pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
"Comparison of the Effectiveness of Conventional Radiofrequency Thermocoagulation and Chemical Ablation With Phenol on Articular Branches of Femoral and Obturator Nerves in Chronic Hip Pain"
NCT Number: NCT06570746
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Chronic Pain
Interventions: DRUG: Sedative
Sponsor: Aydin Adnan Menderes University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 48
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10-01
Completion Date: 2025-06-25
Locations: Adnan Menderes University Faculty of Medicine, Aydın, 09010, Turkey

Summary:
"In our study, we aimed to compare the effects of conventional radiofrequency thermocoagulation applied to the articular branches of the femoral and obturator nerves with chemical ablation using phenol on hip pain."

Primary Outcome Measures: NRS (Numerical Rating Scale), We will assess NRS (Numerical Rating Scale) scores at 1 month and 3 months. A 50% reduction in NRS will be considered statistically significant, preoperative|NRS (Numerical Rating Scale), We will assess NRS (Numerical Rating Scale) scores at 1 month and 3 months. A 50% reduction in NRS will be considered statistically significant, postoperative first month|NRS (Numerical Rating Scale), We will assess NRS (Numerical Rating Scale) scores at 1 month and 3 months. A 50% reduction in NRS will be considered statistically significant, postoperative third month
Secondary Outcome Measures: WOMAC (Western OntarioandMcMasterUniversitiesArthritis Index ), To assess functional capacity preoperatively, we will evaluate the WOMAC (Western Ontario and McMaster Universities Arthritis Index) scale at 1 month and 3 months post-procedure in patients., preoperative|WOMAC (Western OntarioandMcMasterUniversitiesArthritis Index ), To assess functional capacity preoperatively, we will evaluate the WOMAC (Western Ontario and McMaster Universities Arthritis Index) scale at 1 month and 3 months post-procedure in patients., postoperative first month|WOMAC (Western OntarioandMcMasterUniversitiesArthritis Index ), To assess functional capacity preoperatively, we will evaluate the WOMAC (Western Ontario and McMaster Universities Arthritis Index) scale at 1 month and 3 months post-procedure in patients., postoperative third month
Acceptability Research on Integrated Point of Care Sexually Transmitted Infection (STI) Testing and Expedited Partner Therapy (EPT)
NCT Number: NCT06570733
Acronym: ARISE
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Neisseria Gonorrhea|Trichomoniasis Vaginalis|Chlamydia Trachomatis Infection
Sponsor: Wits RHI Research Centre Clinical Research Site
Collaborators: University of Washington
Sex: FEMALE
Age: CHILD, ADULT
Enrollment: 305
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-02-11
Completion Date: 2024-12
Locations: Wits RHI Research Centre, Hillbrow, Gauteng, 2038, South Africa

Summary:
This protocol builds on nearly a decade of collaborative HIV/STI prevention research to conduct a prospective cohort study of Adolescent Girls and Young Women (AGYW) eligible for PrEP in South Africa in which we will assess the acceptability of point-of-care STI testing plus Expedited Partner Therapy (EPT) and its impact on the incidence of common curable STIs over 12 months of follow-up. The social-behavioral scientist will undertake qualitative interviews with participants and their male partners to identify facilitators and barriers to EPT uptake and conduct a comparative cost analysis to estimate the cost per person tested using point-of-care STI testing with and without EPT incremental to the cost of standard of care. Findings from the proposed research will provide essential knowledge for national policymakers to advance approaches to STI screening and treatment that will lead to improvements in AGYW sexual reproductive health and reductions in STIs. The data generated from this project are essential to inform efforts to reduce the burden of STIs and HIV-1 in women and achieve the 2030 Sustainable Development Goals, which includes substantial reductions in HIIV and STIs in key at-risk populations. This project will support global efforts to substantially reduce STIs in key populations.

Primary Outcome Measures: GeneXpert, A PCR instrument used to diagnose chlamydia trachomatis and gonorrhea., 2 years
Secondary Outcome Measures: Osom rapid testing kit, A rapid testing kit to diagnose trichomoniasis., 2 years
Alcohol-focused Support of Survivors In Sororities Training (ASSIST) - Pilot
NCT Number: NCT06570720
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Alcohol Drinking in College
Interventions: BEHAVIORAL: Alcohol-focused Support of Survivors in Sororities Training (ASSIST)
Sponsor: University of Washington
Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 600
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10
Completion Date: 2026-03
Locations: University of Washington, Seattle, Washington, 98195, United States

Summary:
The goal of this clinical trial is to conduct a preliminary evaluation of the ASSIST (Alcohol-focused Support of Survivors in Sororities Training) intervention in sorority chapters. ASSIST is a newly developed web-based intervention to increase peer support of sexual assault survivors and reduce encouragement of drinking to cope within social networks of sororities. To test whether the intervention is feasible and shows preliminary signs of working, a pilot cluster randomized trial will be conducted. Sorority chapters will be recruited and randomly assigned to an intervention condition or an assessment-only condition. Individuals within each sorority will be recruited and complete a norm documentation survey. One month later, participants will complete a baseline survey, and if assigned to the intervention condition, will then receive the web-based ASSIST intervention, which will include normative feedback on values and drinking, psychoeducation about sexual assault recovery and the role of alcohol, and skills training in behaviors that can be used to support survivors without or while moderating heavy drinking. All participants will complete online follow-up surveys at 1-, 3-, and 6-months post-intervention.

Primary Outcome Measures: Perceived helpfulness, Participants will rate the helpfulness of information provided. Range: 1 to 5. Higher scores represent greater helpfulness., Immediate post-intervention|Social Support, On the Multidimensional Scale of Perceived Social Support (MSPSS), participants will rate the support of family, friends, and a significant other. A mean score will be computed. Range: 1 to 7. Higher scores represent more social support., Baseline; 1-, 3-, and 6-month follow-up|Alcohol use, On the Daily Drinking Questionnaire (DDQ), participants will report how many standard drinks (0 to 25+) they consumed each day for a typical week in the past month. Total number of drinks per week will be calculated. Range: 0 to 175. Higher scores represent more alcohol use., Baseline; 1-, 3-, and 6-month follow-up|Alcohol-related consequences, On the Brief Young Adult Alcohol Consequences Questionnaire (B-YAACQ), participants will indicate whether they have experienced each of 24 negative consequences of alcohol use in the past month. A count of number of consequences experienced will be calculated. Range: 0-24. Higher scores represent more consequences experienced., Baseline; 1-, 3-, and 6-month follow-up
Addressing Unintentional Leakage When Using Nasal CPAP - Study B
NCT Number: NCT06570629
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Continuous Positive Airway Pressure|Adverse Effect|Obstructive Sleep Apnea
Interventions: DEVICE: Oronasal CPAP|DEVICE: Nasal CPAP plus Chinstrap
Sponsor: University of Sao Paulo General Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-08-30
Completion Date: 2026-12-31
Locations: Sleep Laboratory, Heart Institute, Pulmonary Division, Hospital das Clínicas da Universidade de São Paulo, Sao Paulo, 55, Brazil

Summary:
Oral unintentional leak is a common side effect of continuous positive airway pressure (CPAP) for obstructive sleep apnea (OSA) treatment. Management of oral unintentional leakage has not been standardized and the effectiveness of potential approaches have not been studied in controlled studies. Higher levels of CPAP are associated with higher leak. In the present study, a sequential approach to control excessive unintentional leak will be tested. In study A, the reduction of therapeutic CPAP level will be tested. In study B, oronasal CPAP will be compared to nasal CPAP with a chinstrap.

Primary Outcome Measures: 95th CPAP unintentional leak, The 95th unintentional leak percentile value will be compared during both interventions, 27 days
Secondary Outcome Measures: CPAP Side-effects questionnaire, This questionnaire addresses CPAP side-effects including those related to excessive air leak using a visual-analog scale., 27 days|Residual apnea-hypopnea index (AHI), Residual AHI will be compared during both interventions, 27 days|Functional Outcomes of Sleep Questionnaire (FOSQ 10), The FOSQ 10 aims to assess the impacts of daytime sleepiness on daily activities. The FOSQ 10 consists of 10 questions comprising 5 items: General productivity, alertness, activity level, social outcomes, and intimate and sexual relationships. Each item generates a score from 1 to 4, and for items with more than one question, the average of the scores is calculated. The overall score is given by multiplying the average of the item scores by 5, obtaining a value from 5 to 20. The higher the score, the better the individual's functional status., 27 days|Pittsburgh questionnaire, The Pittsburgh questionnaire assessed sleep quality over the past month. The questionnaire consists of 19 self-reported questions and 5 questions related to the roommate/bed partner that are not included in the overall score. The 19 self-reported questions are divided into 7 components (respectively, subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime sleep dysfunction), and each component is scored on a scale of 0 to 3. The scores are then summed to form an overall scale of 0 to 21 points. The higher the score, the worse the sleep quality, and a PSQI greater than 5 indicates poor sleep quality., 27 days
Opioid Sparing Effect of an ISP Nerve Block on Post-Op Pain Control in Posterior Cervical Spine Fusion
NCT Number: NCT06570577
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pain, Postoperative
Interventions: PROCEDURE: Inter-semispinalis Plane Block|DRUG: Opioids
Sponsor: Stony Brook University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2025-08
Locations: Stony Brook University Hospital, Stony Brook, New York, 11794, United States

Summary:
Participants who have a surgical procedure called Posterior Cervical (neck) Spine Fusion will normally need pain medication to relieve post operative pain. This usually includes opioid medications. In this study, the consented participant may receive a nerve block procedure, in addition to the pain relieving medication. There is a fifty-fifty chance to receive the nerve block. The goal is to see if the nerve block group needs less opioid medication, has lower pain scores and is discharged from the hospital sooner.

Primary Outcome Measures: Lower opioid use, Comparison of the reduction in Morphine Milligram Equivalent (MME) dose of opioids consumed between the control group versus the nerve block group., 48 hours post Post-Anaesthesia Care Unit (PACU) arrival time
Secondary Outcome Measures: Lower opioid use., MME from anesthesia induction time until PACU arrival time., MME use will be recorded from the patient's Anesthesia induction time until the patient's PACU arrival time. This will be the intra-operative period, which may last several hours, but not expected to exceed eight hours.|Lower opioid use, MME for the 24 hours after PACU arrival time, 24 hours after PACU arrival time|Pain Scores, Using a Numeric Rating Scale (NRS), pain scores will be obtained at specified times and then compared between the two groups. Participants will be asked to rate their pain on a scale from 0 - 10, where zero represents 'no pain at all' and 10 represents 'the worst pain ever possible'., 48 hours after PACU arrival time|Length of hospital stay, The length of hospital stay will be compared between the two groups., The patient's EMR will record the date and time of admission, as well as, the date and time of discharge. This will be quantified by the REDCap software being used for this study, and is not expected to exceed four days.
Upper Versus Lower Limb Exercises on Intermittent Claudication in Diabetic Patients
NCT Number: NCT06570564
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Intermittent Claudication
Interventions: DEVICE: The arm crank ergometer|DEVICE: bicycle ergometer|DEVICE: treadmill
Sponsor: Cairo University
Sex: ALL
Age: ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2023-02-20
Completion Date: 2024-02-20
Locations: Damanhour teaching hospital, Damanhūr, Damanhour, Egypt

Summary:
Sixty patients with intermittent claudication and type 2 diabetes mellitus. Their age will ranged from 45-55 years old. They recruited from internal department at Damanhour Medical National Institute (DMNI), Damanhour, Beheira Governorate, Egypt. Patients randomly assigned into three equal groups:

Group (A):

Upper limb exercises group consist of 20 patients. They received arm cranking exercise three times per week for three consecutive months plus routine physiotherapy program.

Group (B):

Lower limb exercises group consist of 20 patients. They received bicycling exercise three times per week for three consecutive months plus routine physiotherapy program.

Group (C):

The control group consisted of 20 patients. They received only routine physiotherapy program.

Primary Outcome Measures: maximum walking distance (MWD) in meter, the distance that had been walked on the treadmill when patients were unable to continue because of severe claudication pain, three consecutive months|pain free walking distance (PFWD) in meter, the distance that patients can walk on the treadmill before claudication pain begins, three consecutive months|claudication score, Claudication pain scale is a continuous scale from 1, indicating no pain, to 5 indicating severe pain, three consecutive months|Ankle/brachial indices (ABI) by doppler ultrasound, three consecutive months|glycated haemoglobin (HbA1C), It is the average of blood glucose (sugar) levels for the last two to three months. If you have diabetes, an ideal HbA1c level is 48mmol/mol (6.5%) or below, three consecutive months
Continuous Glucose Monitoring System Use in Pediatric Patients With Diabetes
NCT Number: NCT06570551
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Diabetes Mellitus
Interventions: DEVICE: i3 CGM(continuous glucose monitor)
Sponsor: Sinocare
Sex: ALL
Age: CHILD
Enrollment: 78
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-03-30
Completion Date: 2024-09-28
Locations: Hunan Children's Hospital, Changsha, Hunan, China|Children's Hospital of Soochow University, Suzhou, Jiangsu, China|NingBo Women & Children's Hospital, Ningbo, Zhejiang, China

Summary:
To verify and evaluate the efficacy and safety of i3 CGM system manufactured by Changsha Sinocare Inc. for continuous or regular monitoring of interstitial fluid glucose level in pediatric patients with diabetes.

Primary Outcome Measures: Accuracy, percentage of i3 CGM values in the measuring range less than 4.4 mmol/L(80 mg/dL) within ± 1.1 mmol/L(20 mg/dL) of the EKF control., 0-15 days
Transcutaneous Electrical Nerve Stimulation for in the Treatment of Premature Ejaculation
NCT Number: NCT06570512
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Transcutaneous Electrical Nerve Stimulation|Premature Ejaculation
Interventions: DEVICE: transcutaneous posterior tibial nerve stimulation
Sponsor: Assiut University
Sex: MALE
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2017-01
Completion Date: 2018-12
Locations: Cairo University, Cairo, Giza, Egypt

Summary:
Premature ejaculation (PE) is the most prevalent male sexual dysfunction. The currently approved treatments are intolerable to patients due to their side effects.

the investigatorsconducted a blinded randomized controlled trial to evaluate the efficacy and safety of transcutaneous posterior tibial nerve stimulation (TPTNS) for the treatment of PE.

5o male patients complaining of PE with intravaginal ejaculation latency time (IELT) of less than 2 minutes were randomized into two equal groups to receive either TPTNS or sham transcutaneous electrical nerve stimulation (TENS). TPTNS group underwent ten sessions of electrical stimulation of the posterior tibial nerve using a frequency of 20 Hz and a pulse width of 250 microseconds. The primary outcomes were IELT which was calculated by the patient's digital hand watch, and the Arabic index of premature ejaculation (AIPE).

Primary Outcome Measures: intravaginal ejaculation latency time, efore and after treatment, the patients were asked to answer the Arabic Index of premature ejaculation questionnaire (AIPE) which evaluates seven items: time to ejaculation, hard erections for sufficient intercourse, control, sexual desire, satisfaction for the patient and partner, anxiety, or depression. Also, the intravaginal ejaculation latency time (IELT) was calculated using the digital hand watch, as the patients were instructed to count the time between intromission and ejaculation, and to repeat this procedure in one to two coital occasions per week over three weeks after receiving either TPTNS or TENS. The ISSM defined an IELT threshold of 2 minutes as the cut-off point for PE. The treatment success was defined as a decrease in PE severity and an improvement in AIPE score., one to two post coital occasions per week over three weeks
Secondary Outcome Measures: time to ejaculation, time to ejaculation through Arabic Index of premature ejaculation questionnaire (AIPE), one to two post coital occasions per week over three weeks|hard erections for sufficient intercourse, hard erections for sufficient intercourse through Arabic Index of premature ejaculation questionnaire (AIPE), one to two post coital occasions per week over three weeks|satisfaction for the patient and partner, satisfaction for the patient and partner through Arabic Index of premature ejaculation questionnaire (AIPE), one to two post coital occasions per week over three weeks
Comparison of Conventional Impressions, Intraoral Scanners and Digital Photogrammetry for Full-arch Implant Prosthesis.
NCT Number: NCT06570499
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Dental Implant Failed
Interventions: OTHER: Implant impression
Sponsor: Centre Hospitalier Universitaire de Liege
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SCREENING
Start Date: 2024-06-18
Completion Date: 2024-12-15
Locations: Institut de Dentisterie, Liège, Liege, 4000, Belgium

Summary:
The aim of this clinical trial is to compare implant-supported definitive impressions in edentulous patients (mandible or maxilla) with 4 to 8 osseointegrated implants. The main questions it aims to answer are :

The primary outcome of this prospective clinical comparative study is to analyse the precision of a complete-arch impression.

The secondary aim is to obtain patient satisfaction with these new types of impression.

The different impressions (conventional, intraoral scanner and photogrammetry) will be taken twice on the same patient.

Primary Outcome Measures: Compare the precision of a complete-arch impression, 6 impressions are taken on one patient, The impressions will be taken on the same day, the appointment lasts one hour.
Secondary Outcome Measures: Obtain patient satisfaction with these new types of impression., Patients complete a satisfaction questionnaire in VAS format, The questionnaire is handed out after the impressions, during the only appointment of this study (one hour).
Contrast Between Traditional Regression Model and AI in Predicting Prolonged Stay Stay After Head and Neck Tumors
NCT Number: NCT06570486
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Head and Neck Cancer
Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 700
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-03-01
Completion Date: 2025-04-01
Locations: Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, Guangdong, 52100, China

Summary:
This experiment is an observational study of cohort. By establishing a cohort of patients with head and neck tumors transferred to ICU after surgery, investigators compared the prediction effect of AI and the traditional prediction model on whether patients can be transferred to ICU within 24 hours of head and neck tumors. First retrospective analysis of patients after head and neck tumor surgery, medical records were collected, the test results are divided into training group and validation group according to 7:3, divided into 2 groups according to the patient ICU stay time is greater than 24 hours, the prediction model after the ICU duration of head and neck tumor surgery after more than 24 hours. At the same time, clean the data, train the AI with the data, and compare the effectiveness of both sides with the ROC. After the establishment of prediction model and AI training, the patients included in the cohort were evaluated by prediction model and AI immediately after being transferred to the ICU, predicting the possibility of transferring out of the ICU within 24 hours.

Primary Outcome Measures: roll-out icu, The time of patient transfer from ICU to the general ward was set as transfer out, From the date of ICU admission until the date of ICU discharge or death, whichever occurs first, assessed up to 30 days
Feasibility Trial for a Right Ventricular Failure Platform Trial
NCT Number: NCT06570473
Acronym: CRAVE
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Pulmonary Hypertension|Right Ventricular Dysfunction|Right Heart Failure
Interventions: DRUG: Empagliflozin|DRUG: Ranolazine
Sponsor: University of Alberta
Collaborators: Canadian Heart Function Alliance|Accelerating Clinical Trial (ACT) Consortium|Ottawa Heart Institute Research Corporation|Team PHenomenal Hope
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2025-12

Summary:
The primary objective of the CRAVE feasibility trial is to assess the feasibility of conducting a larger CRAVE platform trial by performing a randomized trial of 30 participants with pulmonary hypertension and right ventricular dysfunction, comparing empagliflozin or ranolazine plus standard of care to standard of care alone.

Primary Outcome Measures: The proportion of eligible participants approached that consent, (target ≥30%), 16 weeks|The proportion of participants who consent that are randomized, (target ≥90%), 16 weeks|Average enrolment rate of participants per centre per month, (target ≥1 participant per centre/month), 16 weeks|Loss of follow up or death, Loss of follow up (target at 16 weeks ≤5%), 16 weeks|Ability to capture data for secondary outcomes, (target ≥90% completion), 16 weeks
Secondary Outcome Measures: RV function, assessed using echocardiogram, 16 weeks|Natriuretic peptides, (N-terminal pro-B-type natriuretic peptide \[NT-proBNP\]), 16 weeks|Hemodynamics, assessed using right heart catheterization (RHC), 16 weeks|Exercise capacity measured virtually, 6-minute walk distance (6MWD) assessed using the novel Walk.Talk.Track. mobile app, 16 weeks|Exercise capacity measured in-person, assessed using in-person 6-minute walk distance (6MWD), 16 weeks|NYHA functional class, (New York Heart Association Functional Classification for heart failure), 16 weeks|EmPHasis-10, questionnaire used during clinical assessments to determine how pulmonary hypertension affects someone's life, 16 weeks|KCCQ-12, questionnaire for assessing health-related quality of life in chronic heart failure, 16 weeks|EQ-5D-5L, questionnaire provides a simple descriptive profile of a respondent's health state, 16 weeks|Clinical event outcomes, number of clinical events that occur, 16 weeks
Glofitamab Combination With Chidamide in Patients With Recurrent/Refractory DLBCL
NCT Number: NCT06570447
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Diffuse Large B-Cell Lymphoma-Recurrent|Diffuse Large B-Cell Lymphoma-Refractory
Interventions: DRUG: Glofitamab|DRUG: Chidamide
Sponsor: Tianjin Medical University Cancer Institute and Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 22
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-15
Completion Date: 2028-12-31
Locations: Tianjin Cancer Hospital, Tianjin, 300060, China

Summary:
An open-label, single-arm, single-center, phase II clinical trial to evaluate the feasibility, efficacy and safety of Glofitamab Combination with chidamide in patients with recurrent/refractory diffuse large B-cell lymphoma.

Primary Outcome Measures: complete response rate (CR), To assess the complete response rate (CR) at the end of treatment with Glofitamab combination with chidamide., up to the end of 12 cycles of treatment (each cycle is 28 days)
Secondary Outcome Measures: Overall Response Rate (ORR), Objective Response Rate (ORR) is defined as the proportion of subjects who achieve CR or PR after treatment of Glofitamab combination with chidamide., up to the end of 12 cycles of treatment (each cycle is 28 days)|Duration of Response (DoR), The length of time between the achievement of criteria for response to treatment (first documented complete or partial response) and the first documented relapse or progression., up to 2 years|Progression-free survival (PFS), The time from the enrollment of a subject to the occurrence of (in any way) progression of disease or Death for any reason. patients with indeterminate recurrence or Death at the last follow-up, defined as the date of the last Investigation, up to 2 years|OS, The time from subject enrollment to Death caused by any reason. for patients lost to follow-up, the time of the last follow-up; for patients still alive at the end of study, the date of the end of follow-up., up to 2 years
Other Outcome Measures: To identify biomarkers, To identify biomarkers that may predict response to a combination regimen, biomarkers associated with progression to a more severe disease state, biomarkers that are sensitive to the development of Adverse event, biomarkers that provide evidence of the activity of the combination, or biomarkers that may enhance the understanding or understanding of the biology of the disease., up to 2 years
Phase 1b/2a in SLE With Budoputug
NCT Number: NCT06570434
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Systemic Lupus Erythematosus|SLE|B Cells
Interventions: DRUG: budoprutug
Sponsor: Tenet Medicines
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2025-01
Completion Date: 2027-04

Summary:
The purpose of the study is to determine the safety, tolerability, and pharmacokinetics of budoprutug in participants with SLE

Primary Outcome Measures: Number of participants with Adverse events (AEs) and Serious Adverse events (SAEs), Safety assessments of budoprutug include changes in vital signs, clinical findings on physicial exam, electrocardiogram and clinical laboratory findings, Day 1 through Week 24
Secondary Outcome Measures: PK parameters, Area under the maximum observed concentration (AUC), Day 1 through Week 24|PK parameters, Peak concentration (Cmax), Day 1 through Week 24|PK parameters, Time to maximum observed concentration(T-max), Day 1 through Week 24|PK parameters, Terminal half-life, Day 1 through Week 24|PK parameters, Apparent clearance, Day 1 through Week 24|PK parameters, Volume of distribution, Day 1 through Week 24|Immunogenicity, Incidence of anti-drug antibodies (ADA), Day 1 through Week 24|Immunogenicity, Time-course of anti-drug antibodies (ADA), Day 1 through Week 24|Immunogenicity, Titers of anti-drug antibodies (ADA), Day 1 through Week 24
Other Outcome Measures: Exploratory, Change in urine protein creatinine ratio measured in g/g, Day 1 through Week 24|Exploratory, Changes in b cell subsets measured in µL, Day 1 through Week 24|Exploratory, Change over time in Physician's Global Assessment of Disease Activity, Day 1 through Week 24|Exploratory, Change in Systemic Lupus Erythematosus Disease Activity Index, Day 1 through Week 24|Exploratory, Change in Functional Assessment of Chronic Illness Therapy, Day 1 through Week 24|Exploratory, Change in Participant's Global Assessment of Disease Activity, Day 1 through Week 24
Precision Application of Clostridium Butyricm of Clinical Research on Osteoarthritis
NCT Number: NCT06570408
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Osteoarthritis|Knee
Interventions: BEHAVIORAL: Western Ontario and McMaster University Osteoarthritis Index (WOMAC)|BEHAVIORAL: Visual Analogue Scale (VAS)|DIAGNOSTIC_TEST: Kellgren Lawrence Grading Scale (KL score)|BEHAVIORAL: Quality of Life Questionnaires and Assessments:
Sponsor: China Medical University Hospital
Collaborators: Grape King Bio Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 83
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2023-04-01
Completion Date: 2024-02-29
Locations: China Medical University Hospital, Taichung, North District, 404327, Taiwan

Summary:
Osteoarthritis (OA) is a common joint disease worldwide. The main symptom is that the mechanical wear of the cartilage in the joint and leads to the abnormal proliferation of the surrounding bone and synovial tissue with the chronic inflammation and the narrowing of the joint cavity. The prevalence of OA is increasing due to population increasing and aging, and there are currently about 400 million OA patients in worldwide. The treatment methods of osteoarthritis are mainly divided into medicine and non-medicine therapy. The major function of medicine therapy is to reduce pain and the arthroscopic surgery (arthroscopy) is main treatment of non-medicine therapy. Thus, in this project the investigators will mainly focus on the precise application of Clostridium butyricum on OA and the investigators' previous study successfully demonstrated the therapeutic effects of Clostridium butyricum on OA animal model. Therefore, will test the clinical effects of OA patient with Clostridium butyricum treatment, and whether it is also possible to improve the symptom of OA patients.

Primary Outcome Measures: Western Ontario and McMaster University Osteoarthritis Index (WOMAC), used in the evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales. The maxima score is 105, which have more high score mean more severe level of osteoarthritis., Day 0, 7, 14, 30, 60, 90|Visual Analogue Scale (VAS), one of the pain rating scales used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms. The minima score is 0. The maxima score is 10 for each knee. the higher score mean patient feel more pain on knee joint., Day 0, 7, 14, 30, 60, 90
Evaluating Taste and Health Messaging in Short Nutrition Education Videos to Improve Diet Quality
NCT Number: NCT06570382
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Behavior, Health
Interventions: OTHER: Videos: Taste messaging focused|OTHER: Videos: Health messaging focused
Sponsor: Penn State University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1000
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: OTHER
Start Date: 2024-09
Completion Date: 2024-10

Summary:
The purpose of this study is to develop and evaluate the effectiveness of taste vs. health messaging using nutrition education videos. The nutrition education videos teach Americans the benefits of using herbs and spices to increase diet quality. The investigators aim to test the effectiveness of 10 short videos (5 taste-based messaging and 5 health-based messaging) that translate previous findings of how spices can improve diet quality. These objectives will be pursued via the following hypothesis:

Hypothesis 1: Are taste messaging videos more effective in improving consumer interest, knowledge, and confidence in using herbs and spices compared to health messaging focused videos? Hypothesis 2: Will consumers rate the taste messaging videos higher for liking, engagement, and acceptability of herbs and spices compared to health messaging focused videos?

Primary Outcome Measures: Ratings for interest, knowledge, confidence variables in using herbs and spices in cooking from before to after exposure to nutrition education videos using Likert scales from 0-5 with 0 being strongly disagree to 5 being strongly agree., Participants will provide feedback on the taste and health-based messaging videos which will be used to create more effective messaging in the subsequent video development., Within 5 minutes of watching the nutrition education videos
Secondary Outcome Measures: Ratings for liking, engagement, and acceptability of using herbs and spices in cooking from before to after exposure to nutrition education videos using Likert scales from 0-5 with 0 being strongly disagree to 5 being strongly agree., Participants will provide feedback on the taste and health-based messaging videos which will be used to create more effective messaging in the subsequent video development., Within 5 minutes of watching the nutrition education videos
Assessment of Depression Levels in Elderly Patients With an Orthopedic Fracture Compared to Patients After a Stroke.
NCT Number: NCT06570356
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Depression|Old Age; Debility|Stroke|Fractures, Bone
Interventions: DIAGNOSTIC_TEST: Geriatric Depression Scale - 15
Sponsor: Shmuel Harofeh Hospital, Geriatric Medical Center
Sex: ALL
Age: OLDER_ADULT
Enrollment: 400
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2022-02-02
Completion Date: 2024-11-13
Locations: Shmuel Harofe Geriatric Medical Center, Be'er Ya'aqov, 70300, Israel

Summary:
Depression is common among elderly patients hospitalized due to acute conditions like strokes or osteoporotic fractures. It has significant impacts on quality of life, hospitalization rates, and mortality. Although studies have explored depression and its assessment, most focus on non-geriatric or ambulatory populations. This study examined depressive symptoms in elderly patients after a stroke or fracture. We assessed all patients for depression symptoms using the validated Geriatric Depression Scale - 15 item (GDS-15) and searched for contributing factors in each condition.

Primary Outcome Measures: Depression symptoms prevalence assessed by the Geriatric Depression Scale-15, Depression symptoms prevalence during hospitalization of patients after stroke or orthopedic fractures., on recruitment and during hospitalization (avarege of about 14 days)
Adult HMO Supplementation and the Gut Microbiome
NCT Number: NCT06570330
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Healthy Adults
Interventions: DIETARY_SUPPLEMENT: SuperHMO|DIETARY_SUPPLEMENT: Non-GMO corn Maltodextrin, Rapid Absorption
Sponsor: Seeding, Inc DBA Tiny Health
Collaborators: Mellitas Health Foods, LLC (DBA Layer Origin Nutrition)
Sex: ALL
Age: ADULT
Enrollment: 32
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-09
Completion Date: 2025-07
Locations: Seeding Inc, Rockville, Maryland, 20850, United States

Summary:
The goal of this study is to assess the impact of Layer Origin's SuperHMO prebiotic formulation on the healthy adult gut microbiome. Over the course of 30 days, intervention participants will take SuperHMO prebiotic formulation daily. Control participants will take a placebo daily. We will measure all participants\&#39; gut microbiome using a gut health test before taking SuperHMO prebiotic or placebo and after 30 days of taking the supplement. We hypothesize that taking the SuperHMO prebiotic will improve gut health measurements such as the potential to produce short-chain fatty acids.

Primary Outcome Measures: Quantitative changes in the relative abundance of key bacterial taxa, The investigators will specifically measure the difference in Bifidobacterium spp., Akkermansia spp., Eubacterium rectale-Clostridium Coccoides group, and Faecalibacterium prausnitzii, at baseline and at 30 days., 30 days|Detection of presence of specific HMO digestion genes, Comparing baseline and again after 30 days of taking the study product to assess potential changes in HMO metabolism by the gut microbiota., 30 days|Assess Changes in the diversity metrics of the Gut Microbiome, Measuring the change in alpha diversity (e.g., Shannon index) and beta diversity metrics (e.g., Bray-Curtis dissimilarity) to evaluate overall microbial diversity and community structure shifts between baseline and at 30 days., 30 days|Evaluate Changes in Metabolic Markers, Assess the change in SCFA (namely acetate, propionate, and butyrate) production potential from baseline to 30 days., 30 days|Evaluate Changes in Inflammation Markers, Evaluation of the change in gut inflammatory markers (e.g., hexa-LPS Index, mucus degradation species, hydrogen sulfide levels) between at baseline and at 30 days to investigate potential anti-inflammatory effects of HMO supplementation., 30 days
Nintedanib for the Prevention of Radiation Pneumonia in Unresectable NSCLC
NCT Number: NCT06570317
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: NSCLC|Nintedanib|Radiation Pneumonitis
Interventions: DRUG: Nintedanib
Sponsor: Second Hospital of Shanxi Medical University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-24
Completion Date: 2026-06-30
Locations: Jincheng General Hospital, Jincheng, Shanxi, China|Jinzhong third people's hospital, Jinzhong, Shanxi, China|Frist Hospital of Shanxi Medical University, Taiyuan, Shanxi, China|Second Hospital of Shanxi Medical University, Taiyuan, Shanxi, China|Shanxi Bethune Hospital, Taiyuan, Shanxi, China|Shanxi Hospital of Traditional Chinese Medicine, Taiyuan, Shanxi, China|TISCO General Hospital, Taiyuan, Shanxi, China

Summary:
This study is aimed at patients with unresectable NSCLC who take nintedanib during sequential radiotherapy to explore the incidence of radiation pneumonitis above grade 2 in the nintedanib combined with radiotherapy mode and observe safety. And will further explore the progression-free survival (PFS) and overall survival (OS) of patients treated with nintedanib in combination with radiotherapy and immunotherapy.

Primary objective: To evaluate the safety of nintedanib combined with sequential radiotherapy in patients with unresectable NSCLC and the incidence of radiation pneumonitis above grade 2. Secondary objective: To evaluate the changes in lung function, progression-free survival (PFS) and overall survival (OS) in patients with unresectable NSCLC after nintedanib combined with sequential radiotherapy.

Patients need to receive induction therapy, chemotherapy and/or immunotherapy for at least one cycle. Then they will receive sequential radiotherapy and nintedanib for 6 months. Finally, they will receive immunotherapy maintenance therapy for 16 cycles.

Primary Outcome Measures: security, Incidence of adverse events, Up to 2 years|Incidence rate of radiation pneumonia, Incidence of grade 2 and above radiation pneumonia, Up to 2 years
Secondary Outcome Measures: Pulmonary function index, Changes of pulmonary function indexes（FEV1, Dlco）, Up to 2 years|Progression-free Survival (PFS), From the date of enrollment to the date of disease progression, Up to 2 years|Overall Survival (OS), From the date of enrollment until death by any cause or last follow-up, Up to 2 years
Prevention of Retained Items iN Childbirth Environment and Surgical Sites
NCT Number: NCT06570304
Acronym: PRINCESS
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Retained Surgical Items
Interventions: PROCEDURE: iCount Device
Sponsor: The Royal Wolverhampton Hospitals NHS Trust
Collaborators: Innovate UK
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-12
Completion Date: 2026-05

Summary:
To evaluate the user confidence in the confirmation of correct counts using a novel device and to assess clinical usability of the device during surgery.

Primary Outcome Measures: Understanding user experience/usability factors, User responses on Likert scale for the various usability factors such as user confidence in the accuracy of counts, functional aspects and ease of use collected with an online software-assisted survey., 12 months|How the device sits within the current system, The purpose is to obtain user centred narratives and a rich qualitative data. Semi-structured interviews of staff will be conducted via a virtual platform or in a safe face-to-face manner. These will be recorded with a dictaphone recording device or Microsoft teams auto-transcription, 12 months
Allogenic Adipose-Derived Mesenchymal Progenitor Cells for the Treatment of Knee Osteoarthritis
NCT Number: NCT06570291
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Knee Osteoarthritis
Interventions: DRUG: Mesenchymal progenitor cells|DRUG: Sodium Hyaluronate Injection
Sponsor: Wuxi Cellular Biopharmaceutical Group Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 488
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-10
Completion Date: 2028-12

Summary:
Evaluate the efficacy and safety of Allogenic Adipose Tissue-Derived Mesenchymal Progenitor Cells Therapy

Primary Outcome Measures: WOMAC score, The Western Ontario and McMaster Universities Osteoarthritis Index;0-96 points；96 points mean a worse outcome,will be tested at 24 weeks after the first injection, 24 weeks
Secondary Outcome Measures: MRI quantitative analysis of articular cartilage, Magnetic Resonance Imaging analysis of articular cartilage, will be tested at 48 weeks after the first injection, 48 weeks|WOMAC Score, The Western Ontario and McMaster Universities Osteoarthritis Index;0-96 points；96 points mean a worse outcome, will be tested at 4、12、24、36、48、60、72、84 and 96 weeks after the first injection, 4、12、24、36、48、60、72、84、96 weeks|VAS Score, Visual Analogue Scale/Score；0-10 points；10 points mean the worse outcome,will be tested at 4、12、24、36、48、60、72、84 and 96 weeks after the first injection, 4、12、24、36、48、60、72、84、96 weeks|SF-36, The Medical Outcomes Study 36-Item Short-Form Health Survey;0-100 points；100 points mean a better outcome, will be tested at 4、12、24、36、48、60、72、84 and 96 weeks after the first injection, 4、12、24、36、48、60、72、84、96 weeks|MRI quantitative analysis of articular cartilage, Magnetic Resonance Imaging analysis of articular cartilage, will be tested at 24 and 96 weeks after the first injection, 24 weeks and 96 weeks|Whole-Organ Magnetic Resonance Imaging Score, Whole-Organ Magnetic Resonance Imaging Score(WORMS) of the knee; 0-332points; 332 points means the worst outcome; will be assessed at 24、48 and 96 weeks, 24、48 and 96 weeks|mJSW, Minimum joint space width (mJSW) of the knee, will be measured at baseline and 96 weeks, 96 weeks|Adverse Events and Serious Adverse Events, AE and SAE, will be assessed within the 96 week time span, Day 0 to 96 weeks|Physical examination, Height and weight will be tested and combined to report BMI in kg/m\^2at Day 0 and week 1、2、3、4、12、24、36、48、60、72、84、96, Day 0、week 1、2、3、4、12、24、36、48、60、72、84、96
RES-SAFE (Resorption, Safety, and Efficacy of Absorbable Collagen Membrane)
NCT Number: NCT06570265
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Guided Bone Regeneration
Interventions: DEVICE: GBR membrane
Sponsor: Hyundai Bioland Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-12-16
Completion Date: 2026-06-30

Summary:
The clinical study aims to assess the long-term safety and efficacy of the interventional medical device. The clinical study will enrol up to 50 patients aged 18 years and older, who meet specific inclusion and exclusion criteria designed to ensure patient safety and reliable data collection.

Primary Outcome Measures: Assessment of collagen membrane's - efficacy and safety., Remnants of the collagen membrane, new blood vessels formation, and the absence of inflammation in histological results., 6 months after intervention
Secondary Outcome Measures: Complication rate, Complication rate assessed as the ratio patients with any complication to all patients., 7 days and 6 months after intervention|Change in bone dimensions, % change in horizontal bone dimensions at three subcrestal levels assessed via CBCT., Baseline, 6 and 12 months after intervention|VAS scale, Scale VAS for pain, swelling, bleeding. VAS scale will be used to assess satisfaction of the intervention., On the day of intervention and after 1, 2, 3 days. Satisfaction - on the day of intervention.|Assessment of collagen membrane's - safety., Number of (S)AEs., From the beginning till the end.