venetoclax (a type of inhibitor)
* Rituximab (a type of antibody)

Primary Outcome Measures: Complete Response Rate (CRR), Complete Response (CR) rate is defined as the proportion of participants achieving CR during study treatment. CR is defined based on RECIL criteria., Up to 24 months
Secondary Outcome Measures: Overall response rate (ORR), ORR will be measured as the proportion of participants that achieve a PR or CR per RECIL criteria., Up to 24 months|Partial Remission (PR) Rate, Partial remission (PR) rate is defined as the proportion of participants achieving partial remission RECIL criteria., Up to 24 months|Median Progression Free Survival (PFS), PFS based on Kaplan-Meier methodology will be measured from the time the participant initiates treatment until the first occurrence of documented progression of disease or death from any cause, censored for participants alive without progression., Up to 24 months|Median Overall Survival (OS), OS based on Kaplan-Meier methodology will be measured from the time the participant initiates treatment until death from any cause, censored for participants alive., Up to 36 months|Median Event Free Survival (EFS), EFS will be measured from the time the participant initiates treatment until documented off therapy for any reason, censored for participants who remain on therapy., Up to 24 months|Duration of Response (DOR), DoR will be measured from the time of initial response until documented progression of disease, censored for participants who remain in response., Up to 24 months
Efficacy and Safety of Taitacept in Treatment of Refractory or Recurrent Anti-NMDAR/Anti-LGI1 Encephalitis
NCT Number: NCT06510283
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Anti-N-Methyl-D-Aspartate Receptor Encephalitis
Interventions: DRUG: Taitacept
Sponsor: Beijing Tongren Hospital
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 10
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2028-07-01
Locations: Beijing Tongren Hospital,Capital Medical University, Beijing, Beijing, 100730, China

Summary:
The main objective is to explore the efficacy and safety of Telitacicept in the treatment of refractory/recurrent anti-NMDAR and anti-LGI1 encephalitis.

Through this prospective, single-center, open-label clinical trial, we aim to investigate the effectiveness and safety of Telitacicept in refractory/recurrent anti-NMDAR and anti-LGI1 encephalitis by add-on therapy of Telitacicept combined with traditional treatment.

Primary Outcome Measures: the change of mRS score, Refractory encephalitis: rate of patients with mRS score \<2 or mRS score improvement of ≥2 points from baseline at week 24; Recurrent encephalitis: proportion of patients with no recurrence and \[mRS score \<2 or mRS score improvement of ≥2 points from baseline at week 24., from baseline at week 24
Safety and Efficacy Reconyl for Cough With/Without Sore Throat
NCT Number: NCT06510257
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Cough
Interventions: DRUG: Reconyl|DRUG: Placebo tablet of Reconyl
Sponsor: Dexa Medica Group
Collaborators: Fakultas Kedokteran Universitas Indonesia
Sex: ALL
Age: ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-10
Completion Date: 2025-04
Locations: Imeri Fkui, Jakarta Pusat, DKI Jakarta, 10430, Indonesia|Klinik Satelit Makara UI Depok, Depok, Jawa Barat, Indonesia

Summary:
This study is a prospective, randomized, double-blind and placebo-controlled study to find out if reconyl may relieve the acute cough with/without sore throat.

Primary Outcome Measures: Cough score, Scoring will be performed and recorded daily in the Subject Diary at time 0, every night time and before the morning dose.

At the End of Study (last visit) will be assessed by the subject and recorded by the Investigator.

Cough score:

• Day time: 0 = No cough; 1= Transient cough occasionally during the daytime; 2 = Frequent cough mildly affecting daily life; 3 = Frequent cough severely affecting daily life.

• Night time: 0 = No cough; 1= Transient cough before sleep or occasional cough during the night; 2 = Cough mildly affecting night sleep; 3 = Cough severely affecting night sleep., Day 0, Day 1, Day 2, Day 3|Visual Analogue Scale (VAS), VAS will be assessed and recorded daily in Subject Diary at time 0, every night time and before the morning dose.

At the End of Study (last visit) will be assessed by the subject and recorded by the Investigator., Day 0, Day 1, Day 2, Day 3|Adverse events, Any adverse events (AE) and serious adverse events (SAE) will be observed throughout the study conduct., Day 0, Day 1, Day 2, Day 3
Pain Perception Measurement by EEG and NRS
NCT Number: NCT06510244
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Pain|Electroencephalography|Toothache
Interventions: DEVICE: EEG EMOTIV
Sponsor: Cleveland Dental Institute
Sex: ALL
Age: ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-01-01
Completion Date: 2025-04
Locations: Cleveland Dental Institute, Cleveland, Ohio, 44128, United States

Summary:
Observational study at CDI Cleveland Dental Institute. Investigators will assess the pain perception in one group of patients using two non-invasive methods. First, a numerical rate scale (NRS) and second, a brain wave EEG.

Primary Outcome Measures: Pain Perception Measurement by EEG., to observe the brain waves changes during pain perception, January 2024-December 2024|Pain Perception Measurement by EEG and NRS., To establish a possible correlation between the NRS and EEG measurements., January 2024-December 2024
Inspiratory Muscle Training in HFpEF
NCT Number: NCT06510231
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Heart Failure
Interventions: OTHER: Inspiratory Muscle Training
Sponsor: Mayo Clinic
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 68
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: OTHER
Start Date: 2024-08
Completion Date: 2028-04
Locations: Mayo Clinic in Rochester, Rochester, Minnesota, 55905, United States

Summary:
This study is being done to determine how inspiratory muscle training impacts inspiratory muscle function during exercise in heart failure patients.

Primary Outcome Measures: Change in inspiratory muscle blood flow demand, Inspiratory muscle blood flow demand will be measured via indocyanine green dye venous bolus injection. This will be measured in umol., Baseline, 8 weeks
Secondary Outcome Measures: Change in locomotor muscle blood flow, Locomotor muscle blood flows will be measured via indocyanine green dye venous bolus injection. This will be measured in umol., Baseline, 8 weeks|Change in exercise tolerance, Exercise tolerance will be measured via submaximal exercise test. This will be measured in minutes., Baseline, 8 weeks
The Study is an Oberservational Post-market Follow-up Program to Evaluate Long Term(5 Years) Safety of Mentor Breast Implants in Chinese Population.
NCT Number: NCT06510205
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Breast Augmentation and Breast Reconstruction
Interventions: DEVICE: Mentor Breast implants
Sponsor: Johnson & Johnson Medical (Shanghai) Ltd.
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 5000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-14
Completion Date: 2034-08-31
Locations: Shenzhen Junke Medical Cosmetology Clinic, Shenzhen, 519000, China

Summary:
The Mentor Post-Market Clinical Follow-Up Study is a multicenter observational study conducted in China. It aims to collect safety data on Mentor breast implants over a 5-year follow-up period in the Chinese population. In addition to safety data, the study will also gather information on postoperative pain and participant satisfaction levels. The objective is to explore customers' clinical experiences and use them as a reference for future product development. The study intends to enroll a minimum of 300 subjects per license, with participation from three or more medical institutions.

Primary Outcome Measures: Breast implant related AEs, Post-op 1 month, 3 months, 1 year, 2 years, 3 years, 4 years, 5 years, Up to 5 years
Secondary Outcome Measures: Numerical Pain Scale assessment, Zero means you have no pain, while 10 represents the most intense pain possible., 1 month after surgery|Customer Satisfaction Score measurement, Measured at 1 month, 3 months, 1 year, 2 years, 3 years, 4 years, 5 years after surgery Using a 5-point scoring scale, 5 means very satisfied while 1 means very disatisfied., Up to 5 years after surgery
Effectiveness of Different Types of Toothbrushes on Periodontal Health in Orthodontic Patients
NCT Number: NCT06510179
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Gingivitis|Orthodontics
Interventions: OTHER: Toothbrushing
Sponsor: Okan University
Sex: ALL
Age: ADULT
Enrollment: 36
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2023-08-01
Completion Date: 2024-04-30
Locations: Istanbul Okan University Dental Hospital, Istanbul, Tuzla, 34947, Turkey

Summary:
The goal of this clinical trial is to compare the effectiveness of different toothbrushes in patients with fixed orthodontic appliances who have gingival inflammation. The main questions it aims to answer are:

1. Is a single-tufted toothbrush as effective as orthodontic or conventional toothbrushes?
2. What are the effects of these toothbrushes on dental biofilm removal and gingival inflammation? Researchers will compare conventional toothbrushes, orthodontic toothbrushes, and single-tufted toothbrushes after professional mechanical debridement and oral hygiene instruction.

Participants will:

1. Receive nonsurgical periodontal therapy
2. According to the group they are involved, they will receive an oral hygiene kit (toothbrush and toothpaste) and instruction
3. They will participate in the recalls in the first week, sixth week, and third month.

Primary Outcome Measures: Gingival inflammation, Löe \& Silnesss Gingival index, at the baseline, first week, sixth week and third month|bleeding on probing, bleeding on probing, at the baseline, first week, sixth week and third month
Secondary Outcome Measures: Dental biofilm, Turesky modification of Quigley-Hein plaque Index, at the baseline, first week, sixth week and third month
Other Outcome Measures: Pocket depth, Measuring probing pocket depth by a North Carolina periodontal probe, at the baseline, first week, sixth week and third month
Interest in Combining Intraoperative ElectroEncephaloGram (EEG) With Assessment of Frailty to Predict Postoperative Delirium in Patients Aged >75 Years Undergoing Major Non-cardiac Surgery
NCT Number: NCT06510140
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Post-operative Delirium
Interventions: BEHAVIORAL: Detection of the Post-operative delirium (POD)
Sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sex: ALL
Age: OLDER_ADULT
Enrollment: 55
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-05-15
Completion Date: 2025-10
Locations: Centre Hospitalier Universitaire de Saint Etienne, Saint Etienne, 42055, France

Summary:
Post-operative delirium (POD) is known to be independently associated with pre-operative frailty, pre-operative cognitive status and per-operative ElectroEncephaloGram (EEG). However, no study has focused on the impact of these pre- and peri-operative outcomes on the prediction of Post-operative delirium (POD). Therefore, this study has been designed to assess the performance of a new score that includes pre-operative frailty, and per-operative ElectroEncephaloGram (EEG) in predicting post-operative delirium.

Primary Outcome Measures: Onset of an early Post-operative delirium (POD), Investigation of an early Post-operative delirium (POD), with Confusion Assessment Method (CAM) criteria, 9-question test which assesses the presence, severity and fluctuation of nine clinical features of delirium, on a scale from 0 to 19. Higher scores indicate more severe delirium., Hour : 48
An AI Model Predicts the Efficacy of Neoadjuvant Chemotherapy for Breast Cancer: a Multicenter, Bidirectional Cohort Study
NCT Number: NCT06510127
Status: ENROLLING_BY_INVITATION
Study Type: OBSERVATIONAL
Conditions: Breast Cancer
Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Collaborators: First Affiliated Hospital of Jinan University
Sex: FEMALE
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 840
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-01
Completion Date: 2026-01-31
Locations: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Guangzhou, Guangdong, China

Summary:
Neoadjuvant chemotherapy is an important part of the systematic treatment of breast cancer, and it is of great clinical significance to predict the efficacy of neoadjuvant chemotherapy in early stage. The emergence of multi-modal artificial intelligence model has brought new ideas for it. However, the limited ability of artificial intelligence to integrate multi-modal data, the lack of multi-modal models, and the insufficient level of evidence in clinical promotion of artificial intelligence are all scientific problems that need to be solved. In the early stage of the study, a variety of artificial intelligence accurate prediction and auxiliary diagnosis and treatment models for breast cancer were constructed based on magnetic resonance imaging and pathomics, etc., and the effectiveness of the models in predicting the curative effect of neoadjuvant chemotherapy for breast cancer was explored. In order to further improve the predictive efficiency of the model and fill the gap in the systematic study of multi-modal data fusion model, this clinical study intends to combine pathological images, magnetic resonance imaging, diagnostic report text and clinical variables to establish an artificial intelligence large language model based on multi-task and multi-modal data fusion to accurately predict the efficacy of neoadjuvant chemotherapy for breast cancer. A multicenter, bidirectional cohort study was conducted to explore the predictive effectiveness of the model.

Primary Outcome Measures: Predictive ability of the model for pCR after neoadjuvant chemotherapy in breast cancer patients, receiver operating characteristic curve (ROC curve) were used to evaluate the predictive efficiency of the model, 1 year
Secondary Outcome Measures: Predictive ability of the model for DFS after neoadjuvant chemotherapy in breast cancer patients, receiver operating characteristic curve (ROC curve) were used to evaluate the predictive efficiency of the model, 1 year
Other Outcome Measures: Predictive ability of the model for neoadjuvant chemotherapy drug sensitivity in breast cancer patients, receiver operating characteristic curve (ROC curve) were used to evaluate the predictive efficiency of the model, 1 year
A Randomized Clinical Trial of Intravenous Methylprednisolone With 2 Protocols in Patients With Graves Orbitopathy
NCT Number: NCT06510114
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Graves Ophthalmopathy
Interventions: DRUG: methylprednisolone(daily scheme)|DRUG: methylprednisolone(weekly scheme)
Sponsor: Third Affiliated Hospital, Sun Yat-Sen University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 150
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07
Completion Date: 2026-12

Summary:
Intravenous glucocorticoid (IVGC) is an accessible and effective therapy for Graves orbitopathy (GO); the 4.5-g weekly protocol is well studied, but many details of treatment protocols need to be clarified. The goal of this trial is to compare the efficacy and safety of weekly and daily protocol of IVGC in GO. Researchers will compare daily protocol to weekly protocol to see if daily protocol works to treat GO.

Primary Outcome Measures: the overall response rate at 24 week, "Response" was defined as an improvement in at least two of the following four criteria were present, and the contralateral eye disease did not worsen: (1) the width of the eyelid was reduced by ≥2 mm; (2) The five scores of eyelid congestion, eyelid edema, conjunctival congestion, conjunctival edema and carunculae lacrimalis swelling in CAS decreased by ≥1 point; (3) The regression of exophthalmos ≥2 mm; (4) Increased eye movement ≥8° or improved diplopia ≥ grade I (continuous to interrupted, interrupted to brief, brief to none)., 24 week
Secondary Outcome Measures: Changes of clinical activity score (CAS) from baseline to 24 week, changes of clinical activity score (CAS) from baseline to 24 week, 24 week|changes of quality of life score (QoF-s) from baseline to 24 week, changes of quality of life score (QoF-s ), 24 week|changes of exophthalmos from baseline to 24 week, changes of exophthalmos from baseline to 24 week, 24 week|changes of width of the eyelid from baseline to 24 week, changes of width of the eyelid from baseline to 24 week, 24 week|changes of diplopia grade from baseline to 24 week, changes of diplopia grade from baseline to 24 week, 24 week
Other Outcome Measures: Changes of blood pressure from baseline to 24 week, Changes of blood pressure from baseline to 24 week, 24 week|Changes of weight from baseline to 24 week, Changes of weight from baseline to 24 week, 24 week|Changes of fasting blood glucose from baseline to 24 week, Changes of fasting blood glucose from baseline to 24 week, 24 week|Changes of serum low density lipoprotein cholesterol, Changes of low density lipoprotein cholesterol from baseline to 24 week, 24 week|Changes of serum triglyceride, Changes of serum triglyceride from baseline to 24 week, 24 week
Manual Manipulation and Ex Vivo Flexible Ureteroscopic Lithotripsy to Salvage Deceased Donor Kidneys With Renal Stones: A Case Series
NCT Number: NCT06510101
Status: ENROLLING_BY_INVITATION
Study Type: OBSERVATIONAL
Conditions: Manual Manipulation and Ex Vivo Flexible Ureteroscopic Lithotripsy to Salvage Deceased Donor Kidneys With Renal Stones:a New Method by
Sponsor: Yingxin FU.MD
Collaborators: Shenzhen Third People's Hospital|The University of Hong Kong-Shenzhen Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 9
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-01-01
Completion Date: 2024-07-30
Locations: yingxin Fu, Shenzhen, Guangdong, 518000, China

Summary:
we report the manual manipulation and Ex Vivo Flexible Ureteroscopic Lithotripsy to Salvage Deceased Donor Kidneys with Renal Stones,including nine cases,Renal transplantation was performed with the treated kidney after removing the stones, and the short-term postoperative outcomes were promising. cases were thoroughly reported in this paper.

Primary Outcome Measures: eGFR, renal function, 3monthes after transplantation
Effects of Multimodal Prehabilitation on Frail Elderly Patients Undergoing Elective Gastric Cancer Surgery
NCT Number: NCT06510088
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Elderly|Frail|Gastric Cancer|Prehabilitation
Interventions: PROCEDURE: 3-week multimodal prehabilitation program
Sponsor: Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University
Sex: ALL
Age: OLDER_ADULT
Enrollment: 112
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2019-03-01
Completion Date: 2023-12-31
Locations: Taizhou Hospital of Zhejiang Province Affiliated to Wenzhou Medical University, Taizhou, Zhejiang, China

Summary:
Research indicates that prehabilitation is effective in optimizing physical status before surgery, although this method may be considered "aggressive" for frail elderly patients. This study aimed to evaluate whether multimodal prehabilitation consisting of preoperative physical therapy, nutritional support, and cognitive exercises decreases postoperative complications and improves functional recovery in frail elderly patients undergoing gastric cancer surgery, in comparison to usual clinical care.

Primary Outcome Measures: postoperative complications, 30-day postoperative complications assessed by the Comprehensive Complication Index (CCI); The CCI, a validated index for assessing morbidity and mortality, aggregates all complications using the Clavien-Dindo classification system, resulting in a score from 0 (no complications) to 100 (death), 30-day after surgery|6-minute walking distance (6MWD), Functional capacity was assessed using the 6-MWD, a reliable measure of exercise tolerance in patients undergoing colorectal surgery, with changes of at least 20 meters deemed clinically significant., 30-day after surgery3-month after surgery
Secondary Outcome Measures: recovery of gastrointestinal function, recovery of gastrointestinal function, 30 days after surgery|QoL, QoR-9 scale, 3-month after surgery|physical activity, Short Form (36) health survey (SF-36), 3-month after surgery|psychological status, Hospital Anxiety and Depression scale, 3-month after surgery
Comparative Evaluation of Sustained Acoustic Medicine Device on Circulation
NCT Number: NCT06510062
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Measurement of Circulation on Anatomical Locations of the Body
Interventions: DEVICE: Sustained Acoustic Medicine|DEVICE: Sustained Acoustic Medicine|DEVICE: Sustained Acoustic Medicine|DEVICE: Sustained Acoustic Medicine
Sponsor: ZetrOZ, Inc.
Sex: ALL
Age: ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-22
Completion Date: 2024-12-31
Locations: ZetrOZ Systems LLC, Trumbull, Connecticut, 06611, United States

Summary:
Comparative Evaluation of Sustained Acoustic Medicine Device on Circulation

Primary Outcome Measures: Blood Flow (Perfusion Unit), Blood Flow Flux through Upper Extremity (Perfusion Unit), 0 - 1 hour|Ultrasound Diathermy (Degrees Centigrade), Temperature Measurement on Body (Degrees Centrigrade), 0 - 1 hour
Validity and Reliability of Ultrasound Imaging for Measuring Coronal and Sagittal Angles in Idiopathic Scoliosis
NCT Number: NCT06510049
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Ultrasonography|Coronal|Sagittal|Idiopathic Scoliosis|Validation Studies as Topic|Program Evaluation
Sponsor: The First Affiliated Hospital of Zhejiang Chinese Medical University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-01-22
Completion Date: 2024-05-01
Locations: The First Affiliated Hospital of Zhejiang University of Traditional Chinese Medicine (Zhejiang Provincial Hospital of Traditional Chinese Medicine), Hangzhou, Zhejiang, 310016, China

Summary:
Patients with idiopathic scoliosis (IS), especially children and adolescents, require regular follow-up evaluations. Ultrasound imaging offers a reliable, radiation-free method for assessing spinal curvatures in the coronal and sagittal planes. While manual labeling in traditional ultrasound is error-prone, automated labeling reduces inaccuracies but still needs further validation, particularly in the sagittal plane. This study compared three-dimensional (3D) ultrasound assessments with conventional X-ray images--the clinical gold standard. And it is aimed to evaluate the validity and reliability of ultrasound measurements-Ultrasound Curve Angle (UCA) and Ultrasound Lamellar Angle (USLA)-against established radiographic benchmarks like Cobb's angle, Thoracic Kyphosis (TK), and Lumbar Lordosis (LL).

Primary Outcome Measures: Coronal thorax/thoracolumbar/lumbar cobb angle and sagittal thorax/thoracomaxillary/lumbar anterior and posterior lordosis angles on x-ray, Coronal thorax/thoracolumbar/lumbar cobb angle and sagittal thorax/thoracomaxillary/lumbar anterior and posterior lordosis angles on x-ray, January to May 2024|Coronal thoracic/thoracolumbar/lumbar cobb angle and sagittal thoracic/thoracomaxillary/lumbar anterior-posterior lordosis angle on ultrasound, Coronal thoracic/thoracolumbar/lumbar cobb angle and sagittal thoracic/thoracomaxillary/lumbar anterior-posterior lordosis angle on ultrasound, January to May 2024
Secondary Outcome Measures: gender, gender, January to May 2024|age, age, January to May 2024|BMI, BMI, January to May 2024
Assessment of Pancreatic Physiological and Pathological Characteristics Based on Spectral CT
NCT Number: NCT06510036
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Diagnose Disease
Interventions: OTHER: The post-processing generated after scanning is converted into energy spectrum image data (SBI)
Sponsor: Yu Shi
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1500
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-03-21
Completion Date: 2026-06-21
Locations: Shengjing Hospital of China Medical University, Shenyang, Liaoning, 110004, China

Summary:
Patients who visited our hospital for various reasons from January 2024, underwent CT scans involving the pancreas, and were eligible for spectral post-processing reconstruction were included in the study. This research collected spectral CT data related to the pancreas at different phases, as well as physiological and pathological states for these patients. Quantitative analysis was conducted on post-processed data under different physiological and pathological states, including parameters such as pancreatic iodine uptake features, attenuation interval slopes, and extracellular volume size. In conjunction with general patient status, biochemical tests, and postoperative pathological results, the study aimed to identify correlations between parameters, develop models, and conduct research by comparing traditional CT data, which could be matched with spectral CT from the PACS database since its establishment.

Primary Outcome Measures: spectral imaging data(SBI), Using Philips Intellispace Portal software to reconstruct spectral imaging data images, 21/3/2025|ROI area（mm2）, Using Philips Intellispace Portal software to delineate the Region of Interest (ROI), 21/3/2025
Secondary Outcome Measures: single-energy CT value, Measure the single-energy CT value(Hu), 21/3/2025
Rewards Sensitivity After Brain Injury
NCT Number: NCT06510023
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Acquired Brain Injury
Interventions: BEHAVIORAL: Type of reward presented
Sponsor: Shirley Ryan AbilityLab
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 31
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: FACTORIAL|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2021-03-21
Completion Date: 2022-03-20
Locations: Shirley Ryan AbilityLab, Chicago, Illinois, 60611, United States

Summary:
A study measuring rewards sensitivity in individuals with acquired brain injury at an acute rehabilitation level.

Primary Outcome Measures: Performance on a Cued Response Reaction Time Task, in each of the three rewards conditions (Dollar, Penny, No reward), Accuracy (percentage of correct responses) in a Cued Response Reaction task, 15 minutes|Performance on a Cued Response Reaction Time Task, in each of the three rewards conditions (Dollar, Penny, No reward), Response time (time in milliseconds) in a Cued Response Reaction task, 15 minutes|Electrodermal activity (EDA) before, during and after the Cued Response Reaction task, Number of skin conductance responses (SCRs) before, during and after the task, 30 minutes
A Phase II Study of Anti-EGFR Antibody-drug Conjugate (ADC) Combine With CDK4/6 Inhibitors Posterior Line in the Treatment of Recurrent/Metastatic CDKN2A Gene Variant Head and Neck Squamous Cell Carcinoma
NCT Number: NCT06509997
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Head and Neck Squamous Cell Carcinoma
Interventions: DRUG: MRG003 combined with Dalpicicilip
Sponsor: Lei Liu
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2027-12-31

Summary:
A Single-arm, Phase II Study of MRG003 combined with Dalpicicilip posterior line in the treatment of recurrent/metastatic CDKN2A gene variant head and neck squamous cell carcinoman (HNSCC). The objective of this study was to evaluate the safety and efficacy of MRG003 combined with the Dalpicicilip posterior line in the treatment of recurrent/metastatic CDKN2A gene variant HNSCC.

Primary Outcome Measures: ORR, Objective response rate, approximately 9-10 weeks after start of study treatment|Safety and Tolerability, Number of participants with treatment-related adverse events as assessed by CTCAE v5.0, approximately 9-10 weeks after start of study treatment
Secondary Outcome Measures: OS, overall survival, 2 years|PFS, Progression Free Survival, 1-2years|DOR, Duration of response, 1-2years|DCR, Disease control rates, 2 years
A 20-Week Multicentre, Open Study Assessing the Efficacy and Safety of Apremilast in Patients > 6 Years of Age With EB Simplex Generalized
NCT Number: NCT06509984
Acronym: EBULO
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Inflammatory Epidermal Genodermatoses
Interventions: DRUG: Apremilast treatment
Sponsor: Centre Hospitalier Universitaire de Nice
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2024-08-01
Locations: CHU de Nice, Nice, 06000, France|APHP Necker-Enfants-Malades, Paris, 75015, France|APHP Hôpital Saint-Louis, Paris, 75018, France|chu de Toulouse, Toulouse, 31059, France

Summary:
The goal of this clinical trial is to Assessing the Efficacy and Safety of Apremilast in Patients \> 6 years of age with EB simplex generalized . The main question it aims to answer are: describe efficacity of this treatment.

Participants will take treatments and have to use bullets during the study period.

Primary Outcome Measures: To describe efficacy of apremilast, number of new blister conting every day, weeks 20
Secondary Outcome Measures: Safety of apremilast treatment, number of SAE, weeks 20
A Study of QL1706 (an Anti-PD-1/CTLA-4 Combined Antibody) Combined With Albumin-bound Paclitaxel and Bevacizumab in the Treatment of Platinum-resistant Recurrent Ovarian Cancer
NCT Number: NCT06509971
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Platinum-resistant Recurrent Ovarian Cancer
Interventions: DRUG: QL1706
Sponsor: West China Second University Hospital
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 39
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07
Completion Date: 2026-06

Summary:
* Major objectives To evaluate the efficacy of QL1706 combined with albumin-binding paclitaxel and bevacizumab in the treatment of platinum-resistant recurrent ovarian cancer.
* Secondary Purpose To evaluate the safety of QL1706 in combination with albumin-binding paclitaxel and bevacizumab in the treatment of platinum-resistant recurrent ovarian cancer.

Exploratory analysis of the association between the efficacy of the combination regimen and biomarkers.

Primary Outcome Measures: ORR, Defined as the proportion of subjects achieving optimal total efficacy (Bor) as confirmed Cr or PR (according to RECIST v1.1) . The best overall response was defined as the best response recorded (in order of CR, PR, SD, PD, or non-evaluable) from the beginning of treatment until disease progression, or in cases where PD was not achieved before the initiation of subsequent antitumour therapy or before study discontinuation (whichever occurred first) , the best efficacy was recorded (from the start of treatment until the last evaluable tumour imaging assessment) ., up to 6 months
Phase Ⅱ Study of Adductor Canal Block With HR18034 for Postsurgical Pain Management in TKA
NCT Number: NCT06509958
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Postoperative Pain Management in Total Knee Arthroplasty
Interventions: DRUG: HR18034|DRUG: Ropivacaine Hydrochloride Injection
Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 120
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-20
Completion Date: 2025-04
Locations: Tianjin Medical University General Hospital, Tianjin, Tianjin, 300052, China

Summary:
Phase Ⅱ, randomized, double-blind, comparator-controlled study to evaluate the efficacy, safety and pharmacokinetics of single injection adductor canal block with HR18034 for postoperative pain management in total knee arthroplasty compared with ropivacaine.

Primary Outcome Measures: AUC0-72h of the NRS-A pain intensity scores., AUC of NRS pain intensity scores at activity (NRS-A) through 72 hours after the beginning of study drug administration., 0 to 72 hours
Secondary Outcome Measures: AUC of the NRS-A pain intensity scores., AUC of NRS pain intensity scores at activity (NRS-A) for time periods 0-24, 0-48 hours., 0-24, 0-48hours|AUC of the NRS-R pain intensity scores., 0-24, 0-48，0-72 hours|AUC of NRS pain intensity scores at rest (NRS-R) for time periods 0-24, 0-48 ,0-72 hours., 0-24, 0-48 ,0-72 hours.|Pain intensity assessed using an 12-point NRS ranging., Baseline till 72 hours after the beginning of study drug administration|Proportion of subjects who used no rescue opioid analgesic., 0-24, 24-48, 48-72, 0-72 hours|Total rescue analgesic consumption., 0-24, 24-48, 48-72, 0-72 hours|Time to the first postoperative use of rescue opioid analgesics., 0-72hours|Quadriceps muscle strength score., Baseline till 72 hours after the beginning of study drug administration|Range of motion of the knee joint., Baseline till 72 hours after the beginning of study drug administration|Subjects' satisfaction rating, 72 hours|Investigators' satisfaction rating, 72 hours
Application of a Novel Biomarker Based on Plasma cfDNA Assay in the Early Diagnosis of Prostate Cancer
NCT Number: NCT06509919
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Prostate Cancer
Interventions: DIAGNOSTIC_TEST: Blood draw
Sponsor: Shanghai Changzheng Hospital
Collaborators: Ningbo No. 1 Hospital|The First Affiliated Hospital of Guangzhou Medical University|Jiangsu Provincial People's Hospital|The First Affiliated Hospital of Soochow University
Sex: MALE
Age: ADULT, OLDER_ADULT
Enrollment: 1100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-09
Completion Date: 2025-12
Locations: Changzheng hospital, Shanghai, Shanghai, 201109, China

Summary:
The goal of this diagnostic test is to obtain multiple cell-free DNA （cfDNA） fragment profiles of subjects by whole genome sequencing based on plasma cfDNA, build a prostate cancer prediction model by machine learning, and to validate the efficacy of this model in patients who need to undergo needle prostate biopsy base on their prostate-specific antigen（PSA） or clinical or imaging evidence. Therefore, this study aims to explore the efficacy of this prostate cancer prediction model in distinguishing between patients with PSA "gray zone" (4-10 ng/ml) in the diagnosis of prostate cancer and patients with clinically significant prostate cancer.

Primary Outcome Measures: AUROC value for predicting positive needle biopsy results (prostate cancer) in individuals with PSA levels in the gray zone., Through completion of study and all data analysis which may take up to one and a half years.|Sensitivity for predicting positive needle biopsy results (prostate cancer) in individuals with PSA levels in the gray zone., Through completion of study and all data analysis which may take up to one and a half years.|Specificity for predicting positive needle biopsy results (prostate cancer) in individuals with PSA levels in the gray zone., Through completion of study and all data analysis which may take up to one and a half years.
Secondary Outcome Measures: AUROC value for predicting clinically significant prostate cancer (GS > 7) in pathological results., Through completion of study and all data analysis which may take up to one and a half years.
M9466 in Combination With Topoisomerase 1 Inhibitors-based Regimens in Advanced Solid Tumors and Colorectal Cancer (DDRiver 511)
NCT Number: NCT06509906
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Advanced Solid Tumor
Interventions: DRUG: M9466|DRUG: Irinotecan|DRUG: Folinic acid|DRUG: Fluorouracil (5-FU)|DRUG: Bevacizumab
Sponsor: EMD Serono Research & Development Institute, Inc.
Collaborators: Merck KGaA, Darmstadt, Germany
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 54
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-16
Completion Date: 2026-04-07
Locations: Carolina BioOncology Institute, LLC - Cancer Therapy and Research Center, Pennington, New Jersey, 08534, United States|Vanderbilt University - 150912667, Nashville, Tennessee, 37232, United States|The University of Texas MD Anderson Cancer Center, Houston, Texas, 77030-4009, United States|St George Private Hospital, Kogarah, Australia|Peter MacCallum Cancer Centre - Use the one with Account 2 VCCC, Parkville, Australia|National Cancer Center Hospital, Chuo-ku, Japan|Samsung Medical Center, Seoul, Korea, Republic of|Seoul National University Hospital, Seoul, Korea, Republic of|NEXT Barcelona - NEXT Barcelona, Barcelona, Spain|NEXT Madrid - Hospital Universitario Quironsalud Madrid, Pozuelo de Alarcon, Spain

Summary:
The purpose of this study is to evaluate the safety and preliminary clinical activity of M9466 in combination with topoisomerase 1 inhibitors-based regimens. As such the combination with FOLFIRI (folinic acid, fluorouracil, irinotecan) and Bevacizumab will be evaluated in participants with colorectal cancer, to establish the M9466 maximum tolerated dose if observed and the recommended dose for expansion.

Study Duration: After a Screening period of up to 28 days, enrolled participants will remain in the study until they have completed all the study visits or until they withdraw consent, are lost to follow-up, or die.

Visit Frequency: The participants will come for a Screening Visit and 1 to 2 visits per treatment cycle. After end of study intervention period, the participants will come for an End of Treatment Visit and a Safety Follow-up Visit.

Primary Outcome Measures: Number of Participants with Treatment-Emergent Adverse Events (TEAEs) and Treatment Related TEAEs, Time from signing Informed Consent Form (ICF) up to 30 days after end of study intervention (approximately assessed up to 18.7 months)|Number of Participants with Dose Limiting Toxicity (DLT), Day 1 up to Day 28 of the first two Cycles (each cycle is of 14 days)
Secondary Outcome Measures: Pharmacokinetic (PK) Plasma Concentration of M9466, Pre-dose up to 6 hours post-dose on Cycle 1 Day 1; at pre-dose on Cycle 1 Day 5 and Cycle 1 Day 8 (each cycle is of 14 days)|Objective Response (OR) According to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) Assessed by Investigator, Time from first treatment of study intervention up to planned assessment at 18.7 months
Ticagrelore Alone Post PCI
NCT Number: NCT06509893
Acronym: TICALONE
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Coronary Artery Disease
Interventions: DRUG: aspirin 80 mg and clopidogrel 75 mg daily|DRUG: Ticagrelor 90 MG
Sponsor: Shiraz University of Medical Sciences
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 5400
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2025-09-01
Locations: Cardiology Ward Shiraz University of Medical Sciences, Shiraz, Fars, 51318, Iran, Islamic Republic of

Summary:
After PCI for CCS patients, single center double blind randomization will be done and patients will receive aspirin 80 mg and clopidogrel 75 mg versus 90 mg two times daily of ticagrelor, for 6 months and MACE will be followed in registry of professor Kojuri cardiology clinic

Primary Outcome Measures: stent thrombosis, Post PCI till 6 months any confirmed or suspected episodes of stent thrombosis based on ARCH definition, 6 months|Major adverse cardiovascular events, Any episodes of myocardial infarction, acute coronary syndrome, revascularization, hospital admission and major vascular events will be recorded, 6 months|Bleeding, any major or minor bleeding based on HASBLED criteria, 6 months
Secondary Outcome Measures: Treatment related adverse reactions, Number of participants with treatment-related adverse events as assessed by CTCAE v4.0, 6 months
Comparison of De-Epithelialized Gingival Graft With or Without Platelet Rich Fibrin in Multiple Gingival Recessions
NCT Number: NCT06509867
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Gingival Recession, Generalized
Interventions: PROCEDURE: DGG+PRF|PROCEDURE: DGG
Sponsor: Kutahya Health Sciences University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 15
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2019-05-30
Completion Date: 2021-04-30
Locations: Gazi University Faculty of Dentistry, Ankara, 06490, Turkey

Summary:
The aim of this study is to compare the clinical efficacy and patient reported outcome measures of de-epithelialized gingival graft (DGG) with or without platelet rich fibrin on treatment of multiple adjacent gingival recessions with coronally advanced flap (CAF) technique.

Primary Outcome Measures: percentage of root coverage, Percentage of Root Coverage (RC%) were performed with the following formulas. RC%: \[(Preoperative RD-Postoperative RD)/ Preoperative RD\] x 100., at 6th month
Expanded Access Protocol for STOMP-II Patients Who Were Unable to Receive Treatment Subsequent to Adipose Tissue Collection
NCT Number: NCT06509828
Acronym: EAP-STOMP2
Status: AVAILABLE
Study Type: EXPANDED_ACCESS
Conditions: Perianal Fistula Due to Crohn's Disease
Interventions: BIOLOGICAL: AVB-114
Sponsor: Avobis Bio, LLC
Collaborators: Alimentiv Inc.
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT

Summary:
The goal of this Expanded Access Protocol is to provide expanded access of AVB-114 to patients who had their fat tissue collected as part of a clinical trial (STOMP-II), but who were subsequently not treated with AVB-114 because they did not meet all eligibility criteria or the investigational product was not successfully manufactured.