pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Prospective Real-World Study of HAIC With Raltitrexed or 5-Fluorouracil for the Treatment of Hepatocellular Carcinoma
NCT Number: NCT06519578
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hepatocellular Carcinoma
Interventions: DRUG: hepatic artery infusion chemotherapy
Sponsor: RenJi Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1115
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2027-07-31
Locations: Deparment of Liver Surgery, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, 200127, China|Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, 200127, China

Summary:
This study is a prospective cohort study aimed at comparing the efficacy and safety of RALOX-HAIC and FOLFOX-HAIC in the treatment of hepatocellular carcinoma. It is planned to enroll 1115 patients with BCLC Stage B or C hepatocellular carcinoma, who will receive FOLFOX-HAIC or RALOX-HAIC treatment.

Primary Outcome Measures: Progression-Free Survival (PFS), Defined as the time from the date of enrollment to the date of any recorded tumor progression or death from any cause., 2 years|Time to Progression (TTP), Defined as the time from the date of enrollment to the date of any recorded tumor progression., 2 years|adverse events, Incidence and grading of adverse events (AE) and serious adverse events (SAE)., 2 years
Secondary Outcome Measures: Overall Survival (OS), Defined as the time from the start of patient enrollment to death from any cause., 2 years|Objective Response Rate (ORR), Defined as the percentage of subjects with the best response of CR or PR among all subjects in the analysis dataset, from the first dose to the first record of disease progression or death from any cause (whichever occurs first), using the response evaluation criteria in solid tumors (RECIST 1.1 and mRECIST standards)., 2 years|Disease Control Rate (DCR), Defined as the percentage of subjects with the best response of CR, PR, or SD among all subjects in the analysis dataset, from the first dose to the first record of disease progression or death from any cause (whichever occurs first), using the response evaluation criteria in solid tumors (RECIST 1.1 and mRECIST standards)., 2 years
Safety and Efficacy of PRG-1801 in Recurrent/Refractory Immune Thrombocytopenia (ITP)
NCT Number: NCT06519565
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: EARLY_PHASE1
Conditions: Immune Thrombocytopenia
Interventions: DRUG: PRG-1801
Sponsor: Wuhan Union Hospital, China
Collaborators: Shenzhen Pregene Biopharma Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 9
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-15
Completion Date: 2027-08-15
Locations: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, 430022, China

Summary:
This is a single center, open-label, 3+3 dose escalation, early phase 1 study to evaluate the safety, tolerability, and preliminary efficacy of PRG-1801 for patients with relapsed/refractory immune thrombocytopenia (ITP).

Primary Outcome Measures: Incidence of Treatment-related Adverse Events, Therapy-related adverse events (AE), including severe adverse events (SAE) and laboratory outliers with clinical significance, will be recorded and assessed according to the Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0), Up to 28 days post-infusion|The safe dosage for a single infusion of PRG-1801, The safe PRG-1801 infusion dosage for ITP patients will be evaluated by comprehensively assessing the complete response (CR) rate and the incidence of adverse events (AEs)., Up to 28 days post-infusion
Secondary Outcome Measures: Complete response (CR) rate or Response (R) rate of administering PRG-1801 in the treatment of relapsed/refractory ITP, CR is defined as platelet count ≥100×10\^9/L. R is defined as platelet count ≥30×10\^9/L and at least doubling from baseline, without active bleeding., At Day 28, Month 2, Month 3, Month 6,Month 9, Month 12, Month 18, and Month 24 post-infusion|The proliferation rate and persistence time of CAR-T cells, Evaluation of CAR-T cell expansion and persistence through measurement of CAR copy number in peripheral blood, At baseline, Day 2, Day 6, Day 10, Day 14, Day 21, Day 28, Month 2, Month 3, Month 6, Month 9, Month 12, Month 18, and Month 24 post-infusion|Concentration of serum sBCMA, immunoglobulins (IgG, IgM, IgA), and anti-platelet glycoprotein autoantibodies, Pharmacodynamics of PRG-1801 were assessed by evaluating changes from baseline in serum sBCMA, immunoglobulins (IgG, IgM, IgA), and anti-platelet glycoprotein autoantibodies, At baseline, Day 28, Month 2, Month 3, Month 6,Month 9, Month 12, Month 18, and Month 24 post-infusion
Other Outcome Measures: Evaluation of incidence of Treatment-related Adverse Events and Complete response rate or Response rate of repeated PRG-1801 infusion, The evaluation metrics are the same as those for the primary and secondary outcome measures of single infusion., Up to 24 months after second infusion
A Clinical Study Evaluating the Safety, Tolerability, and Initial Efficacy of JWK008 in Patients With Mucopolysaccharidosis Type I
NCT Number: NCT06519552
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Mucopolysaccharidosis Type I
Interventions: GENETIC: JWK008 Single intravenous infusion administration
Sponsor: West China Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 6
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-22
Completion Date: 2029-06-22
Locations: West China Hospital, Sichuan Universit, Chengdu, Sichuan, 610041, China

Summary:
This study is a single-center, single-arm, non-randomized, open-label, non controlled, dose-escalation, prospective clinical trial designed to assess the safety, tolerability, and preliminary efficacy of JWK008 injection in patients with MPS I.

Primary Outcome Measures: adverse events, Adverse events defined as the number of participants with adverse events according CTCAE 5.0, 5 years
Secondary Outcome Measures: IDUA enzyme activity in blood and cerebrospinal fluid, Changes in IDUA activity in blood and cerebrospinal fluid before and after treatment are detected by laboratory testing., 5 years|GAG levels in blood, urine, and cerebrospinal fluid, Changes in GAG levels in blood, urine, and cerebrospinal fluid before and after treatment are detected by laboratory testing., 5 years|Six-Minute Walk Test, The distance that the patient could withstand the fastest walking distance on flat ground within 6 minutes before and after treatment was measured, 5 years|Range of the joint motion(JROM) testing by measuring ruler, A measuring ruler was used to detect changes in the participant's range of the joint motion before and after treatment, 5 years|Liver and spleen size were detected by CT, Changes in liver and spleen size were detected by CT, 5 years|Vector shedding, As measured by vector concentration (quantitative polymerase chain reaction to JWK008 deoxyribonucleic acid ) in CSF, serum, and urine, 5 years
Exploratory Clinical Study of SHR-0302 and SHR-2554 in Patients With Relapsed/Refractory Peripheral T Cell Lymphoma
NCT Number: NCT06519526
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Relapsed/Refractory Peripheral T Cell Lymphoma
Interventions: DRUG: SHR-0302|DRUG: SHR-2554
Sponsor: Fudan University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 25
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-12
Completion Date: 2027-08-31
Locations: Fudan University Shanghai Cancer Center, Shanghai, 200032, China

Summary:
This is an open-label, prospective and exploratory clinical study to evaluate the efficacy and safety of JAK inhibitor SHR-0302 in combination with EZH2 inhibitor SHR-2554 in patients with R/R PTCL. The study plans to enroll approximately 25 patients. 6-12 patients will receive SHR-0302 monotherapy and SHR-0302+SHR-2554 combination therapy in the safety run-in phase. According to the safety observed, the investigators discuss and decide to select a dose group to explore the efficacy and safety. 13 patients may be enrolled in the expansion phase.

Primary Outcome Measures: Incidence and severity of AEs and SAEs, Incidence and severity of AEs and SAEs will be recorded and graded according to the CTCAE 5.0., The first dose until 30 days after last dose|Objective response rate (ORR), Percentage of participants achieving complete response (CR) and partial response (PR) according to Lugano 2014 criteria., 24 months
Secondary Outcome Measures: Disease Control Rate (DCR), Percentage of patients achieving complete response (CR) and partial response (PR) and stable disease (SD) according to Lugano 2014 criteria., 24 months|Duration of Response (DoR), Defined as the time from the date of the first CR or PR to the date of the first PD or death due to any cause, whichever occurs first., 24 months|Progression-free Survival (PFS), Defined as the time from the date of the first dose to the first documented PD or death due to any cause, whichever occurs first., 24 months|Overall Survival (OS), Defined as the duration of time from start of treatment to death from any cause., 24 months
Laughter Yoga, Stress Level and Burnout Level
NCT Number: NCT06519513
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Burnout, Psychological|Stress|Laughter
Interventions: OTHER: Laughter yoga
Sponsor: Kırklareli University
Sex: FEMALE
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: OTHER
Start Date: 2024-09-25
Completion Date: 2025-07-30
Locations: Kırklareli University, Kırklareli, Turkey

Summary:
The positive interaction between personal and business life results in the health of the healthcare personnel and the success of the institution. Burnout, which occurs as a result of a crisis in an individual's working life, manifests itself as fatigue, lack of energy, feeling inadequate in the professional role and lack of confidence.

Laughter, which helps people to endure stressful situations or processes, improves a person's problem-solving ability by reducing depression and increasing insight. For this reason, laughter reduces a person's exposure to negative environmental cues and helps them with self-control. Laughter, a positive emotion, appears to be a useful and healthy way to cope with stress. The aim of the research to be conducted is to evaluate the effect of laughter yoga on the stress and burnout levels of midwives.

Primary Outcome Measures: Burnout Scale, Developed by Pines and Aronson (1988) to be used on non-professional groups as well as all professional groups, the TOS consists of twenty-one items prepared as self-report on a seven-point scale to evaluate the physical, emotional and mental exhaustion level of individuals., between 2 to 4 weeks|Perceived Stress Scale-10, It measures the extent to which situations in a person's life are evaluated as stressful. Scores of 0-13 are considered low stress. Scores between 14 and 26 are considered moderate stress. Scores between 27 and 40 are considered high perceived stress., between 2 to 4 weeks
Secondary Outcome Measures: General Health Survey-28, It is a screening test created by the individual to detect mental health problems encountered in society and non-psychiatric clinical environments. A minimum of 0 and a maximum of 28 points can be obtained from the scale. A higher total score increases the likelihood of psychological problems., between 2 to 4 weeks
Generation of Organoids of Neuroendocrine Neoplasms of the Gastro-Entero-Pancreatic Tract Obtained From Patients Undergoing Surgery
NCT Number: NCT06519500
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Gastro-entero-pancreatic Neoplasms
Sponsor: Regina Elena Cancer Institute
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-03-03
Completion Date: 2026-11-03
Locations: "Regina Elena" National Cancer Institute, Rome, 00144, Italy

Summary:
Observational, prospective, feasibility pilot study of the preparation of organoids starting from tumor tissue and surrounding healthy tissue, collected during surgery, performed according to standard clinical practice.

Primary Outcome Measures: Set up of at least 10 organoid cultures, The organoids will be generated from tumor tissue samples and surrounding healthy tissue obtained from patients affected by GEP-NEN (who meet the inclusion/exclusion criteria) collected, according to clinical practice, during tumor resection surgery. Only the excess material after carrying out all the investigations necessary for the correct diagnosis histological analysis can be used for the purpose of the project, 42 months
Effect of Elastic Chest Compression on Functional Exercise Capacity and Respiratory Performance in Patients With COPD
NCT Number: NCT06519474
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: COPD|Hyperinflation
Interventions: DEVICE: Theraband chest compression
Sponsor: National Taiwan University Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 17
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-10
Completion Date: 2027-05-31
Locations: National Taiwan University Hospital Hsinchu Branch, Hsinchu, Taiwan

Summary:
The goal of this clinical trial is to investigate the effects of elastic chest compression on functional exercise capacity and respiratory performance of patients with COPD. The main questions it aims to answer are:

Is there difference in functional exercise capacity and respiratory performance without or with the use of elastic upper chest compression? Is there difference in functional exercise capacity and respiratory performance between the use of elastic upper chest compression and elastic lower chest compression?

Participants will:

Be evaluated under three conditions on three different days: without elastic compression, with upper chest compression, and with lower chest compression, with the order of compression application randomly assigned.

The functional capacity and respiratory muscle performance of all patients will be evaluated.

The days for evaluation will be at least three days apart from each other.

Primary Outcome Measures: Functional exercise capacity, 6 minute walk test measured in meters, up to 3 weeks|Respiratory muscle performance, Maximum inspiratory (MIP) and expiratory pressures (MEP) in mmH2O, up to 3 weeks|Respiratory flow performance, peak inspiratory (PIFR) and expiratory flows (PEFR) in liter per minute, up to 3 weeks
A Family-centered Teaching Model in Pediatric Occupational Therapy Internship
NCT Number: NCT06519461
Acronym: FACTmodel
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Internship and Residency
Interventions: BEHAVIORAL: Family-centered teaching model
Sponsor: Jung-Jiun Shie
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 138
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2018-10-17
Completion Date: 2021-10-16
Locations: Kaohsiung Chang Gung Memorial Hospital, Kaohsiung, Taiwan|Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan

Summary:
Most of the occupational therapy students received the knowledge of family-centered services when they studies in universities, however, the experience of family-centered practice during internships is limited. The purpose is to design a family-centered teaching model and to examine the effects of the teaching model. The positive results showed on students' perceptions and children's occupational performance.

Primary Outcome Measures: The 49 interns' family-centered behaviors including four types of behaviors were measured by the self-reported questionnaire of "Measure of Processes of Care for Service Providers", The "Measure of Processess of Care-Service Provider" can measure four types of famly-centered behaviors such as (1) Showing Interpersonal Sensitivity; (2) Providing General Information; (3) Communicating Specific Information; (4) Treating People Respectfully. The questionnire is a reliable and valid self-reported questionnaire The questionnaire comprises 27 items in which each item has a 7-point Likert scale from 1 (not at all) to 7 (to a very great extent)., at the beginning and the end of the internship; an average of 12 weeks|The performance and satisfaction scales of occupational performance for 45 children in both groups were assessed by a semi-structured interview questionnaire of "Canadian Occupational Performance Measure" reported by their caregivers., The occupational performance assessed by the "Canadian Occupational Performance Measure" includes the performance on the self-care, productivity, and leisure activities. The caregiver is asked to identify the activities that is needed and difficult to be completed by their children. The importance of the five most necessary and difficult activities are scored by each caregiver on a ten-point scoring scale. The performance and satisfaction of the five most necessary, difficult and important activities are scored by each client and caregiver on a 10-point scale. The scores of performance or satisfaction scale were aggregated on the five most necessary, difficult and important activities., at the beginning and the end of the internship; an average of 12 weeks
Reducing Non-Alcoholic Steatohepatitis
NCT Number: NCT06519448
Acronym: RedNASH
Status: ENROLLING_BY_INVITATION
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Non-alcoholic Steatohepatitis|Liver Diseases|Diabetes Mellitus, Type 2|Fibrosis, Liver
Interventions: DRUG: Empagliflozin 10 miligrams (mg)
Sponsor: Military University Hospital, Prague
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-04-01
Completion Date: 2027-12-31
Locations: Central Military Hospital, Prague, 16902, Czechia

Summary:
The goal of this clinical trial is to learn if empagliflozin works to treat non-alcoholic steatohepatitis in adults. The objectives are:

Primary Objective To evaluate the change in histological grading and staging of NASH in patients with confirmed non-alcoholic steatohepatitis (NASH) treated with empagliflozin for a duration of 48 weeks.

Secondary Objective To evaluate the change in findings from non-invasive liver elasticity measurements, laboratory tests, and anthropometric assessments after 48 weeks of empagliflozin administration.

Participants will:

Take empagliflozin every day for 12 months. Visit the clinic according to a protocol at weeks: 1, 2, 4, 12, 24, 36, 48 Visits includes checkups and tests (blood count, basic biochemistry, glycosylated hemoglobin, anthropometry, non-invasive liver stiffness measurement).

Primary Outcome Measures: Change in histological activity after 12-month treatment with empagliflozin, Non-alcoholic Fatty Liver Disease Activity Score (NAS) change after intervention. The NAS can range from 0 to 8 and is calculated by the sum of scores of steatosis (0-3), lobular inflammation (0-3) and hepatocyte ballooning (0-2). In patients with NAFLD, NAS score of ≥ 5 strongly correlated with a diagnosis of "definite NASH" whereas NAS ≤ 3 correlated with a diagnosis of "not NASH"., 12 months
Secondary Outcome Measures: Change of liver stiffness, Liver stiffness measured in kilopascals (kPa) by transient elastography at baseline and after intervention., 12 months|Change of liver steatosis, Continuous attenuation parameter measured in decibels per meter (dB/m) at baseline and after intervention., 12 months|Anthropometry (body weight), Measurement of body weight measured in kilograms (kg) and change from baseline., 12 months|Anthropometry (height), Measurement of body height measured in metres (m) to calculate Body Mass Index (BMI)., 12 months|Anthropometry (BMI), Change in BMI from baseline (measured in kg/m\^2)., 12 months|Liver functional tests, Change in activity liver functional tests (LFT) all measured in microkatals per liter (ucat/L) from baseline.

These tests comprise:

Alanine transaminase (ALT) Aspartate transaminase (AST) Gamma-glutamyl transferase (GGT) Alkaline phosphatase (ALP), 12 months|Bilirubin level, Change in activity concentration of bilirubin measured in micromoles per liter (umol/L) from baseline., 12 months|Lipidogram, Change in cholesterol, LDL cholesterol, HDL cholesterol, triglycerides (measured in mmol/L) from baseline., 12 months
Non-invasive Venous Air Plethysmography Assessment of Venous Hemodynamics in Patients Suspected Deep Venous Obstruction Used in Conjunction With Intermittent Pneumatic Compression.
NCT Number: NCT06519435
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Deep Vein Thrombosis
Interventions: DEVICE: Mayo Dopplex ABIlity|DEVICE: Intermittent Pneumatic Compression (IPC)
Sponsor: Mayo Clinic
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 500
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-10
Completion Date: 2025-12

Summary:
The purpose of this research is to measure changes in venous blood flow with an air-filled bladder under an intermittent pneumatic compression device cuff (used to prevent deep venous thrombosis) or venous diagnostic device cuff (used to detect deep venous thrombosis). The devices being used in the study are investigational and not FDA-cleared.

Primary Outcome Measures: Mayo Dopplex ABllity device Venous hemodynamic pressure, Venous hemodynamic pressure to be measured from both the recumbent and sitting positions using the Mayo Dopplex ABllity device. Measured as mmHg., Baseline|Intermittent Pneumatic Compression device Venous hemodynamic pressure, Venous hemodynamic pressure to be measured from both the recumbent and sitting positions using the IPC device. Measured as mmHg., Baseline
Comparison of Bone Graft and Photodynamic Therapy in Class II Furcation
NCT Number: NCT06519409
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Furcation Defects
Interventions: PROCEDURE: Open flap debridement and photodynamic therapy
Sponsor: Krishnadevaraya College of Dental Sciences & Hospital
Sex: ALL
Age: ADULT
Enrollment: 14
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2016-04-08
Completion Date: 2017-05-11
Locations: Dr. Prabhuji MLV, Bengaluru, Karnataka, 562157, India

Summary:
This is a surgical comparative clinical trial which aims to assess class II buccal furcation defects treated with Xenograft alone or preceded by antimicrobial photodynamic therapy.

Primary Outcome Measures: percentage of bone fill, amount of bone formation, 9 months
Secondary Outcome Measures: Clinical efficacy, clinical attachment level, 9 months
Achilles Tendon and Balance in Prediabetes
NCT Number: NCT06519396
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: PreDiabetes
Interventions: DEVICE: ultrasonography evaluation|DEVICE: tetrax device evaluation
Sponsor: Eskisehir Osmangazi University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 90
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-02-01
Completion Date: 2023-11-30
Locations: Fulya Bakilan, Eskisehir, Turkey

Summary:
The aim was to evaluate the Achilles tendon size and static and dynamic balance, as well as the role of Achilles tendon on balance in prediabetes. A total of 96 patients were divided into three groups: 1)the control group, consisting of patients without diabetes; 2)the prediabetes group; 3)the diabetes mellitus group. Ultrasonographic measurements of Achilles tendon sizes were performed. Dynamic balance was assessed using the Berg Balance Scale, static balance was assessed.The Self-Leeds Assessment of Neuropathic Symptoms and Signs was utilized to identify neuropathic pain.

Primary Outcome Measures: ultrasonographic measurement of achilles tendon, measurements of thickness (anterior-posterior), width (medial-lateral), and area of achilles tendon at the level of the medial malleolus were made, baseline|balance measurement, Static balance measurement were made with Tetrax Device, baseline
Comparison Of Implant Position Achieved With Fully Guided Versus Partially Guided Implant Placement
NCT Number: NCT06519383
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Implant Placement
Interventions: PROCEDURE: guided implant surgery
Sponsor: Krishnadevaraya College of Dental Sciences & Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-07
Completion Date: 2025-08

Summary:
Globally implant therapy is currently accepted as a predictable, viable and successful option to replace missing teeth. Ample studies have shown excellent survival and clinical success rates of dental implants for various indications.The correct three-dimensional (3D) positioning of an implant is considered a prerequisite for an optimal outcome.Computer assisted implant surgery maybe beneficial in patients with limited bone and proximity to anatomic structures.Therefore, the aim of this randomized controlled clinical trial is to investigate the accuracy of implant position achieved with static CAIP(Computer Assisted Implant Placement) and to compare this with the accuracy of conventional cast based partially guided implant placement(cPGIP).

Primary Outcome Measures: Accuracy of implant position, 3D deviation of planned implant position to final implant position, 2 weeks
FDA018-ADC vs Investigator's Choice Chemotherapy to Treat Locally Advanced, Recurrent or Metastatic Triple-negative Breast Cancer
NCT Number: NCT06519370
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Triple Negative Breast Cancer
Interventions: DRUG: FDA018-ADC|DRUG: Eribulin|DRUG: Capecitabine|DRUG: Gemcitabine|DRUG: Vinorelbine
Sponsor: Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 350
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-09
Completion Date: 2027-06-20

Summary:
This is a Phase III, randomized, open-label, 2-arm, multicentre, international study assessing the efficacy and safety of FDA018-ADC compared with Investigator's Choice Chemotherapy(ICC) in participants with locally recurrent inoperable or metastatic Triple-negative Breast Cancer(TNBC) who are resistant to, or recurring during or after taxane therapy.

Primary Outcome Measures: Progression-free survival (PFS), PFS is defined as time from randomisation until progression per RECIST 1.1 as assessed by BICR, or death due to any cause, up to 24 months|Overall Survival (OS), OS is defined as the time from randomisation until the date of death due to any cause., up to 24 months
Secondary Outcome Measures: Progression-Free Survival (PFS) by Investigator assessment, PFS is defined as time from randomisation until progression per RECIST 1.1 as assessed by the investigator, or death due to any cause, up to 24 months|Objective Response Rate (ORR), ORR is defined as the proportion of participants who have a confirmed CR or PR, as determined by BICR/investigator assessment, per RECIST 1.1., up to 24 months|Duration of Response Duration of Response (DoR), DoR is defined as the time from the date of first documented confirmed response until date of documented progression per RECIST 1.1, as assessed by BICR/investigator assessment or death due to any cause., up to 24 months|Disease Control Rate (DCR), DCR is defined as the proportion of patients who have achieved complete response，partial response and stable disease assessed by BICR/investigator according to RECIST v 1.1, up to 24 months|Incidence of Treatment-Emergent Adverse Events, Incidence and severity of AEs and SAEs (graded by CTCAE version 5.0)., up to 24 months|Immunogenicity of FDA018-ADC, Presence of ADAs for FDA018-ADC, up to 24 months
A Single-center, Self-controlled, Prospective Case Series Pilot Study to Assess the Effect of Lamivudine (3TC) on Neurocognitive Impairment Biomarkers and Type-I IFN (Interferon)-Stimulated Genes in the Plasma of Patients With Mild Cognitive Impairment (MCI)
NCT Number: NCT06519357
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Mild Cognitive Impairment
Interventions: DRUG: Lamivudine 300 MG
Sponsor: Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
Collaborators: IrsiCaixa
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 25
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2025-06
Locations: Germans Trias I Pujol Hospital, Badalona, Barcelona, 08916, Spain

Summary:
To assess the ability of lamivudine to lower the levels of neurocognitive impairment biomarkers in the plasma of patients with MCI and positive AD biomarkers in a 24 weeks-treatment period.

To assess the incidence, nature, and severity of Treatment Emergent Adverse Events (TEAE).

Primary Outcome Measures: To assess the ability of lamivudine to lower the levels of neurocognitive impairment biomarkers in the plasma of patients with MCI and positive AD biomarkers in a 24 weeks-treatment period., Percentage of change of pTau-217, total Tau, NfL, GFAP, Aβ42, Aβ40, and ratio in plasma from baseline visit to week 24 visit., 24 weeks|To assess the incidence, nature, and severity of Treatment Emergent Adverse Events (TEAE)., Safety and tolerability as measured by incidence, nature, and severity of treatment adverse events (AE), serious AE (SAE), and AE leading to withdrawal., 48 weeks
Secondary Outcome Measures: To assess the ability of lamivudine to lower the levels of type-I IFN-stimulated genes in the plasma and cryopreserved PBMCs of patients with MCI and positive AD biomarkers in a 24 weeks-treatment period., Fold change of type-I IFN-stimulated genes in plasma and cryopreserved PBMCs from baseline visit to week 24 visit., 24 weeks
An Exploratory Clinical Study Evaluating the Safety and Efficacy of Intravenous Anti-CD20/CD30-CAR-T Cell Infusion in Relapsed/Refractory Lymphoma Patients.
NCT Number: NCT06519344
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: EARLY_PHASE1
Conditions: B Cell Malignancies
Interventions: BIOLOGICAL: anti-CD20/CD30-CAR-T Cells
Sponsor: Shanghai Tongji Hospital, Tongji University School of Medicine
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 12
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-31
Completion Date: 2027-07-30

Summary:
This study is a single-center,open-label,single-dose clinical trial of anti-CD20/CD30-CAR-T cell therapy in relapsed/refractory B-cell tumor patients after lymphocyte depletion pre-treatment.

In this study phase,a traditional "3+3"trial design is employed for dose escalation.

Primary Outcome Measures: Incidence of dose-limiting toxicity, The proportion of patients receiving CAR-T cells who encounter dose-limiting toxicities(DLTs). Safety evlauations are performed in accordance with the NCI-CTCAE version 5.0 standards(Cytokine Release Syndrome and neurotoxicity will be graded based on ASTCT/ASBMT grading criteria)., Up to 28 days from CAR-T infusion
Development of a New Method for Liver Stiffness Measurement Using FibroScan
NCT Number: NCT06519331
Acronym: M148
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Liver Diseases
Interventions: DEVICE: Research FibroScan (FS)
Sponsor: Echosens
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 114
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-10-15
Completion Date: 2027-05-31
Locations: Hôpital Pitié-Salpêtrière, Paris, Ile De France, 75013, France|Groupe Hospitalier Nord Essonne - Site Paris- Saclay, Orsay, 91400, France

Summary:
This is an European, prospective, interventional, multicenter clinical investigation that will take place in 2 French sites. 114 adults patients will be included. The study objective is to develop a new method for measuring liver stiffness using FibroScan.

Primary Outcome Measures: Reduced intra-examination dispersion of liver stiffness measurements with the new measurement method., 24 months
Secondary Outcome Measures: Bias between the different stiffness measurements (reference/estimated reference/at rest), Correlation coefficients will be done., 24 months|Bias between the estimated reference stiffness repetitions and between the stiffness at rest repetitions., Intra-class correlation coefficients will be done., 24 months|Bias between the CAP measured with the Research FibroScan and the CAP measured with the Reference FibroScan, Correlation coefficients will be done., 24 months|Bias between the CAP repetitions done with the Research FibroScan, Intra-class correlation coefficients will be done., 24 months
Validity And Reliability of The Incremental Shuttle Walk Test In Type 2 Diabetes Mellitus
NCT Number: NCT06519318
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Type 2 Diabetes Mellitus|Reliability and Validity
Sponsor: Ilayda Kayapinar
Collaborators: Istanbul University - Cerrahpasa (IUC)|Bezmialem Vakif University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 31
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07
Completion Date: 2024-12

Summary:
The aim of our study was to determine the validity and reliability of the incremental shuttle walk test (ISWT) in patients with type 2 diabetes mellitus.This study involves the evaluation of the validity and test-retest reliability of the ISWT.

The assessments will be performed in two separate time periods. At the first visit, baseline assessments of the patient will be performed. These assessments include the recording of demographic information and the ISWT and 6 minute walk test assessments. Both tests will be performed with a 30-minute interval between them.

A retest will be performed 1 week after the initial assessment.

Primary Outcome Measures: Incremental Shuttle Walk Test, For the reliability of the incremental shuttle walk test at the retest will be performed in 1 week. It is a field test consisting of 12 levels in which walking speed is increased. It is based on the principle of walking with an acceleration at an increasing speed in the up and down direction by passing around the cones on a 10-meter track with a distance of 9 metres between two cones by accepting turns around the cones as 0.5 meters. The distance covered is recorded during the test period. The increase in speed every minute is determined by three consecutive signals and only verbal warnings are given so that the individual can catch up with the speed during the test. If the individual is unable to continue the test (reaching maximal heart rate, pain, SpO2 value \<80% extreme dyspnoea, fatigue), the test is terminated and the distance is recorded., 15 minute
Secondary Outcome Measures: Six Minute Walking Test, The validity of the incremental shuttle test will be determined by 6 minute walking test. The test is performed in a thirty metre corridor. The distance walked over 30 meters for 6 minutes is recorded. Heart rate, dyspnoea level using the Borg scale, blood pressure and oxyhaemoglobin saturation can be determined before and after the test., 10 minute
Immune Checkpoint Inhibitor Associated Cardiovascular Adverse Events in Patients With Cancer
NCT Number: NCT06519292
Acronym: ITHACA
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Cardiovascular Diseases|Arterial Thrombosis|Myocardial Infarction|Stroke|Coronary Artery Disease|Atherosclerosis|Cancer
Interventions: DIAGNOSTIC_TEST: Coronary computed tomography angiography (CCTA) at baseline|DIAGNOSTIC_TEST: Coronary computed tomography angiography (CCTA) after 1 year
Sponsor: Hanneke W. M. van Laarhoven
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 214
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-01-25
Completion Date: 2025-12-31
Locations: Amsterdam UMC, Amsterdam, Noord-Holland, 1105AZ, Netherlands

Summary:
Immune checkpoint inhibitors (ICI) have revolutionized cancer treatment and are now approved for various types of cancer. The most common side effects of ICI are immune-related adverse events which can affect any organ or system in the body. Recently, concerns have also risen about cardiovascular effects of ICI. Retrospective studies showed an 4-5 times increased risk of developing an arterial thromboembolic event.

The mechanisms driving the ICI-associated risks of arterial thromboembolic events such as myocardial infarction and stroke, are unclear. Since the risk of a thromboembolism appears to be increased already during the first months after initiation of ICI, immune-related hypercoagulability or (autoimmune) antiphospholipid antibodies may play a role, but data to support this are lacking. The longer-term risk of arterial thromboembolism may be predominantly driven by (accelerated) atherosclerosis, a chronic low-grade inflammatory disease of the larger arteries. Therefore, we assess the effect of ICI on progression of coronary non-calcifid plaque volume by using computed tomography angiography (CCTA).

Primary Outcome Measures: Non-calcified coronary plaque volume (difference between baseline and follow-up CT), 1 year
Secondary Outcome Measures: Plaque characteristics (differences between baseline and follow-up), Difference in plaque characteristics (i.e. fat attenuation index), 1 year|Differences in plasma biomarkers (pro-inflammatory markers) between baseline and follow-up, 3 months, 1 year|Gut microbiota composition (difference between baseline and follow-up), 1 year|Arterial thromboembolic event, 1 year, 5 years
Other Outcome Measures: Venous thromboembolism, 1 year, 5 years
Freezing of Gait - Clinical Outcomes Assessment
NCT Number: NCT06519279
Acronym: FOG-COA
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: PD - Parkinson's Disease
Interventions: DEVICE: Opals
Sponsor: Tel-Aviv Sourasky Medical Center
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08
Completion Date: 2025-12

Summary:
To develop a reliable and reliable clinician-reported outcome (ClinRO) measure (against the new and precise definition) for use by clinicians and researchers to quantify the severity of Freezing of Gait (FOG) in real time.

Primary Outcome Measures: Validate the newly-developed ClinRO, Rate scale of freezing of gait to detect meaningful improvement in freezing of gait. The scale name is " Freezing Of Gait Severity Score". it consist a 8 trials, each one can be rate between 0 to 8. the scale consist a part of frequency of the freezing and part of cumulative duration. The higher the score, the more severe the stagnation and the lower it is, the less stagnation is present., 12/2025
Secondary Outcome Measures: Asses the importance of the FOG symptom for patients, Severity of freezing of gait (FOG) symptoms and patient-reported impact on quality of life. The scale name is " Freezing Of Gait Severity Score". it consist a 8 trials, each one can be rate between 0 to 8. the scale consist a part of frequency of the freezing and part of cumulative duration. The higher the score, the more severe the stagnation and the lower it is, the less stagnation is present., 12/2025
A Pilot Study Evaluating the Potential of 18F Fluorodeoxyglucose PET-CT Imaging in Diagnosing Cardiac Rejection.
NCT Number: NCT06519240
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cardiac Transplant Rejection
Interventions: RADIATION: 18F-Fluorodeoxyglucose Positron Emission Tomography-computed Tomography (18F-FDG PET CT)
Sponsor: Royal Brompton & Harefield NHS Foundation Trust
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-09-30
Completion Date: 2026-10-02

Summary:
This pilot study aims to assess whether 18F-FDG PET CT imaging has the potential in diagnosing cardiac rejection. The investigators aim to recruit 20 heart transplant subjects within two groups of 10 subjects each. One group will have participants with definite rejection and the other group will have participants with definite no rejection. Subjects will be placed into study groups based on their heart muscle biopsy, echocardiogram, clinical symptoms, ECG, and presence or absence of donor specific antibodies. Each group will then undertake a 18F-FDG PET CT scan to identify whether this imaging modality has a role in identifying cardiac rejection. The study subjects and the research team will be blinded to the results of the PET CT until the end of the study.

Primary Outcome Measures: Define the sensitivity and specificity of FDG PET CT in the diagnosis of cardiac rejection, when compared to the current clinical standard (cardiac biopsy and Echocardiography), We aim to confirm the sensitivity and specificity of FDG PET CT in diagnosing cardiac rejection, 18 months
Secondary Outcome Measures: Practicality and acceptability of FDG PET CT imaging to patients, The investigators will aim to undertake a patient survey within 48 hours of the study taking place to ascertain the subjects whether undertaking FDG-PET CT imaging to patients is practical and acceptable to patients., 18 months
Translation and Validation of Rivermead Mobility Index in Urdu
NCT Number: NCT06519227
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Stroke Patients
Sponsor: Riphah International University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 150
Study Design: Observational Model: |Time Perspective: p
Start Date: 2021-05-30
Completion Date: 2023-11-01
Locations: Binash Afzal, Lahore, Punjab, 54000, Pakistan

Summary:
Rivermead Mobility Index (RMI) is an internationally used tool to assess mobility for both research and clinical practice in stroke survivors. This tool had previously been translated into many languages. However, the Urdu version of RMI is not available yet.

The purpose of this study was to translate the RMI into Urdu (RMI-U) and to evaluate the validity and reliability of the translated version among Urdu-speaking stroke survivors in Pakistan. A standardized stepwise forward-backward translation procedure following international guidelines, was used to translate RMI into Urdu. The RMI-U pre-final version underwent thorough psychometric testing. Content validity was evaluated by measuring content validity indices (CVIs). The test-retest reliability of final version was then evaluated among 150 stroke survivors after a one-week interval. Furthermore, internal consistency was measured by Cronbach's alpha and construct validity by exploring factor analysis using the principle of component extraction and a Varimax rotation.

Primary Outcome Measures: Rivermead Mobility Index, mobility assessment, 2nd day
Correlation of Social Media Usage With Physical Activity and Academic Performance in Children
NCT Number: NCT06519214
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Social Media Addiction
Sponsor: Riphah International University
Sex: ALL
Age: CHILD
Enrollment: 289
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-05-01
Completion Date: 2024-07-20
Locations: Riphah International University, Lahore, Punjab, 54000, Pakistan

Summary:
Social media are internet-based applications that allow users to exchange messages or user-generated content for the purposes of social connection, entertainment, or education. WhatsApp, Skype, Facebook, Instagram, Telegram, and Twitter are a few of the most well-known and frequently used virtual social networks. In young children and school-age populations have concentrated on the correlation between watching television and playing video games and academic achievement, demonstrating a detrimental impact on physical health. Children who watch television for more than two hours a day tend to perform worse academically and engage in less physical activity.

Primary Outcome Measures: Academic performance questionnaire, measure academic performance of a child, 8 weeks
Secondary Outcome Measures: Bergen social media questionnaire, measure social participation of a child, 8 weeks
Effectiveness and Safety of SpineCare Used in Conjunction With Spinal Realignment Therapy
NCT Number: NCT06519201
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Scoliosis Idiopathic
Interventions: DEVICE: SRT with SpineCare|DEVICE: SRT without SpineCare
Sponsor: REBOM CLINIC
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 10
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2023-07-14
Completion Date: 2023-11-20
Locations: Rebom Clinic, Seoul, Gangnam, 06099, Korea, Republic of

Summary:
* The goal of this study is to evaluate the safety and effectiveness of traction treatment using SpineCare Device.
* Research period: May 1, 2023 - November 30, 2023 (7 months)
* Research subjects

  * Male/female between 19 and 70 years old
  * Scoliosis patients: Scoliosis patients whose Cobb's angle is less than 15°\~39°
* Treatment method: Group that applied traction treatment using SpineCare (traction device) and group that applied traction treatment without using SpineCare (traction device)
* Treatment period: Treatment twice a week from the 1st to 3rd week from the start of treatment, treatment once a week from the 4th to 7th week, A total of 10 times (takes approximately 2 months)
* Treatment time: approximately 50 minutes

Primary Outcome Measures: Numerical Rating Scale (NRS) score, Patients selected a number that best reflected their pain intensity, where 0 indicates no pain and 10 represents extreme pain, with higher values indicating greater severity of pain., A total of 10 sessions from the start date of treatment (takes approximately 2 months)
Secondary Outcome Measures: Cobb's angle, Cobb's angle is defined as the angle between a line parallel to the upper border of the upper vertebra and a line parallel to the lower border of the lowermost vertebra of the lateral curvature of the spine., A total of 10 sessions from the start date of treatment (takes approximately 2 months)