pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Wearables to Define Postpartum Blood Pressure Trajectories and Facilitate Evidence-based Monitoring Guidelines
NCT Number: NCT06576544
Status: ENROLLING_BY_INVITATION
Study Type: OBSERVATIONAL
Conditions: Hypertension, Pregnancy-Induced|Hypertension|Postpartum Preeclampsia|Postpartum Complication|Postpartum Pre-Eclampsia|Cardiovascular Diseases|Cardiovascular Morbidity|Morbidity;Perinatal
Sponsor: University of California, San Diego
Sex: FEMALE
Age: ADULT
Enrollment: 300
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-16
Completion Date: 2027-09
Locations: Jacobs Medical Center at UC San Diego Health, La Jolla, California, 92037, United States

Summary:
To better understand postpartum blood pressure changes, we are proposing a study to monitor blood pressure after delivery in 100 patients who we expect to have normal blood pressure (i.e. low-risk group), 100 patients who we expect to be at risk of new-onset high blood pressure postpartum (i.e. intermediate-risk group), and 100 patients who had high blood pressure prior to pregnancy (or very early, before 20 weeks in pregnancy) who we know are at high risk of blood-pressure related complications postpartum (i.e. high-risk group). Patients will be given a non-invasive wearable device that monitors blood pressure continuously for 6 weeks postpartum. We expect that the daily changes in blood pressure will be different between these groups, which may allow us to better predict who is at risk, how much monitoring is needed, and when to intervene before the blood pressure abnormalities cause complications. The blood pressure device that will be given to patients is the YHE® BP Doctor Med Blood Pressure Smartwatch. This is a highly-accurate medical grade device that has not received FDA clearance. As such, the device is not being used to make blood pressure management and treatment decisions, but rather to gather data on postpartum cardiovascular physiology. Safety stops are built into the protocol such that elevated readings detected by the watch will trigger clinical referrals and validation by standard blood pressure cuffs prior to determine need for treatment.

Primary Outcome Measures: Define the differences in longitudinal trends in blood pressure during the 6-week postpartum period between (a) subjects at low-risk for postpartum hypertension, (b) an intermediate-risk group, and (c) those at high-risk for postpartum hypertension., 6 week postpartum period
Effect of a Specialized Oral Supplement on Nutritional Status and Quality of Life in Non-dialysis CKD
NCT Number: NCT06576479
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Chronic Kidney Diseases|Protein-Energy Malnutrition
Interventions: DIETARY_SUPPLEMENT: Nutritious Shake|BEHAVIORAL: Nutritional counseling
Sponsor: NIN Institute
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: RANDOMIZED|Intervention Model: FACTORIAL|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2018-07-10
Completion Date: 2025-03
Locations: Hospital Civil Fray Antonio Alcalde, Guadalajara, Jalisco, 44280, Mexico

Summary:
Patients whit chronic kidney disease (CKD) there is a high prevalence of nutritional disorders and negative changes in body composition, which is strongly associated with an increased risk of morbidity and mortality.

Primary Outcome Measures: Serum Albumin (g/dl), Changes in serum albumin (g/dl) for all the patients at baseline and month 4., baseline intervention and 4 months|Dietary intake (kcal/kg/day), Changes in dietary caloric intake of patients at baseline and month 4., baseline intervention and 4 months
Secondary Outcome Measures: Adherence to nutritional treatment, Number of patients who manage to adhere correctly to the treatment, applying a Likert scale., baseline intervention and 4 months|Adverse effects, Number of patients who present adverse effects during the intervention, considering frequency and intensity by applying SAS (symptom assessment scale) and Bristol Scale., baseline intervention and 4 months
Selective Pulmonary-artery Intervention to Reduce Acute Right-heart tEnsion-II
NCT Number: NCT06576427
Acronym: SPIRARE II
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pulmonary Embolism
Interventions: DEVICE: Vertex Pulmonary Embolectomy System
Sponsor: Neptune Medical
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 145
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2026-03

Summary:
This study is a prospective, single-arm, multicenter study to evaluate the safety and effectiveness of the Vertex Pulmonary Embolectomy System in participants presenting with clinical signs and symptoms of acute pulmonary embolism.

Primary Outcome Measures: Reduction in Right ventricle (RV) / Left Ventricle (LV) ratio, Reduction in RV/LV ratio from baseline to 48 hours or discharge by (core lab assessed) CT angiography, From baseline to 48 hours or discharge|Major Adverse Events, a composite of:, Device-related death within 48 hours of the procedure Major bleeding within 48 hours of the procedure

Device-related AEs within 48 hours, including:

* Clinical deterioration
* Pulmonary vascular injury
* Cardiac injury, Within 48 hours of the procedure
Clinical Trial to Evaluate the Safety and Efficacy of EXG001-307 in Patients With Spinal Muscular Atrophy Type I
NCT Number: NCT06576388
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: EARLY_PHASE1
Conditions: Type I Spinal Muscular Atrophy
Interventions: DRUG: EXG001-307 injection
Sponsor: Hangzhou Jiayin Biotech Ltd
Sex: ALL
Age: CHILD
Enrollment: 2
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2022-01-21
Completion Date: 2024-01-21
Locations: Hangzhou Jiayin Biotechnology Co., Ltd, Hangzhou, Zhejiang, 310000, China

Summary:
The purpose of this study was to evaluate the safety and preliminary efficacy of a single intravenous injection of exg001-307 in patients with type I spinal muscular atrophy.

The research process includes the screening period (the screening period is from the time the subject signs the informed consent to the time before hormone pretreatment, with a maximum of 28 days), the treatment period (the subject receives hospitalization and observation including hormone pretreatment and single infusion of study drugs), and the follow-up period (the end of the treatment period until the subject reaches the age of 18 months, loss of follow-up, active withdrawal from the study or death). The qualified subjects in the screening period enter the treatment period, receive exg001-307 treatment, and enter the follow-up period after hospitalization observation. At the end of the study visit (subjects 18 months old), eligible subjects will be asked to transfer to the long-term follow-up study.

Primary Outcome Measures: To evaluate the safety and tolerability of EXG001-307 after a single intravenous infusion, including type and incidence of AE, SAE, AESI, vital signs, physical/neurological examination, immunogenicity, virology, injection/infusion site reactions, 12-lead electrocardiogram, and safety laboratory results recorded, up to 18months
Secondary Outcome Measures: Explore a safe and effective dose range；Assess initial effectiveness；, Explore dose limiting toxicity By the time of the study visit at the age of 18 months, the proportion of subjects who could sit alone for ≥ 30 seconds without support was reached according to the Bailey infant development scale version 3 (bsid-iii) Survival at 14 months. Changes in motor function assessment data relative to baseline after 6 months of treatment at the children's Hospital of Philadelphia neuromuscular disease infant test (chop-intend) Proportion of subjects with chop-int score above 40 after 6 months of treatment After 6 months of treatment, the proportion of subjects whose exercise intensity and functional improvement reached development milestones were evaluated according to bsid-iii scale (head control ≥ 3 seconds; sitting alone ≥ 5 seconds without support; sitting alone ≥ 30 seconds without support), up to 18 months
Efficacy of Dapagliflozin Versus Metformin in Polycystic Ovary Syndrome
NCT Number: NCT06576375
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Polycystic Ovary Syndrome
Interventions: DRUG: Dapagliflozin|DRUG: Metformin
Sponsor: Future University in Egypt
Collaborators: October 6 University
Sex: FEMALE
Age: ADULT
Enrollment: 70
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2025-01

Summary:
In PCOS (Polycystic Ovary Syndrome), studies have found impaired incretin secretion and activity, particularly in overweight/obese individuals.

Conflicting results exist regarding glucagon-like peptide-1(GLP-1) levels in PCOS patients, with studies reporting reduced, normal, or increased levels. Incretin-based therapy has been suggested as a potential treatment to reverse prediabetes risk by preserving β-cell function in patients with impaired fasting glucose(IFG and impaired glucose tolerance(IGT). The study aims to compare the efficacy of Dapagliflozin to Metformin for the treatment of non-diabetic patients with polycystic ovary syndrome (PCOS).

Primary Outcome Measures: Fertility parameters- Luteinizing hormone, Luteinizing hormone (LH) in IU/L, 3-6 months|Fertility parameters-Follicle-stimulating hormone, Follicle-stimulating hormone (FSH) in mIU/mL, 3-6 months|Fertility parameters-Free androgen index, Free androgen index \[ Time Frame: 3-6 months\], 3-6 months|Fertility parameters-Total testosterone, Total testosterone in ng/dL, 3-6 months|Transvaginal ultrasonography, disappearance of PCOS, 3-6 months|Menstrual diaries, Menstruation pattern, 3-6 months
Secondary Outcome Measures: Metabolic parameters, Fasting blood glucose (FBG) in mg/dL, 3-6 months
Evaluation of Ultrasound-guided Transuterine Vaginal Biopsy Technique in Uterine Fibromatous Disease
NCT Number: NCT06576362
Acronym: EFIBIA
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Fibroid|Uterine Corpus Smooth Muscle Neoplasm
Interventions: PROCEDURE: Echoguided transuterine vaginal biopsy performed before myomectomy or hysterectomy
Sponsor: Assistance Publique Hopitaux De Marseille
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 250
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-11-30
Completion Date: 2028-06-30

Summary:
The goal of this diagnostic, prospective study is to evaluate an innovative, minimally invasive surgical technique for diagnosing uterine smooth muscle tumors by biopsy, in women aged 18 and more, and to evaluate complications relating to the the technique and its potential adverse events.

Participants presenting at hospital patients presenting a surgical indication for myomectomy or hysterectomy during the inclusion period will be offered the study.

Preoperatively, women will undergo the following two examinations:

1. A pelvic MRI, the characteristics of which will be analyzed by the expert women\&#39;s imaging team.
2. A BVTE under general anaesthetic in the operating theatre on the day of the planned myomectomy or hysterectomy.

250 women will be included in this study within a periofd of inclusion of 36 months and their participation is estimated to 7 months Total study duration is 43 months

Primary Outcome Measures: Validate an innovative, minimally invasive surgical technique for diagnosing uterine smooth muscle tumors by biopsy, Estimate the anatomopathological sensitivity of BVTE, with its 95% confidence interval, by comparing it with the reference technique, i.e. anatomopathological diagnosis on surgical specimens, to ensure a low number of false negatives (fibroid diagnosis on BVTE with final diagnosis of TMM), From enrollment before surgery to the follow-up visit 3 months after surgery
A Randomized Clinical Trial About Use of 3D Laparoscopy Versus 2D Laparoscopy in Adrenal Surgery
NCT Number: NCT06576336
Acronym: 3DAdrenal
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Adrenal Mass|Adrenal Adenoma|Adrenal Gland Neoplasms
Interventions: PROCEDURE: laparoscopic adrenalectomy
Sponsor: University of Palermo
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 350
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2018-01-01
Completion Date: 2024-06-30
Locations: Giuseppe Di Buono, Palermo, PA, 90144, Italy|Italy, Palermo, 90127, Italy

Summary:
Comparison between 2D traditional laparoscopic surgery and 3D laparoscopy for adrenal surgery.

Primary Outcome Measures: periperative surgical outcomes, evaluation of intraoperative surgical complication during laparoscopic adrenalectomy with YES or NO and questionnaire about resolution of complications. In details the investigators evaluates: vascular complications (Major lesions: renal artery, renal vein; aorta; vena cava; sovrahepatic veins. Minor lesions: adrenal vessels; accessory renal vessels; others); complication hollow viscus (bowel; colonic; stomach; urether); complication parenchymatous viscus (renal; adrenal; spleen; diaphragm); resolution of complications; conversion to open surgery. 30-day postoperative complications (only grade 3 - 4 - 5 sec. Clavien-Dindo classification), 30-postoperative days
Secondary Outcome Measures: depth perception, evaluation of depth perception during surgical procedure with a questionnaire administered to surgical team with a score from 1 (min depth) to 5 (max depth), intraoperatory time|definition of surgical plane, definition of surgical plane during surgery with a questionnaire administered to surgical team with a score from 1 (min definition) to 5 (max definition), intraoperatory time|evaluation of surgical strain, variables of surgical strain: wrist, hand, neck, back, dizziness and/or headache (Yes=1; No=0)., intraoperatory time
Novel Respiratory Training as Part of Palliative Care for Older Adults With Heart Failure
NCT Number: NCT06576297
Acronym: RETRO
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Aging|Heart Failure With Preserved Ejection Fraction|Heart Failure With Reduced Ejection Fraction|Frailty|Physical Function|Quality of Life
Interventions: OTHER: Inspiratory Muscle Training (IMT)|OTHER: Standard of Care
Sponsor: University of Pittsburgh
Collaborators: The Pittsburgh Foundation
Sex: ALL
Age: OLDER_ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-06-30
Completion Date: 2026-10-31
Locations: University of Pittsburgh, Pittsburgh, Pennsylvania, 15213, United States

Summary:
In a randomized controlled trial, to study the utility of inspiratory muscle training (IMT) to improve functional outcomes in adults aged ≥70 years with heart failure (HF) who have been referred to palliative care for end-stage HF management.

* The study team hypothesize that older HF patients will be able to use IMT safely, reliably, and effectively in a 12-week home-based training regimen.
* The study team hypothesize that physical function (sit to stand, gait speed, grip strength), respiratory/pulmonary function, self-efficacy, fatigue and quality of life will increase among older HF patients randomized IMT versus those randomized to usual care.

Primary Outcome Measures: Safety of a 12-week home-based IMT program., AE/SAE (IMT vs. controls): number Completion of the 3-month intervention (IMT vs. controls), Baseline and weekly for 12 weeks
Secondary Outcome Measures: Adherence to IMT training sessions, Number of IMT sessions competed over 12-week intervention, Baseline and weekly for 12 weeks|Improvement in MIP, Improvement in MIP (IMT vs. controls): cm H2O, Baseline, 12 weeks|Sit to stand, 5-times Sit-to-Stand: seconds, Baseline, 12 weeks|Gait speed, 4 m Gait Speed: m/sec, Baseline, 12 weeks|Grip strength, Grip Strength: pounds, Baseline, 12 weeks|Self-efficacy, Self-efficacy: Sullivan Self-Efficacy; 0-52; higher score is more favorable, Baseline, 12 weeks|Quality of Life, Quality of Life: Kansas City Cardiomyopathy Questionnaire (KCCQ): score 0-100; higher is more favorable than lower score., Baseline, 12 weeks|Fatigue, Fatigue: PROMIS Item Bank v1.0 - Fatigue - short form 13a (FACIT-Fatigue): scale 0-52; lower indicates less fatigue., Baseline, 12 weeks
A 36-month Analysis of the Clinical Performance of Individualized CAD/CAM-produced Dental Implants: a Cohort Study
NCT Number: NCT06576284
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Tooth Loss|Dental Implant
Sponsor: University of Sao Paulo
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 12
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09
Completion Date: 2026-10
Locations: School of Dentistry - University of São Paulo, São Paulo, 05508-900, Brazil

Summary:
The goal of this prospective cohort study is to evaluate the clinical performance of a new generation of customized CAD/CAM pre-fabricated root-analog dental implants over a 36-month period. The main questions it aims to answer are:

1. Are these novel implants safe, effective, and clinically viable for 36 months?
2. Do these drilling-free implants result in better post-operative outcomes compared to traditional implant techniques? Twelve patients receiving these customized implants immediately after tooth extraction will undergo clinical and radiographic examinations at 12, 24, and 36 months after prosthesis installation. The study will assess peri-implant tissue health, post-operative comfort, bone preservation, tissue integration, and implant survival rates.

Primary Outcome Measures: Radiographic success, Radiographic success, defined as the absence of peri-implant radiolucency and lack of progressive loss (\> 1.7 mm) of marginal bone level (MBL) over the 36 months following implant restoration., 12 months, 24 months and 36 months
Secondary Outcome Measures: Linear horizontal changes of peri-implant soft tissues, measured from intraoral scans at 1mm, 3mm, and 5mm below the reference gingival margin level at the time of crown placement, at 12, 24, and 36 months., 12 months, 24 months and 36 months|Prosthetic Level outomes, Chipping/fracture of material; Loss of retention of restoration (cementation cement fracture); Connector (Abutment) fracture; Loss/failure of restoration substrate requiring new restoration; The restoration functions as intended/satisfactorily for the subject, 12 months, 24 months and 36 months|Peri-implant clinical parameters, Mobility (MOB), 12 months, 24 months and 36 months
A Study of GSK4527363 in Healthy Participants, Systemic Lupus Erythematosus (SLE) Participants and Healthy Chinese and Japanese Participants
NCT Number: NCT06576271
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Systemic Lupus Erythematosus
Interventions: DRUG: GSK4527363|DRUG: Placebo matching GSK4527363|DRUG: Belimumab
Sponsor: GlaxoSmithKline
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 112
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-02
Completion Date: 2027-04-29
Locations: GSK Investigational Site, Cambridge, CB2 0GG, United Kingdom

Summary:
This study will assess the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of GSK4527363 in healthy participants (Part A), participants with active SLE (Part B), and healthy participants of Chinese and Japanese descent (Part C).

Primary Outcome Measures: Parts A, B and C: Number of participants with non-serious adverse events and serious adverse events, Up to Week 52|Parts A, B and C: Number of participants with clinically significant changes in physical examination, laboratory parameters, vital signs, and 12 lead electrocardiogram (ECG) findings, Up to Week 52|Parts A, B and C: Number of participants with clinically significant changes in Columbia-Suicide Severity Rating Scale (C-SSRS), The C-SSRS is an assessment tool that evaluates suicidal ideation and behavior. A suicidal ideation score will be calculated based on the maximum suicidal ideation category ranging from 1 to 5. Higher score indicates more suicidal ideation. A clinically important change in the C-SSRS is defined as a total score \>0., Up to Week 52
Secondary Outcome Measures: Parts A and C: Area under the concentration-time curve to the last quantifiable concentration (AUC[0-t]) of GSK4527363, Up to Week 52|Parts A and C: Area under the concentration-time curve to infinity (AUC[0-inf]) of GSK4527363, Up to Week 52|Parts A and C: Maximum plasma concentration (Cmax) of GSK4527363, Up to Week 52|Parts A and C: Apparent Terminal phase half-life (t1/2) of GSK4527363, Up to Week 52|Parts A, B and C: Number of participants with anti-drug antibodies (ADAs) against GSK4527363, Up to Week 52|Parts A, B and C: Titers of ADAs against GSK4527363, Up to Week 52|Parts A, B and C: Percentage change from Baseline in cytokine levels, Baseline (Day 1) and up to Week 52|Part B: Area under the concentration-time curve to the end of the dosing period (AUC[0-tau]) of GSK4527363, Up to Week 52|Part B: Maximum plasma concentration (Cmax) of GSK4527363, Up to Week 52|Part B: Concentration at the end of the dosing interval (Ctrough) of GSK4527363, Up to Week 52
Standalone Observational Study Assessing the Performance of an AI/ML Tech-based SaMD on Chest LDCT Images (REALITY)
NCT Number: NCT06576232
Acronym: REALITY
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: High Risk Cancer
Interventions: DEVICE: Median LCS
Sponsor: Median Technologies
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1147
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-09-21
Completion Date: 2024-08-21
Locations: University of Pennsylvania - Penn Center for Innovation, Philadelphia, Pennsylvania, 19104, United States|Baptist Clinical Research Institute, Memphis, Tennessee, 38120, United States|The University of Texas M.D. Anderson Cancer Center, Houston, Texas, 77030, United States|Fundacion instituto de investigacion sanitaria de la fundacion jimenez diaz (FJD), Madrid, 28040, Spain|Universidad de Navarra, Pamplona, 31009, Spain

Summary:
This is a Multinational, Multicenter, retrospective study for the evaluation of the standalone efficacy and safety of an Artificial Intelligence/Machine Learning (AI/ML) technology-based end-to-end Computer assisted Detection/Computer Assisted Diagnosis (CADe/CADx) Software as a Medical Device (SaMD) developed to detect, localize and characterize malignant, and suspicious for lung cancer nodules on Low Dose Computed Tomography (LDCT) scans taken as part of a Lung Cancer Screening (LCS) program.

LDCT Digital Imaging and Communications in Medicine (DICOM) images of patients who underwent lung cancer screening were selected and included into the study. Selected scans will then be analyzed by the CADe/CADx SaMD and compared to radiologist generated reference standards including lesions localization and lesion cancer diagnosis.

Figures of merit at patient level and lesion level detection and diagnostic efficacy will be calculated as well as sub-class analysis to ensure algorithm performance generalizability.

Primary Outcome Measures: AUROC (Area under ROC curve) at patient level, AUROC that measures Median LCS performance at patient level is strictly superior to 0.8.

Support for Primary Endpoint: Derived from the patient level AUROC at the product fixed operating point : Sensitivity, Specificity, PPV, NPV., 12 months
Secondary Outcome Measures: Sensitivity > 70% when Specificity=70%, 12 months|Specificity > 70% when Sensitivity=70%, 12 months|AUC of LROC > 0.75, In contrast to the receiver operating characteristic (ROC) assessment paradigm, localization ROC (LROC) analysis provides a means to jointly assess the accuracy of localization and detection in an observational study., 12 months|Detection sensitivity>0.8 with average FP rate per scan<1, 12 months|ICC>0.8 for average diameter, Intraclass Correlation Coefficient (ICC), is a descriptive statistic that can be used when quantitative measurements are made on units that are organized into groups. It describes how strongly units in the same group resemble each other., 12 months|ICC>0.8 for long axis diameter, 12 months|ICC>0.8 for short axis diameter, 12 months|ICC>0.75 for Volume, 12 months|DICE Coefficient >0.7, 12 months
'My Life is Music' Group Therapy Model - a Feasibility Study for Adolescents with Persistent Pain
NCT Number: NCT06576219
Acronym: PedPainMusic
Status: ENROLLING_BY_INVITATION
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pediatric Pain
Sponsor: Helsinki University Central Hospital
Sex: ALL
Age: CHILD
Enrollment: 24
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2026-12-31

Summary:
The aim of this multi-method feasibility study is to learn if a group therapy model using music can be applied in the treatment of adolescents with persistent pain. We are interested how the patients find participating in the group therapy as part of their rehabilitation and if the patient´s experience of music changes during the therapy process.

Primary Outcome Measures: Semi-structured interviews, Patients and their parents, 12 weeks|Patient Diaries, patient's experiences on group therapy and music, Weekly entries for 8 weeks during intervention
Secondary Outcome Measures: PROMIS Pediatric Profile, Baseline, 12 weeks|Music Questionnares, B-MMR and BMRQ, Baseline, 12 weeks|Feedback Informed Treatment (FIT), Baseline, weekly entries for 8 weeks during intervention
Effects of Bin Therapy on Finger Gnosia And Fine Motor Skill
NCT Number: NCT06576206
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Down Syndrome
Interventions: OTHER: Bin therapy and finger gnosia|OTHER: conventional therapy
Sponsor: Riphah International University
Sex: ALL
Age: CHILD
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-05-14
Completion Date: 2024-08-20
Locations: Riphah International University, Lahore, Punjab, 54000, Pakistan

Summary:
Down syndrome is a hereditary disorder resulting from the occurrence of an additional copy of chromosome 21, resulting in discernible variations in cognitive and physical characteristics. Finger gnosis pertains to the capacity to identify and discriminate among individual fingers. Tactile perception and body awareness are both encompassed by this particular component. Finger gnosis encompasses the sensory and cognitive mechanisms that enable an individual to recognize, label, and differentiate between their own fingers and those belonging to others. The therapeutic approach known as BIN Therapy is a non-invasive and pharmacologically unassisted intervention that use electrical stimulation as a means to enhance manual dexterity in individuals afflicted with neurological conditions

Primary Outcome Measures: Finger Gnosia Assessed by Vernier Caliper, Finger gnosia assessed by vernier caliper by two-point discrimination test. 2-5 mm average score, 6-10 mm mild impairment, 11-15 moderate impairment, 16 mm or above severe impairment, baseline and 8th week
Secondary Outcome Measures: Nottingham sensory assessment, tactile sensation 42 max score, proprioception and Kinesthesia 24 max score, total score 66- 0-20 severe sensory impairment, 21-40 moderate sensory impairment, 41-54 mild sensory impairment, 55 - 66 normal sensory function, baseline and 8th weeks
Effects of Neoadjuvant Therapy With Carboplatin, Paclitaxel Combined With Anti-PD-1 Drugs on Cognitive Function in Patients With Resectable Head and Neck Squamous Cell Carcinoma
NCT Number: NCT06576180
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Head and Neck Squamous Cell Carcinoma
Interventions: DRUG: Carboplatin（ neoadjuvant）|DRUG: Paclitaxel （neoadjuvant）|DRUG: Anti-PD-1 Drugs|PROCEDURE: Surgical resection
Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 306
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-23
Completion Date: 2026-09-01
Locations: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Guanzhou, Guangdong, 510000, China

Summary:
The goal of this observational study is to learn about the Effects of neoadjuvant therapy with carboplatin, paclitaxel combined with anti-PD-1 drugs on cognitive function in patients with resectable head and neck squamous cell carcinoma: a prospective cohort study

Primary Outcome Measures: cognitive adverse events, CoAE, Scores on two or more of the neuropsychological battery tests (NBT) of the HVLT-R, COWA, and TMT are 1.5 SD below the standard mean (or the mean score of an appropriate control group), Or a single test score that is 2.0 SD below the mean can be marked as an objective cognitive adverse event (CoAE)., Baseline, 9 weeks, 6 months, 12 months
Secondary Outcome Measures: Major pathological response rate, Defined as the proportion of subjects with ≤10% viable tumor cells in resection specimens to total subjects, Within 30 days after surgery|Montreal Cognitive Assessment, MoCA, Baseline, 9 weeks, 6 months, 12 months, The total score is obtained by adding up the scores of each item, and the full score is 30 points. The application results of the original English version of the scale designer show that if the number of years of education is ≤12 years, 1 point is added,|perceived cognitive decline events , PCDE, Baseline, 9 weeks, 6 months, 12 months, 1/2 standard deviation (SD) of the PCI score in the baseline healthy population is defined as a minimal clinically important difference (MCID), and a change in PCI score that exceeds the MCID in each test will be labeled as PCDE.|complete pathological response rate, Defined as the proportion of subjects without viable tumor cells in the resection specimen to the total subjects, Within 30 days after surgery
COVID-19 Self-testing IMPROVE
NCT Number: NCT06576167
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: COVID-19
Interventions: BEHAVIORAL: IMPROVE
Sponsor: Temple University
Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1271
Study Design: Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: SCREENING
Start Date: 2023-06-15
Completion Date: 2024-09-30
Locations: Center for Asian Health, Lewis Katz School of Medicine, Temple University, Philadelphia, Pennsylvania, 19140, United States

Summary:
The study aims to engage community partners to implement IMPROVE intervention and promote (COVID-19) rapid testing among vulnerable Asian Americans in the Greater Philadelphia Area and New York City

Primary Outcome Measures: the change in the rate of COVID-19 self-testing, baseline, 1-month follow up, and 3-month follow up
The Role of Antibiotic Prophylaxis in Lowering Wound Infection Rates Post-Open Repair of Primary Elective Groin Hernias in High-Risk Patients
NCT Number: NCT06576154
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Antibiotic Prophylaxis|Wound Infection|Groin Hernia
Interventions: DRUG: Cefazolin 1000 MG
Sponsor: University of Aleppo
Collaborators: Aleppo University Hospital Resident Team
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: PREVENTION
Start Date: 2024-08-01
Completion Date: 2025-09-01
Locations: Aleppo University Hospital, Aleppo, Syrian Arab Republic

Summary:
This study aims to investigate the impact of antibiotic prophylaxis on reducing wound infection rates following open repair of primary elective groin hernias in high-risk patients.

Primary Outcome Measures: Overall Complication Rate, Overall complication rate; graded by the Clavien- Dindo complications classification system, up to 30 days after the surgery.|Wound infection/ Surgical site infection, has been defined and classified as superficial incisional, deep incisional, and organ/ space_ surgical site infection by the Centers for Disease Control and Prevention (CDC) (Anderson 2014; Ban 2017; Berríos-Torres 2017)., up to 30 days after the surgery.
Secondary Outcome Measures: Mortality Rate, The measure of the number of deaths at the end of the study., up to 30 days after the surgery.|Hospital stay, In days: Number of days, patient in hospital since admission., up to 30 days after the surgery.
Other Outcome Measures: Other Adverse events, Any adverse events will be observed during the follow-up period., up to 30 days after the surgery.
Kaleidoscope Virtual Reality Glasses Pain and Anxiety Levels in Venous Blood Collection Children
NCT Number: NCT06576141
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Child, Only
Interventions: OTHER: Kaleidoscope|OTHER: Virtual Reality|OTHER: control
Sponsor: Erzi̇ncan Binali Yildirim Uni̇versi̇tesi̇
Sex: ALL
Age: CHILD
Enrollment: 105
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-09-01
Completion Date: 2025-12-01
Locations: To Sakarya University Training and Research Hospital, Sakarya, Turkey

Summary:
The aim of our research is to investigate the effects of distracting children's attention with a kaleidoscope and virtual reality glasses during venous blood collection on perceived pain and anxiety levels.

Primary Outcome Measures: Wong-Baker Facial Expression Rating Scale (WB-FRS), measuring fear, 1 year|State-Trait Anxiety Inventory for Children, measuring anxiety, 1 year
Ultrasound-Guided Transversus Abdominis Plan (TAP) Block in Endovascular Cardiac Interventions
NCT Number: NCT06576128
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Anesthesiology|Percutaneous Coronary Intervention|Cardiac Catheterization|Analgesia|Satisfaction, Patient
Interventions: DEVICE: ultrasound|PROCEDURE: parenteral local anesthesia
Sponsor: Istanbul University - Cerrahpasa (IUC)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-10
Completion Date: 2025-01-15

Summary:
Sensory innervation of the femoral region which is the entry point for endovascular cardiac interventions such as coronary angiography,cardiac catheterization and percutaneous coronary intervention is complex.It is thought that the ilioinguinal and iliohypogastric nerves contribute mostly.With transversus abdominis plane block(TAPB),it is planned to provide analgesia by creating a block in these nerve branches that contribute to the sensory innervation of the intervention area.In addition;it was aimed to investigate patient's and physician's satisfaction during the procedure.

Primary Outcome Measures: measuring the analgesic efficacy of TAPB, The pain will be assessed by the Numeric Rating Scale-11(NRS -11) to measure the analgesic efficacy of TAPB. Minimum pain score is point zero, maximum pain score is ten points.Minimum pain scores (NRS is less than 4 points) will have positive outcomes., 4 months|For patient and physician satisfaction;5-point Likert scale will be used. Minimum satisfaction score is one point, maksimum satisfaction score is five points.Higher scores have positive outcomes., One point represents strongly unsatisfied and 5 points represent strongly satisfied., 4 months
WeighT LOSS Surgery and Comprehensive Cardiometabolic Responses to to EXercise
NCT Number: NCT06576050
Acronym: WTLOSS-EX
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Heart Failure|Obesity|Weight Loss|Heart Failure With Preserved Ejection Fraction
Sponsor: Massachusetts General Hospital
Collaborators: Amgen
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 21
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-01-25
Completion Date: 2024-11-01
Locations: Massachusetts General Hospital, Boston, Massachusetts, 02114, United States

Summary:
The goal of this study is to define how treatment of obesity impacts cardiometabolic performance during exercise in patients with established HFpEF or at risk for HFpEF. Multi-dimensional physical activity, including 6 minute walk distance, resting metabolic rate, the metabolic cost of initiating exercise, and low-level, intermediate, peak exercise, and recovery oxygen utilization patterns will be examined in relation to weight loss in people having bariatric surgery. The investigators also aim to learn more about the relationship between obesity, exercise intolerance, and heart failure with preserved ejection fraction (HFpEF). The investigators are interested in the extent to which HFpEF\&#39;s manifestations are preventable or reversible with weight-loss interventions. The main questions it aims to answer are:

1. How does weight loss surgery affect comprehensive measures of physical activity?
2. What are the biochemical signatures of obesity and their reversibility in patients with HFpEF and obesity?

Primary Outcome Measures: Change in Peak VO2, To precisely quantify changes in peak oxygen uptake (peak VO2) achieved pre and post gastric sleeve surgery by performing cardiopulmonary exercise testing (CPET) at baseline (pre-surgery) and 12-months post-procedure (+/- 3 months). CPETs will be performed on a cycle ergometer., baseline to month 12
Phase Ib Study of CBP-1019 in Combination With FOLFOX +/- Bevacizumab, Pembrolizumab, or Enzalutamide for Metastatic TRPV6-overexpressing Solid Tumors of Epithelial Origin
NCT Number: NCT06576037
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Solid Tumor
Interventions: DRUG: CBP-1019|DRUG: Oxaliplatin|DRUG: Leucovorin|DRUG: 5-FLUOROURACIL|DRUG: Bevacizumab|DRUG: Pembrolizumab|DRUG: Enzalutamide
Sponsor: M.D. Anderson Cancer Center
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 128
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-12-31
Completion Date: 2029-06-01
Locations: MD Anderson Cancer Center, Houston, Texas, 77030, United States

Summary:
An open-label, Phase Ib dose escalation and dose expansion clinical trial evaluating the safety and efficacy of CBP-1019 combinations in patients with solid tumors of epithelial origin.

Primary Outcome Measures: Safety and Adverse Events (AEs), Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0, Through study completion; an average of 1 year
2 College Truths and 1 Lie
NCT Number: NCT06576011
Acronym: 2T1L
Status: ENROLLING_BY_INVITATION
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Underage Drinking
Interventions: BEHAVIORAL: Gamified Social Norms Marketing Campaign|BEHAVIORAL: Social Norms Marketing Campaign
Sponsor: Loyola Marymount University
Sex: ALL
Age: ADULT
Enrollment: 414
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: PREVENTION
Start Date: 2024-08-05
Completion Date: 2025-05-15
Locations: Loyola Marymount University, Los Angeles, California, 90045, United States

Summary:
This pilot randomized control trial (RCT) aims to assess the feasibility and efficacy of 2 College Truths \& 1 Lie (2T1L), a gamified social norms marketing campaign (SNMC) aimed at preventing and reducing first-year college student drinking. This program is designed to correct overestimations of peers' alcohol use behaviors, which, as shown in previous research, influence one's own future drinking behaviors. To examine the efficacy of 2T1L, this pilot trial will use a longitudinal design to determine whether playing 2T1L during the first few weeks of college will prevent increases in drinking or reduce subsequent alcohol use among first-year students during the same year, relative to exposure to a static social media-delivered SNMC or an assessment-only control condition. The investigators hypothesize that students randomized to receive the interactive 2T1L SNMC game will report less state psychological reactance in response to normative campus drinking statistics than students randomized to the non-gamified SNMC condition. Further, students in the 2T1L game condition will report greater accuracy in their perceptions of campus drinking norms and consume less alcohol following the six-week SNMC (short-term follow-up) and toward the end of the first year (long-term follow-up) compared to those randomized to both the active non-gamified SNMC and assessment-only control conditions.

Primary Outcome Measures: Change from Baseline Daily Drinking at 4 Months, Self-reported number of drinks consumed during an average week in the past 30 days., baseline, 4 months|Change from Baseline Daily Drinking at 9 Months, Self-reported number of drinks consumed during an average week in the past 30 days., baseline, 9 months|Change from Peak Drinking Occasion at 4 Months, Self-reported max number of drinks consumed on a single occasion in the past 30 days., baseline, 4 months|Change from Baseline Peak Drinking Occasion at 9 Months, Self-reported max number of drinks consumed on a single occasion in the past 30 days., baseline, 9 months|Change from Baseline Descriptive Peer Drinking Norms- Drinking Norms Rating form at 4 Months, Assesses perceptions of weekly alcohol consumption among peers over the past 30 days., baseline, 4 months|Change from Baseline Descriptive Peer Drinking Norms- Drinking Norms Rating form at 9 Months, Assesses perceptions of weekly alcohol consumption among peers over the past 30 days., baseline, 9 months
Insomnia in Primary Care
NCT Number: NCT06575998
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Insomnia
Interventions: OTHER: Training|OTHER: Pro-active identification
Sponsor: Leiden University Medical Center
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 315
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-09
Completion Date: 2026-09-09
Locations: Leiden University Medical Center (LUMC), Leiden, Zuid-Holland, 2333ZA, Netherlands

Summary:
The goal of this clinical trial is to learn if training primary care providers on treatment of insomnia can improve insomnia symptoms in patients. Researchers will compare insomnia symptoms of patients receiving care from trained practices with patients receiving care from control practices (providing care-as-usual), to see if the training helps to provide improved insomnia care. Participants will be asked to complete four questionnaires and some participants will be invited for an insomnia consultation in primary care by their primary care providers (PCP).

Primary Outcome Measures: Change in patient reported insomnia symptoms using the Insomnia Severity Index (ISI), Change is measured linearly using the Insomnia Severity Index. Scores range from 0 to 28 points in which higher scores represent a worse outcome. Secondly, the categorically defined treatment response is established 2 months after baseline questionnaire (remission = ISI score \< 11, ISI score reduction ≥ 8)., From baseline to measurements at 2, 6 and 12 months
Secondary Outcome Measures: Patient reported non-pharmacological 'sleep consultation', Patient report of a sleep consultation (survey answer yes/no) combined with patient reported sleep medication use (survey answer yes/no)., 12 months after baseline questionnaire|Report by the PCP of a non-pharmacological 'sleep consultation', PCP reported sleep consultation (survey answer yes/no) combined with PCP reported sleep medication use (survey answer yes/no)., 12 months after baseline questionnaire|Change in patient reported depression symptoms, Measured linearly using the Patient Health Questionnaire-9 (PHQ-9). Scores range from 0 to 27 points in which higher scores represent a worse outcome., From baseline to measurements at 2, 6 and 12 months|Change in patient reported anxiety symptoms, Measured linearly using the General Anxiety Disorder Questionniare (GAD-7). Scores range from 0 to 21 points in which higher scores represent a worse outcome., From baseline to measurements at 2, 6 and 12 months|Change in patient reported general health status, Measured with the Short Form-36 questionnaire (SF-36). Scores represent the percentage of total possible score achieved, ranging from 0 to 100. A higher score represents a better outcome., From baseline to measurements at 2, 6 and 12 months|Change in report of sleep medication use, Patient reported use of sleep medication in the past two weeks (survey answer yes/no)., From baseline to measurements at 2, 6 and 12 months
A Clinical Study to Assess the Effects of JoyRise Recovery Powder on Mitigating Alcohol Aftereffects.
NCT Number: NCT06575972
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Alcohol Aftereffects|Anxiety|Cognitive Impairment
Interventions: DIETARY_SUPPLEMENT: JoyRise Recovery Powder|DIETARY_SUPPLEMENT: Placebo
Sponsor: Joyrise
Collaborators: Citruslabs
Sex: ALL
Age: ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-06-25
Completion Date: 2024-08-01
Locations: Citruslabs, Santa Monica, California, 90404, United States

Summary:
This study assesses the effectiveness of JoyRise Recovery Powder in reducing alcohol aftereffects, cognitive impairment, and anxiousness among participants aged 35-54 who consume alcohol. Participants will be randomly assigned to either the JoyRise group or a placebo group. The study will measure hangover symptoms, cognitive function, and overall well-being through a series of questionnaires and cognitive tests at baseline, 30 minutes after product consumption, and 4 hours later.

Primary Outcome Measures: Reduction in Symptoms Associated with Alcohol Aftereffects, Measurement of the reduction in alcohol aftereffects using the Alcohol Hangover Questionnaire (AHQ). Participants will self-report their symptoms, such as headache, nausea, and tiredness., Baseline and 30 minutes after product consumption on the day following alcohol consumption.
Secondary Outcome Measures: Improvement in Cognitive Function, Measurement of cognitive function using Double Trouble (which assesses selective attention and processing speed). Participants will complete this assessment to determine any changes in cognitive function., Baseline and 30 minutes after product consumption on the day following alcohol consumption.|Improvement in Cognitive Function, Measurement of cognitive function using two cognitive tests: Feature Match (which assesses focus and processing). Participants will complete this assessment to determine any changes in cognitive function., Baseline and 30 minutes after product consumption on the day following alcohol consumption.|Reduction in Feelings of Anxiousness, Measurement of reduction in feelings of anxiousness using self-reported questionnaires. Participants will rate their anxiety levels to determine if the product provides a calming effect., Baseline and 30 minutes after product consumption on the day following alcohol consumption.|Increased User Satisfaction with Overall Well-being, Measurement of user satisfaction with overall well-being through self-reported questionnaires. Participants will rate their satisfaction with their physical and mental state post-alcohol consumption., Baseline and 4+ hours after product consumption on the day following alcohol consumption.