pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
A Virtual Support Intervention for Postnatal Well-being
NCT Number: NCT06557200
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Postnatal Depression|Mother-Infant Interaction
Interventions: BEHAVIORAL: Digital Infant- parents support
Sponsor: Universiti Putra Malaysia
Collaborators: University of Lahore
Sex: ALL
Age: ADULT
Enrollment: 1400
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, OUTCOMES_ASSESSOR)|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-08-15
Completion Date: 2025-08-10
Locations: Ahmad Hospital, Lahore, Punjab, 54590, Pakistan

Summary:
Postnatal depression (PND) and anxiety are significant public health concerns affecting a substantial proportion of new mothers worldwide. These conditions can have profound consequences for both maternal and infant well-being, including increased risk of

1. maternal morbidity
2. impaired parent-infant bonding
3. long-term developmental challenges for the child.

Primary Outcome Measures: Post natal depression, Edinburgh Postnatal Depression Scale (EPDS): A standardized self-report questionnaire to assess symptoms of postnatal depression. Scores are between 0 and 30, with scores 13 and above indicating depressive illness, or a high risk of developing a depressive disorder. Scores of 13 indicate an 80% chance that the mother has depression., Post natal Depression measured at baseline and 12 months|Post natal anxiety, Generalized Anxiety Disorder-7 (GAD-7): A self-report measure to assess symptoms of generalized anxiety disorder. The GAD-7 scores were also represented with clinical categorizations of anxiety levels as follows: GAD-7 score of 0-4 (none), 5-9 (mild), 10-14 (moderate), and 15-21 (severe)., Post natal Anxiety measured at baseline and 12 months|Intervention usage, Intervention usage will be assessed by tracking participants' engagement with the online platform, including login frequency, module completion, and time spent on the platform., Intervention usage measured at 12 months
A Study to Evaluate IMC-002 in Neuromyelitis Optica Spectrum Disorder (NMOSD) Patients
NCT Number: NCT06557174
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Neuromyelitis Optica Spectrum Disorder (NMOSD)
Interventions: DRUG: IMC-002|DRUG: mycophenolate mofetil， MMF
Sponsor: ImmuneCare Biopharmaceuticals (Shanghai) Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 116
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-10-10
Completion Date: 2026-07-10

Summary:
The purpose of this study is to evaluate the efficacy and safety of IMC-002 in the treatment of NMOSD.

Primary Outcome Measures: Proportion of relapse-free patients, Up to Week 24
Secondary Outcome Measures: Time to first relapse (TFR), Up to Week 24|Mean change from baseline in Expanded Disability Status Scale (EDSS) score over the course of the study, The Expanded Disability Status Scale ranges from 0 to 10 in 0.5 unit increments. Higher results represent higher levels of disability, Baseline (Day -28 to Day -1) to Week 24
A Prospective, Open-label, Randomized Controlled, Multicenter Clinical Study of MSD-HSCT Using a TBI or TMLI Conditioning Regimen for Adult ALL
NCT Number: NCT06557161
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Acute Lymphoblastic Leukemia, Adult
Interventions: RADIATION: TBI|RADIATION: TMLI|DRUG: Cyclophosphamide
Sponsor: The First Affiliated Hospital of Zhengzhou University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 170
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2029-12-31

Summary:
This study aims to compare the effects of two different conditioning regimens on patients with acute lymphoblastic leukemia (ALL) undergoing matched sibling donor hematopoietic stem cell transplantation (MSD-HSCT): Total Body Irradiation (TBI) and Total Marrow, Central Nervous System and Lymphoid Irradiation (TMLI). Both regimens are supported and recommended by literature; however, there is no definitive evidence favoring one over the other. We hypothesize that the TMLI regimen, compared to the TBI regimen, may more effectively eliminate leukemia cells in the bone marrow and lymphoid tissues, thereby reducing the risk of relapse, while also minimizing damage to normal tissues, thus reducing conditioning-related toxicity and transplant-related mortality. This study aims to provide evidence for the optimal conditioning regimen for MSD-HSCT in adult ALL patients, with the goal of improving patient quality of life and survival outcomes.

Primary Outcome Measures: Relapse-free survival (RFS), RFS is defined as the time from transplantation to the first relapse or death, with RFS is defined as the time from transplantation to the first relapse or death, with the date of the last follow-up as the endpoint., 2 years|acute Graft Versus Host Disease (aGVHD), The incidence of aGVHD within 100 days post-transplant., 100 days|Overall Survival (OS), OS is defined as the time from transplantation to death, with the date of the last follow-up as the endpoint., 2 years
Secondary Outcome Measures: Transplantation Related Mortality (TRM), The incidence of TRM in 2 years., 2 years|Relapse Rate (RR), The incidence ratio of leukemia relapse in 2 years., 2 years|Conditioning-related Adverse Events (CRAE), Based on CTCAE v5.0., 30 days
A Study Comparing Cancer Imaging Approaches in People With Lobular Breast Cancer
NCT Number: NCT06557148
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Breast Cancer|Lobular Breast Carcinoma|Breast Carcinoma|Metastatic Breast Cancer|Metastatic Lobular Breast Carcinoma|Metastatic Breast Carcinoma
Interventions: DIAGNOSTIC_TEST: 18F-Fluoroestradiol PET/CT
Sponsor: Memorial Sloan Kettering Cancer Center
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-13
Completion Date: 2027-08-13
Locations: Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities), Basking Ridge, New Jersey, 07920, United States|Memorial Sloan Kettering Monmouth (Limited protocol activities), Middletown, New Jersey, 07748, United States|Memorial Sloan Kettering Bergen (All Protocol Activities), Montvale, New Jersey, 07645, United States|Memorial Sloan Kettering Suffolk-Commack (All protocol activity), Commack, New York, 11725, United States|Memorial Sloan Kettering Westchester (Limited Protocol Activities), Harrison, New York, 10604, United States|Memorial Sloan Kettering Cancer Center (All Protocol Activities), New York, New York, 10065, United States|Memorial Sloan Kettering Nassau (Limited Protocol Activites), Rockville Centre, New York, 11553, United States

Summary:
The purpose of this study to compare two types of cancer imaging scans to see which is better at detecting and monitoring metastatic ILC. This study will compare PET/CT (positron emission tomography/computed tomography) scans using the radiotracer fluorine 18 (18F)-fluoroestradiol (FES) with a standard imaging approach for detecting and monitoring ILC, PET/CT scans using the radiotracer 18F-fluorodeoxyglucose (FDG). These scans will be referred to as FES PET/CT scans and FDG PET/CT scans.

Primary Outcome Measures: Comparison of FES PET/CT in Metastatic Invasive Lobular Carcinoma/ILC to standard-of-care (SOC) imaging with FDG PET/CT at baseline, Disease detection by 18F-FES and 18F-FDG PET/CT images at baseline will be directly compared, 1 year
Brachial Versus Femoral Access for Carotid Artery Stenting
NCT Number: NCT06557135
Acronym: BEFIT
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Carotid Artery Stenosis Without Infarction (Disorder)|Ischemic Stroke
Interventions: PROCEDURE: Carotid Artery Stenting (CAS)
Sponsor: The First Affiliated Hospital with Nanjing Medical University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 124
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2025-12

Summary:
Study purpose:

A multicenter, prospective and randomized study is planned to compare the clinical outcomes of carotid artery stenting via brachial artery access and femoral artery access.

Eligible participants will be randomly assigned 1:1 to the brachial artery group or the femoral artery group.

Primary endpoint: surgical success rate.

Secondary endpoints:

1. Operation time (time from first arterial puncture to last angiography)
2. Serious adverse events (SAE) within 90 days;
3. Access puncture complications;

Primary Outcome Measures: Successful rate of CAS, Successful carotid artery stenting (CAS) is defined as access devices can be established, interventional devices can reach the lesion site, operations such as distal brain protection device release, balloon expansion and stent implantation, withdrawal protection device can be completed successfully, and residual stenosis \< 30%., 24 hours
Secondary Outcome Measures: Procedure time, time from first arterial puncture to last angiography, 24 hours|Serious adverse events (SAE), SAEs related to operation and device are defined as those related to operation procedure and device determined by investigators. Includes the incidence of death, new-onset stroke, or severe haemorrhage events within 90 days post-procedure, et al., 90 days|Access puncture complications, Hematoma at access puncture site, pseudoaneurysm, arteriovenous fistula, symptomatic severe stenosis/occlusion, 90 days
Other Outcome Measures: X-ray exposure, X-ray exposure is defined as the duration and equivalent of X-ray exposure recorded by the DSA machine during operation., 24 hours|Access conversion, If the randomized access was not successfully completed, switched to other access, 24 hours|Degree of patient-reported comfort, The comfort scale adopts the simplified General Comfort Questionnaire (GCQ）developed by nursing expert Kolcaba. The scale is scored by level 1 to 4 Likert scale, with a score range of 28-112 points. The lowest score is 28 points and the highest score is 112 points. The higher the score, the higher the comfort. A total score of \< 60 is low comfort, a total score of 60-90 is moderate comfort, and a total score of \> 90 is high comfort., 24 hours
Clinical Study to Compare Two Skin Substitute Categories for Their Effectiveness to Treat Diabetic Foot Ulcers
NCT Number: NCT06557122
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Diabetic Foot Ulcer
Interventions: DEVICE: SOC and Advanced Bioengineered Skin Substitute|OTHER: SOC and Active Comparator
Sponsor: Encoll Corp
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 24
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-25
Completion Date: 2024-10
Locations: Clemente Clinical Research, Los Angeles, California, 90033, United States|Doctors Research Network, South Miami, Florida, 33143, United States|Lower Extremity Institute of Research Therapy (LEIRT), Boardman, Ohio, 44514, United States|Foot and Ankle Specialists of the Mid-Atlantic, Salem, Virginia, 24153, United States

Summary:
The purpose of this clinical evaluation is to collect patient outcome data on a commercially available 510K FDA cleared advanced skin substitute. The commercially available product is Helicoll® Advanced Skin Substitute.

In this trial two groups of subjects with Wagner 1 diabetic foot ulcers (DFUs), will receive standard of care (SOC) treatment for their condition. Half of the patients will have their SOC treatment with Epifix® or Grafix® and the other half will receive a 510K FDA cleared Helicoll® Advanced Skin Substitute as the primary treatment. The primary endpoint is the percentage wound area reduction of the target ulcer. Secondary endpoints include the proportion of subjects that obtain complete closure over the 5-week treatment period, the time to achieve complete wound closure of the target ulcer by the end of 5 weeks, and mean number of IP applications.

Primary Outcome Measures: Percentage of wound area reduction, Percentage wound area reduction from Treatment Visit 1 to Treatment Visit 5 measured manually with digital photography, 5 weeks
Secondary Outcome Measures: Mean number of repeated applications, Mean number of repeated applications of the Advanced Skin Substitute used to obtain wound closure, 5 weeks|Proportion of complete closure, The proportion of subjects that obtain complete closure over the 5-week treatment period, 5 weeks|Time to achieve complete wound closure, The time to achieve complete wound closure of the target ulcer by the end of 5 weeks, 5 weeks
Other Outcome Measures: Appearance of the new skin by visual observation, Visual observation of the newly formed skin for any signs of redness, swelling, or other irregularities, 5 weeks|Structural stability and fragility of the new skin, Structural stability and fragility of the newly formed skin will be evaluated through compression testing using a blunt-edged instrument, 5 weeks|Recurrence of the wound, Any recurrence of the wound also will be monitored, 1 week|Safety analysis for Treatment Emergent Adverse Events, The number and type of Treatment Emergent Adverse Events, 5 weeks
Evaluating the Effects of Popular Music on Cardiopulmonary Resuscitation Training
NCT Number: NCT06557109
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: CPR|Training|Music|Nursing Students
Interventions: OTHER: Popular Music
Sponsor: Eastern Mediterranean University
Sex: ALL
Age: ADULT
Enrollment: 57
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: OTHER
Start Date: 2018-02-15
Completion Date: 2018-06-15
Locations: Eastern Mediterranean University, Famagusta, North Cyprus Via Mersin, 99628, Cyprus

Summary:
This study aims to analyze short- and long-term effects of musical memory created by using a national popular song on achieving the recommended compression rate and depth and compression-breath rate for nursing students, who received CPR training.

In this study, used a popular Turkish song, entitled, 'More Beautiful Than You' and performed by Duman, to create a musical memory to be used as a mental metronome and analyzed short- and long-term effects of using popular national songs on achieving recommended compression rate and depth and compression-breath rate for nursing students, who received CPR training and performed CPR on high-fidelity simulation mannequins for the first time.

Students in the intervention group practiced CPR with music. Students in the control group practiced CPR with a standard mannequin.

CPR performance of the participants was evaluated just after the CPR training (short-term) and six weeks after the training (long-term).

Primary Outcome Measures: the primary outcome, compression rate of 100-120/min and a depth of 5-6 cm, CPR performance of the participants was evaluated just after the CPR training (short-term) and six weeks after the training (long-term).
Secondary Outcome Measures: Secondary outcomes, 1. arm pain intensity during the CPR Arm pain intensity during the CPR was measured with a 10-cm visual analog scale (VAS).

   Right and Left arm circumference was measured in meters weight in kilograms and height in meters were measured
2. satisfaction with the CPR training Satisfaction with the CPR training was measured with a 10-cm visual analog scale (VAS)., CPR performance of the participants was evaluated just after the CPR training (short-term) and six weeks after the training (long-term).
The Effects of Daily Polyvagal Exercises on Stress in Students of Physical Therapy
NCT Number: NCT06557083
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Stress|Anxiety
Interventions: BEHAVIORAL: Polyvagal Breathing Exercises|OTHER: No Intervention
Sponsor: Dominican University New York
Sex: ALL
Age: ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-06-07
Completion Date: 2024-12
Locations: Dominican University New York, Orangeburg, New York, 10962, United States

Summary:
The purpose of this study is to investigate whether specific breathing exercises can stimulate the polyvagal system and thus decrease stress in healthy students of physical therapy. The hypothesis is that practicing daily polyvagal breathing exercises will result in decreased stress/anxiety in physical therapy students compared to the control group who will not be receiving any intervention.

Primary Outcome Measures: Stress Levels, Utilizing at electroencephalography at baseline, during a short stress induced task (a 7 question timed quiz, performed three times), and after the timed stress inducing task.

Q-Stats, a program to analyze the raw data, will be utilized to interpret the findings. The data is linearized. The lower the number, the more calm the individual is. (Thus, it is assumed the stress levels are decreased., 10 minutes|Anxiety Levels, Utilizing at electroencephalography at baseline, during a short stress induced task (a 7 question timed quiz, performed three times), and after the timed stress inducing task. Q-Stats, a program to analyze the raw data, will be utilized to interpret the findings. The data is linearized. The lower the number, the more calm the individual is. (Thus, it is assumed the anxiety levels are decreased., 10 minutes
Secondary Outcome Measures: 10 Item Perceived Stress Scale, PSS-10. There are 10 questions. Each question is on a scale of 0 - 4. The scale ranges between 0 and 40. Higher scores are indicate high stress while lower scores indicate low stress.

Research tool that measures self perceived stress., 3 minutes|7 Item Generalized Anxiety Disorder, GAD-7. There are There are 7 questions. Each question is on a scale of 0 - 3. The scale ranges between 0 and 21. Higher scores are indicate severe anxiety while lower scores indicate minimal anxiety.

Research tool that measures self perceived anxiety., 3 minutes
Impact of Aromatase Inhibitor Therapy on Glucose Homeostasis and Diabetes Risk
NCT Number: NCT06557057
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: HER2-Positive Breast Carcinoma
Interventions: OTHER: Non-Interventional Study
Sponsor: Mayo Clinic
Sex: FEMALE
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 75
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-11-16
Completion Date: 2025-12-01
Locations: Mayo Clinic in Rochester, Rochester, Minnesota, 55905, United States

Summary:
This study assesses the effect of hormone directed treatment for breast cancer on glucose metabolism.

Primary Outcome Measures: DI (disposition index), Will be calculated as the product of beta cell responsivity and Si (insulin action) Si. DI of women with hormone receptor positive breast cancer treated with aromatase inhibitors will be compared to DI of healthy post menopausal women. Participants will undergo a history, physical examination, and a blood collection for fasting glucose, and Hemoglobin A1C (HbA1c) at baseline and one year later. Participants will be contacted at 3 and 6 months by phone to confirm continued use of the endocrine therapy that was initiated by the clinical team., Baseline; up to 1 year|Glucose homeostasis - tamoxifen compared to no treatment, Glucose homeostasis is the process by which the body regulates blood glucose levels, also known as blood sugar, within a narrow range. Glucose homeostasis of women with hormone receptor positive breast cancer treated with tamoxifen will be compared to glucose homeostasis of women without treatment. Participants will undergo a history, physical examination, and a blood collection for fasting glucose, and Hemoglobin A1C (HbA1c) at baseline and one year later. Participants will be contacted at 3 and 6 months by phone to confirm continued use of the endocrine therapy that was initiated by the clinical team., Baseline; up to 1 year|Glucose homeostasis - aromatase inhibitor compared to tamoxifen, Glucose homeostasis is the process by which the body regulates blood glucose levels, also known as blood sugar, within a narrow range. Glucose homeostasis of women with hormone receptor positive breast cancer treated with aromatase inhibitors will be compared to glucose homeostasis of women treated with tamoxifen. Participants will undergo a history, physical examination, and a blood collection for fasting glucose, and Hemoglobin A1C (HbA1c) at baseline and one year later. Participants will be contacted at 3 and 6 months by phone to confirm continued use of the endocrine therapy that was initiated by the clinical team., Baseline; up to 1 year
The Analgesic Efficacy of Pericapsular Nerve Group (PENG) Block in Patients Undergoing Primary Total Hip Arthoplasty:
NCT Number: NCT06557044
Acronym: PENG
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Prospective|Randomized|Double-blind
Interventions: DRUG: Ropivacaine|OTHER: Physiological saline
Sponsor: Diakonie-Klinikum Stuttgart
Collaborators: University Hospital Tuebingen
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 110
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-03-07
Completion Date: 2025-03
Locations: Diakonie-Klinikum Stuttgart, Stuttgart, Baden-Württemberg, 70176, Germany

Summary:
The aim of this study is to investigate the analgesic efficacy of the pericapsular nerve group (PENG) block during the implantation of hip endoprostheses. The study is designed as a prospective randomized double-blind study and the study participants were randomized into 2 arms and either 20 ml ropivacaine 0.5% (verum group) or 20 ml physiological saline solution (placebo group) will be applied.

Primary Outcome Measures: Rate of postoperative opioid administration, The primary objective is to investigate the influence of the PENG block on the need for postoperative ntravenously opioid administration within the first hour in the recovery room., 60 minutes after arrival in the recovery room
Secondary Outcome Measures: Quantity of total opioid consumption, Assessment of total opioid consumption until second postoperative day in both arms, until the evening of the second postoperative day|Intensity of postoperative pain, Subjective perception of postoperative pain, using the numeric rating scale., until the evening of the second postoperative day|Intensity of postoperative nausea and vomiting, Assessment of postoperative nausea/vomiting using the PONV Score, until the evening of the second postoperative day|Postoperative recovery, Assessment of postoperative recovery using the QoR15 score, until the evening of the second postoperative day
Clinical Performance Study of the ABTest Card® Device.
NCT Number: NCT06557031
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Transfusion Reaction
Interventions: DIAGNOSTIC_TEST: ABTest Card®REF and ABTest Card®NEW
Sponsor: Diagast
Collaborators: Soladis
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-09
Completion Date: 2025-01
Locations: CHU Orléans, Orléans, France

Summary:
The study aims to confirm the performance equivalence of the in vitro diagnostic device ABTest Card®REF with the ABTest Card®NEW device.

Primary Outcome Measures: Concordance obtained on patient blood type between ABTest Card®NEW and ABTest Card®REF results., Comparison of the "patient" blood type determined from the results of the ABTest Card®NEW device (A, B, AB, O) with the "patient" blood type determined from the results of the ABTest Card®REF device (A, B, AB, O).

There is concordance if the two "patient" blood types are identical., 1 day.
Secondary Outcome Measures: Concordance obtained on blood bag blood type between the ABTest Card®NEW and ABTest Card®REF results., Comparison of the "donor" blood type determined from the results of the ABTest Card®NEW device (A, B, AB, O) with the "donor" blood type determined from the results of the ABTest Card®REF device (A, B, AB, O).

There is concordance if the two "donor" blood types are identical., 1 day.|Concordance obtained between blood type information from medical record and patient results obtained by ABTest Card®REF., Comparison of the "patient" blood type determined from the results of the ABTest Card®REF device (A, B, AB, O) with the "patient" blood type in the medical record (A, B, AB, O).

There is concordance if the two "patient" blood types are identical., 1 day.|Concordance obtained between blood bag labelling information and blood bag results obtained by ABTest Card®REF., Comparison of the "donor" blood type determined from the results of the ABTest Card®REF device (A, B, AB, O) with the "donor" blood type shown on the blood bag label (A, B, AB, O).

There is concordance if the two "donor" blood types are identical., 1 day.|Blood compatibility between the blood bag and the patient for the ABTest Card®NEW., Comparison of the "patient" blood type determined from the results of the ABTest Card®NEW device (A, B, AB, O) with the "donor" blood type determined from the results of the ABTest Card®NEW device (A, B, AB, O).

There is blood compatibility if the two blood types follow specific associations., 1 day.|Blood compatibility between the blood bag and the patient for the ABTest Card®REF., Comparison of the "patient" blood type determined from the results of the ABTest Card®REF device (A, B, AB, O) with the "donor" blood type determined from the results of the ABTest Card®REF device (A, B, AB, O).

There is blood compatibility if the two blood types follow specific associations., 1 day.
Efficacy and Safety of Liposomal Bupivacaine Using Periarticular Injection in Total Knee Arthroplasty
NCT Number: NCT06557018
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Osteoarthritis, Knee
Interventions: DRUG: liposomal bupivacaine|DRUG: traditional peri-articular injection
Sponsor: Dezhou Hospital Qilu Hospital of Shandong University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-06-25
Completion Date: 2024-09-15
Locations: Qilu Hospital of Shandong University Dezhou Hospital (Dezhou People's Hospital), Dezhou, Shandong, 250012, China

Summary:
The goal of this clinical trial is to learn if drug Bupivacaine liposomes works better than traditional peri-articular injection for Control of Pain in Total Knee Arthroplasty. It will also learn about the safety of drug Bupivacaine liposomes.

The main questions it aims to answer are:

Does Bupivacaine liposomes works better than traditional peri-articular injection for Control of Pain in Total Knee Arthroplasty.

Researchers will compare Bupivacaine liposomes to traditional peri-articular injection to see if drug Bupivacaine liposomes works better for Control of Pain in Total Knee Arthroplasty

Participants will:

Receive peri-articular injection in total Knee Arthroplasty. checkups and tests During hospitalization.

Primary Outcome Measures: The VAS scores, The VAS scores at 6 hours, 12 hours, 24 hours, 36 hours, 48 hours, 60 hours and 72 hours in the resting state and exercise state of the two groups were recorded, 6 hours, 12 hours, 24 hours, 36 hours, 48 hours, 60 hours and 72 hours
Facilitated Transitions From Postpartum to Primary Care Coordination for People With Chronic Conditions
NCT Number: NCT06557005
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hypertension|Diabetes|Postpartum|Pregnancy|Anxiety|Depression|Obesity
Interventions: OTHER: Facilitated Transition to Primary Care
Sponsor: Massachusetts General Hospital
Collaborators: Harvard School of Public Health (HSPH)
Sex: FEMALE
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 1320
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: OTHER
Start Date: 2025-03-01
Completion Date: 2028-03-01
Locations: Massachusetts General Hospital, Boston, Massachusetts, 02115, United States

Summary:
The lack of postpartum primary care coordination is a missed opportunity to increase primary care engagement and manage chronic conditions early in life, especially for the \>30% of pregnant people who have or are at risk for these conditions. This study aims to increase postpartum primary care engagement, quality, and experience by strengthening postpartum transitions to primary care using a behavioral economics-informed, multi-component intervention integrated into usual inpatient postpartum care. Using a randomized controlled trial and repeated outcome assessments through administrative and survey data, this study will generate rigorous, actionable evidence to ensure primary care coordination becomes standard postpartum care practice, potentially catalyzing sustained primary care engagement throughout life.

Primary Outcome Measures: Completion of a primary care visit, Observation of a visit with a primary care clinician for any reason observed in the electronic health record., 122 days after date of delivery|Receipt of recommended health screening and counseling by a primary care clinician, For individuals with gestational diabetes and gestational hypertensive disorders, we consider appropriate management to be condition-specific screening (blood pressure and/or diabetes screening) by the PCP as documented in the electronic health record. For individuals with chronic conditions, we consider appropriate management to be receipt of both condition-specific screening (mood, weight, blood pressure and/or diabetes screening) and receipt of counseling and/or discussion of a management plan from the PCP as documented in the electronic health record. For each individual in the sample, we will construct a variable that is equal to 1 if they had a PCP visit within 4 months of delivery in which they received condition-specific appropriate management. This outcome will be assessed through chart review of the electronic health record., 122 days after date of delivery|Patient report of having a known, reliable primary care clinician, The outcome is the patient report of having a known, reliable primary care clinician (doctor, nurse practitioner, or physician's assistant), which will be ascertained through a survey., 122 days after delivery
Fitness Integrative Training for Pediatric Rheumatology Disorders
NCT Number: NCT06556992
Acronym: FIT Teens 2
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Juvenile Idiopathic Arthritis|Systemic Lupus Erythematosus of Childhood|Joint Hypermobility|Juvenile Dermatomyositis
Interventions: BEHAVIORAL: FIT Teens
Sponsor: Children's Hospital Medical Center, Cincinnati
Sex: ALL
Age: CHILD, ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2025-12
Locations: Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, 45229, United States

Summary:
This study evaluates the feasibility of the Fitness Integrative Training program for Teens (FIT Teens 2), a combined cognitive behavioral therapy and neuromuscular exercise training program in patients with pediatric rheumatic diseases and/or joint hypermobility.

Primary Outcome Measures: Feasibility of Enrollment, Maintain consistent monthly enrollment for the duration of the project, 2 years|Session Attendance, Evaluation of the number of sessions attended out of the 16 sessions offered, 8 weeks|Participant Retention at Post-Treatment, Number of participants completing post-treatment visit, 8 weeks|Treatment Fidelity, All sessions will be video-recorded and trainers adherence to the protocol will be assessed using an 9-item fidelity checklist (e.g., homework and diary review, CBT skill instruction and practice, neuromuscular exercise instruction and practice, CBT and exercise homework planning)., 2 years|Participant Safety, Assessment of frequency and severity of adverse events possibly, likely, or definitely related to the study treatment or procedures, 2 years
Carotid Artery Stenosis and Ischemic Cerebrovascular Events After Radiotherapy in Patients With Head and Neck Cancer
NCT Number: NCT06556979
Acronym: RT-CASinHNC
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Carotid Artery Stenosis|Head and Neck Cancer|Radiation Therapy|Transient Ischemic Attack|Ischemic Stroke
Interventions: RADIATION: Radiotherapy
Sponsor: Chulabhorn Royal Academy
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 907
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-01-01
Completion Date: 2024-02-01
Locations: Department of Surgery, Chulabhorn Hospital, Princess Srisavangavadhana College of Medicine, Chulabhorn Royal Academy, Bangkok, Thailand, Bangkok, 10210, Thailand

Summary:
The study had a cross-sectional design and included patients with HNC involving the oral cavity, pharynx, larynx, nasal cavity, or salivary glands who recieve RT.

the investigators obtained information on their clinical and tumor characteristics and their treatment from the clinical records. Data on risk factors for atherosclerosis, medications used, and radiotherapy were also collected.

Images were analyzed to determine the timing of development of CAS, identify significant (\&amp;gt;50%) CAS using the North American Symptomatic Carotid Endarterectomy Trial criteria, and calculate the total plaque score (TPS) and wall thickness.

The purpose of this study was to determine the incidence of ICVE and of CAS in patients who receive radiotherapy for HNC and the risk factors for CAS.

Primary Outcome Measures: Incidence of ischemic cerebrovascular event after radiotherapy. (Percentage of partcipants who developed ischemic stroke or transient ischemic attack following completion of radiotherapy in all participants), The cumulative incidence of ischemic cerbrovascular event including ischemic stroke or transient ischemic attack in the anterior circulation in HNC patient who receive radiotherapy in 5 years, 5 years
Secondary Outcome Measures: The risk factors that were identified to influence development of new carotid artery stenosis, The risk factors that were identified to influence development of new carotid artery stenosis from the first imaging to last imaging. The investigator assessed the number of patient who develop new carotid artery stenosis after radiotherapy. Carotid artery stenosis was measure by NASCET criteria : % ICA stenosis = (1 - \[narrowest ICA diameter/diameter normal distal cervical ICA\]) x 100, through study completion, an average of 1 year|Incidence of carotid artery stenosis at 12, 24, and 36 months after radiotherapy (Percentage of partcipants who develop carotid artery stenosis), The cumulative incidence of carotid artery stenosis was calculated after radiotherapy. The investigator assessed the number of patient who develop new carotid artery stenosis after radiotherapy. Carotid artery stenosis was measure by NASCET criteria : % ICA stenosis = (1 - \[narrowest ICA diameter/diameter normal distal cervical ICA\]) x 100, 12, 24, 36 months
A Study Assessing the Safety and Tolerability of LY03020 in Chinese Healthy Subjects
NCT Number: NCT06556966
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Schizophrenia|Alzheimer's Disease Psychosis
Interventions: DRUG: LY03020|DRUG: Placebo
Sponsor: Luye Pharma Group Ltd.
Sex: ALL
Age: ADULT
Enrollment: 66
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2025-08

Summary:
This is a single-center, randomized, double-blind, placebo-controlled, ascending single oral dose study to assess the safety, tolerability, and pharmacokinetics of LY03020 in Chinese healthy adult subjects.

Primary Outcome Measures: Frequency of adverse events (AEs), Percentage of adverse events, up to144 hours
Secondary Outcome Measures: Maximum observed concentration (Cmax) of LPM787000048 in plasma, Subject blood samples will be collected at 17 time points and pharmacokinetic parameters will be calculated., up to144 hours|Time to maximum observed concentration (Tmax) of LPM787000048 in plasma, Subject blood samples will be collected at 17 time points and pharmacokinetic parameters will be calculated., up to144 hours|Area under the concentration-time curve from time zero extrapolated to infinity (AUC0-∞) of LPM787000048 in plasma, Subject blood samples will be collected at 17 time points and pharmacokinetic parameters will be calculated., up to144 hours|Area under the concentration-time curve from time zero to the time of last quantifiable concentration (AUC0-t) of LPM787000048 in plasma, Subject blood samples will be collected at 17 time points and pharmacokinetic parameters will be calculated., up to144 hours|Apparent terminal elimination half-life (t1/2) of LPM787000048 in plasma, Subject blood samples will be collected at 17 time points and pharmacokinetic parameters will be calculated., up to144 hours|Apparent volume of distribution（Vz/F） of LPM787000048 in plasma, Subject blood samples will be collected at 17 time points and pharmacokinetic parameters will be calculated., up to144 hours|Apparent total body clearance (CL/F) of LPM787000048 from plasma, Subject blood samples will be collected at 17 time points and pharmacokinetic parameters will be calculated., up to144 hours
Other Outcome Measures: Quantitatively determine the concentration of LPM787000048 and major metabolites (if applicable) in urine and calculate the cumulative excretion ratio in urine., One dose group will be selected for metabolite identification., up to144 hours
Evaluating the Risk of Postoperative Venous Thromboembolism in Cervical Cancer Patients
NCT Number: NCT06556953
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Venous Thromboembolism
Sponsor: Haike Lei
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 1174
Study Design: Observational Model: |Time Perspective: p
Start Date: 2019-01-01
Completion Date: 2023-12-31
Locations: Chongqing University Cancer Hospital, Chongqing, Chongqing, 400030, China

Summary:
The aim of this study is to develop a machine learning model to accurately predict the risk of venous thromboembolism in patients with cervical cancer after surgery.

Primary Outcome Measures: Whether the patient has developed VTE is determined based on the diagnostic criteria in the "Guidelines for the Prevention and Treatment of Tumor-Associated Venous Thromboembolism (2019 Edition).", The diagnosis of VTE primarily includes the diagnosis of DVT and PE. According to the guidelines, DVT is diagnosed using venous compression ultrasound or venography, while PE is diagnosed using CT pulmonary angiography (CTPA) or nuclear lung ventilation/perfusion imaging., December 31, 2023
G.I. Pharmacokinetics of LMN-401 in Individuals With Ileostomies
NCT Number: NCT06556940
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: EARLY_PHASE1
Conditions: Travelers Diarrhea
Interventions: BIOLOGICAL: LMN-401
Sponsor: Lumen Bioscience, Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 12
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-09-18
Completion Date: 2025-12-02

Summary:
The goal of this interventional study is to learn about the intraluminal pharmacokinetics (PK) of the investigational drug LMN-401 in adult healthy volunteers with ileostomies. LMN-401 is being developed as a potential new treatment for Traveler's Diarrhea. The study will also learn about the safety of the investigational drug LMN-401.

The main questions it aims to answer are:

* What is the timing and amount of components of investigational drug LMN-401 detected in the collected ileostomy material?
* Is LMN-401 safe and well tolerated in healthy volunteers taking the investigational drug?

Researchers will compare the timing and amount of investigational drug components detected in the ileostomy material in volunteers taking the investigational drug LMN-401 formulated into tablets with different properties. The impact of the study participant's fed or fasted state on the timing and amount of drug components detected in the ileostomy material will also be evaluated.

Each study participant will come into the research clinic for four study visits. Study participants will receive the investigational product formulated into tablets with different properties. Ileostomy material will be collected at baseline (pre-dose) and every two hours after investigational product dose administration for 10 hours.

Primary Outcome Measures: Quantification of LMN-401 components in ileostomy material over time., Measurement of individual VHH levels in ileostomy material over time after oral administration of LMN-401, Ten hours post administration of study drug
The Laughter, Pregnancy, Anxiety and Llife Quality
NCT Number: NCT06556927
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Anxiety|Life Style|Gestational Diabetes|Pregnancy Related
Interventions: OTHER: Laughter yoga
Sponsor: Kırklareli University
Sex: FEMALE
Age: ADULT
Enrollment: 80
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-09-01
Completion Date: 2025-07-30
Locations: Kırklareli University, Kırklareli, Turkey

Summary:
Gestational Diabetes is one of the most common medical complications during pregnancy. It is seen between the 24th and 28th weeks of pregnancy with the increase in insulin resistance in the second trimester and ends with the end of the birth process. Due to this feature, it is distinguished from Type 2 diabetes. This disease, which is seen for the necessary energy needs of the fetus and placenta, is defined as the diabetogenic effect of pregnancy.

Laughter is a universal response to humorous stimuli that exists in our lives. Laughter yoga is holistic with breathing techniques. It is a form of yoga that utilizes the brain's inability to distinguish between real and fake laughter. Laughter yoga helps people cope with stressful times and helps the person control themselves by reducing negative cognitive reactions. In line with this information, the aim of the study was to determine the effect of laughter yoga applied to pregnant women with gestational diabetes on perceived stress and quality of life.

Primary Outcome Measures: Quality of Life Scale During Pregnancy, It aims to optimally evaluate the quality of life of women with normal pregnancies and consists of nine items. It is a scale specific to singleton pregnancies that should be used in clinical and social research because it provides a better perspective on the quality of life of pregnant women rather than a general quality of life scale. The total score of the scale varies between 9-45, with higher scores indicating higher quality of life.There is no adverse substance in the scale. It can be used in every trimester, between 2 to 4 weeks|State-Trait Anxiety Inventory, The lowest and highest scores that can be obtained from each subscale are 20 and 80, respectively. Higher scores are associated with more anxiety., between 2 to 4 weeks|Psychometric Properties of Eurohis (Whoqol-8.Tr) Turkish Version in Turkish Society, EUROHIS-QOL 8 was developed by the World Health Organization (WHO) in 2003. It consists of 8 items and was validated in Turkish by Eser et al in 2010. The total score determines the overall quality of life level; higher scores indicate higher quality of life, between 2 to 4 weeks
Effect of Albumin Replacement on Oxygen Delivery in Sepsis Patients
NCT Number: NCT06556914
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Sepsis|Intensive Care Unit
Sponsor: Samsun University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 45
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-01
Completion Date: 2025-02-15
Locations: Samsun University, Samsun, Ilkadım, 55100, Turkey

Summary:
Fluid resuscitation is a critical component of sepsis treatment. Research has shown that intravenous (IV) fluid therapy in sepsis positively impacts cardiac output and thereby oxygen (O2) delivery through a complex interaction of central venous pressure, right atrial pressure, venous resistance, ventricular compliance, cardiac contractility, and systemic vascular resistance. The 2021 sepsis prevention guidelines recommend balanced crystalloids as first-line therapy. However, no studies in the literature have evaluated the effect of albumin on O2 delivery. In our study, the investigators aim to assess the impact of albumin replacement on O2 delivery in sepsis patients in the intensive care unit.

Primary Outcome Measures: oxygen delivery, Effect of albumin replacement on oxygen delivery.Arterial oxygen saturation (SaO2), hemoglobin (Hb), partial pressure of oxygen in the arterial blood (PaO2) values will be obtained by blood gas measurements.DO2(oxygen delivery): CO x 10 x (Hbx1,34x SaO2) When oxygen delivery to tissue is calculated according to this formula, normal values are 5 x 10 x 15 x 1,34 x 0.98 =984 ml/dk., Up to 1 hour after albumin replacement
Secondary Outcome Measures: change in SOFA score, Effect of albumin replacement on change in SOFA score. By evaluating the Central nervous system, Cardiovascular system, Respiratory system, Coagulation, Liver and Renal function, each organ system receives a score ranging from 0 (normal) to 4 (most abnormal), with a minimum SOFA score of 0 and a maximum SOFA score of 24., Up to 12 hour after albumin replacement
Management of Patients Who Claim to be Electrosensitive
NCT Number: NCT06556901
Acronym: IEI CEM EN MED
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Electromagnetic Field
Interventions: OTHER: retrospective study about reasons for consultations
Sponsor: University Hospital, Brest
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 1400
Study Design: Observational Model: |Time Perspective: p
Start Date: 2021-01-01
Completion Date: 2021-09-01
Locations: CHRU de Brest, Brest, 29609, France

Summary:
Know qualitatively the ways to deal with these patients, in general medicine in Brittany, and the difficulties encountered, through thematic and lexicometric analysis of responses

Primary Outcome Measures: principal, The main endpoint is to have taken care of a patient who claims to have electromagnetic sensibility., 2 years
Observatory of Immunological Thrombopenic Purpura in the Brest Region
NCT Number: NCT06556888
Acronym: OPTIMIST
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Immune Thrombocytopenia
Sponsor: University Hospital, Brest
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 500
Study Design: Observational Model: |Time Perspective: p
Start Date: 2019-06-20
Completion Date: 2039-11-30
Locations: Hematology Department - Institute of Oncology and Hematology, University Hospital of Brest, Brest, Bretagne, 29609, France

Summary:
Database of patients with ITP, diagnosed, treated and followed in the Brest University Hospital.

Primary Outcome Measures: Description chronicity, Identification/description of risk factors of chronicity, 1 year|Description treatment responses, Identification/ description of risk factors of bad responses, 1 year