pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Mechanisms for Atrial Fibrillation in Obstructive Sleep Apnea
NCT Number: NCT06465134
Acronym: AF-MiTriSto
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Atrial Fibrillation|Obstructive Sleep Apnea|Hypertension|Autonomic Dysfunction|Arterial Stiffness
Interventions: OTHER: No intervention
Sponsor: Danderyd Hospital
Collaborators: Istituto Auxologico Italiano|University of Trieste
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 300
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-11-01
Completion Date: 2026-05
Locations: San Luca Hospital, Milan, 20145, Italy|Cattinara Hospital, Trieste, Italy|Danderyd Hospital, Stockholm, 182 88, Sweden

Summary:
Atrial fibrillation (AF) is the most common rhythm disorder and involves an increased risk of cardiovascular disease and death, impaired quality of life and a high proportion of healthcare consumption. An important risk factor is obstructive sleep apnea (OSA). However, it is not fully understood why OSA induces AF. It may be due to a proinflammatory state, sympathetic activation and acute changes in blood pressure during apnéas, but few studies are performed. Hypertension with its coherent arterial stiffness is related to all these factors, is common in OSA, and is the most common cause of AF. The cause of AF in hypertensive subjects is believed due to a pressure overloaded left heart, with dilation and fibrosis of the left atrium, promoting the development of AF. Hypertension and arterial stiffness can thus be important triggering factors for AF in OSA.

In this project, teh investigators investigate the occurrence of OSA in AF patients. Furthermore, underlying mechanisms for the development and recurrence of AF after intervention in OSA patients are investigated.

300 patients scheduled for AF ablation or cardioversion are invited and examined with sleep registration, 24h blood pressure, aortic stiffness measurement, test of autonomic function, echocardiography, ECG and labs. The patients are followed at months 3, 6 and 12 with 7 days ECG for recurrence. The aim is to give insights into the need for screening for OSA in patients with AF. The study also aim at enabling preventive treatment through better understanding of underlying treatable mechanisms. The results are believed to lead to fewer new AFs, as well as fewer AF recurrences in patients with OSA.

Primary Outcome Measures: Time to recurrence of AF measured on 7 days electrocardiography at month 3, 6, 12, Recurrence of atrial fibrillation after AF ablation or cardioversion, one year
Secondary Outcome Measures: aortic stiffness measured by tonometry; pulse wave velocity (m/s), measured aortic stiffness (measured as pulse wave velocity in m/s) in subjects with OSA compared to those without OSA in the cohort, baseline measurements
Difficult Intravenous Access in Pediatric Patients: Paramedical Care Using Ultrasound Guidance
NCT Number: NCT06465121
Acronym: VVParamECHO
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Catheter Related Complication
Interventions: PROCEDURE: peripheral intravenous catheterization performed with ultrasound guidance by a trained nurse
Sponsor: CHU de Reims
Sex: ALL
Age: CHILD, ADULT
Enrollment: 120
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-09
Completion Date: 2026-05
Locations: Chu Reims, Reims, 51092, France

Summary:
Obtaining intravenous access is difficult in the pediatric population. Ultrasound-guidance allows real-time visualization of target veins which are invisible and impalpable. We hypothesize that the use of ultrasound by a trained nurse team would improve the success rate of peripheral intravenous catheter insertion in pediatric patients with difficult intravenous access, compared to palpation of the vein alone.

For this study, when peripheral intravenous catheterization will be indicated in one of the participating pediatric services for an eligible patient, state-certified nurse investigators, trained in ultrasound guidance, will be contacted. After verification of eligibility criteria and all informed consents obtained, one of the investigators will randomize the patient in one of the 2 treatment groups under study: peripheral intravenous catheterization by visualization and palpation of the vein alone (standard of care) or by ultrasound guidance performed by a trained nurse.

Several outcomes will be measured and compared between the 2 groups (e.g. successful insertion of intravenous catheter, pain, adverse events).

Primary Outcome Measures: Number of Participants with success at first intravenous catheter insertion attempt, Success at first attempt of intravenous catheter insertion with ultrasound-guidance compared to standard of care for pediatric patients with difficult venous access, Day 0
Safety, Pharmacokinetics and Efficacy of MBX 2109 in Patients With Hypoparathyroidism
NCT Number: NCT06465108
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Hypoparathyroidism
Interventions: DRUG: MBX 2109|OTHER: Placebo
Sponsor: MBX Biosciences
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 48
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-06-07
Completion Date: 2025-06
Locations: MBX Biosciences Investigational Site, Jacksonville, Florida, 32204, United States|MBX Biosciences Investigational Site, Jacksonville, Florida, 32216, United States|MBX Biosciences Investigational Site, Macon, Georgia, 31210, United States|MBX Biosciences Investigational Site, Jackson, Mississippi, 39202, United States|MBX Biosciences Investigational Site, Las Vegas, Nevada, 89148, United States|MBX Biosciences Investigational Site, Albany, New York, 12203, United States|MBX Biosciences Investigational Site, Greenville, North Carolina, 27834, United States|MBX Biosciences Investigational Site, Dallas, Texas, 75208, United States|MBX Biosciences Investigational Site, El Paso, Texas, 79935, United States|MBX Biosciences Investigational Site, Fort Worth, Texas, 76132, United States|MBX Biosciences Investigational Site, Round Rock, Texas, 78681, United States|MBX Biosciences Investigational Site, San Antonio, Texas, 78231, United States|MBX Biosciences Investigational Site, Weslaco, Texas, 78596, United States

Summary:
The purpose of this study is to investigate the safety and tolerability of MBX 2109 administered once weekly to patients with hypoparathyroidism.

Primary Outcome Measures: To evaluate the effect of pooled weekly doses of MBX 2109 on the proportion of responder patients defined by serum calcium levels and treatment with active vitamin D and calcium supplements at Week 12., Proportion of patients pooled across MBX 2109 doses meeting the composite criteria at week 12.

* Independence from active vitamin D supplements
* Oral elemental calcium doses of ≤600 mg/day
* Serum albumin-adjusted calcium (AdjCa) values of 8.2 to 10.6 mg/dL, Week 12
Evaluation of Inflammasome Gene Polymorphisms in Periodontitis Patients
NCT Number: NCT06465095
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Periodontal Diseases|Periodontitis
Interventions: GENETIC: Baseline
Sponsor: Marmara University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 240
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-01
Completion Date: 2025-04-14
Locations: Marmara University, İstanbul, Maltepe, 34854, Turkey

Summary:
The present study aimed to evaluate the distribution of NLRP3, AIM2, and IFI16 inflammasome gene polymorphisms in individuals with Stage III Grade B and C periodontitis and periodontally healthy individuals. 80 periodontally healthy, 80 Stage III Grade B and 80 Stage III Grade C periodontitis patients will be enrolled. Blood samples will be collected from each participants and clinical parameteres will be recorded for whole mouth. DNA isolation will be performed from all samples. The SNP regions with the numbers rs4612666, rs75985579, and rs2793845 will be detected from DNA material using Real-Time PCR device genotyping kits. Data will be analyzed using statistical tests.

Primary Outcome Measures: NLRP3 gene polymorphism, SNP, Baseline
Secondary Outcome Measures: AIM2 gene polymorphism, SNP, Baseline|IFI16, SNP, Baseline
Diaphragmatic Thickening Fraction as a Predictor of Successful Weaning
NCT Number: NCT06465082
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Weaning From Mechanical Ventilation
Sponsor: Mansoura University Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 55
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-05
Completion Date: 2024-11-15
Locations: Mohamed AbdElmoniem, Mansoura, 35516, Egypt

Summary:
The aim of this study is to assess the validity of the diaphragmatic thickening Fraction measured by ultrasound as a predictor for successful weaning from mechanical ventilation.

Primary Outcome Measures: Diaphragmatic thickening Fraction as predictor for weaning from mechanical ventilation., assess the validity of the diaphragmatic thickening Fraction measured by ultrasound as a predictor for successful weaning from mechanical ventilation., Baseline and after 6 month
HFPEF-project: Heart Failure Phenotyping - Exploring the Fingerprints
NCT Number: NCT06465043
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Heart Failure With Preserved Ejection Fraction
Sponsor: University of Helsinki
Collaborators: Aarne Koskelo Foundation|Finnish Foundation for Cardiovascular Research
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 300
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-01
Completion Date: 2030-06

Summary:
With an ageing population, the number of patients with heart failure with preserved ejection fraction (HFpEF) or diastolic heart failure is increasing rapidly. This condition is associated with significantly increased morbidity and mortality, but effective treatment options that improve prognosis are very limited.

Further understanding of the nature and determinants of this disease is needed to develop better treatments of HFpEF and to improve the prognosis and quality of life of these patients.

This study will collect a comprehensive, prospective dataset of patients with HFpEF and determine which factors influence the prognosis of this patient group.

The specific aim is to create an accurate description of the spectrum and subtypes of HFpEF enabling better tools to plan and implement individualised treatment for patients.

The main objectives of the study are:

* to describe and categorize the phenotype of HFpEF patients (deep phenotyping) using the latest biochemical, functional and imaging techniques
* identifying factors affecting prognosis and potential new prognostic markers
* prospective follow-up of a contemproary cohort of HFpEF patients to assess outcomes, such as hospitalisations for heart failure, mortality, and quality of life
* identification of specific or aberrant HFpEF phenotypes for genetic studies.

Target population:

* Patients (minimum18 years old) with hospitalization for heart failure (1' or 2' cause for hospitalization) or outpatients with heart failure AND
* Left ventricular ejection fraction (LVEF) \>40% within 12 months prior to or during index hospitalization (assessed by ECHO, MRI, LV-cineangiography or radionuclide imaging) AND
* Elevated BNP/NTproBNP AND
* Impaired myocardial relaxation (diastolic dysfunction) assessed by tissue doppler imaging (TDI) velocities on ECHO: lateral mitral annulus velocity (lat E') \>9cm/s or septal annulus velocity (sept E') \>8 cm/s
* Both de-novo HF and patients with previously diagnosed HF will be eligible

The study prospective, observational study is carried out at Helsinki and Uusimaa Hospital District (HUS).

Primary Outcome Measures: All- cause mortality, Death from any cause, 1 year
Secondary Outcome Measures: Heart Failure Hospitalisation, Rate of hospitalisation for worsening heart failure, 12 months|All cause mortality, Death from any cause, 5 years|Cardiovascular mortality, Death from cardiovascular causes, 1 year
Other Outcome Measures: Functional status, 6-minute walking test (walk distance in meters), 6 months
Identification of Pattern and Factors Affecting Recurrence in Head and Neck Carcinoma
NCT Number: NCT06465030
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Recurrent Head and Neck Squamous Cell Carcinoma
Sponsor: Sohag University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 35
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-15
Completion Date: 2025-06
Locations: Sohag Faculty of Medicine, Sohag, Egypt

Summary:
The study will evaluate the local experiences in treatment of head and neck carcinoma by retrospectively analyzing the incidence and location of recurrence, and also studying factors affecting this recurrence.

Primary Outcome Measures: Pattern of relapse in recurrent head and neck squamous cell carcinoma, evident clinically and measured by images "US,CT, MRI and endoscopy"., Local, locoregional recurrence by MRI neck and CT Neck and distant recurrence by pan CTs., At least obsevation of 1 year FU of the patient
ImmunoPET Targeting Trophoblast Cell-Surface Antigen 2 (Trop-2) in Thyroid Cancer
NCT Number: NCT06465017
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Tumor|Solid Tumor|Thyroid Cancer|Positron-Emission Tomography
Interventions: DIAGNOSTIC_TEST: standard-of-care imaging (18F-FDG and 68Ga-FAPI PET/CT), 68Ga-THP-Trop2 VHH PET/CT
Sponsor: The First Affiliated Hospital of Xiamen University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 90
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-06-12
Completion Date: 2026-06-30
Locations: The First Affiliated Hospital of Xiamen University, Xiamen, Fujian, 361003, China

Summary:
The objective of the study is to construct a noninvasive approach 68Ga-THP-Trop2 VHH PET/CT to detect the Trop-2 expression of tumor lesions in patients with thyroid cancer and to identify patients benefiting from Trop-2 targeting antibody-drug conjugate treatment.

Primary Outcome Measures: Diagnostic efficacy, The sensitivity, specificity, and accuracy of standard-of-care imaging (18F-FDG and 68Ga-FAPI PET/CT) and 68Ga-THP-Trop2 VHH PET/CT were calculated and compared to evaluate the diagnostic accuracy., 2 years
Secondary Outcome Measures: Number of lesions, The numbers of positive primary and metastatic lesions of standard-of-care imaging (18F-FDG and 68Ga-FAPI PET/CT) and 68Ga-THP-Trop2 VHH PET/CT were recorded by visual interpretation., 2 years|SUV, Standardized uptake value (SUV) of standard-of-care imaging (18F-FDG and 68Ga-FAPI PET/CT) and 68Ga-THP-Trop2 VHH PET/CT for each target lesion of subject or suspected primary tumor or/and metastasis., 2 years
Pilot Trial: Bioavailability Animal vs. Plant Protein Drink
NCT Number: NCT06465004
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Nutrition, Healthy|Leucine Sensitivity
Interventions: DIETARY_SUPPLEMENT: Consumption of protein - rich drink
Sponsor: ETH Zurich
Sex: ALL
Age: ADULT
Enrollment: 12
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-06-08
Completion Date: 2024-08-30
Locations: SLA - ETH Zurich, Schwerzenbach, Zurich, 8603, Switzerland

Summary:
A pilot study is being conducted to compare a new plant-based protein drink to commercially available animal-based protein drinks. The goal is to assess if the plant-based drink delivers amino acids to the bloodstream as effectively as the animal-based drinks, potentially offering a viable option for those on plant-based diets.

The study will involve approximately 12 healthy adults aged 18-40. Each participant will try all three drinks (the new plant-based drink, a commercial animal-based drink, and another animal-based recipe) on separate days in a randomized order. Before and after (30, 60, and 90 minutes) consuming each drink, a small blood sample will be drawn to measure amino acid levels (leucine).

By comparing the results, the investigators hope to determine if the plant-based drink can match the effectiveness of animal-based protein drinks in delivering essential nutrients. This research could contribute to the development of sustainable and nutritious plant-based protein alternatives.

Primary Outcome Measures: leucine content in the blood, Assessment of leucine content in blood before and 30-60-90 min after consumption of drink, 4 hours
Stapler Reinforcement Patches Compared to Standard Staplers in Gastrojejunostomy
NCT Number: NCT06464978
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Gastric Cancer|Gastrostomy|Anastomotic Leakage|Postoperative Complications
Interventions: DEVICE: Stapler Reinforcement Patch|DEVICE: Standard Stapler
Sponsor: Nanchong Central Hospital
Collaborators: Guang'an Central Hospital|Pengan County People's Hospital|Yilong County people's Hospital|Nanbu Hospital of County Chinese Medicine|Langzhong People's Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 382
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-05-30
Completion Date: 2026-06
Locations: Yunhong Tian, Nanchong, Sichuan, 637000, China

Summary:
This is a multi-center, prospective, randomized controlled study aimed at compareing the impact of stapler reinforcement patches versus standard staplers on postoperative complications in gastrojejunostomy.

Primary Outcome Measures: Rate of Anastomotic Leakage, The incidence of anastomotic leakage within 30 days post-surgery. Anastomotic leakage is defined as the presence of fluid containing enteric content in the abdominal cavity or the appearance of leakage confirmed by imaging or endoscopy., 30 days post-surgery
Secondary Outcome Measures: Rate of Anastomotic Stricture, The incidence of anastomotic stricture within 3 months post-surgery. Anastomotic stricture is defined as difficulty in food passage or narrowing confirmed by imaging or endoscopy., 3 months post-surgery|Postoperative Bleeding Rate, The incidence of postoperative bleeding within 30 days post-surgery. Postoperative bleeding is defined as the occurrence of bleeding requiring intervention or causing significant hemoglobin drop., 30 days post-surgery|Mortality Rate, The rate of mortality within 30 days post-surgery., 30 days post-surgery|Readmission Rate, Readmission Rate, 3 months post-surgery
Clinical Study of Cord Blood-Derived CAR-NK Cells in Gastric Cancer and Pancreatic Cancer
NCT Number: NCT06464965
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Gastric Cancer|Pancreas Adenocarcinoma
Interventions: BIOLOGICAL: CB CAR-NK182
Sponsor: Zhejiang Provincial People's Hospital
Collaborators: Zhejiang University|Hangzhou RongGu Biotechnology Limited Company
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-19
Completion Date: 2027-06
Locations: Zhejiang Provincial People's Hospital, Hangzhou, Zhejiang, China

Summary:
Main Objective: To study the maximum tolerated dose (MTD) and dose-dependent toxicity (DLT) of cord blood-derived CAR-NK cells (CB CAR-NK182) targeting Claudin18.2 in patients with advanced gastric cancer and advanced pancreatic cancer.

Secondary Objective: To evaluate the efficacy of CB CAR-NK182 in patients with advanced gastric cancer and advanced pancreatic cancer: overall objective tumor response rate (ORR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), duration of response (DOR), etc.

To evaluate the CAR-NK amplification and persistence of CB CAR-NK182 in the blood of patients with advanced gastric cancer and advanced pancreatic cancer;

Primary Outcome Measures: MTD, Maximum Tolerated Dose, 3 years|DLT, Dose-Dependent Toxicity, 3 years
Secondary Outcome Measures: ORR, Overall objective tumor response rate, 3 years|DCR, Disease control rate, 3 years|PFS, progression-free survival, 3 years|OS, overall survival, 3 years|DOR, duration of response, 3 years
Phase 2 Study of KH001 in Long-term Relief From Dentin Hypersensitivity
NCT Number: NCT06464939
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Dentin Hypersensitivity
Interventions: DRUG: KH001|DRUG: Placebo
Sponsor: HysensBio Co., Ltd
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 120
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-19
Completion Date: 2025-06-30
Locations: ADA Forsyth, Cambridge, Massachusetts, 02142, United States

Summary:
The purpose of this study is to evaluate the efficacy and safety of KH001 in subjects with dentin hypersensitivity.

Primary Outcome Measures: Change from baseline in Schiff sensitivity score, Schiff sensitivity score 0-3 by an evaporative air, Baseline and Week 5
Secondary Outcome Measures: Change from baseline in a Schiff sensitivity score, Schiff sensitivity score 0-3 by an evaporative air, Baseline, Up to 8 Weeks|Change from baseline in a Tactile threshold, Tactile threshold by yeaple probe, Baseline, Up to 8 Weeks|Change from baseline in Visual Analogue Scale, Visual Analogue Scale by an evaporative air, Baseline, Up to 8 Weeks
A Predictive Model for Recurrent Acute Pancreatitis
NCT Number: NCT06464887
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Acute Pancreatitis
Sponsor: Qinghao Wang
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 659
Study Design: Observational Model: |Time Perspective: p
Start Date: 2016-01-01
Completion Date: 2018-06-30

Summary:
The goal of this observational study is to learn about recurrent acute pancreatitis (RAP) .The main questions it aims to answer are:

1. What are the risk factors for RAP?
2. How to predict RAP?

All patients with acute pancreatitis will be given standardized treatment for the condition.

The researchers will compare the RAP group with the non-RAP group to find the risk factors for RAP.

Primary Outcome Measures: Number of Participants Who Experience Recurrent Acute Pancreatitis, Recurrent acute pancreatitis was defined as two or more confirmed episodes of acute pancreatitis, excluding chronic pancreatitis, with an interval of more than 3 months between attacks, and complete resolution of symptoms during the inter-episodic periods., From admission to 3 years after discharge.
Endoscopic Therapy for Laterally Spreading Tumors (LSTs)
NCT Number: NCT06464874
Acronym: LST
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: To Compare the Efficacy and Safety of Hybrid ESD and ESD in the Treatment of Colorectal LST
Interventions: PROCEDURE: Conventional ESD|PROCEDURE: Hybrid ESD
Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 890
Study Design: Observational Model: |Time Perspective: p
Start Date: 2020-05-01
Completion Date: 2023-12-30
Locations: 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China, Hangzhou, Zhejiang, 310009, China

Summary:
This study will retrospectively include LST patients who were admitted to 6 medical centers (The Second Affiliated Hospital, College of Medicine, Zhejiang University; The Affiliated Jinhua Hospital, Zhejiang University School of Medicine; First Affiliated Hospital of Huzhou University; The Second Hospital of Jiaxing; Jinhua People's Hospital; Lanxi People's Hospital) from 2020.05.01 to 2023.04.30 with the purpose of comparing the efficacy and safety of hybrid ESD and ESD in the treatment of colorectal LST. The complete resection rate, operation time, operation cost, intraoperative and postoperative complications of hybrid ESD and ESD LST will be compared. To provide strong evidence for the selection of endoscopic treatment strategies for LST.

Primary Outcome Measures: complete resection rate, One-time complete excision, 2 weeks
Sequential Treatment of CD19 CARNK and 7x19 CAR-T in R/R B Cell Lymphoma
NCT Number: NCT06464861
Acronym: CD19-CARNK/T
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Primary Mediastinal B-cell Lymphoma (PMBCL)|Mantle Cell Lymphoma (MCL)|Diffuse Large B Cell Lymphoma( DLBCL)
Interventions: BIOLOGICAL: CD19-CAR-NK/T
Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 52
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-10
Completion Date: 2027-06-30

Summary:
To study the safety and efficacy of cord blood-derived CD19 CAR-NK cells sequential with 7x19 CAR-T in relapse / refractory B cell lymphoma

Primary Outcome Measures: Incidence of dose limiting toxicity (DLTs), To evaluate the safety and tolerability of cord blood-derived anti-CD19 CAR-NK Cell sequential with 7X19 CAR-T for B-cell Non-Hodgkin Lymphoma, Up to 28 days
Secondary Outcome Measures: Overall survival (OS), To determine the OS of CB CD19 CAR-NK Cell sequential with 7X19 CAR-T for B-cell Non-Hodgkin Lymphoma, Up to 2 years|Progression free survival (PFS), To determine the anti-tumor efficacy of CB CD19 CAR-NK Cell sequential with 7X19 CAR-T for B-cell Non-Hodgkin Lymphoma, Up to 2 years|Duration of response (DOR), To determine the DOR of CB CD19 CAR-NK Cell sequential with 7X19 CAR-T for B-cell Non-Hodgkin Lymphoma, Up to 2 years|Complete response rate (CR), To determine the CR rate of CB CD19 CAR-NK Cell sequential with 7X19 CAR-T for B-cell Non-Hodgkin Lymphoma, Up to 2 years|Partial response rate (PR), To determine the PR rate of CB CD19 CAR-NK Cell sequential with 7X19 CAR-T for B-cell Non-Hodgkin Lymphoma, Up to 2 years
Effects of iTBS Combined With NMES on Dysphagia After Stroke
NCT Number: NCT06464835
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Stroke|Dysphagia|Intermittent Theta Burst Stimulation|Neuromuscular Electrical Stimulation|Functional Near-infrared Spectroscopy
Interventions: DEVICE: Transcranial magnetic stimulation
Sponsor: The First Affiliated Hospital of Zhengzhou University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 45
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2025-12-01

Summary:
In recent years, research on intermittent Theta Burst Stimulation (iTBS), as a special high-frequency （repetitive transcranial magnetic stimulation，rTMS） stimulation paradigm, has focused on exploring the effects in healthy people. Based on previous studies, it is believed that the central magnetic stimulation combined with peripheral electrical stimulation based on the "central-peripheral-central" closed-loop rehabilitation concept has the best effect, but there are few clinical studies on the efficacy and mechanism of iTBS combined treatment of dysphagia after stroke, and the selection of the optimal stimulation scheme and target has not yet been determined, therefore, this study aims to observe the efficacy and mechanism of implementation of iTBS combined with neuromuscular electrical stimulation (NMES) on with patients with dysphagia (PSD) .

Primary Outcome Measures: functional near-infrared spectroscopy, Functional near-infrared spectroscopy (fNIRS) is a non-invasive neuroimaging technology based on blood vessels, which can be used to evaluate the activation of brain regions associated with swallowing, immediately before and immediately after the intervention|Standardized Swallowing Assessment Scale, The Standard Swallowing Assessment Scale is a method of assessing a patient's swallowing function. During the assessment, the patient's level of consciousness, head and trunk control, breathing patterns, lip closure, soft palate movements, laryngeal function, gag reflex, and voluntary cough should be recorded.The highest score on the scale is 46 points, and the lowest score is 18 points, and the lower the score, the better the swallowing function., immediately before and immediately after the intervention|The Yale Pharyngeal Residue Severity Rating Scale, The Yale Pharyngeal Residue Severity Rating Scale is a laryngoscopy-based assessment scale used to assess the degree of food residue.The scale divided the residues of the valley of the eglottis and the piriform fossa into grades 1-5 according to the severity of the scale, respectively. The higher the grade, the more severe the food residue, immediately before and immediately after the intervention
Prospective Data on Bariatric Surgery Effect on IPSS and LUTS
NCT Number: NCT06464822
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Bariatric Surgery Candidate|Lower Urinary Tract Symptoms
Interventions: PROCEDURE: Bariatric Surgery
Sponsor: Chinese University of Hong Kong
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 5000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2008-01-01
Completion Date: 2029-12-31
Locations: Prince of Wales Hospital, Hong Kong, 999077, Hong Kong

Summary:
To establish a central database on clinical parameters for patients who has morbid obesity, which aiming at

1. to compare the results of those with or without receiving invasive bariatric treatment in Prince of Wales Hospital ( Multidiciplinary Clinic of Metabolic \& Bariatric Surgery) and CUHK Medical Centre (Weight Management \& Metabolic Surgery Clinic).
2. To audit and compare outcome between PWH, CUHK Medical Centre, and with other bariatric surgery centers in Hong Kong (Hong Kong Bariatric \& Metabolic Surgery Registry)
3. To compare outcome with the regional/international center databse for benchmarking performance of HK bariatric surgery

Primary Outcome Measures: IPSS, International prostate symptom score, Annually up to 10 years post-operatively|BMI, Body mass index, Annually up to 10 years post-operatively|Percentage excess body weight loss, The amount of body mass lost due to bariatric surgery, Annually up to 10 years post-operatively|Short Form Health Survey, SF 36, Annually up to 10 years post-operatively|Eating Disorder Examination Questionnaire, EDE-Q, Annually up to 10 years post-operatively|Adverse events, Side effect / new symptom after surgery, Up to 30 days post-operatively
Treatment Intervention of Patients With Carpal Tunnel Syndrome (CTS)
NCT Number: NCT06464809
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Carpal Tunnel Syndrome
Interventions: OTHER: kinesio taping (KT)
Sponsor: China Medical University Hospital
Collaborators: Ministry of Science and Technology, Taiwan
Sex: ALL
Age: ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2014-09-24
Completion Date: 2015-12-30
Locations: China Medical University, Taichung, 406040, Taiwan

Summary:
The purpose of this study was to investigate the effectiveness of KT versus TENS combining self-myofascial stretching in treatment of CTS through clinical, functional assessment and sensory measurements.

Primary hypothesis The KT group has a more substantial improvement in hand grip, pain relief, enhancing proprioceptive sensitivity and dexterity compare to the TENS group. treatment program,

Primary Outcome Measures: The SSS and FSS of the Boston Carpal Tunnel Questionnaire (BCTQ), Assess symptoms and functional status. The SSS subscale includes 11 items assessing pain, paresthesia, numbness, weakness, nocturnal symptoms and over-all functional status. The FSS subscale includes 8 items assessing the hand function during common daily activities. Each item is scored on a 5-point scale (1-5), from 1(no symptoms) to 5 (the worst symptoms) for SSS, and from 1 (no difficulty) to 5 (cannot perform the activity at all) for FSS. The overall SSS and FSS scores are calculated as the mean of the scores for 11 and 8 individual items respectively, such that the higher the score obtained, the worse the SSS or FSS., pre-intervention, 4-week intervention, and 4-week follow-up.|Hand grip and key pinch strengths, pinch strength included palmar, three-jaw chuck, tip, and lateral pinches., pre-intervention, 4-week intervention, and 4-week follow-up.|Two-point discrimination (2PD), cutaneous sensory perception threshold. The larger the value of distance, the worse the sensory ability., pre-intervention, 4-week intervention, and 4-week follow-up.|Modified Moberg pick-up test (MMPUT), hand dexterity. The shorter the time, the more dexterity the hand., pre-intervention, 4-week intervention, and 4-week follow-up.|The visual analog scale (VAS), pain measurement. 100 mm straight line, with 0 mm on the far left and 100 mm on the far right, 0 mm positions It is not painful, and 100 mm is extremely painful., pre-intervention, 4-week intervention, and 4-week follow-up.
Effectiveness of Motor Imagery Techniques in the Management of Acute Lateral Ankle Sprains in Soccer Players
NCT Number: NCT06464796
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Ankle Sprains
Interventions: OTHER: Motor Imagery Techniques|OTHER: Conventional Exercise Therapy
Sponsor: Riphah International University
Sex: MALE
Age: ADULT
Enrollment: 38
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2023-11-14
Completion Date: 2024-06-04
Locations: Hayatabad Sports Complex, Peshawar, Khyber Pakhtunkhwa, 25124, Pakistan

Summary:
To determine the effects of motor imagery techniques on pain, proprioception, instability and strength in acute lateral ankle sprains in soccer players

Primary Outcome Measures: Visual Analogue Scale, A Visual Analogue Scale (VAS) is an instrument which evaluates that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured, 3 weeks|Cumberland Ankle Instability Test questionnaire, Cumberland Ankle Instability Test questionnaire (CAIT) is a 9-items and 30-points scale, to determine the FAI severity, 3 weeks|Star Excursion Proprioception Test, The SEBT is a valid test that needs participants with maximum strength, Plibility, and proprioception. The objective is to sustain stance on single leg while reaching as far as possible with the opposite leg, 3 weeks|Manual Muscle Testing, Muscle testing is an important examination tool to assess diminishment and shortfall in muscle performance, including strength, power, or endurance, 3 weeks
Effectiveness of Comprehensive Corrective Exercises Program on Kyphosis in Recreational Cyclists
NCT Number: NCT06464783
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Thoracic Kyphosis|Cyclists
Interventions: OTHER: Comprehensive Corrective Exercise Program|OTHER: Thoracic Exercise Program
Sponsor: Riphah International University
Sex: MALE
Age: ADULT
Enrollment: 28
Study Design: Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2023-11-20
Completion Date: 2024-04-24
Locations: Kulsum International Hospital Islamabad, Islamabad, Pakistan

Summary:
My study aim to investigate the effectiveness of comprehensive corrective exercise program on kyphosis in recreational cyclists. Additionally, i want to investigate the post exercise effects on thoracic kyphosis angle, pain levels and thoracic ranges of motion. Our study on kyphosis in cyclists and what treatment plan could be best to minimize and treat the conditions which are affecting cyclist posture, daily life quality this is very rare study as there are no studies which explains such parameters, in these studies we will effectively describe comprehensive exercise plan to reduce kyphosis angle, increase thoracic roms, decrease pain levels and maintain good quality of life.

Primary Outcome Measures: Thoracic Kyphosis Angle, thoracic spine curvature, is a postural condition marked by an unnatural increase in the thoracic kyphosis angle. This angle typically falls between 20° and 40°, but values of 45° to 50° or higher are thought to be suggestive of hyperkyphosis, increased kyphosis, or postural kyphosis., 4th week
Secondary Outcome Measures: Visual Analogue Scale, The 10 cm visual analogue scale (VAS), that varies from 0 to 10 and 0 represents "no pain" to 10 as "worst pain imaginable," was used to measure the primary effectiveness outcome based on self-reported pain levels, 4th week|Thoracic Ranges of motions, Normal values of Thoracic Ranges of motions are as in Thoracic Flexion 50 degrees , thoracic extension 45 degrees, Side Flexion 40 degrees, and thooracic rotation 30 degrees, 4th week
Optimizing Infection Prophylaxis Prior to Shoulder Surgery
NCT Number: NCT06464770
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Arthroplasty Shoulder|Periprosthetic Joint Infection
Interventions: DRUG: Chlorhexidine Gluconate
Sponsor: University of Washington
Sex: MALE
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-07-01
Completion Date: 2027-12-31
Locations: University of Washington, Seattle, Washington, 98105, United States

Summary:
The goal of this interventional study is to determine the amount of skin C. acnes reduction with increased pressure during the chlorhexidine gluconate, brand name ChloraPrep, application. The main question it aims to answer is:

Does changing the pressure applied during the ChloraPrep application impact the amount of C. acnes bacteria on the skin after one hour? Researchers will compare ChloraPrep applied at a pressure similar to a gentle wipe to ChloraPrep applied at a pressure similar to a massage to see if wash the amount of C. acnes on the skin after one hour is different.

Participants will have one shoulder washed with ChloraPrep using pressure meant to impact the dermal layer, similar to a gentle wipe, and the other shoulder washed with ChloraPrep using pressure meant to impact the subdermal layer, similar to a massage. Participants will have swabs taken of their skin before the ChloraPrep application and again one hour after application to look for the amount of C. acnes on the skin.

Primary Outcome Measures: Number of Quadrants on Culture Plate of Cutibacterium Growth After ChloraPrep Application with Dermal Pressure, 60 Minutes After ChloraPrep Wash|Number of Quadrants on Culture Plate of Cutibacterium Growth After ChloraPrep Application with Subdermal Pressure, 60 Minutes After ChloraPrep Wash
Laryngomalacia, Examinations and Quality of Life in Children Before and After Treatment With Follow-up After 1 Year
NCT Number: NCT06464757
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Laryngomalacia|Sleep Apnea, Obstructive|Sleep Apnea|Ear, Nose and Throat Disorder|Pediatric Disorder|Surgery|Quality of Life
Sponsor: Oslo University Hospital
Collaborators: University of Oslo|Lovisenberg Diakonale Hospital
Sex: ALL
Age: CHILD
Enrollment: 50
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-01-01
Completion Date: 2034-12-31
Locations: Oslo University Hospital, Oslo, 0372, Norway|Lovisenberg Diaconal Hospital, Oslo, 0456, Norway

Summary:
Laryngomalacia is the most frequent cause of stridor in children under 1 year. The airway obstruction generates turbulent airway flow and creates the characteristic high-frequency stridor sound. In addition, the airway obstruction can cause apnea, a following drop in oxygen saturation and sleep disturbances. The symptoms of laryngomalacia are often worsened by activity, feeding, crying and lying flat on the back. The diagnosis is made with flexible laryngoscopy when the child is awake. The children are most often treated with expectation, information and guidance, observation with help with feeding and reflux treatment. Up to 20% of patients have a severe degree of laryngomalacia with apneas, which is an indication for surgical treatment. The investigators want to examine whether sleep examinations can help us deciding which child benefit from surgery, and follow-up the child again after 4-6 weeks and 1 year. The sleep examinations are carried out with polygraphy and/or polysomnography with simultaneous audio records and video monitoring and with Somnofy from VitalThings. The investigators want to use artificial intelligence and machine learning when analyzing the sleep examinations. The investigators also want to have a control group examining the sleep and breathing during night at home. In both groups the investigators want to examine the quality of life with the questionnaire ITQoL-SF47.

Primary Outcome Measures: Apnea-hypopnea-index, Apnea-hypopnea-index, 10 years|Quality of life in toddlers, Quality of life by using the Infant and Toddler Quality of Life Questionnaire (ITQOL-SF47), 10 years
Endovascular Treatment for Mild Ischemic Stroke Due to Acute Large Vessel Occlusion in the Anterior Circulation
NCT Number: NCT06464731
Acronym: Mild-MT
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Endovascular Treatment|Mild Stroke
Interventions: PROCEDURE: EVT
Sponsor: Wen-huo Chen
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2017-01-01
Completion Date: 2024-12-30
Locations: Zhangzhou Municipal Hospital, Zhangzhou, Fujian, 363000, China|Gansu Provincial Hospital of Traditional Chinese Medicine, Lanzhou, Gansu, 730050, China|Jiamusi Central Hospital, Jiamusi, Heilongjiang, 154000, China|Ganzhou People's Hospital, Ganzhou, Jiangxi, 330000, China|The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, 330006, China|Songyuan Jilin Oilfield Hospital, Songyuan, Jilin, 138000, China|Shenyang First People's Hospital, Shenyang, Liaoling, China|Lishui Central Hospital, Lishui, Zhejiang, 310000, China|Taizhou First People's Hospital, Taizhou, Zhejiang, 310000, China

Summary:
Explore the effectiveness and safety of emergency endovascular treatment in patients with mild ischemic stroke due to acute large vessel occlusion in the anterior circulation, identified through perfusion imaging.

Primary Outcome Measures: The rate of excellent outcome, mRS score 0-1, 90±7 days
Secondary Outcome Measures: The rate of good outcome, mRS score 0-2, 90±7 days|mRS shift, distribution of mRS scores, 90±7 days
Other Outcome Measures: The rate of symptomatic intracranial hemorrhage, According to the Heidelberg criteria, Within 48 hours|Rate of early neurological deterioration, An increase in NIHSS≥4 or an increase of ≥2 in any individual item, Within 7 days|Mortality, Death, 90±7 days
Effectiveness of Calcium and Vitamin D, With and Without Collagen Peptide, in Enhancing Bone Mineral Density on Postmenopausal Women With Osteopenia
NCT Number: NCT06464718
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Osteopenia
Interventions: DRUG: Fortibone|DRUG: Chewable Tablet
Sponsor: Frontier Medical and Dental College, Abbotabad
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2022-06-20
Completion Date: 2023-01-16
Locations: Frontier Medical and Dental College, Abbottābād, KPK, Pakistan

Summary:
Osteopenia is characterized by bone mineral density (BMD) being lower than normal but not reaching the osteoporosis threshold, poses a serious problem for women after menopause. Osteopenia is a precursor to osteoporosis that is associated with increased risk of fractures, morbidity, and mortality. Using strategies to improve or maintain bone density is important for preventing osteoporosis and its associated complications. The combination of collagen peptide (CP) with calcium and vitamin D supplementation may provide several ways to improve bone health. This study aims to provide preliminary evidence of the effectiveness of traditional medicine in improving bone health through the effectiveness of CP.

Primary Outcome Measures: Blood Test, Calcium levels in blood, baseline and after 3 months|Blood Test, Vitamin B, baseline and after 3 months|Blood Test, Osteocalcin, baseline and after 3 months|Dexa Scan, Bone Mineral Density, baseline and after 3 months
To Investigate the Effect of PEMF for Pateitns After Anterior Cruciate Ligament Reconstruction With Hamstring Autograft
NCT Number: NCT06464705
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Anterior Cruciate Ligament Reconstruction|Hamstring Muscle
Interventions: DEVICE: PEMF treatment|DEVICE: Placebo treatment
Sponsor: Chinese University of Hong Kong
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-06-13
Completion Date: 2027-03-31
Locations: Prince of Wales Hospital, Sha Tin, Hong Kong

Summary:
Anterior cruciate ligament (ACL) tear is common. It accounts for over 50% of all knee injuries. Anterior cruciate ligament reconstruction (ACLR) with hamstring tendon (HT) autograft is the common graft choice for ACLR. However, the outcomes of donor site healing and recovery of muscle strength of HT are not satisfactory, resulting in hamstring muscle weakness and hamstring strength deficit during deep knee flexion, which may lead to hamstring strain after ACLR. Moreover, activation of the hamstring muscle is vital for maintaining dynamic knee joint stability and preventing excessive ACL shear forces. The presence of hamstring muscle deficits after surgery therefore affects the function of the reconstruction ACL. A previous study has reported that the hamstring muscle showed nearly 20% strength deficit at 4 months after ACLR with hamstring autograft

Pulsed electromagnetic field (PEMF) treatment is a non-invasive therapy that has been shown to enhance muscle cell activity and accelerate tissue repair. In clinic, PEMF treatment has been reported to be safe.

This study aims to conduct a double-blinded, placebo-controlled randomised clinical trial to investigate the effects of PEMF therapy for improving the tissue regeneration and strength of the HT donor site in ACLR patients with HT autograft.

Primary Outcome Measures: Isokinetic Test, The Cybex dynamometer will be used to test the hamstring muscle strength., Change from baseline (post-ACLR 4 months) hamstring muscle strength at post-ACLR 5 months|Isokinetic Test, The Cybex dynamometer will be used to test the hamstring muscle strength., Change from baseline (post-ACLR 4 months) hamstring muscle strength at post-ACLR 6 months|Isokinetic Test, The Cybex dynamometer will be used to test the hamstring muscle strength., Change from baseline (post-ACLR 4 months) hamstring muscle strength at post-ACLR 12 months