pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Evaluation of Adjuvant Use in Selective Trunk Block
NCT Number: NCT06540534
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Analgesia|Nerve Blocks|Postoperative Pain, Acute
Interventions: PROCEDURE: Dexamethasone|PROCEDURE: kontrol group
Sponsor: Gaziosmanpasa Research and Education Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 71
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, CARE_PROVIDER)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2023-01-01
Completion Date: 2024-02-01
Locations: Gaziosmanpasa Research and Education Hospital, Istanbul, 34000, Turkey

Summary:
"Evaluation of the Anesthetic and Analgesic Efficacy of Dexamethasone in Selective Trunk Blocks

Primary Outcome Measures: onset times of motor and sensory blocks, primary aim is to compare the effects of adding dexamethasone as an adjuvant to bupivacaine in selective trunk blocks on the onset times of motor and sensory blocks required for anesthesia., first 30 minutes after the block aplication
Secondary Outcome Measures: postoperative total motor block duration and analgesia duration., To compare the effects of dexamethasone as an adjuvant on postoperative total motor block duration and analgesia duration, within 24 hours after the surgery|first postoperative rescue analgesia, To evaluate the time to the first postoperative rescue analgesia, within 24 hours after the surgery hours
Bolt CSP-M Holter Study
NCT Number: NCT06540521
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Heart Failure|Bradycardia
Interventions: OTHER: No intervention
Sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 75
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08
Completion Date: 2025-10
Locations: Shanghai Chest Hospital, Shanghai, Shanghai, China|Zhejiang Greentown Cardiovascular Hospital, Hangzhou, Zhejiang, China

Summary:
The purpose of this study is to investigate the cardiac electrical characteristics in different pacing outputs and body positions in LBB area pacing (LBBAP), from which the findings may help to develop and support data validation of a novel algorithm for LBB capture determination for LBBAP.

Primary Outcome Measures: Intracardiac electrical characteristics in different pacing outputs., 12-lead ECG and LBBAP EGM characteristics and duration in different pacing outputs., received LBBAP therapy >= 1 month for 1 to 4 months (including 1 and 4 month); and an optional follow-up 6 month after the enrollment
Secondary Outcome Measures: Intracardiac electrical characteristics under different body position., 12-lead ECG and LBBAP EGM characteristics and duration under different body positions., received LBBAP therapy >= 1 month for 1 to 4 months (including 1 and 4 month); and an optional follow-up 6 month after the enrollment|The correlation between LBB capture status and LBBAP EGM characteristics, ECG and EGM characteristics in different LBB capture status, received LBBAP therapy >= 1 month for 1 to 4 months (including 1 and 4 month); and an optional follow-up 6 month after the enrollment
Application of Integrated Proteomic and Serum Metabolomic Analysis in Assessing the Efficacy and Prognosis of TACE Combined With Targeted Immunotherapy in Unresectable Hepatocellular Carcinoma
NCT Number: NCT06540508
Status: ENROLLING_BY_INVITATION
Study Type: OBSERVATIONAL
Conditions: Hepatocellular Carcinoma
Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-02-01
Completion Date: 2025-05-01
Locations: Cancer Hospital, Chinese Academy of Medical Sciences, Beijing, Beijing, 100021, China

Summary:
Application of Integrated Proteomic and Serum Metabolomic Analysis in Efficacy and Prognosis Assessment: A multi-omics analysis based on gut microbiota to evaluate the predictive value of microbial-derived proteins and metabolites on treatment efficacy and patient outcomes, developing non-invasive tools for treatment monitoring and prognostic prediction.

Primary Outcome Measures: Differences in Macroproteomics and Serum Metabolomics Expression between Effective and Ineffective Treatment Groups., Using two-dimensional liquid chromatography to separate proteins and perform data independent acquisition (DIA) for tissue and macro proteome analysis. Qualitative and quantitative analysis of DIA data was performed using data analysis software Spectronaut, and statistical algorithms were used to obtain differentially expressed proteins in HCC tissue and macro proteome between the effective and ineffective treatment groups. At the same time, non targeted metabolomics analysis methods were used to perform metabolomics analysis on serum samples from two groups of patients., Starting from the completion of treatment and evaluation for all patients, up to 6 months|Model for predicting the efficacy and prognosis of advanced HCC treatment, Perform pathway and biological function enrichment analysis of differentially expressed proteins through IPA, analyze signal pathways and interaction networks of different bacterial strains through Unipept software, and perform pathway and functional analysis of differential metabolites through MetaboAnalyst to further screen important biomarkers. By using machine learning methods and combining ROC curves to construct efficacy prediction and prognosis judgment models, the optimal biomarker combination is obtained, and a prediction model is established., Within six months after the completion of treatment and evaluation for all patients.
Reliability and Validity of The Figure of 8 Walk Test With and Without Dual-Task
NCT Number: NCT06540482
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Stroke
Interventions: DIAGNOSTIC_TEST: Reliability test
Sponsor: Afyonkarahisar Health Sciences University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 32
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-09-25
Completion Date: 2024-07-25
Locations: Afyonkarahisar Health Science University, Afyonkarahisar, 03030, Turkey

Summary:
For people with stroke, walking on a curved path is more difficult than walking on a straight path and can lead to falls. Most of the outcome scales assessing the gait of people with stroke involve walking in a straight line or with one turn. Assessing a person with stroke walking on a straight path may not be indicative of real-life gait-related performance. The Figure of 8 Walk Test (F8WT) includes a straight and curved gait that may represent the daily gait. To the best of our knowledge, there are no studies evaluating the reliability and validity of the dual-task F8W test in individuals with stroke. Therefore, the aim of this study was to evaluate the validity and reliability of the F8W and dual-task F8W test in individuals with stroke.

Primary Outcome Measures: The Figure of 8 Walk Test (F8WT), The test starts from the center of two cones at a certain distance. Participants are asked to walk around the cones in 8 shapes at their normal walking speed. The test ends when the participant reaches the starting point again. The duration of the test is recorded in seconds., The test will be administered first and third day.|Dual-task The Figure of 8 Walk Test (F8WT), The test starts from the center of two cones at a certain distance. Participants were asked to walk around the cones in 8 shapes at their normal walking speed when they conducted the cognitive or motor task. The test ends when the participant reaches the starting point again. The duration of the test is recorded in seconds., The test will be administered first and third day.
Digital Based Home Care Service for Ostomy Patients
NCT Number: NCT06540430
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Colorectal Neoplasms|Stoma Colostomy|Stoma Ileostomy
Interventions: BEHAVIORAL: The Use of a Mobile Application for Stoma Self-Care
Sponsor: Wonju Severance Christian Hospital
Collaborators: The Korean Society of Coloproctology
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 120
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-09-01
Completion Date: 2026-02-28

Summary:
This study aims to enhance the physical, psychological, and social aspects of stoma care by providing a self-management service via a smartphone application, and to evaluate the impact of this digital-based application on patients' quality of life.

Primary Outcome Measures: Peristomal Dermatitis, Evaluated using the DET Score (Discoloration, Erosion, and Tissue Overgrowth) on a scale ranging from 0 to 3., enrollment, 1 month, and 6 months.|Wound Infection, stoma retraction, bleeding, hernia, and Acute kidney injury, Incidence rate as a percentage of patients affected., enrollment, 1 month, and 6 months.|Readmission Rate, Incidence rate as the percentage of patients readmitted due to stoma-related complications., enrollment, 1 month, and 6 months.
Secondary Outcome Measures: Evaluation of Anxiety and Depression, The EuroQol-5 Dimension (EQ-5D) will be utilized to gauge the general health status.

The EQ-5D-5L score consists of two components. One component is the Visual Analogue Scale (VAS), which assesses an individual's overall health status on a scale from 0 to 100. A score of 0 represents "the worst imaginable health state," while a score of 100 represents "the best imaginable health state." The other component assesses health status across five dimensions, each rated on a five-level scale ranging from 1 (no problems) to 5 (extreme problems). The combination of these five dimensions represents a specific health state, and a value set specific to each country is used to calculate a score based on this state. This score typically ranges from 0 to 1, with 1 indicating "perfect health.", enrollment, 1 month, and 6 months.|Evaluation of Quality of Life, The Stoma Quality-of-Life Scale will be used to assess the quality of life specifically related to stoma management and its impacts.

The Stoma-QoL questionnaire consists of 20 questions, with a total score range from 20 to 80. Higher scores indicate a better quality of lif, enrollment, 1 month, and 6 months.
Effect of Knee Mobilisation on Joint Position Sense and Tissues
NCT Number: NCT06540404
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Manual Therapy|Knee
Interventions: OTHER: Pulse traction|OTHER: Continuous traction|OTHER: Sham therapy
Sponsor: The Jerzy Kukuczka Academy of Physical Education in Katowice
Sex: ALL
Age: ADULT
Enrollment: 126
Study Design: Allocation: RANDOMIZED|Intervention Model: FACTORIAL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-01-08
Completion Date: 2024-09
Locations: Motion Analysis Laboratory, The Jerzy Kukuczka Academy of Physical Education, Katowice, Poland

Summary:
The aim of this study is to evaluate the effects of traction mobilizations on position sense in the knee joint and on the biomechanical properties of the knee joint tissues.

Primary Outcome Measures: Joint position sense, A passive-active test will be used to assess the joint position sense. The parameters will be measured angular position (degree of flexion) of the knee joint in the position passively set by the researcher and in the position actively recreated by the participant in both knee joints., Before intervention and immediately after intervention
Secondary Outcome Measures: Biomechanical properties of knee joint tissues: Frequency, The values of knee joint tissue parameters will be assessed by using MyotonPro, Before intervention and immediately after intervention|Biomechanical properties of knee joint tissues: Stiffness, The values of knee joint tissue parameters will be assessed by using MyotonPro, Before intervention and immediately after intervention|Biomechanical properties of knee joint tissues: Relaxation, The values of knee joint tissue parameters will be assessed by using MyotonPro, Before intervention and immediately after intervention|Biomechanical properties of knee joint tissues: Decrement, The values of knee joint tissue parameters will be assessed by using MyotonPro, Before intervention and immediately after intervention|Biomechanical properties of knee joint tissues: Creep, The values of knee joint tissue parameters will be assessed by using MyotonPro, Before intervention and immediately after intervention
A Phase 1b Trial to Evaluate Safety of MB097 in Combination With Pembrolizumab in Melanoma Patients
NCT Number: NCT06540391
Acronym: MELODY-1
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Melanoma
Interventions: BIOLOGICAL: MB097|BIOLOGICAL: Pembrolizumab|DRUG: Vancomycin
Sponsor: Microbiotica Ltd
Collaborators: Merck Sharp & Dohme LLC
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2027-08

Summary:
A Phase 1b study to evaluate the safety and tolerability of MB097 given in combination with pembrolizumab in patients with melanoma who demonstrate primary resistance to anti-PD1 therapy.

Primary Outcome Measures: Safety and tolerability of MB097 in combination with pembrolizumab, Assessed by the following:

* The incidence and severity of treatment-emergent AEs (TEAEs) per NCI CTCAE v5.0;
* Immune-related AEs (irAEs);
* AESIs; and
* Any clinically significant abnormalities in laboratory results, physical examination findings, 12-lead ECG findings, and vital signs using the NCI CTCAE v5.0., From Visit 1 to 30 days after the last dose of study treatment
Secondary Outcome Measures: Best objective response rate (b-ORR) by RECIST v1.1 and iRECIST, b-ORR is the best response recorded from the start of the treatment until disease progression/recurrence (Complete Response (CR), Partial Response (PR), Stable Disease (SD) or Progressive Disease (PD)), Up to Week 24 or Week 105(for patients in extended treatment)|Overall response rate (ORR) by RECIST v1.1 and iRECIST, Overall response of CR, PR, SD or PD., Up to Week 24 or Week 105(for patients in extended treatment)|Disease control rate (DCR) by RECIST v1.1 and iRECIST, DCR is defined as the proportion of patients with CR, PR, or SD for 8 weeks or more, by RECIST v1.1 and iRECIST, Up to Week 24 or Week 105(for patients in extended treatment)|Duration of response, The time from first objective response until progression of disease or death, Up to Week 24 or Week 105(for patients in extended treatment)|Progression-free survival,, The time from enrollment until disease progression or death, Up to Week 24 and Week 36, and Week 105(for patients in extended treatment)|Time to progression, Time until disease progression and overall survival, Up to Week 24 or Week 105(for patients in extended treatment)|Quantification of MB097 strains at baseline and over the intervention period in patients treated with MB097 with and without vancomycin preconditioning and correlation to efficacy measures, Up to Week 24 or Week 105(for patients in extended treatment)
Stiripentol for the Treatment of Refractory Status Epilepticus
NCT Number: NCT06540378
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Status Epilepticus
Interventions: DRUG: Stiripentol
Sponsor: University Hospital Marburg
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 25
Study Design: Observational Model: |Time Perspective: p
Start Date: 2013-01-01
Completion Date: 2024-05

Summary:
The investigators retrospectively analyzed all patients who were admitted to the Department of Neurology at Marburg University Hospital between 2013 and 2023 with a diagnosis of (super)-refractory status epilepticus and who received additional treatment of SE with STP. All patients who received STP during the SE were included, regardless of previous medication.

Primary Outcome Measures: Cessation of Status epilepticus, time to cessation of SE, normally during the first days of admission, up to one week|Number of participants with cessation of SE by STP, up to one week|Median dose of STP, From date of first admission until the date of first documented improvement of status epilepticus or severe sideeffects or termination due to lack of effect or date of death from any cause, whichever came first, assessed up to 12 months
Secondary Outcome Measures: Treatment in combination with other anti-seizure medication, From date of first admission until the date of first documented improvement of status epilepticus or severe sideeffects or termination due to lack of effect or date of death from any cause, whichever came first, assessed up to 12 months|Individualised order of the anti-seizure medication administered, From date of first admission until the date of first documented improvement of status epilepticus or severe sideeffects or termination due to lack of effect or date of death from any cause, whichever came first, assessed up to 12 months
Applying the Pathways and Resources for Engagement and Participation Protocol Among People With Muscles Dystrophies
NCT Number: NCT06540365
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Duchenne Muscular Dystrophy|Becker Muscular Dystrophy
Interventions: BEHAVIORAL: Pathways and Resources for Engagement and Participation (PREP)
Sponsor: University of Haifa
Collaborators: McGill University
Sex: MALE
Age: CHILD, ADULT
Enrollment: 6
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2025-02

Summary:
Taking part in community activities is essential for health and well-being. Yet, it is highly restricted for young people with Duchenne and Becker Muscular Dystrophies (DBMD), especially as they grow into adulthood. The Participation Pathways and Resources for Engagement and Participation (PREP) intervention is designed to help remove barriers in the environment.

This study aims to see if the PREP intervention is useful and practical for youth and young adults with DBMD. The main question is: How useful is the PREP intervention for improving participation in community-based activities chosen by the participants? Participants will start the study at different times (4, 5, or 6 weeks) and work one-on-one with an occupational therapist on a leisure activity of their choice. They will have eight sessions over 12 to 18 weeks to work on this activity.

They will use the Canadian Occupational Performance Measure (COPM) every week to track their performance and satisfaction with the chosen activity before, during, and after the intervention. The findings of this study can guide clinicians, families, and policymakers to select effective approaches that promote the participation of youth and young adults with DBMD in 'real world' activities they choose. It can also increase motivation and compliance and reduce the burden on the healthcare system, families, and people with DBMD themselves.

Primary Outcome Measures: Canadian Occupational Performance Measure, A gold-standard 10-point scale that measures activity performance and satisfaction. The score ranges from 1 (unable to perform) to 10 (performs extremely well), Up to 18 weeks (once a week, during base-line and intervention phase)
A Study to Select the Dose and Evaluate the Effectiveness and Safety of the Drug Refralon®, Tablets, 1 mg for Long-term Use to Prevent Recurrence of Atrial Fibrillation/Flutter After Terminating Its Persistent Form
NCT Number: NCT06540352
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Atrial Fibrillation|Atrial Flutter
Interventions: DRUG: 4-Nitro-N-[(1RS)-1-(4-fluorophenyl)-2-(1-ethylpiperidin-4-yl)ethyl]benzamide hydrochloride|DRUG: Mannitol
Sponsor: National Medical Research Center for Cardiology, Ministry of Health of Russian Federation
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: 2024-06-03
Completion Date: 2025-12-31
Locations: National Medical Research Center for Cardiology, Ministry of Health of Russian Federation Organization, Moscow, Russian Federation

Summary:
Refralon® tablets in two different doses (1 or 2 tablets per day) will be evaluated vs. placebo in patients with persistent atrial fibrillation/flutter after synus rhythm restoration in order to prevent recurrence of arrhythmia. Efficacy and safety of Refralon® tablets will be studied, its optimal dose will be selected and its pharmacokinetics will be evaluated in 14 days, 1, 3 and 6 months.

Primary Outcome Measures: Proportion of subjects in the group who were shown to maintain sinus rhythm at the end of 6 months of follow-up;, 6 months
Clinical Study of Second-line Treatment in Advanced Colorectal Cancer With Chemotherapy With Bevacizumab or Cetuximab
NCT Number: NCT06540326
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Colorectal Cancer Metastatic
Interventions: DRUG: irinotecan liposome (II)|DRUG: fluorouracil|DRUG: cetuximab|DRUG: bevacizumab
Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-15
Completion Date: 2027-10-31

Summary:
Guidelines recommend FOLFIRI in combination with bevacizumab or cetuximab as a treatment option for advanced second-line colorectal cancer, and this study explores the efficacy and safety of a clinical study of liposomal irinotecan (II), fluorouracil, in combination with bevacizumab or cetuximab for the second-line treatment of patients with advanced colorectal cancer.

Primary Outcome Measures: Progression-free survival, Progression-Free-Survival, median progression-Free-Survival approximately 4-7 months
Secondary Outcome Measures: Overall survival, Overall survival, median overall survival approximately 8-20 months|Objective Response Rate, Objective Response Rate, through study completion, an average of 1 year.|Adverse Events, All adverse medical events occurring after the subject has received the experimental All adverse medical events occurring after the subject has received the experimental intervention, through study completion, assessed up to 50 months|Qol, Assessment of patients' quality of life by means of quality of life score questionnaires, through study completion, assessed up to 50 months
Effects of Repetitive Transcrannial Magnetic Stimulation on Non-Suicidal Self-Injury
NCT Number: NCT06540300
Status: ENROLLING_BY_INVITATION
Study Type: INTERVENTIONAL
Phases: NA
Conditions: NSSI
Interventions: OTHER: rTMS stimulation of right IPL
Sponsor: Nanjing Medical University
Sex: ALL
Age: CHILD, ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, CARE_PROVIDER)|Primary Purpose: TREATMENT
Start Date: 2024-06-30
Completion Date: 2025-06-15
Locations: Nanjing Brain Hospital, Nanjing, Jiangsu, 210029, China

Summary:
Non-suicidal self-injury (NSSI) refers to a series of direct and consequently repeated injuries to one's body without suicidal intent. At present, it has become an important issue of mental disorders. This article focuses on the formation mechanism of NSSI and the intervention effect of rTMS on NSSI patients. At the same time, NSSI patients are collected, a treatment plan is designed to complete a two-week treatment, and the results are analyzed. The aim is to provide theoretical basis for the clinical diagnosis and treatment of NSSI, and also to provide reference for the clinical diagnosis and treatment of NSSI patients.

Primary Outcome Measures: Ottawa Self-injury Inventory, OSI was evaluated by professionally trained doctors (non experimental intervention) at baseline and two weeks after treatment to assess the effectiveness of the treatment. Comparing the differences in self harm thoughts and behaviors between the baseline period and the intervention group and the control group, p\<0.05 indicates a significant difference., 2 weeks|Magnetic resonance imaging, 2 weeks
Outcomes of Surgery for Degenerative Lumbar Spine Diseases
NCT Number: NCT06540274
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Degenerative Lumbar Spine Diseases
Interventions: PROCEDURE: lumbar surgery
Sponsor: Assiut University
Sex: ALL
Age: OLDER_ADULT
Enrollment: 49
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-15
Completion Date: 2026-04-30
Locations: Mahmoud, Assiut, Egypt

Summary:
The purpose of this study is to determine the effectiveness of surgery on the elderly patients with DSD.

Primary Outcome Measures: Visual analogue scale (VAS)., Subjective measurement for back and leg pain.The highest degree which consider worse is 8-10 and the degree which consider better is 0-3, baseline
Secondary Outcome Measures: Oswestry Disability Index., To measure satisfaction of the patient and the functional disability. The score 0-20 consider better and the score 40-100 consider worse, baseline
The Study of ONO-7913, ONO-4538 and the Standard of Care as First-line Treatment in Patients Colorectal Cancer
NCT Number: NCT06540261
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Unresectable Advanced or Recurrent Colorectal Cancer
Interventions: DRUG: ONO-7913|DRUG: ONO-4538|DRUG: Fluorouracil|DRUG: Oxaliplatin|DRUG: Levofolinate|DRUG: Bevacizumab|DRUG: Cetuximab
Sponsor: Ono Pharmaceutical Co. Ltd
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 65
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2021-09-23
Completion Date: 2025-01-31
Locations: Fujita Health University Hospital, Toyoake, Aichi, Japan|National Cancer Center Hospital East, Kashiwa, Chiba, Japan|Hokkaido University Hospital, Sapporo, Hokkaido, Japan|Kobe City Medical Center General Hospital, Kobe, Hyogo, Japan|St. Marianna University Hospital, Kawasaki, Kanagawa, Japan|Kanagawa Cancer Center, Yokohama, Kanagawa, Japan|Kurashiki Central Hospital, Kurashiki, Okayama, Japan|Kansai Medical University Hospital, Hirakata, Osaka, Japan|Osaka Medical and Pharmaceutical University Hospital, Takatsuki, Osaka, Japan|Saitama Medical University International Medical Center, Hidaka, Saitama, Japan|Saitama Cancer Center, Ina, Saitama, Japan|Cancer Institute Hospital of JFCR, Koto-Ku, Tokyo, Japan|National Cancer Center Hospital, Chuo Ku, Toyko, Japan|Chiba Cancer Center, Chiba, Japan|National Hospital Organization Osaka National Hospital, Osaka, Japan|Osaka General Medical Center, Osaka, Japan|Osaka International Cancer Institute, Osaka, Japan

Summary:
To confirm the tolerability and safety of combined administration of ONO-7913, ONO-4538 and the standard of care FOLFOX in combination with bevacizumab or cetuximab as first-line treatment in patients with unresectable advanced or recurrent colorectal cancer

Primary Outcome Measures: Dose-limiting toxicities（DLT）, 28 days|Adverse event (AE), Up to 30 days after the last dose
Secondary Outcome Measures: Pharmacokinetics（Plasma concentration of ONO-7913）, Through study completion, an average of 1 year.|Pharmacokinetics（Plasma concentration of ONO-4538）, Through study completion, an average of 1 year.|Objective Response Rate (ORR), Through study completion, an average of 1 year.|Disease Control Rate (DCR), Through study completion, an average of 1 year.|Overall Survival (OS), Through study completion, an average of 3 years.|Progression-Free Survival (PFS), Through study completion, an average of 1 years.|Duration of Response (DOR), Through study completion, an average of 1 years.|Time to Response (TTR), Through study completion, an average of 1 years.|Best Overall Response (BOR), Through study completion, an average of 1 years.|Percent change in the sum diameters of the target lesions, Through study completion, an average of 1 years.|Maximum percent change in the sum diameters of the target lesions, Through study completion, an average of 1 years.|Early Tumor shrinkage（ETS）, Up to 8 weeks|Change From Baseline in Tumour Biomarkers (CEA and CA19-9), Through study completion, an average of 1 year.
Real-life Clinical Experience With Ialuadapter Study
NCT Number: NCT06540248
Acronym: Ialuadapter
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Interstitial Cystitis, Chronic|Overactive Bladder Syndrome|Recurrent Urinary Tract Infection
Interventions: DEVICE: Ialuadapter
Sponsor: Radboud University Medical Center
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 61
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-11-01
Completion Date: 2023-11-30
Locations: Radboudumc, Nijmegen, Gelderland, 6525 HB, Netherlands

Summary:
A retrospective study from a single center was performed. Quantitative and qualitative data was obtained on the use of the syringe adapter (IALUADAPTER®) in 61 patients with IC/BPS (n=48), rUTI (n=6) and mixed /other diagnoses (including OAB; n= 7) who were receiving intravesical therapy. The evaluation period was 6 months during 2018-2019. Reasons for trying the syringe adapter, reasons for continuing with it and occurrence of UTIs before and during the evaluation period were recorded. In addition, 3 year follow-up data were obtained to assess long-term usage of the syringe adapter.

Primary Outcome Measures: Number of participants who reported success (in using syringe adapter) Yes/No, pt self reported general assessment of successful instillation using the syringe adapter, 6 months
Secondary Outcome Measures: PRO; patient reported reasons for trying syringe adapter in stead of regular catheter (5 options), patient reported subjective reasons for trying the syringe adapter: options: urethral pain, convenience, fear of catheter, urine tract infections or other, 6 months|Total number of UTI's during syringe adapter use amongst all patients, Recorded UTI's reported in electronic patient database during the time they used syringe adapter, 6 months|Number of participants who use syringe adapter 3 years after initial assessment (yes/no), long term adherence to syringe adapter (still using in in clinical practice), 1 yr|PRO ; patient reported reasons to continue syringe adapter (5 options), Subjective reasons given by patients for continuing with syringe adapter compared to regular catheter. Option were : hope for fewer urine tract infections, less pain, easier to use, self -sustainability, other), 6 months
The Effect of Bone-Conducted Stimulation on Rotary Chair Time Constants in Patients With Vestibular Migraines
NCT Number: NCT06540235
Acronym: VIBRANT-VM
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Vestibular Migraine
Interventions: DEVICE: Otolith Device Active|DEVICE: Otolith Device Inactive
Sponsor: Otolith Labs
Collaborators: Dizzy and Vertigo Institute of Los Angeles
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 42
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-08-27
Completion Date: 2025-07
Locations: Dizzy and Vertigo Institute of Los Angeles, Beverly Hills, California, 90211, United States

Summary:
The goal of this clinical trial is to learn if the Otolith Labs device can improve vestibular function of subjects with vestibular migraine.

The main questions it aims to answer are:

* When the Otolith Labs device is on, are objective measures of the vestibular system better than when the device is off?
* When the Otolith Labs device is on are subjective measures of the vestibular system better than when the device is off?
* Are the objective measures related to the subjective measures?

Researchers will change the order of the device settings to ensure the changes aren't due to the order they are tested.

Participants will:

* Wear the Otolith Labs device while in a rotary chair at different settings for different tests. All of the rotary chair testing will take less than an hour.
* Answer questions about how the rotary chair testing made them feel for each test.
* Answer questions about their every-day susceptibility to motion sickness and about their vestibular migraine symptoms.

Primary Outcome Measures: Reduction of time constant, Time constant of slow-phase saccade attenuation in rotary chair, 60 minutes
Secondary Outcome Measures: Motion sickness symptom, Fast Motion Scale (FMS: min 0 to max 20, where "0" indicates no sickness at all and "20" indicates frank sickness), 60 minutes|Vestibular migraine handicap, Vestibular Migraine Patient Assessment Tool and Handicap Inventory (VM-PATHI: min 0 to max 100, where "0" indicates no handicap at all and "100" indicates complete handicap), 60 minutes|Motion sickness experience, Motion Sickness Susceptibility Questionnaire Short-form (MSSQ-Short: min 0 to max 54, where "0" indicates never sick and "54" indicates frequently sick), 60 minutes
Comparison of Effectiveness of Zinc Supplementation With ORS and Bacillus Clausii Versus Zinc With ORS and Saccharomyces Boulardii in Acute Watery Diarrhea in Paediatric Patients
NCT Number: NCT06540209
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Acute Watery Diarrhea
Interventions: DRUG: Bacillus clausii|DRUG: Saccharomyces boulardii|DRUG: Zinc|DRUG: ORS
Sponsor: RESnTEC, Institute of Research
Sex: ALL
Age: CHILD
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-04-01
Completion Date: 2023-09-30
Locations: University of Child Health Sciences, The Children's Hospital, Lahore, Punjab, 54000, Pakistan

Summary:
The current study was carried out to directly compare the effectiveness of zinc supplementation with ORS and Bacillus clausii versus zinc with ORS and Saccharomyces boulardii among the local pediatric population presenting with acute watery diarrhea.

Primary Outcome Measures: Stool frequency, Number of stools per day, 5 days|Stool consistency, Graded on a five-point scale as firm, soft, thick liquid, opaque watery, and watery, 5 days
Percutaneous Intramyocardial Septal Radiofrequency Ablation for Obstructive Hypertrophic Cardiomyopathy in Children
NCT Number: NCT06540183
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Hypertrophic Cardiomyopathy, Obstructive
Interventions: PROCEDURE: Percutaneous intramyocardial septal radiofrequency ablation
Sponsor: Xijing Hospital
Sex: ALL
Age: CHILD, ADULT
Enrollment: 16
Study Design: Observational Model: |Time Perspective: p
Start Date: 2020-09-01
Completion Date: 2024-06-07
Locations: Xijing Hospital, Xi'an, Shaanxi, 710032, China

Summary:
The primary purpose of this study was to demonstrate the safety and efficacy of percutaneous intramyocardial septal radiofrequency ablation (PIMSRA) in children and assessed its performance and functional outcomes in the follow-up. This is an observational, single-arm, single-center study.

Primary Outcome Measures: Safety composite outcome, The number of people who reach the composite safety outcome (the occurrence of at least one) of the following measured variables: 1) all-cause death; 2) heart failure; 3) ventricular fibrillation., 30 days|Feasibility outcome, The proportion of people with a peak left ventricle outflow tract gradient lower than 30 mmHg or decreased by more than 50%., 6 months
Secondary Outcome Measures: Major surgery-related adverse events, Emergency surgery, severe pericardial tamponade, conduction block due to deviation in ablation range, surgery related ventricular septal perforation, stroke and malignant arrhythmias., 30 days|LVOT gradient, Left ventricular outflow tract gradient as measured by echocardiography., through study completion, an average of 2 years|Maximum interventricular septal thickness, Maximum septal thickness as measured by echocardiography., through study completion, an average of 2 years|New York Heart Association functional scale, New York Heart Association class, including grade I, grade II, grade III, grade IV. A higher grade means worse heart function., through study completion, an average of 2 years
Studying the Effect of Ethanol Applied on the Corneal Surface During PRK Surgery.
NCT Number: NCT06540131
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Corneal Ulcer of Bilateral Eyes
Sponsor: Minia University
Sex: ALL
Age: ADULT
Enrollment: 70
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-03-05
Completion Date: 2024-06-25
Locations: Roaa Eye Center, Minya, 61111, Egypt

Summary:
The goal of this observational study is to learn about the effects of the duration of ethanol contact with the corneal surface. The main question it aims to answer is: Does this affect the behavior of corneal epithelial healing?

Primary Outcome Measures: epithelial healing, assessment of the time at which corneal epithelium is completely healed after PRK surgery, The patients were folllowed daily upto 2 weeks
Leveraging Artificial Intelligence and Multi-Omics Data to Predict Opioid Addiction
NCT Number: NCT06540105
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Opioid Use Disorder|Addiction, Opioid
Sponsor: University of California, San Diego
Collaborators: VA Palo Alto Health Care System|San Diego Veterans Healthcare System
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 300
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-20
Completion Date: 2027-09-30

Summary:
The primary goal of this proposal is to validate a novel genomic and microbiome predictive model that may be used to assess a person's risk of developing opioid use disorder (OUD). The following will be tested: (1) MODUS (Measuring risk for Opioid use Disorder Using SNPs), which is a genomic panel consisting of a set number of proven single nucleotide polymorphisms (SNP) that utilizes machine learning to determine an individual's risk; and (2) MICROUD (MICRObiome for Opioid Use Disorder), which will be a novel microbiome prediction panel for OUD risk. MODUS and MICROUD will be developed using existing public datasets with genomic and microbiome data (e.g., All of Us, Human Microbiome Project). During development of these predictive models, in parallel, an external prospective validation cohort will be recruited consisting of subjects from the University of California, San Diego, Veteran Affairs of San Diego, and Veteran Affairs of Palo Alto (each site with separate IRB). The hypothesis is that MODUS and MICROUD will have high predictive potential for identifying high risk patients for OUD.

Primary Outcome Measures: opioid use disorder at baseline based on the DSM-5 criteria, risk of opioid use disorder based on genomics, social determinants of health, microbiome, and other clinical data. Patients with OUD will be enrolled and compared to healthy controls using data from external datasets such as NIH All of Us Research Program. Diagnosis of opioid use disorder will be based on the DSM-5 criteria for opioid use disorder, baseline
Secondary Outcome Measures: response to opioid use disorder treatment after 6 months from baseline based on the DSM-5 criteria, prediction of response to opioid use disorder treatment. Remission from opioid use disorder will be based on DSM-5 criteria for remission from substance use disorder, 6 months|opioid use disorder remission after 6 months from baseline based on the DSM-5 criteria for remission, prediction of remission of opioid use disorder based on the DSM-5 criteria for remission from substance use disorder, 6 months|severity of opioid use disorder at baseline based on the DSM-5 criteria for opioid use disorder, prediction of severity of opioid use disorder based on the DSM-5 criteria for opioid use disorder, baseline|co-substance use at baseline, risk of developing co-substance use disorder based on DSM-5 criteria for substance use disorders, baseline|Relapse to opioid use disorder after 6 months from baseline, risk of relapse to opioid use disorder based on DSM-5 criteria for opioid use disorder, 6 months
Early Pregnancy Ultrasound Measurements and Prediction of First Trimester Pregnancy Loss.
NCT Number: NCT06540092
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: First Trimester Abortion
Interventions: DIAGNOSTIC_TEST: ultrasound
Sponsor: Kasr El Aini Hospital
Sex: FEMALE
Age: ADULT
Enrollment: 126
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-03-19
Completion Date: 2024-07-30
Locations: kasr Al Aini, Faculty of Medicine, Cairo University, Cairo, Old Cairo, 11562, Egypt

Summary:
Ultrasound measurements of fetus during first trimester may be an indicator of first trimester pregnancy loss. Investigators took 4 measurements of the fetus on 2 intervals during first trimester to confirm this hypothesis.

Primary Outcome Measures: The relation between early pregnancy ultrasound measurements (GSD, YSD, CRL, HR), viability, and continuation of pregnancy till 13 weeks of gestation., 2 measures of the fetus were obtained and compared to get first trimester pregnancy outcome, 6-7 weeks
Comparative Efficacy of Advanced and Traditional Wound Dressings in Post-Operative Orthopedic Care
NCT Number: NCT06540040
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Orthopaedics Wound Dressings
Interventions: DEVICE: Aquacel Ag|DEVICE: OPSITE|DEVICE: MEPILEX POST OP BORDER|DEVICE: Traditional Dressing
Sponsor: Nidhi Srivastava
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 320
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2022-08-10
Completion Date: 2022-12-10
Locations: Base Hospital Delhi cantt, New Delhi, 110010, India

Summary:
Title: Comparative Efficacy of Advanced and Traditional Wound Dressings in Post-Operative Orthopedic Care: A Randomized Controlled Trial

Objective:

The primary objective of this study is to evaluate and compare the efficacy of advanced wound dressings versus traditional gauze-based dressings in post-operative orthopedic care. The study aims to assess various parameters including patient comfort, pain management, ease of application, exudate management, and the incidence of early surgical site complications.

Primary Outcome Measures: Incidence of Early Surgical Site Complications, The primary outcome measure will be the incidence of early surgical site complications, including blisters, skin margin infection, maceration, rashes, redness, swelling, and wound dehiscence. These complications will be assessed at three time points: day 3, day 7, and day 14 post-surgery., Day 3, Day 7, Day 14 post-surgery
Secondary Outcome Measures: Pain Levels During Dressing Changes, Pain levels experienced by patients during dressing changes will be assessed using a Visual Analog Scale (VAS) from 0 to 10, where 0 corresponds to no pain and 10 corresponds to unbearable pain. This will be measured at day 3, day 7, and day 14 post-surgery., Day 3, Day 7, Day 14 post-surgery|Patient Comfort and Mobility, Patient comfort and ability to perform activities of daily living will be assessed using a 0-to-10-point scale, where 0 indicates absolute discomfort and 10 indicates no limitation due to the dressing. This will be measured at day 3, day 7, and day 14 post-surgery., Day 3, Day 7, Day 14 post-surgery|Nurses' Ease of Application and Removal of Dressings, Nurses will rate the ease of application and removal of the dressing using a 0-to-10-point scale, considering factors such as time taken, difficulty, and any issues encountered during the process. This will be measured at day 3, day 7, and day 14 post-surgery., Day 3, Day 7, Day 14 post-surgery|Patient Satisfaction Levels, Patient satisfaction with the dressing will be assessed using a structured questionnaire. This will be measured at day 14 post-surgery., Day 14 post-surgery
The Effect of Minimally Invasive Surgery on Systemic Inflammatory Response in Rectal Cancer
NCT Number: NCT06540027
Status: ENROLLING_BY_INVITATION
Study Type: OBSERVATIONAL
Conditions: Colorectal Cancer|Colorectal Adenocarcinoma|Rectal Cancer|Rectal Cancer Stage|Immune System Disorder
Interventions: PROCEDURE: rectal cacer surgery
Sponsor: Başakşehir Çam & Sakura City Hospital
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-01
Completion Date: 2025-03-01
Locations: Yigit Duzkoylu, Istanbul, 34480, Turkey

Summary:
As a hypothesis and shown in many meta-analyses and randomized controlled studies, minimally invasive surgery causes less surgical trauma and therefore less proinflammatory response and immunosuppression develop, and postoperative recovery is faster. Although various prognostic studies on the relationship between gastrointestinal cancer types and SII (systemic inflammatory index) and the use of minimally invasive surgery have been published, the high level of this response and the type of surgery in the treatment of colorectal cancer have not yet been shown to have a direct effect on SII.

Primary Outcome Measures: immune response, the level of SII, 1 day
The Difference of Weight Gain Tendencies and Obesity During Pregnancy
NCT Number: NCT06540014
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Obesity, Maternal|Weight Gain, Maternal|Birth Weight|Birth Outcome, Adverse
Interventions: OTHER: No intervention
Sponsor: Zekai Tahir Burak Women's Health Research and Education Hospital
Sex: FEMALE
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 323
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-09-01
Completion Date: 2024-06-15
Locations: Buca Seyfi Demirsoy RTH, Izmir, Turkey

Summary:
Background: Excess weight and obesity are a global pandemic, particularly among women of childbearing age. Pre-pregnancy obesity is linked to adverse maternal and neonatal outcomes, including preterm birth, macrosomia, stillbirth, and neonatal death. These risks vary by maternal age, race, and ethnicity, with rising rates among immigrant and minority women. This study investigates overweight and obesity rates in pregnant women, weight gain during pregnancy, and adherence to guidelines and possible neonatal outcomes, comparing Turkish and Syrian immigrant women.

Methods: This retrospective single-center study was conducted at Buca Seyfi Demirsoy Teaching and Research Hospital in Izmir, Turkey, over one year. Data collected included demographic information, pregnancy complications, delivery modes, maternal and neonatal anthropometric measurements, and neonatal morbidity and mortality. The study included Turkish and Syrian women with complete medical records. Statistical analyses were performed using SPSS software, with significance set at p \< 0.05.

Primary Outcome Measures: Maternal weight gain, Total body weight gained by pregnant women during pregnancy according to the measurements made by "Tanita" scale, 1 year period until inclusion
Secondary Outcome Measures: Obesity and overweight, Pregestational obesity or being overweight, 6 months
Other Outcome Measures: Neonatal morbidities, Neonatal morbidities experienced by the babies, 6 months|Adherence to the weight gain guidelines, Adherence to the recommendations of current guidelines regarding total body weight gain according to the measurements made by "Tanita" scale, 6 months