pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Financial Navigation Program for Improving Financial Toxicity Among Breast Cancer in China
NCT Number: NCT06484140
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Breast Neoplasm Female|Financial Toxicity|Financial Navigation
Interventions: BEHAVIORAL: Financial Navigation|OTHER: Usual Care
Sponsor: Fudan University
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 76
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-06-24
Completion Date: 2024-12-31
Locations: Fudan University Shanghai Cancer Center, Shanghai, Shanghai, 200032, China

Summary:
The goal of this study is to access the impact of a financial navigation program on improving financial toxicity among patients with breast cancer in China.

The main questions it aims to answer are:

* Does the intervention alleviate participants' financial toxicity?
* Does the intervention enhance participants' cost-related health literacy?
* Does the intervention improve participants' shared decision-making?
* Does the intervention reduce participants' perceived stress?

Researchers will compare the financial navigation program with usual oncology care to evaluate its effectiveness.

Participants will receive the comprehensive financial navigation, including:

* Needs assessment;
* Cost-related health education, mainly including topics regarding communication of cost, treatment-related cost, health insurance policies, and family support;
* Resource and service referral;
* Personalized counseling.

Primary Outcome Measures: Financial toxicity, Financial toxicity will be measured with the Comprehensive Score for Financial Toxicity-Functional Assessment of Chronic Illness Therapy Version 2 (COST-FACIT-V2); lower scores (range, 0-44) indicating greater financial toxicity., Baseline, 1st month and 3rd month since baseline|Material domain of financial toxicity, Material domain of financial toxicity will be measured with 2 items adapted from the Medical Expenditure Panel Survey (MEPS)., 1st month and 3rd month since baseline|Behavioral domain of financial toxicity, Behavioral domain of financial toxicity will be measured by employment changes and cost-related nonadherence with 6 items adapted from MEPS and previous literature., 1st month and 3rd month since baseline
Secondary Outcome Measures: Cost-related health literacy, The cost-related health literacy will be measured with homemade 10-item questionnaire, with higher scores indicating higher cost-related health literacy., Baseline, 1st month and 3rd month since baseline|Shared decision-making, The shared decision-making ability will be measured with 9-item shared decision-making questionnaire (SDM-Q-9); higher scores (range, 0-45) indicating a greater degree of participants' involvement in shared decision-making., Baseline, 1st month and 3rd month since baseline|Perceived stress, The perceived stress will be measured with Perceived Stress Scale (PSS); higher scores (range, 0-56) indicating greater perceived stress., Baseline, 1st month and 3rd month since baseline
Heterogeneity of Tertiary Lymphoid Structures Predicts Distinct Malignancy and Immune Microenvironment in Prostate Cancer: a Retrospective Cohort Study
NCT Number: NCT06484127
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Prostate Cancer
Sponsor: Fudan University
Sex: MALE
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-12-01
Completion Date: 2024-05-30
Locations: Fudan University Shanghai Cancer Center, Shanghai, Shanghai, 200000, China

Summary:
The aim of this study was to reveal the predictive value of spatial heterogeneity and maturity difference of tertiary lymphoid structure in pathological sections of prostate cancer patients for clinical features and prognosis. It provides a new idea for the selection of prostate cancer immunotherapy population in the future.

Primary Outcome Measures: Correlation between the detection of TLS(tertiary lymphoid structure) and clinical features, 1 month
Functional Characterization of CD8+ T Cells After Supramaximal Exercise
NCT Number: NCT06484101
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Exercise Induced CD8+ T Cell Recruitment and Characterization of Function and Phenotype of These Cells
Interventions: PROCEDURE: Exercise
Sponsor: Karolinska Institutet
Sex: ALL
Age: ADULT
Enrollment: 7
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2023-03-31
Completion Date: 2024-02-14
Locations: Karolinska Sjukhuset Huddinge, Huddinge, Stockholm, Sweden

Summary:
Healthy human subjects perform supramaximal exercise with venous blood samples obtained before and up to 60 minutes after the exercise bout.

Primary Outcome Measures: CD8 T cell absolute nr after exercise, CD8 nr, Before, directly after, 60 minutes after exercise|CD8 T cell cytotoxicity against cancer cells, CD8 T cell lysis of cancer cells, Cryopreserved CD8 cells from Day 1 and Day 8 of the experiment, obtained before and after exercise|CD8 T cell pheontype after exercise, Flow cytometry analysis of CD8 T cells, Before, directly after, 30 minutes and 60 minutes after exercise
Study Brain Mechanisms of Frustration With Magnetoencephalography in Healthy Volunteers
NCT Number: NCT06484088
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: EARLY_PHASE1
Conditions: Irritability
Interventions: OTHER: Frustration task
Sponsor: National Institute of Mental Health (NIMH)
Sex: ALL
Age: ADULT
Enrollment: 40
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-09-10
Completion Date: 2027-08-31
Locations: National Institutes of Health Clinical Center, Bethesda, Maryland, 20892, United States

Summary:
Background:

Irritability can be defined as an unusually strong response to frustration; these responses may include severe temper outbursts and a constant grumpy mood. Irritability is a common symptom of many mental health disorders. Little is known about how the brain responds to frustration, and few treatments are available for this problem. Researchers want to know more about how the brain responds to frustration.

Objective:

To learn how the brain responds to frustration.

Eligibility:

Healthy adults aged 18 to 55 years. They must have been screened through studies 01-M-0254 or 17-M-0181.

Design:

Participants will have up to 3 study visits in 2 months. Each visit will last up to 4 hours.

Visit 1: Participants will be screened. They will have a physical exam. They will complete questionnaires about how often and how easily they get angry or grumpy. They will be trained to use a device that measures hand grip.

Visit 2: Participants will have a magnetic resonance imaging (MRI) scan. They will lie on a table that slides into a tube. Padding will hold their head still.

Visit 3: Participants will undergo magnetoencephalography (MEG). A cone with detectors will be lowered over their head while they are seated. The MEG will measure the magnetic fields in the participant s brain both while they are resting and while they are doing the frustration task. For the task, they will hold a grip device in each hand. They will use the devices to pick 1 of 2 doors on a computer screen. The task has 3 parts. The participant s face will be filmed during this task....

Primary Outcome Measures: (1) The power of neural oscillations in the cortical-basal ganglia-thalamic circuit; (2) Coherence of neural oscillations in this circuit; (3) Frustration rating by self-report, facial expression, and the duration and strength of gripping., MEG recording is acquired during the frustration task. 3-6 minutes of resting-state recording is acquired before, between, and after each block of the frustration task. Feelings of frustration and unhappiness were assessed after each run using 9-point Likert scales. Frustration assessment takes place before and after the task and between each block within the task. The strength and duration of gripping the press device during the task is recorded for all trials., The measurements will be taken during the MEG/frustration task session.
Suvorexant for Alcohol Use Disorder (AUD): Neural Mechanisms
NCT Number: NCT06484075
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Alcohol Use Disorder (AUD)|Healthy Volunteers
Interventions: DRUG: Suvorexant|DRUG: Placebo
Sponsor: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 150
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-09-10
Completion Date: 2029-12-31
Locations: National Institutes of Health Clinical Center, Bethesda, Maryland, 20892, United States

Summary:
Background:

Alcohol use disorder (AUD) is a leading cause of disease and death worldwide. New treatments for AUD are needed. Dopamine, a chemical that carries signals between brain cells, is thought to play a role in alcohol addiction. Researchers want to learn how Suvorexant, a drug used to treat sleep disorders, affects dopamine receptors in the brain.

Objective:

To see how Suvorexant affects dopamine receptors in people with AUD and in healthy people.

Eligibility:

People aged 18 to 75 years seeking treatment for AUD. Healthy volunteers are also needed.

Design:

Participants with AUD will stay in the clinic for at least 3 to 4 weeks for alcohol detoxification. They will receive normal treatment for AUD.

Suvorexant is a medicine used to treat sleep problem that is taken taken by mouth, once a day. Some participants will take the study drug. Others will take a placebo. The placebo looks like the study drug but does not contain any medicine. Participants will not know which they are taking.

Participants will wear a device that looks like a wristwatch to track their movements during their clinic stay.

Participants will have blood tests and 3 brain imaging scans before starting on the study drug: 2 positron emission tomography (PET) and 1 magnetic resonance imaging (MRI) scan. They will be injected with a radioactive tracer during each PET scan.

Participants will have tests to assess their thinking, memory, and attention. They will have sleep studies.

Imaging scans and other tests will be repeated at the end of the study.

Healthy volunteers will have 1 MRI and 2 PET scans. They will have tests to assess of their thinking, memory, and attention. They will wear a wristwatch like movement monitor for 1 week.

Primary Outcome Measures: To examine the impact of suvorexant on dopamine receptors in adults with AUD undergoing detoxification and to compare against baseline measures in healthy controls., We hypothesize that suvorexant compared to placebo will (1) increase striatal dopamine D2 receptors while decreasing the balance of D1 to D2 receptor signaling (D1R/D2R) and (2) improve sleep and reduce alcohol craving and dysphoria., 3 years
Secondary Outcome Measures: To examine suvorexant s effects on sleep quality and alcohol craving in adults with AUD undergoing detoxification., We hypothesize that suvorexant compared to placebo will improve sleep and reduce alcohol craving and dysphoria., 3 years
Prospective Observational Clinical Study on Changes in Cognitive Levels in Elderly Patients Before and After Hematopoietic Stem Cell Transplantation
NCT Number: NCT06484049
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Hematopoietic Stem Cell Transplantation
Sponsor: Institute of Hematology & Blood Diseases Hospital, China
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-30
Completion Date: 2026-05-31

Summary:
To investigate the potential improvement in cognitive levels in elderly individuals following hematopoietic stem cell transplantation, which will help better understand the changes in cognitive levels after transplantation in elderly patients, providing crucial reference for future clinical practice and research.

Primary Outcome Measures: To observe changes in cognitive levels in patients aged ≥55 years receiving allogeneic hematopoietic stem cell transplantation (allo-HSCT) before and after allo-HSCT., 1.Post-transplant Assessment: Cognitive level follow-up assessments at 1 month, 3 months, 6 months, and 1 year post-operation. Evaluation content is consistent with pre-transplant assessments. Cerebrospinal fluid testing is scheduled for 3 months post-transplant.4. Survival and Disease Follow-up: Follow-up for one year after transplantation to observe overall survival rate, disease-free survival rate, etc., 1YEAR
Effectiveness of Periodontitis Treatment on the Metabolic Activity of Symptomatic Carotid Atherosclerotic Plaque Responsible for Ischemic Stroke
NCT Number: NCT06484036
Acronym: PerioStroke
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Severe Periodontitis|Ischemic Stroke
Interventions: PROCEDURE: periodontal treatment strategy
Sponsor: Assistance Publique - Hôpitaux de Paris
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 157
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-09-01
Completion Date: 2028-09-01

Summary:
Cardiovascular disease is the world's leading cause of death. Atherothrombosis is a common cause of ischemic stroke.

A strong epidemiological link has been established between periodontitis and the risk of stroke. It shares common risk factors with atherothrombosis, and its severe form is associated with low-grade systemic inflammation and daily low-intensity bacteremia. Atherothrombosis is a frequent cause of ischemic stroke.

Periodontal bacteria have been found within atheromatous plaques, correlated with a greater risk of rupture.

Thus, periodontitis could be a modifiable risk factor for atherothrombosis and future vascular events: its early diagnosis and treatment could have a major impact on cardiovascular prevention.

Hypothesis: In patients with periodontitis who have had an ischemic stroke, periodontal treatment may reduce atherosclerotic plaque activity.

Primary Outcome Measures: Percentage evolution (relative evolution) of patients with Target-to-Background (TBR) becomes <1.6 (threshold)., The evolution of the metabolic activity of the atherosclerotic plaque measured by the Target-to-Background ratio (TBR) measured by PET scan after injection of 18-FDG at 6 months versus at baseline in percentage evolution (relative evolution) and in number of patients for whom the TBR becomes \<1.6 (threshold)., At 6 months|Number of patients with Target-to-Background (TBR) becomes <1.6 (threshold)., The evolution of the metabolic activity of the atherosclerotic plaque measured by the Target-to-Background ratio (TBR) measured by PET scan after injection of 18-FDG at 6 months versus at baseline in percentage evolution (relative evolution) and in number of patients for whom the TBR becomes \<1.6 (threshold)., At 6 months
Secondary Outcome Measures: Absolute change on Target-to-Background (TBR) ratio, Nominal change in atherosclerotic plaque metabolic activity measured by Target-to-Background (TBR) ratio measured by PET scan after 18-FDG injection at 6 months versus at baseline (absolute change)., At 6 months|Proportion of TBR success becomes <1.6, At 6 months|cardiovascular event, At 12 months|ischemic stroke, At 12 months|Atherothrombotic event, At 12 months|Acute coronary syndrome, At 12 months|Limb ischemia, At 12 months|Mortality, At 12 months|Difference in hs-CRP measurement, 6 months and 12 months|Difference in Lp-PLA2 measurement, 6 months and 12 months|Serious and non-serious adverse events, up to 12 Months
Posterior Tibial Transcutaneous Neurostimulation in Idiopathic Overactive Bladder
NCT Number: NCT06484023
Acronym: TENVESI
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Overactive Bladder
Interventions: OTHER: Survey
Sponsor: Hopital Nord Franche-Comte
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 45
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-03-29
Completion Date: 2024-06-17
Locations: Hôpital Nord Franche-Comté, Trevenans, France

Summary:
Overactive bladder is a clinical diagnosis affecting up to 17% of women. The existing medical treatment, anticholinergics, has many side effects and is sometimes ineffective. Neurostimulation of the posterior tibial nerve is a validated 3rd-line therapy, after failure of perineal re-education and medication. Studies on TENS have shown a real impact on patients quality of life and encourage its use in routine clinical practice. TENSI+ medical device is a treatment for overactive bladder. It is non-invasive, placed over the posterior tibial nerve pathway and sends electrical stimulation via electrodes located on the skin. Discreet and without side effects for users, this treatment is indicated as 3rd-line treatment for people suffering from idiopathic overactive bladder with no contraindications. The aim of this study is to assess the quality of life of patients using this device, both before use and after at least 3 months of use.

Primary Outcome Measures: Assessment of quality of life in patients who received treatment correctly treatment with TENSI +, Comparison of patients' quality of life with the OAB-q questionnaire after the installation of this therapy with patients' quality of life before the introduction of this therapy, Comparison before/after 3 month at least of TENS use
Diet, Hepcidin, and Chemotherapy RDI
NCT Number: NCT06483997
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Breast Cancer Female|Ovarian Cancer|Fallopian Tube Cancer|Primary Peritoneal Carcinoma|Endometrial Cancer|Gynecologic Cancer
Sponsor: George Washington University
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-16
Completion Date: 2026-07
Locations: George Washington University Cancer Center, Washington, District of Columbia, 20052, United States

Summary:
This prospective, observational cohort study will evaluate the extent of associations between self-reported pro- or anti- inflammatory dietary intake patterns for one month before induction chemotherapy for gynecological cancer or neo/adjuvant chemotherapy for breast cancer and baseline serum hepcidin concentrations. Associations between hepcidin concentration and relative dose intensity (RDI) of chemotherapy will also be evaluated.

Primary Outcome Measures: Serum hepcidin concentration, ng/ml, continuous, pre-chemotherapy, single measure|Chemotherapy relative dose intensity, Calculated variable that represents the ratio of chemotherapy actually received during the duration of treatment to the planned chemotherapy dose during the planned duration, during chemotherapy (up to 6 months, depends on duration of chemotherapy regimen), represents repeated measures
Secondary Outcome Measures: Hematologic toxicity, Incidence of CTCAE grade 3 or higher hematologic toxicity (anemia, neutropenia, thrombocytopenia), at any point during chemotherapy or within 30 days after completion of chemotherapy (up to 6 months, depends on length of chemotherapy regimen)|Treatment delays, Delay of chemotherapy due to chemo-related adverse events, including hematologic toxicity, infection, hospitalization, or severe symptoms, at any point during chemotherapy (up to 6 months, depends on length of chemotherapy regimen)|Treatment change or discontinuation, Change of chemotherapy regimen or discontinuation of treatment due to chemo-related adverse events, including hematologic toxicity, infection, hospitalization, or severe symptoms, at any point during chemotherapy (up to 6 months, depends on length of chemotherapy regimen)|Blood transfusion, Infusion of red blood cells, platelets, fresh frozen plasma, or other donated human blood products due to chemo-related hematologic toxicity, at any point during chemotherapy or up to 30 days after completion of chemotherapy (up to 6 months, depends on length of chemotherapy regimen)|Hospitalizations, Unscheduled admission to a hospital or similar medical facility due to due to chemo-related adverse events, including hematologic toxicity, infection, or severe symptoms, at any point during chemotherapy or up to 30 days after completion of chemotherapy (up to 6 months, depends on length of chemotherapy regimen)
Noninvasive Ventilation Facemasks Favoring Carbon Dioxide Washout
NCT Number: NCT06483984
Acronym: MASHUP
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Respiratory Insufficiency
Interventions: DEVICE: Noninvasive ventilation
Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10-01
Completion Date: 2025-10-01
Locations: General intensive care unit, Fondazione Policlinico A. Gemelli IRCCS, Roma, Italy|Fondazione Policlinico Universitaro A. Gemelli IRCCS, Rome, Italy

Summary:
The objective of this randomized cross-over trial is to assess the physiological effects of three different facemasks for noninvasive ventilation (Nivairo, Visairo, Optiniv) in patients with acute hypercapnic respiratory failure

Primary Outcome Measures: Metabolic work of breathing, Simplified pressure-time-product per minute of the transdiaphragmatic pressure, 45 minutes
Secondary Outcome Measures: Normalized metabolic work of breathing, Simplified pressure-time-product per minute of the transdiaphragmatic pressure normalized to arterial carbon dioxide divided by 45 mmHg, 45 minutes|Inspiratory effort, expressed in cmH2O, Positive inspiratory deflection of transdiaphragmatic pressure, 45 minutes|Corrected minute ventilation, Minute ventilation assessed with electrical impedence tomography, normalized to normalized to arterial carbon dioxide divided by 45 mmHg, 45 minutes|Dyspnea, Dyspnoea, defined according to visual analog scale of dyspnea (0-10, where 10 represents worst perceivable dyspnea)., 45 minutes|Discomfort, Discomfort, defined according to visual analog scale of discomfort (0-10, where 10 represents worst perceivable discomfort)., 45 minutes|End-expiratory lung volume, Global impedance-derived end-expiratory lung volume (EELI), measured with electrical impedance tomography, 45 minutes|Regional End-expiratory lung volume, Regional (ventral-midventral-middorsal-dorsal) impedance-derived end-expiratory lung volume (EELI), measured with electrical impedance tomography, 45 minutes|Arterial carbon dioxide, expressed in mmHg, Arterial carbon dioxide, measured with arterial blood gas analysis, 45 minutes|Arterial acid-base state, Arterial pH, measured with arterial blood gas analysis, 45 minutes|Recuitment of expiratory muscles, expressed in cmH2O of gastric pressure, Expiratory increases in gastrinc pressure, 45 minutes|Tidal volume distribution, Tidal volume distribution in the different lung regions (ventral-midventral-middorsal-dorsal),assessed with electrical impedance tomography, 45 minutes
Comparison of Oral Isotretinoin vs Ancomparison of Oral Isotretinoin vs Antibiotics on Corneal Thickness With AV
NCT Number: NCT06483971
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cornea
Interventions: DIAGNOSTIC_TEST: Oral Isotretinoin|COMBINATION_PRODUCT: Antibiotics
Sponsor: Superior University
Sex: ALL
Age: ADULT
Enrollment: 36
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2023-11-01
Completion Date: 2024-10-30
Locations: Shalamar Hospital Mughalpura, Lahore, Punjab, Pakistan

Summary:
Comparison of Oral Isotretinoin versus comparison of Oral Isotretinoin versus Antibiotics on Corneal Thickness in Patients with Acne Vulgaris

Primary Outcome Measures: Optical Coherence Tomography (OCT), Standardized OCT imaging protocols to ensure consistency and accuracy across all measurements., 12 Months|Snellen Chart, Visual acuity measured at 3-month and 6-month intervals. Units: Snellen fraction (e.g., 20/20, 20/40), 12 months
Palliative Care Protocol for Adult Patients Hospitalized in Critical Care Units.
NCT Number: NCT06483958
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: End of Life Care|Critical Illness|Palliative Care
Interventions: BEHAVIORAL: palliative care protocol
Sponsor: University of Chile
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 248
Study Design: Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-01-02
Completion Date: 2025-12-30
Locations: Verónica Rojas, Santiago, Me, 8380420, Chile

Summary:
The goal of this clinical trial is to determine the effectiveness of a palliative care protocol in improving the quality of care of adult patients at high risk of dying hospitalized in the critical care unit.

Assessing symptom burden (dyspnea, pain and/or anxiety/agitation) until death or day 5 (whichever comes first)

Researchers will compare the impact of the palliative care protocol with standard care to see if it improves the quality of care.

Participants will:

1. Symptom management.
2. Respect for the autonomy of the patient and his/her family environment.
3. Respectful management of clinical information.
4. Provision of holistic care and support.

Primary Outcome Measures: Burden of symptoms present in the last 24 hours prior to death (or end of follow-up)., The percentage of patients with at least one episode of pain, dyspnea, agitation, or anxiety, From recruitment until death or day 5 of follow up
Secondary Outcome Measures: Family satisfaction, Family satisfaction in relatives of adult patients at high risk of death., Up to 4 week after death or hospital discharge
Dexcom Continuous Glucose Monitoring System Use in aReal-World, Global Registry (Dexcom Global Registry)
NCT Number: NCT06483945
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Diabetes
Interventions: DEVICE: Dexcom CGM G6/G6 Pro/G7
Sponsor: DexCom, Inc.
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 5000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-02-28
Completion Date: 2028-06-30
Locations: Institute of Endocrinology Diabetes, Health & Hormones, Stockbridge, Georgia, 30281, United States|Palm Research Center, Las Vegas, Nevada, 89148, United States

Summary:
"To evaluate the use of the Dexcom CGM System when used according to approved commercial labeling during standard clinical use and its impact on intended users in a real-world setting"

Primary Outcome Measures: Patient Reported Outcomes (PROs), Patients will be asked to complete multiple questionnaires over a period of 4 years for data to be analyzed and reported., 4 years
Barberry and Cardiometabolic Risk Factors in Individuals With Hypertriglyceridemia
NCT Number: NCT06483932
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hyperlipidemias|Hypertriglyceridemia
Interventions: OTHER: Dried barberry|OTHER: Low-calorie diet
Sponsor: Shahid Beheshti University
Collaborators: Shahid Beheshti University of Medical Sciences|Kashan University of Medical Sciences
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 52
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-07-01
Completion Date: 2025-03-15
Locations: Shahid Beheshty Unversity Hospital, Kāshān, Isfahan, Iran, Islamic Republic of

Summary:
Barberry is a well-documented medicinal plant that is utilized as a feed additive in a variety of food cultures. Barberry is a rich source of antioxidants, minerals, phenolic compounds, and flavonoids. Based on the results of animal and human studies, barberry may have therapeutic and medicinal properties, including the ability to improve blood lipid profile. The present study will investigate the effect of seedless barberry consumption on cardiometabolic factors in overweight or obese individuals with mild to moderate hypertriglyceridemia.

Primary Outcome Measures: Plasma concentration of triglycerides, The plasma triglyceride concentration 12 hours after the subjects had fasted, At baseline, the fourth week and the eighth week of study|Plasma concentration of high-density lipoprotein cholesterol (HDL-C), The plasma HDL-C concentration 12 hours after the subjects had fasted, At baseline, the fourth week and the eighth week of study
Secondary Outcome Measures: Body weight, Body wight loss (kg), At baseline, the fourth week and the eighth week of study|Plasma Cholesterol, The plasma total cholesterol and LDL-C concentrations 12 hours after the subjects had fasted, At baseline, the fourth week and the eighth week of study|Plasma proprotein convertase subtilisin/kexin type 9 (PCSK9), The plasma PCSK9 concentration 12 hours after the subjects had fasted, At baseline and the eighth week of study|Plasma C-reactive protein, The plasma CRP concentration, At baseline and the eighth week of study|Plasma Insulin, The plasma insulin concentration 12 hours after the subjects had fasted, At baseline and the eighth week of study|Blood pressure, Systolic and diastolic bliood pressure, At baseline, the fourth week and the eighth week of study|Urinary polyphenol, Total polyphenol concentration in spot urine sample, At baseline, the fourth week and the eighth week of study
The Predictive Value of Proteome Profiling for Brain Metastasis in Limited-Stage Small-Cell Lung Cancer
NCT Number: NCT06483919
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Small-cell Lung Cancer
Sponsor: Jinming Yu
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 228
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-10-01
Completion Date: 2025-01-30
Locations: Shandong Cancer Hospital and Institute, Jinan, Shandong, 250000, China

Summary:
This study aims to evaluate the predictive value of proteome profiling for brain metastasis in limited-stage small-cell lung cancer

Primary Outcome Measures: Brain metastases free survival, The length of time after the ending of primary treatment that the patient survives without any brain metastases signs or symptoms, 2 years
Secondary Outcome Measures: Overall survival, The length of time after the ending of primary treatment that the patient survives., 2 years
Venetoclax and Azacitidine Combined With Homoharringtonine, Followed by Allo-HSCT for Intermediate and High-risk AML.
NCT Number: NCT06483906
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Acute Myeloid Leukemia
Interventions: DRUG: Venetoclax, Azacitidine and Homoharringtonine
Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Sex: ALL
Age: ADULT
Enrollment: 56
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-02
Completion Date: 2028-07-01
Locations: Shanghai General hospital,Shanghai Jiao Tong University School of Medicine, Shanghai, Shanghai, China

Summary:
This study is a single-center, single-arm, prospective phase II clinical trial evaluating the efficacy and safety of the VAH (Venetoclax and Azacitidine combined with Homoharringtonine) regimen, followed by allo-HSCT for intermediate and high-risk AML. Eligible patients receive two cycles of the VAH chemotherapy regimen. If minimal residual disease (MRD) is negative after these two cycles, patients proceed to the transplantation process. If MRD remains positive, patients receive an additional two cycles of the VAH regimen. Upon achieving MRD negativity, they then proceed to the transplantation process.

The conditioning regimen includes fludarabine at 30 mg/m²/day from day -7 to day -3 (5 days), cytarabine at 1-1.5 g/m²/day from day -7 to day -3 (5 days), and busulfan at 3.2 mg/kg/day from day -5 to day -3 (3 days). Conditioning begins on day -6, and donor hematopoietic stem cell infusion is performed on day 0.

All patients will undergo bone marrow examination on day 14 and day 28 post-transplant, followed by bone marrow examinations every 30 days within the first year after transplantation, and every 60 days within the second year. If disease relapse is suspected during the follow-up period, bone marrow or extramedullary relapse site examinations will be conducted at any time.

The primary endpoint is the 1-year and 2-year overall survival (OS). Secondary endpoints include the complete response (CR) rate after 1 and 2 cycles of chemotherapy; 1-year and 2-year disease-free survival (DFS) following the achievement of CR through induction therapy; cumulative relapse rate; non-relapse mortality (NRM); incidence of acute graft-versus-host disease (GVHD) within 180 days post-transplant; and the cumulative incidence of chronic GVHD within 1 year and 2 years post-transplant.

Primary Outcome Measures: 1y and 2y-OS, 1-year and 2-year overall survival (OS) after enrollment, up to 2 years
Ultrasound-Guided Thyroid Cartilage Plane Block vs Ultrasound-Guided Traditional Superior Laryngeal Nerve Block for Awake Fiberoptic Intubation in Patients With Limited Neck Mobility Undergoing Cervical Spine Fixation
NCT Number: NCT06483893
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Patient Satisfaction
Interventions: PROCEDURE: US-guided thyroid cartilage plane block (group TCPB)|PROCEDURE: US-guided traditional superior laryngeal nerve block (group traditional SLNB)
Sponsor: Beni-Suef University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-01
Completion Date: 2025-07-01
Locations: Beni-Suef University hospital, Banī Suwayf, Beni Suef, 62814, Egypt

Summary:
The aim of the work to compare between the effectiveness and safety of ultrasound-guided superior laryngeal nerve block through surface injection of local anesthetic solution on the thyroid cartilage and ultrasound-guided traditional superior laryngeal nerve block on quality of airway anesthesia for awake fiberoptic intubation in patients with limited neck mobility undergoing cervical spine fixation.

Primary Outcome Measures: the time taken to perform block, from the start of ultrasound probe positioning to completion of drug administration, During surgery, upon performing block
Secondary Outcome Measures: quality of airway anesthesia a, Assessment of quality of airway anesthesia was done on a 5-point scale as described by Reasoner et al.\[13\] 0 = No coughing or gagging in response to intubation, 1 = Mild coughing and/or gagging that did not hinder intubation, 2 = Moderate coughing and/or gagging that interfered minimally with intubation, 3 = Severe coughing and/or gagging that made intubation difficult, 4 = very severe coughing and/or gagging that required additional local anesthetic (LA) and/or change in technique to achieve successful intubation., During surgery, upon intubation|Ramsay Sedation Score, The Ramsay Sedation Score is as follows: 6 points for unarousable, 5 points for slow response to stimulus, 4 points for asleep but easily aroused, 3 points for quiet and cooperative with orientation, 2 points for asleep, anxious, restless, and 1 point for asleep, agitated, and restless. Satisfactory sedation falls within 2-4 points, while oversedation is indicated by 5-6 points., T0: upon entry to the operating room,T1: before insertion of the tracheal tube,T2: immediately after tracheal tube insertion,T3: 5 minutes after successful intubation ]
The Role of Adjuvant Albendazole After Pulmonary Hydatid Cyst Resection
NCT Number: NCT06483880
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pulmonary Hydatid Cyst
Interventions: DRUG: Albendazole|DRUG: Placebo
Sponsor: Ain Shams University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 24
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: PREVENTION
Start Date: 2024-02-01
Completion Date: 2024-08-31
Locations: Ain Shams University Hospitals, Cairo, Al Abbasiya, Egypt

Summary:
The aim of this study is to study the role of adjuvant Albendazole after pulmonary hydatid cyst resection versus placebo in reducing recurrence with a short- term follow-up of six months.

Primary Outcome Measures: Recurrence of pulmonary hydatid disease, Recurrence of pulmonary hydatid disease in six months in both groups, assessed by:

1. Chest X-ray radiography after the 2 weeks.
2. CT chest in six months and after one year or symptoms requiring CT chest at any timing., six months
Secondary Outcome Measures: Liver function tests (AST and ALT) between both groups., AST and ALT will be measured in U/L before operation and after completing the two 15-day cycles of Albendazole or Placebo in either group. And after six months in both groups., Six months|Length of hospital stay between both groups., Six months|In hospital mortality between both groups., Six months|Financial cost between both groups., Six months
The Correlation Between Tissue Oxygenations Using NIRS and Clinical Outcomes in Very Preterm Infants.
NCT Number: NCT06483867
Acronym: TCBTOUNACOIVPI
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Tissue Oxygenation
Sponsor: The First Hospital of Jilin University
Sex: ALL
Age: CHILD
Enrollment: 151
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-01
Completion Date: 2025-07-01

Summary:
With the development of neonatal critical medicine, the survival rate of premature infants has gradually increased, and the incidence of late complications has significantly decreased, but preterm delivery is still the main cause of death of children in China.

Near infrared spectroscopy (NIRS) makes use of the different absorption spectra of oxygenated and deoxyhemoglobin in the near infrared band to provide tissue oxygenation index, which is non-invasive and convenient. Due to the thin skin and bone of newborns, near infrared spectroscopy has a broad prospect and important significance in the field of newborns. Non-invasive, real-time and continuous monitoring of brain oxygenation, intestinal oxygenation and tissue perfusion of premature infants can provide doctors with important information support and auxiliary means, which can help to detect and deal with various complications in time and improve the survival rate and health status of premature infants. The current research is mainly focused on exploring the relationship between some specific indicators and corresponding diseases, but there is a lack of research on a series of complications related to premature infants, especially in very premature infants, due to the immaturity of multiple organ system development. They had a significantly higher risk of complications such as severe intraventricular hemorrhage, necrotizing enterocolitis (NEC), retinopathy of prematurity (ROP), bronchopulmonary dysplasia (BPD) and so on. However, there is a lack of cohort study on the prediction of early complications in such children. The purpose of this study is to further explore the changes of tissue oxygen saturation and related indexes in the early postnatal period and their relationship with related complications. It is assumed that the tissue oxygen saturation in the early postnatal period is related to the adverse outcome in hospital, so as to intervene the children early and reduce the occurrence of adverse outcome.

Primary Outcome Measures: The composite outcome, death or any 1 of the following morbidities: bronchopulmonary dysplasia (BPD), retinopathy of prematurity ≥stage 3,periventricular leukomalacia, Necrotizing Enterocolitis≥stage II, and sepsis, 2023.12-2024.12
Healer-initiated HIV Counseling and Testing Versus Standard of Care in Rural South Africa
NCT Number: NCT06483854
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hiv
Interventions: DIAGNOSTIC_TEST: HIV counseling and testing from a traditional health practitioner
Sponsor: Vanderbilt University Medical Center
Collaborators: University of Witwatersrand, South Africa
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 230907
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SCREENING
Start Date: 2024-11-01
Completion Date: 2028-09-01

Summary:
South Africa has made progress towards their 95-95-95 goals, yet a substantial proportion of the population do not test regularly. To reach people who otherwise may avoid testing, we propose to build on our successful healer-initiated HIV counseling and testing pilot to conduct a cluster randomized controlled trial in 42 clinical catchment areas to evaluate an expanded Healer-Initiated HIV Testing and Linkage to Care intervention in rural South Africa.

Primary Outcome Measures: Uptake of HIV counseling and testing, At the time of a healer visit, we will assess the % of people who receive an HIV test divided by the total number of people who are invited to test and who are eligible., 24 months
Impact of Dental Anxiety Coping Module on Children With Dental Anxiety
NCT Number: NCT06483828
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Dental Anxiety
Interventions: BEHAVIORAL: Dental Anxiety Coping Module
Sponsor: University of Malaya
Sex: ALL
Age: CHILD
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, CARE_PROVIDER)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-07-04
Completion Date: 2025-07-04

Summary:
The aim of this study is to evaluate the impact of the Dental Anxiety Coping Module (DACM) in children with dental anxiety. The main questions to answer are:

1. Will the Dental Anxiety Coping Module has any effect on dental anxiety in primary school children based on MY-ACDAS and HRV-Biofeedback?
2. Is there any difference in dental anxiety between control and intervention group on baseline and post-test measured with MY-ACDAS?
3. Is there any difference in dental anxiety between control and intervention group on baseline, during and post-test measured with and HRV-Biofeedback?

Primary Outcome Measures: Changes in Malaysian- Abeer Children Dental Anxiety Scale (MY-ACDAS) score, Malaysian- Abeer Children Dental Anxiety Scale (MY-ACDAS) range value from 13-39, a child is considered anxious if his/her overall score is equal or more than 26. Hence participant that score 26 and above considered having dental anxiety and will be included in the study, Before intervention and dental procedure and immediately afterwards on the same day
Secondary Outcome Measures: Changes in HRV-Biofeedback coherence, Coherence will be measured using Heart Rate Variability (HRV) biofeedback., Before intervention and dental procedure, during dental procedure and immediately afterwards on the same day
Fungal Infections During and After the SARS-CoV-2 Pandemic: A Retrospective Comparison
NCT Number: NCT06483815
Status: ENROLLING_BY_INVITATION
Study Type: OBSERVATIONAL
Conditions: Fungal Infections
Interventions: DIAGNOSTIC_TEST: Culture, İsolation
Sponsor: Bekir Sami Uyanık
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1441
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-01
Completion Date: 2024-07-30
Locations: Hisar Hospital Intercontinental, Istanbul, 34768, Turkey

Summary:
his study aims to retrospectively compare fungal positivity rates between the SARS-CoV-2 pandemic and the post-pandemic periods. During the pandemic, Candida species had a positivity rate of 17.36%, and Aspergillus had a rate of 2.22%. Post-pandemic, these rates decreased to 9.29% and 1.00%, respectively. The overall fungal positivity rate decreased from 9.15% during the pandemic to 5.13% post-pandemic. Statistical analysis revealed a significant decrease in fungal positivity rates post-pandemic (p \< 0.01). These findings underscore the effectiveness of post-pandemic healthcare interventions and infection control strategies.

Primary Outcome Measures: Fungal positivity rates during the SARS-CoV-2 pandemic period and post-pandemic period, Fungal infection data from samples of patients, 623 of whom were during the SARS-CoV-2 epidemic and 818 of whom were in the post-epidemic period, were retrospectively examined. Fungal positivity rates for different fungal agents such as Candida species and Aspergillus were calculated separately and compared statistically., 2020-2024
Efficacy and Safety of HB-1 for Panic Disorder
NCT Number: NCT06483789
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Panic Disorder|Mental Illness
Interventions: DRUG: HB-1|DRUG: Telmisartan Only Product in Oral Dose Form|DRUG: Verapamil Only Product in Oral Dose Form|DRUG: Placebo
Sponsor: Honeybrains Biotech LLC
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 240
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2026-02

Summary:
The purpose of this study is to determine the safety and efficacy of HB-1, versus placebo and two monotherapies, in male and female adult patients aged 18 to 65 years, inclusive, with Panic Disorder.

Primary Outcome Measures: Number of Unexpected Panic Attacks, Efficacy will be evaluated through a comparison of the number of unexpected panic attacks from Screening as compared to protocol-specified timepoints per protocol., Screening, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, and Week 12|Incidence of Treatment-Emergent Adverse Events, Safety will be evaluated through the monitoring of Adverse Events and the review of clinically significant changes in routine laboratory tests, ECGs, and orthostatic vital signs., Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12 and Week 13.
Secondary Outcome Measures: Change in Clinical Global Impression-Severity Scale (CGI-S), Efficacy will be evaluated through an evaluation in Clinical Global Impression Severity scale (CGI-S) scores from Baseline as compared to protocol-specified timepoints per protocol. The Clinical Global Impression Severity Scale is rated on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (amongst the most severely ill patients)., Baseline, Week 4, Week 8 and Week 12|Change in Panic Disorder Symptom Severity Scale (PDSS), Efficacy will be evaluated through an evaluation in Panic Disorder Symptom Severity Scale (PDSS) scores from Screening as compared to protocol-specified timepoints per protocol., Screening, Week 4, Week 8 and Week 12