pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Minimal Instrumentation With Intracanal Heating and Activation of Sodium Hypochlorite for the Management of Teeth With Periapical Lesions
NCT Number: NCT06461728
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Heating and Activation of Sodium Hypochlorite
Interventions: DEVICE: a new prototye device that heat and activate sodium hyochlorite (Aseptico)
Sponsor: Saint-Joseph University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 32
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2023-11-07
Completion Date: 2025-06-07
Locations: Saint Joseph University, Beirut, 1481, Lebanon

Summary:
this study is the first to demonstrate the efficacy of minimally invasive root canal treatment combined with intracanal heating and activation of NaOCl using a prototype needle on the healing of asymptomatic apical periodontitis of necrotic single rooted teeth. 32 teeth will be randomaly assigned into 2 groups :conventional and conservative technique .In the conventional group : each canal will be prepared using Reciproc Blue 25/08, approximetly 27 ml of NaOCl will be used , the canal will be activated using 20.02 taper tip of a sonic decive . This cyclel will be repeated 3 times and the obturation will be done using a single cone technique with AH plus resin-based sealer . In the second group a size 10 k file will be introduced to confirm patency and to record working length after filling the canal with NaOCl. A glide path will be established using the size 10 FlexoFile to the WL, than Proglider 16.02 to the foramen. After the glide path, the canal will be irrigated with 3 ml of 5, 25 % of NaOCL .The prototype needle tip will be placed in the canal to the length that is a little shorter than the length at binding point , in order to heat and activate the irrigant solution for 30 seconds.Step one is repeated 4 more times and a fresh solution of NaOCl is replaced every time. Canals will be dried using sterile paper points size 15 and the obturation will be performed for all teeth using the same technique as group 1 but with a standardized gutta percha point 2% tapered

Primary Outcome Measures: efficiency of minimal instrument combined with intracanal heating and activation of NaOCl, evaluation of the clinical and radiographic healing of minimally invasive root canal treatment performed with minimal instrumentation combined with intra-canal heating and activation of NaOCl using a prototype needle on necrotic single rooted tooth with apical periodontitis compared to conventional root canal treatment with sonic activation by comparing the change of the area of the lesion, 3 , 6 and 9 months follow up
Secondary Outcome Measures: To evaluate the speed of repair of healing periapical lesions, To evaluate the speed of repair of healing periapical lesions, using the following formulas:

Absolute speed of shrinkage (mm2/day) = ((initial detected area-final area))/(duration of treatment) Relative speed of shrinkage (per day)= ((initial detected area-final area) x 100)/(initial detected area x duration of the treatment ), 3,6 and 9 months follow up
Left Bundle Branch Area Pacing 3D Guidance System
NCT Number: NCT06461715
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Left Bundle Branch Pacing|Heart Failure|Bradycardia
Interventions: OTHER: Machine learning with artificial intelligence software program
Sponsor: Guy's and St Thomas' NHS Foundation Trust
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 300
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-01
Completion Date: 2025-05-31
Locations: Imperial College Nhs Healthcare Trust, London, W12 0HS, United Kingdom

Summary:
The investigator's project proposes the development of a 3D hybrid guidance system which has the aim of avoidance of scar and septal perforation through targeted lead deployment via a personalised septal real time image overlay onto x-ray fluoroscopy imaging during left bundle branch pacing. The investigators hypothesise that the use of cardiac anatomy and myocardial scar distribution derived from cardiac magnetic resonance imaging (MRI) as well as 3D position of the pacing lead, may improve LBBAP lead deployment success and improve clinical outcomes by guiding the physician towards optimal lead positioning.

Primary Outcome Measures: Detection of the position of the left bundle branch area on x-ray fluoroscopy, The accuracy of left bundle branch area detection will be measured as intersection-over-union (IoU) with the use of a convolutional neural network, 12 months
Clinical Exploration Trial of YOLT-101 in the Treatment of Familial Hypercholesterolemia (FH)
NCT Number: NCT06461702
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: EARLY_PHASE1
Conditions: Familial Hypercholesterolemia
Interventions: DRUG: YOLT-101
Sponsor: First Affiliated Hospital Bengbu Medical College
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 13
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-04-01
Completion Date: 2025-12
Locations: The First Affiliated Hospital of Bengbu Medical College, Bengbu, An Hui, 233004, China

Summary:
This study is a single arm, open, single dose escalation trial aimed at evaluating the safety and tolerability of YOLT-101 administration in patients with familial hypercholesterolemia; Determination of YOLT-101 OBD; Preliminary evaluation of the effects of single administration of YOLT-101 on plasma lipid and lipoprotein levels.

Note: OBD is defined as the dosage at which plasma PCSK9 protein levels decrease between 60% and 95% from baseline on the 28th day after YOLT-101 administration. OBD ≤ Maximum Tolerable Dose (MTD).

Primary Outcome Measures: safety evaluation of YOLT-101, The safety of YOLT-101 evaluated by the proportion of subjects experiencing adverse events (AEs), serious adverse events (SAEs), through week 52
Secondary Outcome Measures: pharmacokinetics of YOLT-101, The Peak Plasma Concentration (Cmax) of YOLT-101. 0.5 predose,0.5,1,1.5,2,4,6,8,12,24,48,72,144,312 hours, through Day 28|pharmacodynamics, The effect of YOLT-101 on serum levels of LDL-C, through week 52|pharmacodynamics, The effect of YOLT-101 on plasma levels of PCSK9, through week 52|pharmacokinetics of YOLT-101, Area under the plasma concentration versus time curve (AUC). 0.5 predose,0.5,1,1.5,2,4,6,8,12,24,48,72,144,312 hours, through Day 28|pharmacokinetics of YOLT-101, Tmax, through Day 28|pharmacokinetics of YOLT-101, T1/2, through Day 28
Comparison of Changes in Tumor Burden in 68Ga-PSMA-11 PET/CT and 177Lu-PSMA SPECT/CT in Metastatic Castration-resistant Prostate Cancer
NCT Number: NCT06461689
Acronym: PROLUT
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Prostate Cancer Metastatic
Interventions: DRUG: 177Lu-PSMA-617
Sponsor: Central Hospital, Nancy, France
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-01
Completion Date: 2026-03-01
Locations: CHRU de NANCY, Vandoeuvre les Nancy cedex, 54511, France

Summary:
To demonstrate the prognostic value of using post-therapy 177Lu-PSMA SPECT/CT versus 68Ga-PSMA-11 PET/CT in mCPRC patients progressing despite chemotherapy and treated with 177Lu-PSMA.

Primary Outcome Measures: Measurement of TMTV (total metabolic tumor volume), Measurement of TMTV (total metabolic tumor volume) on 68Ga-PSMA-11 PET/CT (pre-treatment, after 4th treatment and after 6th treatment) and on SPECT/CT (after each treatment)., 12 months|Measurement of TLA (total lesion activity), Measurement of TLA (total lesion activity) on 68Ga-PSMA-11 PET/CT (pre-treatment, after 4th treatment and after 6th treatment) and on SPECT/CT (after each treatment)., 12 months
CairnSurgical Breast Cancer Locator (BCL) Post-Market Study
NCT Number: NCT06461663
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Breast Cancer
Interventions: DEVICE: Breast Cancer Locator Guided Breast Conserving Surgery
Sponsor: CairnSurgical, Inc.
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 35
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2022-07-22
Completion Date: 2024-04-19
Locations: Agaplesion Markus Hospital, Frankfurt, 60431, Germany|Universitats Klinikum Heidelberg, Heidelberg, Germany|Humanitas Research Hospital, Milan, Italy|Ospdale Santa Chiara, Pisa, Italy|Spital Zollikerberg, Zürich, Switzerland

Summary:
This interventional, post-market, multicenter clinical investigation is designed to evaluate the performance of a custom-made medical device, "the Breast Cancer Locator (BCL)" in Subjects with non-palpable breast cancer, in Europe.

Primary Outcome Measures: Positive Margin Rate, To evaluate the performance of BCL in reducing the positive margin rate, the proportion of patients with positive margins after partial mastectomy with the BCL will be obtained., Pathology results will from the index procedure be available within 14 days from the day of sample arrival at the pathological lab.
Secondary Outcome Measures: Specimen volume, To calculate the specimen volume after BCL guided partial mastectomy, the water displacement method (WDM) will be used., Results will be obtained the same day of surgery.|Surgeon's Perception, To evaluate the surgeon's perception of the BCL system, a survey asking them if they strongly disagree, somewhat disagree, are undecided, somewhat agree, or strongly agree that the BCL made tumor localization easier, was easy to use, made tumor excision easier, and would be recommended by them, will be used., Results will be obtained prior to subject discharge after the study procedure (within approximately 2 days after surgery)|Adverse events, To evaluate the safety and tolerability of BCL, adverse events will be reported, including frequency, maximum intensity, relation to study treatment, seriousness, action taken, and outcome. Safety data will be handled descriptively., From supine MRI 10-40 days prior to surgery through 6 weeks +/- 7 days post surgery|Patient Satisfaction, To evaluate the patient's satisfaction, the BREAST-Q patient-reported outcome measure will be used. Patient satisfaction scores range from 0-100, with a higher score meaning greater satisfaction or better quality of life (depending on the scale)., 6 weeks +/- 7 days post surgery
Signature for Precise Chemosensitivity Prediction in PDAC
NCT Number: NCT06461598
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Pancreatic Cancer
Interventions: DRUG: Chemotherapy
Sponsor: Ruijin Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 365
Study Design: Observational Model: |Time Perspective: p
Start Date: 2018-01-01
Completion Date: 2021-05-31
Locations: Ruijin Hospital, Shanghai, 200025, China

Summary:
Pancreatic ductal adenocarcinoma (PDAC) is largely heterogeneous. We sought to develop and validate a signature to precisely predict chemotherapy sensitivity in PDAC. Genetic events of the four most commonly mutated genes in PDAC and expressions of 12 PI3K/AKT/mTOR pathway markers were examined in consecutive patients with PDAC. A 9-feature signature for prediction of chemotherapy benefits was constructed using the LASSO Cox regression model, and validated in two independent cohorts.

Primary Outcome Measures: Overall survival, Time between resection and death of any cause, 3-year
Effects of Sprint Interval Training Versus Arabic Exercises BMI
NCT Number: NCT06461585
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: PCOS
Interventions: OTHER: Sprint interval training
Sponsor: Riphah International University
Sex: FEMALE
Age: ADULT
Enrollment: 36
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2023-12-10
Completion Date: 2024-07-10
Locations: Jinnah Hospital, gynae ward, Lahore, Punjab, 54000, Pakistan

Summary:
Polycystic ovary syndrome (PCOS) is the most common endocrine disorder in women of reproductive age and is the leading cause of infertility and anovulation. According to the Rotterdam criteria, the prevalence of PCOS is estimated to affect up to 20% of the female population. PCOS is characterized by increased androgen production and decreased ovulation leading to clinical manifestations including acne, hirsutism, male pattern baldness, irregular menstrual cycles, and infertility. In addition to concerns about fertility and hyperandrogenism, PCOS is considered a metabolic disorder, with an increased risk of developing insulin resistance (IR), hyperinsulinemia, dyslipidemia, and low-grade inflammation. In addition to genetic involvement, environmental aspects such as obesity conditions. affect the progression of PCOS or even make patients' clinical conditions worse. Exercise is an important component of PCOS management, and exercises have been shown to improve metabolic and reproductive outcomes in women with PCOS. The study will be a randomized clinical trial. This study will be completed in a time duration of 7 months after the approval of the synopsis. Sample size 32 is calculated by the Epi tool.variable for the sample size is BMI. By the non-probability convenience sampling technique, participants will be divided into 2 groups. Group A the Interventional group will receive SIT and Group B will receive the aerobic exercise. Group A will perform SIT 3 times a week for 30-second sprints on a cycle ergometer with 4 minutes of rest between each sprint, complete session will be for 30 -40 minutes while Group B will perform the aerobic exercise for 30-40 minutes of moderate-intensity continuous exercise on a treadmill and stationary cycle. The outcome measure will be evaluated by using the BMI Calculator, PCOSQOL, measuring tape Borg scale. After Collecting data from the before and after treatment sessions. The data will be analyzed by using SPSS version 25.

Primary Outcome Measures: Modified Borg CR10 RPE scale (For Exertion level), PCOSQOL, 8 weeks|Waist-to-hip ratio: (Measuring tape), BMI Calculator:

BMI Calculator:, 8 weeks
Effects of Power Ball on Proximal Muscle and Refractive Errors in Developmental Delay.
NCT Number: NCT06461572
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Developmental Delay
Interventions: OTHER: conventional therapy|OTHER: conventional therapy along with standard therapy and stability exercises.
Sponsor: Riphah International University
Sex: ALL
Age: CHILD
Enrollment: 32
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-05-20
Completion Date: 2024-08-29
Locations: Riphah international university, Lahore, Punjab, 540000, Pakistan

Summary:
When a child does not meet developmental milestones at the anticipated times, it is referred to as having a developmental delay. These benchmarks cover social, emotional, cognitive, physical, and communication abilities. Developmental delays can result from a number of factors, including genetic circumstances, early delivery, specific medical issues, or external variables. Although they mainly impair vision, refractive errors are unrelated to developmental delays. Because vision facilitates interaction with the environment, it is vital to a child's development. Early detection of uncorrected refractive defects and related vision loss in children can pose a challenge. To ascertain whether an increase is suitable and successful, a thorough evaluation of the child's readiness and the application of pertinent measurement techniques may be necessary. An analysis looks into Randomized Controlled Trial will be the type of study design used. There will be two groups of conveniently randomized sample size of thirty-two. The data analysis will be done using SPSS version 22.0. To verify normality, the Shapiro-Wilk test will be employed. The study will be carried out in the department of physical therapy of the rising sun and the Lahore rehab facility. The study will be finished six months from the time the synopsis is approved. A sample size of thirty-two was determined using the OPENEPI tool. The VQOL/item Tool and pediatric manual muscle testing will be used. For four weeks, the control group will receive standard physical therapy care. Group B: Experimental Group: For five weeks, a traditional physical therapy regimen and Powerball exercises will be administered.

Primary Outcome Measures: VQOL/ITEM Tool, The refractive errors and visual acuity of children who have developmental delays will be assessed using this tool. The ability of child to identify the size of the letters on a card held 20 feet (6 meters) away or on a standardized chart (Snellen chart). There will be specific charts used for testing at less than 20 feet (6 meters)., 4 weeks|Pediatric functional muscle testing, PFMT will be a useful tool for measurement of muscle strength for children with developmental delay if it be some modifications., 4 weeks|snellen chart for refractive errors, The most popular method for assessing visual acuity in clinical settings is still the Snellen chart. A handy tool for rapidly evaluating both monocular and binocular visual acuity is the Snellen chart., 4 weeks
Pilot Study of Preoperative Intestinal Training Using Antegrade Ileostomy Infusion
NCT Number: NCT06461559
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Stoma Ileostomy|Ileostomy; Complications
Interventions: OTHER: ileostomy infusion
Sponsor: University of California, San Diego
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2025-11-01
Locations: UC San Diego, La Jolla, California, 92093, United States

Summary:
This research study is being conducted to study the effect of infusing your contents from your ostomy bag back into your intestine to re-train them prior to the ostomy takedown operation, which is a surgery to reverse your ostomy to put your intestine back together. Because your intestine past the ostomy hasn't seen any intestinal content for several weeks to months before the takedown operation, it is no longer used to handling the daily work of processing intestinal content and will take time to recover its normal function after surgery. We hope to speed up this process by training them before your planned surgery.

Primary Outcome Measures: timing to return of bowel function, time to return of bowel function after stoma surgery, 1-5 days
Secondary Outcome Measures: ease of stoma infusion, how easy was it for patients to infuse contents, 2 weeks prior to surgery to time of surgery|complications, if there are any complications from using the stoma infusion, 2 weeks prior to surgery to 30 days post operatively
Comparative Effects of Jandas's Approach With and Without Post Isometric Relaxation Technique
NCT Number: NCT06461507
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: PELVIS Syndrome
Interventions: OTHER: Janda's Approach
Sponsor: Riphah International University
Sex: ALL
Age: ADULT
Enrollment: 38
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-06
Completion Date: 2024-09-30
Locations: Shafeen medical complex Punjab Pakistan, Lahore, Punjab, 54000, Pakistan

Summary:
Posterior lower crossed syndrome is a perplexing puzzle of muscular imbalance, manifests as an intricate interplay between weakened glutes and tight flexors. The aim of the study will be to determine the effects of Jandas's approach with and without post-isometric relaxation technique on pain, muscle flexibility, and functional disability in patients with the posterior lower crossed syndrome.

Primary Outcome Measures: Numerical pain rating scale (NPRS), o Changes from base Line Numeric Pain rating scale is a scale for pain starting from 0-10. where 0 indicate no pain and 10 indicate severe pain.

The Numerical Pain Rating Scale (NPRS) is a subjective measure in which individuals rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain)., upto 4 weeks|Finger to floor test -Muscle flexibility test, * The patient is asked to bend forward and attempt to reach for the floor with their fingertips.
* The physical therapist then measures the distance between the patient's right long finger and the floor using a standard measuring tape
* Ask the client whether pain, stiffness or both limit the movement(Fingertips to floor (FTF) test).
* If the FTF test is limited by pain, the location and pain score out of 10 should be documented.
* If the FTF test is 0 cm or the patient is able to place their palms to the floor with no pain, a different outcome measure should be considered., upto 4 weeks|Modified Thomas Test- Muscle flexibility test, * Have the patient lie supine on a firm surface, with their legs straight.
* Place your hand under the patient's lower back to maintain a neutral spine.
* Slowly flex the patient's hip, bringing their knee towards their chest, until their thigh is perpendicular to the table.
* Assist the patient in flexing their hip further, keeping their knee bent at a 90-degree angle.
* Measure the angle between the patient's thigh and the table using a goniometer or inclinometer.
* Compare the measurement to the normal range (usually around 15-20 degrees) to determine if there is a restriction in iliopsoas flexibility., upto 4 weeks
Hypertrophic Cardiomyopathy Federated Learning Implementation Platform
NCT Number: NCT06461468
Acronym: HCM FLIP
Status: ENROLLING_BY_INVITATION
Study Type: OBSERVATIONAL
Conditions: Hypertrophic Cardiomyopathy
Sponsor: American Heart Association
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-05
Completion Date: 2026-01
Locations: Thomas Hospital, Fairhope, Alabama, 36532, United States|Riverside Medical Center, Kankakee, Illinois, 60901, United States|Johns Hopkins University School of Medicine, Baltimore, Maryland, 21287, United States|University of Michigan Medical Center, Ann Arbor, Michigan, 48109, United States|Wooster Community Hospital, Wooster, Ohio, 44691, United States|The University of Texas Southwestern Medical Center, Dallas, Texas, 75390, United States

Summary:
HCM FLIP study is a two-phase protocol focusing on the detection of Hypertrophic Cardiomyopathy using Electrocardiograms and Echocardiograms through Federated Learning.

Primary Outcome Measures: Diagnosis of HCM, The number/instances of HCM diagnoses as identified by the ML model as compared to clinical diagnosis confirmation. Due to model training and efficacy goals, HCM diagnosis determined clinically via EKG/ECHO reading will be compared to the ML model's capacity to identify HCM correctly and efficiently., Through study completion, an average of 2 years
Secondary Outcome Measures: Diagnosis of different types of HCM, Diagnosis of different types of HCM (i.e., apical, obstructive), HCM without hypertrophy, genetic positive/negative indicators, among others, as identified by the ML model as compared to clinical diagnosis confirmation. Due to model training and efficacy goals, HCM diagnosis determined clinically via EKG/ECHO reading will be compared to the ML model's capacity to identify HCM correctly and efficiently., Through study completion, an average of 2 years
Clinical Performance Evaluation of Two Frequent Replacement Silicone Hydrogel Multifocal Toric Contact Lenses
NCT Number: NCT06461455
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Presbyopia|Astigmatism
Interventions: DEVICE: Lehfilcon A multifocal for astigmatism contact lenses|DEVICE: Samfilcon A multifocal for astigmatism contact lenses|DEVICE: CLEAR CARE
Sponsor: Alcon Research
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 82
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-26
Completion Date: 2024-11
Locations: Dr.Elsa Pao, O.D, Oakland, California, 94607, United States|Pacific Rims Optometry, San Francisco, California, 94127, United States|Drs. Giedd, P.A., Maitland, Florida, 32751, United States|Vision Health Institute, Orlando, Florida, 32803, United States|Oculus Research, Inc., Garner, North Carolina, 27529, United States|ProCare Vision Centers, Inc., Granville, Ohio, 43023, United States|Optometry Group, PLLC, Memphis, Tennessee, 38111, United States|Dawn M. Rakich, OD, San Antonio, Texas, 78213, United States

Summary:
The purpose of this study is to evaluate on-eye clinical performance of the investigational contact lenses following 30 days of wear in the intended population.

Primary Outcome Measures: Binocular visual acuity at distance (4 meters) at Day 30 with study lenses, High contrast, high illumination visual acuity (VA) will be assessed at a distance of 4 meters for both eyes together with study lenses in place. VA will be measured using letter charts and recorded in logarithm minimum angle of resolution (logMAR), with a logMAR value of 0 equating to 20/20 Snellen VA (normal distance eyesight) and lower logMAR values representing better eyesight., Day 30 (-2/+1) of each wear period. A wear period is 30 days (-2/+1) according to randomization assignment.]
A Trial for a Preliminary Estimate of the Effectiveness of a Novel Theoretical Framework
NCT Number: NCT06461416
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Prostate Cancer|Breast Cancer
Interventions: BEHAVIORAL: ActiveHeal
Sponsor: University of Arkansas
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-06-10
Completion Date: 2024-12-30
Locations: University of Arkansas for Medical Science, Fayetteville, Arkansas, 72203, United States

Summary:
* Aim 1: To determine the preliminary effect sizes of al ActiveHeal EST (Engage-Sustain-Triumph) Program on occupational resilience.
* Aim 2: To determine the preliminary effect sizes of ActiveHeal EST (Engage-Sustain-Triumph) on health status \[quality of life (QoL) and Psychological wellbeing (PWB)\].
* Aim 3: To determine the extent to which ActiveHeal EST (Engage-Sustain-Triumph) Program is an acceptable and feasible Intervention for breast and prostate cancer survivors.

Primary Outcome Measures: Occupational Resilience Measure (ORM 1.0), The ability to persist in selected daily activity despite challenges, Week 7-8; Week 21-22
Secondary Outcome Measures: World Health Organization Quality of Life Scale (WHOQOL-BREF), Overall quality of life, Week 7-8; Week 21-22|Psychological Wellbeing Scale, Wellbeing, Week 7-8; Week 21-22
Other Outcome Measures: Acceptability of Intervention Measure- Experiment Group only, Survey, Week 21-22|Feasibility of Intervention Measure- Experiment Group only, Survey, Week 21-22
Clinical Performance of Bulk-fill Restorations in Class II Cavities
NCT Number: NCT06461364
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cavity, Dental
Interventions: PROCEDURE: Assessment of cuspal deflection of bulk-fill restorations
Sponsor: Egymedicalpedia
Collaborators: Al-Azhar University
Sex: ALL
Age: ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2022-07-20
Completion Date: 2023-07-25
Locations: Faculty of Dentistary - Al-Azhar University, Cairo, Egypt

Summary:
Direct composite resin restorations are considered an essential treatment option in the dental clinic because of increasing the demands for esthetics. These materials are primarily used as anterior and posterior filling materials for the restoration of dental caries, crown fractures, tooth wear, and congenital defects.

Primary Outcome Measures: FDI criteria Esthetic, evaluated surface luster and surface staining, from 3 months to 12 months|FDI criteria Functional, evaluated fracture of material and retention,occlusal contour and wear, from 3 months to 12 months|FDI criteria Biological, Biological evaluated post operative hypersensitivity and recurrence caries, from 3 months to 12 months
Long-term Observational Study of Patients Treated With Inaticabtagene Autoleucel Injection
NCT Number: NCT06461351
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: B-cell Tumors
Interventions: OTHER: Inaticabtagene autoleucel Injection
Sponsor: Juventas Cell Therapy Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-03-30
Completion Date: 2040-03-30
Locations: Institute of Hematology & Blood Diseases Hospital, Tianjin, Tianjin, China

Summary:
This clinical trial adopts an observational research method to conduct annual follow-up and monitoring of patients receiving treatment with Inaticabtagene Autoleucel Injection after its commercialization, in order to evaluate the delayed adverse events of Inaticabtagene Autoleucel Injection.

Primary Outcome Measures: Replication-competent lentivirus，RCL, Real time quantitative polymerase chain reaction was used for detection, QPCR method., once a year from date of Inaticabtagene Autoleucel Injection treatment until date of death from any cause, assessed up to 15 years.
Secondary Outcome Measures: Long-term Adverse Drug Reaction, Individual adverse drug reactions related to Inaticabtagene Autoleucel Injection after marketing, mainly including secondary tumors, etc after marketing, mainly including secondary tumors, etc, once a year from date of Inaticabtagene Autoleucel Injection treatment until date of death from any cause, assessed up to 15 years.
Surgical Management Of Gastroschisis
NCT Number: NCT06461325
Acronym: LAPS
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Gastroschisis|Neonatal Disease|Hernia, Umbilical|Complication,Postoperative
Sponsor: University Hospital, Clermont-Ferrand
Sex: ALL
Age: CHILD
Enrollment: 30
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-05-01
Completion Date: 2024-08-28
Locations: Clermont-Ferrand University Hospital, Clermont-Ferrand, Auvergne, 63000, France

Summary:
The investigators aim to analyze the management of children born with gastroschisis between January 2009 and December 2023, i.e. to evaluate post-operative follow-up, hospitalization costs, the risk of post-operative umbilical hernia, and the parents' and the child's appreciation of the scar.

Primary Outcome Measures: Number of patients with medical complications, sepsis, infections,, through study completion, an average of 1 year|Number of patients with surgical complications, disunion, hernia scar, through study completion, an average of 1 year
Secondary Outcome Measures: Length of stay, Length of stay, through study completion, an average of 1 year|Rate of Hospitalization Cost by patient, Costs by department, overall costs, through study completion, an average of 1 year
Combined PRF of the Pudendal Nerve With Ganglion Impar Block Effectively Alleviates Pudendal Neuralgia
NCT Number: NCT06461312
Acronym: PRF
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pudendal Neuralgia|Pulsed Radiofrequency
Interventions: PROCEDURE: Combined pulsed radiofrequency of the pudendal nerve with ganglion impar block
Sponsor: Peking University People's Hospital
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-05-01
Completion Date: 2024-12-31
Locations: People's Hospital of Peking University, Beijing, Beijing, 100044, China

Summary:
Patients with pudendal neuralgia suffer from long-term pain, which severely affects their quality of life. Due to unclear etiology, there is a lack of specific treatment methods. The aim of this study is to evaluate the efficacy of combined pulsed radiofrequency with ganglion impar block therapy helps evaluate the effectiveness of this treatment method for pudendal neuralgia, comparing it with traditional treatments or single interventions, and providing guidance for clinical practice.

Primary Outcome Measures: Patient Global Impression of Change, 0 -100%#0=no change,100%= complete relief of pain symptoms., 1month|Patient Global Impression of Change, 0 -100%#0=no change,100%= complete relief of pain symptoms., 2months|Patient Global Impression of Change, 0 -100%#0=no change,100%= complete relief of pain symptoms., 3months|Patient Global Impression of Change, 0 -100%#0=no change,100%= complete relief of pain symptoms., 6months
Secondary Outcome Measures: Numeric Rating Scale, 0-10#0 =no pain, 10 = the most severe pain., 1month|Numeric Rating Scale, 0-10#0 =no pain, 10 = the most severe pain., 2months|Numeric Rating Scale, 0-10#0 =no pain, 10 = the most severe pain., 3months|Numeric Rating Scale, 0-10#0 =no pain, 10 = the most severe pain., 6months
Study to Evaluate the Efficacy, Safety, and Tolerability of Sarecycline for Treating Periorificial Dermatitis
NCT Number: NCT06461299
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Perioral Dermatitis
Interventions: DRUG: Seysara Oral Product
Sponsor: The Dermatology Institute of Boston
Sex: ALL
Age: ADULT
Enrollment: 9
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-07-17
Completion Date: 2024-03-31
Locations: The Dermatology Institute of Boston, Boston, Massachusetts, 02116, United States

Summary:
A Single-Center Pilot Study to Evaluate the Efficacy, Safety, and Tolerability of Sarecycline for Treating Periorificial Dermatitis

Primary Outcome Measures: PODSI score, The PODSI represents the sum of individual scores for erythema, papules and scaling. Each of these key features is graded on a scale from 0 to 3 including intermediate values (0.5, 1.5 and 2.5). The PODSI is defined as the sum score of the 3 features, and may range from 0 to 9. All patients with a PODSI from 0.5 to 2.5 were regarded as mild, whereas severe cases scored with a PODSI from 6.0 to 9.0. All remaining patients with a PODSI from 3.0 to 5.5 were classified as moderate., 4 weeks
Amygdala MRI-TIS for Depression
NCT Number: NCT06461260
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Major Depressive Disorder
Interventions: DEVICE: Nervio-X
Sponsor: Shanghai Pudong New Area Mental Health Center, School of Medicine, Tongji University
Collaborators: Ruijin Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-05-27
Completion Date: 2025-04-28
Locations: Shanghai Pudong New Area Mental Health Center, Shanghai, Shanghai, China

Summary:
The study utilizes a non-invasive deep brain stimulation (temporal interference, TI) technique primarily targeting the amygdala to preliminarily explore the clinical efficacy and potential mechanisms of MRI-compatible TI technology in regulating the amygdala in depressive disorders, providing a more comprehensive basis for the application of TI technology.

Primary Outcome Measures: HAMD-17, Baseline, treatment completion day, 1 week, 4 weeks and 8 weeks
Secondary Outcome Measures: HAMA, HAMA is a questionnaire that designed to evaluate the presence and intensity of anxiety symptoms in both clinical and research settings., Baseline, treatment completion day, 1 week, 4 weeks and 8 weeks|SHAPS, The SHAPS is a questionnaire that used to measure the severity of anhedonia, a common symptom in various mental health conditions., Baseline, 4 weeks and 8 weeks|SF-36, Baseline and 8 weeks|WHOQOL-BREF, Baseline and 8 weeks|PSQI, Baseline, 4 weeks and 8 weeks|THINC-it®, THINC-it® is a screening tool for assessment of cognitive functioning in patients with a major depressive episode/disorder, Baseline, treatment completion day and 8 weeks|Blood sample, Peripheral blood will be collected at baseline and one 4 weeks after treatment for transcriptomic and proteomic studies to explore the molecular mechanisms of temporal interference (TI) in the treatment of depressive disorders and to identify molecular markers for predicting therapeutic efficacy, Baseline, 4 weeks|GAD-7, Baseline, treatment completion day, 1 week, 4 weeks and 8 weeks|QIDS-SR, Baseline, treatment completion day, 1 week, 4 weeks and 8 weeks|MADRS, Baseline, treatment completion day, 1 week, 4 weeks and 8 weeks
Compliance With Standard Care vs Ready to Eat Meals Prior to Bariatric Surgery
NCT Number: NCT06461247
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Bariatric Surgery Candidate
Interventions: OTHER: Very Low Calorie Diet Ready-to-eat (VLCD RTE) meals|OTHER: Standard Care Group
Sponsor: National University Hospital, Singapore
Collaborators: Alexandra Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 140
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-01
Completion Date: 2026-03
Locations: Alexandra Hospital, Singapore, Singapore|National University Hospital, Singapore, Singapore

Summary:
Currently, a ketosis-inducing programme, usually a liquid meal replacement, is the standard of care for pre-operative dietary management. However, compliance with liduiqd meal replacement is challenging primarily due to individual taste preferences, limited variety, having to take a liquid diet, lifestyle factors, and other obstacles. Therefore, there is a need for RTE meals to enhance patient satisfaction and compliance, ultimately resulting in improved pre-operative weight loss outcomes. Hence, this RCT study aims to determine whether Very Low Calorie Diet Ready-to-eat (VLCD RTE) meals would lead to greater compliance as measured by blood ketones and meal logging via Nutritionist Buddy app (nBuddy App) compared to standard care liquid meal replacement (Optifast) prior to bariatric surgery.

Primary Outcome Measures: Compliance rate of the RTE meals, The compliance rate is assessed via food logging in the nutritionist buddy keto app, Daily for intervention period of 28 days|Blood Ketones Measurement, Fasting blood ketone measurements measured at study visit, 1st week, 2nd week, 3rd week, 4th week, surgery day
Secondary Outcome Measures: Satisfaction of the RTE meals, Assessed via a self-reported questionnaire with a numeric scale of 1 to 5, 3rd week and surgery day|Weight Change, Weight changes at study visit, 1st week, 2nd week, 3rd week, 4th week, surgery day
tFUS to Enhance Alertness and Performance
NCT Number: NCT06461221
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Reaction Time|Alertness
Interventions: DEVICE: Transcranial Focused Ultrasound|DEVICE: Transcranial Focused Ultrasound|DEVICE: Transcranial Focused Ultrasound|DEVICE: Transcranial Focused Ultrasound
Sponsor: Medical University of South Carolina
Sex: ALL
Age: ADULT
Enrollment: 36
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-08-01
Completion Date: 2026-08-01
Locations: Medical University of South Carolina, Charleston, South Carolina, 29425, United States

Summary:
The investigators goal is to target FUS energy to the centromedian nucleus of the thalamus (CMT), the core of arousal, which is inaccessible by traditional non-invasive neuromodulation devices. The CMT is an ideal stimulation target for augmenting alertness, as it is intimately linked with the cortex through the well described thalamocortical circuit to entrain network oscillations.

Primary Outcome Measures: EEG changes pre- to post-FUS, Frequency band analysis of EEG data, 2 years|Reaction time on Psychomotor vigilance task, Measuring reaction time on PVT pre- to post-FUS, 2 years
Computer Aided Respiratory Therapy Based on Audio and Spirometry Signals
NCT Number: NCT06461195
Acronym: COMPASS
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Respiratory Therapy
Interventions: OTHER: Monitoring of patients
Sponsor: Lieven De Maesschalck
Collaborators: KU Leuven|Universitair Ziekenhuis Brussel
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 15
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-06-25
Completion Date: 2025-09-30

Summary:
The purpose of the study is to collect data: audio in the form of respiratory sounds and instructions from the therapist, spirometry data during the execution of the therapy, physiological parameters, and patient information. With the help of this data, algorithms will be developed for the automatic detection, localization, and classification of respiratory sounds, linked to the respiratory cycle using spirometric signals.

Primary Outcome Measures: Respiration flow, Measured in liter per minute, measured by a spirometer., 1 year|Respiration volume, Measured in liter, measured by a spirometer., 1 year
Secondary Outcome Measures: Heart rate, Measured in beats per minute by photoplethysmography using a wrist watch with a sensor, 1 year|Skin conductivity, Measured in Siemens using a wrist watch with a sensor, 1 year|Body temperature, Measured in degrees Celsius using a wrist watch with a sensor, 1 year|Oxygen saturation, Measured in percentage by photoplethysmography using a wrist watch with a sensor, 1 year
Ga-68-CXCR4 PET/CT in Indolent B-cell Lymphoma
NCT Number: NCT06461182
Acronym: PentixaFor
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Indolent B-Cell Non-Hodgkin Lymphoma
Interventions: DRUG: Ga-68-CXCR4
Sponsor: Koo Foundation Sun Yat-Sen Cancer Center
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 15
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-04-29
Completion Date: 2027-04
Locations: Koo Foundation Sun Yat-Sen Cancer Center, Taipei, Beitou, 1125019, Taiwan

Summary:
This study explores the efficacy of Ga-68-PentixaFor PET/CT in detecting, assessing treatment response, and monitoring the risk of aggressiveness in indolent B-cell lymphoma. The background introduces CXCR4 and discusses its role in cancer research. Currently, FDG-PET is the primary imaging tool for lymphoma staging, but it lacks diagnostic accuracy for low-grade lymphomas. Ga-68-PentixaFor PET demonstrates promising detection capabilities across various lymphomas, suggesting its potential as a superior imaging modality for low-grade lymphomas.

Primary Outcome Measures: Performance of Ga-68-CXCR4 PET/CT in indolent B cell lymphoma, Detection rate = number of positive scan / total number of scan Sensitivity = number of true positive scan / total number of proven recurrent patient Specificity = number of true negative scan / total number of proven free of disease patient Accuracy = number of (true positive scan + true negative scan) / total number of scan Positive predictive value = number of true positive scan / number of positive scan Negative predictive value = number of true negative scan / number of negative scan, up to 24 months
Secondary Outcome Measures: Ga-68-CXCR4 compared to F-18-FDG PET/CT, McNemar test, Two-tailed，P\<.05, up to 24 months|Clinical impact of Ga-68-CXCR4 compared to F-18-FDG PET/CT, Treatment plan questionnaires before and after Ga-68-CXCR4 PET/CT, up to 24 months|Prognostic value of Ga-68-CXCR4 PET/CT scan, The correlation between the radiomic features of Ga-68-CXCR4 PET/CT scan and progression free survival.

CXCR4 radiomics : Feature extraction was performed with the open-source Python package pyradiomics. For each volume of interest (VOI), including first-order statistics, shape features, grey level co-occurrence matrix (GLCM), grey level run length matrix (GLRLM), grey level size-zone matrix (GLSZM), neighborhood grey level different matrix (NGLDM), and grey level dependence matrix (GLDM)., up to 36 months
The Effect of Stress Ball on COPD Patients Receiving Noninvasive Mechanical Ventilation Support
NCT Number: NCT06461169
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Mechanical Ventilation Pressure High|COPD
Interventions: OTHER: stress ball
Sponsor: Kafkas University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-06-15
Completion Date: 2024-10-15
Locations: Kafkas University, Kars, Merkez, 36000, Turkey

Summary:
The aim of this randomised controlled trial was to investigate the effect of a stress ball on pain, anxiety and physiological parameters in Chronic Obstructive Pulmonary Disease (COPD) patients on non-invasive mechanical ventilation (NIMV).

Primary Outcome Measures: face anxiety scale, Developed in 2003, the Facial Anxiety Scale is a measurement tool in which patients self-report their anxiety levels and is 11 × 42 cm in size. It consists of five face shapes, the leftmost facial expression indicates the absence of anxiety, while the level of anxiety increases towards the right (scored between 0-5). According to the Facial Anxiety Scale, a score of 3 and above by the patients indicates that the level of anxiety is at medium and high levels., change in anxiety score before and after the intervention|Visual Analogue Scale (Pain) Visual analog scale (VAS), Visual analog scale is used to convert parameters that cannot be measured numerically into a numerical value. For pain, '0: I have no pain and 10: I have unbearable/severe pain' is written on one end of a 100 mm line and the patient marks his/her current condition on this line., change in pain score before and after the intervention
Secondary Outcome Measures: systolic blood pressure (mm/Hg), the effect of the intervention on systolic blood pressure is examined, at the beginning of the intervention and at the 15th, 30th, 45th and 60th minutes of the intervention|diastolic blood pressure (mm/Hg), the effect of the intervention on diastolic blood pressure is examined, at the beginning of the intervention and at the 15th, 30th, 45th and 60th minutes of the intervention|SpO2-peripheral oxygen saturation (%), the effect of the intervention on peripheral oxygen saturation is examined, at the beginning of the intervention and at the 15th, 30th, 45th and 60th minutes of the intervention|respiratory rate (minute value), the effect of the intervention on respiratory rate is examined, at the beginning of the intervention and at the 15th, 30th, 45th and 60th minutes of the intervention|heart rate (minute value), the effect of the intervention on heart rate is examined, at the beginning of the intervention and at the 15th, 30th, 45th and 60th minutes of the intervention
Intraosseous Local Anesthesia System in Children With Molar Incisor Hypomineralization
NCT Number: NCT06461143
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Molar Incisor Hypomineralization|Hypersensitivity|Composite Restoration
Interventions: DRUG: (%4 articaine with 1:200 000 adrenaline
Sponsor: Istanbul University
Sex: ALL
Age: CHILD
Enrollment: 80
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-24
Completion Date: 2025-05-24
Locations: Istanbul University, Faculty of Dentistry, Department of Pedodontics, Istanbul, Turkey

Summary:
The goal of this clinical trial is to compare in effectiveness of intraosseous anesthesia and inferior alveolar block anesthesia in children with molar incisor hypomineralization (MIH). The main question it aims to answer are:

- Is intraosseous anesthesia is more effective in pain control when restoring hypersensitive teeth with MIH?

Primary Outcome Measures: Wong-Baker FACES Pain Rating Scale, Patient-reported pain, Before and after local analgesia administration
Secondary Outcome Measures: Frankl behaviour rating scale, Behaviour assessment, Behaviour at the time of initial examination and during local analgesia administration|Pulse rate, Pulse rate, Before and during local analgesia administration|Blood pressure, Blood pressure, Before and during local analgesia administration|MCDAS(f) Turkish version, Dental anxiety, Before and after local analgesia administration