pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
An Exploratory Clinical Study of CD19 CAR NK Cell Injection for the Treatment of Relapsed/Refractory Autoimmune Diseases
NCT Number: NCT06464679
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Autoimmune Diseases
Interventions: DRUG: CD19 CAR NK cells
Sponsor: Changhai Hospital
Collaborators: Rui Therapeutics
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 72
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-27
Completion Date: 2026-06-30
Locations: Changhai Hospital, Shanghai, China

Summary:
A single arm, open-label pilot study is designed to determine the safety and effectiveness of CD19 CAR NK cells in patients with autoimmune diseases. 36-72 patients are planned to be enrolled in the dose-escalation trial. The primary objective of the study was to evaluate the safety and feasibility of CD19 CAR-NK cells for the treatment of patients with autoimmune diseases. The secondary objective is to evaluate the efficacy of CD19 CAR-NK cells in patients with autoimmune diseases.

Primary Outcome Measures: Incidence of Dose-Limiting Toxicity (DLT), To characterize the safety of CD19 CAR NK Cells (KN5501) for Relapsed/Refractory autoimmune diseases, up to 48 weeks after infusion|Incidence of Treatment Emergent Adverse Events (TEAEs), To characterize the safety of CD19 CAR NK Cells (KN5501) for Relapsed/Refractory autoimmune diseases, up to 48 weeks after infusion
Secondary Outcome Measures: The overall response rate (ORR), To characterize the efficacy of CD19 CAR NK Cell (KN5501) for Relapsed/Refractory autoimmune diseases, Time Frame: 1, 3, 6, 12 and 12 months after infusion|Disease control rate (DCR), To characterize the efficacy of CD19 CAR NK Cell (KN5501) for Relapsed/Refractory autoimmune diseases, Time Frame: 1, 3, 6, 12 and 12 months after infusion
Association Between Renal Resistive Index(RRI) and AKI(Acute Kidney Injury) in Cardiac Surgery Patients With Cardiopulmonary Bypass (CPB)
NCT Number: NCT06464666
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Acute Kidney Injury|Renal Resistive Index
Interventions: PROCEDURE: Renal interlobar artery US|PROCEDURE: Renal inter-lobular artery US
Sponsor: Yonsei University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 250
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-01
Completion Date: 2025-06-30

Summary:
AKI(Acute Kidney Injury) is a common complication after cardiac surgery which is associated with increased mortality and morbidity. The conventiional marker for detecting AKI is serum creatinine, however, which has many limits. RRI(Renal Resistive Index) is a non-invasive test measured by ultrasound and could be a useful tool to evaulate renal insult in the early phase. Early detection of renal insult and prevention of progression to AKI can contribute to reduing mortality and morbidity in cardiac surgical patients.

Primary Outcome Measures: post-operative AKI incidence, The definition of AKI refers to Kidney Disease: Improving Global Outcomes (KDIGO) Acute Kidney Injury Work Group. KDIGO Clinical Practice Guideline for Acute Kidney Injury., within first 1 week after surgery
Secondary Outcome Measures: Major adverse kidney outcome (MAKE) 30, MAKE30 includes new dialysis, eGFR decrease more than 25% from the baseline, and mortality, within first 1 month after surgery
Forel's Field Electrical Stimulation for Lennox-Gastaut Syndrome
NCT Number: NCT06464653
Acronym: FESL
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Lennox Gastaut Syndrome
Interventions: DEVICE: Forel's Field H-DBS ON
Sponsor: Xuanwu Hospital, Beijing
Sex: ALL
Age: CHILD, ADULT
Enrollment: 5
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-30
Completion Date: 2025-08-30
Locations: Xuanwu Hospital,Capital Medical University, Beijing, Beijing, 100053, China

Summary:
The primary objective of this research is to study the efficacy and safety of deep brain stimulation (DBS) of Forel's Field H as adjunctive therapy for alleviating symptoms in Lennox-Gastaut Syndrome.

Primary Outcome Measures: Seizure Frequency (SF28), Seizure frequency (SF28) is defined as seizure count per month (28-day) period. The SF28 is calculated as follows, where D=total number of days for which seizure information is collected for the specific 28-day interval:

SF28=(Total number of seizures in D days/D)\*28. In addition, the baseline seizure frequency is defined as mean of 3- month SF28 in the baseline period. The seizure frequency in double-blind phase is defined as SF28 per month during the double-blind period. Percent change in seizure frequency=100\*(double-blind SF28-baseline SF28)/baseline SF28., Up to 1 year after Forel's Field H-DBS
Secondary Outcome Measures: Seizure Responder Rate, The proportion of patients with a ≥ 50% reduction from Baseline in seizure frequency., Up to 1 year after Forel's Field H-DBS|Life quality evaluation, Percentage change from baseline in Quality of Life in Epilepsy-31 inventory (QOLIE-31) score. The minimum and maximum values, and whether higher scores mean a better or worse outcome., Up to 1 year after Forel's Field H-DBS|Cognitive function evaluation (MMSE), Percentage change from baseline in Mini-Mental State Examination (MMSE) score. The MMSE score ranges from 0 to 30, with higher scores representing better cognitive function and lower scores indicating greater cognitive impairment., Up to 1 year after Forel's Field H-DBS|Cognitive function evaluation (MoCA), Percentage change from baseline in Montreal Cognitive Assessment (MoCA) score. The MoCA score ranges from 0 to 30, with higher scores indicating better cognitive function and lower scores suggesting greater cognitive impairment., Up to 1 year after Forel's Field H-DBS|Adverse Events, Rate of adverse events which were judged to be study-related throughout the study., Up to 1 year after Forel's Field H-DBS|Incidence of Sudden Unexpected Death in Epilepsy (SUDEP), The number presented is for Definite and Probable SUDEP. The rate is calculated per 1000 subject years of follow-up., Up to 1 year after Forel's Field H-DBS
Physical Activity Reduces Anxiety and Depression in Youth Affected by Displacement: a Randomized Controlled Trial of the Game Connect Program in Uganda
NCT Number: NCT06464627
Acronym: Game Connect
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Anxiety|Depression
Interventions: BEHAVIORAL: Physical activity
Sponsor: KU Leuven
Collaborators: Makerere University|The University of New South Wales|AVSI|Olympic Refuge Foundation
Sex: ALL
Age: CHILD, ADULT
Enrollment: 866
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2022-09-01
Completion Date: 2023-08-31
Locations: Makerere University, Kampala, Uganda

Summary:
This randomized controlled trial investigated 12 weeks of physical activity or to 12 weeks in a waiting control condition in youth aged 15 to 24 years old affected by displacement.

Primary Outcome Measures: Patient Health Questionnaire-9, 2 weeks|Generalized Anxiety Disorder -7, 2 weeks
Adebrelimab in Combination With Apatinib and Chemotherapy/Chemoradiotherapy in Immuno-experienced Second-line ESCC.
NCT Number: NCT06464614
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Esophageal Cancer
Interventions: DRUG: Adebrelimab|DRUG: Apatinib|DRUG: Investigator chosen chemotherapy (ICC)|RADIATION: Radiotherapy
Sponsor: The First Affiliated Hospital of Henan University of Science and Technology
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 54
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-15
Completion Date: 2026-08-01
Locations: The First Affiliated Hospital of Henan University of Science and Technology, Luoyang, Henan, 470000, China

Summary:
To assess the efficacy and safety of adebrelimab in combination with apatinib mesylate and chemoradiotherapy in immuno-experienced second-line esophageal squamous cell carcinoma (with symptomatic dysphagia or oligometastatic disease)，and to evaluate the efficacy and safety of adebrelimab in combination with apatinib mesylate and chemoradiotherapy in immuno-experienced second-line esophageal squamous cell carcinoma (without symptomatic dysphagia or oligometastatic disease).

Primary Outcome Measures: Progression-free survival，PFS, Time from randomization to patient's tumor progression or death, 9 months
Secondary Outcome Measures: Objective Response Rate，ORR, The proportion of patients whose tumor shrinks to a certain amount and remains for a certain period of time, 1 year|Overall survival,OS, The time from the beginning of randomization to death due to any cause., 1 year|Duration of Response,DoR, The time from the first assessment of the tumor as CR or PR to the first assessment of PD (Progressive Disease) or death from any cause., 1 year|Disease control rate,DCR, The proportion of patients whose tumors have shrunk or stabilized and remain for a certain period of time (mainly for solid tumors), including cases of complete response (CR), partial response (PR) and stable disease (SD)., 1 year|Time to response, Time from randomization to the achievement of the first objective response, 1 year|1-year OS rate, Percentage of patients who are still alive after 1 year, 1 year|9-month survival rate, Percentage of patients who are still alive after 9-month, 1 year
Comparison of Vocal Biomarkers for Depression and Anxiety to Formal Clinical Assessments
NCT Number: NCT06464575
Status: ENROLLING_BY_INVITATION
Study Type: OBSERVATIONAL
Conditions: Depression/Anxiety
Sponsor: Ellipsis Health
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 540
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-01-12
Completion Date: 2024-06
Locations: Ellipsis Health, San Francisco, California, 94104, United States

Summary:
Participants will be recruited to complete self reported surveys normally used as standards of care for screening and monitoring depression and anxiety symptom severity, provide a voice sample composed of an answer to open ended questions and then be assessed by a mental health professional using structured and clinically validated assessment tools for depression and anxiety. Their voice will be analyzed by machine learning models that predict the severity of depression and anxiety symptoms. The models' performance will be compared to the clinician assessments and how that correlation compares to a similar comparison between the clinician assessments with the self reported surveys. It is hypothesized that the performance of the machine learning models in assessing the severity of depression and anxiety symptoms is no worse than the self reported surveys when both are compared to clinician assessments. It is also hypothesized that presence or absence of the diagnoses of Major Depressive Disorder and Generalized Anxiety Disorder can be predicted better than chance by the analysis of the participant's voice sample using machine learning models.

Primary Outcome Measures: Primary Outcome A, Extent of categorical agreement, measured in weighted kappa, between Ellipsis Health Software as a Medical Device severity of depression and clinician's rating of severity of depression., 4 days|Primary Outcome B, Extent of categorical agreement, measured in weighted kappa, between Ellipsis Health Software as a Medical Device severity of anxiety and clinician's rating of severity of anxiety., 4 days
Secondary Outcome Measures: Secondary Outcome A, Extent of agreement of presence, measured in the Equal Error Rate on the Receiver Operating Characteristic curve, between Ellipsis Health Software aa a Medical Device detection of Major Depressive Disorder and clinician's assessment for the diagnosis of Major Depressive Disorder, as expressed as Sensitivity and Specificity., 4 days|Secondary Outcome B, Extent of agreement of presence, measured in the Equal Error Rate on the Receiver Operating Characteristic curve, between Ellipsis Health Software as a Medical Device detection of Generalized Anxiety Disorder and clinician's assessment for the diagnosis of Generalized Anxiety Disorder, as expressed as Sensitivity and Specificity., 4 days
Spontaneous Eye Blinking Evaluation for Cognitive Assessment of Individuals With Severe Acquired Brain Injury
NCT Number: NCT06464549
Acronym: SEE-ABI
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Disorders of Consciousness|Acquired Brain Injury
Interventions: DIAGNOSTIC_TEST: EEG-EOG recording at rest and during an auditory oddball paradigm
Sponsor: Alfonso Magliacano
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 55
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-25
Completion Date: 2025-09-30
Locations: Polo Specialistico Riabilitativo Fondazione Don Carlo Gnocchi ONLUS, Sant'Angelo dei Lombardi, AV, 83054, Italy|IRCCS Fondazione Don Carlo Gnocchi Firenze, Firenze, Italy

Summary:
Assessment of consciousness and attention in individuals with severe Acquired Brain Injury (sABI) is crucial for planning rehabilitation, but it is often hindered by coexisting sensory-motor and/or cognitive-behavioural disorders.

This project aims at evaluating the value of spontaneous eye blinking features to assess patients' attentional abilities and to distinguish patients with unresponsive wakefulness syndrome (UWS) from those in minimally conscious state (MCS).

Patients will undergo an EEG-EOG recording at rest and during an auditory oddball task. Eye blinking features on EOG will be analysed and compared to that of healthy individuals. A machine-learning-based algorithm using blinking features for the diagnosis of patients with sABI will be studied and validated preliminarily.

This project will help to stratify patients with sABI using easy-to-detect clinical markers, supporting clinicians' decision-making about patient's management. Additionally, blinking patterns related to residual attentional abilities in patients emerged from disorders of consciousness will be investigated.

Primary Outcome Measures: Coma Recovery Scale-Revised, The Coma Recovery Scale-Revised is a clinical scale with a total score ranging from 0 to 23, with higher scores indicating a higher level of consciousness, Within 2 weeks from study entry|Levels of Cognitive Functioning, Levels of Cognitive Functioning is a clinical scale with a score ranging from 1 to 8, with higher scores indicating a higher level of cognitive functioning, Within 2 weeks from study entry
Evaluation of the Efficacy of Compression With Tight Surgical Gloves in Patients With Taxane-based Therapy
NCT Number: NCT06464536
Acronym: ComPrendo
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Taxane-induced Peripheral Neuropathy
Interventions: OTHER: Compression
Sponsor: St.Gallen University of Applied Sciences
Collaborators: University of Zurich
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 114
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-08
Completion Date: 2025-08

Summary:
In this study, the effect of compression therapy of the hands with tight surgical gloves to reduce peripheral neuropathy in adult patients during the application of taxanes will be evaluated.

Primary Outcome Measures: peripheral polyneuropathy, measured with the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grades 0-4 : 0=none, 1=Asymptomatic; clinical or diagnostic observations only, 2=Moderate symptoms; limiting instrumental ADL; 3=Severe symptoms; limiting self care ADL; 4=Life-threatening consequences; urgent intervention indicated (i.e., higher scores meaning worse symptoms), at the beginning (first day) of each of the first four cycles of chemotherapy for each participant (Cycles range from 7 to 28 days)
Secondary Outcome Measures: peripheral polyneuropathy patient reported outcome, measured with the neuropathy Subscale of the Functional Assessment of Cancer Therapy - Gynecologic Oncology Group - Neurotoxicity (FACT/COG-NTX), The FACT-NTX subscale comprises 11 5-point ordinal scaled items (0=not at all to 4=very much). The points for each item are totaled and can range from 0=no symptoms to 44=severe symptoms. The participant is counted as a case if the change in the FACT-NTX reaches ≥5 points., at the beginning (first day) of each of the first four cycles of chemotherapy for each participant (Cycles range from 7 to 28 days)|comfort of compression therapy, comfort will be measured with a 0 to 3 scale (0=not comfortable at all, 3=very comfortable), at the beginning (first day) of each of the first four cycles of chemotherapy for each participant (Cycles range from 7 to 28 days)|adherence with compression therapy, percentage of time that compression should have been administered, at the beginning (first day) of each of the first four cycles of chemotherapy for each participant (Cycles range from 7 to 28 days)|Frequency of the application of manual abilities (like sewing, knitting, painting, playing the piano or similar), Ordinal 1-item scale, ranging from from 0=never to 4=daily, at the beginning (first day) of each of the first four cycles of chemotherapy for each participant (Cycles range from 7 to 28 days)
HPV Education, Early Diagnosis and Knowledge
NCT Number: NCT06464523
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Female Teachers
Interventions: BEHAVIORAL: Face to face education|BEHAVIORAL: Online education
Sponsor: Mehmet Akif Ersoy University
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 156
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2021-09-15
Completion Date: 2022-03-14
Locations: Burdur Mehmet Akif Ersoy University, Burdur, Bucak, 15000, Turkey

Summary:
The aim of this study was to determine the effect of health education given to female teachers on HPV knowledge and screening test. The population of the study consisted of all female teachers belonging to the Bucak Directorate of National Education between September 2021 and March 2022. The sample of the study consisted of 144 healthy female teachers who were registered in the institutions affiliated to the District Directorate of National Education between the specified dates, met the inclusion criteria and volunteered to participate in the study. In this study area, with the assumption that the rate of cervical cancer screening test of 70% of the women in the Healthy Life Centre after the trainings would be considered significant, the effect size d=0.18 was calculated to include at least 98 women in 3 groups at 95% power and 0.05 error level. The calculation was performed with the 'G Power 3.1.9.2' package programme. In this context, the total sample of the study was determined as 156 participants, 52 in each group.

Primary Outcome Measures: Human Papilloma Virus (HPV) Knowledge Scale:, HPV Knowledge Scale is a knowledge test developed by Waller et al. (2013) to determine the level of knowledge of individuals about HPV agent, HPV screening tests and vaccine. The scale, whose Turkish validity and reliability was conducted by Demir and Özdemir in 2019, has a total of 33 items. The HPV Knowledge Scale consists of four sub-dimensions: general HPV knowledge (items 1-16), HPV screening test knowledge (items 17-22), general HPV vaccine knowledge (items 23-27) and knowledge of the current HPV vaccination programme (items 28-33)., 5-10 minutes
The Effects Of Probiotics On Stress Among Healthy Adults From Umm Al-Qura University At Makkah
NCT Number: NCT06464484
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Stress|Constipation|Anthropometry|Bowel Disease
Interventions: DIETARY_SUPPLEMENT: Probiotics (Lactobacillus rhamnosus GG (ATCC 53103)
Sponsor: Umm Al-Qura University
Sex: ALL
Age: ADULT
Enrollment: 85
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-01-26
Completion Date: 2024-04-30
Locations: Umm Al-Qura University, Mecca, 21955, Saudi Arabia

Summary:
The goal of this clinical trial is to study the effects of probiotic supplementation on stress levels and bowel habits in healthy Saudi adults for both males and females.

The main questions it aims to answer are:

Does probiotic supplementation decrease stress levels? Does probiotic supplementation improve bowel habits?

Researchers compared between the intervention group receiving probiotic supplements with high stress levels with a control group not receiving probiotics with high stress levels to see if probiotics decreases stress levels.

Primary Outcome Measures: Stress, Perceived stress scale (PSS) was used in both English and Arabic versionsndividual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress.

Scores ranging from 0-13 would be considered low stress. Scores ranging from 14-26 would be considered moderate stress. Scores ranging from 27-40 would be considered high perceived stress., Post intervention at 30 days|Bowel function, The questionnaire was developed to collect, comorbid illnesses, a prescription list, and specific questions related to bowel habits including fluid intake, usual diet, fecal matter consistency, frequency of defecation, and straining. The questionnaire also contained questions about laxative usage, previous surgeries, and lifestyle. The questionnaire was translated by an authorised translator and was based on a previous study., Post intervention at 30 days
Optimization of iTBS for Depression
NCT Number: NCT06464445
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Neuromodulation
Interventions: DEVICE: Monophasic iTBS|DEVICE: Biphasic iTBS|DEVICE: Monophasic-Long iTBS
Sponsor: Université de Sherbrooke
Sex: ALL
Age: ADULT
Enrollment: 30
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-08-01
Completion Date: 2025-07-01
Locations: Centre de recherche du Centre hospitalier universitaire de Sherbrook, Sherbrooke, Quebec, J1H 5H3, Canada

Summary:
Repetitive TMS (rTMS) is a well-established method for modulating brain activity. Through successive stimulations in the form of magnetic fields, it is possible to modify the sensitivity of neurons in the brain, also known as cortical excitability. Cortical excitability is important for the induction of brain plasticity, the ability of the brain to reorganize itself and form new connections in response to stimuli. A particular class of rTMS, intermittent theta burst TMS (iTBS), is commonly used to modulate cortical excitability and induce plasticity for therapeutic purposes, notably for treatment-resistant depression.

Different iTBS stimulation parameters can be used to induce plasticity. This study will focus on two parameters, namely, the form and duration of the electromagnetic stimulation. The shape of the electromagnetic pulse refers to how the electromagnetic wave is configured over time, while the duration is simply the period during which this electromagnetic pulse remains active. These parameters are expected to influence the effectiveness of iTBS in modulating cortical activity but remain little studied.

The main aim of this study will be to compare the effectiveness of different stimulation parameters in the induction of plasticity, which will then make it possible to improve the rTMS protocols used for treatment-resistant depression.

Primary Outcome Measures: TMS derived measure of cortical plasticity, Change in Peak-to-peak motor evoked potential (MEP) amplitude induced by the administration of the test stimulus (stimulation intensity required to produce an MEP of 1 millivolt, approximately 120% of rMT) after iTBS, Pre-iTBS, Every 5 minutes post iTBS intervention up to 60 minutes post intervention.
Effect of Lithotomy Position on Optic Nerve Sheath Diameter
NCT Number: NCT06464419
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Optic Nerve Cup|Intracranial Pressure Increase
Interventions: DEVICE: ultrasound
Sponsor: Başakşehir Çam & Sakura City Hospital
Collaborators: Ankara Etlik City Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 52
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-10
Completion Date: 2024-09-01
Locations: EtlikCityHospital, Ankara, Turkey

Summary:
In this study, the effect of increased venous return and increased intra-abdominal pressure on intracranial pressure in the lithotomy position was evaluated.

Primary Outcome Measures: Effect of lithotomy position on optic nerve sheath diameter, In patients in the lithotomy position, the linear probe of the ultrasound will be placed on the patient's upper eyelid in a transverse and longitudinal manner without applying compression, and the optic nerve's entry into the orbit will be visualized and measured. The increase in the optic nerve sheath diameter will be recorded by measuring at 7 different times in total.Before general anesthesia (t1), 3 minutes (min.) (t2) and 5 min. (t3) after general anesthesia, 3 min. (t4) and 5 min. (t5) after lithotomy position was given, before lithotomy position was corrected (t6) and when 10 minutes after patients go to the recovery room (t7)., intraoperative and postoperative 10 minutes
Anti-cancer Potentiality of Saffron Against Hepatocellular Carcinoma
NCT Number: NCT06464380
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Hepatocellular Carcinoma
Interventions: DIETARY_SUPPLEMENT: Saffranal|DIETARY_SUPPLEMENT: Placebo
Sponsor: Ain Shams University
Collaborators: Mohamed, Ahmed A., M.D.|Amr Amin College of Medicine, University of Sharjah, Sharjah 27272, UAE.|Ahmed Cordie Endemic Medicine department, Cairo University Hospitals.|Nouran Mohamed Endemic Medicine department, Cairo University Hospitals.|Gamal Esmat Faculty of Biotechnology, Misr University for Science and Technology, Giza, Egypt.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-07-30
Completion Date: 2025-08-01
Locations: Amal A. Elkholy, Al 'Abbāsīyah, Al Abbasiya, 123456, Egypt|Dermatology Clinic of National Hepatology and Tropical Medicine Research Institute, Cairo, 123456, Egypt

Summary:
Saffron has recently gained considerable interest for its capacity to interfere with cancer at initiation and promotion stages as well as for cancer treatment. Although saffron and its constituents have been shown to have antitumorigenic and proapoptotic activities in different cancer cell lines.

The aim of the current investigation is to identify the anti-cancer potentiality of saffron on hepatocellular carcinoma patients.

Primary Outcome Measures: overall survival, overall survival in patients presented with end-stage hepatocellular carcinoma., three months
Secondary Outcome Measures: treatment response, response to treatment through impact on the underlying liver status, three months
Comparison of the Mammary Harvesting Technique
NCT Number: NCT06464354
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Ischemic Heart Disease
Interventions: PROCEDURE: The mammary artery harvesting by the pedicle technique|PROCEDURE: The mammary harvesting using the skeletonization technique|PROCEDURE: No intervention
Sponsor: University Hospital Ostrava
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 90
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-06-01
Completion Date: 2023-12-31
Locations: University Hospital Ostrava, Ostrava, Moravial-Silesian Region, 70852, Czechia

Summary:
The skeletonization technique of left internal artery (LIMA) harvesting is reported as more spar-ing to the vascular supply of the sternum. Some studies report a greater length and greater flow of the graft additionally. The aim of our study was to measure the difference in post-op sternal blood supply compared to the pedicle harvesting technique and to measure the length and flow of the LIMA graft.

Primary Outcome Measures: Rewarming time difference, Duration of spontaneous rewarming of the skin surface of the caudal sternum after a cold stimulus, measured from 24°C to 27°C. Unit: seconds (s), first preoperatively and on 4th postoperative day
Secondary Outcome Measures: Duration of the mammary graft harvesting, Time from the start of the harvesting to complete graft release. Unit: minute (min)., during surgery, immediately after the graft harvesting|Length of the mammary artery graft, Length from the distance of the graft from the chest wall to its distal end. Unit: millimeter (mm)., during surgery, immediately after the graft harvesting|Free outflow of the mammary artery, After trimming the distal clip on the graft at an arterial pressure of 70 mmHg, free flow for 30 seconds, then multiplied by two. Unit: millilitre per minute (ml/min)., during surgery, just before the graft use
The Impact of Tai Chi Combined With Music Therapy Intervention on Depression and Anxiety Among College Students
NCT Number: NCT06464328
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Unrecognized Condition
Interventions: BEHAVIORAL: Tai Chi Combined with Music Therapy Intervention|BEHAVIORAL: Music intervention only|BEHAVIORAL: Tai Chi intervention only
Sponsor: Wu Jiarun
Sex: ALL
Age: ADULT
Enrollment: 120
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER
Start Date: 2023-02-05
Completion Date: 2023-09-05
Locations: Universiti Sains Malaysia, Kota Bharu, Kelantan, 16150, Malaysia

Summary:
This study aims to investigate the effects of Tai Chi combined with music therapy on alleviating depression and anxiety among college students. Depression and anxiety are prevalent among college students and have a significant impact on their lives and academic performance. Therefore, exploring effective interventions is crucial for promoting the mental health of college students.

Primary Outcome Measures: Change from the Self-Rating Depression Scale (SDS) at week 12, The SDS, developed by American researchers Zung (1965), is specifically designed to evaluate the degree of depression in participants. The survey comprises 20 items, and participants express their feelings using a Likert scale ranging from 1 (Never) to 4 (Always). The SDS has been widely utilized worldwide to measure depression levels, demonstrating strong internal consistency and validity (Cronbach's Alpha = 0.832), and has been well-established in clinical and research settings (Campo-Arias et al., 2006)., 12 weeks|Change from the Self-Rating Anxiety Scale (SAS) at week 12, The SAS developed by American researchers Zung, (2013), is tailored to assess the anxiety level of participants. This instrument consists of a concise 20-item questionnaire, and participants use a Likert scale ranging from 1 (Strongly Disagree) to 4 (Strongly Agree) to express their emotions. The SAS exhibits robust psychometric properties in assessing participants' anxiety levels, with acceptable reliability values. The internal consistency, measured through Cronbach's Alpha, is 0.897, and the test-retest reliability, represented by the intra-class correlation coefficient (ICC), is 0.913 (Samakouri et al., 2012)., 12 weeks
Functional Substrate-Only Guided VT Ablation
NCT Number: NCT06464315
Acronym: NoMoVT
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Ventricular Tachycardia|Sudden Cardiac Death
Interventions: PROCEDURE: Functional Substrate-Only Mapping without VT Induction|PROCEDURE: Standard-of-Care Mapping/Imaging
Sponsor: VA Office of Research and Development
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 36
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-10-01
Completion Date: 2028-09-30
Locations: VA San Diego Healthcare System, San Diego, CA, San Diego, California, 92161-0002, United States

Summary:
Ventricular tachycardia (VT) is a leading cause of death and suffering in the Veteran population. Currently, ablation procedures are performed to destroy the diseased tissue that causes this problem. This study will test to see if an experimental strategy of only targeting regions of slow conduction without the induction of VT can improve the efficacy and safety of VT ablation. Once this study is completed, the investigators will know whether this ablation strategy could help increase the efficacy, safety and efficiency of ablation therapy of fatal heart rhythms.

Primary Outcome Measures: Time to composite endpoint (VT recurrence, death, or acute hemodynamic decompensation), Ventricular arrhythmia recurrence is defined by an episode of sustained VT lasting 30 seconds or appropriate implantable cardioverter-defibrillator therapy including anti-tachycardia pacing or shock.

Acute hemodynamic decompensation is defined by escalation of at least 1 new high dose inotrope/pressor occurring after anesthesia induction with persistent requirement during stable rhythm, \>20% drop in cardiac index, unplanned insertion of percutaneous hemodynamic support device., 6 months
Secondary Outcome Measures: VT burden (ICD therapy including shocks and ATP, sustained VT episodes >30 seconds), Total number of ICD therapies (ATP and shocks) and recorded sustained VT episodes\>30 seconds, compared 6 months before and 6 months after ablation., 6 months|Total Mapping Time, dwell time of multi-electrode mapping catheters, immediately at the end of the procedure|Total fluoroscopy time, Total amount of fluoroscopy time during the entire procedure, immediately at the end of the procedure|total procedural time, time from introduction of catheters to removal of catheters, immediately at the end of the procedure|Procedural adverse events or complications, Major complications include: new acute pericardial effusion requiring intervention, vascular complication requiring intervention, embolic stroke confirmed by brain imaging, limb ischemia requiring intervention, or bacteremia.

Major adverse events include: cardiogenic shock (requiring escalation of inotropes or salvage mechanical circulatory support), 1 month|Use of general anesthesia, Whether general anesthesia (intubation) is required/used during the procedure, immediately at the end of the procedure
Investigation of the Effect of Age and Injury Severity on Short-term Intra-hospital Outcomes After Surgical Stabilized Rib Fractures
NCT Number: NCT06464302
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Rib Fractures|Rib Trauma|Rib Fracture Multiple|Thorax; Fracture
Interventions: PROCEDURE: Surgical stabilisation of rib fractures (SSRF)|OTHER: Non-operative management of rib fractures
Sponsor: University Hospital Muenster
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 700
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-05-01
Completion Date: 2025-06-30
Locations: Department for trauma, hand and reconstructive surgery, University hospital Muenster, Münster, NRW, 48149, Germany

Summary:
The study aims to investigate the effect of surgical stabilisation of rib fractures (SSRF) on clinical outcomes measured during the hospital stay (mortality, days on a mechanical ventilator, intensive care unit and hospital length of stay, rate of complications). Furthermore, the effect of the patients age and overall injury severity on the outcomes after SSRF will be investigated. We hypothesise that the combination of high age and high injury severity will lead to worse outcomes after SSRF.

Primary Outcome Measures: In hospital-mortality, Mortality rate from injury to initial hospital discharge, binary, From injury up to initial hospital discharge or death, whichever came first, assessed up to 2 month.|Intensive care unit length of stay, The duration in days a patient spent in the intensive care unit from the time of hospital admission to the time of initial hospital discharge., From injury up to initial hospital discharge or death, whichever came first, assessed up to 2 month.
Secondary Outcome Measures: Intubation rate, Proportion of patients intubated at any time, From injury up to initial hospital discharge or death, whichever came first, assessed up to 2 month.|Multi-organ failure, Rate of Multi-organ failure, From injury up to initial hospital discharge or death, whichever came first, assessed up to 2 month.|Single organ failure, Rate of single organ failure, From injury up to initial hospital discharge or death, whichever came first, assessed up to 2 month.|Sepsis, Rate of Sepsis, From injury up to initial hospital discharge or death, whichever came first, assessed up to 2 month.|Lung-failure, Rate of Lung-failure, From injury up to initial hospital discharge or death, whichever came first, assessed up to 2 month.|Clinical outcome, Clinical outcome according to the Glasgow outcome scale (GOS), At the time point of initial hospital discharge or at death, whichever came first, assessed up to 2 month.|Duration of hospital stay, Duration of hospital stay in days from injury to initial discharge, From injury up to initial hospital discharge or death, whichever came first, assessed up to 2 month.
Dexmedetomidine Versus Midazolam-Fentanyl for Analgesia and Sedation
NCT Number: NCT06464263
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Valvular Cardiac Surgeries
Interventions: DRUG: Dexmedetomidine
Sponsor: Egymedicalpedia
Sex: ALL
Age: ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-02-10
Completion Date: 2026-02-10
Locations: Al-Azhar University hospitals, Cairo, Egypt

Summary:
Postoperative sedation is an essential component in recovery of the patient undergoing cardiac surgery. It facilitates the patient's unawareness of the environment as well as reduce the discomfort and anxiety caused by surgery, intubation, mechanical ventilation, suction, and physiotherapy.

Despite the advances in anesthesia and surgical techniques, the duration of mechanical ventilation (MV) may be prolonged after cardiac surgery, due to the classic high-dose narcotic-based cardiac anesthesia.

Primary Outcome Measures: Pain Relieve, Assessment of the pain post-operatively in patients with pain score by VAS as : Total scores vary from 0 to 10 in this method, with a higher score indicating more severe pain, 2 hours post operative
Extremes of Respiratory Effort in Weaning Failure From Mechanical Ventilation: a Prospective Observational Study
NCT Number: NCT06464224
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Mechanical Ventilation Pressure High|Weaning Failure
Interventions: BEHAVIORAL: low respiratory effort|BEHAVIORAL: high respiratory effort
Sponsor: Universidade Federal do Rio de Janeiro
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-04-01
Completion Date: 2026-07
Locations: Gloria D'or hospital, Rio De Janeiro, 22211230, Brazil

Summary:
The presence of high levels of respiratory effort in patients under mechanical ventilation may worsen the adjacent lung injury even after adapting protective ventilation. Primary outcome: To evaluate the failure rate of weaning from IMV and its relationship with the lower and upper extremes of respiratory effort and the upper extreme of dynamic pulmonary stress during the first 7 days of spontaneous ventilation. Analyze the influence of these extremes based on the thresholds of Pocc, P0.1 and their derivatives Pmus, Ptp, din and MP: in relation to days off MV (in the 28-day interval); Total weaning time; Rate and time for tracheostomy; Length of stay in the ICU and hospital; In-hospital mortality rate. CAAE: 78185823.4.0000.5249. Prospective multicenter observational study, carried out in the ICUs of Glória D'or and Niteroi D'or hospitals, from January 2024 to July 2026, in patients over 18 years old, undergoing orotracheal intubation and IMV, in their first 7 days on spontaneous ventilation. Hypothesis: Extremes of respiratory effort and dynamic pulmonary stress would be associated with a higher rate of weaning from IMV, as well as longer time on IMV and subsequent longer hospital stay.

Primary Outcome Measures: weaning rate from mechanical ventilation, weaning rate from mechanical ventilation (%), 2 years
Secondary Outcome Measures: days outside the MV (in the 28-day interval), days outside the MV (in the 28-day interval), 2 years|Total weaning time (first attempt until success), Total weaning time (first attempt until success) (days), 2 years|Rate and time for tracheostomy, Rate and time for tracheostomy (%), 2 years|Length of stay in the ICU and hospital, Length of stay in the ICU and hospital (days), 2 years|In-hospital mortality rate, In-hospital mortality rate (%), 2 years|electrical impedance tomography, spontaneous breathing trial failure rate (%) evaluated by electrical impedance tomography, 2 years|diaphragmatic ultrassound, spontaneous breathing trial failure rate (%) evaluated by diaphragmatic ultrassound, 2 years
The Effect of Family Counseling Program on Anxiety and Conscious Awareness Levels
NCT Number: NCT06464211
Acronym: not
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Anxiety|Awareness|Family Therapy|Cognitive Behavioral Therapy
Interventions: BEHAVIORAL: Cognitive Behavioral Model-Based Family Counseling Program
Sponsor: Istanbul University - Cerrahpasa (IUC)
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2022-01-02
Completion Date: 2024-06-01
Locations: IstanbulUC, Şişli, Istanbul, 34360, Turkey

Summary:
This study investigates the effect of a Cognitive Behavioral Therapy (CBT)-based Family Counseling Program on the anxiety and mindfulness levels of university students experiencing future anxiety. The research highlights the significance of university education in career development, noting the associated biopsychosocial challenges faced by students. These challenges often manifest as future anxiety-a condition characterized by fear, uncertainty, and stress about future prospects, which can impact students' academic performance, social relationships, and overall mental health. Literature reveals that interventions like CBT, mindfulness practices, and family counseling are effective in managing anxiety and enhancing emotional resilience. The program integrates these approaches to provide dual-layer support, addressing individual thought patterns and family dynamics, thus potentially reducing anxiety and increasing mindfulness among students. This study aims to provide a comprehensive understanding of the program's effectiveness in a controlled setting, contributing to both national and international literature on mental health interventions.

Primary Outcome Measures: Reduction in Future Anxiety Levels, This measure assesses the change in future anxiety levels among university students participating in the Cognitive Behavioral Therapy-based Family Counseling Program. The Future Anxiety Scale for University Students will be used to quantify this change. The scale ranges from a minimum score of 19 to a maximum score of 95. Higher scores indicate an increase in the level of future anxiety., Baseline (at study start) and at 8 weeks post-intervention.|Improvement in Mindfulness Awareness Levels, This outcome measures the enhancement in mindfulness awareness levels as determined by the Turkish version of the Mindfulness Awareness Scale for Adolescents and Adults. Changes from baseline to post-intervention will be assessed to determine the effectiveness of the intervention. The scale ranges from a minimum score of 18 to a maximum score of 90. Higher scores indicate an increase in the level of mindfulness awareness, Baseline (at study start) and at 8 weeks post-intervention.
Prospective Registry Study on the Implementation of Simultaneous Postoperative Radiochemotherapy for Salivary Gland Carcinomas of the Head and Neck Region
NCT Number: NCT06464198
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Locally Advanced Salivary Gland Carcinoma
Interventions: PROCEDURE: simultaneous postoperative radiochemotherapy
Sponsor: University of Erlangen-Nürnberg Medical School
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-01
Completion Date: 2037-06
Locations: Erlangen, Universitätsklinikum Strahlenklinik, Erlangen, 91054, Germany

Summary:
This is a prospective registry study based on a standard therapy concept for postoperative simultaneous radiochemotherapy established in Erlangen and elsewhere. The efficacy and tolerability of simultaneous postoperative radiochemotherapy is being investigated. Patients with locally advanced high-grade salivary gland carcinoma after oncological resection are admitted.

Primary Outcome Measures: Creation of a database, Creation of a database of a representative homogeneously treated patient cohort with locally advanced salivary gland tumours receiving postoperative radiochemotherapy., 63 months (12 weeks therapy plus 5 years follow-up)
Secondary Outcome Measures: Observation of Overall survival, 63 months (12 weeks therapy plus 5 years follow-up)|Observation of Disease-free survival, 63 months (12 weeks therapy plus 5 years follow-up)|Observation of Disease-specific survival, 63 months (12 weeks therapy plus 5 years follow-up)|Observation of Local recurrence-free survival, 63 months (12 weeks therapy plus 5 years follow-up)|Observation of Survival free of distant metastases, 63 months (12 weeks therapy plus 5 years follow-up)|Determination of toxicity, 63 months (12 weeks therapy plus 5 years follow-up)
A Prospective Clinical Study of CD3-CD20 Bisspecific Antibody Based Therapy Combined With CD19-CAR T Cells in the Treatment of Relapsed Refractory B-cell Non-Hodgkin Lymphoma
NCT Number: NCT06464185
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: B-cell Non-Hodgkin Lymphoma
Interventions: DRUG: Bispecific antibody-based combined with CAR-T cell therapy
Sponsor: Institute of Hematology & Blood Diseases Hospital, China
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 27
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-04-30
Completion Date: 2027-04-30
Locations: Institute of Hematology and Blood Diseases Hospital ,Chinese Academy of Medical Sciences, Tianjin, Tianjin, China

Summary:
The aim of this study was to analyze the safety and efficacy of CD3-CD20 bispecific antibody-based therapy in combination with CD19-CAR-T cells for the treatment of relapsed and refractory B-cell Non-Hodgkin's （B-NHL） lymphoma.

The main questions it aims to answer：

1. The safety of CD3-CD20 bispecific antibody-based therapy in combination with CD19-CAR-T cells in B-NHL;
2. The effect of different doses of bispecific antibody maintenance therapy on CAR-T cell expansion.

Primary Outcome Measures: Incidence rate and severity of adverse events (AE) of patients treated with bispecific antibody combined with CD19-CAR-T cells in B-NHL.（Assessed by CTCAE criteria v5 and ASTCT 2019 criteria for CRS/ICANS adverse events.）, Assess the safety and toxicity of CD3-CD20 bispecific antibody-based therapy in combination with CD19-CAR-T cells in B-NHL. Assessed in all patients given at least one dose of study treatment and infused., Up to 30 days after last treatment.From registration and during the bridging treatment, until end of post-treatment safety reporting window (up to six months after last dose of glofitamab)
Secondary Outcome Measures: Complete Response (CR) Rate, Up to 12 months after last treatment|Overall Response Rate (ORR), Up to 12 months after last treatment