pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Clinical Evaluation of Orion Lamina Cover in Patients Undergoing Lumbar Laminectomy With Instrumented Fusion
NCT Number: NCT06532968
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Degenerative Lumbar Spinal Stenosis|Degenerative Spondylolisthesis|Spinal Stenosis|Scoliosis|Spinal Fracture
Interventions: DEVICE: Sham|DEVICE: ORION spinal lamina cover
Sponsor: Orion Biotech Inc.
Collaborators: Taipei Veterans General Hospital, Taiwan
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2022-03-30
Completion Date: 2024-05-22
Locations: Taipei Veterans General Hospital, Taipei, Taiwan

Summary:
Laminectomy with internal fixation and osseofusion is a common surgery for treating degenerative spinal diseases. It removes excessive bone spurs and removes the lamina for decompression to relieve nerve compression, and then utilizes a spinal fixation system to stabilize the structure to relieve lower limb pain, paralysis, and other symptoms. However, the spinal cord that lacks lamina coverage after surgery is often compressed by scar tissue formation and hematoma, leading to postoperative back and lower limb pain. Therefore, this trial is divided into two groups, comparing the use of the cross connector of the ORION spinal system - the spinal lamina cover and the general spinal fixation system (without lamina cover). For participants undergoing laminectomy with internal fixation and osseofusion, after utilizing the spinal lamina cover of the ORION spinal system, whether the nerve compression caused by postoperative scar tissue formation and hematoma can be effectively reduced, and the pain in the back and lower limbs can be improved.

Primary Outcome Measures: Magnetic Resonance Imaging (MRI), To observe the recovery of the participants' spine, Six months after surgery|Visual Analogue Scale (VAS), To measure the pain and numb of the participants' back and limbs, Pre-surgery; one month after surgery; three months after surgery; six months after surgery
Secondary Outcome Measures: Oswestry Disability Index (ODI), To evaluate the functional disability of the participants' limbs, Pre-surgery; one month after surgery; three months after surgery; six months after surgery|Sort Form-12 Health Survey (SF-12), To evaluate the physical health of the participants, Pre-surgery; one month after surgery; three months after surgery; six months after surgery
Color Stability and Wear Resistance of Direct Flowable and Preheated Composite Using the Injectable Technique
NCT Number: NCT06532916
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Resin Composite Restorations|Esthetic Restorations
Interventions: OTHER: Experimental: Group1: Estelite Sigma Quick|OTHER: Experimental: Group 2: Estelite Flow Quick
Sponsor: King Abdullah University Hospital
Collaborators: Jordan University of Science and Technology
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 142
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2014-03-01
Completion Date: 2026-03-01
Locations: Jordan University of Science and Technology, Irbid, P.O.Box 3030, Jordan

Summary:
The aim of this study is to conduct the first clinical trial to assess the color stability and wear resistance of the highly filled injectable flowable composite materials compared to preheated conventional ones and evaluate the in vivo performance of the injectable composite technique.

Primary Outcome Measures: The wear resistance of the injectable flowable composite veneers compared to their preheated resin composites counterparts., Participants will be assessed at baseline, directly after the finishing and polishing procedure, and at review visits according to the following criteria:

-The gypsum replicas will be scanned three-dimensionally using a 3D laser scanner at baseline, 6 months and 12 months of clinical service, to analyse the volumetric material loss, which can be associated with structural wear, using 3D analysis software (Medit Link, Medit, Seoul, Republic of Korea) \[28, 29\] \[30\] \[31\] \[32\]. Follow up images will be superimposed on baseline images, Assessment at baseline, 6 months and 1 year after the restorations of the teeth.|The color stability of the injectable flowable composite veneers compared to their preheated resin counterparts., -Shade measurements will be taken at baseline, one week, one month, 3 months and 6 months using the following methods:

1. Using a spectrophotometer (VITA Easyshade V; VITA Zahnfabrik, Bad Säckingen, Germany), color values (L\*, a\*, b\*) according to the Commission Internationale d'Eclairage (CIELab) will be taken at the middle of each restored tooth using a customized jig to fix the position and in the afternoon with sunlight and standardized room illumination and at each evaluation period. The color changes will be determined using the CIEDE2000 formula.
2. Using Vita classical shade guide (Vita Zahnfabrik, Bad Säckingen, Germany) and a professional photograph before treatment, at baseline and at each review visit., Assessment at baseline, 6 months and 1 year after the restorations of the teeth.
Functional Recovery From Facial Paralysis
NCT Number: NCT06532903
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Peripheral Facial Paralysis|Facial Palsy|Synkineses
Interventions: OTHER: Selective muscle electrostimulation with exponential current|OTHER: Facial muscle reeducation in front of the mirror
Sponsor: Universidad Nacional del Nordeste, Argentina
Collaborators: National Council of Scientific and Technical Research, Argentina
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-06-01
Completion Date: 2025-12-31
Locations: Servicio Universitario de Kinesiologia, Corrientes, 3400, Argentina

Summary:
This is a controlled, single-blind (hybrid) clinical investigation that aims to analyze the process of recovery of muscle function in people with peripheral facial paralysis who receive kinesthetic treatment with electrostimulation compared to those who receive treatment without electrostimulation, in the UNNE University Kinesiology Service, during the period 2023-2025, to promote early reintegration into their social activities of daily life.

An initial evaluation will be carried out, the movements that cause the requested gestures will be observed and recorded and recorded on a monitoring sheet and on video. The House Brackman and Sunnybrook scale will be used to measure functional outcomes. The initial and final evaluations will be external and blind. Patients will sign informed consent approved by Resolution No 04/23 of the Health Sciences Research Bioethics Committee.

The following inclusion criteria will be taken into account: patients with a medical referral that indicates a diagnosis of peripheral facial paralysis, Bell's palsy, frigori facial paralysis, idiopathic facial paralysis, who have not received previous kinesic treatment. Patients with central facial paralysis (associated with stroke), with peripheral facial paralysis of more than 6 months of evolution, who present dermal lesions that interfere with the application of electrical currents (open wounds, lacerations or burns) will be excluded from the study. ) In addition, those patients who attend with a medical prescription that advises in writing against the use of electrostimulation will be excluded.

Primary Outcome Measures: FUNCTIONAL RECOVERY, ability to make facial gestures evaluated using the House Brackman scale and the Sunnybroock system, 24 months|Functional recovery time, number of sessions necessary to achieve recovery of facial muscle function and ability to make facial gestures., 24 months
Optimal Pediatric Heart Transplant Immunosuppression With MicroRNAs (OPTIMA)
NCT Number: NCT06532890
Acronym: OPTIMA
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Cardiac Failure|Graft Rejection
Sponsor: Inova Health Care Services
Sex: ALL
Age: CHILD, ADULT
Enrollment: 150
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-10-01
Completion Date: 2029-10-01
Locations: Inova Health System, Falls Church, Virginia, 22042, United States

Summary:
This study aims to discover circulating microRNAs (associated with drug doses and levels) that can be used to characterize the overall immune state in pediatric heart transplant patients and predict patients that will go on to develop infection and rejection. MicroRNAs (miRs) are small, non-coding RNA molecules that regulate gene expression and serve as molecular biomarkers found in the circulation.

Primary Outcome Measures: Time-to-Event Analysis of Circulating microRNAs (miRs) Predicting Infection in Pediatric Heart Transplant Recipients, A time-to-event analysis will be performed to identify specific circulating microRNAs (miRs) that predict the risk of infection in heart transplant recipients. Infections are defined as any bacterial, viral, fungal, or opportunistic infection leading to: 1) hospitalization, 2) prescription of antimicrobial therapy, or 3) reduction in immunosuppression., up to 2 years post-transplant|Time-to-Event Analysis of Circulating microRNAs (miRs) Predicting Rejection in Pediatric Heart Transplant Recipients, A time-to-event analysis will be performed to identify specific circulating microRNAs (miRs) that predict the risk of rejection in heart transplant recipients. Rejection is defined as treated rejection based on 1) endomyocardial biopsy (EMB) pathology, 2) unexplained graft dysfunction, or 3) molecular testing; leading to treatment with pulse dose steroids, monoclonal antibodies, plasmapheresis, and/or intravenous immunoglobulin (IVIg).

EMB Pathology: Acute Cellular Rejection (ACR) Grade ≥ 2R and/or Antibody-mediated Rejection (AMR) Grade ≥ pAMR1, per International Society for Heart and Lung Transplantation (ISHLT) grading systems.

Graft Dysfunction: Left Ventricular Ejection Fraction (LVEF) decline ≥ 10% from baseline and \< 50% absolute LVEF by echocardiography.

Molecular Testing: Presence of 2 of the following 3 criteria-presence of HLA-DSA, elevated donor-derived cell-free DNA (dd-cfDNA), or gene expression results from blood or EMB testing., up to 2 years post-transplant
Qigong Exercise and Sleep Quality
NCT Number: NCT06532864
Status: ENROLLING_BY_INVITATION
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Sleep Quality
Interventions: BEHAVIORAL: Practice Mawangdui Guiding Technique
Sponsor: Hunan University of Traditional Chinese Medicine
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-06-01
Completion Date: 2024-08-12
Locations: Healthcare Hospital, Changsha, Hunan, 410000, China

Summary:
The purpose of this study was to investigate whether 12 weeks of practicing Mawangdui Guiding Technique has an improvement effect on subjective sleep quality, objective sleep quality, and daytime fatigue in older adults in a healthcare hospital.

Primary Outcome Measures: Pittsburgh Sleep Quality Index, The PSQI is a comprehensive sleep self-assessment tool containing 19 items., baseline; 4 weeks; 12weeks|Insomnia Severity Index, The ISI is a self-assessment tool consisting of seven items designed to assess various aspects of insomnia, baseline; 4 weeks; 12weeks|Polysomnography, PSG is the internationally recognized gold standard for diagnosing sleep disorder disorders and can provide an objective basis for the diagnosis, classification and identification of sleep disorders., baseline; 4 weeks; 12weeks|Flinders Fatigue Scale, The FFS scale is a 7-item scale that measures various characteristics of fatigue, baseline; 4 weeks; 12weeks
Optimized Strategies for Malperfusion Syndrome
NCT Number: NCT06532838
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Aortic Dissection
Interventions: PROCEDURE: Optimized treatment strategies|PROCEDURE: Traditional treatment strategies
Sponsor: Xiamen Cardiovascular Hospital, Xiamen University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 236
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2026-10-30
Locations: Xiamen Cardiovascular Hospital at Xiamen University, Xiamen, Fujian, 361008, China

Summary:
An investigator-initiated, randomized, multicenter, two-arm, open-label study of consecutive patients presenting with acute type A aortic dissection (ATAAD) and malperfusion syndrome (MPS).

Objectives: The present study aimed to investigate the difference in all-cause mortality after optimized treatment strategies (OTS) versus traditional treatment strategies (TTS) for ATAAD patients with MPS.

Background: The mortality of ATAAD with MPS is high. However, the management strategies of MPS patients still not to be confirmed. Compare with TTS, OTS as a strategy for ATAAD patients with MPS might have be beneficial results.

Primary Outcome Measures: Operative Mortality (OM), Patients who died within 30 days, 30-day
Secondary Outcome Measures: Rate of composite of Major Adverse Events (MAE), Number of participants with MAE which will include the composite rate of low cardiac output syndrome, new cerebrovascular accident, intestinal ischemia, lower limb necrosis, multiple organ failure according to Common Terminology Criteria for Adverse Events v4.0 (CTCAE), 30-day|Rate of composite of Major Adverse Pulmonary Events (MAPE), Number of participants with MAPE which will include the composite rate of intubation \>48 hours, pneumonia, reintubation, tracheostomy according to the Common Terminology Criteria for Adverse Events v4.0 (CTCAE), 30-day|Rate of reintervention, The number of participants who will require reoperation for distal aorta, 3 year|Mid-term survival, The secondary endpoint of the study is the evaluation of mid-term survival, 3 year
Cardiac Autonomic Dysfunction as a Sign of Irreversible Advanced Heart Failure
NCT Number: NCT06532825
Acronym: CADYSH
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Heart Failure
Interventions: DIAGNOSTIC_TEST: heart monitoring
Sponsor: University Hospital Bispebjerg and Frederiksberg
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-01
Completion Date: 2025-12-31
Locations: Cardiology department Y, Bispebjerg-Frederiksberg Hospital, Frederiksberg, 2000, Denmark

Summary:
The main hypothesis is that autonomic dysfunction cannot improve among patients reaching end-stage heart failure. To evaluate this, patients admitted with acute decompensated heart failure in Bispebjerg hospital, and history one or more admissions with the same condition within the prior year, will undergo repeated brief heart monitoring (10 min). Baseline recordings (at admission) will be compared with equivalent measurements before discharge to explore whether heart rate variability increases. Patients will be followed for six months after discharge from the hospital.

Primary Outcome Measures: number of rehospitalizations, number of emergency rehospitalizations, classified according to:

1. new decompensation of heart failure
2. side effects / complications to therapy for heart failure
3. other, up to six months after discharge from index admission
Secondary Outcome Measures: Heart rate Variability change from admission to discharge, Measurement of heart-rate oscillations over a short term (30 min) of continuous three-lead electrocardiogram recording divided into two time domains:

Domain 10min: relaxed, supine position for 10 min Domain 30 min: comprising the first 10 min-domain in addition to stand-up and walking for 5 min, followed by sitting relaxed until completing 30 min recording in total, repeated measurement at baseline (within 48h from time of index admission) and before discharge (estimated one week on average from index admission)
TIL Gean Therapy Combined With Immunotherapy for Advanced or Metastatic Refractory Breast Cancer
NCT Number: NCT06532812
Acronym: BAH249
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Breast Cancer|Breast Carcinoma|Breast Cancer Metastatic|Breast Cancer Triple Negative
Interventions: BIOLOGICAL: Tumor Infiltrating Lymphocytes (TIL)|DRUG: Cyclophosphamid|DRUG: Fludarabine|DRUG: Interleukin-2|DRUG: Pembrolizumab
Sponsor: Essen Biotech
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 85
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-22
Completion Date: 2026-12-28
Locations: District One Hospital, Beijing, Beijing, 086-373, China

Summary:
This Phase I/II study evaluates the safety and efficacy of autologous tumor-infiltrating lymphocytes (TIL) therapy combined with Pembrolizumab (Keytruda) immunotherapy in patients with advanced or metastatic refractory breast cancer. TILs will be harvested from patients' tumors, expanded in vitro, and infused back into the patients following a non-myeloablative lymphodepletion regimen. Pembrolizumab, a monoclonal antibody that targets the PD-1 receptor on T cells, will be administered to enhance the immune response. The primary endpoint is to determine the objective response rate (ORR) of this combined therapy. Secondary endpoints include disease control rate (DCR), progression-free survival (PFS), overall survival (OS), duration of response (DOR), and quality of life (QoL). This trial aims to provide a novel, personalized treatment option for patients with limited therapeutic alternatives.

Primary Outcome Measures: Adverse Events, To characterize the safety profile of (TIL) and natural autologous TIL in patients with advanced solid tumors who were failed to standard treatment as assessed by incidence of adverse events., 6 months
Secondary Outcome Measures: Objective Response Rate (ORR), Proportion of patients with response per Response Evaluation Criteria in Solid Tumors, Up to 36 months|Disease Control Rate (DCR）, Percentage of patients that meet CR, PR and SD criteria set in this study, Up to 36 months|Duration of Response (DOR), The time length between the first confirmed objective response to the treatment and the subsequent disease progression, Up to 36 months|Progression-Free Survival (PFS), The time length between TIL infusion and confirmed subsequent disease progression, Up to 36 months
TIL Therapy Combined With Pembrolizumab for Advanced or Metastatic Refractory Stomach and Esophageal Cancer
NCT Number: NCT06532799
Acronym: BAH250
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Stomach Cancer|Stomach Cancer Recurrent|Stomach Cancer, Adenocarcinoma|Esophageal Cancer|Esophageal Cancer Metastatic to Bone|Esophageal Cancer Metastatic to Lung|Esophageal Cancer Metastatic to Liver
Interventions: BIOLOGICAL: Tumor Infiltrating Lymphocytes (TIL)|DRUG: Cyclophosphamid|DRUG: Fludarabine|DRUG: Interleukin-2|DRUG: Pembrolizumab
Sponsor: Essen Biotech
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 75
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-10
Completion Date: 2026-12-28
Locations: District One Hospital, Beijing, Beijing, 086-373, China

Summary:
This Phase I/II study evaluates the safety and efficacy of autologous tumor-infiltrating lymphocytes (TIL) therapy combined with Pembrolizumab (Keytruda) immunotherapy in patients with advanced or metastatic refractory stomach and esophageal cancer. Lifileucel (Amtagvi), the first FDA-approved TIL therapy, has shown significant promise in treating unresectable or metastatic melanoma by leveraging the patient's own immune cells to target and destroy cancer cells. This study aims to apply a similar approach to stomach and esophageal cancers. TILs will be harvested from patients' tumors, expanded in vitro, and infused back into the patients following a non-myeloablative lymphodepletion regimen. Pembrolizumab, a monoclonal antibody that targets the PD-1 receptor on T cells, will be administered to enhance the immune response. The primary endpoint is to determine the objective response rate (ORR) of this combined therapy. Secondary endpoints include disease control rate (DCR), progression-free survival (PFS), overall survival (OS), duration of response (DOR), and quality of life (QoL). This trial aims to provide a novel, personalized treatment option for patients with limited therapeutic alternatives.

Primary Outcome Measures: Adverse Events, To characterize the safety profile of (TIL) and natural autologous TIL in patients with advanced solid tumors who were failed to standard treatment as assessed by incidence of adverse events., 6 months
Secondary Outcome Measures: Objective Response Rate (ORR), Proportion of patients with response per Response Evaluation Criteria in Solid Tumors, Up to 36 months|Disease Control Rate (DCR）, Percentage of patients that meet CR, PR and SD criteria set in this study, Up to 36 months|Duration of Response (DOR), The time length between the first confirmed objective response to the treatment and the subsequent disease progression, Up to 36 months|Progression-Free Survival (PFS), The time length between TIL infusion and confirmed subsequent disease progression, Up to 36 months
Identification of Sodium Channel Fragments as Serum Biomarkers of a Traumatic Central Nervous System Injury
NCT Number: NCT06532760
Acronym: SpasT-SCI-T
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Spinal Cord Injury|Spasticity, Muscle|Brain Injuries
Interventions: OTHER: Blood sampling
Sponsor: Assistance Publique Hopitaux De Marseille
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-10-01
Completion Date: 2027-04-01

Summary:
Following spinal cord injury (SCI), 75% of patients develop spasticity of the limbs characterized by an increase in muscle tone causing severe pain. Currently, the diagnosis of spinal cord injury is based on clinical and radiological evaluation by CT and MRI, but there is no reliable biomarker capable of predicting the medium and long-term clinical course in terms of emergence and severity of spasticity and neurological recovery. Recently, pre-clinical models in rats have shown the presence of protein fragments from a cleavage of sodium channels in spinal cords below the level of injury. Other studies have also shown the presence of these fragments in the brain following a head injury. These fragments would be potentially useful as a biomarker of the SCI. The detection of sodium fragments would be potentially useful as a biomarker of a lesion of the central nervous system (spinal cord or brain) and of the severity of the spasticity in patients suffering from SCI. The main objective of this study is to detect the presence of sodium fragments in blood samples from patients with SCI from or brain injury. The secondary objectives will be to study the post-lesional / injury kinetics of sodium fragments, to determine their diagnostic values in terms of the severity of the injury, and their prognostic values concerning the emergence of the spasticity in patients with SCI. An initial prospective cohort will include 40 people. The fragments of sodium channels will be measured in blood samples taken within 6 hours post-trauma, then 1, 3, 5 and 7 days post-trauma, as well as 3 and 6 months post-trauma. The overall expression of sodium fragments will be compared to that of healthy controls. Participants will be recruited in the acute care units of the AP-HM. Participants will be recruited from the main acute care units of the AP-HM. Post-traumatic follow-up assessments during their rehabilitation will be carried out at 3 and 6 months in the neurosurgery department of North Hospital from APHM.

Primary Outcome Measures: Detect the presence of sodium fragments in blood samples from patients, 6 hours to 6 months post-injury
Secondary Outcome Measures: kinetics of sodium fragments in patients with acute SCI and in traumatic brain injury patients in the post-trauma period, 6 hours to 6 months post-injury|To correlate measurements of sodium fragments in blood from 6 hours to 6 months post-injury with the occurence of spasticity in the post-trauma period, 3 and 6 months-post-injury
Barrett's Esophagitis in Anorexia Nervosa Binge/Purge Subtype
NCT Number: NCT06532734
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Barrett Esophagus|Anorexia Nervosa, Binge Eating/Purging Type|Rumination|Vomiting|Eating Disorders|Esophageal Adenocarcinoma
Interventions: DEVICE: EsoGuard
Sponsor: Denver Health and Hospital Authority
Collaborators: Lucid Diagnostics, Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 25
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09
Completion Date: 2024-09
Locations: ACUTE Center for Eating Disorders and Severe Malnutrition, Denver, Colorado, 80204, United States|Denver Health and Hospital Authority, Denver, Colorado, 80204, United States

Summary:
To better define the presence of Barrett's esophagus (BE) via non-endoscopic testing in an eating disorder cohort with purging (vomiting/rumination) behaviors

Primary Outcome Measures: Number of patients positive for BE, Individuals with severe forms of eating disorders with purging and ruminating behaviors not meeting a current screening guidelines for BE will test positive for BE, 12 months
Opioid Prescribing Practices in Laparoscopic Gynecologic Surgery
NCT Number: NCT06532708
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Opioid Use|Postoperative Pain
Interventions: OTHER: 5x Oxycodone Oral Tablets|OTHER: 16x Oxycodone Oral Tablets
Sponsor: University of Tennessee
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 12
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-07-12
Completion Date: 2024-10-31
Locations: University of Tennessee Health Science Center, Memphis, Tennessee, 38103, United States

Summary:
The purpose of this study is to compare opioid prescribing practices by either routine provider prescribing practices, or with the use of a calculator, i.e., the Opioid Calculator, published by the University of Michigan (www.opioidcalculator.org), with the intent of decreasing the number of pills.

Primary Outcome Measures: Number of pills used, All participants will be contacted on postoperative days 2 and 7 to inquire how many pills they have taken, Within 1 week following surgery
Secondary Outcome Measures: Postoperative pain, All participants will be contacted on postoperative days 2 and 7, and at their two-week follow-up visit to inquire where their pain level is on the Visual Analog Scale (VAS). This scale ranges from 0 to 10, with 0 indicating no pain and 10 indicating worst possible pain., Within 2 weeks following surgery
Efficacy of Dapagliflozin in Early Diabetic Nephropathy in Type 1 Diabetes
NCT Number: NCT06532682
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Diabetic Kidney Disease|Type 1 Diabetes
Interventions: DRUG: dapagliflozin|DRUG: ACE inhibitor
Sponsor: The First Affiliated Hospital with Nanjing Medical University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 54
Study Design: Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-01
Completion Date: 2026-10-01
Locations: Nanjing Medical University First Affiliated Hospital, Nanjing, Jiangsu, 210000, China

Summary:
Diabetic kidney disease (DKD) is a leading cause of chronic and end-stage kidney disease, affecting 25-40% of type 1 diabetes (T1D) patients and 5-40% of type 2 diabetes (T2D) patients. Despite standard treatments like ACE inhibitors and ARBs, many patients continue to develop DKD, indicating a need for better kidney protection. This study aims to evaluate the efficacy and safety of dapagliflozin combined with insulin in early DKD patients with T1DM, using ACEi/ARB as standard treatment, to provide new insights into kidney protection and support precision medicine goals.

Primary Outcome Measures: Urinary albumin-to-creatinine ratio, Average change from baseline to 24 weeks after treatment, From baseline to 24 weeks|estimated Glomerular Filtration Rate, Average change from baseline to 24 weeks after treatment, From baseline to 24 weeks
Secondary Outcome Measures: 24-hour urine biochemical quantification, Average change from baseline to 24 weeks after treatment, From baseline to 24 weeks|HbA1c, Change from baseline to 24 weeks after treatment, From baseline to 24 weeks|Weight, Change from baseline to 24 weeks after treatment, From baseline to 24 weeks|Time in Range, Evaluate blood glucose control through continuous glucose monitoring, From baseline to 24 weeks|Daily insulin dose, Change from baseline to 24 weeks after treatment, From baseline to 24 weeks
Active Health Management for Children
NCT Number: NCT06532669
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Child Development
Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sex: ALL
Age: CHILD, ADULT
Enrollment: 1435
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07
Completion Date: 2030-07

Summary:
The purpose of this study was to develop a children's active health index based on the three main factors-the environment, lifestyle, and the physiological and behavioral traits of children of various ages. To acquire dynamic data, a prospective cohort research was carried out. Construct a dynamic digital health portrait to detect and warn children's health problems early, intervene in a timely manner, and explore a new paradigm of children's active health management.

Primary Outcome Measures: Child Health Index, Child Health Index serves as a comprehensive metric to evaluate and measure how children actively maintain, promote, and enhance their own health status through positive lifestyles and healthy behaviors, with the goal of preventing the onset of diseases and delaying their progression. This index encompasses multiple aspects, such as children's dietary habits, exercise routines, sleep quality, and mental health status., 0-6 years
Secondary Outcome Measures: Subitem Child Health Index, Child Health Index is a comprehensive index comprised of multiple subitem child health index, designed to thoroughly capture children's performance across diverse health dimensions., 0-6 years
Safety and Efficacy of Anti-CD20/CD30 CAR-T Cells in Subjects With Relapsed/Refractory Lymphoma
NCT Number: NCT06532643
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: EARLY_PHASE1
Conditions: Relapsed/Refractory Lymphoma
Interventions: GENETIC: anti-CD20/CD30-CAR-T cells|DRUG: Fludarabine|DRUG: Cyclophosphamide
Sponsor: Shanghai First Song Biotechnology Co., LTD
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 9
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-08-24
Completion Date: 2026-09-01
Locations: The First Affiliated Hospital of Anhui Medical University, Hefei, Anhui, 230022, China

Summary:
This study is an exploratory clinical trial of a single-center, open-label, single-dose treatment of anti-CD20/CD30-CAR-T cells in subjects with relapsed/refractory lymphoma.

Primary Outcome Measures: Safety and tolerance, Incidence of dose-limiting toxicity (DLT), 28 days after infusion of anti-CD20/CD30-CAR-T cells|Manufacturing feasibility, Percentage of subjects for whom the required dose of anti-CD20/CD30-CAR-T cells can be successfully manufactured., 1 year
Anti-CD19-CAR-T Cells in Subjects With Relapsed/Refractory B Cell Malignancies
NCT Number: NCT06532630
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: EARLY_PHASE1
Conditions: B-Cell Malignancy
Interventions: GENETIC: Anti-CD19-CAR-T cells|DRUG: Fludarabine|DRUG: Cyclophosphamide
Sponsor: Shanghai First Song Biotechnology Co., LTD
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 9
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-08-24
Completion Date: 2026-09-01
Locations: The First Affiliated Hospital of Anhui Medical University, Hefei, Anhui, 230022, China

Summary:
This is a single-center, single-arm, open-label, exploratory study to determine the safety, tolerability, feasibility, and preliminary anti-tumor activity of anti-CD19-CAR-T cells in subjects with relapsed/refractory (r/r) B-cell malignancies.

This study plans to enroll patients with relapsed/refractory CD19-positive B-cell malignancies, who will receive a single infusion of anti-CD19-CAR-T cells after screening, PBMC collection, and lymphodepleting chemotherapy.

Primary Outcome Measures: Safety and tolerance, Incidence of dose-limiting toxicity (DLT), 28 days after anti-CD19-CAR-T cells infusion|Manufacturing feasibility, Percentage of subjects for whom the required dose of anti-CD19-CAR-T cells can be successfully manufactured., 1 year
Cadonilimab Combined With S-1 or Capecitabine as Second-line Treatment for Advanced Pancreatic Cancer
NCT Number: NCT06532617
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Pancreatic Neoplasms
Interventions: DRUG: Cadonilimab+S-1or Capecitabine
Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
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: 2027-08-01
Locations: Shanghai General Hospital, Shanghai, Shanghai, 200040, China

Summary:
This is a single arm, single cencer, phase II clinical trial. This study aims to evaluate the efficacy and safety of Cadonilimab combined with S-1 or capecitabine as a second-line treatment for advanced pancreatic cancer.

Primary Outcome Measures: Objective response rate (ORR), Defined as the proportion of patients with a complete response or partial response to treatment according to RECIST1.1, Up to 2 years
Secondary Outcome Measures: Overall survival (OS), Defined as the length of time from the first dose to death from any cause., Up to 2 years|Progression-free survival (PFS), Defined as the length of time from the first dose to progression disease or death from any cause., Up to 2 years|Disease control rate (DCR), Defined as the proportion of patients with a complete response, partial response or stable disease to treatment according to RECIST1.1, Up to 2 years|Duration of response (DoR), Defined as the length of time from first tumor response (CR or PR) to disease progression (PD) or death., Up to 2 years
Other Outcome Measures: Biomarker analysis, Biomarkers that potentially predict efficacy include, but are not limited to, PD-L1 expression and T cell subpopulations in tumor tissue specimens or blood samples and so on., Up to 2 years
Neoadjuvant/Adjuvant Cadonilimab Plus Chemotherapy in Patients With Resectable PD-L1 Negative NSCLC
NCT Number: NCT06532591
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: NSCLC
Interventions: DRUG: cadonilimab+paclitaxel+carboplatin
Sponsor: Sichuan Cancer Hospital and Research Institute
Sex: ALL
Age: 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: 2025-10-01

Summary:
The purpose of this study is to observe and evaluate the efficacy and safety of cadonilimab combined with chemotherapy in patients with resectable IB (≥ 4cm) - IIIB (N2) stage PD-L1 negative non-small cell lung cancer

Primary Outcome Measures: Major pathological response (MPR), MPR is defined as the percentage of residual viable tumour cells (%RVT) in the tumour bed of no more than 10%., At time of surgery
Secondary Outcome Measures: Pathologic complete response (pCR), pCR is defined as no invasive and no in situ residuals in lung and nodes, At time of surgery|Objective response rate (ORR), ORR is defined as the percentage of participants, who has a CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions). The percentage of participants who experiences a confirmed CR or PR is according to RECIST 1.1, Up to 1 year|Event free survival at 24 months (EFS24), EFS24 is defined as patient outcomes were evaluated at diagnosis and in the subsets of patients achieving event-free status at 24 months from diagnosis., Up to 2 year|Treatment-Emergent Adverse Event (TEAE), TEAE is defined as any adverse and unexpected change in body structure, function, or chemistry or any exacerbation of an existing condition (i.e., any clinically significant adverse change in frequency and/or intensity) during treatment. The type, frequency, and severity of TEAE will be assessed during treatment., Up to 2 year
Evaluate the Safety and Efficacy of CPX101 in Overweight and Obese Subjects Without Diabetes Mellitus
NCT Number: NCT06532578
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Overweight and Obesity
Interventions: BIOLOGICAL: CPX101 or placebo 120mg Q2W|BIOLOGICAL: CPX101 or placebo 160mg Q4W|BIOLOGICAL: CPX101 or placebo 160mg Q2W|BIOLOGICAL: CPX101 or placebo 240mg Q4W|BIOLOGICAL: CPX101 or placebo 240mg Q2W
Sponsor: Guangzhou Chia Tai Innovative Pharmaceutical Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 240
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-13
Completion Date: 2026-03
Locations: Paratus Clinical Research, Chatswood, New South Wales, Australia

Summary:
The study is designed to evaluate the preliminary efficacy, safety, population PK profile, and immunogenicity of CPX101 in subjects with obesity or overweight with weight related comorbidities but without diabetes mellitus.

Primary Outcome Measures: Efficacy of CPX101 in body weight loss in Kg, To evaluate the efficacy of CPX101 in body weight loss by dose levels after 24 weeks of multiple subcutaneous injections in overweight and obese subjects without diabetes mellitus., Up to 24 weeks after administration
Secondary Outcome Measures: Other efficacy parameters of CPX101(Waist circumference in centimeters), To evaluate the efficacy of waist circumference of CPX101 by dose levels after 24 weeks of multiple subcutaneous injections in overweight and obese subjects without diabetes mellitus, Up to 24 weeks after administration|Other efficacy parameters of CPX101(BMI), BMI = wight (kg)/(height\[m\])\^2 ;To evaluate BMI of CPX101 by dose levels after 24 weeks of multiple subcutaneous injections in overweight and abese subjects without diabetes mellitus., Up to 24 weeks after administration|Incidence of AE/SAE, The safety of CPX101, Up to 36 weeks|The plasma concentration of CPX101, Measurement of the plasma concentration of CPX101 in serum after multiple subcutaneous injections in overweight and obese subjects without diabetes mellitus., Up to 24 weeks after administration|Immunogenicity of CPX101, Measurement of the anti-CPX101 antibody in serum after multiple subcutaneous injections in overweight and obese subjects without diabetes mellitus., Up to 24 weeks after administration
Other Outcome Measures: Efficacy of CPX101 in body weight loss in Kg, To evaluate the efficacy of CPX101 in body weight loss at week 36 in overweight and obese subjects without diabetes mellitus, At week 36
Comparison of VA (Venetoclax, Azacitidine), VACl (VA, Cladribine), VACh (VA, Chidamide), and Alternating VACl/VACh in Newly Diagnosed Acute Myeloid Leukemia
NCT Number: NCT06532552
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Acute Myeloid Leukemia, Adult|Newly Diagnosed
Interventions: DRUG: VACl|DRUG: VACh|DRUG: VACl Alternating With VACh|DRUG: VA
Sponsor: The First Affiliated Hospital of Soochow University
Collaborators: Jining Medical University|Qilu Hospital of Shandong University|The Affiliated Hospital of Qingdao University|The First Affiliated Hospital of Anhui Medical University|Tongji Hospital|First Affiliated Hospital Bengbu Medical College
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 172
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-29
Completion Date: 2028-08-01
Locations: The First Affliated Hospital of Soochow University, Suzhou, Jiangsu, 215006, China

Summary:
This prospective, multi-center, randomized, controlled Phase II study is to compare the therapeutic efficacy and side effect of VACl (Venetoclax,Azacitidine,Cladribine) alternating with VACh (Venetoclax,Azacitidine,Chidamide), VACl, VACh and VA in newly diagnosed adult acute myeloid leukemia (AML) patients ineligible for intensive therapy or declining. Cladribine is a purine analogue widely used in hematologic malignancies. The monocytic leukemia stem cell is selective sensitivity to Cladribine. Chidamide, a newly designed selective histone deacetylase inhibitor, could down regulate myeloid cell leukaemia 1 (MCL1) expression in Venetoclax resistant AML cells. Chidamide or Cladribine have synergistic anti-leukemia effects with VA through their unique mechanisms, which can eradicate leukemia stem cells and prevent the occurrence of drug resistance.

Primary Outcome Measures: Event-free survival (EFS), It is defined as the number of days from the date of randomization to the date of earliest evidence of relapse, subsequent treatment other than stem cell transplant while in composite complete remission (CR+CRi), or death. If the specified event (relapse, start of subsequent treatment, or death) does not occur, subjects will be censored at the date of last disease assessment., 1 year|Cumulative incidence of relapse (CIR), Time from CR to disease recurrence or progression, 1 year
Secondary Outcome Measures: Composite complete response (CRc), CRc rate was defifined as patients achieving a CR or CRi, At the end of Cycle 1 (each cycle is 21-28 days)|Overall Survival (OS), Time from date of treatment start until date of death due to any cause, 1 year|Adverse reactions in hematology, Record of adverse events in hematological system during and after VA,VACl,VACh,VACl alternating with VACh regimen induction (agranulocytosis days, platelet（PLT）/red blood cell (RBC) transfusion units), At the end of Cycle 1 (each cycle is 21-28 days)|Nonhematological adverse reactions, Record of adverse events in other organs or systmes during and after VA,VACl,VACh,VACl alternating with VACh regimen induction (infection and organ injury), At the end of Cycle 1 (each cycle is 21-28 days)
Addressing Durable Health Disparities Through Critical Time Legal Interventions in Medically Underserved Latinx and Migrant Communities
NCT Number: NCT06532487
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Health Harming Legal Needs
Interventions: OTHER: Critical Time Medical-Legal Partnership Intervention
Sponsor: Stony Brook University
Collaborators: University of Central Florida|Boston University|University of Puerto Rico
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 1140
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2025-01
Completion Date: 2027-06

Summary:
This clinical trial will examine the effects of legal services on primary care outcomes for medically underserved communities.

The aims of the study are:

1. To test the effectiveness and cost-benefits of a critical-time intervention Medical-Legal Partnership (CTI-MLP) on patient outcomes.
2. To determine the most efficient mechanisms for CTI-MLP delivery.
3. To develop innovative community engagement strategies for addressing health-harming legal needs within community health centers.

Eligible patients will be asked to complete a questionnaire 4 times, first when they join the study and then at 3 months, 6 months, and 12 months. In the survey, they will be asked to provide information about themselves, their health care, aspects of their daily life, and hardships they face. They will also allow researchers to access their electronic health record information housed in the community-based organization and attorney notes.

Patient information will be completely confidential and de-identified, meaning, the research team will not know the identity of the person who answered the questions.

Participating community health centers will be randomized (assigned by chance) to provide basic legal information and referral to legal aid; or have an attorney on-site to provide legal aid to those who screen for legal needs.

Primary Outcome Measures: PROMIS Global Health-10, PROMIS Global Health-10, a self-administered measured included in the survey described below. It includes general domains of health and functioning including overall physical health, mental health, social health, pain, fatigue, and overall perceived quality of life., 1) baseline (point of contact with patient); 2) 3-month, 3) 6- month, 4) and 12-month follow ups.
A Trial of Three- and Seven-days Insulin Infusions Set
NCT Number: NCT06532461
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Type 1 Diabetes
Interventions: DEVICE: Mio Advanced infusions set|DRUG: Novorapid|DEVICE: Extended wear insulin infusion (EWIS)|DRUG: Humalog
Sponsor: Steno Diabetes Center Copenhagen
Sex: ALL
Age: CHILD, ADULT
Enrollment: 80
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-20
Completion Date: 2026-12-31
Locations: Steno Diabetes Center Copenhagen, Herlev, Capital, 2730, Denmark

Summary:
More and more children and adolescents are using diabetes devices attached to the skin. The attachment of infusions sets to the skin provoke allergenic or toxic eczema, the continous infusion of insulin provoke subcutaneous changes and prolonged wear time seems to increase the risk of these complication. On the other site fewer skin stripping episodes with longer wear time and filtration of the insulin may be beneficial for the skin, therefore comparing the occurrence of subcutaneous hyper echogenicity, eczema and the skin barrier in users of 3 and 7 days infusions set is highly relevant. The primary aim of present study is to investigate if the use of three days insulin infusion set is superior to seven days in preventing the occurrence of hyperechogenicity in areas recently used for insulin infusion and if the type of insulin matter comparing insulin aspart - Novo Rapid, or insulin lispro - Humalog

Primary Outcome Measures: Occurence of hyperchogenicity at last two positions for infusions sets, Ultrasound scan of skin area for last two positions, 2 weeks
Secondary Outcome Measures: Time-in-range (3.9 - 10 mmol/l), Download data from continous glucose platform (Carelink or Stenopool) for the last two weeks before visits, 2 weeks data|Insulin need per kg, Download of data from insulin pump platform (Carelink or Stenopool) for the last 2 weeks, 2 weeks data|Electric impedance Spectrocopy (EIS), Measures of electric impedans at last two sites for infusion, 2 weeks|Tissue red blood cell count, Imaging with TiVI (tissue viability imaging) showing microcirculation, 2 weeks