pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
A Clinical Study of Albumin-bound Paclitaxel/Granulocyte-based Therapy for Recurrent/Metastatic Breast Cancer
NCT Number: NCT06496724
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Breast Cancer
Interventions: BIOLOGICAL: Albumin paclitaxel/neutrophil drug
Sponsor: JIANG LONGWEI
Collaborators: China Pharmaceutial University
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 1
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-01
Completion Date: 2025-07-01
Locations: Jinling Hospital, Nanjing, Jiangsu, 210002, China|Jinling Hospital, Nanjing, Jiangsu, 210002, China

Summary:
The goal of this clinical trial is to learn if Albumin-bound Paclitaxel/Granulocyte drug can treat patients with recurrent/metastatic breast cancer. The main questions it aims to answer are:

To verify the safety of Albumin-bound Paclitaxel/Granulocyte drug in patients with recurrent/metastatic breast cancer.

To evaluate the efficacy of Albumin-bound Paclitaxel/Granulocyte drug in patients with recurrent/metastatic breast cancer.

To detect the pharmacokinetic behavior of Albumin-bound Paclitaxel/Granulocyte drug in patients with recurrent/metastatic breast cancer.

Primary Outcome Measures: To verity the safety of Albumin-bound Paclitaxel/Granulocyte in the treatment of Recurrent/Metastatic Breast Cancer, The adverse events and severe adverse events will be evaluated., 13 months
Secondary Outcome Measures: To evaluate the efficiency of Albumin-bound Paclitaxel/Granulocyte drug in the treatment of Recurrent/Metastatic Breast Cancer, The objective clinical response will be evaluated., 13 months
Impact of Suture Technique on Wound Healing in Ankle Fracture Surgery: A Randomized Controlled Trial
NCT Number: NCT06496698
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Ankle Fractures
Interventions: PROCEDURE: Simple Interrupted Suture|PROCEDURE: Subcuticular Suture
Sponsor: University of Puerto Rico
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-15
Completion Date: 2026-07-15

Summary:
Our primary aim is to compare the complication rates of patients with ankle fractures who underwent skin closure using a running subcuticular suture pattern compared to an interrupted suture pattern. At the time of the operation, participants will be assigned to either the Subcuticular Suture Group (SSG) or the Simple Interrupted Suture Group (SISG) using computer-generated randomization programs. The surgeon will perform the assigned closure technique using standardized techniques. Running subcuticular Vicryl 3-0 sutures will be placed on patients in the experimental group while simple interrupted Monocryl 3-0 sutures patients in our control group.

Patients will be followed up at the two-week and eight-week postoperative mark where we will use the Patient and Observer Scar Assessment Scale (POSAS) to evaluate and compare wound healing. Additionally, photographs of the scars will be captured to visually assess the healing progression.

Primary Outcome Measures: Postoperative Complication rates, Complications include wound infection, dehiscence, suture breakage, suture abscess, necrosis, allergic reactions, malunion, hardware failure, and the need for reoperation or revision surgery., 2 and 8 weeks post-op.
Secondary Outcome Measures: Patient and Observer Scar Assessment Scale (POSAS), The Patient and Observer Scar Assessment Scale (POSAS) is a comprehensive tool used to evaluate the quality of scars from both the patient's and observer's perspectives. It consists of two parts: the Patient Scale and the Observer Scale., 2 and 8 weeks post-op.|Self-reported foot and ankle score (SEFAS), Consists of 12 items related to pain, limping, swelling, and use of orthotics and walking., 2 and 8 weeks post-op.
The Wrist-Free Study - Comparing Traditional Above Elbow Casts to Ones That Free the Wrist
NCT Number: NCT06496672
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Supracondylar Humerus Fracture
Interventions: PROCEDURE: Modified long arm cast|PROCEDURE: Traditional long arm cast
Sponsor: KK Women's and Children's Hospital
Sex: ALL
Age: CHILD, ADULT
Enrollment: 76
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-11-09
Completion Date: 2024-08-31
Locations: KK Women's and Children's Hospital, Singapore, 229899, Singapore

Summary:
This randomized controlled trial compares clinical outcomes, patient comfort and satisfaction of freeing the wrist in casts for supracondylar humerus fractures in children.

Primary Outcome Measures: Patient Satisfaction, Measured using QDASH, 3-4 Weeks
Secondary Outcome Measures: Complications in healing, Observe for loss of reduction in fracture, 3-4 Weeks
Antidepressant Adherence for Depressed Adults in Primary Care
NCT Number: NCT06496646
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Depression
Interventions: BEHAVIORAL: Reminders|BEHAVIORAL: Incentives
Sponsor: University of Pennsylvania
Sex: ALL
Age: ADULT
Enrollment: 525
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2025-02-01
Completion Date: 2029-03-31

Summary:
The goal of this randomized controlled trial study is to compare different adherence support strategies for primary care patients with depression who have been newly prescribed antidepressant medications. We will examine whether personalized daily text messages with and without financial incentives improves anti-depressant adherence and depression symptoms as compared to treatment as usual (no messages or incentives for taking medications).

We will measure adherence with a wireless pill bottle and by assessment of electronic health prescription records. Participants in the study will be asked to complete assessments of depression symptoms via telephone at 6 and 12 weeks.

Primary Outcome Measures: Depression symptom response 12 weeks, A reduction of 50% in depression score from baseline as assessed by PHQ-9, 12 weeks from baseline
Secondary Outcome Measures: Antidepressant adherence, measurement of antidepressant adherence through electronic pill bottles, 6 and 12 weeks|Depression symptom response 6 weeks, A reduction of 50% in depression score from baseline as assessed by PHQ-9, 6 weeks from baseline
Echocardiography-guided Percutaneous Septal Radiofrequency Ablation for Obstructive HCM After Alcohol Septal Ablation
NCT Number: NCT06496633
Acronym: HCM
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Hypertrophic Cardiomyopathy
Interventions: PROCEDURE: Percutaneous Intramyocardial Septal Radiofrequency Ablation
Sponsor: Xijing Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 12
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-03-26
Completion Date: 2024-12-31
Locations: Ultrasonic Diagnosis Department of Xijing Hospital, Fourth Military Medical University, Xi'an, Shaanxi, 710032, China

Summary:
After alcohol ablation, some HOCM patients have serious clinical symptoms and adverse complications, and need to undergo invasive surgery again when adequate drug therapy is not effective or cannot tolerate the side effects of drugs. Liwen surgery is a safe and effective new minimally invasive treatment for HOCM patients, so the purpose of this study was to evaluate the safety and efficacy of Liwen surgery in HOCM patients who failed alcohol ablation and provide new treatment methods for patients.

Primary Outcome Measures: treatment success rate, For survival, the left ventricular outflow tract pressure gradient (LVOT pressure gradient) decreased by ≥ 50% or the resting left ventricular outflow tract pressure gradient (LVOT pressure gradient) was \< 30 mmHg, Six months after procedure.
A Study to Evaluate Solrikitug in Participants With COPD (ZION)
NCT Number: NCT06496620
Acronym: ZION
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: COPD
Interventions: DRUG: Biological: Solrikitug low dose|DRUG: Biological: Solrikitug high dose|OTHER: Placebo
Sponsor: Uniquity One (UNI)
Collaborators: DevPro Biopharma
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 135
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-06-30
Completion Date: 2025-08-31

Summary:
A Randomized, Double-blind, Placebo-controlled, Multiple Dose-Ranging Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Solrikitug in Participants with Chronic Obstructive Pulmonary Disease (COPD).

Primary Outcome Measures: Change from baseline in blood eosinophil counts, To assess the effect of multiple doses of solrikitug on blood eosinophil counts compared with placebo, Through week 12
Secondary Outcome Measures: Change from baseline in FEV1 Adverse events (AEs) and serious adverse events (SAEs), To assess the safety and tolerability of multiple doses of solrikitug, Through week 12 To week 28
A Study to Evaluate Solriktug in Adult Participants With Asthma
NCT Number: NCT06496607
Acronym: RAINIER
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Asthma
Interventions: DRUG: Biological: Solrikitug Low Dose|DRUG: Biological: Solrikitug Mid Dose|DRUG: Biological: Solrikitug High Dose|OTHER: Placebo
Sponsor: Uniquity One (UNI)
Collaborators: DevPro Biopharma
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 84
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-26
Completion Date: 2025-08-31
Locations: Research Site 006, Mobile, Alabama, 36608, United States|Research Site 021, Huntington Beach, California, 92647, United States|Research Site 020, Newport Beach, California, 92663, United States|Research Site 024, Englewood, Colorado, 80110, United States|Research Site 001, Clearwater, Florida, 33765, United States|Research Site 025, Leesburg, Florida, 34748, United States|Research Site 003, Miami, Florida, 33186, United States|Research Site 022, Meridian, Idaho, 83642, United States|Research Site 018, Winfield, Illinois, 60190, United States|Research Site 019, Merrillville, Indiana, 46410, United States|Research Site 011, Sioux City, Iowa, 51106, United States|Research Site 005, Lafayette, Louisiana, 70508, United States|Research Site 016, South Dartmouth, Massachusetts, 02747, United States|Research Site 014, Henderson, Nevada, 89052, United States|Research Site 004, Gastonia, North Carolina, 28054, United States|Research 013, Winston-Salem, North Carolina, 27103, United States|Research Site 007, Edmond, Oklahoma, 73034, United States|Research Site 009, Medford, Oregon, 97504, United States|Research Site 008, Rock Hill, South Carolina, 29732, United States|Research Site 017, Boerne, Texas, 78006, United States|Research Site 015, Houston, Texas, 77070, United States|Research Site 010, McKinney, Texas, 75071, United States|Research Site 023, Hampton, Virginia, 23666, United States

Summary:
Phase 2 study to evaluate the safety, tolerability, PK, immunogenicity, and pharmacodynamics of solriktug with adult participants with asthma.

Primary Outcome Measures: To assess the effect of multiple doses of solrikitug on blood eosinophil counts compared with placebo, Change from baseline in blood eosinophil counts evaluated over Weeks 8 to 12, Over weeks 8 and 12
Secondary Outcome Measures: To assess the safety and tolerability of multiple doses of solrikitug, Adverse events (AEs) and serious adverse events (SAEs), To week 12
Ultrasonic Scaler VS Erythritol for Peri-implant Maintenance of Loaded Implants With Crowns Made by Different Materials
NCT Number: NCT06496594
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Peri-implant Mucositis
Interventions: OTHER: Erythritol prophylactic powders|OTHER: Ultrasonic scaler with peek inserts
Sponsor: University of Pavia
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07
Completion Date: 2025-01
Locations: Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia, Pavia, Lombardy, 27100, Italy

Summary:
The aim of the study is to assess the effect of a 6-moht peri-implant protocol with erythritol orultrasonic scaler with peek inserts for dental implants with crowns made by different materials .

Patients will be randomly divided into two groups:

Erythritol group: erythritol with a particle size of \~14 µm will be used for 5 seconds (AIRFLOW® PLUS EMS) Ultrasonic scaler group: a piezoelectric handpiece with peek inserts (Mini Piezon EMS; PI EMS) .

Different subgroups will be defined according to the material of the dental crown of the related implant.

The mechanical debridement appointments will be carried out at the baseline and after 6 months, after instruction and motivation of the patient, completion of the clinical chart with the recording of the Probing Depth (evaluation in mm of the peri-implant sulcus taken by a periodontal probe; 4 surfaces of the gingival margin are detected: vestibular, palatal/lingual, mesial, distal), Bleeding on Probing and Plaque Index.

Primary Outcome Measures: Change in Probing Depth (PD), Evaluation in mm of the peri-implant sulcus taken by a periodontal probe. 4 surfaces of the gingival margin are detected: vestibular, palatal/lingual, mesial, distal., Baseline (T0), 6 months (T1)|Change in Bleeding on Probing (BoP), Evaluation of the presence or absence of gingival bleeding during a probing, Baseline (T0), 6 months (T1)|Change in Plaque Index, evaluation of the amount of soft deposits on implant surfaces at each session, Baseline (T0), 6 months (T1)
Evaluation of U-AKIpredTM for Predicting AKI in Critically Ill Patients Within 12 Hours: a Multicenter Prospective Cohort Study
NCT Number: NCT06496555
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: External Effectiveness Validation of Model
Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 2100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-01
Completion Date: 2025-12-31
Locations: 2nd Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang, China

Summary:
The goal of our study is to evaluate U-AKIpredTM for predicting AKI in critically ill patients within 12 h by the multicenter prospective cohorts. AKI was diagnosed by Kidney Disease Improving Global Outcomes (KDIGO) criteria. We designed five aspects including the overall fitting effecience evaluation, calibration curve, quantifying calibration performance, quantifying discrimination performance, quantifying clinical utility to evaluate the external validation model.

Primary Outcome Measures: AKI occurrence, 12 hours
Renal Oxygen Consumption, Insulin Sensitivity, and Daily Caloric Restriction in ADPKD
NCT Number: NCT06496542
Acronym: EXPLORE
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Autosomal Dominant Polycystic Kidney
Interventions: BEHAVIORAL: Daily caloric restriction|OTHER: Standard advice control
Sponsor: University of Colorado, Denver
Collaborators: Nutrition Obesity Research Center|National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2023-01-13
Completion Date: 2026-01-01
Locations: University of Colorado- Anschutz Medical Campus, Aurora, Colorado, 80045, United States

Summary:
The proposed research is a pilot study assessing kidney oxidative metabolism and insulin sensitivity after a 2-year weight loss intervention in those with autosomal dominant polycystic kidney disease who are overweight or obese.

Primary Outcome Measures: Change in renal oxygen consumption, Renal oxygen consumption will be assessed by a PET/CT scan using 11-C acetate, Baseline, 24-months|Change in insulin sensitivity, Insulin sensitivity will be assessed by a hyperinsulinemic-euglycemic clamp, Baseline, 24-months
Transperineal Ultrasound for Assessing and Predicting Response in Hospitalized Patients with a Flare of Ulcerative Colitis
NCT Number: NCT06496516
Acronym: TAPAS-UC
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Ulcerative Colitis
Sponsor: Sunshine Coast Hospital and Health Service
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09
Completion Date: 2025-09

Summary:
Our aim is to determine how useful transperineal ultrasound is to assess the severity of inflammation in patients with ulcerative colitis. At the moment, there is a small amount of evidence showing it may be just as good as flexible sigmoidoscopy for this purpose. It is a non-invasive test, which means if it is equivalent, it may reduce the need for invasive tests like flexible sigmoidoscopy in the future.

Patients admitted to hospital with a flare of ulcerative colitis will be invited to participate. Participants will undergo standard of care treatment and investigation. In addition to this, they will undergo a specialized non-invasive ultrasound test through the perineum (TPUS) as well as the abdomen (TA-IUS). The results from this will be compared to the current standard, flexible sigmoidoscopy. Patients will undergo repeat ultrasound and flexible sigmoidoscopy ten weeks after hospital discharge.

We aim to show that transperineal ultrasound is useful for assessing disease severity and predicting the treatment course of hospitalized patients, and may be able to replace flexible sigmoidoscopy in some circumstances.

Primary Outcome Measures: Diagnostic accuracy of transperineal ultrasound, The diagnostic accuracy of transperineal ultrasound when compared to the gold standard of flexible sigmoidoscopy., At enrolment and at week 10 after hospital discharge
Secondary Outcome Measures: Additive diagnostic accuracy of transperineal ultrasound compared to transabdominal intestinal ultrasound, Additive diagnostic accuracy of transperineal ultrasound compared to transabdominal intestinal ultrasound - the absolute and relative change in diagnostic accuracy when compared to flexible sigmoidoscopy, At enrolment and at week 10 following hospital discharge|Patient reported acceptability of transperineal ultrasound, Patient reported acceptability of transperineal ultrasound, assessed using a Likert scale, from 0 "Not at all acceptable" to 5 "Very acceptable", At enrolment and at week 10 following hospital discharge|Additive diagnostic accuracy of transabdominal intestinal ultrasound compared to transperineal ultrasound, Additive diagnostic accuracy of transperineal ultrasound compared to transabdominal intestinal ultrasound - the absolute and relative change in diagnostic accuracy when compared to flexible sigmoidoscopy, At enrolment and at week 10 following hospital discharge
We Designed and Implemented the 'MASTER Framework' as a Theoretical Framework to Guide the Design and Delivery of PE and Sports.
NCT Number: NCT06496464
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Help PE Teachers Learn and Develop the Critical Skills Needed to Create a Positive Teaching Environment
Interventions: BEHAVIORAL: Intervention
Sponsor: Soochow University
Sex: ALL
Age: CHILD
Enrollment: 200
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2025-06-01

Summary:
Our research team is committed to improving the quality of physical education in China. Based on the needs of teachers and sports coaches in China, we designed and implemented the 'MASTER Framework' as a theoretical framework to guide the design and delivery of PE and sports. This framework aims to help PE teachers learn about and develop the critical skills needed to create a positive teaching environment and facilitate effective PE class delivery using a games-based approach (GBA).

Primary Outcome Measures: PE teacher Confidence and Competence, PE Teacher questionnaire: PE teachers will be also asked to complete a purpose-designed questionnaire collecting 1) Confidence to teach basketball; 2) Competence to teach basketball. The teachers' Confidence to teach basketball and Competence to teach basketball will be analysed together as a composite outcome., 2 weeks|Student assessments, Students' game skills (assessed at Basketball lesson): Video analysis of decision-making, and attacking and defensive play will be conducted using a previously validated game performance assessment instrument (Miller et al., 2015). These skills are deemed essential for success in invasion games (including basketball) and are skills utilised by all players on the court (irrespective of position played)., 2 weeks
Secondary Outcome Measures: Student perceptions, Student assessments: Enjoyment of Sport (Basketball Lesson). It will be using an adapted version of the Physical Activity Children's Enjoyment., 2 weeks
Frataxin mRNA in Biofluids
NCT Number: NCT06496451
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Friedreich Ataxia
Interventions: OTHER: Spinal tap for CSF collection|OTHER: Venipuncture for blood sample
Sponsor: University of Florida
Collaborators: Friedreich's Ataxia Research Alliance
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 10
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-30
Completion Date: 2025-07

Summary:
The purpose of this research study is to determine a way to measure frataxin messenger RNA (mRNA) in fluids such as blood and cerebrospinal fluid (CSF) from patients with Friedreich's ataxia (FRDA). The gene mutation in FRDA leads to low levels of the mRNA and then low levels of the protein frataxin that leads to the disease. Treatments being developed for FRDA have the ability increase these levels including in brain where it is needed. Currently, there is no accepted way to measure frataxin protein or the messenger RNA (from which the protein is made) in the spinal fluid that surrounds the brain. In our study, we aim to measure frataxin mRNA in both the blood and CSF. We will use our ability to isolate structures called exosomes from these fluids. Exosomes are tiny, microscopic sacs that are known to contain many important biological molecules and we are able to detect frataxin mRNA in CSF from patients with other illnesses and from non-diseased participants. We believe that parallel studies of exosomes in blood and CSF from patients with FRDA can tell us as to whether the frataxin mRNA in the CSF or blood of FRDA patients can serve as a measure of frataxin production in the brain. With one participation visit we will be able to study the relationship of frataxin mRNA levels in your CSF and blood with measures of disease severity. If successful, this will provide an important tool to monitor treatments for FRDA that aim to increase frataxin production.

Primary Outcome Measures: Measurement of Frataxin mRNA in human biofluids, The study plans to measure frataxin mRNA in exosomes from blood and spinal fluid as a biomarker in Friedreich ataxia, One year
Evaluation of the Psychoeducation Program Given to the Elderly Living Alone at Home in Terms of Some Parameters
NCT Number: NCT06496399
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Nursing Caries
Interventions: BEHAVIORAL: psychoeducation
Sponsor: Kastamonu University
Sex: ALL
Age: OLDER_ADULT
Enrollment: 48
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-05-10
Completion Date: 2025-06-29
Locations: Zeynep ARABACI, Kastamonu, (506) 265 26 53, Turkey

Summary:
It was aimed to evaluate the effectiveness of the psychoeducation program given to the elderly living alone at home. In this context, the psychoeducation given was planned to evaluate the effect of the psychological well-being, self-integration and coping levels of the elderly.

Primary Outcome Measures: Evaluation of Psychoeducation Program in Terms of Some Parameters, psychological well-being, self-integration and coping levels of the elderly, 8 week
Robotic Assisted Major Lung Resection in Elderly Patients
NCT Number: NCT06496386
Acronym: ELDERLY
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Lung Cancer
Sponsor: Scientific Institute San Raffaele
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 386
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-30
Completion Date: 2024-10-31
Locations: Istituto Clinico Humanitas, Rozzano, Milan, 20089, Italy|Scientific Institute Ospedale San Raffaele, Milan, 20132, Italy

Summary:
The study is a retrospective observational study. The study is designed to be multicentric and it will analyze medical records from selected patients that underwent major lung resection using DaVinci surgical platform performed in the participating centers.

There are no risks for the patients, as this is a retrospective data collection.

Primary Outcome Measures: The perioperative complications, the investigators will measure the perioperative complications of robotic lung resection in patients with 80 or more than 80 years (very elderly patients) compared to those with less than 80 years. Complications will be categorized according to the Clavien-Dindo scale., from the surgery at 30-90 days after|spirometry tests, the investigators will measure the pre-operative respiratory function (Forced expiratory volume (FEV) , forced vital capacity (FVC)), in the two groups ., from hospitalizzation to the discharge date at maximum one week|Postoperative hospital stay, the investigators will measure the post-operative hospital stay in days in the two groups., from hospitalizzation to the discharge date at maximum one week
Clinical Study of XP-004 Personalized mRNA Tumor Vaccine Combined With PD-1 Inhibitor for Postoperative Adjuvant Therapy for Pancreatic Cancer in Patients With Advanced Solid Tumors
NCT Number: NCT06496373
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Pancreatic Cancer Recurrent
Interventions: BIOLOGICAL: Personalized tumor preventive vaccines
Sponsor: Ruijin Hospital
Collaborators: Shanghai Xinpu BioTechnology Company Limited
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-04-01
Completion Date: 2027-03-31
Locations: Ruijin Hospital Shanghai Jiaotong University School of Medicine, Shanghai, Shanghai, 200025, China

Summary:
The main purpose of this study is to observe and evaluate the safety and tolerance of XP-004 personalized mRNA vaccine encoding tumor neoantigen combined with PD-1 inhibitor for adjuvant treatment of patients who cannot tolerate chemotherapy after radical resection of pancreatic cancer.

The secondary objective was to observe the initial efficacy of adjuvant therapy with XP-004 personalized mRNA vaccine combined with PD-1 inhibitor in patients with pancreatic cancer after radical surgery by the indicators of XP-004 personalized mRNA vaccine induced activstion of Antigen specific CD4 and CD8 T cells, Recurrence free survival (RFS), and Overall Survival (OS).

Primary Outcome Measures: Reaction of antigen-specific T cells in peripheral blood, personalized tumor vaccine induced neoantigen-specific CD4+ and CD8+ T lymphocyte responses, Up to 39 weeks
Secondary Outcome Measures: Recurrence-free survival (RFS), Recurrence-free survival of Personalized mRNA Tumor Vaccine, Up to 3 years|overall survival (OS), Overall Survival of Personalized mRNA Tumor Vaccine, Up to 3 years
Prediction of Mediastinal Station IV Lymph Node Metastasis in Non-small Cell Lung Cancer
NCT Number: NCT06496360
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Non-small Cell Lung Cancer
Interventions: DIAGNOSTIC_TEST: Artificial Intelligence
Sponsor: Qilu Hospital of Shandong University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 150
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-01
Completion Date: 2025-06
Locations: Qilu Hospital of Shandong University, Jinan, Shandong, 250063, China

Summary:
Mediastinal lymph node metastasis is a common metastasis pathway of non-small cell lung cancer (NSCLC), and its occurrence is closely related to the lymphatic drainage pattern, which is different in different pulmonary lobe NSCLC, which poses a challenge for the formulation of individualized treatment strategies. Accurate staging is the prerequisite for accurate treatment of NSCLC. Computed Tomograph (CT) examination is an important tool for evaluating mediastinal lymph node metastasis, which is crucial for making treatment plan and evaluating patient prognosis. However, it is difficult to diagnose metastatic lymph nodes with insignificant imaging features. Especially metastatic lymph nodes in areas 4 and 7. Both zone 4 and zone 7 are hot spots for mediastinal lymph node metastasis. However, clinical guidelines do not make clear provisions on lymph node dissection in zone 4, which makes preoperative clinical staging and prognosis evaluation of patients with NSCLC particularly important. By integrating and analyzing a large amount of data in CT images, the newly emerging CT radiomics technology captures subtle features that may be overlooked in conventional CT scans, showing great application prospects in the accuracy of non-invasive diagnosis of lymph node metastasis. This study aims to explore the mediastinal drainage pattern and the role of CT in evaluating mediastinal lymph node metastasis, in order to provide valuable imaging evidence for accurately judging mediastinal lymph node metastasis of NSCLC, formulating appropriate lymph node dissection scope, optimizing treatment strategy, and improving patient prognosis.

Primary Outcome Measures: Area under the Curve(AUC), To evaluate the ability and clinical practicability of the model to predict lymph node metastasis, June 2025|Receiver operator characteristic curve(ROC), Sensitivity and specificity of different models under different thresholds, June 2025
CBB Satisfaction Survey
NCT Number: NCT06496347
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Alzheimer Disease|Cognitive Impairment
Sponsor: Cheng Sheng Chen
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 192
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-05-09
Completion Date: 2023-05-18
Locations: Kaohsiung Medical University Hospital, Kaohsiung, Taiwan

Summary:
The Cogstate Brief Battery (CBB) is a computerized measure for cognitive screening that consists of four cognitive tasks to assess psychomotor function, attention, learning, and working memory, and provides an easy-to-interpret report without the need for manual scoring. Clinical trials and research studies have proven the validity of CBB for cognitive assessment and distinguish MCI or dementia from normal aging.

Participants express a growing acceptance of the use of computerized tests for detecting cognitive impairment, viewing it as a potential tool to improve quality of patient care and the patient-clinician relationship when used in conjunction with the "human touch." The CBB utilizes non-verbal playing-card stimuli in order to minimize language, educational and cultural biases affecting performance. It has the advantages of being portable (adaptable to notebooks, tablets, and even smart phones), short (20-30 min), game-like in presentation and thus motivating, and cross-culturally adaptable. The CBB is well liked in waiting rooms of primary care settings. It is assumed that the CBB will also be highly accepted by Taiwanese.

Primary Outcome Measures: CBB Testing Score and Brain Age Score, Participant satisfaction with using CBB will be measured by the paper-and-pencil satisfaction survey including 15 questions. See Appendix 1: Satisfaction Survey for Participant. Score of Question 2 will be ranged from "Strongly agree" (1) to "Strongly disagree" (5). Scores of Question 3\~13 will be ranged from "Strongly disagree" (1) to "Strongly agree" (5).

The participant satisfaction rates will be estimated from Question 2, 3, 5, 6, 8, 9, 11, 12 and 13, and calculated in accordance with the following formula:

Satisfaction rate = (number of score 5 and 4 / number of answers) x 100% The satisfaction rate of each question mentioned above and the frequency of each score of each question will be evaluated and presented by groups of HC and MCI., Data analysis and study report: 3 months
Forensic Facial Reconstruction (FFR) From CT Scans
NCT Number: NCT06496334
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Forensic Facial Reconstruction
Sponsor: Queen Mary University of London
Collaborators: Egyptian Ministry of Higher Education
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 2
Study Design: Observational Model: |Time Perspective: p
Start Date: 2014-05-28
Completion Date: 2015-04-30
Locations: Barts School of Medicine and Dentistry, Queen Mary University of London, London, EC1M 6BQ, United Kingdom

Summary:
1. Reconstructing faces derived from CT scanned skulls using the average facial templates and employing computer facial reconstruction software programme.
2. Evaluating the accuracy of facial reconstructions by objective comparison between the reconstructed face and the CT scanned face.
3. Evaluating the accuracy of facial reconstructions by subjective assessment via 2 groups of individuals, experienced and inexperienced in facial images perception.

Primary Outcome Measures: The percentage of correct identifications and resemblance scores of the target reconstructed faces by human assessors., 3 years
Secondary Outcome Measures: The influence of previous experience in the field of facial image recognition and perception on the identification of the reconstructed faces., 3 years
Morbidity of Conventional and No-touch Saphenectomy in Coronary Artery Bypass Grafting.
NCT Number: NCT06496321
Acronym: TNT
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Saphenectomy|No Touch|Coronary Artery Disease|Cardiovascular Diseases|Wound Complication
Interventions: PROCEDURE: Conventional Saphenous vein harvest|PROCEDURE: No touch Saphenous vein harvest
Sponsor: Instituto Nacional de Cirugia Cardiaca, Uruguay
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 52
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-03-15
Completion Date: 2025-12-31
Locations: Instituto Nacional de Cirugia Cardiaca, Montevideo, 11600, Uruguay

Summary:
A clinical research project will be carried out that will consist of a non-inferiority study. The objective is to compare the morbidity of two different surgical techniques for the extraction of the internal saphenous vein, intended to be used as a conduit in coronary bypass.

Primary Outcome Measures: Demonstrate the non-inferiority of the "no touch" technique over the conventional technique in terms of wound morbidity., Our primary objective will be to demonstrate the non-inferiority of the "no touch" technique over the conventional technique in terms of wound morbidity in patients undergoing coronary revascularization, within a non-inferiority margin. Defining morbidity as the combined result of local infection, hematoma, blisters, secretions, necrosis, wound dehiscence, paresthesias, pain and functional impotence., 1 week, 1 month, 6 months
Secondary Outcome Measures: Incidence of local infection, hematoma, flictena, secretions, necrosis, wound dehiscence, paresthesia, pain, functional impotence and then compare them between both groups at different times., Find the incidence of each of the study factors: local infection, hematoma, flictena, secretions, necrosis, wound dehiscence, paresthesia, pain, functional impotence and then compare them between both groups at different times., 1 week, 1 month, 6 months
Other Outcome Measures: Saphenous vein bypass patency, Patients will be offered computed tomography angiography one year after surgery to evaluate graft patency., 1 year
Bendamustine and Rituximab With or Without Orelabrutinib in MCL Treatment
NCT Number: NCT06496308
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Mantle Cell Lymphoma (MCL)
Interventions: DRUG: Orelabrutinib|DRUG: Bendamustine|DRUG: Rituximab|DRUG: Venetoclax
Sponsor: Ruijin Hospital
Collaborators: Third Xiangya Hospital of Central South University|Anhui Provincial Cancer Hospital|Fujian Medical University Union Hospital|Yantai Yuhuangding Hospital|Huadong Hospital Affiliated with Fudan University, Shanghai|The First Affiliated Hospital of Anhui Medical University|Jiangxi Provincial Cancer Hospital|Fujian Cancer Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 78
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-10
Completion Date: 2027-07-10
Locations: Ruijin Hospital, Shanghai, 200025, China

Summary:
This multicenter, open-label, randomized controlled trial aims to evaluate the efficacy and safety of Orelabrutinib in combination with Bendamustine and Rituximab (OBR) versus Bendamustine and Rituximab (BR) in patients with intermediate- to high-risk mantle cell lymphoma (MCL) who are ineligible for transplantation. The primary objective is to assess the complete response (CR) rate during the induction phase, with secondary objectives including progression-free survival (PFS), overall survival (OS), objective response rate (ORR), and safety. Exploratory analysis will investigate the correlation between tumor biomarkers and treatment efficacy.

Primary Outcome Measures: Complete response rate, Percentage of participants with complete response was determined on the basis of investigator assessments according to 2014 Lugano criteria., End of induction treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=28 days]
Secondary Outcome Measures: Overall Response Rate, Percentage of participants with overall response was determined on the basis of investigator assessments according to 2014 Lugano criteria., End of induction treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=28 days]|Progression-free survival, Progression-free survival was defined as the time from the date of randomization until the date of the first documented day of disease progression or relapse, using 2014 Lugano criteria, or death from any cause, whichever occurred first., Baseline up to data cut-off (up to approximately 2 years)|Overall survival, Overall survival was defined as the time from the date of randomization to the date of death from any cause., Baseline up to data cut-off (up to approximately 2 years)
The Use of a Novel Vaginal Speculum for Cervical Cancer Screening in Sunrise Community Health Patients
NCT Number: NCT06496295
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Cervical Cancer Screening
Interventions: DEVICE: Vaginal Speculum Exam
Sponsor: Rocky Vista University, LLC
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-01
Completion Date: 2024-12-31
Locations: Rocky Vista University, Englewood, Colorado, 80112, United States

Summary:
The specific aim of this research is to determine if the Bouquet Speculum TM , compared to the existing 2-bladed vaginal speculum, provides better visualization of the cervix, is easier for the provider to use and is more comfortable for the patient.

Additionally, the clinician's experience with vaginal speculum exams and the patient's last vaginal speculum exam, parity and self-reported weight classification will be surveyed to see what effect, if any, it has on visualization of the cervix, ease-of use, and comfort level for the patient.

The objective of this project is to investigate the use of a novel, FDA-cleared, 5-petaled vaginal speculum in cervical cancer screening (Pap test and/or HPV probe) on 200 patients from Sunrise Community Health Clinics in the Denver-Metro area.

Primary Outcome Measures: Evaluating the use of the Bouquet Speculum for cervical visibility, ease-of-use, and comfort level, 200 women will be selected from the Sunrise Clinics in the Denver-Metro area. The clinician will then be assigned a letter and complete three questions on a survey for each patient regarding 1. visualization of the cervix 2. ease-of-use 3. experience with speculum exams. The patient will be consented and de-identified and assigned a number to their survey of four questions: 1. comfort level 2. last vaginal speculum exam 3. self-reported description of weight (underweight, normal, overweight, obese) 4. parity (number of births).

The Bouquet Speculum has been FDA-cleared and is a Class II medical device and poses a non-significant risk for use in humans. Regulation Number: 884.4520, 3 months
Barrigel® PPRT (Post-Prostatectomy Radiation Therapy) Trial
NCT Number: NCT06496256
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Prostate Cancer
Interventions: DEVICE: Barrigel|DEVICE: Transrectal Ultrasound
Sponsor: Palette Life Sciences, Inc.
Collaborators: Teleflex
Sex: MALE
Age: ADULT, OLDER_ADULT
Enrollment: 84
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: PREVENTION
Start Date: 2024-08-05
Completion Date: 2027-12-31
Locations: GenesisCare Ringwood, Melbourne, Victoria, 3002, Australia

Summary:
Barrigel is intended to temporarily position the anterior rectal wall away from the prostate or prostate bed during radiotherapy treatment for prostate cancer and, in creating this space, it is the intent of Barrigel to reduce the radiation dose delivered to the anterior rectum.

Primary Outcome Measures: Reduction in volume of rectum receiving radiation dose, Investigational subjects only: Achievement of a ≥ 25% change in reduction in the volume of rectum receiving 90% of the prescription dose in 70% of the subjects., 3 months
Secondary Outcome Measures: Grade 2 Toxicities, Test whether the use of the Barrigel spacer does not increase the incidence of acute grade 2+ GI toxicity within the first 3 months, which will be assessed using the proportion of subjects who have one or more incidences of acute grade 2+ GI toxicity within the first 3 months., 3 Months|Expanded Prostate Cancer Index Composite (EPIC) bowel QOL, Evaluate the change in Expanded Prostate Cancer Index Composite (EPIC) Bowel Assessment composite score (from baseline within 3 months after completion of radiation therapy, 3 months|Expanded Prostate Cancer Index Composite (EPIC) Urinary QOL, Evaluate the change in Expanded Prostate Cancer Index Composite (EPIC) Urinary Assessment composite score from baseline within 3 months after completion of radiation therapy, 3 months
Other Outcome Measures: Adverse Events, All adverse events, 3 months
Impact of Obicetrapib and Obicetrapib Plus Repatha on Lp(a) Levels
NCT Number: NCT06496243
Acronym: VINCENT
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Dyslipidemias
Interventions: DRUG: obicetrapib 10 mg + obicetrapib/evolocumab 140 mg Q 2 weeks
Sponsor: NewAmsterdam Pharma
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: NA|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2025-07

Summary:
The goal of this open label 16 week trial is to evaluate Lp(a) levels for patients with elevated Lp(a) being treated with obicetrapib and obiceptrapib/evolocumab

Patients will:

Have baseline Lp(a) tested at randomization Take 10mg/dL obiceptrapib daily for 8 weeks and have Lp(a) tested at Week 8 Take 10 mg/dL obicetrapib daily/evolocumab 140 every other week for 8 weeks and have Lp(a) retested at Week 16

Primary Outcome Measures: To evaluate the effect of evolocumab in combination with obicetrapib on lipoprotein (a) (Lp[a])., Lp(a) reduction on combination therapy, 16 weeks from baseline; 8 weeks on combination therapy
Secondary Outcome Measures: To evaluate the effect of obicetrapib alone on Lp(a)., Lp(a) reduction on obicetrapib, 8 weeks
Open Trial of Technology-Enhanced Behavioral Intervention for Buprenorphine Retention in Pregnant and Postpartum People
NCT Number: NCT06496230
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: EARLY_PHASE1
Conditions: Opioid Use Disorder|Pregnancy Related
Interventions: BEHAVIORAL: Empowering Pregnant Women and People Receiving Medications for Opioid Use Disorder
Sponsor: Medical University of South Carolina
Collaborators: National Institute on Drug Abuse (NIDA)
Sex: FEMALE
Age: ADULT
Enrollment: 26
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-16
Completion Date: 2026-07-31

Summary:
This study involves testing how useful a technology-enhanced intervention is for pregnant people prescribed buprenorphine for the management of opioid use disorder. The intervention being studied is a brief therapy protocol and a mobile application. Participation involves four 60-minute biweekly (i.e., once every other week) therapy appointments during pregnancy, and three 30-minute therapy appointments monthly during the first three months after childbirth. The mobile application will be accessible for at least the duration of the study. Participants will also be asked to complete questionnaires at enrollment and again at 1-month postpartum and 3-months postpartum, and will be contacted approximately once a month to conduct a medication count. The total duration of the study is 6 months.

Primary Outcome Measures: Intervention Feasibility, Feasibility of the intervention (e.g., Recruitment: 20 pregnant women with OUD prescribed buprenorphine; Study retention: ≥50% participants retained through 3-month postpartum assessment; Protocol adherence: ≥50% attend all EMPWR therapy sessions;145 Satisfaction: qualitative feedback to assess what participants liked/did not like about the intervention), 1 year
Secondary Outcome Measures: Buprenorphine retention, Prescription drug monitoring program (y/n), 6 months|Buprenorphine adherence, Mobile application data, medication possession ratios (%), 6 months