pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Long Term Follow-up Study of Type-1 Gaucher Subjects Post FLT201 Dose (GALILEO-2)
NCT Number: NCT06545136
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Gaucher Disease, Type 1
Interventions: GENETIC: FLT201
Sponsor: Freeline Therapeutics
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 75
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-05-13
Completion Date: 2029-05
Locations: Lysosomal Rare Disorders Research and Treatment Center, Fairfax, Virginia, 22030-6066, United States|Hospital de Clinicas de Porto Alegre (HCPA), Porto Alegre, Brazil|Hospital Quironsalud Zaragoza, Zaragoza, Spain|Salford Royal Hospital, Salford, United Kingdom

Summary:
This is a multicenter, long-term, follow-up trial of participants with Gaucher disease type 1 who received FLT201 treatment in a preceding clinical trial. Participants will be followed for 5 years post-treatment.

Primary Outcome Measures: Incidence of treatment-emergent adverse events (TEAEs) (including DLTs), Treatment-emergent adverse events (including dose-limiting toxicities), with AEs graded per CTCAE version 5.0 (or later), Week 38 to Month 60
Retinol Binding Protein 4 Protein in Alopecia Areata Treated With Barcitinib
NCT Number: NCT06545110
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Alopecia Areata
Interventions: DRUG: Baricitinib Oral Tablet
Sponsor: South Valley University
Sex: ALL
Age: CHILD, ADULT
Enrollment: 120
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2023-09-01
Completion Date: 2024-10-30
Locations: South Valley University, Qinā, الكيلو 6 Qena - Safaga Rd, Qena, Qena Governorate, +20963211279, Egypt

Summary:
Assess serum and tissue retinol binding protein 4 in patients with severe alopecia areata in correlation with healthy individuals .

Estimate genetic profile of retinol binding protein4 in severe alopecia areata patients

Assess possible role of retinol binding protein 4 genetic mutation in response to barcitinib treatment in patients with severe alopecia areata .

Primary Outcome Measures: Assess serum and tissue retinol binding protein 4 in patients with severe alopecia, Assess serum and tissue retinol binding protein 4 in patients with severe alopecia in serum and tissue samples in response to Baricitinib ., baseline
Secondary Outcome Measures: Estimate genetic profile of retinol binding protein4 in severe alopecia areata patients, Estimate genetic variations of Retinol binding protein 4 in blood samples before and after Baricitinib., baseline
A Study of Cebranopadol for the Treatment of Acute Pain After Abdominoplasty
NCT Number: NCT06545097
Acronym: ALLEVIATE1
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Acute Pain
Interventions: DRUG: Cebranopadol|DRUG: Cebranopadol|DRUG: Placebo
Sponsor: Tris Pharma, Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 300
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2025-05
Locations: ALLEVIATE 1 Site 001106, Little Rock, Arkansas, 72211, United States|ALLEVIATE 1 Site 001112, Miami, Florida, 33014, United States|ALLEVIATE 1 Site 001110, Bellaire, Texas, 77401, United States|ALLEVIATE 1 Site 001111, San Antonio, Texas, 78240, United States

Summary:
The purpose of this study is to evaluate the efficacy and safety of Cebranopadol for acute pain after a Abdominoplasty.

Primary Outcome Measures: Primary Outcome Measure, Pain Numerical Rate Scale (NRS) area under the curve from 4 through 48 hours (AUC4-48), 4-48 hours
Secondary Outcome Measures: Secondary Outcome Measure:, Pain Numerical Rate Scale (NRS) AUC4-24, 4-48 hours|Secondary Outcome Measure:, Number of doses of rescue medication, 48 hours|Secondary Outcome Measure:, Pain NRS AUC, 24-48 hours|Other Secondary Endpoint, Pain NRS, Partial AUCs: 4-12, 12-24, 24-36, 36-48, and 4-36 hours|Other Secondary Endpoint, Rescue Medication, Proportion of subjects who take at least 1 dose of rescue medication up to hours 12, 24, and 36|Other Secondary Endpoint, MOAA/S, peak sedation, total score and AUC4-48
Evaluation of Periapical Healing Following Endodontic Microsurgery With Leukocyte and Platelet Rich Fibrin (L-PRF)
NCT Number: NCT06545084
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Apical Periodontitis
Interventions: PROCEDURE: Leukocyte and Platelet Rich Fibrin
Sponsor: University of Pennsylvania
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-01
Completion Date: 2026-06-30
Locations: Penn Dental Medicine, Philadelphia, Pennsylvania, 19104, United States

Summary:
The purpose of the study is to evaluate peri-radicular healing after root-end surgery using Leukocyte and Platelet Rich Fibrin. The study population includes patients diagnosed with persistent periapical pathology and scheduled for Endodontic Microsurgery at the University of Pennsylvania School of Dental Medicine, Department of Endodontics. Patients undergoing routine endodontic microsurgery and who meet the inclusion criteria will be given the opportunity to opt in to receive L-PRF in the osteotomy site to promote bone formation. Healing will be assessed radiographically and clinically at six, twelve, eighteen, and twenty-four months.

Primary Outcome Measures: Peri-radicular Healing, Evaluate Peri-radicular healing after Endodontic Microsurgery with the use of autologous L-PRF plug., 12 and 24 months
Safety Profile of Ropivacaine in Dorsal Penile Nerve Block for Male Circumcision: a Large Cohort Study in Children
NCT Number: NCT06545058
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Pain|Necrosis
Interventions: PROCEDURE: Penile block
Sponsor: Universitair Ziekenhuis Brussel
Sex: MALE
Age: CHILD
Enrollment: 1000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2000-01-01
Completion Date: 2026-12

Summary:
Dorsal penile nerve block (DPNB) according to Dalens' technique by using local anesthetics (LAs) is a fundamental part of a multimodal analgesic approach following circumcision. Ropivacaine has a favorable cardiovascular and neurological toxicity profile. However, its application in DPNB is limited because of the theoretical concerns about its vasoconstrictive properties and the potential risks of ischemia of the glans. The aim is to evaluate the incidence of necrosis of the glans penis and the safety profile of ropivacaine following its use in the DPNB in a large pediatric population.

Primary Outcome Measures: Incidence of necrosis of the glans penis, To evaluate the incidence of necrosis of the glans penis following the use of ropivacaine in the Dorsal penile nerve block in a large pediatric population., During time of surgery|Safety profile of Ropivacaine, To evaluate the safety profile of ropivacaine following its use in the Dorsal penile nerve block in a large pediatric population., During time of surgery
Minimal Invasive Transforaminal Lumbar Interbody Fusion for Degenerative Lumbar and Lumbosacral Spine Diseases
NCT Number: NCT06545032
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Degenerative Spine Diseases
Interventions: PROCEDURE: lumbar fusion
Sponsor: Sohag University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2025-10

Summary:
The aim of this study is to evaluate clinical and surgical outcome of MI-TLIF for degenerative lumbar and lumbosacral spine diseases.

Primary Outcome Measures: severity of pain according to visual analog score(vas), comparison between pre \& post operative pain, 1 year
Evaluation of the Efficacy and Safety of Microneedling Combined With Botulinum Toxin-A Versus Meso-Botox Injection in the Treatment of Atrophic Acne Scars: A Split-face Comparative Study
NCT Number: NCT06544993
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Atrophic Acne Scar
Interventions: DRUG: Meso-botox
Sponsor: Sohag University
Sex: ALL
Age: ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-05-01
Completion Date: 2025-05-01
Locations: Sohag university Hospital, Sohag, Sohag, Egypt

Summary:
Post-acne scars are psychologically disappointing and therapeutically challenging condition. No standard treatment for atrophic acne scars.

Micro-Botox, is a highly diluted BTX-A which could be injected safely intra-dermally. It targets the superficial fibers of facial muscles, sweat, and sebaceous glands inducing pores shrinkage, decreasing the sebum and excessive sweating, in addition to face lifting and reducing fine wrinkles without affecting emotions, this subsequently makes the skin tighter and gives the facial skin a smooth appearance.

Also, BTX-A appears to have an inhibitory effect on fibroblasts and collagen remodeling activity, in addition to releasing muscular tension at scar edges through superficial muscle relaxation. So, it can reduce the tethering and pulling effect of the muscles surrounding the acne scars. Also, it has anti-inflammatory and angiogenesis induction effects. Therefore, micro-Botox is believed to improve acne scars.

Therefore, it will be interesting to compare the efficacy and safety of microneedling combined with BTX-A versus meso-Botox injection in the treatment of atrophic acne scars through a split-face clinical study.

Primary Outcome Measures: Goodman and Baron Qualitative Global Scarring Grading System:, Acne scarring severity will be graded before and after treatment. Grade 1 (macular) erythematous, hyper/hypopigmented flat marks; Grade 2 (mild) mild atrophy or hypertrophic scars that may not be obvious at a distance of 50cm or greater \& may be covered adequately by makeup or beard hair in men; Grade 3 (moderate) moderate atrophy or hypertrophic scarring obvious at a distance of 50cm or greater, not covered by makeup or beard hair but can be flattened by manual stretching of the skin; and Grade 4 (severe) severe atrophy or hypertrophic scarring not flattened by manual stretching of the skin., 6 months
Measuring Upper Airway Cross Sectional Areas During Residual Neuromuscular Blockade and After Reserval
NCT Number: NCT06544980
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Postoperative Residual Curarization|Airway Obstruction on Anaesthetic Emergence
Sponsor: Tamas Vegh, MD
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-01-02
Completion Date: 2025-12-31
Locations: University of Debrecen, Debrecen, Hajdú-Bihar, 4008, Hungary

Summary:
In our study, the investigators sought to answer the question of how the retroglossal pharyngeal areas measured after extubation of patients compare to baseline (before muscle relaxation) values. The investigators also investigated how these areas change as a function of TOF ratios measured at extubation, thus looking for a correlation between residual muscle relaxant effect and airway area.

Primary Outcome Measures: The differences in retroglossal pharyngeal cross sectional areas (inspiration and exspiration) measured at different TOF values, The differences in retroglossal pharyngeal cross sectional areas (inspiration and exspiration) measured at different train of four TOF values, and changes in these values compared to (initial) retroglossae pharyngeal areas detected before administration of muscle relaxants. Areas are measured in pixels and the rate of reduction of areas is expressed as a percentage., before intubation, after extubation of the trachea
Differences Between Male and Femal Fetal Brain Biometry by Ultrasound
NCT Number: NCT06544967
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Fetal Brain Biometry by Ultrasound
Sponsor: Sohag University
Sex: FEMALE
Age: ADULT
Enrollment: 500
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-01
Completion Date: 2025-06-01
Locations: Sohag university hospital, Sohag, Egypt

Summary:
Differences of fetal brain biometry as Biparietal diameter,Head circumference,Transcerebellar diameter, Cavum septum pellucidum as regard to fetal gender by ultrasound

Primary Outcome Measures: Fetal brain biometry, In male and female fetuses, 6 months
Study on Home Obstructive Respiratory Exacerbations
NCT Number: NCT06544928
Acronym: SHORE
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: COPD Exacerbation|COPD (Chronic Obstructive Pulmonary Disease) With Acute Lower Respiratory Infection|COPD Exacerbation Acute|COPD
Interventions: DEVICE: RESP Biosensor
Sponsor: Strados Labs, Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-30
Completion Date: 2025-10-01
Locations: Jefferson Einstein Philadelphia Hospital, Philadelphia, Pennsylvania, 19141, United States

Summary:
Listening to breath sounds with a stethoscope/auscultation is used by pulmonary physicians in conjunction with pulmonary function, signs and symptoms, oxygen saturation and diagnostic testing to admit, follow, and discharge patients from the hospital. Of these, only auscultation routinely ceases upon discharge from the hospital. Healthcare utilization statistics have shown that for more than a decade, readmission after discharge for an exacerbation of COPD remains a major problem. The Strados RESP Biosensor has been designed to extend the range of lung sound recording both geographically and temporally to improve the standard of care when access to continuous monitoring has been replaced by periodic or no monitoring. The primary purpose of this study is to assess the associations between RESP Biosensor-acquired lung findings and subjective measures of respiratory symptoms as measured by validated measurement tools, and objective measure of respiratory physiology as determined by home pulse oximetry.

Primary Outcome Measures: Statistically significant associations between RESP Biosensor-acquired lung findings and 1) subjective measure of respiratory symptoms measured by validated measurements tools and 2) home spirometry, Recordings started prior to bedtime and continue for at least 6 hours, every other sleep for 6 months.
Secondary Outcome Measures: Univariate and multivariate assessment of predictors of up to 6-month total respiratory exacerbation rate (moderate + severe), Recordings started prior to bedtime and continue for at least 6 hours, every other sleep for 6 months.
Evaluating the Effects of a Synbiotic Versus Probiotic or Placebo on Gut Microbiota and Cardiometabolic Health: A Randomized Double-Blind Placebo Controlled Trial
NCT Number: NCT06544915
Acronym: GUTRCT
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Blood Pressure, Body Composition, Immune Function
Interventions: DIETARY_SUPPLEMENT: Synbiotic, Probiotic, Placebo
Sponsor: Skidmore College
Sex: ALL
Age: ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-07-23
Completion Date: 2025-01-01
Locations: Skidmore College, Saratoga Springs, New York, 12866, United States

Summary:
Accordingly, the purpose of this study is to evaluate the efficacy of 1) supplementation with Synbiotic (Plexus® Triplex), 2) commercially-available Probiotic, or 3) placebo control over 30 days on the gut microbiome, cardiometabolic health, body weight and body composition in healthy individuals.

Primary Outcome Measures: Gut microbial diversity, alpha- and beta-diversity, Baseline, 15 days, 30 days|Gut microbial count, Gut microbial species identification and quantification, Baseline, 15 days, 30 days|Short Chain fatty acids, Short Chain Fatty Acid concentration, Baseline, 15 days, 30 days
Secondary Outcome Measures: Blood pressure, Brachial and estimated central blood pressure, Baseline, 15 days, 30 days|Vascular Stiffness, Aortic vascular stiffness, Baseline, 15 days, 30 days|Vascular reactivity, Using the near-infrared vascular occlusion test, Baseline, 15 days, 30 days|Heart Rate Variability, Time and frequency domain HRV parameters, Baseline, 15 days, 30 days|Dietary Analysis, Dietary analysis using the ASA24 system, Baseline, 15 days, 30 days|Body Composition, Body mass, % body fat using Tanita RD 545, Baseline, 15 days, 30 days|Blood Lipids, Blood lipid profile using Cholestech system, Baseline, 15 days, 30 days|Salivary inflammation profile, Salimetrics ELISA for key inflammatory and immunity parameters (SIgA, IgG, alpha amylase, cortisol, c-reactive protein), Baseline, 15 days, 30 days
Multi-national, Multi-center, Randomized Controlled Trial to Evaluate the Clinical Utility of Non-invasive Endometrial Receptivity Test (Ora) in Patients With Implantation Failure
NCT Number: NCT06544837
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: IVF|Window of Implantation|microRNA|Implantation|Non-invasive Testing|Endometrial Receptivity
Interventions: DIAGNOSTIC_TEST: Window of Implantation
Sponsor: Inti Labs
Sex: FEMALE
Age: ADULT
Enrollment: 1000
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-06-22
Completion Date: 2027-06-01
Locations: Hanoi Hospital, Hanoi, Vietnam

Summary:
The adjustment of the timing of embryo transfer based on the endometrial receptivity profile and transferring embryo(s) of good quality with normal chromosomes (diagnosed by Preimplantation Genetic Testing for Aneuploidy, PGT-A) are the two main causes to improve the success of assisted reproduction treatments (ART). Previously, endometrial receptivity analysis was performed on women undergoing IVF treatment through an invasive endometrial tissue biopsy. The aim of this study is to determine the clinical benefits of ORA, a novel non-invasive endometrial receptivity test that determines the optimal time for embryo transfer through a blood draw instead of an invasive endometrial tissue biopsy. It is expected to recruit 1000 couples whose embryos will be analyzed by PGT-A and/or who are going to evaluate their endometrium expression profile for endometrial receptivity. The patients will be randomized into two groups, (1) Control group : undergoing PGT-A only; (2) Study group : the undergoing both PGT-A and ORA. ART will be performed based on the results of PGT-A and/or ORA. Reproductive success, such as implantation rates (IR), pregnancy rates (PR), ongoing pregnancy rates (OGP) and live birth rates (LBR) will be tracked and compared.

Preliminary results demonstrate that both PGT-A and ORA can contribute to reproductive success, improving implantation rates in patients with implantation failure. Our hypothesis suggests that PGT-A and ORA could improve the performance of ART in infertile patients.

Primary Outcome Measures: Clinical pregnancy, Presence of one or more intrauterine gestational sacs after 6 weeks estimated gestational age, 6 weeks after embryo transfer
Secondary Outcome Measures: Ongoing pregnancy, Presence of fetal heartbeat after 12 weeks of gestation., 12 weeks after embryo transfer|Live birth, Baby survival after 20 weeks of gestation, 20 weeks after embryo transfer
Accuracy Comparison: Optoelectronic Motion Capture and Markerless System
NCT Number: NCT06544824
Acronym: OPR
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Children, Adult|Motor Disorders
Interventions: OTHER: Measure gait spatiotemporal parameters and kinematics from optoelectronic system|OTHER: Measure gait spatiotemporal parameters and kinematics from markerless system
Sponsor: IRCCS Eugenio Medea
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 25
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-05-15
Completion Date: 2025-05-15
Locations: IRCCS E. Medea, Bosisio Parini, 22037, Italy

Summary:
The purpose of this study was to assess the Openpose reliability to measure kinematics and spatiotemporal gait parameters and to evaluate the minimum technical requirements. This analysis used video and optoelectronic motion capture simultaneously recorded. We assessed more of 20 subject with different motor gait impairments

Primary Outcome Measures: Absolute Error, Absolute errors were calculated for the kinematics parameters and for each spatiotemporal variable by taking the absolute value after subtracting the values obtained using pose estimation methods from the value measured using mark-er-based motion capture, Through study completion, an average of 1 year|intraclass correlation coefficients, To confirm if the data obtained by OpenPose agreed with the data obtained by optoelectronic system, the ICCs (two-way mixed effects model, absolute agreement, average measurements) between the spatiotemporal and kinematics data obtained by OpenPose and Optoelectronics system. The ICC values were inter-preted as poor agreement for ICC \<0.5, as moderate agreement for the values between 0.5 and 0.75,a good agreement for values between 0.75 and 0.9 , and as excellent agreement for value greater than 0.90, Through study completion, an average of 1 year|cross-correlation coefficients, the cross-correlation coefficients (CCC) between both systems were used to evaluate the similarity of angles during gait cycle. The CCC values were interpreted as weak or no coupling for values -0.3 \< CCC \< 0.3, moderate coupling for values 0.3 \< CCC \< 0.70 or -0.7 \< CCC \<-0.3, and strong coupling for values CCC \>0.7 or CCC \< -0.7 ., Through study completion, an average of 1 year
American Indian Smokefree Native RCT
NCT Number: NCT06544811
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Smoking Cessation
Interventions: OTHER: Smoking Cessation Program|OTHER: Cultural Smoking Cessation Program
Sponsor: Masonic Cancer Center, University of Minnesota
Collaborators: University of Minnesota
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 416
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2026-06-01
Completion Date: 2029-10-01

Summary:
The aim of this clinical trial is to test the efficacy of a culturally aligned digital smoking cessation resource for American Indian persons who smoke, via a remotely conducted randomized controlled trial.

Primary Outcome Measures: Percent of participants that are biochemically confirmed 7-day abstinence from smoking at 6 months., 6 months
Secondary Outcome Measures: Percent of participants that are biochemically-confirmed 7-day abstinence, Percent of participants that are biochemically-confirmed 7-day abstinence at 1, 3 months, 1 and 3 months|Percent of participants that self-report 24-hour abstinence, Percent of participants that self-report 24-hour abstinence at 1, 3, and 6 months, 1, 3, and 6 months|Percent of participants that self-report 7-day abstinence, Percent of participants that self-report 7-day abstinence at 1, 3, and 6 months, 1, 3, and 6 months|Percent of participants that self-report 30-day abstinence, Percent of participants that self-report 30-day abstinence at 1, 3, and 6 months, 1, 3, and 6 months|Change in mean cigarettes per day in past 7 days, Change in mean cigarettes per day in past 7 days at 1, 3, and 6 months, 1, 3, and 6 months|Number of 24-hour quit attempts in past 30 days, Number of 24-hour quit attempts in past 30 days at 1, 3, and 6 months, 1, 3, and 6 months|Percent of participants that used nicotine replacement therapy and pharmacotherapy, Percent of participants that used nicotine replacement therapy and pharmacotherapy (e.g.

nicotine patch, Chantix) in past 30 days at 1, 3, and 6 months, 1, 3, and 6 months|Percent of participants that used other behavioral support, Percent of participants that used other behavioral support (e.g. in-person, quitline) for smoking cessation in past 30 days at 1, 3, and 6 months, 1, 3, and 6 months|Percent of participants that used other commercial tobacco products, Percent of participants that used other commercial tobacco products (e.g., smokeless tobacco, e-cigarettes) in the past 30 days 1, 3, and 6 months, 1, 3, and 6 months
Long-term Follow-up of Gene Therapy for Radiation-Induced Xerostomia
NCT Number: NCT06544798
Status: ENROLLING_BY_INVITATION
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Grade 2 and 3 Late Xerostomia Caused by Radiotherapy for Cancers of the Upper Aerodigestive Tract, Excluding the Parotid Glands
Interventions: GENETIC: AAV2-hAQP1
Sponsor: MeiraGTx, LLC
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 120
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-02
Completion Date: 2031-02
Locations: Atrium Health, Charlotte, North Carolina, 28209, United States

Summary:
This study will assess the long-term safety and efficacy of bilateral intra-parotid administration of AAV2-hAQP1 in adults with Grade 2 or Grade 3 radiation-induced late xerostomia.

Primary Outcome Measures: Number of participants with study drug-related adverse events and serious adverse events, From study start until Month 60 post-treatment
Confirmatory Factor Analysis For A Questionnaire About Organ Donation
NCT Number: NCT06544759
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Tissue and Organ Procurement
Interventions: BEHAVIORAL: Aa educational Documentry
Sponsor: Rahmah Health Foundation
Collaborators: Rawalpindi Medical College
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 425
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-09-15
Completion Date: 2024-06-30
Locations: Rahmah Health Foundation, Islamabad, Islamabad Capital Territory, 44000, Pakistan

Summary:
Purpose of the Study The study aims to understand how different messages can influence people's decisions to become organ donors. Researchers want to find out which types of messages are most effective in encouraging organ donation registration.

Who Can Take Part? Adults aged 18 and older who are eligible to register as organ donors can participate in this study.

How the Research Will Happen Participants will be shown different types of messages about organ donation. They will then be asked questions to see how the messages affect their willingness to register as organ donors. The study will compare the responses to determine which messages work best.

Benefits of the Study By identifying the most effective messages, this study aims to increase the number of registered organ donors. This can help save lives by making more organs available for transplantation.

Primary Outcome Measures: Composite Score of Knowledge, Attitudes, and Intentions Towards Organ Donation, The primary outcome measure is the composite score derived from the validated questionnaire, which assesses participants' knowledge, attitudes, and intentions regarding organ donation. This score will be calculated by summing responses to key items within the questionnaire that reflect these three domains., mmediately after message delivery (one-time assessment)
Association Between Restorative Emergence Profiles and Peri-implant Bone Loss in Different Implant Systems:
NCT Number: NCT06544746
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Dental Implant-Abutment Designs
Interventions: RADIATION: Periapical radiographs
Sponsor: Saint-Joseph University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 76
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-12-01
Completion Date: 2024-08-01
Locations: Saint Joseph University Of Beirut, Beirut, Lebanon

Summary:
The goal of this observational study is evaluate the association between different emergence profile angulation on marginal bone loss progression around different implant systems (bone level, tissue level and switching platform).

Does different emergence profile angulation have the same effect on peri-implant marginal bone loss? Standardized periapical radiograph that were captured after crown placement on implants will be compared with the new radiographs done after recalling the patient.

Primary Outcome Measures: Compare Marginal Bone Loss (MBL):, measured mesially and distally from the implant platform until the first coronal contact of the bone with the implant. Then the total bone loss on each implant is calculated. This is achieved on the software in millimeters., Minimum of 3 years post loading|Compare Emergence angulation assessment, The EA was calculated as the angle between the implant's long axis and a line tangent to the restoration. First, a line parallel to the implant's long axis was drawn at the outer collar of the implant. Then, another line tangential to the restoration from the platform was drawn. The angle of intersection was measured as the emergence angle. Measured in degree, Minimum of 3 years post loading|Compare Emergence profile assessment:, Each EP was categorized as either concave, straight, or convex., Minimum of 3 years post loading
Secondary Outcome Measures: Number of Platform switching, Available or not, Minimum of 3 years post loading|Height of Abutments, Height measurement of the abutment. Measured in mm, Minimum of 3 years post loading
SCG142 TCR-T Cells for Human Papillomavirus-Associated Carcinomas
NCT Number: NCT06544720
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Human Papillomavirus Associated Carcinomas|Cervical Cancer|Head and Neck Cancers|Anal Cancer|Vulva Cancer|Vaginal Cancer|Penile Cancer|HPV-Related Malignancy
Interventions: BIOLOGICAL: SCG142 TCR-T cells
Sponsor: The Affiliated Hospital of Qingdao University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 18
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-08-02
Completion Date: 2026-12-31
Locations: The affiliated hosptial of qingdao university, Qingdao, Shandong, 266071, China

Summary:
A multicenter, open, single arm dose escalation and dose expansion phase I study to evaluate the safety, tolerability, and efficacy of SCG142 TCR-T cells in Subjects with advanced HPV associated carcinomas.

Primary Outcome Measures: DLT, Number of subjects with adverse events (AEs) and laboratory abnormalities defined as dose limiting toxicities (DLT), 28 days
Secondary Outcome Measures: Efficacy: antitumor activity of SCG142, Assessed by RECIST 1.1 and iRECIST, 2 years
A Study Designed to Evaluate Tear Production
NCT Number: NCT06544707
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Dry Eye Disease
Interventions: DRUG: 0.003% AR-15512
Sponsor: Alcon Research
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10
Completion Date: 2025-03
Locations: Contact Alcon Call Center for Trial Locations, Fort Worth, Texas, 76134, United States

Summary:
The purpose of this study is to evaluate tear production following acute administration of AR-15512 ophthalmic solution 0.003% (0.003% AR-15512) in subjects with dry eye disease (DED).

Primary Outcome Measures: Change from baseline (pre-drop compared to 3 minutes post-drop) in tear meniscus height (TMH) as measured by optical coherence tomography (OCT), TMH (the distance between the line of reflection along the top of the tear prism to the edge of the eyelid) will be measured in millimeters using optical coherence tomography (OCT), a non-invasive imaging test that uses light waves to take cross-section pictures of the eye. A positive change value from baseline will indicate improvement. Each eye will be assessed individually., Day 1, Minute 0 (pre-instillation); Day 1, Minute 3 (post-instillation)
A Study to Investigate the Effect of 0.003% AR-15512 on Subjects With Dry Eye Disease
NCT Number: NCT06544694
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Dry Eye Disease
Interventions: DRUG: 0.003% AR-15512|OTHER: Artificial Tears
Sponsor: Alcon Research
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 70
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-10
Completion Date: 2025-05
Locations: Contact Alcon Call Center for Trial Locations, Fort Worth, Texas, 76134, United States

Summary:
The purpose of this study is to evaluate the effect of AR-15512 ophthalmic solution 0.003% (0.003% AR-15512) on ocular surface characteristics of subjects with dry eye disease (DED).

Primary Outcome Measures: Percentage change from baseline in goblet cell density at Day 90, Goblet cells are specialized epithelial cells that secrete mucins onto the ocular surface to help hydrate and lubricate the eye surface. Samples of conjunctiva will be collected on filter papers based on a technique called impression cytology. The filter papers will then be processed in a lab to identify the number of goblet cells. The percent change in goblet cell density at Day 90 compared to Day 1 (Baseline) will be calculated. A positive change value will indicate an improvement., Baseline (Day 1 pre-instillation), Day 90
Evaluation and Treatment Strategy Development of Coronary Heart Disease Guided by OCT Based on Multimodal Deep Learning
NCT Number: NCT06544681
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Coronary Disease|Coronary Artery Disease
Interventions: PROCEDURE: Coronary stenting with planned drug eluting stent (DES).
Sponsor: Xiang Ma
Collaborators: Shihezi University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 2000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-20
Completion Date: 2026-12-31

Summary:
This is a retrospective, multicenter, observational study aimed at assessing stent apposition for coronary stent implantation by an optical coherence tomography system constructed by deep learning algorithms and evaluating the prognosis of patients after stent implantation in conjunction with multimodal diagnostic and therapeutic information.

Primary Outcome Measures: MACE, Patients were followed up within 1 year after OCT and PCI. The follow-up included major adverse cardiac events: All causes were death, recurrent myocardial infarction, target vessel reconstruction, and stent thrombosis., Post-procedure within 1 year
A Study for Dynamic Prediction Model of Breast Cancer Bone Metastases
NCT Number: NCT06544668
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Breast Cancer|Bone Metastases
Interventions: OTHER: Breast cancer patients with bone metastasis|OTHER: Breast cancer patients without bone metastasis
Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 3500
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-06
Completion Date: 2025-01-20
Locations: National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, Beijing, 100021, China

Summary:
The purpose of this study is to identify the risk factors of bone metastasis in breast cancer patients so as to develop a dynamic prediction model using real world clinical data. The multicenter data will be retrospectively collected, and the clinical characteristics related to bone metastasis will be analyzed.

Primary Outcome Measures: To identify the risk factors and develop a prediction model for bone metastasis in breast cancer patients, The correlation between clinical characteristics and bone metastasis, and the accuracy of prediction model, 60 months
A Study of BMS-986484 Alone and Combination Therapy in Participants With Advanced Solid Tumors
NCT Number: NCT06544655
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Advanced Solid Tumors
Interventions: DRUG: BMS-986484|BIOLOGICAL: Nivolumab
Sponsor: Bristol-Myers Squibb
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 134
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10-29
Completion Date: 2027-10-14
Locations: Local Institution - 0003, Tucson, Arizona, 85724, United States|Local Institution - 0007, Los Angeles, California, 90033, United States|Local Institution - 0014, Aurora, Colorado, 80045, United States|Local Institution - 0018, Aurora, Colorado, 80045, United States|Local Institution - 0011, Grand Rapids, Michigan, 49546, United States|Local Institution - 0004, Sioux Falls, South Dakota, 57104, United States|Local Institution - 0013, San Antonio, Texas, 78229, United States|Local Institution - 0021, Darlinghurst, New South Wales, 2010, Australia|Local Institution - 0019, Elizabeth Vale, South Australia, 5112, Australia|Local Institution - 0017, Toronto, Ontario, M5G 2M9, Canada|Local Institution - 0016, Montréal, Quebec, H2X 0A9, Canada

Summary:
The purpose of this study is to assess the safety and tolerability of BMS-986484 administered alone, in combination with nivolumab in participants with advanced/metastatic solid tumors including non-small cell lung cancer (NSCLC), microsatellite stable (MSS) colorectal carcinoma (CRC), pancreatic ductal adenocarcinoma (PDAC), gastric/gastroesophageal junction adenocarcinoma (G/GEJC), and squamous cell carcinoma of the head and neck (SCCHN).

Primary Outcome Measures: Incidence of adverse events (AEs), Up to approximately 2 years|Incidence of serious adverse events (SAEs), Up to approximately 2 years|Incidence of AEs meeting protocol defined dose-limiting toxicity (DLT) criteria, Up to approximately 28 days|Incidence of AEs leading to discontinuation, Up to approximately 2 years|Incidence of AEs leading to death, Up to approximately 2 years
Secondary Outcome Measures: Maximum observed concentration (Cmax), Up to approximately 2 years|Time of maximum observed concentration (Tmax), Up to approximately 2 years|Area under the concentration-time curve (AUC), Up to approximately 2 years|Incidence of anti-drug antibodies (ADAs), Up to approximately 2 years|Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), Up to approximately 2 years|Disease control rate (DCR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), Up to approximately 2 years|Duration of response (DOR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), Up to approximately 2 years
Imjudo & Imfinzi PMS
NCT Number: NCT06544629
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Hepatocellular Carcinoma
Sponsor: AstraZeneca
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 246
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-12-30
Completion Date: 2029-02-28

Summary:
Based on the re-review of new drugs article, Korean pharmaceutical act, the objectives of this study are to assess safety and effectiveness of the study drugs(Imjudo \& Imfinzi) in a real world setting in patients who treated according to the approved indications in Korea.

Primary Outcome Measures: Safety (adverse events (AEs), serious AEs (SAEs), adverse drug reactions (ADRs), serious ADRs (SADRs), unexpected AEs/ADRs), To assess safety of the study drugs for patients treated with the study drugs under the approved indication in Korea, For Imjudo will be conducted for 90 days from the first dose of the treatment. For Imfinzi will be separately conducted for 1 year from the first dose.
Secondary Outcome Measures: Objective Response Rate(ORR), To assess effectiveness of the study drugs for patients treated with the study drugs under the approved indication in Korea, For 1 year from the first dose of the treatment
Other Outcome Measures: Disease Control Rate (DCR), To assess effectiveness of the study drugs for patients treated with the study drugs under the approved indication in Korea, For 1 year from the first dose of the treatment
Safety of Elacestrant in ER+/HER2- and ESR1 Mutations MBC
NCT Number: NCT06544577
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: ESR1 Gene Mutation|Advanced Breast Cancer|Safety
Interventions: DRUG: ELacestrant
Sponsor: SciClone Pharmaceuticals
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 350
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-13
Completion Date: 2026-08-01
Locations: Hainan Hospital of Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine (Boao Research Hospital, Hainan), Qionghai, Hainan, China

Summary:
This study is a prospective non-interventional real-world study enrolling patients with advanced breast cancer who are ER+/HER2- and have ESR1- gene mutations, collecting information on patients' complaints, physical examination, laboratory tests, imaging tests and adverse events to observe the safety of elacestrant treatment.

Primary Outcome Measures: Adverse event rate, Percentage of occurrences of adverse events, 6 months
Secondary Outcome Measures: Serious adverse event rate, Percentage of occurrences of serious adverse events, 6 months
Human Amniotic Membrane(s) On Venous Leg Ulcers In an Elderly Population
NCT Number: NCT06544564
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Venous Leg Ulcer
Interventions: DEVICE: Membrane-Wrap Lite™|DEVICE: CT-Shield™|DEVICE: Membrane Wrap™|DEVICE: Membrane Wrap - Hydro™|OTHER: Standard of Care
Sponsor: BioLab Holdings
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 375
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-30
Completion Date: 2026-08-30

Summary:
This study is designed to assess the clinical effectiveness of human amniotic membrane(s) for the management of difficult to heal partial- or full-thickness venous leg ulcers (VLUs)

Primary Outcome Measures: Time to wound closure by or on week 12., Wound Closure is defined as:

* Full epithelialization of the wound with the absence of drainage
* Epithelialization is defined as a layer of epithelium visible on the wound surface, 12 weeks|Frequency of wound closure by or on week 12., Wound Closure is defined as:

* Full epithelialization of the wound with the absence of drainage
* Epithelialization is defined as a layer of epithelium visible on the wound surface, 12 weeks
Secondary Outcome Measures: Rate of VLU improvement by or on End of Study (EOS) from baseline, defined by:

* \>60% reduction in area, or
* \>60% reduction in depth, or
* \>75% reduction in volume Rate of VLU improvement by or on End of Study (EOS) from baseline, 12 weeks
Other Outcome Measures: Incidence of ulcer recurrence within the 12-week study period, Incidence of ulcer recurrence within the 12-week study period, 12 weeks|Mean number of ulcer free days within the 12-week study period, Mean number of ulcer free days within the 12-week study period, 12 weeks
Acute Kidney Injury After Cardiac Arrest
NCT Number: NCT06544538
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Acute Kidney Injury
Sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 82
Study Design: Observational Model: |Time Perspective: p
Start Date: 2013-01-01
Completion Date: 2022-12-31
Locations: Bakırköy Dr. Sadi Konuk Training and Research Hospital, Istanbul, 34140, Turkey

Summary:
The development of AKI (Acute Kidney Injury) after cardiac arrest is a common factor associated with mortality. In this study, we aimed to evaluate the factors that increase the risk of developing AKI after cardiac arrest.

For the study, patients were evaluated for the incidence of acute kidney injury (AKI), factors that increase the risk of AKI, and the impact of AKI on mortality. In this process, demographic data, comorbidities, hemodynamic data, laboratory data, clinical symptoms and findings recorded in the electronic decision support system were recorded and analyzed.

Primary Outcome Measures: Acute Kidney Injury (AKI), Creatinine values in the first 48 hours of intensive care unit admission after cardiac arrest, Within 48 hours after intensive care unit admission
Secondary Outcome Measures: AKI incidence, Determination of the incidence of AKI development after cardiac arrest, Within 48 hours after intensive care unit admission|Mortality, Impact of AKI development on mortality in the early post-cardiac arrest period, Clinical and laboratory data within 48 hours after intensive care unit admission will be used
Anxiety and Pain Level in Patients Undergoing Obesity Surgery
NCT Number: NCT06544512
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Anxiety|Pain, Postoperative
Interventions: OTHER: progressive relaxation exercise
Sponsor: Ataturk University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 84
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-01-01
Completion Date: 2024-09-30
Locations: Van Yüzüncü Yıl University Dursun Odabaş Medical Center, VAN, 65000, Turkey

Summary:
The aim of this clinical trial is to find out whether progressive relaxation exercises work on the effect of anxiety and pain level in patients undergoing obesity surgery. The main questions that it aims to answer are:

* Do progressive relaxation exercises reduce participants' pain levels?
* Do progressive relaxation exercises reduce participants' anxiety levels? The researchers will compare the effect of progressive relaxation exercises on the level of anxiety and pain between experimental and control groups .

Participants:

* He will experience obesity surgery surgery as planned for the first time

  \* Who volunteered to participate in the research
* 18 years and over
* The mental state is healthy

Primary Outcome Measures: VAS( Visual Analog Scale), It is a scale with two different names on the two ends on a 10 cm long vertical or horizontal line (0=no pain, 10=most severe pain). The patient is asked to mark the point on this line that corresponds to the intensity of pain he feels., between 1-2 days|state-trait anxiety scale, The State-Trait Anxiety Inventory, which was adapted to Turkish culture by Öner and Le Compte (1983), and in which validity and reliability studies were conducted as well as norm studies, consists of a total of 40 items, including a State Anxiety Scale consisting of 20 items and a Trait Anxiety Scale consisting of 20 items. According to the "Item Remainder" correlation technique, which provides detailed information about the reliability and validity of the items forming the scale; the item reliability correlations of the Turkish form are between 0.34 and 0.72 for the Trait Anxiety Scale and between 0.42 and 0.85 for the State Anxiety Scale., between 1-2 days