pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Extending the Time Window for Intravenous Tenecteplase in Patients With Distal Medium Vessel Occlusions Stroke
NCT Number: NCT06559436
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Acute Ischemic Stroke
Interventions: DRUG: Intravenous thrombolysis|OTHER: Standard medical management
Sponsor: The First Affiliated Hospital of University of Science and Technology of China
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 560
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2026-12-01
Locations: The First Affiliated Hospital of University of Science and Technology of China, Hefei, Anhui, China

Summary:
To assess the safety and efficacy of beyond time window TNK intravenous thrombolysis for distal Medium Vessel Occlusion (MeVO) related stroke in a prospective randomized clinical trial.

Primary Outcome Measures: Rates of 90 day good functional outcomes, (mRS score ≤ 1 is defined as good prognosis), 90 (± 14 days) after procedure
Secondary Outcome Measures: Proportion of patients with mRS 0-2, modified Rankin scale (range, 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death), 90 (± 14 days) after procedure|Proportion of patients with mRS 0-3, modified Rankin scale (range, 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death), 90 (± 14 days) after procedure
Other Outcome Measures: Symptomatic intracranial hemorrhage (sICH), SICH means any hemorrhage with neurological deterioration, as indicated by an NIHSS score that was higher by ≥4 points than the value at baseline or the lowest value in the first 24 hours , or any hemorrhage leading to death., 24 hours after procedure
Combined Non-ablative Er:YAG Laser and Magnetic Stimulation for Treatment of Female Urinary Incontinence
NCT Number: NCT06559423
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Stress Urinary Incontinence|Urinary Incontinence
Interventions: DEVICE: non-ablative Er:YAG laser and high intensity Tesla magnetic stimulation (HITS)
Sponsor: Zdravstveni Zavod Štrumbelj
Collaborators: Fotona d.o.o.
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 25
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2021-04-23
Completion Date: 2022-10-21
Locations: Zdravstveni Zavod Štrumbelj, Ljubljana, 1000, Slovenia

Summary:
This single-arm pilot study aims to investigate the efficacy and safety of a combined non-ablative Erbium:Yttrium-Aluminium-Garnet (Er:YAG) laser and High Intensity Tesla magnetic Stimulation (HITS) treatment for female urinary incontinence. The study involves 25 women diagnosed with mild to moderate stress or mixed urinary incontinence. Participants will receive three vaginal Er:YAG laser treatments and six HITS sessions. The primary objective is to improve symptoms of urinary incontinence, as measured by changes in scores on two questionnaires compared to baseline. Secondary objectives include improvement in sexual function, durability of improvement in urinary incontinence symptoms at 3- and 6- month follow-up, patient-reported improvement, and discomfort during treatment.

Primary Outcome Measures: Efficacy of the combined laser and HITS treatment, Improvement of symptoms of stress and/or mixed urinary incontinence as measured by change in ICIQ-UI SF and QUID scores from the baseline., up to 6 months after treatment|Safety of the combined laser and HITS treatment, Incidence and severity of treatment-related Adverse Events, up to 6 months after treatment
Secondary Outcome Measures: Improvement of sexual function, Improvement of sexual function as measured by FSFI scores change from baseline, up to 6 months after treatment|Durability of the effect, Improvement of the urinary incontinence symptoms measured at 3 and 6 months follow-up, up to 6 months after treatment|Patient reported assessment of improvement, Assessed by PGI-I questionnaire, up to 6 months after treatment|Patient reported assessment of discomfort during treatment, Measured by visual analog scale pain score, up to 24 hours after each laser and HITS session
Convulsions in Neonates With Congenital Heart Diseases
NCT Number: NCT06559410
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Neonatal Convulsion
Interventions: OTHER: Electroencephalogram (EEG), CT Brain, Echocardiogram
Sponsor: Assiut University
Sex: ALL
Age: CHILD
Enrollment: 80
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-10
Completion Date: 2026-03-31

Summary:
analyze the etiology, electroencephalographic (EEG) findings, neuroimaging, and neurological sequalae of newborns with congenital heart disease who were presented with seizures during their neonatal intensive care unit admission.

Primary Outcome Measures: analyze the etiology of seizures in newborns with congenital heart disease, analyze the etiology of seizures whether it is related to hypoxia, electrolytes disturbances, heart failure or any other casue, baseline|analyze the electroencephalographic (EEG) finding and neuroimaging of newborns with congenital heart disease who were presented with seizures, neuroimaging including Brain MSCT, baseline|state neurological sequalae of newborns with congenital heart disease who were presented with seizures, state if there is any neurological sequalae, baseline
Proprioceptive Puzzle: Effects on Quantitative Sensory Tests and Body Awareness
NCT Number: NCT06559397
Status: ENROLLING_BY_INVITATION
Study Type: OBSERVATIONAL
Conditions: Cervical Proprioceptive Error in Healthy Young Individuals
Interventions: OTHER: Assessment of cervical proprioception
Sponsor: Atılım University
Sex: ALL
Age: ADULT
Enrollment: 60
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-01
Completion Date: 2025-02-01
Locations: Atılım University, Ankara, 06560, Turkey

Summary:
Background: Cervical proprioception, referring to the awareness of the head's position in space, plays a crucial role in maintaining postural control and preventing musculoskeletal injuries. While previous research has established the importance of cervical proprioception in motor function, its specific impact on body awareness and pain-related aspects remains less explored, particularly in healthy young individuals.

Aim: This prospective cross-sectional study aims to investigate the impact of cervical proprioceptive error on body awareness, pressure pain threshold, pressure pain tolerance, conditioned pain modulation, and temporal summation in healthy young individuals.

Methods: In asymptomatic participants, cervical proprioception will be assessed using the 'head position error test' in both right and left rotation directions with the CROM device. Participants will be then divided into two groups based on the presence of proprioceptive deviation (\>5°). Body awareness will beassessed using the 'Body Awareness Questionnaire,' while pressure pain threshold, pain tolerance, and temporal summation will be measured bilaterally with an algometer device (2 cm lateral to the C2 and C7 spinal processes, midpoint of the upper part of the trapezius, and over the temporomandibular joint) in both groups. Subsequently, the two groups will be compared using independent samples t-tests.

Primary Outcome Measures: Quantitative sensory testing, Quantitative sensory testing including pain threshold, tolerance, conditioned pain modulation, and temporal summation will be assessed by pressure algometer. The "pain threshold" is the point at which a person first feels pain, the "pain tolerance" is the last point that a person can tolerate, and the "temporal summation" is the first painful threshold evaluated after 10 repeats of the pain threshold. Conditioned pain modulation is the modulation of pain perception under varying conditions. In the current study, a cold stimulus will be used., Immediately after the intervention|Assessment of body awareness, Body awareness will be assessed through a questionnaire, consisting of 18 items, divided into 4 subgroups aimed at determining the sensitivity level of normal or abnormal body composition (1. Changes during the body process, 2. Sleep-wake cycle, 3. Estimation of disease onset, 4. Prediction of bodily reactions). Participants are asked to rate each item on a scale of 1 to 7. The overall score is calculated, and a higher score indicates better body awareness. The validity and reliability of the questionnaire are reported to be high., Immediately after the intervention
Facilitators and Barriers to Dental Care in Head and Neck Cancer Patients
NCT Number: NCT06559384
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Behavior
Interventions: OTHER: Interviews
Sponsor: University Medical Center Goettingen
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 32
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08
Completion Date: 2025-08

Summary:
The aim of this study is to identify potential facilitators and barriers to dental care in head-neck cancer patients from the perspective of affected patients, dentists, and oncologists (specialists in radiotherapy and specialists in otolaryngology).

Primary Outcome Measures: Questionnaire, Completion of a questionnaire, 5 minutes|Interview, Semi-structured interview, 60 minutes
68Ga FAPI PET/CT Evaluation of Axillary Lymph Node Status After Neoadjuvant Therapy in Patients With Clinical Axillary Lymph Node Positive Breast Cancer
NCT Number: NCT06559371
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: BREAST CANCER|PET/CT
Sponsor: Shanghai Jiao Tong University School of Medicine
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 51
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-30
Completion Date: 2025-06-30

Summary:
The goal of this observational study is to learn whether 68Ga-FAPI PET/CT may be used as a new effective methods for evaluating axillary lymph node efficacy after neoadjuvant treatment for breast cancer. The main question it aims to answer is:

Could 68Ga-FAPI PET/CT effectively evaluate axillary lymph node after neoadjuvant treatment for breast cancer? Participants will have a 68Ga-FAPI PET/CT test between last neoadjuvant therapy and surgery.

Primary Outcome Measures: Sensitivity and specificity of 68Ga FAPI PET/CT in predicting residual axillary lymph node lesions after neoadjuvant therapy, Sensitivity and specificity of 68Ga FAPI PET/CT, up to the end of surgery
Secondary Outcome Measures: Sensitivity and specificity of 68Ga FAPI PET/CT in predicting pathological complete response (Breast pCR) of breast lesions in neoadjuvant therapy, Sensitivity and specificity of 68Ga FAPI PET/CT in predicting pathological complete response (Breast pCR) of breast lesions in neoadjuvant therapy, up to the end of surgery|Sensitivity and specificity of 68Ga FAPI PET/CT in predicting objective response rate (ORR) of neoadjuvant therapy, Sensitivity and specificity of 68Ga FAPI PET/CT in predicting objective response rate (ORR) of neoadjuvant therapy, up to the end of surgery
Subthreshold Stimulation Versus Suprathreshold Stimulation in People With Chronic Low Neck Pain
NCT Number: NCT06559358
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pain|Trigger Point Pain, Myofascial
Interventions: DEVICE: electrical stimulation
Sponsor: Beni-Suef 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: 2024-09-01
Completion Date: 2024-12-30

Summary:
this trial will involve three groups. Group 1 will receive subthreshold stimulation. Group 2 will receive suprathreshold stimulation. Group 3 will receive shame treatment.

Primary Outcome Measures: Pain intensity, Neck pain intensity will be assessed by the visual analog scale (VAS). Participants will be asked to explain their present pain by putting a mark on a 10 mm horizontal line with 0 degrees indicating "no pain" and 10 indicating the "worst possible pain", 2-3 months|Pressure threshold, Myofascial trigger points' sensitivity will be measured by a pressure-pain algometer from upper trapezius muscle., 2-3 months|Electromyography, The EMG activity from the upper trapezius muscle will be recorded during rest and voluntary maximum contraction., 2-3 months|Range of motion, Flexion, lateral rotation to both sides, lateral flexion to both sides, 2-3 months
A Prospective, Open-label, Randomized Controlled, Multicenter Clinical Study of Haplo-HSCT Using a TBI or TMLI Conditioning Regimen for Pediatric ALL
NCT Number: NCT06559345
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Acute Lymphoblastic Leukemia, Pediatric
Interventions: RADIATION: TMLI|RADIATION: TBI|DRUG: Cyclophosphamide
Sponsor: The First Affiliated Hospital of Zhengzhou University
Sex: ALL
Age: CHILD
Enrollment: 276
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2029-08-31

Summary:
This study aims to compare the effects of two different conditioning regimens on patients with acute lymphoblastic leukemia (ALL) undergoing haploidentical allogeneic hematopoietic stem cell transplantation (haplo-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 haplo-HSCT in pediatric 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., 100 days|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
Coronary Artery Disease Assessment Strategies in TAVI Patients
NCT Number: NCT06559332
Acronym: CAT
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Transcatheter Aortic Valve Replacement|Coronary Artery Disease|Heart Disease Risk Factors
Interventions: DIAGNOSTIC_TEST: Risk-based CAD management|DIAGNOSTIC_TEST: Invasive coronary angiography
Sponsor: Insel Gruppe AG, University Hospital Bern
Sex: ALL
Age: OLDER_ADULT
Enrollment: 546
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: DIAGNOSTIC
Start Date: 2024-10-01
Completion Date: 2031-07-31
Locations: University Hospital Bern, Department of Cardiology, Bern, 3010, Switzerland

Summary:
Coronary artery disease (CAD) and aortic stenosis frequently coincide. Before valve intervention, invasive coronary angiography is routinely performed to assess coronary status.

As the impact of percutaneous revascularization on clinical outcomes beyond symptom improvement is subject to debate and treatment of aortic stenosis itself reduces ischemic burden and symptoms, the benefit/risk balance of routine invasive coronary angiography prior to transcatheter aortic valve implantation (TAVI) is unclear.

The CAT Trial aims to compare a non-invasive risk management strategy to routine invasive coronary angiography for the assessment of coronary artery disease in patients with severe, symptomatic aortic stenosis selected to undergo TAVI with respect to adverse clinical outcomes at 1 and 3 years (primary objective) and patient reported outcome measures (secondary objective).

Primary Outcome Measures: Composite of all-cause death, myocardial infarction, any stroke, bleeding , acute kidney injury and heart failure hospitalization, Co-primary early endpoint. Valve Academic Research Consortium (VARC)-3 definitions) bleeding: VARC-3 type 2-4 acute kidney injury: VARC-3 stage 2-4, 1 year|Composite of all-cause death, myocardial infarction, any stroke and heart failure hospitalization, Co-primary late endpoint VARC-3 definitions, 3 years
Secondary Outcome Measures: Patient reported health status, Seattle Angina Questionnaire-7 (score from 0 to 100, with higher values indicating better health), 1, 3 and 5 years|Patient reported health status, Kansas City Cardiomyopathy Questionnaire-12 (score from 0 to 100, with higher values indicating better health), 1, 3 and 5 years|Patient reported health status, EuroQol 5D 5L (index scores range from -0.59 to 1, with higher values indicating better health), 1, 3 and 5 years|Rate of all cause death, 1, 3 and 5 years|Rate of cardiovascular death, 1, 3 and 5 years|Rate of disabling strokes, 1, 3 and 5 years|Rate of myocardial infarction, 1, 3 and 5 years|Rate of unplanned, urgent revascularization, 1, 3 and 5 years|Rate of elective revascularization, 1, 3 and 5 years|Rate of cardiovascular hospitalization, 1, 3 and 5 years|Rate of heart failure hospitalization, 1, 3 and 5 years|Rate of bleeding, 1, 3 and 5 years|Rate of acute kidney injury, 1, 3 and 5 years|Rate of tachyarrhythmia, 1, 3 and 5 years|Rate of permanent pacemaker implantation, 1, 3 and 5 years
The Basophil Activation Test For Egg Allergy
NCT Number: NCT06559319
Acronym: BAT
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Food Allergy
Interventions: DIAGNOSTIC_TEST: blood sampling
Sponsor: Xia Peng
Sex: ALL
Age: CHILD
Enrollment: 174
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-10
Completion Date: 2027-03-25
Locations: Shanghai General Hospital, Shanghai, China

Summary:
In this study, basophil activation test (BAT) established by the investigators' lab was evaluated for its sensitivity and specificity in child egg allergy diagnosis. Children with suspected IgE mediated allergy to egg will be recruited in the study. Specific IgE to egg allergen and BAT will be detected. The diagnostic accuracy of the BAT will be assessed against clinical diagnosis based on history, clinical symptoms and laboratory results.

Primary Outcome Measures: Sensitivity of the BAT, Sensitivity of the BAT compare to clinical comprehensive diagnosis with a threshold value of 5% for the BAT in a population of child egg allergy.

Sensitivity is defined as the capacity for BAT to have a positive result when comprehensive diagnosis result is also positive, 2 days|Specificity of the BAT, Specificity is defined as the capacity for BAT to have a negative result when comprehensive diagnosis result is also negative., 2 days
Pilot Feasibility Study of Laryngeal Ultrasound in the Paediatric Population - ECHO LARYNX
NCT Number: NCT06559293
Acronym: ECHO-LARYNX
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Laryngeal Diseases|Ultrasound
Interventions: DIAGNOSTIC_TEST: laryngeal ultrasound
Sponsor: University Hospital, Bordeaux
Sex: ALL
Age: CHILD
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-15
Completion Date: 2024-09-15
Locations: CHU de Bordeaux, Hôpital Pellegrin, Service d'oto-rhino-laryngologie, de chirurgie cervico-faciale et d'ORL pédiatrique, Bordeaux, 33076, France

Summary:
Nasofibroscopy is the gold standard for laryngeal pathology diagnosis. However, this examination is invasive and can be poorly tolerated in the pediatric population. Laryngeal ultrasound appears to be a better tolerated alternative. However, few data exist in the pediatric population in the literature. The aim of this study is to evaluate the feasibility of laryngeal ultrasound in a larger pediatric population of pathological and non-pathological subjects.

Primary Outcome Measures: Reproducible ultrasound images, Define detailed and reproducible ultrasound images using consistent anatomical landmarks for diagnostic assessment of the larynx, At Baseline (D0)
Secondary Outcome Measures: Demographic characteristics, We will evaluate the demographic characteristics that may affect the reproducibility of ultrasound images, At Baseline (D0)
The Effect of Subclinical Dose of Ketamine on Early Postoperative Pain Sensitivity in Patients Undergoing Salpingectomy
NCT Number: NCT06559280
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: EARLY_PHASE1
Conditions: Ectopic Pregnancy
Interventions: DRUG: esketamine
Sponsor: Fujian Provincial Hospital
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-08
Completion Date: 2025-08

Summary:
The experiment aims to explore the clinical effect of subclinical doses of ketamine on early postoperative pain sensitivity in ectopic pregnancy population.

Primary Outcome Measures: Postoperative pain sensitivity, The pain sensitivity scale is used to measure the pain sensitivity of patients. Patients imagine certain scenarios in their daily lives and score their pain to evaluate their individual pain sensitivity. This scale contains 17 items, requiring testers to fill in a number on the numerical rating scale from 0 (no pain) to 10 (most pain) to indicate the degree of pain in this situation. There are three items interspersed among them that describe situations where there is no pain under normal circumstances, as a reference for testers to feel no pain. In addition, the 14 pain items cover various types of pain and pain intensity levels, and completing the PSQ generally takes 5-10 minutes. The total score of PSQ is based on the average score of 14 pain items, ranging from 0 to 10. The results are divided into two categories: PSQ moderate and PSQ minor, which reflect the expected pain levels of different intensity stimuli. The higher the score, the more sensitive it is to pain stimuli., Preoperative, one day after surgery, the second day after surgery, and one week after surgery
ConnectedNest: a Digital Platform Connecting Individuals With Cancer to Social Care
NCT Number: NCT06559228
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Cancer
Interventions: OTHER: ConnectedNest|OTHER: Standard of care
Sponsor: University of Minnesota
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 300
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2025-01-01
Completion Date: 2026-06-01

Summary:
Social determinants of health (SDoH) such as housing instability, food insecurity, and financial burden largely shape the health and well-being of individuals, create health inequities, and drive a large portion of avoidable adverse health outcomes and healthcare costs. With new advancements in treatment and rising out-of-pocket expenses, individuals facing cancer are especially vulnerable to the adverse effects of SDoH. To address these barriers, a novel solution is needed to support oncology patients, clinical teams, and community-based organizations (CBOs) across the cancer continuum. In a Phase I contract award, XanthosHealth developed ConnectedNest, a novel electronic social care referral platform to screen for SDoH needs and connect individuals with cancer to social and community services provided by CBOs while engaging the oncology team in the SDoH referral process. Through additional funding, a pilot study was completed in Minneapolis, Minnesota, in partnership with Minnesota Cancer Alliance, involving the collaboration of 14 CBOs focused on cancer. 50 cancer survivors from these CBOs were enrolled to utilize the ConnectedNest platform for a 90-day duration. Our study involved the collection and analysis of crucial metrics related to patient and CBO engagement, SDoH needs, and the volume of feasible social care referrals. In Phase II, the technical features and integration capabilities of ConnectedNest will be enhanced based on learnings in Phase I and completed pilot study. The platform will be implemented and tested among patients seen at multiple oncology clinics, evaluating health outcomes of patients who use the platform.

Primary Outcome Measures: Number of reported social needs, change in the number of reported social needs met from baseline (time of randomization) to day 90 after enrollment using the validated Accountable Health Communities Health-related social needs screening tool., Day 90
CD19x22 Chimeric Antigen Receptor T-cell Therapy (CAR T) in Pediatric B-ALL
NCT Number: NCT06559189
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: B-cell Acute Lymphoblastic Leukemia
Interventions: BIOLOGICAL: CD19x22 CAR T
Sponsor: University of Colorado, Denver
Sex: ALL
Age: CHILD, ADULT
Enrollment: 26
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-12
Completion Date: 2029-12
Locations: Children's Hospital Colorado, Aurora, Colorado, 80045, United States

Summary:
This study will evaluate the safety and tolerability of administering a novel bispecific CD19/CD22-directed CAR T cell product (CD19x22) for the treatment of relapsed or refractory pediatric B-ALL.

Primary Outcome Measures: Safety Measured by Adverse Events, The safety of the administering this bispecific CD19/CD22-directed CAR T cell product will be measured by the monitoring the frequency and severity of adverse events in patients with advanced or refractory B-Cell Acute Lymphoblastic Leukemia, including those previously treated with cell therapy., 1 year
Secondary Outcome Measures: Overall Response Rate, The efficacy of this bispecific CD19/CD22-directed CAR T cell product will be measured by the evaluating the overall response rate in patients with advanced or refractory B cell hematologic malignancies, including those previously treated with cell therapy., 1 year|Progression Free Survival, 1-year progression-free survival (PFS) rate in subjects with relapsed/refractory B-ALL treated with this bispecific CD19/CD22-directed CAR T cell product., 1 year|Overall Survival, 1-year overall survival (OS) rate in subjects with relapsed/refractory B-ALL treated with this bispecific CD19/CD22-directed CAR T cell product., 1 year
A Study of Obexelimab in Patients With Systemic Lupus Erythematosus
NCT Number: NCT06559163
Acronym: SunStone
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Systemic Lupus Erythematosus
Interventions: DRUG: Obexelimab|DRUG: Placebo
Sponsor: Zenas BioPharma (USA), LLC
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 190
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2026-03

Summary:
This study aims to examine the efficacy and safety of obexelimab in participants with systemic lupus erythematosus (SLE).

Primary Outcome Measures: Primary Outcome Measure, Proportion of patients who achieve a response according to the BILAG-Based Composite Lupus Assessment (BICLA) Response, 24 weeks
Secondary Outcome Measures: Secondary Outcome Measures, Proportion of patients who achieve response according to the Systemic Lupus Erythematosus Responder Index 4 (SRI-4)., 24 weeks
Other Outcome Measures: Additional Outcome Measures, Number of patients with treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and injection site reactions., 24 weeks
A Phase II Study of Ensifentrine in Non-Cystic Fibrosis Bronchiectasis
NCT Number: NCT06559150
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Non-cystic Fibrosis Bronchiectasis
Interventions: DRUG: Nebulized Ensifentrine Suspension; 3 mg|DRUG: Nebulized Placebo Solution
Sponsor: Verona Pharma plc
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 180
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2026-09

Summary:
This study is a randomized, double-blind, placebo-controlled study designed to assess the efficacy and safety of ensifentrine inhalation suspension (3 mg) delivered twice daily via standard jet nebulizer over at least 24 weeks, compared to placebo, in subjects with non-cystic fibrosis bronchiectasis (NCFBE).

Primary Outcome Measures: Rate of protocol-defined pulmonary exacerbations (number of events per subject-year, rate ratio), Through study completion (a maximum of 3 years from the date of randomization)
Secondary Outcome Measures: Time to the onset of the first protocol-defined pulmonary exacerbation, Through study completion (a maximum of 3 years from the date of randomization)|Mean change from Baseline in Evaluating Respiratory Symptoms (E-RS) Cough and Sputum Domain score, The E-RS is a patient reported outcome that is derived from the EXAcerbation of Chronic Pulmonary Disease Tool (EXACT)-PRO in the participants e-diary, to quantify the severity of symptoms. The score ranges from 0 to 40 with a higher score representing more severe symptoms., Baseline, Week 6, Week 12, and Week 24|Mean change from Baseline in Saint George's Respiratory Questionnaire (SGRQ) score, SGRQ scores range from 0 to 100, with a higher score representing worse health., Baseline, Week 6, Week 12, and Week 24|Mean change from Baseline in quality of life - bronchiectasis questionnaire (QOL-B) Respiratory Symptoms Domain score, The QOL-B Respiratory Symptoms Domain score ranges from 0 to 100, with higher scores representing better functioning., Baseline, Week 6, Week 12, and Week 24|Mean change from Baseline in Chronic Airways Assessment Test (CAAT) score, CAAT scores range from 0-40 with a higher score representing worse health., Baseline, Week 6, Week 12, and Week 24|Mean change from Baseline in Percent of the predicted forced expiratory volume over 1 second (FEV1), Baseline, Week 12, and Week 24|Mean change from Baseline in quality of life - bronchiectasis questionnaire (QOL-B) total score, The QOL-B score ranges from 0 to 100, with higher scores representing better functioning., Baseline, Week 6, Week 12, and Week 24|Incidence of Adverse Events, Through study completion (a maximum of 3 years from the date of randomization)|PK Sub-study only: Ensifentrine area under the curve from time 0 to 12 hours (AUC 0 -12), Week 12, Week 18, and Week 24|PK Sub-study only: Ensifentrine maximum plasma drug concentration (Cmax), Week 12, Week 18, and Week 24|Pharmacokinetic (PK) Sub-study only: Ensifentrine time to Cmax (tmax) post morning dose, Week 12, Week 18, and Week 24
RCT of Cast or Functional Ankle Orthosis After Ankle Fracture Surgery
NCT Number: NCT06559111
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Ankle Fracture|Postoperative Treatment
Interventions: DEVICE: 2-week casting followed by 4-week bracing|DEVICE: 6-week casting
Sponsor: Töölö Hospital
Collaborators: Tampere University Hospital
Sex: ALL
Age: ADULT
Enrollment: 134
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2005-12-01
Completion Date: 2012-03-16

Summary:
The goal of this randomized clinical trial was to compare the effect of 6-week casting versus 2-week casting followed by 4-week ankle bracing in adult patients with surgically treated ankle fractures.

The primary outcome measures used were the functional results 3 months after surgery evaluated using two functional outcome measures (Olerud and Molander score (OMAS) and Kaikkonen et al score) and the patient return to work.

In the casting group, the traditional plaster was changed to a fiberglass one at 2 weeks and the cast treatment continued until 6 weeks. In the functional treatment group, the traditional plaster cast was changed to an reusable semi-rigid plastic orthosis (Aircast) at 2 weeks after surgery and its use was continued as an ankle support for up to 6 weeks. Follow-ups including subjective and objective evaluations were at 2, 6, 12 and 52 weeks and at 2 years postoperatively.

Primary Outcome Measures: Olerud-Molander score, Patient-reported outcome measure, 0-100 points, higher points indicating better result., 3 months and 24 months
Secondary Outcome Measures: Olerud-Molander score, Patient-reported outcome measure, 0-100 points, higher points indicating better result., 6 weeks and 12 months|Kaikkonen score, Patient-reported outcome measure, 0-100 points, higher points indicating better result., 6 weeks, 3, 12, and 24 months|Pain-VAS, 0-10, higher score indicating more pain., 6 weeks, 3, 12, and 24 months|Swelling of the ankle, Circumference in millimetres compared to unaffected side, 6 weeks, 3, 12, and 24 months|Atrophy of the calf muscles, Circumference in millimetres compared to unaffected side, 6 weeks, 3, 12, and 24 months|Ankle active dorsiflexion, Degrees compared to unaffected side, 6 weeks, 3, 12, and 24 months|Ankle active plantarflexion, Degrees compared to unaffected side, 6 weeks, 3, 12, and 24 months|Return-to-work, Days after the injury, Within 24 months|Subjective symptoms and return to activities, The patients were questioned about the subjective symptoms (pain, swelling, stiffness and giving way) and about the compliance of using the cast or brace. In addition the patients were asked about the length of their inability to work and participate in the daily activities and/or sports at the preinjury level., 2 and 6 weeks; 3, 12, and 24 months
Other Outcome Measures: Complications, Infection, loss of reduction, implant loosening, deep vein thrombosis, 2 and 6 weeks; 3, 12, and 24 months
Posterior Versus Lateral Laparoscopic Mesh Rectopexy for the Management of Complete Rectal Prolapse
NCT Number: NCT06559085
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Posterior Laparoscopic|Lateral Laparoscopic|Rectopexy|Complete Rectal Prolapse
Interventions: PROCEDURE: Laproscopic posterior mesh rectopexy (Wells or LPMR)|PROCEDURE: Laparoscopic lateral mesh rectopexy (Orr-Loygue)
Sponsor: Assiut University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-15
Completion Date: 2026-10-01
Locations: Assiut university, Assiut, Egypt

Summary:
Aim of the study is to evaluate the outcomes of two different methods of mesh placement during laparoscopic rectopexy for the management of complete rectal prolapse lateral versus posterior mesh rectopexy

Primary Outcome Measures: Operative time, Operative time will be measured (Time Frame: from inflation of abdomen till deflation in laparoscopic repair and from skin incision up to skin closure in open repair), Until the conclusion of the surgical procedure|Intraoperative injuries, Intra operative injuries will be recorded including bowel or vascular injuries, Until the conclusion of the surgical procedure
Secondary Outcome Measures: Improving of symptoms, Laparoscopic lateral mesh rectopexy versus posterior mesh rectopexy regarding to improving of symptoms will be recorded, 28 days after surgery|Recurrence rate, Laparoscopic lateral mesh rectopexy versus posterior mesh rectopexy regarding to recurrence rate will be recorded The recurrence rate was 3% (1/35) after a mean follow-up of 36 months in laparoscopic lateral mesh rectopexy (Orr-Loygue) and recurrence rates ranged from 0% to 11% in laproscopic posterior mesh rectopexy (Wells or LPMR), 28 days after surgery|Complications, Complications will be recorded such as early as bleeding, incontinence, intestinal obstruction, late as constipation, sexual dysfunction, intestinal obstruction, erosion of mesh, 28 days after surgery
Ultra-early STatin in Patients With Aneurysmal subaRachnoid Hemorrhage (Ue-STAR)
NCT Number: NCT06559072
Acronym: Ue-STAR
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Subarachnoid Hemorrhage|Subarachnoid Hemorrhage, Aneurysmal|Aneurysmal Subarachnoid Hemorrhage|Hemorrhage, Aneurysmal Subarachnoid
Interventions: DRUG: Atorvastatin
Sponsor: The George Institute
Collaborators: Tianjin Medical University General Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 522
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2026-09-01
Locations: Tianjin Medical University General Hospital, Tianjin, China

Summary:
A researcher-initiated and conducted multicenter, randomized controlled trial aimed at evaluating the efficacy and safety of ultra-early statin therapy in the treatment of acute aneurysmal subarachnoid hemorrhage (aSAH).

Primary Outcome Measures: Utility-Weighted Modified Rankin Scale, A utility-weighted Modified Rankin Scale (UW-mRS) was derived by averaging values from time-tradeoff (patient centered) and person-tradeoff (clinician centered) studies. Utility values were 1.0 for Modified Rankin Scale (mRS) level 0; 0.91 for mRS level 1; 0.76 for mRS level 2; 0.65 for mRS level 3; 0.33 for mRS level 4; 0 for mRS level 5; and 0 for mRS level 6. Higher scores mean a better outcome., 6 months after discharge
Secondary Outcome Measures: Modified Rankin Scale Score, The modified Rankin Scale (mRS) is the most widely used scale to measure the degree of handicap in stroke patients, ranging from 0 (no symptoms) to 6 (dead). Higher scores mean a worse outcome., 6 months after discharge|Glasgow Outcome Scale Extended, The Glasgow Outcome Scale Extended (GOS-E) is a clinical assessment tool used to assess outcome after head injury and nontraumatic acute brain insults. GOS-E divides patients' states into the following eight levels: dead, vegetative state, lower seven disability, upper seven disability, lower moderate disability, upper moderate disability, mild disability, lower good recovery, and basic recovery., 6 months after discharge|The 5-level EQ-5D version, The 5-level EQ-5D version (EQ-5D-5L) essentially consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled "The best health you can image" and "The worst health you can image"., 6 months after discharge
Evaluating the Implementation of a Comprehensive Multilevel Virtual Oncology Program Among Veterans Diagnosed With Lung, Colorectal, Prostate, and Breast Cancers in the US Department of Veterans Affairs
NCT Number: NCT06559059
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Lung Cancer Diagnosis|Colorectal Cancer (Diagnosis)|Prostate Cancer Diagnosis|Breast Cancer Diagnosis
Sponsor: NYU Langone Health
Collaborators: National Cancer Institute (NCI)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1800
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-18
Completion Date: 2027-01-01
Locations: NYU Langone Health, New York, New York, 10016, United States

Summary:
The purpose this pragmatic trial to test the effectiveness of an existing, ongoing clinical service, the VA National TeleOncology program (NTO), a multilevel telehealth population health management program. The primary aims are to study the intervention and determine its effectiveness on telehealth engagement, clinical quality, and healthcare cost outcomes across levels of Social Determinants of TeleHealth (SDTH) with the goal of promoting health equity.

Primary Outcome Measures: Number of raw telehealth visits, Telehealth utilization among Veterans with cancer will be measured through raw telehealth visit counts., Post-NTO implementation (up to 3 months)|Fraction of patients engaging in at least one telehealth visit, Telehealth utilization among Veterans with cancer will be measured by fraction of patients engaging in at least one telehealth visit., Post-NTO implementation (up to 3 months)
Secondary Outcome Measures: Change in provider level Quality Oncology Practice Initiative (QOPI) score, The quality of care of the intervention will be evaluating utilizing the American Society of Clinical Oncology Practice Initiative (QOPI) performance measures. The scale consists of 26 performance measures assessed at the patient, provider, and facility levels. Each cancer care provider will have his or her patient QOPI measures aggregated together for a provider level QOPI score. Our primary interest is the difference in QOPI score by intervention condition, as estimated by the fixed-effect coefficient for the intervention indicator variable. Scores of 75% or more indicate the standard is met, scores less than 75% indicate the standards have not been met. An increase in the QOPI score indicates improvement., Pre-implementation, post-NTO implementation (up to 3 months)|Time of consultation to time of first appointment, Time to care will be measured through time of consultation to time of first appointment., Pre-implementation, post-NTO implementation (up to 3 months)|Time of consultation to time of first treatment, Time to care will be measured through time of consultation to time of first treatment., Pre-implementation, post-NTO implementation (up to 3 months)|Average total cost for cancer diagnosis, treatment and downstream HealthCare utilization, Post-NTO implementation (up to 3 months)
A CT-BASED Deep Learning Model for Predicting WHO/ISUP Pathological Grades of Clear Cell Renal Cell Carcinoma (ccRCC) :A Multicenter Cohort Study
NCT Number: NCT06559046
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Tumor Grading|Deep Learning|Clear Cell Renal Cell Carcinoma
Sponsor: Ting Huang
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 483
Study Design: Observational Model: |Time Perspective: p
Start Date: 2019-01-01
Completion Date: 2024-06-30
Locations: Department of Urology, Affiliated Jinhua Hospital, Zhejiang University School of Medicine, Jinhua,Zhejiang, China, Jinhua, Zhejiang, 321000, China

Summary:
This study aims to establish an effective deep learning model to extract relevant information about renal tumors and kidneys from computed tomography (CT) images and predict the pathological grades of clear cell renal cell carcinoma (ccRCC).

Retrospective data were collected from 483 ccRCC patients across three medical centers. Arterial phase and portal venous phase CT images from the dataset were segmented for renal tumors and kidneys. Three convolutional neural networks (CNNs) were employed to extract features from the regions of interest (ROI) in the CT images across multiple dimensions including 3D, 2.5D, and 2D. Least absolute shrinkage and selection (LASSO) regression was used for feature selection. The models were evaluated using receiver operating characteristic (ROC) curves and decision curve analysis (DCA).

Primary Outcome Measures: predict the pathological grades of clear cell renal cell carcinoma (ccRCC), AUC curve, 2019-2024|predict the pathological grades of clear cell renal cell carcinoma (ccRCC), DCA curve, 2019-2024
Determine the Frequency of Variants in the GBA/PSAP Genes in Patients With MM or MGUS
NCT Number: NCT06559033
Acronym: GAMY
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Monoclonal Gammopathy of Undetermined Significance|Myeloma Multiple
Interventions: BIOLOGICAL: Evaluation of the presence and number of mutated alleles of the GBA/PSAP genes in patients with MM or MGUS
Sponsor: University Hospital, Rouen
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 300
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-10-01
Completion Date: 2027-04-01

Summary:
No effective specific treatment is currently available for the management of Multiple Myeloma (MM) and Monoclonal Gammopathy of Undetermined Significance (MGUS). A better understanding of the pathophysiological mechanisms would make it possible to propose treatments specifically targeting the deregulated pathways.

Primary Outcome Measures: Frequency of variants in the GBA/PSAP genes in patients with MM or MGUS, The main aim of the research is to determine the frequency of variants in the GBA/PSAP genes in patients with MM or MGUS., inclusion (one day)
Secondary Outcome Measures: Plasma concentrations of LGL1 in patients with MM or MGUS, Compare the plasma concentration of LGL1 in MM and MGUS patients versus control individuals, inclusion (one day)|Reactivity of monoclonal antibodies in MM and MGUS patients, Assess the % (proportion of patients with reactivity (% reactivity greater than 0) and those without (% reactivity equal to 0)) of reactivity of monoclonal antibodies from MM and MGUS patients to LGL1, inclusion (one day)
Predictors and Outcomes of Kangaroo Mother Care: A Quasi-Experimental Study in Pakistan
NCT Number: NCT06559020
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Low Birth Weight Infants|Preterm Infants
Interventions: BEHAVIORAL: Kangroo mother care
Sponsor: Services Institute of Medical Sciences, Pakistan
Sex: FEMALE
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 400
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2020-01-10
Completion Date: 2022-12-31
Locations: Services Institute of Medical sciences, Lahore, Punjab, 54000, Pakistan

Summary:
This quasi-experimental study evaluated the impact of Kangaroo Mother Care (KMC) versus Conventional Care (CC) on the growth, developmental milestones, breastfeeding, vaccination, and mortality of low birth weight infants in Services Hospital Lahore, Pakistan. A total of 400 infants were enrolled and followed for one year.

Primary Outcome Measures: Duration of Breastfeeding, breastfeeding initiation within 2 hours, exclusive breastfeeding for 6 months, breastfeeding up to one year, from 2 hours to 1 year|Number of babies with complete vaccination, infant receiving all scheduled vaccinations within their first year of life, 1 year|Average weight of baby, Weight of infant in Kg at birth, 6 weeks, 1 year, 6 months, and 1 year, 1 year|average length of infant, Length of infant in cms at birth, 6 weeks, 1 year, 6 months, and 1 year, 1 year|Average head circumference of infant, Head circumference of infant in cms at birth, 6 weeks, 1 year, 6 months, and 1 year, 1 year|Number of babies Holding head up, baby able to hold their head up, 3 months|Number of babies Sitting without support, Baby gets into sitting position without help, 6 months|Number of babies roll over, baby able to roll from side to side, 8 months|Number of babies crawling, baby able to move forward on hands and knees, 10 months|Number of babies babbles, baby able to produce repititive incomprehensible sounds, 6 months|Number of babies produce 2 syllable sounds, baby able to produce words that have two definite sounds, 9 months|cumulative Mortality rate, Death of baby, 1 year
Secondary Outcome Measures: Number of babies with Hypothermia, core body temperature less than 35 degree celsius, 72 hours|Number of babies with Sepsis, infection leading to life threatening inflammatory response, 72 hours