pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
DASH Diet, Quality of Life and Cardiac Parameters of Patients With Acute Coronary Syndrome
NCT Number: NCT06485765
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Acute Coronary Syndrome|Hypertension
Interventions: OTHER: Diet planning
Sponsor: Bandırma Onyedi Eylül University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 34
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2020-06-01
Completion Date: 2021-09-01
Locations: Bandırma Onyedi Eylul University, Balıkesir, Bandırma, 10200, Turkey

Summary:
The clinical trail study aimed to determine effect of DASH eating plan on cardiac parameters and quality of life in hypertensive individuals diagnosed with acute coronary syndrome.

The main questions it aims to answer are:

1. DASH diet improve quality of life?
2. DASH diet improve cardiac parameters?

The researchers assessed the results of 12 weeks of the DASH diet.

Patients will apply the DASH diet prepared individually by the researchers for 12 weeks.

Primary Outcome Measures: Quality of Life (MacNew Heart Disease Health-Related Quality of Life Scale), The quality of life of the patients at the beginning of the study and at the end of the 12th week was assessed with the MacNew Heart Disease Health-Related Quality of Life Scale. The scale is a different form of the Post-MI Quality of Life Scale, which was developed to determine especially depression and anxiety in patients with acute MI (Myocardial Infarction) and which can be evaluated by patients responding to the scale. The scale can be used in different cardiac patients such as MI, angina pectoris and heart failure patients and there is a high correlation between it and other tools that assess quality of life. MacNew Heart Disease Health-Related Quality of Life Scale consists of three sub-dimensions (emotional, physical and social) and 27 items in 7-point Likert type. The answer to each item is between 1-7. A low score indicates poor quality of life, while a high score indicates better quality of life., 12 week|Ejection Fraction (%), A measurement of the percentage of blood leaving the heart each time it squeezes (using echocardiographic imaging), 12 weeks
Valproate Versus Propranolol in Migraine
NCT Number: NCT06485726
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Migraine Disorders
Interventions: DRUG: Valproic Acid 500 MG|DRUG: Propranolol
Sponsor: Kafrelsheikh University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 600
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2023-01-23
Completion Date: 2024-07-05
Locations: Kafr Elsheikh University Hospital, Kafr Ash Shaykh, 33511, Egypt

Summary:
Investigators aim to compare the effect of valproate versus propranolol in migraine by assessing the absolute reduction in MMD in each group and the percentage of patients who achieved ≥ 50% reduction in the monthly headache days frequency compared to the baseline frequency.

Primary Outcome Measures: The change in migraine days per 28 days, The investigators will assess the change in migraine days per 28 days in each group., 28 days
Secondary Outcome Measures: The total number of migraine days after three months of treatment, The investigators will assess the total migraine days after three months of regular use of 500-1000 mg valproate daily or propranolol (160 mg once daily)., 3 months|The percentage of patients who achieved ≥ 50% change in the monthly migraine days frequency compared to the baseline frequency., We will assess The percentage of patients who achieved ≥ 50% reduction in the monthly headache days frequency compared to the baseline frequency in each group, 3 months|HIT-6 score absolute change in each group after three months of treatment, The investigators assessed the absolute change in HIT6 score; the Headache Impact Test-6 (HIT-6) evaluated the burden of headache in each group; the HIT-6 consists of six items: pain, social functioning, role functioning, vitality, cognitive functioning, and psychological distress, the patient answers each of the six related questions using one of the following five responses: "never," "rarely," "sometimes," "very often," or "always." These responses are summed to produce a total HIT-6 score that ranges from 36 to 78, where a higher score indicates a more significant impact of headaches on the daily life of the respondent. It has four impact grades: little-to-no impact (HIT-6 score: 36-49), moderate impact (HIT-6 score: 50-55), substantial impact (HIT-6 score: 56-59), and severe impact (HIT-6 score: 60-78), 3 months|Incidence of Treatment-Emergent Adverse Events, The safety of treatment was evaluated by monitoring and documenting treatment-emergent adverse events (TEAE) in patients through regular follow-up procedures for three months., 3 months
Efficacy and Safety of Trifluridine/Tipiracil Combined With Fufuquitinib for Third-line Treatment of mCRC
NCT Number: NCT06485713
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Metastatic Colorectal Cancer|Drug Therapy
Interventions: DRUG: trifluridine/tipiracil combined with fufuquitinib|DRUG: fufuquitinib|DRUG: Trifluridine/tipiracil
Sponsor: First Affiliated Hospital of Wenzhou Medical University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, CARE_PROVIDER)|Primary Purpose: TREATMENT
Start Date: 2024-03-01
Completion Date: 2026-06-01
Locations: The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China

Summary:
To evaluate the efficacy and safety of trifluridine/tipiracil combined with fufuquitinib versus trifluridine/tipiracil and fufuquitinib in patients with unresectable metastatic colorectal cancer.

Primary Outcome Measures: Progression-free survival, up to 24 weeks
Secondary Outcome Measures: Total survival time, up to 2 years
Peers and Technology for Adherence, Access, Accountability, and Analytics (PT4A)
NCT Number: NCT06485700
Acronym: PT4A
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cardiovascular Disease|Hypertension
Interventions: OTHER: Peer Delivery of Medications|OTHER: Health Information Technology (HIT) Platform
Sponsor: NYU Langone Health
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1140
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-10-01
Completion Date: 2028-12-31
Locations: Study Site, Webuye, Bungoma County, Kenya|Study Site, Kitale, Trans Nzoia County, Kenya|Study Site, Eldoret, Uasin Gishu County, Kenya

Summary:
Peer-based medication delivery decreases the cost of transportation and the opportunity cost of travel while HIT can support peer activities by facilitating targeted adherence counseling, teleconsultation, synchronization of clinical care, and pharmacy activities. The investigators have implemented a pilot program of door-to-door peer-based medication delivery and HIT in western Kenya, and preliminary data indicate improved adherence and blood pressure. However, the effectiveness of this implementation strategy is not fully established. Therefore, the objective of the study is to use the PRECEDE-PROCEED framework to conduct transdisciplinary implementation research to test the hypothesis that integrating peer delivery of medications with HIT (PT4A) improves medication adherence and reduces blood pressure among patients with uncontrolled hypertension in western Kenya.

Primary Outcome Measures: Mean Change in SBP from Baseline to Month 12, Baseline, Month 12|Pill Count Adherence Ratio (PCAR) at Month 12, PCAR is calculated as the percentage of pills taken over the previous month and is measured over a 30-day time period., Month 12|Number of Patient E-Signatures, Measure of fidelity., Up to Month 12|Number of Completed HIT Forms, Measure of fidelity., Up to Month 12
Secondary Outcome Measures: Mean Change in SBP from Baseline to Month 6, Baseline, Month 6|Percentage of Participants with Controlled Blood Pressure (BP) at Month 6, BP measured using automatic BP monitor., Month 6|Percentage of Participants with Controlled BP at Month 12, BP measured using automatic BP monitor., Month 12
Low Intensity Focused Ultrasound for Binge Eating Disorder
NCT Number: NCT06485687
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Binge-Eating Disorder
Interventions: DEVICE: LIFU Neuromodulation
Sponsor: Ali Rezai
Sex: ALL
Age: ADULT
Enrollment: 15
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10-01
Completion Date: 2027-12-31

Summary:
This study is a prospective, single-center, single-arm early feasibility study, to establish safety and tolerability of LIFU for neuromodulation in patients with Binge Eating Disorder (BED)

Primary Outcome Measures: Occurrence of Treatment Emergent Adverse Events, All adverse events that are related to LIFU procedure will be assessed, [baseline and day 7 and 90 after study procedure
Secondary Outcome Measures: Effect of LIFU on Food craving, Visual Analog scale and food diary, Day 1, Day 7, Day 30, Day 60, Day 90; comparisons will be made relative to baseline, pre-LIFU.
Long-Term Organ Damage: Anifrolumab Versus Real-World Standard of Care in Adult Patients With Active Systemic Lupus Erythematosus
NCT Number: NCT06485674
Acronym: LASER
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Long-Term Organ Damage in Adult Patients With Active Systemic Lupus Erythematosus
Sponsor: AstraZeneca
Collaborators: IQVIA Pvt. Ltd|University Health Network, Toronto
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 478
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-05-09
Completion Date: 2024-10-31
Locations: Research Site, Toronto, Ontario, M5G 1L7, Canada

Summary:
This is an External control arm study to generate evidence on the comparative effect of anifrolumab plus Standard of Care in TULIP versus Real World Standard of Care on organ damage in adult patients with moderately to severely active Systemic lupus erythematosus (SLE). Patients who initiated 300 mg of anifrolumab in TULIP-1 or -2 will be indexed at the date of initiating anifrolumab and will be followed up until the earliest occurrence of death, loss to follow-up, trial dis-enrollment, or week 208 assessment (in LTE study).

Primary Outcome Measures: SLICC/ACR damage index (SDI) at week 208, Organ Damage measured using the SDI . The SDI is designed to assess irreversible damage across 12 organ systems in SLE patients, independently of cause or attribution., 208 weeks
Secondary Outcome Measures: SDI at week 208 by organ damage at baseline, To estimate the effect of anifrolumab plus SOC in TULIP compared to RW SOC on organ damage accrual as measured by SDI at 208 weeks post-treatment initiation in the following subgroups: patients with no organ damage at baseline, and patients with any organ damage at baseline., 208 weeks|Time to first organ damage progression as measured by SDI., To estimate effect of anifrolumab plus SOC in TULIP compared to RW SOC on time to first organ damage progression as measured by SDI., 208 weeks|Cumulative steroid intake, To estimate the effect of anifrolumab plus SOC in TULIP compared to RW SOC on cumulative steroid intake (prednisone equivalent) up to 208 weeks post-treatment initiation., 208 weeks|Average daily steroid dose, To estimate the effect of anifrolumab plus SOC in TULIP compared to RW SOC on average daily steroid dose (prednisone equivalent) at 208 weeks post-treatment initiation., 208 weeks
Effect of Captopril on GLS in Duchenne Myodystrophy
NCT Number: NCT06485661
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: EARLY_PHASE1
Conditions: Effect of Drug
Interventions: DRUG: Captopril Tablets
Sponsor: Ain Shams University
Sex: MALE
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-01-01
Completion Date: 2024-09-30
Locations: Ain Shams university, Cairo, Egypt

Summary:
To outline the intermediate term effect of prescribing Captopril as an add on therapy on Left ventricular functions as measured by Global longitudinal strain in patients with Duchenne myodystrophy (DMD)

Primary Outcome Measures: The impaired global longitudinal strain will change in echo in the number of participants with duchenne myodystrophy, Impaired Global longitudinal strain will be changed in echo after 6 months of treatment with Captopril in patients with duchenne myodystrophy, 6 months
Real-life-persistence to Antifibrotic Treatments
NCT Number: NCT06485635
Acronym: REPEAT
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Idiopathic Pulmonary Fibrosis
Interventions: DRUG: Nintedanib|DRUG: Pirfenidone
Sponsor: Boehringer Ingelheim
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 800
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-09
Completion Date: 2024-09-23
Locations: Clinityx, Boulogne-Billancourt, 92100, France

Summary:
This study will help to better understand the persistence rate to antifibrotic (AF) treatment in real life in France and to identify potential areas for improvement by investigating the factors associated with a non-persistence rate to AF treatment.

Primary objective of the study is to measure the percentage of patients still treated up to 30 months after AF treatment initiation.

Primary Outcome Measures: Persistence to antifibrotic (AF) treatment (measured as percentage of patients still treated up to 30 months after AF treatment initiation), up to 30 months
Secondary Outcome Measures: AF prevalence in French population, up to 5 years|AF incidence in French population, up to 4 years|Number of AF treated patients split by indication, Indications:

* Idiopathic Pulmonary Fibrosis (IPF)
* Interstitial Lung Disease associated with Systemic Sclerosis (SSc-ILD)
* Progressive Pulmonary Fibrosis (PPF), up to 2 years|Number of patients adherent to AF treatment, In incident AF patients, percentage of days covered (PDC) will be calculated at different time point to measure the adherence to AF treatment for patients persistent to treatment at this time point.

The PDC is the ratio dividing the number of days exposed by the number of days in the period evaluated.

A PDC≥ 80% is considered as a good adherence to medication., up to 30 months|Percentage of the target cumulative dose of treatment received by the patients, up to 30 months|Influence of factors (yes/no) associated with persistence to AF treatments, For a pre-determined list of variables (as defined in the study protocol) in incident AF patients, a multivariate time-dependant Cox model will test several covariates to check if they are associated with persistence to AF treatment., up to 30 months|Number of patients with switch from one AF treatment to the another with no treatment stop, up to 5 years|Number of patients at site of follow-up (identified as 2 lung function tests performed in the center), up to 5 years|Overall Survival (defined as time from index date (first reimbursement of AF treatment) to death from any cause), up to5 years|Event-free survival, Defined as the time from index date to

* oxygenotherapy onset
* hospitalisation for respiratory exacerbations
* hospitalisation for other respiratory diseases
* ath from any cause, up to 5 years
Clinical Study of Radical Right Hemicolectomy Versus Radical Right Hemicolectomy Combined With Indocyanine Green Fluorescence Imaging Lymphatic Tracer Dissection for the Treatment of Right Colon Cancer
NCT Number: NCT06485609
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Colon Cancer
Interventions: PROCEDURE: radical right hemicolectomy combined with indocyanine green fluorescence imaging lymphatic tracer dissection
Sponsor: Sun Yat-sen University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 520
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-10
Completion Date: 2031-07-01
Locations: The Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou, China

Summary:
The purpose of this study is to explore the clinical outcomes of indocyanine green fluorescence using in laparoscopic radical right hemicolectomy for right colon cancer（T1-T4a N+ M0）

Primary Outcome Measures: Disease-free survival rate, 3 years
Secondary Outcome Measures: Number of lymph nodes cleared, Immediately after surgery
HOPE at Heart (HOPE) of Donor Hearts After Circulatory Death (DCD) Using the XVIVO Heart Assist Transport System.
NCT Number: NCT06485596
Acronym: HOPE@Heart
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Heart Failure
Interventions: DEVICE: XVIVO Heart Assist Transport System
Sponsor: XVIVO Perfusion
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07
Completion Date: 2026-06

Summary:
The purpose of the clinical investigation is to support the use of direct procurement of donor hearts in donation after circulatory death followed by hypothermic oxygenated perfusion using the XVIVO Heart Assist Transport System. Thereby increasing the utilization of DCD donor hearts in donation after circulatory death.

The primary objective is to evaluate patient survival after direct procurement and hypothermic oxygenated machine perfusion of DCD donor hearts using the XVIVO Heart Assist Transport System.

The secondary objectives are to evaluate patient outcomes and graft function post-transplant.

Primary Outcome Measures: Patient survival, 30 days post-transplant
Secondary Outcome Measures: Cardiac related mortality, 30 days post-transplant|Incidence of Mechanical circulatory support, 30 days post-transplant|Incidence of severe Primary Graft Dysfunction (PGD) at 24 hours post-transplant (Kobashigawa et al., 2014), 30 days post-transplant|Cardiac function as assessed by left ventricular ejection fraction (LVEF) at 24 hours and 30 days post-transplant, 30 days post-transplant|Incidence of perfused hearts which are not used for transplantation, 30 days post-transplant|Total duration of ICU stay (days), 30 days post-transplant|Incidence of biopsy proven rejections > 1 ACR (leading to changed immunosuppressive regime), 30 days post-transplant|Cardiac related mortality at 6 months post-transplant, 6 months post-transplant|Cardiac function as assessed by left ventricular ejection fraction (LVEF), 6 months post-transplant|Number of days until hospital discharge from index procedure, 30 days post-transplant|Incidence of biopsy proven rejections > 1 ACR (leading to changed immunosuppressive regime), 6 months post-transplant
Comparison Between the Efficacy of CIMT and NDT Along With Conventional Physiotherapy Treatment on Upper Extremity Rehabilitation Among Patients of Stroke
NCT Number: NCT06485583
Acronym: CIMT
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Strokes Thrombotic
Interventions: OTHER: Constraint-induced movement therapy|OTHER: Neurodevelopmental Treatment
Sponsor: Shalamar Institute of Health Sciences
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 10
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-06-28
Completion Date: 2025-01-29
Locations: Ayesha Fatima, Lahore, Punjab, 54000, Pakistan

Summary:
To compare the efficacy of CIMT and NDT among stroke patients To study the phenomena of transfer of training To study relationship between the MMSE score and stroke rehabilitation

Primary Outcome Measures: upper extremity rehabilitation, The Motor Assessment Scale (MAS) by Carr and Shepherd is a clinical tool used to evaluate upper extremity rehabilitation in stroke patients. It assesses motor recovery through eight items, each reflecting daily activities, scored on a 7-point scale from 0 (unable to perform) to 6 (optimal performance). For upper extremity assessment, the MAS includes tasks like hand movements (grasping, releasing, manipulating objects), advanced hand activities (fine motor skills such as writing or buttoning a shirt), and upper arm function (reaching, lifting, placing objects). Patients perform these tasks while clinicians observe and score their performance. The MAS provides a quantitative measure of motor recovery, facilitating progress tracking, goal setting, and personalized therapy interventions, making it a reliable and straightforward tool for capturing functional changes in stroke patients., 6 WEEKS
A Prospective Cohort Study of Neoadjuvant Chemotherapy Plus Sintillumab in the Treatment of Resectable NSCLC
NCT Number: NCT06485557
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Resectable Non-small Cell Lung Cancer
Interventions: DRUG: sintilimab plus platinum-based chemotherapy|DRUG: sintilimab plus platinum-based chemotherapy|DRUG: sintilimab plus platinum-based chemotherapy
Sponsor: Tang-Du Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 90
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2026-08-01

Summary:
This study uses a prospective cohort design.Subjects are randomly divided into three groups (A, B, C) before surgery. Group A gets 3 cycles of sintilimab + chemo, Group B gets 2 cycles + 1 cycle, and Group C gets 1 cycle + 2 cycles.

Non-squamous NSCLC subjects receive pemetrexed/albumin paclitaxel + platinum, while squamous NSCLC subjects get albumin paclitaxel + platinum.

Primary Outcome Measures: pCR rate, rate of pathological complete response, 4 months
Secondary Outcome Measures: MPR rate, rate of major pathologic response, 4 months|R0 resectability rate, R0 resection indicates a microscopically margin-negative resection, in which no gross or microscopic tumor remains in the primary tumor bed, 4 months|The completion rate of surgery on schedule, The rate of surgical completion as per the pre-established schedule represents a crucial metric in evaluating the efficiency and precision of medical institutions, 4 months
Neoadjuvant Adebrelimab in Resectable SCLC: A Randomized Trial
NCT Number: NCT06485544
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Small Cell Lung Cancer (SCLC)
Interventions: DRUG: Adebrelimab + Etoposide + Platinum-based Therapy|DRUG: Etoposide + Platinum-based Therapy
Sponsor: Tang-Du Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 104
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-01
Completion Date: 2026-12-30
Locations: Tangdu Hospital Affiliated to the Fourth Military Medical University, Xi'an, Shannxi, 710038, China

Summary:
This study is a randomized, open-label, multicenter exploratory research aiming to evaluate the efficacy and safety of Adebrelimab in combination with chemotherapy (etoposide and platinum-based therapy) as neoadjuvant treatment for resectable stage I-IIIB (stage IIIB limited to T1-4N1-2M0) small cell lung cancer (SCLC). The study is primarily conducted at Tangdu Hospital of the Fourth Military Medical University. A total of 104 patients with stage IA-IIIB SCLC (stage IIIB limited to T1-4N1-2M0) will be enrolled and randomized 1:1 to receive either Adebrelimab plus chemotherapy or chemotherapy alone. Each patient will undergo 3 cycles of study treatment followed by a 3-4 week break before surgery. Treatment will be discontinued if patients experience disease progression, intolerable drug-related adverse events, withdrawal of informed consent, or other specified conditions during the study. Effectiveness and safety outcomes will be monitored throughout the trial. The primary objective is to evaluate pathological complete response (pCR) with Adebrelimab combination therapy. Secondary objectives include assessing event-free survival (EFS), major pathological response (mPR), objective response rate (ORR), disease-free survival (DFS), and safety.

Primary Outcome Measures: Pathological complete response rate(pCR), Pathologic complete response (pCR), defined as the absence of tumor cells in all specimens (ypT0N0) ., 7 days after surgery.
Secondary Outcome Measures: Event-free survival (EFS), The length of time after primary treatment for a cancer ends that the patient remains free of certain complicationsor events that the treatment was intended toprevent or delay., Long term follow-up will continue until preoperative progression, postoperative recurrence, or death from any cause at least two years.|Major pathologic response (MPR), MPR is defned as less than 10% residual viable tumor after neoadjuvant therapy., 7 days after surgery.|Objective response rate (ORR), Per Response Evaluation Criteria in Solid Tumorsersion 1.1(REClST 1.1) using Investigator assessments, is defneas the number (%) of patients with responseof Complete Response or Partial Response., 7 days before surgery|Disease-free survival(DFS), The length of time after primary treatment for a cancer ends that the patient survives without any signs or symptoms of that cancer., Long term follow-up will continue until the death of the subiect or the end of the studv. at least two years
Integration of the 5G-based Remote Healthcare System in Critical Care
NCT Number: NCT06485518
Acronym: IT5GRHSCI
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Emergency Medicine|Telemedicine|Augmented Reality
Interventions: BEHAVIORAL: The 5G RHS group receiving audio-video conferencing and effective data management for decision-making via augmented reality platform RealHealthcare System.
Sponsor: Sir Run Run Shaw Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 220
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-07-01
Completion Date: 2023-08-01
Locations: Sir Run Run Shaw Hospital Zhejiang University School of Medicine, Hangzhou, Zhejiang, 310012, China

Summary:
The primary objective of this initial report is to address the following questions: Under what circumstances do clinical teams at satellite locations utilize the 5G RHS? Does the implementation of 5G RHS result in significant clinical enhancements? Furthermore, additional analyses will be conducted to assess specific improvements in various use cases (e.g., emergency room, diagnosis, treatment, task guidance, and medical education) and to examine whether factors such as the expertise of central physicians, patient and physician locations, and the timing of calls influence clinical outcomes.

Primary Outcome Measures: critical conditions, For all patients receiving care through the 5G RHS platform during the specified time period, we gathered clinical data from electronic health records (EHRs). This data encompasses information related to critical conditions., from July 2022 to June 2023|background situation, For all patients receiving care through the 5G RHS platform during the specified time period, we will gather clinical data from electronic health records (EHRs). This data encompasses information related to the emergency situation,, from July 2022 to June 2023|reasons for consultation, For all patients receiving care through the 5G RHS platform during the specified time period, we will gather clinical data from electronic health records (EHRs). This data encompasses information related to reasons for seeking remote consultation (including complex challenges, new medical scenarios, and educational interactions)., from July 2022 to June 2023|treatment outcomes, For all patients receiving care through the 5G RHS platform during the specified time period, we will gather clinical data from electronic health records (EHRs). This data encompasses information related to treatment outcomes., from July 2022 to June 2023
Isotretinoin Versus Excimer Light an Adjuvant in Treating Onychomycosis
NCT Number: NCT06485505
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Onychomycosis
Interventions: DRUG: ISOtretinoin 10 MG|DEVICE: excimer light|DRUG: Itraconazole 200 mg
Sponsor: Zagazig University
Sex: ALL
Age: ADULT
Enrollment: 36
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-07
Completion Date: 2024-12

Summary:
3 groups of patients with onychomycosis will be recruited. Group A will receive itraconazole alone. Group B will receive itraconazole + low dose isotretinoin and group C will be treated with itraconazole + excimer light sessions.

Primary Outcome Measures: Clinical improvement, using onychomycosis severity index at baseline, last session and follow up vistis, 6 month frame: clinical assessment will be done at first presentation of the patients, monthly during the treatment course, at the last visit and 3 month after stoppage of treatment at the follow up visit in a total span of 6 months|Culture, Fungal culture to detect fungal cause and presence after treatment, 6 month frame: Fungal culture will be done at first presentation of the patients, at the last visit and 3 month after stoppage of treatment at the follow up visit in a total span of 6 months
Aneurysm Embolization System for Intracranial Aneurysms
NCT Number: NCT06485492
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Ruptured Cerebral Aneurysm
Interventions: PROCEDURE: Implant an aneurysm embolization system
Sponsor: Jiangsu CED Medtech Co., Ltd
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 150
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2026-07-31

Summary:
The purpose of this clinical study was to evaluate the safety and efficacy of the aneurysm embolization system produced by Jiangsu Changyida Medical Technology Co., Ltd. in patients with intracranial aneurysms (including ruptured aneurysms)

Primary Outcome Measures: Adequate embolization rate at 1 year follow-up., Full embolization means that the aneurysm is completely occluded or only the neck remains., 1year
Effective Ads for Quitting Smoking
NCT Number: NCT06485479
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Smoking Behaviors
Interventions: BEHAVIORAL: Intervention ads|BEHAVIORAL: Control ads
Sponsor: University of North Carolina, Chapel Hill
Collaborators: Food and Drug Administration (FDA)|National Institute on Drug Abuse (NIDA)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1400
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-08-15
Completion Date: 2024-10-15
Locations: University of North Carolina, Chapel Hill, North Carolina, 27599, United States

Summary:
The main purpose of this trial is to identify effective quit smoking ads for people who smoke menthol cigarettes. Investigators will conduct an online randomized trial with a nationally representative sample of \~1,400 US adults (ages 21+) who smoke menthol cigarettes.

Primary Outcome Measures: Perceived message effectiveness for motivation, Perceived effectiveness of the ads at encouraging quitting smoking, measured by 1 survey item for each ad (6 items total). Range 1 to 5, with higher values indicating higher perceived message effectiveness., During exposure to the ads, assessed during one-time online 15-minute survey.
Secondary Outcome Measures: Perceived message effectiveness for response efficacy, Perceived effectiveness of the ads at communicating the benefits of quitting smoking, measured by 1 survey item for each ad (6 items total). Range 1 to 5, with higher values indicating higher perceived message effectiveness., During exposure to the ads, assessed during one-time online 15-minute survey.|Perceived message effectiveness for self-efficacy, Perceived effectiveness of the ads at creating confidence that one can quit smoking, measured by 1 survey item for each ad (6 items total). Range 1 to 5, with higher values indicating higher perceived message effectiveness., During exposure to the ads, assessed during one-time online 15-minute survey.|Intentions to quit smoking, Motivation to quit smoking, measured by 1 survey item. Range 1 to 5, with higher values indicating higher intentions to quit smoking., After exposure to the ads, assessed during one-time online 15-minute survey.|Response efficacy, Belief that quitting smoking improves health, measured by 1 survey item. Range 1 to 5, with higher values indicating higher response efficacy., After exposure to the ads, assessed during one-time online 15-minute survey.|Self-efficacy, Confidence that one can quit smoking, measured by 1 survey item. Range 1 to 5, with higher values indicating higher self-efficacy., After exposure to the ads, assessed during one-time online 15-minute survey.
TACE Plus Camrelizumab and Apatinib for Unresectable Hepatocellular Carcinoma
NCT Number: NCT06485466
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Unresectable Hepatocellular Carcinoma|Transarterial Chemoembolization|Camrelizumab|Apatinib
Interventions: COMBINATION_PRODUCT: TACE plus camrelizumab and apatinib|COMBINATION_PRODUCT: Camrelizumab and apatinib
Sponsor: Guohui Xu
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 101
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-01
Completion Date: 2028-06-30
Locations: Sichuan Cancer Hospital and Research Institute, Chengdu, Sichuan, 610041, China

Summary:
Hepatocellular carcinoma (HCC) is the sixth most common cancer and the third most common cause of cancer-related death worldwide. The majority of patients with HCC are diagnosed as intermediate or advanced stage disease, and not eligible for curative treatments including transplantation, resection, and ablation. Transarterial chemoembolization (TACE) is recommended as first-line treatment for patients with intermediate-stage HCC, while it is also widely used in the unresectable HCC.

The clinical efficacy and safety in advanced HCC patients of camrelizumab plus apatinib were reported in phase 3 trial (CARES-310). Camrelizumab plus apatinib with a median progression-free survival of 5.7 months and a median overall survival of 22.1 months in advanced HCC.

This study is randomized, open-label, multicenter controlled trial; which was focused in initial BCLC-B/C HCC patients. This study aimed to compare the efficacy and safety of TACE plus programmed death-1 inhibitor (camrelizumab), and anti-angiogenic therapy (apatinib) with camrelizumab plus apatinib.

Primary Outcome Measures: progression free survival (PFS), Progression free survival period refers to the period from the beginning of treatment to the time when patients with cancer progress is observed or death occurs for any reason., Up to 24 months, from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Secondary Outcome Measures: objective response rate (ORR), The proportion of patients whose tumor volume reduction reaches the predetermined value and can maintain the minimum time limit. It is the sum of the proportion of complete response (CR) and partial response(PR). That is, ORR

* CR + PR minimum time limit. It is the sum of the proportion of complete response (CR) and partial response(PR). That is, ORR
* CR + PR, within 1 year|disease control rate (DCR), It is the sum of the proportion of complete response (CR), partial response(PR) and stable disease(SD). That is, DCR

= CR + PR + SD, within 1 year|overall survival (OS), the time from the beginning of treatment to death caused by any reason (the last follow-up time is for the patients who lost the visit; the end of the study is for the patients who are still alive), From date of randomization until the date of study completion or date of death from any cause, whichever came first, assessed up to 48 months
Predictive Urodynamic Parameters for The Treatment Efficacy of Onabotulinum A Toxin in Neurogenic Lower Urinary Tract Dysfunction
NCT Number: NCT06485453
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Neurogenic Bladder Disorder
Interventions: DRUG: Botox 200 UNT Injection
Sponsor: University of Gaziantep
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 74
Study Design: Observational Model: |Time Perspective: p
Start Date: 2013-09-01
Completion Date: 2024-06-01

Summary:
Purpose: To evaluate urodynamic parameters predicting the treatment efficacy of onabotulinumtoxin A (onaBoNT-A) in patients with neurogenic lower urinary tract dysfunction (NLUTD).

Methods: Patients with NLUTD who received 200 IU onaBont-A injections at Gaziantep University, Faculty of Medicine, Department of Urology between September 2013 and September 2023 were included in the study. Urodynamic parameters, including cystometric capacity, detrusor pressure (Pdet), and compliance, detrusor leak point pressure (DLPP), phasic or terminal neurogenic overactivity were assessed. Additionally, the correlations between these parameters and treatment outcomes were analyzed.

Changes in the number of pads used per day due to UI were assessed every 3 months during the postoperative period. The time lapsed to return to the pad usage levels before onaBoNT-A injections was recorded as the duration of the benefit.

Preoperative urodynamic data of the patients were compared between groups. Additionally, a subgroup analysis was conducted in patients who benefited from treatment to evaluate the correlation between treatment efficacy, duration of benefit from treatment, and urodynamic parameters.

Primary Outcome Measures: Number of patients after onabotulinum a toxin injections who respond to treatment, received 200 IU of onaBoNT-A injections for the first time, and followed up regularly for the duration of at least 12 months.
Secondary Outcome Measures: treatment succes duration of patients, The duration of the decrease in the number of pads used was calculated, Received 200 IU of onaBoNT-A injections for the first time, and followed up regularly for the duration of at least 12 months.
The Effects of Preoperative Botulinum Toxin A Injection on Respiratory System Function
NCT Number: NCT06485440
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Botulinum Toxins, Type A|Hernia
Interventions: DRUG: Dysport 300 UNT Injection
Sponsor: Swissmed Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 10
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-25
Completion Date: 2024-11-01
Locations: Swissmed Hospital, Gdańsk, 80-215, Poland

Summary:
Hernias are common complications post-abdominal surgeries, often leading to significant issues such as "loss of domain," where organs shift permanently, reducing abdominal cavity capacity. This complicates surgeries as there is insufficient space to reposition organs. A growing method to address this involves preoperative botulinum toxin A (BTA) injections into lateral abdominal muscles. BTA induces temporary paralysis, expanding the abdominal cavity and aiding muscle approximation for hernia repair. Initiated in 2009, this approach is particularly used for defects over 10cm. However, standardized protocols are lacking, and the impact on respiratory function remains under-researched. This study aims to evaluate the effects of preoperative BTA injections on respiratory volumes. Ten patients will undergo pulmonary function tests before and after BTA injections. The study will focus on changes in respiratory efficiency, given the respiratory challenges associated with large hernias and the "loss of domain" effect.

Primary Outcome Measures: FVC (forced vital capacity), FVC before and 4-6 after BTA injection, 4-6 weeks|FEV1 (forced expiratory volume in one second), FEV1 before and 4-6 after BTA injection, 4-6 weeks|PEF (peak expiratory flow), PEF before and 4-6 after BTA injection, 4-6 weeks
Other Outcome Measures: MEF (Maximal Mid Expiratory Flow), MEF before and 4-6 after BTA injection, 4-6 weeks|FIVC (Forced Inspiratory Vital Capacity), FIVC before and 4-6 after BTA injection, 4-6 weeks
Investigating the Association Between Central Sensitization and Breathing Pattern Disorders
NCT Number: NCT06485414
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Central Sensitisation
Sponsor: Sahmyook University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-03
Completion Date: 2024-08-31
Locations: Honam University, Gwangju, 62399, Korea, Republic of

Summary:
Breathing pattern disorders can cause mechanical, physiological, and psychological issues in the body, contributing to the initiation and chronicity of pain. Therefore, considering breathing patterns is significant in managing chronic pain, yet direct research on central sensitization and breathing pattern disorders remains scant. This study aims to analyze the correlation between central sensitization and breathing pattern disorders in adults by assessing both respiration and pain.

Primary Outcome Measures: Respiratory function, This study utilized the Self Evaluation of Breathing Questionnaire (SEBQ) to assess respiratory function. The SEBQ is a self-administered questionnaire designed to measure symptoms and severity associated with respiratory dysfunction. It consists of 25 items, each rated on a 4-point scale (0 = not at all, to 3 = very much so), with a total possible score ranging from 0 to 75. While there is no definitive cutoff score for the SEBQ, experts consider a total score above 25 to indicate a problem with respiratory function. The SEBQ has a test-retest reliability (ICC) of 0.89 and internal consistency (Cronbach's α) of 0.93., During the assessment period
To Compare the Safety and PK/ PD Characteristics of ADC189 Between Hepatic Impairment and Normal Hepatic Function Subjects
NCT Number: NCT06485401
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Influenza Type A|Influenza Type B
Interventions: DRUG: ADC189
Sponsor: Jiaxing AnDiCon Biotech Co.,Ltd
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 32
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-03-14
Completion Date: 2024-10-31
Locations: The First Affiliated Hospital of Soochow University, Suzhou, China

Summary:
This study aims to evaluate the pharmacokinetics, pharmacodynamics, safety, and tolerability of ADC189 in subjects with hepatic impairment compared with subjects with normal hepatic function.

Primary Outcome Measures: Cmax of ADC189/ADC189-I07, 15 days|AUClast of ADC189/ADC189-I07, 15 days
Use of Thermography for the Prevention and Diagnosis of Diabetic Foot
NCT Number: NCT06485362
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Diabetic Foot|Diabetic Neuropathies|Diabetic Angiopathy
Interventions: DIAGNOSTIC_TEST: Termography
Sponsor: University of Seville
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-01
Completion Date: 2026-09-01
Locations: University of Seville, Seville, 41008, Spain

Summary:
Diabetic foot is a serious complication of diabetes mellitus that can lead to ulcerations, infections and, in extreme cases, amputations. Early detection of changes in skin temperature can help prevent these complications. Infrared thermography is a noninvasive technique that allows the visualization and quantification of skin temperature and could be an effective tool for the early detection of alterations in diabetic foot.

Objective

To evaluate the effectiveness of infrared thermography in the early detection and diagnosis of diabetic foot, comparing the temperatures of the feet of healthy subjects and subjects with diabetic foot.

Primary Outcome Measures: Temperature maximun, Maximum foot temperatures, One measurement will be taken at the start of the study and another measurement the following year.|Temperature minimum, Minimum foot temperatures, One measurement will be taken at the start of the study and another measurement the following year.
Prophylactic Treatment With Atorvastatin for Chronic Migraine (ChronicStatinMig)
NCT Number: NCT06485336
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Chronic Migraine
Interventions: DRUG: Atorvastatin 40mg|DRUG: Placebo
Sponsor: St. Olavs Hospital
Collaborators: Haukeland University Hospital|Oslo University Hospital|University Hospital of North Norway|University Hospital, Akershus|Ullevaal University Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 300
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-05-01
Completion Date: 2029-02-28
Locations: Haukeland University Hospital, Bergen, Norway|University Hospital, Akershus, Lørenskog, Norway|Oslo University Hospital, Rikshospitalet, Oslo, Norway|Oslo University Hospital, Ullevål, Oslo, Norway|University Hospital Northern Norway, Tromsø, Norway|St. Olavs hospital, Trondheim, Norway

Summary:
The main objective of this study is to see whether the favorable preventative effect of Atorvastatin 40mg per day in episodic migraine, that was found previously in three smaller randomized controlled cross-over studies, can be confirmed in a larger, multicenter, randomized controlled parallel group study. In addition it will be investigated whether 1) the favorable side effect profile, seen in previous studies, can be confirmed, and whether it is even better with the smaller dose, and 2) estimating the cost of Atorvastatin treatment, considering cost of medicine, cost of acute attack medicine, and cost of lost worktime.

Primary Outcome Measures: Number of migraine days, Change in number of migraine days/4 weeks from the baseline period to the intervention period., 4 weeks
Secondary Outcome Measures: Number of responders, Number of responders (≥ 50 % improvement from baseline), 12 weeks|Rate of adverse events, Number of patients with adverse events, 12 weeks|Number of doses with acute medication, Doses of triptans or analgesics per 4 weeks, 12 weeks|Number of days with sick leave, Days with sick leave per 4 weeks, 12 weeks
MRI Pseudo-CT Sequences for Obstetrical Pelvimetry.
NCT Number: NCT06485323
Acronym: Pelvi-MRI
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Obstetric Labor Complications
Interventions: DEVICE: MRI pelvimetry
Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 95
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2023-07-05
Completion Date: 2024-12-31
Locations: Cliniques Universaires Siant Luc, Brussels, 1200, Belgium

Summary:
It is possible to perform a pelvimetry by MRI as a substitute to pelvimetry by CT, hence sparing the patient from a dose of irradiation.

Primary Outcome Measures: Prove the non-inferiority of MRI compared to CT for pelvimetry., Measurement of pelvic bone diameters in pregnant women, 30 minutes (duration of the exam+ measurement)
Secondary Outcome Measures: Evaluate patient convenience for both examinations (CT and MRI), questionnaire (scale from zero to ten, zero = more pleasant, ten=least pleasant), immediately after both examinations