pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Salvage Stereotactic Body Radiotherapy of the Prostate Bed for Biochemical Recurrence After Radical Prostatectomy.
NCT Number: NCT06523634
Acronym: STEREOBED
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Prostate Cancer
Interventions: RADIATION: stereotactic body radiotherapy|RADIATION: SOC RT
Sponsor: Jules Bordet Institute
Sex: MALE
Age: ADULT, OLDER_ADULT
Enrollment: 284
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-12-01
Completion Date: 2030-12-01

Summary:
This is a a randomized phase II/III trial comparing salvage SBRT with standard of care (SOC) regimens for patients with a persistent detectable PSA or biochemical progression during follow-up after radical prostatectomy.

Primary Outcome Measures: SBRT impact on patient-reported GI and GU symptoms, two-year change score from baseline for the urinary and bowel domain of the EPIC-26. The EPIC-26 is a validated instrument that measures health-related quality of life across 5 PCa-specific domain. 0-100 scale., 2 years post treatment
Secondary Outcome Measures: Patient Reported Outcomes, Patient-reported outcomes according to the different

* EPIC-26 domains (0-100)
* IPSS score (0-35)
* EQ-5D-5L scores (five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression), at end of RT and following time-points counted from start of RT : 4-7 weeks (only in experimental arm), 3 months, 6 months, 1 year and yearly up to 5 years|Ccost-utility during radiotherapy, Cost-utility analysis based on EQ-5D-5L (five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression)versus costs of RT and transportation during radiotherapy, during radiotherapy|Physician-scored toxicity, Physician-scored toxicity according to CTCAE 5.0 (grades) (Early: within 90 days; or late: 90 or more days after SBRT). Proportion of patients with G2+ toxicity will be reported specifically., up to 5 years|Blood lymphocyte evolution between study arms, Lymphocyte count nadir relative to baseline, 5 years|To compare biochemical progression-free survival (bPFS) to historical control and between study arms, Biochemical progression-free survival (bPFS), 5 years|To compare local and regional recurrences between study arms, up to 5 years., Local and regional control, 5 years|To compare Overall survival (OS) between study arms, up to 5 years., Overall survival (OS), 5 years|To compare distant metastases-free survival (dmFS) between study arms, Distant metastases-free survival (dmFS)., 5 years
Evaluation of the Pharmacokinetic Drug-drug Interactions Between VX-993 and Metformin in Healthy Adults
NCT Number: NCT06523595
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Pain
Interventions: DRUG: VX-993|DRUG: Metformin
Sponsor: Vertex Pharmaceuticals Incorporated
Sex: ALL
Age: ADULT
Enrollment: 32
Study Design: Allocation: NA|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-31
Completion Date: 2024-09
Locations: ICON Salt Lake City, Salt Lake City, Utah, 84124, United States

Summary:
The purpose of this study is to evaluate the pharmacokinetic drug-drug interactions, safety, and tolerability of co-administration of VX-993 and metformin in healthy participants.

Primary Outcome Measures: Maximum Observed Plasma Concentration (Cmax) of Metformin in Absence and Presence of VX-993, From Day 1 up to Day 14|Area Under the Concentration Versus Time Curve for the Last Measurable Concentration (AUClast) of Metformin in Absence and Presence of VX-993, From Day 1 up to Day 14|Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of Metformin in Absence and Presence of VX-993, From Day 1 up to Day 14
Secondary Outcome Measures: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs), From Day 1 up to Day 29|Renal Clearance (CLr) of Metformin in the Presence and Absence of VX-993, From Day 1 up to Day 14|Metformin Fraction Excreted Unchanged (fe) in Urine in the Presence and Absence of VX-993, From Day 1 up to Day 14
Mobile Health Interventions to Prevent Heart Disease After Hypertensive Disorders of Pregnancy
NCT Number: NCT06523569
Acronym: mHEART
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hypertension in Pregnancy|Pre-Eclampsia|Eclampsia|Gestational Hypertension
Interventions: OTHER: Remote patient monitoring (RPM) system|OTHER: Mobile health application
Sponsor: Northwestern University
Collaborators: Friends of Prentice|Northwestern Senior Faculty Academy
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 120
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-08-01
Completion Date: 2026-06-30

Summary:
The purpose of this research is to study digital health interventions to prevent cardiovascular disease in individuals who have had a hypertensive disorder of pregnancy (HDP).

Primary Outcome Measures: Systolic blood pressure, All participants will have systolic blood pressure measured at 3 months and 12 months postpartum, 3 months postpartum; 12 months postpartum
Secondary Outcome Measures: Weight, All participants will have weight measured at 3 months and 12 months postpartum, 3 months postpartum; 12 months postpartum|Subclinical cardiovascular dysfunction via echocardiography, All participants will have echocardiography performed at 3 months and 12 months postpartum to assess subclinical cardiovascular dysfunction, 3 months postpartum; 12 months postpartum|Study feasibility, The investigators will assess study feasibility (% enrolled in digital health intervention) at the end of the study, 12 months postpartum|Participant engagement, The investigators will assess participant engagement (% continuing to actively use digital health interventions) at the end of the study, 12 months postpartum|Anti-hypertensive medication use (%), The investigators will assess participant anti-hypertensive medication use (%) at 3 months and 12 months, 3 months postpartum; 12 months postpartum
Ultra-early Identification of Fetal Chromosomal Characteristics From Extravillous-trophoblast Cells
NCT Number: NCT06523543
Acronym: CellF-Cervix
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Pregnant Women
Interventions: PROCEDURE: Inclusion (Visit 1 - Week 7-16)|DIAGNOSTIC_TEST: Second semester of pregnancy (Visit 2 - Week 20-24)|DIAGNOSTIC_TEST: Third semester of pregnancy (Visit 3- Week 34)
Sponsor: University Hospital, Montpellier
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 25
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-01
Completion Date: 2027-09-01
Locations: CHU de Montpellier, Montpellier, 34295, France

Summary:
Demonstrate the efficacy of an ultra-early, non-invasive prenatal diagnostic method adaptable to various genetic indications to detect fetal chromosomal abnormalities.

Primary Outcome Measures: Establish an ultra-early detection method, Collect fetal phenotypic data obtained during the second or the 3rd trimester via ultrasound echography, Visit 2 (Week 20-24)
Secondary Outcome Measures: Evaluate the ability of the method to provide a result in the context of a progressive pregnancy, * Time (minutes) elapsed between sampling and biological validation of the result
* Number of trophoblast cells identified
* Failure rate: number of samples for which biological signals were not successful to determine the fetal chromosomal sex, Visit 2 (Week 20-24)|Expected benefit of ultra-early cytogenetic information, Evaluate the ability of the method to provide a rapid result and evaluate the impact of information about pregnant women, Visit 2 (Week 20-24)
Efficacy and Safety of Eliglustat in Chinese Pediatric Patients With Gaucher Disease Type 1 and Type 3
NCT Number: NCT06523517
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Gaucher Disease
Interventions: DRUG: Eliglustat Tartrate Capsules
Sponsor: Peking Union Medical College Hospital
Sex: ALL
Age: CHILD, ADULT
Enrollment: 5
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2025-07-31
Locations: Peking union medical college hospital, Beijing, China

Summary:
Primary Objective:

Evaluate the efficacy and safety of eliglustat in Chinese pediatric patients (≥12 to \<18 years old) with Gaucher disease type 1 and type 3.

Secondary Objective:

Evaluate the quality of life in Chinese pediatric patients (≥12 to \<18 years old) with Gaucher disease type 1 and type 3 treated with eliglustat.

Primary Outcome Measures: Changes in hemoglobin level, Absolute change from baseline for hemoglobin (g/dL), Baseline, Weeks 13, 26, 39 and 52|Changes in platelet count, Percent change from baseline for platelet count, Baseline, Weeks 13, 26, 39 and 52|Changes in spleen volume, Percent change from baseline for spleen volume, Baseline, Weeks 26 and 52|Changes in liver volume, Percent change from baseline for liver volume, Baseline, Weeks 26 and 52|Changes in Lyso-GL1 level, Percent change from baseline for Lyso-GL1 level, Baseline, Weeks 13, 26, 39 and 52|Skeletal improvement, Proportion of patients with improvement in skeletal disease, Baseline, Weeks 26 and 52|Assessment of pharmacokinetic (PK) parameter of eliglustat: Cmax, Peak concentration (Cmax) of eliglustat in plasma (ng/mL), Baseline, Weeks 2, 13, 26 and 52|Assessment of pharmacokinetic (PK) parameter of eliglustat: Ctrough, Trough concentration (Ctrough) of eliglustat in plasma (ng/mL), Baseline, Weeks 2, 13, 26 and 52|Adverse events, Number of adverse events in pediatric patients, Up to Week 52
Secondary Outcome Measures: Changes in Quality of Life, Health-related quality of life will be measured by the Pediatric Quality of Life Inventory™ (PedsQL™) questionnaires, Baseline and Week 52
Atropine (0.02%, 0.04%) Combined With Defocus DIMS for Moderate and High Myopia Control
NCT Number: NCT06523504
Acronym: atropine
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Myopia
Interventions: DEVICE: DIMS|DRUG: The 0.02% ATP Group|DRUG: The 0.04% ATP Group|COMBINATION_PRODUCT: 0.02%ATP+DIMS|COMBINATION_PRODUCT: 0.04%ATP+DIMS
Sponsor: Ruihua Wei
Collaborators: Beijing Tongren Hospital
Sex: ALL
Age: CHILD
Enrollment: 410
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-02-01
Completion Date: 2026-03-31
Locations: Tianjin Medical University Eye Hospital, Tianjin, Tianjin, 120120, China

Summary:
To evaluate the effectiveness and safety of DIMS, low concentration atropine eye drops,and atropine combined with DIMS in controlling axial length and refraction in children with moderate to high myopia.

Primary Outcome Measures: Best Corrected Visual Acuity, Best Corrected Visual Acuity, up to 24 months
Statin Combined With Amlodipine Treats Primary Aldosteronism
NCT Number: NCT06523465
Acronym: STOP-PA
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Primary Aldosteronism|Statin|Mineralocorticoid Receptor Antagonist|Hypertension
Interventions: DRUG: Simvastatin combined with Amlodipine besylate|DRUG: Simvastatin combined with Spironolactone and Amlodipine besylate.|DRUG: Amlodipine besylate combined Spironolactone
Sponsor: Third Military Medical University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 180
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2026-07-30

Summary:
The drug treatment for primary aldosteronism (PA) is limited and difficult to improve long-term cardiovascular outcomes. This study plans to enroll patients with primary aldosteronism and randomly divide into 3 groups: scheme 1: Statin combined with amlodipine besylate, scheme 2: Statin combined with Spironolactone and Amlodipine besylate. scheme 3: Amlodipine besylate combined with Spironolactone , to observe the changes in plasma aldosterone level, 24-hour urinary aldosterone, blood pressure, and long-term cardiovascular risk.

Primary Outcome Measures: changes in plasma aldosterone levels, blood samples are collected at baseline and 6 months after treatment to measure plasma aldosterone levels， and compare between groups and within groups (pg/ml), 6 month|changes in 24-hour urinary aldosterone levels, 24 hours urine are collected at baseline and 6 months after treatment to measure 24-hour urinary aldosterone， and compare between groups and within groups(pmol/24h), 6 month
Secondary Outcome Measures: changes in office blood pressure and home blood pressure, Record office blood pressure at baseline and at follow-up after medical treatment (mmHg), and compare between groups and within groups, 6 month|changes in serum potassium levels, blood samples are collected at baseline and 6 months after treatment to measure serum potassium levels， and compare between groups and within groups (mmol/L), 6 month|changes in serum renin level, blood samples are collected at baseline and 6 months after treatment to measure serum renin levels, and compare between groups and within groups (mU/L), 6 month|changes in plasma cholesterol levels, blood samples are collected at baseline and 6 months after treatment to measure plasma cholesterol levels， and compare between groups and within groups (mmol/L), 6 month|changes in blood glucose, blood samples are collected at baseline and 6 months after treatment to measure blood glucose， and compare between groups and within groups (mmol/L), 6 month
Accelerated Intermittent Theta Burst in Treatment-Naive Adolescents
NCT Number: NCT06523439
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Major Depressive Disorder|Depression in Adolescence|Depression|Major Depressive Episode
Interventions: DEVICE: MagPro X100 edition (MagVenture, Skovlunde, Denmark)|DEVICE: MagPro X100 edition (MagVenture, Skovlunde, Denmark)
Sponsor: University of Texas at Austin
Collaborators: Magnus Medical
Sex: ALL
Age: CHILD, ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2026-09

Summary:
This is a single-site open-label clinical trial of the Stanford Accelerated Intermittent Neuromodulation Therapy (SAINT®) protocol. The goal of this clinical trial is to learn if a new form of transcranial magnetic stimulation (TMS)-known generally as accelerated intermittent theta burst stimulation (aiTBS) and specifically as SAINT®-is effective as a first-line therapy in treating adolescents aged 14-19 years-old in their first episode of depression who have not undergone a full course of depression treatment prior to starting the trial and who remain antidepressant-free throughout the trial.

The main questions this trial aims to answer are:

* Does SAINT® relieve symptoms of depression as a first-line therapy in adolescents?
* Is SAINT® a feasible option as a first-line treatment for adolescent depression?

Researchers will measure the depression symptoms in adolescent participants before and after SAINT®. Parents of the adolescent participant will also participate in the study providing information about their experience and preference for TMS as a first-line treatment.

Adolescent participants will:

* Remain antidepressant-free throughout the study period of 6-7 weeks.
* Receive an MRI of their head for precision targeting
* Receive 5 days of aiTBS (SAINT®)

Primary Outcome Measures: Childhood Depression Rating Scale-Revised (CDRS-R) Remission Rates, Seventeen item diagnostic questionnaire which psychiatrists use to measure the severity of depressive symptoms in adolescents with depression.

The investigators will assess the difference in CDRS-R scores/remission rates between Standard SAINT® group compared to those who received Truncated SAINT® at the one-month follow up visit., Baseline, One Month Follow Up Visit|Childhood Depression Rating Scale-Revised (CDRS-R) Remission Rates, The investigators will assess the difference in CDRS-R response rates (reduction \>50% of CDRS-R baseline score) between the Standard SAINT® group compared to those who received Truncated SAINT®., Baseline, One Month Follow Up Visit
Ambulatory Geriatric Endoscopic Spine
NCT Number: NCT06523426
Acronym: AGES
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Lumbar Decompression
Interventions: DIAGNOSTIC_TEST: Patient treated by spinal endoscopy
Sponsor: University Hospital, Bordeaux
Sex: ALL
Age: OLDER_ADULT
Enrollment: 50
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07
Completion Date: 2026-12
Locations: Cliniques Terrefort Bordeaux-Bruges, Bruges, 33520, France|Clinique Saint Jean - Sud de France, Saint-Jean-de-Védas, 24430, France|Clinique Saint Jean - Sud de France, Saint-Jean-de-Védas, 24430, France

Summary:
The research focuses on evaluating the clinical outcomes of endoscopic lumbar decompression surgery performed in an outpatient setting for patients over 75 years old. This prospective, multicentric, non-interventional study aims to assess the feasibility and effectiveness of endoscopic techniques, specifically biportal and uniportal approaches, in reducing operative morbidity and hospital stay duration within this demographic. The primary objective is to determine the success rate of outpatient treatment using these endoscopic procedures in elderly patients

Primary Outcome Measures: Success of outpatient care : Number of patient with convention hospitalization or readmission after endoscopic surgery, The success of ambulatory management is the number of patients for whom an indication for endoscopic surgery is given and performed without the need for conventional hospitalization secondary to surgery, or readmission within 30 days of surgery, 3 months visit
Secondary Outcome Measures: Evaluation of Treatment Efficacy, Evolution of perceived health scores specific to the treated pathology. ODI (Oswestry Disability Index) is a self-questionnaire with 10 items. Each question is rated from 0 to 5 and total score that varies from 0 to 50, Inclusion visit, 3 months visit|Evaluation of Treatment Safety, Number of serious medical complications, Inclusion visit, 3 months visit|Evaluation of Treatment Safety, Number of surgical site infections., Inclusion visit, 3 months visit|Evaluation of Treatment Safety, Number of mechanical complications., Inclusion visit, 3 months visit|Evaluation of Treatment Safety, Number of neurological complications., Inclusion visit, 3 months visit|Evaluation of Treatment Safety, Number of surgical re-interventions., Inclusion visit, 3 months visit|Evaluation of Treatment Efficacy, Evaluation of quality of life by self-questionnaire EQ-5D-5L, Inclusion visit, 3 months visit|Evaluation of Treatment Efficacy, Evaluation of geriatric autonomy by IADL., Inclusion visit, 3 months visit|Evaluation of Treatment Efficacy, Evaluation of quality of life by self-questionnaire ODI, Inclusion visit, 3 months visit|Evaluation of Treatment Efficacy, Evaluation of quality of life by self-questionnaire SF-36, Inclusion visit, 3 months visit
Online Pivotal Response Treatment Training in Autism Spectrum Disorder
NCT Number: NCT06523387
Acronym: PRT-O
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Autism Spectrum Disorder|Autism
Interventions: BEHAVIORAL: Pivotal Response Treatment Online (PRT-O) Course
Sponsor: Stanford University
Sex: ALL
Age: CHILD
Enrollment: 44
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-15
Completion Date: 2027-12-30
Locations: Stanford University, Stanford, California, 94305-5719, United States

Summary:
This is a research study that will assess the effects of a Pivotal Response Treatment Online Training Course (PRT-O) for training parents of children with Autism Spectrum Disorder (ASD). The study will specifically investigate whether participants can learn to deliver PRT effectively following participation in the Online training.

Primary Outcome Measures: Change from Baseline on Parent Fidelity of Pivotal Response Treatment Implementation as measured on the Home Video Observation (HVO), Parent Fidelity of Pivotal Response Treatment Implementation will be rated from 10 min HVO by trained coders naïve to treatment assignment and timepoint using established operational definitions from prior PRT studies (e.g., Hardan et al., 2015; Gengoux et al., 2019)., 6 Weeks and 12 Weeks|Change from Baseline on Child Functional Verbal Utterances as measures on the Home Video Observation (HVO), Child Functional Verbal Utterances will be rated from 10 min HVO by trained coders naïve to treatment assignment and timepoint using established operational definitions from prior PRT studies (e.g., Hardan et al., 2015; Gengoux et al., 2019)., 6 Weeks and 12 Weeks
Secondary Outcome Measures: Change from Baseline on the Clinical Global Impression Scales (CGI), 6 Weeks and 12 Weeks|Change from Baseline on the Vineland Adaptive Behavior Scales -3 (VABS-3) Communication Domain, 12 Weeks|Change from Baseline on the MacArthur-Bates Communication Scales (CDI), 12 Weeks
Other Outcome Measures: Change from Baseline on the Stanford Social Dimension Scale (SSDS), 12 Weeks|Change from Baseline on the Parent Stress Index (PSI), 12 Weeks|Change from Baseline on the Dimensional Assessment of Repetitive Behavior Scale (DARB), 12 Weeks|Change from Baseline on the Neurobehavioral Evaluation (NET) Tool, 12 Weeks
Ultrasound of the Quadriceps Femoris Compared With the Clinical Frailty Scale
NCT Number: NCT06523348
Acronym: QUADRI-REA
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Frailty|Intensive Care Unit Syndrome
Interventions: DIAGNOSTIC_TEST: quadricipital muscle ultrasound
Sponsor: University Hospital, Toulouse
Sex: ALL
Age: OLDER_ADULT
Enrollment: 70
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-01
Completion Date: 2025-11-01

Summary:
This is a single-centre prospective diagnostic study. When a patient is admitted to the inclusion centre, the clinician responsible for the patient checks the inclusion and exclusion criteria. The no objection from the patient (or their trusted support person or, failing that, a close if the patient is unable to give consent) is sought.The CFS scale is completed and recorded by the clinician in the observation observation notebook.The clinician performs a quadricipital muscle ultrasound, specifically for research purposes, with no changes to the therapeutic and its results are recorded in the observation notebook.

observation notebook.At 3 months after inclusion, information was collected from the medical records to identify secondary endpoints.

Translated with DeepL.com (free version)

Primary Outcome Measures: Bilateral ultrasound depth of the quadriceps femoris muscle, Bilateral ultrasound depth of the quadriceps femoris muscle: The ultrasound consists of 3 measurements per side of the thickness of the rectus femoris muscle. The ultrasound loops will be recorded on an ultrasound machine (GE) after anonymisation.

The images will be analysed a posteriori by the principal investigator and the associate investigators, experts in ultrasound analysis of this muscle., 24 hours
Improving Independent Multi-joint Arm Control After Stroke
NCT Number: NCT06523335
Acronym: NICE
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Stroke
Interventions: OTHER: Neuromuscular coordination-guided rehabilitative training|OTHER: Force strengthening-guided rehabilitative training
Sponsor: University of Houston
Collaborators: UT Health Houston|Korea Advanced Institute of Science and Technology
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 74
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2029-09-01
Locations: University of Houston, Houston, Texas, 77204, United States

Summary:
The purposes of this study include:

1. - To identify whether features of aberrant intermuscular coordination patterns can be used to predict motor impairment after stroke.
2. - To test whether muscle synergies are malleable to a non-invasive EMG-guided exercise that induces changes in intermuscular coordination of upper extremity muscles after stroke.

Primary Outcome Measures: Change in Fugl-Meyer Assessment (FMA) score, To measure severity of motor impairment after stroke, FMA will be performed in the human upper extremity. FMA is commonly used to assess severity of motor impairment and motor recovery. The maximum FMA upper extremity motor score is 66 (i.e., 0: complete motor impairment; 66: normal motor performance). Each item is scored on a 3-point scale (0 = cannot perform, 1 = performs partially, 2 = performs fully)., before any training, after the 6 weeks of training, respectively, and 1 and 3 months after the last training session, respectively|Change in Action Research Arm Test (ARAT) score, To measure motor function after stroke, ARAT will be performed in the human upper extremity. 19 Items comprising the ARAT are categorized into four subscales (grasp, grip, pinch, and gross movement) and arranged in order of decreasing difficulty, with the most difficult task examined first, followed by the least difficult task. Task performance is rated on a 4-point scale, ranging from 0 (no movement) to 3 (movement performed normally)., before any training, after the 6 weeks of training, respectively, and 1 and 3 months after the last training session, respectively|Change in intermuscular coordination patterns, EMGs will be recorded from 12 muscles. To assess whether muscle-synergy guided and/or force-guided exercise induce changes in the composition of intermuscular coordination patterns, non-negative matrix factorization will be applied to EMGs to identify and compare ICoPs., before any training, after the 6 weeks of training, respectively, and 1 and 3 months after the last training session, respectively
Secondary Outcome Measures: Brain imaging data recording, A non-invasive electroencephalography (EEG) measurement setup will be employed to collect the EEG signal, specifically, thirty-two EEG electrodes will be placed on the scalp, and EEG signals will be measured during an isometric assessment., before any training, after the 6 weeks of training, respectively, and 1 and 3 months after the last training session, respectively
Electroacupuncture Treatment of Behavioral and Psycological Symptoms in Patients With Alzheimer's Disease
NCT Number: NCT06523309
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: BPSD (Behavioral and Psycological Symptoms of Dementia)|Alzheimer's Dementia
Interventions: OTHER: Electroacupuncture treatment
Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 1000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-30
Completion Date: 2027-10-31
Locations: Beijing United Family Rehabilitation Hospital, Beijing, Beijing, 100015, China|China-Japan Friendship Hospital, Beijing, Beijing, 100029, China|Guang'anmen Hospital of China Academy of Chinese Medical Sciences, Beijing, Beijing, 100053, China|Xuanwu Hospital of Capital Medical University, Beijing, Beijing, 100053, China|Beijing Geriatric Hospital, Beijing, Beijing, 100095, China|Fujian University of Traditional Chinese Medicine, Fuzhou, Fujian, 350122, China|The Second Affiliated Hospital of Heilongjiang University of Chinese Medicine, Ha'erbin, Heilongjiang, 150001, China

Summary:
This study aims to establish a prospective case registration research platform for electroacupuncture in treating behavioral and psychological symptoms in patients with mild to moderate Alzheimer's disease, and to investigate the dose-effect relationship and cost-effectiveness of electroacupuncture for these symptoms.

Primary Outcome Measures: Neuropsychiatric Inventory (NPI), NPI is used to evaluate neuropsychiatric behavioral symptoms of dementia patients. The scale assesses the neuropsychiatric disorders of patients according to the caregiver's view of the patient's behavior and the corresponding distress felt by the patient. The scoring range of the patient evaluation scale is 0-144 points, and the scoring of the caregiver distress scale is 0-60 points, the lower the score is, the better the patient's condition is., NPI will be performed before treatment and every month after treatment for up to 24 months|Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC), ADCS-CGIC is a global rating of change developed to assess clinically significant change in symptoms over time in AD clinical trials. Clinicians rate patient symptoms on the ADCS-CGIC as: very much improved (1), much improved (2), minimally improved (3), no change (4), minimally worse (5), much worse (6), and very much worse (7) compared to baseline symptoms., The ADCS-CGIC will be performed before treatment and every 2 month after treatment for up to 24 months
Presence of Anti-RACH Antibodies and Neurocognitive Disorder in Myasthenic or Alzheimers's Patients.
NCT Number: NCT06523296
Acronym: ARN-MA
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Alzheimer Disease|Myasthenia
Interventions: PROCEDURE: Adults with Alzheimer's disease|PROCEDURE: Adults with Myasthenia|OTHER: Healhty controls
Sponsor: Centre Hospitalier Universitaire de Nice
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-10-01
Completion Date: 2026-11-01
Locations: CHU de Nice, Nice, Alpes Maritimes, 06000, France

Summary:
The purpose of the study is to evaluate if there is a specific association between the presence of anti Rach antibodies in the CSF and the presence of a cogntive disorder in myasthenic patients. Moreover the investigator wants to study if there is a link between the presence of Anti RACH antibodies in myasthenia and Alzheimers's disease.

For that, the investigator will recruit myasthenic patient with cognitive disorder that has undergo a diagnostic process including lombar punction for memory trouble in Nice memory center as well as Alzheimer's patient having go through the same process.

The study will consist in one additionnal blood draw. Anti RACH antibodies will be analyzed in historical CSF stored in biocollection and serum collected for the study.

LCS of healthy control will also be analyzed.

Primary Outcome Measures: Correlation between the levels of RACH antibodies detected in the serum and cereborspinall liquid and the clinical scores, at day 0
Secondary Outcome Measures: Measurement of RACH antibodies in serum, dosage by ELISA method of RACH antibodies, at day 0|Measurement of RACH antibodies in cerebrospinal liquid, dosage by ELISA method of RACH antibodies, at day 0
Advanced Imaging Holistic Omics Biobank
NCT Number: NCT06523270
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Oncologic Disorders|Neurologic Disorder|Pulmonary Disease|Cardiovascular Diseases
Interventions: RADIATION: Computed Tomography (CT) using Photon Counting CT scanner (Neaotom Alpha, Siemens) and Magnetic Resonance (MRI)
Sponsor: IRCCS San Raffaele
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-15
Completion Date: 2034-09-15

Summary:
Imaging methods today represent the pillar of prevention, diagnosis, patients monitoring and treatment. Improvement in technology led the development of increasingly high-performance scanners whose potential has not yet been fully explored. In particular, recently introduced photon counting CT scanner and new high filed MRI offers a lake of latent information derived from the images (e.g. spectral data from CT) of potentially great interest and potentially able to provide new insight but that are currently mostly unexplored .These features are also called "opportunist features" because they are in each exam and can be freely derived from images without changing the study protocol used for clinical practice examination but extracted a posteriori from the images representing a precious source of deep characterization of the patients, equally or even more than a genomic analysis, with possible high relevance in the field of screening and prevention, being able to contribute to defining signatures indicating a particular risk of remotely developing a specific pathological condition. The prospective collection of clinical and imaging data from subjects undergoing diagnostic tests with advanced technology has the potential to increase knowledge of the pathophysiological mechanisms of different pathological conditions, to explore and validate the diagnostic-predictive value of opportunistic features not currently used in practice clinical, to increase the diagnostic and prognostic accuracy of CT and MRI examinations and to provide a unique pool for scientific research. Previous relevant experience was conducted in the United Kingdom (UK biobank) where data from over 500,000 patients have been collected in the last 10 years, providing an enormous pool for spontaneous and funded scientific research. This project (UK biobank), although of enormous scientific value, is currently obsolete in terms of the imaging technology used.

Primary Outcome Measures: a large scale multiomics archive of patients submitted to advanced imaging studies to support a wide range of research intended to identify imaging signature able to improve the prevention, diagnosis and treatment of disease, Follow-up collection yearly for 10 years
Comparing Photodisinfection of Chitosan NP Enriched ICG Over ICG as Adjunct to OFD: RCT
NCT Number: NCT06523244
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Periodontal Pocket
Interventions: PROCEDURE: PHOTODYNAMIC THERAPY
Sponsor: Krishnadevaraya College of Dental Sciences & Hospital
Sex: ALL
Age: ADULT
Enrollment: 24
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-07
Completion Date: 2025-08

Summary:
The current study is a prospective randomised study-Comparison of photodisinfection with chitosan nanoparticles enriched indocyanine green over indocyanine green as an adjunct to open flap debridement in the management of stage II/III grade B/C periodontitis.

Primary Outcome Measures: MICROBIAL ANALYSIS, LEVELS OF P. GINGIVALIS, 3 MONTHS
A Clinical Trial to Investigate the Efficacy of a Supplement to Improve and Maintain Cognitive Function and Memory
NCT Number: NCT06523218
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cognitive Decline|Cognitive Function
Interventions: DIETARY_SUPPLEMENT: MindMD Supplement|OTHER: Placebo
Sponsor: Scale Media Inc
Collaborators: Citruslabs
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-05-17
Completion Date: 2024-08-17
Locations: Citruslabs, Santa Monica, California, 90404, United States

Summary:
This study will evaluate the efficacy of 1MD Nutrition's MindMD supplement in improving and maintaining cognitive function and memory. The randomized controlled trial will include 50 healthy participants aged 50-75 years, lasting for 3 months. Participants will be randomized to receive either the test product or a placebo.

Primary Outcome Measures: Cognitive Function and Memory Improvement, Measurement of cognitive function and memory through Cognitive Battery Testing. The Cognitive Battery Testing includes assessments such as Polygons, Double Trouble, Feature Match, Paired Associates, Digit Span, and Spatial Planning. These assessments provide objective measurements of various cognitive functions, including processing speed, memory recall, selective attention, and executive function., Baseline, Month 2, and Month 3
Secondary Outcome Measures: Participants' Perceptions of Cognitive Function and Memory using the Cognitive Function Questionnaire, Evaluation of participants' self-reported perceptions of the effect of the MindMD supplement on cognitive function and memory. This includes aspects such as focus and attentiveness, comprehension and mental clarity, learning acuity, absentmindedness, and overall quality of life. These perceptions will be measured through the Cognitive Function Questionnaire (CFQ) at specified time points: Baseline (Day 0), Month 1, Month 2, and Month 3., Baseline, Month 1, Month 2, and Month 3|Participants' Quality of Life, Assessment of participants' quality of life using the WHO-5 Well-Being Index. These assessments will be conducted at Baseline (Day 0), Month 1, Month 2, and Month 3., Baseline, Month 1, Month 2, and Month 3|Participants' Focus and Attentiveness, Evaluation of participants' focus and attentiveness using the Visual Analog Scale (VAS). These assessments will be conducted at Baseline (Day 0), Month 1, Month 2, and Month 3., Baseline, Month 1, Month 2, and Month 3
Relationships Between Tenascin C, Smoking and Periodontal Status
NCT Number: NCT06523205
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Periodontitis|Smoking|Periodontal Diseases
Interventions: DIAGNOSTIC_TEST: Clinical Measurements and Saliva Sample Collection
Sponsor: Necmettin Erbakan University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-01
Completion Date: 2024-09-15

Summary:
The goal of this observational study is to determine if there is a relationship between different periodontal conditions (gingival healthy, stage 2 grade B, stage 2 grade C, stage 3 grade B, stage 3 grade C) and the levels of tenascin C, IL-1 beta, IL-4, and IL-6 in saliva samples from smokers and non-smokers. The main questions it aims to answer are:

Is there a difference in the levels of tenascin C, IL-1 beta, IL-4, and IL-6 between smokers and non-smokers with different periodontal conditions? Do these biomarkers correlate with the severity and grade of periodontal disease?

Researchers will compare the saliva samples from smokers and non-smokers across the different periodontal conditions to see if there are significant differences in the biomarker levels. Participants will:

Provide saliva samples. Be categorized based on their smoking status and periodontal condition.

Primary Outcome Measures: 1.Periodontal clinical parameters (plaque index (PI) and gingival index (GI)), The measurements will be performed using a Williams periodontal probe (Hu-Friedy, Chicago, IL, USA) and will include plaque index (PI) and gingival index (GI) at six sites per tooth (mesio-buccal, buccal, disto-buccal, mesio-lingual, lingual and disto-lingual) on each tooth.

Gingival Index (GI) Unit: Numerical score Plaque Index (PI) Unit: Numerical score, baseline|Periodontal clinical parameters (percentage bleeding on probing (BOP)), The measurements will be performed using a Williams periodontal probe (Hu-Friedy, Chicago, IL, USA) and will include percentage bleeding on probing (BOP) at six sites per tooth (mesio-buccal, buccal, disto-buccal, mesio-lingual, lingual and disto-lingual) on each tooth.

Percentage Bleeding on Probing (BOP) Unit: Percentage (%), baseline|Periodontal clinical parameters (Clinical Attachment Level (CAL) and Probing Pocket Depth (PPD)), The measurements will be performed using a Williams periodontal probe (Hu-Friedy, Chicago, IL, USA) and will include probing pocket depth (PPD) and clinical attachment level (CAL) at six sites per tooth (mesio-buccal, buccal, disto-buccal, mesio-lingual, lingual and disto-lingual) on each tooth.

Clinical Attachment Level (CAL) Unit: Millimeters (mm) Probing Pocket Depth (PPD) Unit: Millimeters (mm), baseline|Levels of Tenascin C, IL-1β, IL-4 and IL-6 saliva samples, Levels of Tenascin C, IL-1β, IL-4 and IL-6 saliva samples (ng/L)

Unit: Picograms per milliliter (pg/mL)

Tenascin C, IL-1β, IL-4 and IL-6 levels will be assayed with commercially available kits using the enzyme-linked immunosorbent assay (ELISA) method., baseline
Validation of the English Version of the Drug Hypersensitivity Quality of Life Questionnaire
NCT Number: NCT06523192
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Drug Hypersensitivity|Quality of Life
Interventions: OTHER: Questionnaires
Sponsor: University Hospitals, Leicester
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 146
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-03-21
Completion Date: 2024-05-01
Locations: UNiversity Hospitals Leicester, Leicester, LE39QP, United Kingdom

Summary:
We aim to validate the English (UK) translation of the DrHy-Q, and test its reliability in the UK population. This will facilitate for the subsequent economical evaluation of penicillin allergy delabelling.

This research project is part of an MSc in Allergy undertaken by the principal applicant, Dr Patricia Romero, supervised through Imperial College London.

Target population are patients with a drug allergy diagnosed by an Allergist prospectively at the Drug Allergy Clinic.

Is the English version of the Drug Hypersensitivity Quality of Life Questionnaire suitable to be used in the UK population?

Primary Outcome Measures: Validation of the English version of the Drug Hypersensitivity Questionnaire, Reliability and validity, March 2023 May 2024
Evaluation of Risk of hEpatocellular Carcinoma
NCT Number: NCT06523179
Acronym: PERSPECTIVE
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: NASH|HCC|Genetic Predisposition
Interventions: OTHER: quantify the impact of genetic risk factors
Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 500
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2018-01-01
Completion Date: 2025-12
Locations: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Istituto di Ricovero e Cura a Carattere Scientifico di natura pubblica, Milan, Milano, 20122, Italy

Summary:
Hepatocellular carcinoma (HCC) is the fifth most common solid cancer and the second cause of cancer-related mortality worldwide. Nonalcoholic fatty liver disease (NAFLD), that is hepatic accumulation of fat in excess of 5% not explained by at risk alcohol intake, is projected to become the leading cause of HCC in Western countries within 2025.NAFLD is most frequently caused by insulin resistance due to unhealthy lifestyle. Due to the epidemics of obesity and type 2 diabetes, NAFLD now affects one in three individuals worldwide.

NAFLD-HCC frequently develops without overt cirrhosis suggesting that steatosis directly promotes hepatic carcinogenesis.

Primary Outcome Measures: The quantify the impact of genetic risk factors for NAFLD-HCC and their interaction, The different inclusion criteria are able to identify the number of individuals at risk for NAFLD-HCC among patients with NAFLD following up, Understand the impact of individual genetic variants on HCC risk and rates of patients hosting gene mutations in evolving fat accumulation in liver (global cohorts and according to enrolment criteria), up to 84 months|The quantify the impact of genetic risk factors for NAFLD-HCC and their interaction, The impact of genetic risk factors for NAFLD-HCC and their interaction will be realized by evaluating the interaction with risk factors and developing a score to predict NAFLD-HCC. These elements will enable us to select patients for whom screening can be effective., up to 84 months
A Study of the Investigational Monoclonal Antibody, VYD2311, in Healthy Participants
NCT Number: NCT06523153
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: COVID-19
Interventions: BIOLOGICAL: VYD2311|OTHER: Placebo
Sponsor: Invivyd, Inc.
Collaborators: Novotech (Australia) Pty Limited
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: OTHER
Start Date: 2024-08
Completion Date: 2025-04
Locations: Invivyd Investigative Site, Joondalup, Western Australia, Australia

Summary:
A study to investigate the safety, tolerability, and pharmacokinetics of a SARS-CoV-2-directed monoclonal antibody in healthy participants

Primary Outcome Measures: Incidence of TEAEs (including AEs and SAEs), Through Month-6 visit
Secondary Outcome Measures: PK parameter of VYD2311, AUC0-inf (area under the concentration-time curve from time 0 extrapolated to infinity), Through Month-6 visit|PK parameter of VYD2311, AUClast (area under the concentration-time curve from time 0 to the last quantifiable concentration), Through Month-6 visit|PK parameter of VYD2311, AUC0-t (area under the concentration-time curve from time 0 to t), Through Month-6 visit|PK parameter of VYD2311, Cmax (maximum serum concentration), Through Month-6 visit|PK parameter of VYD2311, Tmax (time to reach maximum serum concentration), Through Month-6 visit|PK parameter of VYD2311, CL (clearance), Through Month-6 visit|PK parameter of VYD2311, t1/2 (half-life), Through Month-6 visit|PK parameter of VYD2311, Vss (apparent volume of distribution at steady state), Through Month-6 visit|PK parameter of VYD2311, Vz (apparent volume of distribution during terminal phase), Through Month-6 visit|Incidence of ADAs against VYD2311, Through Month-6 visit
Withholding of Life-sustaining Treatment and Quality of Life After Severe Acute Brain Injury: Qualitative Analysis and Ethical Issues
NCT Number: NCT06523127
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Quality of Life|Brain Injuries|Post ICU
Interventions: OTHER: Recording data from the ICU stay and the post-ICU follow-up.
Sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 14
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-03
Completion Date: 2024-09
Locations: Centre Hospitalier Universitaire de Saint Etienne, Saint Etienne, 42055, France

Summary:
Withdrawal of life-sustaining treatment affects 10-15% of ICU patients, including those with severe acute brain injury, whose care appears futile in terms of prognosis based on clinical and paraclinical data, expected quality of life, patient preferences, age, or reduced quality of life.

There are few studies on withholding treatment compared with withdrawing treatment, and even fewer on survivors after a decision to withhold treatment.

Quality of life is defined by WHO as "an individual's perception of his or her position in life in the context of the culture and value systems in which he or she lives and in relation to his or her goals, expectations, standards and concerns". The relationship between quality of life and neurological outcome after severe acute brain injury is controversial and therefore difficult to predict.

That's why the investigators question the legitimacy of making decisions to withhold treatment from patients with severe acute brain injury based on their expected quality of life, when this prediction is uncertain.

Primary Outcome Measures: Interpretative Phenomenological Analysis, Qualitative analysis of the quality of life in patients with severe acute brain injury and with withholding of life-sustaining treatment, 24 months after ICU discharge
Secondary Outcome Measures: International survey among neurointensivists from ANARLF network - questionnaires, Comparison of the number of decisions of withholding treatment in the clinical cases versus real life, Month : 3|International survey among neurointensivists from ANARLF network - follow-up, Comparison of the predicted neurological outcome and quality of life by neurointensivists versus the real neurological outcome and quality of life assessed at the post-ICU follow-up., Month : 3