pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Adebrelimab in Combination With NALIRIFOX in Locally Advanced Pancreatic Cancer
NCT Number: NCT06475326
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Pancreatic Cancer
Interventions: DRUG: Adebrelimab|DRUG: Oxaliplatin 100 MG|DRUG: Irinotecan liposome|DRUG: Calcium Folinate|DRUG: Fluorouracil
Sponsor: Fudan University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 87
Study Design: Allocation: NA|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-05
Completion Date: 2025-12
Locations: Fudan University Shanghai Cancer Center, Shanghai, 200032, China

Summary:
In this study, Adebrelimab combined with NALIRIFOX conversion therapy was performed in subjects with locally advanced pancreatic cancer to evaluate the efficacy and safety of conversion therapy with immunotherapy combined with chemotherapy, followed by different treatment methods such as surgery, continued conversion therapy, and advanced systemic therapy according to different transformation outcomes, to improve the survival benefit of subjects with locally advanced pancreatic cancer.

Primary Outcome Measures: Surgical Conversion Rate, The surgery is scheduled to take place after a minimum of 4 weeks from the last dose to allow the effects of the drug to wear off. The eligible subjects can undergo surgery within 8 weeks from the last dose., 8 weeks
Secondary Outcome Measures: Pathologic response rate (pCR/MPR), pCR is defined as the proportion of subjects with complete disappearance of cancer cells from tumor lesions and lymph nodes. MPR is defined as the proportion of cancer cells in tumor lesions and lymph nodes \< 10% of subjects, and the viable cells of carcinoma in situ are not included in the calculation of pCR. All tumor tissue and associated lymph node tissue samples should be grossly examined. Tissue samples should be sectioned at a thickness of 0.5 cm. Pathological evaluation should be performed for more extensive tumors with at least 1.0 cm thick sections., up to approximately 1 years|Objective response rate (ORR), ORR=(CR+PR)/ITT\*100%, and the binomial distribution was used to calculate its 95%CI., up to approximately 1 years|Event-free survival (EFS), defined as the time from the start of treatment to the occurrence of any disease progression affecting surgery, postoperative disease progression or recurrence (per RECIST v1.1), or death due to any cause, whichever occurs first., up to approximately 1 years|Overall survival (OS), defined as the time from the first dose to death from any cause, whichever occurs first. Participants who were still alive at the last follow-up had OS as data censored at the time of the last follow-up. For participants lost to follow-up, OS was counted as data censored as the time to last confirmed survival before loss-to-follow., up to approximately 1 years
A Study of BL-B01D1+PD-1 Monoclonal Antibody in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer, Nasopharyngeal Carcinoma and Other Solid Tumors
NCT Number: NCT06475300
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Non-small Cell Lung Cancer|Nasopharyngeal Carcinoma|Solid Tumor
Interventions: DRUG: BL-B01D1|DRUG: PD-1 Monoclonal Antibody
Sponsor: Sichuan Baili Pharmaceutical Co., Ltd.
Collaborators: Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 126
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-25
Completion Date: 2026-07
Locations: Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China

Summary:
This phase II study is a clinical study to explore the efficacy and safety of BL-B01D1 combined with PD-1 Monoclonal Antibody in patients with locally advanced or metastatic non-small cell lung cancer, nasopharyngeal carcinoma and other solid tumors.

Primary Outcome Measures: Objective Response Rate (ORR), Objective response rate (ORR) is defined as the number of CR and PR in the treatment and control groups divided by the number of that group in the full analysis set (FAS)., Up to approximately 24 months|Recommended Phase II Dose (RP2D), The RP2D is defined as the dose level chosen by the sponsor (in consultation with the investigators) for phase II study, based on safety, tolerability, efficacy, PK, and PD data collected during the dose escalation study of BL-B01D1., Up to approximately 24 months
Secondary Outcome Measures: Progression-free survival (PFS), Progression-free survival (PFS) as assessed by BIRC is defined as the time between the date subjects are randomized and the first observation of disease progression (based on BICR's image-based assessment) or death., Up to approximately 24 months|Disease Control Rate (DCR), Disease Control Rate (DCR) : Percentage of all randomized subjects who rated the best overall response (BOR) as complete response (CR), partial response (PR), and disease stabilization (SD) according to RECIST 1.1 criteria., Up to approximately 24 months|Duration of Response (DOR), Duration of Response (DOR) : defined as the period from the date when tumor response is first recorded to the date when objective tumor progression is first recorded or the date of death., Up to approximately 24 months|Treatment Emergent Adverse Event (TEAE), TEAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally emerging, or any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition during the treatment of BL-B01D1. The type, frequency and severity of TEAE will be evaluated during the treatment of BL-B01D1., Up to approximately 24 months
HAIC Combined With TQB2450 and Anlotinib in Second-line Treatment of Advanced Hepatocellular Carcinoma
NCT Number: NCT06475287
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Hepatocellular Carcinoma
Interventions: DRUG: HAIC（Mitoxantrone+Raltitrexed）、anlotinib、TQB2450
Sponsor: Fudan University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 42
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-20
Completion Date: 2026-07-31
Locations: Fudan University Shanghai Cancer Center, Shanghai, Shanghai, 200032, China

Summary:
Overall, although there are many options for second-line treatment of liver cancer, the ORR is mostly limited to within 20-30%, with a median PFS of 3-5 months and a median OS of 10-20 months. The overall situation is still unsatisfactory, with low objective tumor response rates and targeted immune resistance being the main reasons affecting treatment efficacy. Increasing local treatment or overcoming resistance is currently a hot research topic. The aim of this study is to explore the effectiveness and safety of HAIC combined with TQB2450 and anlotinib for second-line treatment of advanced HCC patients.

Primary Outcome Measures: Objective response rate, The proportion of patients whose tumors have shrunk to a certain amount and maintained for a certain period of time, including complete response and partial response, 24 months
Influence of Osteopathic Intervention on Cervical Muscles in Tension Headaches in Women
NCT Number: NCT06475248
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Tension Headaches
Interventions: OTHER: Placebo Technique|OTHER: Stretching technique|OTHER: Inhibition of the suboccipital
Sponsor: Escola Superior de Tecnologia da Saúde do Porto
Sex: FEMALE
Age: ADULT
Enrollment: 43
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2024-12-11
Locations: Escola Superior da Saúde do Porto, Porto, 4200-072, Portugal

Summary:
This study aims to understand whether there is any relationship between the intervention on the trapezius, sternocleidomastoid and suboccipital muscles in patients with chronic tension headaches.

Primary Outcome Measures: Change in the intensity and frequency of pain after the three treatment sessions;, The scale Hit-6 will be the instrument used to evaluate the level the intensity and frequency of tension headache. This instrument consists of six questions about the characteristics of headaches, with each question presenting five choices. The answers range from never to always. This data will be collected immediately before the first investigation and one month after the first evaluation, through the volunteers filling out the scale., One month after the first intervention
Adebrelimab + Apatinib in SCLC Maintenance Therapy
NCT Number: NCT06475209
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: SCLC
Interventions: DRUG: Adebrelimab combined with Apatinib
Sponsor: Tang-Du Hospital
Collaborators: Jiangsu Hengrui Pharmaceutical Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-20
Completion Date: 2026-12-20
Locations: Tangdu Hospital Affiliated to the Fourth Military Medical University, Xi'an, Shannxi, 710038, China

Summary:
This prospective clinical study aims to evaluate and observe the efficacy and safety of Atezolizumab combined with Apatinib in maintenance therapy for extensive-stage small cell lung cancer using a single-arm trial design.

The study is planned to be conducted in Shaanxi Province, China, with an initial target enrollment of 60 patients. The study commenced in February 2024, and recruitment is expected to conclude around December 2025, with the trial anticipated to end by December 2026. Assuming no occurrences such as withdrawal of informed consent by subjects, intolerable adverse drug reactions, or investigator-assessed unsuitability for further participation, each participant's estimated duration of study treatment will continue until radiographically confirmed tumor progression.

Primary Outcome Measures: Progression-free survival, Progression free survival (PFS) refers to the time from recording the first chemotherapy treatment to the date of disease progression, as assessed by researchers., Progression-free survival (PFS) analysis based on investigator assessment per RECIST 1.1, and will be assessed up to 2 years
Secondary Outcome Measures: Overall Survival, Overall survival (OS) refers to the time that researchers evaluate from recording the first chemotherapy to death (of any cause)., The maximum time from receiving treatment to dying for any reason is 4 years.|Objective response rate, Per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) using Investigator assessments, is defined as the number (%) of patients with response of Complete Response or Partial Response, will be assessed up to 1 years., Data obtained up until progression, or the last evaluable assessment in the absence of progression, will be assessed up to 1 years|Complete Response rate, Per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) using Investigator assessments, is defined as the number (%) of patients with response of Complete Response, will be assessed up to 1 years., up to 1 years|Duration of Response, Duration of Response（DoR）refers to the time from the first assessment as CR or PR to the first assessment as PD or (due to any reason) death, Duration of Response（DoR）analysis based on investigator assessment per RECIST 1.1, and will be assessed up to 1 years
Prospective Cohort Study of Neoadjuvant Therapy With Sintilimab (PD-1 Inhibitor) Combined With Chemotherapy in Resectable ESCC
NCT Number: NCT06475196
Status: ENROLLING_BY_INVITATION
Study Type: OBSERVATIONAL
Conditions: Resectable Esophageal Squamous Cell Carcinoma
Interventions: DRUG: Sintilimab (PD-1 inhibitor)
Sponsor: Tang-Du Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 90
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-20
Completion Date: 2025-06-20
Locations: Tangdu Hospital of the Fourth Millitary Medical University, Xi'an, Shaanxi, 710000, China

Summary:
This study is an open-label, prospective, cohort clinical study to evaluate the safety and efficacy of different cycles of sintilimab in combination with platinum-containing chemotherapy as preoperative neoadjuvant therapy in patients with resectable esophageal cancer. In the study, all subjects who meet the enrollment criteria will be randomized 1:1:1 to receive sintilimab combined with platinum-containing chemotherapy Q3W for 3 cycles (Group A), sintilimab combined with platinum-containing chemotherapy Q3W for 2 cycles + sintilimab for 1 cycle (Group B), sintilimab combined with platinum-containing chemotherapy for 1 cycle + sintilimab Q3W for 2 cycles (Group B) as neoadjuvant therapy, and receive radical surgery within 4-6 weeks after the completion of the last neoadjuvant therapy. Whether the subjects need adjuvant therapy and adjuvant treatment regimen after surgery are determined by the investigator, and all subjects need to complete the follow-up plan formulated by the study after surgery.

Primary Outcome Measures: complete pathologic response (pCR), no residual tumor cells in the surgically resected tumor specimen and all sampled regional lymph nodes after neoadjuvant treatment., 3 mouths
Probiotic Chocolate Study in Multiple Sclerosis
NCT Number: NCT06475183
Acronym: ProChocolate
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Multiple Sclerosis|Healthy Nutrition
Interventions: DIETARY_SUPPLEMENT: Bouchard Belgian Dark Chocolate Probiotic Napolitains, containing bifidobacterium longum
Sponsor: Columbia University
Sex: ALL
Age: ADULT
Enrollment: 110
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-06-01
Completion Date: 2025-02-06
Locations: Columbia University Irving Medical Center, New York, New York, 10032, United States

Summary:
The goal of this study is to assess the effects of probiotics on persons with multiple sclerosis (MS), persons at higher genetic risk for MS (first degree family members of persons with MS), and healthy controls. Participants will be asked to consume probiotic containing chocolates (Bouchard Belgian Dark Chocolate Probiotic Napolitains containing 10 billion CFUs of bifidobacterium longum per day) for 6 weeks. Participants will undergo blood draws before and after the 6 weeks of probiotic containing chocolate and microbial metabolites and immune markers will be compared before and after the probiotics, as well as between groups.

Primary Outcome Measures: peripheral blood mononuclear cell (PBMC) profile: Change in Regulatory T (Treg) cells, percent change in Treg cells from baseline to week 6, baseline (week 0) to week 6|peripheral blood mononuclear cell (PBMC) profile: Change in T helper (TH) cells, change in ratio of TH1 to Th2 cells from baseline to week 6, baseline (week 0) to week 6|peripheral blood mononuclear cell (PBMC) profile: Change in T helper Th17 cells, percent change in Th17 cells from baseline to week 6, baseline (week 0) to week 6|Change in serum microbial metabolites, percent change in short chain fatty acid levels from baseline to week 6, baseilne (week 0) to week 6
Secondary Outcome Measures: Change in Modified Fatigue Impact Scale-5 Impact Scale, brief patient reported measure of fatigue, range of values is 0-20 with a higher score indicating worse outcome, week 0, week 6|Change in Patient-Determined Disability Scale (PDDS), brief-patient reported meausre of disability in MS, range of values is 0-8 with higher score indicating worse outcome, week 0, week 6|Change in Bowel Control Scale, brief patient reported measure of bowel control and impact of bowel problems on everyday life, range of scores is 0-16 with higher score indicating worse outcome, week 0, week 6|Change in Multiple Sclerosis Rating Scale- Revised (MSRS-R) Patient-Determined Disease Steps Scale, brief patient reported measure of disability in MS, range of scores is 0-32 with higher score indicating higher disability, week 0, week 6
Preliminary Efficacy Analysis of 'λ+α' Double-Tract Reconstruction After Laparoscopic Proximal Gastrectomy
NCT Number: NCT06475170
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Gastric Cancer|Reflux Esophagitis
Interventions: PROCEDURE: proximal gastrectomy combined with 'λ+α' double-tract anastomosis
Sponsor: Northern Jiangsu People's Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (CARE_PROVIDER, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2025-12-31
Locations: Northern Jiangsu People'S Hospital, Yangzhou, China

Summary:
The incidence of proximal gastric cancer has increased significantly in recent years. This may be due to weight gain, alcohol consumption, gastroesophageal reflux disease (GERD), and precancerous lesions. With a deeper understanding of the pattern of lymph node metastasis and the emergence of anti-reflux procedures, proximal gastrectomy has gradually received clinical attention. For early-stage upper gastric cancer and esophagogastric combination cancer cases that are expected to have a good prognosis, the ideal surgical procedure should be to preserve the distal stomach to improve the quality of life and to choose a reasonable digestive tract reconstruction method to prevent reflux. The anti-reflux effect of various proximal gastrectomy digestive tract reconstruction methods and the advantages and disadvantages of various surgical procedures are controversial, and the recognized ideal reconstruction method has not yet been established. Therefore, based on the stomach's anatomical features and the intercalated jejunum's anti-reflux mechanism, we propose a true dual-channel anastomosis for GI reconstruction, i.e., the "λ+α dual-channel anastomosis". This study aimed to investigate the efficacy and safety of proximal gastrectomy combined with "λ+α double-channel anastomosis" in the treatment of early gastric cancer.

Primary Outcome Measures: incidence of reflux esophagitis, The percentage (%) of patients developing postoperative reflux esophagitis after surgery in each group., 12 months after surgery
Secondary Outcome Measures: incidence of anastomotic leakage, The percentage (%) of patients developing postoperative anastomotic leakage after surgery in each group., 30 days after surgery|incidence of anastomotic stenosis, The percentage (%) of patients developing anastomotic stenosis after surgery in each group., 12 months after surgery|operative time, The duration, measured in minutes, spent on reconstructing the digestive tract using different reconstruction methods, 1 day after surgery
Artificial Intelligence-enhanced Electrocardiogram Diagnoses and Predicts Future Regurgitant Valvular Heart Diseases
NCT Number: NCT06475157
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Electrocardiogram, Valvular Heart Disease
Interventions: OTHER: No intervention
Sponsor: Shanghai Zhongshan Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 500000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-03-01
Completion Date: 2024-05-30
Locations: 180 Fenglin Road, Shanghai, 200032, China|Hammersmiths Hospital, London, United Kingdom

Summary:
This is a retrospective study to establish models for the prediction of future valvular heart diseases with artificial intelligence-enhanced electrocardiogram (ECG).

Primary Outcome Measures: Progression of valvular heart diseases, There would be echo records of subjectes of the study during follow-up. So for subjects with baseline none or mild valvular heart diseases, including mitral regurgitation, aortic regurgitation, and tricuspid regurgitation, there might be some with progression to moderate or severe valvular heart diseases, and some other without this progression. The primary outcome of the study would be the progression of valvular heart diseases from none or mild to moderateor severe, as assessed by echocardiography., 15 years
Comparison of Serum Myokine Dosages and Imaging Methods in the Evaluation of Sarcopenia in Patients With Hepatocellular Carcinoma
NCT Number: NCT06475118
Acronym: Myomachia
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Sarcopenia|Hepatocellular Carcinoma
Interventions: OTHER: Dynamometry measurement, myokine dosing, sarcopenia calculation
Sponsor: CHU de Reims
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 139
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-08
Completion Date: 2026-04
Locations: Damien JOLLY, Reims, France

Summary:
It is known that some substances present in the blood, called 'myokines,' influence muscle loss. Some may accelerate this loss, while others may prevent it. Inflammatory substances in the blood can also contribute to muscle loss. Sarcopenia is assessed by an imaging technique called 'Skeletal Muscle Mass Index (SMI)' to measure muscle mass. This analysis can be done from radiological examinations. Sarcopenia has a serious impact on patients with hepatocellular carcinoma. It increases the risk of death, cancer recurrence, and decreases the response to treatments. Therefore, the investigators want to determine if blood tests for myokines obtained by simple blood draw can improve the assessment of sarcopenia in this specific setting.

Primary Outcome Measures: Determine if serum myokines measured in patients with HCC are correlated with muscle mass index assessed by standard scanographic technique., Analysis of correlation between serum myokines measured in patients with HCC and muscle mass index assessed by standard scanographic technique, Day 1
Secondary Outcome Measures: Determine the serum myokine concentration threshold for the diagnosis of sarcopenia defined by an L3 SMI < 50 cm2/m2 in men, Analysis of correlation between serum myokines thresholds in patients with HCC and sarcopenia defined by an L3 SMI \< 50 cm\^2/m\^2 in men, Day 1|Determine the serum myokine concentration threshold for the diagnosis of sarcopenia defined by an L3 SMI < 39 cm2/m2 in women, Analysis of correlation between serum myokines thresholds in patients with HCC and sarcopenia defined by an L3 SMI \< 39 cm\^2/m\^2 in women, Day 1|Determine if serum myokines measured in patients with HCC are correlated with muscle strength assessed by dynamometry, Analysis of correlation between serum myokines measured in patients with HCC and Muscle strength assessed by dynamometry, Day 1|Determine if inflammatory cytokines (IL6, TNFα) measured in patients with HCC are correlated with muscle mass index assessed by the standard scanographic technique, Analysis of correlation between inflammatory cytokines (IL6, TNFα) measured in patients with HCC and muscle mass index assessed by the standard scanographic technique, Day 1
Relation Between Muscle Mass, Total Body Fat, Visceral Fat, Waist Hip Ratio and Sleeping Hours in Patient With Nonspecific Back Pain
NCT Number: NCT06475092
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Obesity|Back Pain|Sleep
Interventions: OTHER: Tanita device
Sponsor: Ahram Canadian University
Sex: ALL
Age: ADULT
Enrollment: 30
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-26
Completion Date: 2024-07-30
Locations: Ahram Canadian university, Giza, 12573, Egypt

Summary:
Objective: To find out if there are a relation between muscle mass, total body fat, visceral fat, waist hip ratio and sleeping hours in patient with nonspecific back pain.

Design: Cross sectional study. Subjects: 30 male and female patients with age ranged from 25 to 40 years old diagnosed as nonspecific low back pain will participate in this study.

Main measures: the Outcome measures will be including the assessment of muscle mass, total body fat, visceral fat, waist hip ratio and sleeping hours.

Results: The results will be analyzed via co relation test.

Primary Outcome Measures: Tanita device will be used for measurement of total body fat , muscle mass and visceral fat, bioelectric impedance analysis device will be used for assessment of total body fat ,muscle mass and viseral fat, baseline|Waist hip ratio will be measured by tape measurement, The waist-hip ratio or waist-to-hip ratio (WHR) is the dimensionless ratio of the circumference of the waist to that of the hips. This is calculated as waist measurement divided by hip measurement (W⁄H)., base line
Correlation Between BMI and Craniovertebral Angle and Their Impact on Hand Grip Strength and Neck Functional Disability in Egyptian University Student
NCT Number: NCT06475079
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Neck Pain
Interventions: OTHER: • FHP app (Pyeongtaek, South Korea) mobile application
Sponsor: Ahram Canadian University
Sex: ALL
Age: ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-26
Completion Date: 2024-07-01

Summary:
Objective: To find the relation between cranio-vertebral angle and hand grip strength in university student mobile users.

Design: cross sectional study. Setting: Ahram Candian University Subjects:100 male and female university students with age ranged from 20 to 30 years old will participate in this study.

Intervention: cross sectional study to detect the relation between cranio-vertebral angle and hand grip strength in university student mobile users.

Main measures:

* FHP app (Pyeongtaek, South Korea) mobile application
* Hand dynamometer (the JAMAR® Hydraulic Hand) (Lupton-Smith et al.,2022)
* Mechanical height and weight scale
* Visual Analogue Scale
* Arabic Neck Disability Index Results: The results will be obtained via one-way analyses of variance (ANOVA).

Primary Outcome Measures: craniovertebral angle will measured by FHP (Forward Head Posture ) mobile application, It is a mobile application which is objective to detect the cervical posture by measuring the CV angle. It is an application that requires an Android version 4.0 or higher installed on a smartphone, baseline|Hand grip strength will measured by Hand dynamometer (the JAMAR® Hydraulic Hand), it is tool used to asses hand grip strength, baseline|Pain level will measured by Visual Analogue Scale, VAS is a line with a length of 10 where one end (right) means no pain and the other means severe unbearable pain. Each patient was asked to put a mark on the line that mostly describe his or her pain intensity., base line|Neck functional disability will assess by Arabic Neck Disability Index, it consist of 10 questions in total, including ones about pain intensity, personal care, lifting, reading, headaches, driving, concentration, work, sleeping, and recreation Each item is scored from 0 (no disability) to 5 (total disability), baseline
Visual Performance of Center Distance Daily Disposable Multifocal Lenses
NCT Number: NCT06475053
Acronym: ViPCD3
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Myopia
Interventions: DEVICE: NaturalVue Enhanced Multifocal 1 Day contact lens|DEVICE: MiSight 1 Day contact lens
Sponsor: Visioneering Technologies, Inc
Collaborators: Ohio State University
Sex: ALL
Age: CHILD, ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: OTHER
Start Date: 2024-07-31
Completion Date: 2025-12-31
Locations: The Ohio State University College of Optometry, Columbus, Ohio, 43210, United States

Summary:
The purpose of this study is to compare visual performance (high and low contrast acuity, reading acuity, contrast sensitivity, stereoacuity, accommodative response, eye hand coordination, far near vision, and dynamic vision) between Visioneering Technologies, Inc. NaturalVue Multifocal and CooperVivion MiSight.

Primary Outcome Measures: Comparison of visual performance (high and low contrast acuity) between VTI NaturalVue Enhanced Multifocal and CooperVision MiSight., log MAR vision scale, 2 months
TMS for Anxiety and Trauma-related Disorders
NCT Number: NCT06475040
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Anxiety Symptoms|Anxiety Disorders
Interventions: DEVICE: transcranial magnetic stimulation
Sponsor: Shanghai Mental Health Center
Collaborators: Brigham and Women's Hospital
Sex: ALL
Age: ADULT
Enrollment: 15
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-19
Completion Date: 2025-06
Locations: Shanghai Mental Health Center, Shanghai, Shanghai, 200030, China

Summary:
The present pilot study will apply accelerated intermittent theta burst stimulation (aiTBS) to a novel transcranial magnetic stimulation (TMS) target for anxiety derived via causal network mapping.

Primary Outcome Measures: Effectiveness as measured by Beck Anxiety Inventory, Measure of severity of anxiety - total score of Beck Anxiety Inventory ranges from 0 to 63 (higher numbers indicate higher severity), Anxiety symptoms will be measured before the TMS treatment, immediately after 5 days of TMS, 1 week and 4 weeks respectively after completion of the TMS treatment
Secondary Outcome Measures: Safety as measured by number of participants with Adverse Events, Count of Adverse Events Reported during follow up, Each afternoon after treatment during the 5 days of treatment|Resting-state functional MRI (rsfMRI) scan, Functional MRI scan will be conducted before and after treatment to assess for treatment-induced changes in brain connectivity, Baseline (before treatment) and after 5 days of TMS stimulation|Hamilton Anxiety Rating Scale (HAMA), Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, Baseline (before treatment), 5 days of TMS treatment, and 1 and 4 weeks after the end of the TMS stimulation|State-Trait Anxiety Inventory (STAI), State and trait anxiety will be assessed separately with 20 respective questions. Scores range from 20 to 80, with higher scores indicating greater anxiety, Baseline (before treatment), 5 days of TMS treatment, and 1 and 4 weeks after the end of the TMS stimulation|Hamilton Depression Rating Scale (HAMD), Measure of depression severity - total score of Hamilton Depression Scale ranges from 0 (no depression) to 60 (most severe depression), Baseline (before treatment), 5 days of TMS treatment, and 1 and 4 weeks after the end of the TMS stimulation|Sheehan Disability Scale (SDS), Three domains can be summarized to evaluate global functional impairment by adding the scores of each, resulting in global SDS score ranges from 0 (unimpaired) to 30 (highly impaired), Baseline (before treatment), 5 days of TMS treatment, and 1 and 4 weeks after the end of the TMS stimulation
Application of Knee Measurements on 3D CT in TKR
NCT Number: NCT06475014
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Knee Osteoarthritis|Knee Disease
Interventions: PROCEDURE: Total knee replacement
Sponsor: Vinmec Healthcare System
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 45
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-04-25
Completion Date: 2023-12-01
Locations: Vinmec Times City Hospital, Hanoi, Hai Ba Trung, 100000, Vietnam

Summary:
A 3D Computed Tomographic Study of Vietnamese Knee Morphology for Total knee Replacement

Primary Outcome Measures: Radiology outcome, Position of implants compare to the plan on CT, measure the discrepancies by degree, 30/06/2023|Clinical outcome, self-administered questionnaire, Western Ontario and McMaster Universities Arthritis Index (WOMAC) score, from 0-96, lower is better, 30/06/2024|Clinical outcome, by surgeon's evaluating, The 2011 Knee Society Scoring System, from 0 to 100, higher is better, 30/06/2024
Other Outcome Measures: AP-ML dimesion, Size of knee on stimulated bone resection slice, AP and ML dimension in millimeters, 30/06/2023
Dose-Response Characterization of VER-01 in the Treatment of Patients With Chronic Non-specific Low Back Pain
NCT Number: NCT06475001
Acronym: RESPONSE
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Chronic Non-specific Low Back Pain
Interventions: DRUG: VER-01|DRUG: Placebo
Sponsor: Vertanical GmbH
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 800
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-06-28
Completion Date: 2025-07
Locations: St Pancras Clinical Research, London, United Kingdom

Summary:
Dose-response characterization of VER-01 in patients with chronic non-specific low back pain (CLBP) for whom drug treatment is indicated and previous optimized treatments with non-opioid analgesics have not led to sufficient pain relief or were unsuitable due to contraindications or intolerance.

Primary Outcome Measures: Efficacy based on pain reduction, Change in mean pain intensity measured on an 11-point numerical rating scale (NRS), End of the Treatment Phase (Week 7) compared to Baseline (Week -1)
Secondary Outcome Measures: Efficacy based on pain reduction in patients with neuropathic pain, Change in mean pain intensity measured on an 11-point numerical rating scale (NRS) in the subgroup of patients with neuropathic pain, End of the Treatment Phase (Week 7) compared to Baseline (Week -1)|Pain responders, Number and percentage of 30% and 50% pain responders, End of the Treatment Phase (Week 7) compared to Baseline (Week -1)|Pain responders in the subgroup of patients with neuropathic pain, Number and percentage of 30% and 50% pain responders in the subgroup of patients with neuropathic pain, End of the Treatment Phase (Week 7) compared to Baseline (Week -1)|PGIC, Percentage of patients by answer category ('Improved', 'Not improved') of the global assessment of symptoms (PGIC, 7-point Likert scale where 0=very much better to 6=very much worse), At the end of the Treatment Phase (Week 7)|Safety: TEAEs and TESAEs, Occurrence of treatment-emergent adverse events (TEAEs)/treatment-emergent serious adverse events (TESAEs), Week 1 up to Week 13|Satisfaction with tolerability, Percentage of patients by answer category ("satisfied", "unsatisfied") based on the satisfaction of the patient with tolerability (5-point Likert scale, where 0=very satisfied to 4=very unsatisfied), At the end of the Treatment Phase (Week 7)
Characterization of Biophysical and Mechanical Parameters on Skin of Breast Cancer Patients
NCT Number: NCT06474988
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Breast Cancer|Estrogen Receptor Positive Tumor
Interventions: OTHER: Skin tests
Sponsor: European Institute of Oncology
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 150
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-05-27
Completion Date: 2025-05-31
Locations: European Institute of Oncology, Milan, 20141, Italy

Summary:
Aim of this study is to characterize the chemical/physical and structural parameters of the skin in patients with breast cancer undergoing oncological adjuvant treatment in order to understand how to prevent and manage adverse skin events during hormone therapy, also through the formulation of new functional dermocosmetics.

Primary Outcome Measures: Forearm hydration degree assessmnent, Forearm hydration degree evaluated using instrumental skin tests, 1 day|Evaluation of Effects of Skin Disease on Quality of Life, Collection of Skindex29 questionnaire (minimum value: 1, maximum value: 5 - higher scores mean a greater agreement with the statement), 1 day
Intra-SURGerY High-resolution Specimen PET/CT Imager for Margin Assessment in Early-stage Breast Cancer
NCT Number: NCT06474975
Acronym: SURGYPET
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Breast Cancer|Breast-conserving Surgery
Interventions: DEVICE: AURA 10 PET/CT
Sponsor: European Institute of Oncology
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 150
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-07
Completion Date: 2026-07
Locations: European Institute of Oncology, Milan, Italy

Summary:
This study is a diagnostic open-label, prospective, single-arm non-inferiority clinical trial.

The primary endpoint is the accuracy to detect positive invasive margins in invasive ductal carcinoma (IDC) patients by high-resolution specimen Positron Emission Tomography/Computed Tomography (PET/CT) imaging.

Primary Outcome Measures: Evaluation of the accuracy to detect positive invasive margins in IDC patients, Evaluation of intraoperative high-resolution specimen PET/CT imaging for the identification of all invasive positive margins during primary breast-conserving surgery (BCS) of invasive ductal carcinoma (IDC), as compared to perioperative gross pathology evaluation. Permanent pathology is used as the gold standard for margin assessment., 1 month
Secondary Outcome Measures: Evaluation of diagnostic performance of PET/CT in the detection of positive margins respect to gross pathology, determining the diagnostic performance of intraoperative high-resolution specimen PET/CT imaging and gross pathology to detect all positive margin;, 1 month|Detection of malignant cells in resected lymph nodes and cavity shaves, exploring the ability of intraoperative high-resolution specimen PET/CT imaging to detect the presence of malignant cells in resected lymph nodes and cavity shaves;, 1 month|Definition of optimal SUVmax cut-off, determining the optimal SUVmax cut-off in intraoperative high-resolution specimen PET/CT imaging for the correct detection of malignant vs. non-malignant tissues, using pathology results as standard-of-reference, 1 months
Local Anesthetic for Plateau Fractures
NCT Number: NCT06474949
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Tibial Plateau Fractures
Interventions: DRUG: Bupivacaine injection|OTHER: Saline
Sponsor: University of Washington
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-08-01
Completion Date: 2027-08-01

Summary:
Subjects may receive an injection at the end of the surgery to fix their broken leg that may reduce their pain and hospital stay

Primary Outcome Measures: Pain in the knee visual analogue scale 11 point scale 0(no pain) -10 (worst pain), Pain at time of visit, From date of hospitalization to end of follow-up at 6 months
Secondary Outcome Measures: Length of stay for hospitalization, Length of stay for hospitalization, From date of hospitalization up to one month post surgery
Multimodal Data-assisted Primary Screening for Allergic Rhinitis Based on Voice Recognition and Face Recognition
NCT Number: NCT06474923
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Body Image|Speech Sound Disorder
Interventions: BEHAVIORAL: Face image and voice audio
Sponsor: Zheng Liu
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 1500
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-01
Completion Date: 2025-06-01
Locations: Professor of Otolaryngology-Head & Neck Surgery Vice Director Department of ENT Tongji Hospital Tongji Medical College Huazhong University of Science and Technology Affiliation: Huazhong University of Science and Technology, Wuhan, Hubei, 430030, China

Summary:
Collect facial images and voice and audio of patients with rhinitis in the department of otolaryngology, and collect the examination results of patients with rhinitis who have received electronic fiber nasopharyngoscopy. Skin prick test to a standard panel of aeroallergens or by using the ImmunoCAP Phadiatop test for detecting immunoglobulin E antibodies against various common inhalant allergenswere detected, and a prediction model for the type of rhinitis was finally established.

Primary Outcome Measures: Allergen Test Results, Atopic status was evaluated by skin prick test to a standard panel of aeroallergens or by using the ImmunoCAP Phadiatop test (Phadia, Uppsala, Sweden) for detecting immunoglobulin E antibodies against various common inhalant allergens. Allergic rhinitis was diagnosed in patients with a positive skin prick or positive blood IgE., 30 minutes
Connective Tissue Massage in Scleroderma
NCT Number: NCT06474910
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Scleroderma
Interventions: OTHER: Connective tissue massage|OTHER: Exercise
Sponsor: Firat University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-06-21
Completion Date: 2024-09-20
Locations: Songul Baglan Yentur, Elazığ, 23100, Turkey

Summary:
The only study in the literature that examined connective tissue massage in patients with scleroderma is by Bongi et al. In this study, connective tissue massage and Mc Mennell joint manipulation technique were applied to the experimental group in addition to the home exercise program. The control group was offered only a home exercise program. The results of the study showed that the group in which connective tissue massage and Mc Mennell joint manipulation technique were applied were effective on hand functions, quality of life and mobility. The aim of our study was to examine the effects of connective tissue massage applied in addition to the exercise program.The study will include 30 patients diagnosed with scleroderma according to American College of Rheumatology/European League Against Rheumatism criteria and followed up in Fırat University Rheumatology Department. Patients will be divided into two groups; 15 patients in the first group will be applied connective tissue massage to the hand and forearm area in addition to the exercise program for hand rehabilitation. In the second group, 15 patients will only receive an exercise program.

Primary Outcome Measures: Mobility assessment, The hand function test developed for SSc patients will be used to assess specific functions of the patients. The ability to use the hand in daily tasks and limitation of movement will be evaluated. Finger movements, grasping, releasing, pronation, supination movements are scored between 0-3., 2 minutes
Secondary Outcome Measures: Skin thickness assessment, The modified Rodnan skin score (mRSS) will be used to assess skin thickness. Normal skin thickness will be scored as zero, mild skin thickening as one, difficulty in making skin folds and wrinkle-free skin thickness as two, inability to hold the skin between two fingers and severe skin thickness as three., 1 minute|Range of motion assessment, The ROM of the fingers will be measured with a finger goniometer. Distal interphalangeal (DIP), proximal interphalangeal (PIP) and metacarpophalangeal (MCP) joint flexion ranges of motion will be measured with the forearm and wrist in neutral position and fingers in maximum flexion (fist position)., 2 minutes
Comparison of Mobilization and Ozone Therapy in Impingement Syndrome
NCT Number: NCT06474897
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Impingement Syndrome
Interventions: OTHER: Ozone therapy|OTHER: Mulligan Mobilization
Sponsor: Firat University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-06-21
Completion Date: 2024-09-20
Locations: Songul Baglan Yentur, Elazığ, 23100, Turkey

Summary:
Studies investigating the efficacy of the Mulligan technique and ozone therapy in patients with shoulder impingement syndrome are limited in the literature. The aim of this study was to compare the effectiveness of Mulligan mobilization method and ozone therapy in patients with shoulder impingement syndrome. Ozone therapy will be practiced to study group. Mulligan mobilization will be practiced to control group. Pain, range of motion and function will be assessed before and after treatment.

Primary Outcome Measures: Pain assessment, The Visual Analog Scale (VAS), which quantifies parameter values that cannot be measured numerically, will be used to assess the pain intensity of the participants. VAS is a simple and commonly used scale that numerically indicates the severity of pain. A 10 cm line is divided into 10 equal parts and numbered from 0 to 10. The two extremes are defined as the minimum and maximum pain intensity., 1 minute
Secondary Outcome Measures: Range of motion assessment, n order to evaluate the active and passive range of motion of the participants, measurements will be made with a goniometer, which gives an objective and numerical value., 1 minute|Function assessment, The Shoulder Arm and Hand Problems Questionnaire (DASH) will be used to assess shoulder function. It is one of the most validated questionnaires used to assess functionality after upper extremity injuries., 2 minutes
The Safety and Efficacy of Single Antiplatelet Therapy After Pipeline Flex With Shield for Intracranial Aneurysms
NCT Number: NCT06474884
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Treatment
Sponsor: Xuanwu Hospital, Beijing
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 165
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-01-01
Completion Date: 2025-12-30
Locations: Xuanwu Hospital, Capital Medical University, Beijing, China

Summary:
The objective of this study was to evaluate the safety and efficacy of single antiplatelet therapy after Pipeline flex with Shield stent implantation for intracranial aneurysms.

Primary Outcome Measures: Rate of complete aneurysm occlusion in 6 months, The Raymond-Roy occlusion classification (RROC) is an angiographic classification scheme for grading the occlusion of flow diverter treated cerebral aneurysms (class I: complete obliteration, class II: residual neck, class III: residual aneurysm). Higher class represent a worse outcome. The percentage of Success aneurysm occlusion in which class 1 or 2 is achieved on the Raymond-Roy occlusion classification Scale at the 6 months follow-up angiographic assessments will be evaluated., assessed at 6 months after procedure|Hemorrhagic, ischemic events, or neurological deficits occurring within 6 months postoperatively., Ischemic events include intraoperative and postoperative ischemic stroke, transient ischemic attack, stent thrombosis, emergency revascularization, and cerebrovascular death.

Hemorrhagic events include: symptomatic or asymptomatic intracranial hemorrhagic events (subarachnoid hemorrhage and intracerebral hemorrhage) within 6 months after surgery; or non-intracranial hemorrhagic events (such as skin petechiae, epistaxis, gingival bleeding, gastrointestinal bleeding, genitourinary bleeding, etc.)., assessed at 6 months after procedure
Effects of Obesity on COPD
NCT Number: NCT06474858
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: COPD|Obesity|Chronic Obstructive Pulmonary Disease
Sponsor: Rijnstate Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 166
Study Design: Observational Model: |Time Perspective: p
Start Date: 2014-06-30
Completion Date: 2016-09-01
Locations: Department Of Pulmonology, Rijnstate Hospital, The Netherlands, Arnhem, Netherlands

Summary:
The purpose of this study is to investigate whether obese COPD patients experience more or less discomfort in daily life. Furthermore the investigators will evaluate if body composition or body fat distribution has effects on symptoms and performance.

Primary Outcome Measures: Dyspnoea - mMRC, Level of dyspnoea perceived in daily life measured using the Modified Medical Research Council (mMRC) dyspnoea scale. The mMRC dyspnoea scale ranges from grade 0 to 4. Higher scores mean a worse outcome., At inclusion|Dyspnoea - NCSI, Level of dyspnoea perceived in daily life measured using the Nijmegen Clinical Screening Instrument (NCSI). The NCSI ranges from grade 0 to 11. Higher scores mean a worse outcome., At inclusion|Change in dyspnoea, Level of dyspnoea using the Borg score. The Borg score ranges from grade 0 to 10. Higher scores mean a worse outcome., Before and after the 6 minute walking test
Secondary Outcome Measures: 6 minute walking test, distance walked in 6 minutes measured in metres, At inclusion