pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Confirmatory Study of Topical HyBryte™ vs. Placebo for the Treatment of CTCL
NCT Number: NCT06470451
Acronym: FLASH2
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: CTCL/ Mycosis Fungoides|CTCL|Mycosis Fungoides|Cutaneous T Cell Lymphoma
Interventions: DRUG: Hypericin|DRUG: Placebo
Sponsor: Soligenix
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-10
Completion Date: 2026-10

Summary:
To evaluate the use of HyBryte, a topical photosensitizing agent, to treat patients with patch/plaque phase cutaneous T-cell lymphoma (mycosis fungoides).

Primary Outcome Measures: Number of Participants with a Treatment Response in the Modified Composite Assessment of Index Lesion Disease Severity (mCAILS) score, A treatment response is defined as a ≥50% improvement in the cumulative mCAILS score of the index lesions at Week 18 when compared to the mCAILS score at baseline.

The Modified Composite Assessment of Index Lesion Disease Severity (mCAILS) score measures: Erythema (or redness) on a scale of 0 (no redness) to 8 (very red), Scaling on a scale of 0 (no scaling) to 8 (all of the lesion is covered by a very rough surface), Plaque Elevation on a scale of 0 (no evidence of plaque above normal skin level) to 3 (plaque shows marked elevation above normal skin level) and Surface Area on a scale of 0 (no lesion/surface area is 0 cm\^2) to 18 (the lesion is larger than 300 cm\^2). A lower score means a better outcome., 18 weeks
Secondary Outcome Measures: Patch Lesion Response Rates, The proportion of patch lesions achieving a treatment response at Week 18. A treatment response is defined as a ≥50% improvement in mCAILS score when compared to the mCAILS score at baseline for individual lesions.

The Modified Composite Assessment of Index Lesion Disease Severity (mCAILS) score is measured as previously described., 18 weeks|Plaque Lesion Response Rates, The proportion of plaque lesions achieving a treatment response at Week 18. A treatment response is defined as a ≥50% improvement in mCAILS score when compared to the mCAILS score at baseline for individual lesions.

The Modified Composite Assessment of Index Lesion Disease Severity (mCAILS) score is measured as previously described., 18 weeks
Personalized Management of Autoimmune Diseases With AI-Guided (GenAIS TM) Dietary Supplementation
NCT Number: NCT06470412
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Autoimmune Diseases
Interventions: OTHER: Control group|OTHER: AI-Guided Group
Sponsor: S.LAB (SOLOWAYS)
Collaborators: Triangel Scientific|Center of New Medical Technologies
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 160
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2023-02-02
Completion Date: 2024-06-10
Locations: Center of New Medical Technologies, Novosibirsk, Novosibisk Region, 630090, Russian Federation

Summary:
The study "Personalized Management of Autoimmune Diseases with AI-Guided (GenAIS TM) Dietary Supplementation" investigated the effectiveness of AI-guided dietary supplement (DS) prescriptions compared to standard physician-guided prescriptions in managing autoimmune diseases. This 6-month randomized controlled trial included 160 participants with conditions like rheumatoid arthritis, lupus, and multiple sclerosis. Participants were divided into two groups: one received DS based on physician judgment, and the other based on GenAIS AI system analysis. Primary outcomes focused on changes in disease activity, while secondary outcomes included quality of life, metabolic markers, and DS adherence. Data collection involved genetic, metabolic, and clinical profiling, with ethical considerations ensuring participant confidentiality and informed consent

Primary Outcome Measures: The percent change in disease activity scores (DAS28 for rheumatoid arthritis, SLEDAI for lupus) for the AI-Guided group compared with the Control group., Systemic Lupus Erythematosus Disease Activity Index (SLEDAI), which has a score range from 0 to 105, to measure disease activity in participants with lupus.

Disease Activity Score 28 (DAS28), which has a score range from 0 to 10, to measure disease activity in participants with rheumatoid arthritis., 6 months
Secondary Outcome Measures: Percent change in specific symptoms of autoimmune disease, 6 months|Percent change in high-sensitivity C-reactive protein (hsCRP)., 6 months|Percent change in body weight and BMI., 6 months|Incidence of adverse effects related to dietary supplements., 6 months|Participant adherence to the prescribed dietary supplements regimen, 6 months|Changes in quality of life score SF-36, Short Form (SF-36) Health Survey, which has a score range from 0 to 100, to measure the quality of life in participants, with higher scores indicating better health and well-being., 6 months|Changes in quality of life score WHOQOL-BREF, World Health Organization Quality of Life - BREF (WHOQOL-BREF), which has a score range from 0 to 100, to measure the quality of life in participants, with higher scores indicating better quality of life., 6 months
AI-Guided (GenAIS TM) Versus Standard Physician-Guided Dietary Supplementation for Managing Metabolic Syndrome
NCT Number: NCT06470399
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Metabolic Syndrome
Interventions: OTHER: Standard therapy group|OTHER: AI-Guided Group
Sponsor: S.LAB (SOLOWAYS)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 160
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2023-02-02
Completion Date: 2024-06-05
Locations: Center of New Medical Technologies, Novosibirsk, Novosibisk Region, 630090, Russian Federation

Summary:
The study "AI-Guided (GenAIS TM) Versus Standard Physician-Guided Dietary Supplementation for Managing Metabolic Syndrome" aimed to compare the effectiveness of AI-guided dietary supplement (DS) prescriptions versus standard physician-guided prescriptions in managing metabolic syndrome. This 6-month randomized controlled trial included 160 participants diagnosed with metabolic syndrome. Participants were divided into two groups: one received DS based on physician judgment, and the other based on GenAIS AI system analysis. Primary outcomes focused on changes in metabolic parameters, while secondary outcomes included individual components of metabolic syndrome, inflammation levels, body weight, and adherence to the DS regimen. Data collection involved genetic, metabolic, and clinical profiling, with ethical considerations ensuring participant confidentiality and informed consent.

Primary Outcome Measures: Composite Metabolic Syndrome Score, This includes measuring and tracking changes in the five main components of metabolic syndrome: waist circumference, triglycerides, high-density lipoproteins ( HDL) cholesterol, blood pressure, and fasting glucose. These components are central to the definition of metabolic syndrome and are commonly used to assess the efficacy of interventions, 6 months
Secondary Outcome Measures: Waist Circumference change in cm, 6 months|Triglycerides change in mg/dl, 6 months|HDL Cholesterol change in mg/dl, 6 months|Blood Pressure change in mmHg, 6 months|Fasting Glucose in mg/dl, 6 months|High-Sensitivity C-Reactive Protein change, 6 months|Body Weight change in kg, 6 months|body mass index (BMI) change, 6 months|Incidence of any Adverse Effects, 6 months
A Phase 3 Clinical Trial to Compare RBS-001 to Eylea® in Subjects With Neovascular Age-Related Macular Degeneration
NCT Number: NCT06470373
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Neovascular Age-related Macular Degeneration (nAMD)
Interventions: DRUG: RBS-001 Solution for intravitreal injection|DRUG: Eylea® Solution for intravitreal injection
Sponsor: Rophibio, Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 434
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, CARE_PROVIDER)|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2026-09
Locations: Associated Retina Consultants - Phoenix, Phoenix, Arizona, 85021, United States|Associated Retina Consultants - Gilbert, Phoenix, Arizona, 85297, United States|Retina Partners of Northwest Arkansas, PLLC, Springdale, Arkansas, 72764, United States|Erie Retina Research, Erie, Pennsylvania, 16507, United States|Charles Retina Institute, Germantown, Tennessee, 38138, United States|Retina Research Institute of Texas, Abilene, Texas, 79606, United States|Strategic Clinical Research Group, LLC, Willow Park, Texas, 76087, United States

Summary:
This clinical study is designed to demonstrate the equivalence of the two Investigational Products by comparing the efficacy, safety, tolerability and immunogenicity of RBS-001 and Eylea® in subjects with Neovascular age-related macular degeneration.

Primary Outcome Measures: Change in Best-Corrected Visual Acuity (BCVA) measured by Early treatment Diabetic Retinopathy Study (ETDRS) letter score at 8 weeks after the IP treatment, The change from baseline (Day 1) to 8 weeks after the IP treatment
Secondary Outcome Measures: Change in Best-Corrected Visual Acuity (BCVA) measured by Early treatment Diabetic Retinopathy Study (ETDRS) letter score at 4, 8, 12, 16, 20, and 24 weeks after the IP treatment, The change from baseline (Day 1) to 4, 8, 12, 16, 20, and 24 weeks after the IP treatment
Comparison of the Safety of Absorbable and Hem-o-lok Clips in Laparoscopic Cholecystectomy
NCT Number: NCT06470360
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Laparoscopic Cholecystectomy
Interventions: OTHER: Surgycal procedure
Sponsor: Ulas Aday
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 120
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-06-15
Completion Date: 2025-07-01
Locations: Kartal Koşuyolu Higher Specialization Training and Research Hospital, Istanbul, Kartal, 34000, Turkey

Summary:
Safe closure of the cystic duct is the critical step in laparoscopic cholecystectomy. In the literature, the investigators did not observe any prospective study analysing the use of absorbable single clip and Hem-o-lok single clip. In this prospective study, the reliability of the two methods will be compared using a single clip.

Primary Outcome Measures: Complications of patients using absorbable and haem-olok clips will be compared according to the Clavien-Dindo scoring system., Is it safe to close the cystic stump with a single (haem-o-lok or absorbable) clip?, first 30 day
Secondary Outcome Measures: The costs of the clips used, The costs of the clips used will be determined in dollars using Student's t-test., one week
A Real-World Study of Pyrrolitinib Maleate Tablets for HER-2-Positive Early or Locally Advanced Breast Cancer After Adjuvant Trastuzumab Therapy
NCT Number: NCT06470347
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: HER-2 Positive Advanced Breast Cancer
Interventions: DRUG: A Real-World Study of Pyrrolitinib Maleate Tablets for HER-2-Positive Early or Locally Advanced Breast Cancer After Adjuvant Trastuzumab Therapy
Sponsor: Zunyi Medical College
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 67
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2022-11-01
Completion Date: 2025-11-01
Locations: Affiliated Hospital of Zunyi Medical University, Zunyi, Guizhou, China

Summary:
Purpose of the Study:

Primary Study Objective:

To evaluate the efficacy of pyrrolitinib maleate tablets in the treatment of HER-2-positive early or locally advanced breast cancer after adjuvant therapy with trastuzumab

Secondary Research Objectives:

To evaluate the safety of pyrrolitinib maleate tablets in the treatment of HER-2 positive early or locally advanced breast cancer after trastuzumab adjuvant therapy

Study Endpoints Primary Study Endpoint:

Invasive disease free survival (iDFS)

Secondary Study Endpoints:

1. overall survival (OS);
2. disease-free survival (DFS);
3. distant metastasis free survival (DDFS);
4. safety Study Population: Patients with early or locally advanced HER-2 positive breast cancer with clinical stage 0-III who have received prior neoadjuvant or adjuvant therapy. where the neoadjuvant and/or adjuvant treatment phase has been completed at least ≥24 weeks (8 dosing cycles) of trastuzumab therapy and the time interval between the end of the last course of trastuzumab therapy and entry into the study must be ≤1 year Study Design: Single-arm, multicenter, interventional study Administration Pyrrolitinib: The recommended dose of this product is 400 mg orally once daily within 30 minutes after breakfast for 52 weeks (approximately one year).

Dose adjustments may be made in accordance with this protocol, taking into account adverse reactions in subjects. Each consecutive suspension of piretinib during the course of the study should not exceed 14 days, prophylactic use of medications for the treatment of diarrhea is permitted during the course of treatment, multiple suspensions of study medication due to adverse events are permitted, and doses of piretinib that are missed for any reason will not be made up.

Primary Outcome Measures: invasive disease-free survival, 18 months Max
Biopsychosocial Predictors of Nicotine Relapse
NCT Number: NCT06470321
Acronym: BioNic
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Smoking|Smoking Cessation|Nicotine Addiction|Tobacco Smoking Behavior
Sponsor: University of Cyprus
Sex: ALL
Age: ADULT
Enrollment: 200
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2022-01-01
Completion Date: 2025-05-01

Summary:
This study aims to investigate the associations between emotion regulation ability, stress-induced neural activity changes, and susceptibility to relapse in smokers attempting to quit. Participants will undergo assessments of emotion regulation, neural activity via quantitative electroencephalography (qEEG), and stress responses before and during a 24-hour nicotine abstinence period. They will then participate in a computerized smoking cessation intervention, and their abstinence status will be monitored for 6 months.

Primary Outcome Measures: Maintenance of Abstinence, Defined as biochemically verified (via expired carbon monoxide) continuous abstinence from smoking for the full 6 month period after the quit date, Measured at 3 and 6 month follow-ups|Time to First Smoking Lapse, Defined as the number of days between the quit date and the first smoking lapse (smoking even a puff of a cigarette). Smoking lapses will be monitored continuously via self-report., 6 months
Secondary Outcome Measures: Withdrawal Symptoms, Assessed via standardized withdrawal symptom questionnaires at baseline and after 24 hours of abstinence., Baseline, 24 hours|Emotion Regulation, Measured via heart rate variability before and after stress exposure at baseline and 24-hour timepoints, Baseline, 24 hours|Neural Activity, Quantitative EEG spectral power and coherence between brain regions involved in emotion regulation assessed at baseline and after 24-hour abstinence., Baseline, 24 hours|Stress Responses, Salivary cortisol levels measured before and after stress exposure at baseline and 24-hour timepoints, Baseline, 24 hours
Effect of C-peptide on Hypoglycemic Counterregulation
NCT Number: NCT06470295
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: EARLY_PHASE1
Conditions: Hypoglycemia|Type 1 Diabetes
Interventions: OTHER: Saline|BIOLOGICAL: C-peptide
Sponsor: University of Cincinnati
Sex: ALL
Age: ADULT
Enrollment: 38
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: SINGLE (PARTICIPANT)|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-06-01
Completion Date: 2028-01-01
Locations: University of Cincinnati, Cincinnati, Ohio, 45267-0547, United States

Summary:
Iatrogenic hypoglycemia is the most prominent barrier to the safe, effective management of blood sugar in people with type 1 diabetes due to periodic over-insulinization. During insulin-induced hypoglycemia, glucagon secretion is diminished in type 1 diabetes which, in turn, reduces hepatic glucose production and increases the depth and duration of hypoglycemic episodes. We have observed that the naturally occurring protein C-peptide increases glucagon secretion in dogs during insulin-induced hypoglycemia, which increases hepatic glucose production; the experiments in this application will shed light on the translation of this finding to the human.

Primary Outcome Measures: Glucagon, from plasma, During procedure, up to 2.5 hours|Hepatic glucose production, from plasma, During procedure, up to 2.5 hours|Glucose infusion rate, Amount of glucose required to maintain glycemia at 55 mg/dL, During procedure, up to 2.5 hours
Secondary Outcome Measures: epinephrine, from plasma, During procedure, up to 2.5 hours|peripheral glucose uptake, from plasma, During procedure, up to 2.5 hours|cortisol, from plasma, During procedure, up to 2.5 hours|C-peptide, from plasma, During procedure, up to 2.5 hours
Examining Clinical Reasoning With Eye-tracking
NCT Number: NCT06470269
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Diagnosis|Educational Problems
Interventions: BEHAVIORAL: Eye tracking
Sponsor: University of Alberta
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 42
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-05-01
Completion Date: 2024-05-30
Locations: University of Alberta, Edmonton, Alberta, T6G 2R3, Canada

Summary:
The process of medical information intake, interpretation and diagnosis, commonly referred to as clinical reasoning, involves a complex interaction between visual perception and multiple cognitive processes. Assessing students' clinical reasoning skills is a challenging but critical task in developing an optimal teaching curriculum. In this project, the investigators plan to apply the eye-tracking technology to medical education with a specific goal of examining cognitive processing during reading medical chart and x-ray films. Data collected by eye tracking technology will help investigate the perceptual and cognitive underpinnings of clinical reasoning (CR), misinterpretation and misdiagnosis among three participant groups with different levels of clinical experience. Knowledge gained from this project will help to decode the intricate cognitive loop involved in medical interpretation. Further, this study will help to develop alternative methods of assessing student's clinical reasoning skills and promote medical education with novel eye tracking technology.

Primary Outcome Measures: Eye Fixation, Eye fixation over key reading area, During case reading (about 5 minutes)
Secondary Outcome Measures: Eye Saccade, Rapid eye shift between key reading areas, During case reading (about 5 minutes)
Palliative Hepatectomy Combined With Targeted Therapy and Immunotherapy for Advanced Hepatocellular Carcinoma
NCT Number: NCT06470256
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Advanced Hepatocellular Carcinoma
Interventions: PROCEDURE: Palliative Hepatectomy|DRUG: Durvalumab|DRUG: Lenvatinib
Sponsor: Zhiyong Huang
Collaborators: Wuhan Union Hospital, China|Zhongnan Hospital of Wuhan University|Renmin Hospital of Wuhan University|Taihe Hospital|Hubei Cancer Hospital|Xiangyang Central Hospital|Wuhan Central Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-01
Completion Date: 2028-06-01
Locations: Tongji Hospital, Wuhan, Hubei, China

Summary:
Hepatocellular carcinoma (HCC) is one of the most common malignant tumors and the leading cause of cancer-related death worldwide. Surgical resection has always been the best hope for long-term survival of patients with HCC. However, due to the fact that most patients are already in the middle and late stages of treatment, only about 20% of patients have the opportunity to undergo surgical resection. Palliative cytoreductive surgery has been used in the treatment of a variety of malignant tumors, but it is not recommended for the treatment of HCC. Under the premise of targeted therapy and immunotherapy, palliative hepatectomy can reduce tumor burden and may further improve the therapeutic effect of HCC. The aim of this study is to explore whether palliative hepatectomy combined with targeted therapy and immunotherapy can improve the therapeutic effect of advanced HCC, ultimately prolong the survival time of patients, and provide a new treatment direction for patients with advanced HCC.

Primary Outcome Measures: Objective Response Rate (ORR), ORR refers to the proportion of patients whose tumors shrink to a certain amount and maintain for a certain period of time (6 weeks after first dose of Durvalumab), including CR+PR cases. CR (complete response): disappearance of all target lesions, PR (partial response): reduction of the sum of the length and diameter of the baseline lesions by ≥30%., 6 weeks after first dose of Durvalumab
Secondary Outcome Measures: Overall Survival (OS), OS was defined as time from diagnosis to death from any cause or the last follow-up, through study completion, an average of 2 year|Progression Free Survival (PFS), PFS refers to the time from subject enrollment to disease progression according the Response Evaluation Criteria in Solid Tumors version 1.1 (RECISTv1.1) or death, 18 months
RESPECT: (REsearching Stigma in PEdiatric Cancer Tool)
NCT Number: NCT06470230
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Stigma
Sponsor: St. Jude Children's Research Hospital
Collaborators: National Cancer Institute (NCI)
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 972
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-08
Completion Date: 2025-06
Locations: St. Jude Children's Research Hospital, Memphis, Tennessee, 38105, United States

Summary:
Researchers want to learn more about the way stigma affects children with cancer and their caregivers. They want to develop two clinical tools to identify and measure stigma in the pediatric cancer population within culturally diverse global settings of the United States, Guatemala, and Jordan.

Primary Objectives

* Develop two clinical tools that can be used to identify and measure stigma as experienced by (1) pediatric oncology patients/survivors and (2) their guardians/caregivers in culturally diverse global settings.
* Pilot new stigma tools in geographically and culturally diverse cancer referral settings in the United States, Guatemala, and Jordan.

Primary Outcome Measures: Develop two clinical tools that can be used to identify and measure stigma as experienced by (1) pediatric oncology patients/survivors and (2) their guardians/caregivers in culturally diverse global settings., Concept mapping, a mixed-methods approach, combining qualitative group brainstorming and sorting with descriptive statistical analysis will be utilized to describe ideas and represent them graphically. Content expert participants, including members of the research team and global healthcare professionals, will generate novel items by answering prompts. Participants will sort the items into distinctive themes and conduct cluster analyses to create an initial concept map that improves understanding of stigma domains and will be asked to rate the importance and feasibility of each item. A panel of experts will review the item and domain sorts and ratings to remove confusing or duplicative items and produce final pilot tools containing patient-centered and clinically relevant items. Pragmatic design principles will be used to make the tools short and easy to use in a variety of settings., Up to 2 months after the start of study|Pilot new stigma tools in geographically and culturally diverse cancer referral settings., Pilot data will be analyzed using R. Data will be descriptively analyzed before psychometric analysis focusing on item- and domain-level characteristics, including inter-item correlation and scale internal consistency (Cronbach's alpha). Confirmatory factor analysis will test the structural validity (i.e., dimensionality) of the tools. The tools will be refined by dropping items, changing domains, or editing language. The analyses will highlight items that have poor fit and the expert team will review these items and make relevant updates to the overall measure based on these analyses and feedback regarding usability. This will result in a final version of the tools in all three languages., Approximately one year after the start of study
A Clinical Study of B007 in the Treatment of Primary Membranous Nephropathy.
NCT Number: NCT06470191
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2|PHASE3
Conditions: Primary Membranous Nephropathy
Interventions: DRUG: B007|DRUG: Cyclosporin Capsules
Sponsor: Shanghai Jiaolian Drug Research and Development Co., Ltd
Collaborators: Shanghai Pharmaceuticals Holding Co., Ltd
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 216
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-30
Completion Date: 2026-12-31
Locations: Beijing Tsinghua Changgung Hospital, Beijing, China|Peking university first hospital, Beijing, China|The Second Norman Bethune Hospital of Jilin University, Chang chun, China|The First Affiliated Hospital of Dalian Medical University, Dalian, China|Guangdong Provincial People's Hospital, Guangzhou, China|The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China|Zhujiang Hospital of Southern Medical University, Guangzhou, China|Sir Run Run Shaw Hospital , affiliated with the Zhejiang University School of Medicine, Hangzhou, China|The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China|Shandong Provincial Hospital, Jinan, China|The First Affiliated Hospital of Guangxi Medical University, Nanning, China|Affiliated Hospital of Nantong University, Nantong, China|The Affiliated Hospital of Qingdao University, Qingdao, China|Northern Theater Command General Hospital, Shenyang, China|Shengjing Hospital affiliated to China Medical University, Shenyang, China|Peking University Shenzhen Hospital, Shenzhen, China|Renmin Hospital of Wuhan University, Wuhan, China|Wuxi People's Hospital, Wuxi, China|Xi'an Daxing Hospital, Xi'an, China|The Second Affiliated Hospital of Xingtai Medical college, Xingtai, China|Northern Jiangsu People's Hospital, Yangzhou, China|Yantai Yuhuangding Hospital, Yantai, China|The First People's Hospital of Zigong, Zigong, China

Summary:
To evaluate the efficacy and safety of B007 in the Treatment of Primary Membranous Nephropathy

Primary Outcome Measures: ORR（Overall Remission Rate）, Approximately 2 years
Secondary Outcome Measures: CRR（Complete Remission Rate）, Approximately 2 years|PRR（Partial Remission Rate）, Approximately 2 years|Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs), Approximately 2 years
Priority-Matching Correction Technique in Degenerative Lumbar Scoliosis
NCT Number: NCT06470165
Acronym: PMCTDLS
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Degenerative Lumbar Disease|Scoliosis|Degenerative Scoliosis
Interventions: PROCEDURE: Priority-matching correction technique in DLS|PROCEDURE: Traditional correction technique in DLS
Sponsor: Xuanwu Hospital, Beijing
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-21
Completion Date: 2026-12-31
Locations: Xuanwu Hospital Capital Medical University, Beijing, Beijing, 100053, China

Summary:
Surgical outcomes, including radiographic outcomes, patient-reported outcomes, postoperative complications, and revision surgery rates, were compared in patients with degenerative lumbar scoliosis (DLS) who underwent correction surgery with reference to our priority-matching correction technique and the standard reported by Obeid and colleagues. Our findings may provide tangible guidance for surgical decision-making in DLS.

Primary Outcome Measures: Scoliosis Research Society-22, The 22-item SRS-22r questionnaire is specific to scoliosis-related patient-reported outcomes, and consists of 6 domains: function, pain, self-image, mental health, satisfaction, and subtotal, with each domain being scored from 1 to 5 where higher scores correspond to better patient outcomes., One month, 3 months, 6 months, 1 year, and 2 years after surgery|Oswestry disability index, The validated ODI is a self-administered questionnaire for evaluating back-specific functional disability, consisting of 10 items with scores from 0 to 5, and higher ODI indicates more severe disability., One month, 3 months, 6 months, 1 year, and 2 years after surgery|Achievement of minimal clinically important difference, A prespecified MCID of 10 points was used for the ODI. The minimum clinically important difference (MCID) values for the SRS-22r based on data from a Japanese cohort have previously been reported as follows: function = 0.90, pain = 0.85, self-image = 1.05, mental health = 0.70, and subtotal = 1.05., Two years after surgery
A Novel Classification of Sagittal Spinal Alignment to Aid Surgical Planning for Adult Spinal Deformity
NCT Number: NCT06470152
Acronym: CSSAASD
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Adult Spinal Deformity|Sagittal Deformity|Sagittal Alignment|Sagittal Imbalance
Interventions: PROCEDURE: Correction strategy in reference to our PI-dependent clustering of sagittal alignment|PROCEDURE: Correction strategy in reference to the SAAS score
Sponsor: Xuanwu Hospital, Beijing
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-12-01
Completion Date: 2027-12-01
Locations: Xuanwu Hospital Capital Medical University, Beijing, Beijing, 100053, China

Summary:
Surgical outcomes, including radiographic outcomes, patient-reported outcomes, postoperative complications, and revision surgery rates, were compared in patients with adult spinal deformity who underwent correction surgery with reference to our pelvic incidence-dependent (PI-dependent) clustering of sagittal spinal alignment and existing standards (sagittal age-adjusted score \[SAAS\], global alignment and proportion \[GAP\] score, and Roussouly classification). Our findings may provide tangible guidance for surgical decision-making in ASD.

Primary Outcome Measures: Proximal Junctional Kyphosis, Proximal junctional kyphosis (PJK) was defined by a proximal junctional angle (PJA) (Cobb angle between the superior endplate of UIV+2 and inferior endplate of UIV) of \> 10° and a PJA angle difference of \> 10° from baseline at any time point up to latest follow-up., Two years after surgery
Secondary Outcome Measures: Scoliosis Research Society-22, The 22-item SRS-22r questionnaire is specific to scoliosis-related patient-reported outcomes, and consists of 6 domains: function, pain, self-image, mental health, satisfaction, and subtotal, with each domain being scored from 1 to 5 where higher scores correspond to better patient outcomes., One month, 3 months, 6 months, 1 year, and 2 years after surgery|Oswestry disability index, The validated ODI is a self-administered questionnaire for evaluating back-specific functional disability, consisting of 10 items with scores from 0 to 5, and higher ODI indicates more severe disability., One month, 3 months, 6 months, 1 year, and 2 years after surgery|Achievement of minimal clinically important difference, A prespecified MCID of 10 points was used for the ODI. The minimum clinically important difference (MCID) values for the SRS-22r based on data from a Japanese cohort have previously been reported as follows: function = 0.90, pain = 0.85, self-image = 1.05, mental health = 0.70, and subtotal = 1.05., Two years after surgery
Disinfection Effect of Gaseous Ozone
NCT Number: NCT06470126
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Endodontic Treatment
Interventions: PROCEDURE: 2.5% NaOCl group: The interventions performed in the study are root- canal therapies and disinfection procedure of these therapies.|PROCEDURE: 0.9% sterile saline solution combined with 80 seconds: The OzonyTronX® interventions performed in the study are root- canal therapies and disinfection procedure of these therapies.|PROCEDURE: 2.5% NaOCl with 80 seconds OzonyTronX®:The interventions performed in the study are root- canal therapies and disinfection procedure of these therapies.
Sponsor: Ankara University
Sex: ALL
Age: CHILD
Enrollment: 36
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: BASIC_SCIENCE
Start Date: 2010-12-26
Completion Date: 2012-08-12

Summary:
The current study aimed to investigate the effect of gaseous ozone in disinfection the root canals of primary teeth. Thirty-six primary molars of 36 completely healthy patients (aged 5-10) were included in the study.The included teeth were randomly divided into three groups as follows:

- sodium hypochlorite applied group, ozone applied group, ozone and sodium hypochlorite applied group.The study hypothesized that the antimicrobial efficiency of gaseous ozone would be higher than the other groups compared.

Primary Outcome Measures: Values of C. albicans and E. faecalis prior to the application and following the applications, The results of the descriptive statistical analyses of the values of C. albicans and E. faecalis prior to the application and following the applications were shown in Log CFU., 6 months
Secondary Outcome Measures: Assessment the change in the amount of C. albicans and E. faecalis in percentage following irrigation/disinfection procedures, The Wilcoxon signed-rank test determined the change in the microorganisms in root canals in percentage to compare the effect of irrigation procedures (E. faecalis and C. albicans) (intergroup comparisons-between the groups)., 6 months
Clinical Multicenter Randomized Controlled Study of Simultaneous Cognitive Training With Transcranial Magnetic Stimulation in the Treatment of VaD-MCI Patients
NCT Number: NCT06470113
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: VaD-MCI
Interventions: DEVICE: simultaneous cognitive training with transcranial magnetic stimulation
Sponsor: Xuanwu Hospital, Beijing
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 164
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2026-11
Locations: Xuanwu Hospital, Capital Medical University., Beijing, Beijing, 100053, China

Summary:
A multicenter randomized controlled clinical study was conducted in the Xuanwu hospital of Capital Medical University to preliminarily explore the efficacy and safety of simultaneous cognitive training with transcranial magnetic stimulation in the treatment of VaD-MCI patients, to clarify the effective mechanism and form an effective clinical treatment plan.

Primary Outcome Measures: Clinical Global Impression Scale, Evaluate the improvement of clinical symptoms, 1-12 weeks
Secondary Outcome Measures: resting EEG, EEG power in multiple band, 1-12 weeks|head MRI, Changes of brain function by fMRI, 1-12 weeks
Dexamethasone vs. Dexmedetomidine for ESPB in Pain Management After Knee Arthroplasty
NCT Number: NCT06470100
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Knee Osteoarthritis|Knee Arthritis|Knee Disease|Knee Pain Chronic
Interventions: DRUG: 0.9% Sodium Chloride Injection|DRUG: Dexamethasone|DRUG: Dexmedetomidine
Sponsor: Poznan University of Medical Sciences
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 90
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-01
Completion Date: 2025-09-30
Locations: Poznan University of Medical Sciences, Poznan, Poznań, 61-701, Poland

Summary:
Effect of perineurial dexamethasone and dexmedetomidine on erector spinal plane block duration for knee arthroplasty

Primary Outcome Measures: first need of opiate, Time after surgery when the patient needs opiate for the first time, 48 hours after surgery
Secondary Outcome Measures: Opioid consumption, Total opioid consumption after surgery, 48 hours after surgery|Numerical Rating Scale [range 0:10], NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever), 4 hours after surgery|Numerical Rating Scale [range 0:10], NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever), 8 hours after surgery|Numerical Rating Scale [range 0:10], NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever), 12 hours after surgery|Numerical Rating Scale [range 0:10], NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever), 16 hours after surgery|Numerical Rating Scale [range 0:10], NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever), 20 hours after surgery|Numerical Rating Scale [range 0:10], NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever), 24 hours after surgery|Numerical Rating Scale [range 0:10], NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever), 36 hours after surgery|Numerical Rating Scale [range 0:10], NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever), 48 hours after surgery|NLR, Neutrophil-to-lymphocyte ratio, 24 hours after surgery|NLR, Neutrophil-to-lymphocyte ratio, 48 hours after surgery|PLR, Platelet-to-lymphocyte ratio, 24 hours after surgery|PLR, Platelet-to-lymphocyte ratio, 48 hours after surgery
High Purity Type I Collagen Based Skin Substitute Vs Dehydrated Human Amnion/Chorion Membrane in Treatment of DFUs
NCT Number: NCT06470087
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Diabetic Foot Ulcer (DFU)
Interventions: DEVICE: SOC and Type-I Collagen-based Skin Substitute|OTHER: SOC and Human Amnion/Chorion Membrane
Sponsor: Adichunchanagiri Institute of Medical Sciences, B G Nagara
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 24
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-05-28
Completion Date: 2024-08-31
Locations: Adichunchanagiri Institute of Medical Sciences, Mandya, Karnataka, 571448, India

Summary:
This is a randomized controlled clinical investigation in patients suffering from diabetic foot ulcers. The study intends to compare patient outcome data using Standard of Care with Type-I Collagen-based Skin Substitute and Standard of Care with Dehydrated Human Amnion/Chorion Membrane.

Primary Outcome Measures: Percentage wound area reduction from week 1 through 4 measured manually with digital photography, Percentage wound area reduction from week 1 through 4 measured manually with digital photography, 4 weeks
Secondary Outcome Measures: The time to achieve complete wound closure of the target ulcer by the end of 4 weeks, The time to achieve complete wound closure of the target ulcer by the end of 4 weeks, 4 weeks|The proportion of subjects that obtain complete closure over the 4-week treatment period, The proportion of subjects that obtain complete closure over the 4-week treatment period, 4 weeks|Mean number of repeated applications of the Advanced Skin Substitute & Human Amnion/Chorion Membrane used to obtain wound closure, Mean number of repeated applications of the Advanced Skin Substitute \& Human Amnion/Chorion Membrane used to obtain wound closure, 4 Weeks
Other Outcome Measures: Appearance, Visual observation of the newly formed skin for signs of redness, swelling and other abnormalities., 5 weeks including 1 week follow-up|Structural stability and fragility, Structural stability and fragility of the newly formed skin will be assessed by compression testing using a blunt-edged tool., 5 weeks including 1-week follow-up|Wound recurrence, Subject will be observed for any recurrence of the wound after its closure during the 1-week follow-up, During 1-week follow-up
Clinical Multicenter Randomized Controlled Study of Non-invasive Brain Oscillation Modulation in the Treatment of AD-MCI Patients
NCT Number: NCT06470074
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: AD-MCI
Interventions: DEVICE: Transcranial electrical stimulation
Sponsor: Xuanwu Hospital, Beijing
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 124
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2026-11
Locations: Xuanwu Hospital, Capital Medical University., Beijing, Beijing, 100053, China

Summary:
A multicenter randomized controlled clinical study was conducted in the Xuanwu hospital of Capital Medical University to preliminarily explore the efficacy and safety of transcranial electrical stimulation in the treatment of AD-MCI patients, to clarify the effective mechanism and form an effective clinical treatment plan.

Primary Outcome Measures: Clinical Global Impression Scale, Evaluate the improvement of clinical symptoms, 1-12 weeks
Secondary Outcome Measures: resting EEG, EEG power in multiple band, 1-12 weeks|head MRI, Changes of brain function by fMRI, 1-12 weeks
A Clinical Study to Evaluate Ianalumab in Participants With Diffuse Cutaneous Systemic Sclerosis
NCT Number: NCT06470048
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Diffuse Cutaneous Systemic Sclerosis
Interventions: DRUG: Placebo|DRUG: Ianalumab
Sponsor: Novartis Pharmaceuticals
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-31
Completion Date: 2030-07-15
Locations: West Tennessee Research Institute, Jackson, Tennessee, 38305, United States

Summary:
The purpose of this study is to evaluate efficacy, safety and tolerability of s.c. ianalumab administered in participants with diffuse cutaneous systemic sclerosis relative to placebo

Primary Outcome Measures: 3/5 rCRISS25 response, To demonstrate the superiority of ianalumab, compared to placebo, in achieving 3/5 Revised Composite Response Index in Systemic Sclerosis 25 (rCRISS25) response at Week 52, Week 52
Secondary Outcome Measures: Change from baseline in FVC% predicted at Week 52, To demonstrate the superiority of ianalumab, compared to placebo, on change from baseline in percent-predicted forced vital capacity (FVC%) at Week 52, Week 52|Change from baseline in mRSS at Week 52, To demonstrate the superiority of ianalumab, compared to placebo, on change from baseline in modified Rodnan Skin Score (mRSS) at Week 52, Week 52|Change from baseline in HAQ-DI at Week 52, To demonstrate the superiority of ianalumab, compared to placebo, on change from baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 52, Week 52|Ianalumab concentrations in serum during treatment and Follow-up Period, To assess the pharmacokinetics of ianalumab, Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 52, Week 64, Week 76, Week 88, Week 104, Week 108, Week 112, Week 116, Week 120, Week 124 and Week 208|Incidence and titer of anti-drug (ianalumab) antibodies (ADAs) in serum over time, To evaluate the immunogenicity of ianalumab, Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 52, Week 64, Week 76, Week 88, Week 104, Week 124, Week 208|Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs), The distribution of adverse events for ianalumab will be done via the analysis of frequencies for Adverse Event (AEs) and Serious Adverse Event (SAEs) through the monitoring of relevant clinical and laboratory safety parameters., Up to Week 208
Portable Neuromodulation Stimulator (PoNS®) Therapy for Gait and Balance Deficits in Chronic Stroke Survivors: A Randomized Controlled Trial.
NCT Number: NCT06470009
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Chronic Stroke Survivors
Interventions: DEVICE: Portable Neuromodulation Stimulator (PoNS)|DEVICE: Portable Neuromodulation Stimulator (PoNS)
Sponsor: Helius Medical Inc
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-06-12
Completion Date: 2025-01-30
Locations: Synaptic Health, Calgary, Alberta, T2G 3A5, Canada|Neuphysio, London, Ontario, N6J 2K4, Canada|Neuro-Concept, Verdun, Quebec, H4H1M5, Canada

Summary:
Double blind, randomized, placebo controlled, interventional clinical trial investigating the efficacy and safety of PoNS therapy on improving dynamic gait and balance deficits in chronic stroke survivors.

Primary Outcome Measures: Primary safety endpoints, treatment - related serious adverse events (SAE) over 12 week treatment, 12 week
Effects of Connective Tissue Massage in Patients With Fibromyalgia
NCT Number: NCT06469996
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Fibromyalgia
Interventions: OTHER: Connective tissue massage|OTHER: Self myofascial relaxation
Sponsor: Firat University
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-06-20
Completion Date: 2024-08-30
Locations: Songul, Elazığ, 23100, Turkey

Summary:
Connective tissue massage (CTM), one of the various manual therapy techniques for FMS, produces local mechanical effects on mast cells in the connective tissue with short and long tractions, thereby reducing sympathetic activity and producing vasodilation. The aim of the study was to compare the effectiveness of self myofascial release technique and connective tissue massage in patients with FMS. At least 30 FMS patients will be included in the study. Fibromyalgia Impact Questionnaire, pain, quality of life and sleep quality will be evaluated. CTM will be practiced to study group and foam roller will be practiced to control group.

Primary Outcome Measures: disability, Fibromyalgia Impact Questionnaire is a scale consisting of 10 questions to assess the health status and physical functionality of an individual diagnosed with FM., 2 minutes
Secondary Outcome Measures: pain assesment, Pain will be evaluated with Visual Analog Scale. Patients will be asked to rate the severity of pain between 0-10., 1 minute|Quality of life assesment, Quality of life will be assessed with the Health Assessment Questionnaire (HRA). The HRA is one of the first disability questionnaires used in adults with arthritis. The highest scores of each subgroup are summed and the result is divided by eight to obtain the participant's SDQ score., 2 minutes