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<\|newrecord\|> nctId: NCT06305923 id: RNN/275/21/KE id: 503/3-066-02/503-31-001 type: OTHER_GRANT domain: Medical University of Lodz briefTitle: The Efficacy of a Cosmetic Preparation Containing Sheep Colostrum on Mature Skin acronym: COLMATSKIN overallStatus: COMPLETED date: 2022-03-01 date: 2022-06-30 date: 2022-07-31 date: 2024-03-12 date: 2024-03-12 name: Medical University of Lodz class: OTHER briefSummary: The goal of this clinical trial is to learn about colostrum as a cosmetic in mature skin. . The aim of the study was to examine the effect of a cosmetic preparation containing sheep colostrum on skin with signs of aging in mature women Participants will be given the creams and asked to apply one -two doses in the evening after nighttime facial cleaning. They were also asked to use sunscreens during the day. During the first visit and after eight weeks of everyday use of the tested cream, the skin parameters will be measured three times on both cheeks, and the results were averaged.
Participants will be enrolled to the colostrum cream or base cream groups and will not be informed which group they belonged to. conditions: Skin Aging studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: SINGLE whoMasked: PARTICIPANT count: 52 type: ACTUAL name: colostrum cream name: placebo cream measure: hydration measure: transepidermal water loss measure: erythema and melanin content measure: sebum measure: firmness of the skin measure: firmness of the skin sex: FEMALE minimumAge: 40 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Medical University of Lodz city: Lodz zip: 90-419 country: Poland lat: 51.75 lon: 19.46667 hasResults: False
<\|newrecord\|> nctId: NCT06305910 id: CMN-DMGVac-01 briefTitle: CD200AR-L and Allogeneic Tumor Lysate Vaccine Immunotherapy for Recurrent HGG and Newly Diagnosed DMG/DIPG in Children and Young Adults overallStatus: RECRUITING date: 2024-03-15 date: 2025-09-15 date: 2027-01-15 date: 2024-03-12 date: 2024-03-12 name: OX2 Therapeutics class: INDUSTRY briefSummary: This is a single center Phase I study of a new adjuvant CD200 activation receptor ligand, CD200AR-L, in combination with imiquimod and GBM6-AD vaccine to treat malignant glioma in children and young adults.
The primary objective of this study is to determine the maximum tolerated dose (MTD) of CD200AR-L when given with a fixed dose of GBM6-AD vaccine, imiquimod, and a single dose of radiation for patients with recurrent High Grade Glioma (HGG) or following standard of care therapy radiation therapy for newly diagnosed Newly Diagnosed Diffuse Midline Glioma/Diffuse Intrinsic Pontine Glioma (DIPG/DMG). conditions: Diffuse Midline Glioma, H3 K27M-Mutant conditions: Recurrent High Grade Glioma studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SEQUENTIAL interventionModelDescription: 3+3 design primaryPurpose: TREATMENT masking: NONE count: 24 type: ESTIMATED name: Treatment with CD200AR-L measure: Maximum Tolerated Dose (MTD) of CD200AR-L measure: Incidence of serious adverse events (SAEs) measure: Time to progression (TTP) by 24 months measure: Progression free survival (PFS) by 24 months measure: Overall survival (OS) by 24 months sex: ALL minimumAge: 2 Years maximumAge: 25 Years stdAges: CHILD stdAges: ADULT facility: Children's Minnesota status: RECRUITING city: Minneapolis state: Minnesota zip: 55404 country: United States name: Anne Bendel, MD role: CONTACT phone: 612-813-5940 email: anne.bendel@childrensmn.org lat: 44.97997 lon: -93.26384 hasResults: False
<\|newrecord\|> nctId: NCT06305897 id: CS5_10B briefTitle: Evaluation of the Tolerance (Main Objective) and Performance of Cyto-selective Difluoroethane-based Cryotherapy in the Treatment of Brown Spots (Solar and Senile Lentigines, Post-inflammatory Hyperpigmentation) on the Face acronym: CS5_10B overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-12 date: 2024-12 date: 2024-03-12 date: 2024-04-17 name: Cryonove Pharma class: INDUSTRY briefSummary: The goal of this clinical trial is to compare the 3 different prototype of cyto-selective cryotherapy devices (name of the devices : CRYONOVE) use in brown spots on the face of subject from different ethnicities. The main questions it aims to answer are:
* the tolerance of 3 prototypes of cyto-selective cryotherapy treatments
* the performance of 3 prototypes of cyto-selective cryotherapy treatments
Participants will be treated for each spots with a definied prototype during 6 treatment visits.
Researchers will compare the tolerance and performance of the 3 prototypes. conditions: Lentigo conditions: Solar Lentigo conditions: Post Inflammatory Hyperpigmentation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Proof of concept study concerning 3 prototypes of cyto-selective cryotherapy devices corresponding to a modified CE marked medical device (ref: 822-v1). primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 45 type: ESTIMATED name: CRYONOVE (EC14_4osc) name: CRYONOVE (EC+05_1osc) name: CRYONOVE (EC+05_2osc) measure: Tolerance measure: Performance sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06305884 id: OSU-21287 id: NCI-2023-03077 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) briefTitle: Transcutaneous Sensors for the Detection of Cancer-Related Lymphedema, Project Limb Rescue Study overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-12-31 date: 2025-12-31 date: 2024-03-12 date: 2024-03-12 name: Ohio State University Comprehensive Cancer Center class: OTHER briefSummary: This clinical trial studies how well new adhesive-based sensors that stick to the skin (transcutaneous) work in detecting cancer-related long-term arm swelling (lymphedema). For many patients, lymphedema s painful, unsightly, and weakening. The early signs of lymphedema are hard to see, and sometimes it is only diagnosed by hospital equipment at larger centers. Treating lymphedema early is usually more successful than trying to treat in later stages. The adhesive-based sensors used in this study work by using techniques called photoplethysmography (PPG) and bioimpedance (BI). PPG is an optical technique that can be used to detect blood volume changes in tissue. BI evaluates how tissue responds to an externally applied electrical current. This study may assist researchers in distinguishing participants with lymphedema in comparison to participants without lymphedema, and develop a way for patients to check for lymphedema at home. conditions: Hematopoietic and Lymphoid System Neoplasm conditions: Lymphedema conditions: Malignant Solid Neoplasm studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 70 type: ESTIMATED name: Bioelectric Impedance Analysis name: Exercise name: Photoplethysmography name: Questionnaire Administration measure: Unique signature describing photoplethysmography and bioimpedance at rest and during activity measure: Patient reported outcomes measure: Tolerability of sensors measure: Likely classification for lymphedema sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ohio State University Comprehensive Cancer Center city: Columbus state: Ohio zip: 43210 country: United States name: Carlo M. Contreras, MD role: CONTACT phone: 614-293-3465 email: Carlo.Contreras@osumc.edu name: Carlo M. Contreras, MD role: PRINCIPAL_INVESTIGATOR lat: 39.96118 lon: -82.99879 hasResults: False
<\|newrecord\|> nctId: NCT06305871 id: 2023-NHLHCRF-YYPPLC-ZR-09 briefTitle: Clinical Study of Ultrasound-guided Radiofrequency Ablation in the Treatment of Refractory Hyperthyroidism overallStatus: ACTIVE_NOT_RECRUITING date: 2023-08-01 date: 2025-07-31 date: 2025-07-31 date: 2024-03-12 date: 2024-03-12 name: Zhang Bo class: OTHER briefSummary: Hyperthyroidism is an endocrine disease with a high incidence rate, and some patients are difficult to effectively control the condition after long-term drug treatment, and the disease recurs, forming refractory hyperthyroidism. The search for a new safe, effective and minimally invasive treatment has become a research hotspot. Ultrasound-guided radiofrequency ablation is a hot spot in clinical research due to its advantages of low trauma, high safety, precise inactivation of lesions, and multiple ablation. However, there is no unified standard for the number and scope of ablation in the treatment of refractory hyperthyroidism by radiofrequency ablation, and there is a lack of data on the effectiveness and safety of the treatment with large samples and long-term effects. Therefore, how to establish a standardized treatment strategy and appropriate plan for ablation of refractory hyperthyroidism based on clinical practice is an urgent problem to be solved. The purpose of this study was to prospectively include refractory hyperthyroidism for ultrasound-guided radiofrequency ablation, and to evaluate the efficacy and safety of hyperthyroidism ablation by comparing the changes in symptoms and signs, serology, and imaging of patients before and after ablation. The relevant factors affecting the efficacy of ablation were analyzed and the most appropriate ablation scope was determined. Radiofrequency ablation was retrospectively compared with traditional surgery and 131I treatment, and the near- and medium-term treatment effects, incidence of adverse reactions and complications, as well as the economic benefits and sociopsychological differences of the three treatment methods were compared.
The expected outcome of this study is to establish a research cohort of hyperthyroidism ablation based on a large sample population, and to establish the most appropriate and effective regimen for radiofrequency ablation of refractory hyperthyroidism compared with traditional surgery and 131I treatment with safety and near- and medium-term efficacy. The Department of Ultrasound Medicine of China-Japan Friendship Hospital has accumulated rich experience in the ablation treatment of benign and malignant thyroid nodules and hyperthyroidism, and has completed more than 200 cases of thyroid ablation in the past two years. Under the leadership of Professor Zhang Bo, the research team of this project has conducted a number of clinical studies on the ultrasound diagnosis and treatment of thyroid diseases, presided over and participated in more than 20 national, provincial and university-level scientific research courses, and the first author or corresponding author wrote more than 70 articles in related fields, which laid a solid research foundation for the conduct of this study. conditions: Hyperthyroidism/Thyrotoxicosis studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Ablation therapy measure: Discontinuation rate measure: Recurrence rate sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: China-Japan friendship hospital city: Beijing state: Beijing zip: 100000 country: China lat: 39.9075 lon: 116.39723 hasResults: False
<\|newrecord\|> nctId: NCT06305858 id: UKA - PFJ briefTitle: Partial Versus Total Knee Replacement in Bicompartmental Gonarthrosis (Medial and Patellofemoral): Prospective Functional Assessment Study overallStatus: RECRUITING date: 2022-03-01 date: 2025-09 date: 2025-12 date: 2024-03-12 date: 2024-03-12 name: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio class: OTHER briefSummary: The study is, in accordance with current legislation, definable as a prospective single-center interventional randomized study.
The aim of the study is to evaluate the post-operative recovery of the group A patient undergoing the partial knee replacement surgical procedure compared to the group B patient undergoing the total knee replacement surgical procedure through clinical/functional scores.
The primary outcome is evaluate the difference in score of the KSS questionnaire, at 1 month after surgery, completed by the patient of group A compared to the patient of group B.
The population consists of 48 adult patients with gonarthrosis divided into two groups:
24 patients Group A experimental group: partial denture surgical procedure
24 patients Group B control group: total denture surgical procedure with patellar resurfacing conditions: Knee Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: PARTICIPANT count: 48 type: ESTIMATED name: Prosthetic Surgical Procedure measure: Assess the difference in score of the KSS (Knee Society Score) questionnaire, completed by the patient in group A compared to the patient in group B sex: ALL minimumAge: 40 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Istituto Clinico San Siro status: RECRUITING city: Milan country: Italy name: Elena Cittera role: CONTACT phone: 0283502224 email: elena.cittera@grupposandonato.it name: Andrea Parente role: PRINCIPAL_INVESTIGATOR lat: 45.46427 lon: 9.18951 hasResults: False
<\|newrecord\|> nctId: NCT06305845 id: 152012023 briefTitle: Digital Crowns Versus Prefabricated Crowns on Primary Teeth overallStatus: ACTIVE_NOT_RECRUITING date: 2023-06-01 date: 2023-09-20 date: 2024-09 date: 2024-03-12 date: 2024-03-12 name: National Research Centre, Egypt class: OTHER briefSummary: Badly decayed primary molars will be treated by performing the pulp therapy technique indicated, then the patients will be randomized into two groups to receive the restorative intervention. For the intervention group, teeth will be prepared to receive the digital crown after intraoral scanning while for the control group, teeth will be prepared to receive the prefabricated zirconia crowns. Teeth will be followed up clinically for 1 year, at 1, 6 and 12 months. conditions: Dental Caries in Children studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: a randomized clinical trial with two parallel arms primaryPurpose: TREATMENT masking: SINGLE maskingDescription: participants will not be informed of which crown they will receive whoMasked: PARTICIPANT count: 58 type: ESTIMATED name: Digital crowns measure: Patient and parent satisfaction measure: Crown retention measure: Gingival inflammation measure: Color match sex: ALL minimumAge: 4 Years maximumAge: 10 Years stdAges: CHILD facility: National Research Centre city: Cairo country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False
<\|newrecord\|> nctId: NCT06305832 id: IUNU-PC-120 briefTitle: Salvage Radiotherapy Combined With Androgen Deprivation Therapy (ADT) With or Without Rezvilutamide in the Treatment of Biochemical Recurrence After Radical Prostatectomy for Prostate Cancer overallStatus: RECRUITING date: 2023-09-07 date: 2028-03 date: 2028-03 date: 2024-03-12 date: 2024-03-12 name: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School class: OTHER briefSummary: To evaluate the efficacy and safety of rezvilutamide in combination with androgen deprivation therapy(ADT) and standard salvage radiation therapy(SRT) or SRT combination with ADT in prostate cancer patients with biochemical recurrence of prostate-specific antigen(PSA) persistence after radical prostatectomy(RP). conditions: Prostate Cancer conditions: Biochemical Recurrence studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 102 type: ESTIMATED name: Rezvilutamide name: Androgen deprivation therapy (ADT) name: SRT measure: 3-year biochemical progression-free survival measure: progression-free survival (PFS) measure: metastasis-free survival (MFS) measure: percentage of undetectable PSA measure: ctDNA-positive rate measure: ctDNA clearance rate measure: Adverse Events sex: MALE minimumAge: 40 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institute of Urology, Nanjing University status: RECRUITING city: Nanjing state: Jiangsu zip: 210000 country: China name: Shun Zhang role: CONTACT phone: 15050589789 phoneExt: 15050589789 email: explorershun@126.com lat: 32.06167 lon: 118.77778 facility: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School status: RECRUITING city: Nanjing state: Jiangsu zip: 210000 country: China name: Hongqian Guo, Phd role: CONTACT phone: 13605171690 email: dr.ghq@nju.edu.cn name: Shun Zhang role: CONTACT name: Hongqian Guo role: PRINCIPAL_INVESTIGATOR lat: 32.06167 lon: 118.77778 hasResults: False
<\|newrecord\|> nctId: NCT06305819 id: 2023057 briefTitle: Effectiveness of a Self-management Program After Traumatic Injury acronym: SEMPO overallStatus: RECRUITING date: 2024-01-01 date: 2030-12-31 date: 2030-12-31 date: 2024-03-12 date: 2024-04-12 name: Oslo University Hospital class: OTHER name: South-Eastern Norway Regional Health Authority name: Sunnaas Rehabilitation Hospital name: University of Oslo briefSummary: Traumatic injuries, defined as a physical injury with sudden onset, are a leading cause to disability and impaired health. Persons who sustain a traumatic injury often report problems in daily life activities and reduced quality of life, which may limit participation in work/studies, leisure activities and family life. Consequently, complex rehabilitation and support is recommended in National Trauma guidelines due to the often long-lasting physical and psychological sequela of the injury.
The main goal of this study is to determine the effectiveness of a self-management support program delivered to persons with a moderate or severe traumatic injury in the sub-acute phase of recovery (i.e. 3-4 months after injury). The self-management program aims to enhance patients' self-efficacy by building skills and self-management strategies to cope with injury-related consequences. The program has a group-based format and consists of eight sessions comprising psychoeducation, skill mastery and sharing of experiences. The participants who will be included in the study must be between 18 and 70 years, be residing in the southeast region of Norway, be admitted to Oslo University hospital or transferred from local hospital within 72 hours after injury, have at least a two-day hospital stay, and be able to read and understand Norwegian language. Participants will be randomly assigned to either intervention or control group. A group of patients will also be able to self-select if they want to receive the self-management support program or be in the control group. The latter is an explorative part of the study to evaluate the influence of patients' treatment-preferences on the study outcomes. Participants in the control group will receive treatment as usual. conditions: Trauma Injury conditions: Trauma, Multiple conditions: Polytrauma studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 220 type: ESTIMATED name: self-management support program name: Control group measure: Trauma Coping Self-Efficacy measure: Rivermead Post-Concussion Symptom Questionnaire measure: Fatigue Severity Scale measure: Insomnia Severity Index measure: Brief Pain Inventory -short form measure: International Physical Activity Questionnaire measure: Cognitive Failures Questionnaire measure: Patient Health Questionnaire-9 measure: Generalised Anxiety Disorder-7 measure: Impact of Event Scale - Revised measure: Return to work measure: Resilience Scale for Adults measure: EuroQol five-dimensional questionnaire measure: Target Outcomes measure: Patient Global Impression of Change measure: Intervention acceptability and satisfaction measure: Intervention satisfaction measure: WHO Disability Assessment Scale measure: Glasgow Outcome Scale - Extended measure: Communication with physicians measure: Health Literacy Questionnaire measure: Received health care services sex: ALL minimumAge: 18 Years maximumAge: 72 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Oslo University Hospital status: RECRUITING city: Oslo country: Norway name: Mari Storli Rasmussen, PhD role: CONTACT phone: +4799797575 email: masras@ous-hf.no name: Solveig L. Hauger, PhD role: CONTACT phone: +4791310358 email: solveig.hauger@gmail.com lat: 59.91273 lon: 10.74609 hasResults: False
<\|newrecord\|> nctId: NCT06305806 id: Pro00112597_B id: OTA-21-015G type: OTHER domain: NIH Grant to RTI; RTI subcontracting with DCRI briefTitle: RECOVER-AUTONOMIC: Platform Protocol, Appendix B (Ivabradine) overallStatus: ENROLLING_BY_INVITATION date: 2024-03-11 date: 2025-12 date: 2026-03 date: 2024-03-12 date: 2024-04-09 name: Kanecia Obie Zimmerman class: OTHER briefSummary: This study is a platform protocol designed to be flexible so that it is suitable for a wide range of settings within health care systems and in community settings where it can be integrated into COVID-19 programs and subsequent treatment plans.
This protocol is a prospective, multi-center, multi-arm, randomized, controlled platform trial evaluating various interventions for use in the treatment of autonomic dysfunction symptoms, including cardiovascular complications and postural orthostatic tachycardia syndrome (POTS), in PASC participants. The interventions tested will include non-pharmacologic care and pharmacologic therapies with study drugs. conditions: Long COVID conditions: Long Covid19 conditions: Long Covid-19 studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: In each Appendix trial, each participant will be assigned with equal probability to one of the factorial combinations based on two factors: (1) a study intervention/control and (2) non-pharmacologic intervention/control if the participant is eligible for the study intervention. primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: Double blind whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 180 type: ESTIMATED name: Ivabradine name: Ivabradine Placebo name: Coordinated Care name: Usual Care measure: Change in Orthostatic Hypotension Questionnaire (OHQ)/Orthostatic Intolerance Questionnaire (OIQ) Composite Score measure: Change in Composite Autonomic Symptoms Score 31 (COMPASS-31) measure: Change in Malmo POTS Symptom Score measure: Change in Active Stand Test measure: Change in blood pressure (BP) measure: Change in heart rate (HR) measure: Change in 6-min Walk Test measure: Change in PROMIS-29 + 2 Questionnaire measure: Change in step count as measured by a wearable device measure: Change in heart rate as measured by a wearable device measure: Proportion of participants who experience individual SAEs measure: Proportion who experience any one or more SAEs measure: Incidence of SAEs leading to discontinuation measure: Incidence of Events of Special Interest (ESIs) measure: Changes in Autonomic Function Testing measure: Change in Vanderbilt Orthostatic Symptoms Score (VOSS) measure: Change in PASC Symptom Questionnaire sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: All sites listed under NCT06305780 city: Durham state: North Carolina zip: 27710 country: United States lat: 35.99403 lon: -78.89862 hasResults: False
<\|newrecord\|> nctId: NCT06305793 id: Pro00112597_A id: OTA-21-015G type: OTHER domain: NIH Grant to RTI; RTI subcontracting with DCRI briefTitle: RECOVER-AUTONOMIC: Platform Protocol, Appendix A (IVIG) overallStatus: ENROLLING_BY_INVITATION date: 2024-03-11 date: 2025-12 date: 2026-03 date: 2024-03-12 date: 2024-04-08 name: Kanecia Obie Zimmerman class: OTHER briefSummary: This study is a platform protocol designed to be flexible so that it is suitable for a wide range of settings within health care systems and in community settings where it can be integrated into COVID-19 programs and subsequent treatment plans.
This protocol is a prospective, multi-center, multi-arm, randomized, controlled platform trial evaluating various interventions for use in the treatment of autonomic dysfunction symptoms, including cardiovascular complications and postural orthostatic tachycardia syndrome (POTS), in Post-Acute Sequelae of SARS-CoV-2 infection (PASC) participants. The interventions tested will include non-pharmacologic care and pharmacologic therapies with study drugs. conditions: Long COVID conditions: Long Coronavirus Disease 2019 (Covid19) conditions: Long Covid-19 studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: In each Appendix trial, each participant will be assigned with equal probability to one of the factorial combinations based on two factors: (1) a study intervention/control and (2) non-pharmacologic intervention/control if the participant is eligible for the study intervention. primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: Double blind whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 200 type: ESTIMATED name: IVIG (intravenous immunoglobulin) name: IVIG Placebo name: Coordinated Care name: Usual Care measure: Change in Orthostatic Hypotension Questionnaire (OHQ)/Orthostatic Intolerance Questionnaire (OIQ) Composite Score measure: Change in Composite Autonomic Symptoms Score 31 (COMPASS-31) measure: Change in Malmo POTS Symptom Score measure: Change in Active Stand Test measure: Change in blood pressure measure: Change in heart rate (HR) measure: Change in 6-min Walk Test measure: Change in Patient-Reported Outcomes Measurement Information System (PROMIS-29) + 2 Questionnaire measure: Change in step count as measured by a wearable device measure: Change in heart rate as measured by a wearable device measure: Proportion of participants who experience individual (SAEs measure: Proportion who experience any one or more ( Serious Adverse Event) SAEs measure: Incidence of SAEs leading to discontinuation measure: Incidence of Events of Special Interest (ESIs) measure: Changes in Autonomic Function Testing measure: Change in Vanderbilt Orthostatic Symptoms Score (VOSS) measure: Change in PASC Symptom Questionnaire sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: All sites listed under NCT06305780 city: Durham state: North Carolina zip: 27710 country: United States lat: 35.99403 lon: -78.89862 hasResults: False
<\|newrecord\|> nctId: NCT06305780 id: Pro00112597 id: OTA-21-015G type: OTHER domain: NIH Grant to RTI; RTI subcontracting with DCRI briefTitle: RECOVER-AUTONOMIC Platform Protocol overallStatus: ENROLLING_BY_INVITATION date: 2024-03-11 date: 2025-12 date: 2026-03 date: 2024-03-12 date: 2024-04-08 name: Kanecia Obie Zimmerman class: OTHER briefSummary: This study is a platform protocol designed to be flexible so that it is suitable for a wide range of settings within health care systems and in community settings where it can be integrated into COVID-19 programs and subsequent treatment plans.
This protocol is a prospective, multi-center, multi-arm, randomized, controlled platform trial evaluating various interventions for use in the treatment of autonomic dysfunction symptoms, including cardiovascular complications and postural orthostatic tachycardia syndrome (POTS), in PASC participants. The interventions tested will include non-pharmacologic care and pharmacologic therapies with study drugs. conditions: Long COVID conditions: Long Covid19 conditions: Long Covid-19 studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: In each Appendix trial, each participant will be assigned with equal probability to one of the factorial combinations based on two factors: (1) a study intervention/control and (2) non-pharmacologic intervention/control if the participant is eligible for the study intervention. primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: Double blind whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 380 type: ESTIMATED name: IVIG + Coordinated Care name: IVIG Placebo + Coordinated Care name: Ivabradine + Coordinated Care name: Ivabradine Placebo + Coordinated Care name: IVIG + Usual Care name: IVIG Placebo + Usual Care name: Ivabradine + Usual Care name: Ivabradine Placebo + Usual Care measure: Change in Orthostatic Hypotension Questionnaire (OHQ)/Orthostatic Intolerance Questionnaire (OIQ) Composite Score measure: Change in Composite Autonomic Symptoms Score 31 (COMPASS-31) measure: Change in Malmo POTS Symptom Score measure: Change in Active Stand Test measure: Change in blood pressure measure: Change in heart rate (HR) measure: Change in 6-min Walk Test measure: Change in PROMIS-29 + 2 Questionnaire measure: Change in step count as measured by a wearable device measure: Change in heart rate as measured by a wearable device measure: Proportion of participants who experience individual SAEs measure: Proportion who experience any one or more SAEs measure: Incidence of SAEs leading to discontinuation measure: Incidence of Events of Special Interest (ESIs) measure: Changes in Autonomic Function Testing measure: Change in Vanderbilt Orthostatic Symptoms Score (VOSS) measure: Change in PASC Symptom Questionnaire sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Colorado Anschutz Medical Campus Clinical and Translational Research Center (CTRC) - Appendix A & B city: Aurora state: Colorado zip: 80045 country: United States lat: 39.72943 lon: -104.83192 facility: Rush University Medical Center - Appendix A & B city: Chicago state: Illinois zip: 60612 country: United States lat: 41.85003 lon: -87.65005 facility: NorthShore University HealthSystem - Evanston Hospital - Appendix B Only city: Evanston state: Illinois zip: 60201 country: United States lat: 42.04114 lon: -87.69006 facility: University of Kansas Medical Center CTSU Fairway - Appendix A & B city: Fairway state: Kansas zip: 66205 country: United States lat: 39.02223 lon: -94.6319 facility: St. Lawrence Health Medical Campus - Appendix A & B city: Canton state: New York zip: 13617 country: United States lat: 44.59562 lon: -75.16909 facility: Sentara Norfolk General Hospital - Appendix A and B city: Norfolk state: Virginia zip: 23507 country: United States lat: 36.84681 lon: -76.28522 facility: Providence Medical Research Center - Appendix A & B city: Spokane state: Washington zip: 99204 country: United States lat: 47.65966 lon: -117.42908 hasResults: False
<\|newrecord\|> nctId: NCT06305767 id: V940-005 id: V940-005 type: OTHER domain: Merck id: U1111-1292-1952 type: OTHER domain: WHO id: 2023-505658-17 type: OTHER domain: EU CT briefTitle: A Study of Pembrolizumab (MK-3475) Plus V940 in Participants With Bladder Cancer Post-Radical Resection (V940-005) overallStatus: RECRUITING date: 2024-03-28 date: 2026-10-08 date: 2031-04-08 date: 2024-03-12 date: 2024-04-25 name: Merck Sharp & Dohme LLC class: INDUSTRY name: ModernaTX, Inc. briefSummary: The purpose of this study is to assess the safety and efficacy of V940 in combination with pembrolizumab (MK-3475) compared to pembrolizumab alone as an adjuvant treatment for participants with pathologic high-risk muscle-invasive urothelial carcinoma (MIUC) after radical resection. The primary study hypothesis is that V940 in combination with pembrolizumab results in a superior disease-free survival (DFS) as assessed by the investigator compared to pembrolizumab alone in participants with high-risk MIUC after radical resection. conditions: Bladder Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 200 type: ESTIMATED name: Pembrolizumab name: V940 name: Placebo measure: Disease Free Survival (DFS) measure: Overall Survival (OS) measure: Distant Metastasis-Free Survival (DMFS) measure: Number of Participants Who Experience an Adverse Event (AE) measure: Number of Participants Who Discontinue Study Treatment Due to an AE sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: AdventHealth Orlando-AdventHealth Medical Group Hematology & Oncology at Orlando ( Site 0102) status: RECRUITING city: Orlando state: Florida zip: 32804 country: United States name: Study Coordinator role: CONTACT phone: 205-520-6512 lat: 28.53834 lon: -81.37924 facility: One Clinical Research ( Site 1807) status: RECRUITING city: Nedlands state: Western Australia zip: 6009 country: Australia name: Study Coordinator role: CONTACT phone: +61862799466 lat: -31.98184 lon: 115.8073 facility: Centre Hospitalier de l'Université de Montréal ( Site 0005) status: RECRUITING city: Montréal state: Quebec zip: H2X 3E4 country: Canada name: Study Coordinator role: CONTACT phone: 5148908000 lat: 45.50884 lon: -73.58781 facility: Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0 status: RECRUITING city: Quebec City state: Quebec zip: G1J 1Z4 country: Canada name: Study Coordinator role: CONTACT phone: 4185254444 lat: 46.81228 lon: -71.21454 facility: Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 0801) status: RECRUITING city: Bydgoszcz state: Kujawsko-pomorskie zip: 85-796 country: Poland name: Study Coordinator role: CONTACT phone: 48501446778 lat: 53.1235 lon: 18.00762 facility: HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 1003) status: RECRUITING city: Pozuelo de Alarcon state: Madrid zip: 28223 country: Spain name: Study Coordinator role: CONTACT phone: +34914521987 lat: 40.43293 lon: -3.81338 hasResults: False
<\|newrecord\|> nctId: NCT06305754 id: 2870-009 id: 2023-504910-31 type: REGISTRY domain: EU CT id: U1111-1288-3804 type: OTHER domain: UTN id: MK-2870-009 type: OTHER domain: Merck briefTitle: Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) and Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009) overallStatus: NOT_YET_RECRUITING date: 2024-06-03 date: 2028-09-12 date: 2030-06-14 date: 2024-03-12 date: 2024-04-29 name: Merck Sharp & Dohme LLC class: INDUSTRY briefSummary: The purpose of this study is to evaluate sacituzumab tirumotecan versus pemetrexed in combination with carboplatin for the treatment of epidermal growth factor receptor (EGFR)-mutated advanced non-squamous non-small cell lung cancer (NSCLC). Participants in this study have NSCLC that has continued to progress on prior treatment with EGFR tyrosine kinase inhibitors (TKIs).
The primary hypotheses of this study are that sacituzumab tirumotecan is better than platinum-based doublet chemotherapy (pemetrexed and carboplatin) in regard to progression-free survival (PFS) and overall survival (OS). conditions: Non-small Cell Lung Cancer (NSCLC) studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Unblinded Open-label whoMasked: OUTCOMES_ASSESSOR count: 520 type: ESTIMATED name: Sacituzumab tirumotecan name: Pemetrexed name: Carboplatin name: Antihistamine name: H2 Receptor Antagonist name: Acetaminophen (or equivalent) name: Dexamethasone (or equivalent) measure: Progression-Free Survival (PFS) measure: Overall Survival (OS) measure: Objective Response Rate (ORR) measure: Duration of Response (DOR) measure: Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score measure: Change From Baseline in the Dyspnea (Item 8) Score, on the EORTC QLQ-C30 measure: Change from Baseline in the Cough (Item 31) Score, on the EORTC Lung-Cancer specific Quality of Life Questionnaire (QLQ-LC13) measure: Change from Baseline in the Chest Pain (Item 40) Score, on the EORTC QLQ-LC13 measure: Time to Deterioration (TTD) in Global Health Status/Quality of Life (Items 29 and 30) Combined Score, on the EORTC QLQ-C30 measure: TTD in the Dyspnea (Item 8) Score, on the EORTC QLQ-C30 measure: TTD in the Cough (Item 31) Score, on the EORTC QLQ-LC13 measure: TTD in the Chest Pain (Item 40) Score, on the EORTC QLQ-LC13 measure: Number of Participants Who Experience One or More Adverse Events (AEs) measure: Number of Participants Who Discontinue Study Treatment Due to an AE sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06305741 id: 24-060 briefTitle: A Study of an Anxiety Intervention for Latino/Latina/Hispanic Older Adults With Cancer and Their Caregivers overallStatus: RECRUITING date: 2024-03-05 date: 2026-03 date: 2026-03 date: 2024-03-12 date: 2024-03-12 name: Memorial Sloan Kettering Cancer Center class: OTHER briefSummary: The purpose of this study is to find out if an anxiety treatment program is practical and effective for Latino older adults with cancer (OACs) and their caregivers. conditions: Cancer Patients conditions: Care Givers studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 60 type: ESTIMATED name: Managing Anxiety from Cancer (MAC) measure: percentage of participants to complete all study procedures sex: ALL minimumAge: 55 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Memorial Sloan Kettering at Basking Ridge (All Protocol Activities) status: RECRUITING city: Basking Ridge state: New Jersey zip: 07920 country: United States name: Kelly McConnell, PhD role: CONTACT phone: 646-888-0026 lat: 40.70621 lon: -74.54932 facility: Memorial Sloan Kettering Monmouth (All Protocol Activities) status: RECRUITING city: Middletown state: New Jersey zip: 07748 country: United States name: Kelly McConnell, PhD role: CONTACT phone: 646-888-0026 lat: 40.39652 lon: -74.09211 facility: Memorial Sloan Kettering Bergen (All Protocol Activities) status: RECRUITING city: Montvale state: New Jersey zip: 07645 country: United States name: Kelly McConnell, PhD role: CONTACT phone: 646-888-0026 lat: 41.04676 lon: -74.02292 facility: Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities) status: RECRUITING city: Commack state: New York zip: 11725 country: United States name: Kelly McConnell, PhD role: CONTACT phone: 646-888-0026 lat: 40.84288 lon: -73.29289 facility: Memorial Sloan Kettering Westchester (All Protocol Activities) status: RECRUITING city: Harrison state: New York zip: 10604 country: United States name: Kelly McConnell, PhD role: CONTACT phone: 646-888-0026 lat: 40.96899 lon: -73.71263 facility: Memorial Sloan Kettering Cancer Center (All protocol activities) status: RECRUITING city: New York state: New York zip: 10065 country: United States name: Kelly McConnell, PhD role: CONTACT phone: 646-888-0026 lat: 40.71427 lon: -74.00597 facility: Memorial Sloan Kettering Nassau (All Protocol Activities) status: RECRUITING city: Rockville Centre state: New York zip: 11553 country: United States name: Kelly McConnell, PhD role: CONTACT phone: 646-888-0026 lat: 40.65871 lon: -73.64124 hasResults: False
<\|newrecord\|> nctId: NCT06305728 id: 23-367 briefTitle: A Study of Early Cancer Detection in People at High Risk of Developing Pancreatic Ductal Adenocarcinoma (PDAC) overallStatus: RECRUITING date: 2024-03-04 date: 2030-03-04 date: 2030-03-04 date: 2024-03-12 date: 2024-03-12 name: Memorial Sloan Kettering Cancer Center class: OTHER briefSummary: The purpose of this study is for researchers to find ways of detecting pancreatic ductal adenocarcinoma/PDAC early to avoid the invasive procedure of surgery. The study researchers think a combination of imaging and a series of blood tests may be an effective way to detect PDAC early. In this study, researchers will look at whether a combination of the following types of imaging with blood tests can detect PDAC in pancreatic cysts:
* The ImmunoPET scan (immune-positron emission tomography scan) with the imaging agent 89Zr-DFO-HuMab-5B1
* The HP MRI scan (hyperpolarized pyruvate magnetic resonance imaging scan) conditions: Pancreatic Cyst studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 25 type: ESTIMATED name: 89Zr-DFO-HuMab-5B1 immunoPET name: HP MRI name: Blood assay measure: Sensitivity of ImmunoPET to identify presence or absence of adenocarcinoma sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities) status: RECRUITING city: Basking Ridge state: New Jersey zip: 07920 country: United States name: Kevin Soares, MD role: CONTACT phone: 212-639-3195 lat: 40.70621 lon: -74.54932 facility: Memorial Sloan Kettering Monmouth (Limited protocol activities) status: RECRUITING city: Middletown state: New Jersey zip: 07748 country: United States name: Kevin Soares, MD role: CONTACT phone: 212-639-3195 lat: 40.39652 lon: -74.09211 facility: Memorial Sloan Kettering Bergen (Limited Protocol Activities) status: RECRUITING city: Montvale state: New Jersey zip: 07645 country: United States name: Kevin Soares, MD role: CONTACT phone: 212-639-3195 lat: 41.04676 lon: -74.02292 facility: Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity) status: RECRUITING city: Commack state: New York zip: 11725 country: United States name: Kevin Soares, MD role: CONTACT phone: 212-639-3195 lat: 40.84288 lon: -73.29289 facility: Memorial Sloan Kettering Westchester (Limited Protocol Activities) status: RECRUITING city: Harrison state: New York zip: 10604 country: United States name: Kevin Soares, MD role: CONTACT phone: 212-639-3195 lat: 40.96899 lon: -73.71263 facility: Memorial Sloan Kettering Cancer Center (All protocol activites) status: RECRUITING city: New York state: New York zip: 10065 country: United States name: Kevin Soares, MD role: CONTACT phone: 212-639-3195 lat: 40.71427 lon: -74.00597 facility: Weill Cornell Medical Center (Specimen Analysis Only) status: NOT_YET_RECRUITING city: New York state: New York zip: 10065 country: United States name: David Lyden, MD role: CONTACT phone: 212-746-6565 lat: 40.71427 lon: -74.00597 facility: Memorial Sloan Kettering Nassau (Limited Protocol Activites) status: RECRUITING city: Rockville Centre state: New York zip: 11553 country: United States name: Kevin Soares, PhD role: CONTACT phone: 212-639-3195 lat: 40.65871 lon: -73.64124 hasResults: False
<\|newrecord\|> nctId: NCT06305715 id: IIT-THOMPSON-RADIANCE-LUNG-X briefTitle: Radiation Prior to TKI to Delay Progression in Advanced Driver-Mutated Non-small Cell Lung Cancers (RadiaNCe Lung X) overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2027-06-15 date: 2028-06-15 date: 2024-03-12 date: 2024-03-12 name: Medical College of Wisconsin class: OTHER briefSummary: This prospective, two-part, single-arm, phase II trial is designed to evaluate whether the use of definitive radiation to the primary lung lesion prolongs progression-free survival (PFS) in treatment-naïve, metastatic, driver-mutated non-small cell lung cancers (NSCLC) patients who are subsequently placed on a tyrosine kinase inhibitor (TKI). conditions: Non Small Cell Lung Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 34 type: ESTIMATED name: Radiation Therapy name: Targeted TKI therapy measure: Progression Free Survival sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Froedtert Hospital & the Medical College of Wisconsin city: Milwaukee state: Wisconsin zip: 53226 country: United States name: Jonathan Thompson, MD, MS role: CONTACT phone: 414-805-4600 email: jrthomps@mcw.edu lat: 43.0389 lon: -87.90647 hasResults: False
<\|newrecord\|> nctId: NCT06305702 id: LZRXN-001 briefTitle: Real-world Study of Inetetamab in HER2-positive Metastatic Breast Cancer overallStatus: COMPLETED date: 2022-07-01 date: 2023-12-31 date: 2024-01-31 date: 2024-03-12 date: 2024-03-12 name: Liaoning Tumor Hospital & Institute class: OTHER briefSummary: A multicenter real-world study was conducted to gather clinicopathological data from patients with HER2-positive metastatic breast cancer who were treated with inetetamab between 2022 and 2023. The study aimed to estimate the progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR), and adverse events (AEs) associated with inetetamab therapy. conditions: HER2-positive Metastatic Breast Cancer studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: RETROSPECTIVE count: 500 type: ACTUAL name: inetetamab measure: Progression Free Survival(PFS) measure: objective response rate (ORR) measure: Adverse events (AEs) sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Liaoning Cancer Hospital &Institue city: Shenyang country: China lat: 41.79222 lon: 123.43278 hasResults: False
<\|newrecord\|> nctId: NCT06305689 id: 79144 briefTitle: Defining Treatment Outcomes and Genetic Architecture in Idiopathic Toe Walking* acronym: ITW overallStatus: RECRUITING date: 2022-01-01 date: 2024-07-01 date: 2024-12-31 date: 2024-03-12 date: 2024-04-03 name: Shriners Hospitals for Children class: OTHER briefSummary: To compare and contrast the clinical, gait and parent-reported outcomes following either non-operative (casting) or operative treatment for children with idiopathic toe walking (ITW) and determine whether there are specific genes associated with ITW. conditions: Idiopathic Toe Walking studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 180 type: ESTIMATED name: Surgery name: Serial Casting measure: Gait parameters: Velocity measure: Gait Paremeters:Stride Length (m) measure: Three dimensional Gait Analysis:Kinematics (degrees) measure: Dynamic Motor Control Index during Walking (Walk-DMC) measure: Three dimensional Gait Analysis:Kinetics (nm/kg) measure: Quantitative Assessment of Toe Walking measure: Pediatric Outcomes Data Collection Instrument measure: Passive Range of Motion measure: Muscle Strength measure: The Toe Walking Tool measure: Selective Motor Control measure: Coactivation Tool measure: Bruininks-Oseretsky Test of Motor Proficiency (BOT-2) measure: Genomics sex: ALL minimumAge: 6 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Shriners Hospitals for Children status: RECRUITING city: Sacramento state: California zip: 95817 country: United States name: Vincent Basas role: CONTACT phone: 916-453-2132 email: vincent.basas@shrinenet.org name: Jon R Davids, MD role: PRINCIPAL_INVESTIGATOR lat: 38.58157 lon: -121.4944 facility: Shriners Hospitals for Children status: RECRUITING city: Chicago state: Illinois zip: 60707 country: United States name: Ann Flanagan role: CONTACT phone: 773-622-5400 email: aflanagan@shrinenet.org name: Kelsey Davidson, MD role: PRINCIPAL_INVESTIGATOR lat: 41.85003 lon: -87.65005 facility: Shriners Hospitals for Children status: RECRUITING city: Lexington state: Kentucky zip: 40508 country: United States name: Daniella Hudgins role: CONTACT phone: 859-268-5772 email: Daniella.Hudgins@shrinenent.org name: Rebekah Leet, MD role: PRINCIPAL_INVESTIGATOR lat: 37.98869 lon: -84.47772 facility: Shriners Hospitals for Children status: RECRUITING city: Portland state: Oregon zip: 97239 country: United States name: Paige Lemhouse role: CONTACT phone: 971-544-3377 email: plemhouse@shrinenet.org name: Jeremy Bauer, MD role: PRINCIPAL_INVESTIGATOR name: Susan Sienko, PhD role: SUB_INVESTIGATOR lat: 45.52345 lon: -122.67621 facility: Shriners Hospitals for Children status: RECRUITING city: Philadelphia state: Pennsylvania zip: 19140 country: United States name: Natalie Williams role: CONTACT phone: 215-430-4248 email: Natalie.Wiliams@shrinenet.org name: Sean Waldron, MD role: PRINCIPAL_INVESTIGATOR lat: 39.95233 lon: -75.16379 facility: Shriners Hospitals for Children status: RECRUITING city: Greenville state: South Carolina zip: 29605 country: United States name: Brittney Southerland role: CONTACT phone: 864-255-7955 email: Brittney.Southerland@shrinenet.org name: Lauren Hyer, MD role: PRINCIPAL_INVESTIGATOR name: David Westberry, MD role: SUB_INVESTIGATOR lat: 34.85262 lon: -82.39401 facility: Shriners Hospitals for Children status: RECRUITING city: Salt Lake City state: Utah zip: 84103 country: United States name: Lisa Certer role: CONTACT phone: 801-536-3807 email: Lcarter@shrinenet.org name: Kristin Carroll, MD role: PRINCIPAL_INVESTIGATOR name: Bruce MacWilliams, PhD role: SUB_INVESTIGATOR lat: 40.76078 lon: -111.89105 facility: Shriners Children's Spokane status: RECRUITING city: Spokane state: Washington zip: 99204 country: United States name: Charlotte Preuschoff role: CONTACT phone: 509-623-0427 email: cpreuschoff@shrinenet.org name: Ted Sousa, MD role: PRINCIPAL_INVESTIGATOR lat: 47.65966 lon: -117.42908 hasResults: False
<\|newrecord\|> nctId: NCT06305676 id: MCC-23073 briefTitle: Biomarker Approach to Screening for the Early Detection of HPV-related Oropharyngeal Cancer (BASH OPC) acronym: BASH OPC overallStatus: RECRUITING date: 2024-01-22 date: 2029-01 date: 2029-01 date: 2024-03-12 date: 2024-03-13 name: H. Lee Moffitt Cancer Center and Research Institute class: OTHER name: National Institutes of Health (NIH) briefSummary: Investigators seek to determine the sensitivity and specificity of a combined HPV 16 DNA and host gene methylation oral biomarker panel to distinguish early Oropharyngeal Cancer (OPC) cases from controls among 100 early and 100 late disease pre-treatment OPC cases, and 200 controls matched by sex, age, race/ethnicity, and tobacco use collected from the Moffitt Cancer Center (Moffitt) and the University of Pittsburgh Medical Center Hillman Cancer Center (Pittsburgh). conditions: Oropharyngeal Cancer conditions: HPV-Related Carcinoma studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 400 type: ESTIMATED name: combined HPV 16 DNA and host gene methylation oral biomarker panel measure: Diagnostic Sensitivity measure: Diagnostic Specificity sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Moffitt Cancer Center status: RECRUITING city: Tampa state: Florida zip: 33612 country: United States name: Kimberly Isaacs-Soriano role: CONTACT phone: 813-745-6992 email: kimberly.Isaacs-Soriano@moffitt.org name: Anna Giuliano, PhD role: PRINCIPAL_INVESTIGATOR name: Antonio Amelio, PhD role: PRINCIPAL_INVESTIGATOR name: Jimmy Caudell, MD, PhD role: SUB_INVESTIGATOR name: Christine Chung, MD role: SUB_INVESTIGATOR name: Bruce Wenig, MD role: SUB_INVESTIGATOR lat: 27.94752 lon: -82.45843 facility: University of Pittsburgh Medical Center (UPMC) Hillman Cancer Center status: RECRUITING city: Pittsburgh state: Pennsylvania zip: 15232 country: United States name: Jose P. Zevallos, MD, PhD role: CONTACT email: zevallosjp@upmc.edu name: Robert Ferris, PhD role: CONTACT email: ferrrl@UPMC.EDU lat: 40.44062 lon: -79.99589 hasResults: False
<\|newrecord\|> nctId: NCT06305663 id: 921 briefTitle: A Study to Evaluate the Safety and Efficacy of the Bausch + Lomb Myopia Control Lens for the Correction of Myopic Ametropia and Slowing the Progression of Myopia in Children overallStatus: NOT_YET_RECRUITING date: 2024-03-29 date: 2027-01-31 date: 2027-01-31 date: 2024-03-12 date: 2024-03-12 name: Bausch & Lomb Incorporated class: INDUSTRY briefSummary: A Study to Evaluate the Safety and Efficacy of the Bausch + Lomb Myopia Control Lens for the Correction of Myopic Ametropia and Slowing the Progression of Myopia in Children conditions: Myopia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: The identity of the study eye will be masked to subjects, assessors, and other masked personnel while masking is maintained.. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 418 type: ESTIMATED name: Bausch + Lomb (kalifilcon A) Myopia Control Soft (Hydrophilic) name: CooperVision MiSight (omafilcon A/60%) Myopia Control one day Soft Contact Lens measure: Mean change from baseline in axial length. measure: Mean change from baseline in cycloplegic SERE. sex: ALL minimumAge: 8 Years maximumAge: 12 Years stdAges: CHILD facility: Site 105 city: Beijing state: Beijing zip: 100044 country: China lat: 39.9075 lon: 116.39723 facility: Site 107 city: Dongcheng state: Beijing zip: 100730 country: China facility: Site 109 city: Xiamen state: Fujian zip: 361004 country: China lat: 24.47979 lon: 118.08187 facility: Site 111 city: Haikou state: Hainan zip: 570311 country: China lat: 20.04583 lon: 110.34167 facility: Site 110 city: Wuhan state: Hubei zip: 430012 country: China lat: 30.58333 lon: 114.26667 facility: Site 102 city: Shanghai state: Shanghai zip: 200433 country: China lat: 31.22222 lon: 121.45806 facility: Site 106 city: Taiyuan state: Shanxi zip: 030072 country: China lat: 37.86944 lon: 112.56028 facility: Site 108 city: Shenzhen state: Shenzhen zip: 518040 country: China lat: 22.54554 lon: 114.0683 facility: Site 103 city: Chengdu state: Sichaun Province zip: 610044 country: China lat: 30.66667 lon: 104.06667 facility: Site 104 city: Nankai state: Tianjin zip: 300392 country: China facility: Site 101 city: Wenzhou state: Zhejiang zip: 325027 country: China lat: 27.99942 lon: 120.66682 hasResults: False
<\|newrecord\|> nctId: NCT06305650 id: WK2024001 briefTitle: Probiotic Influence on Obesity-Related Lipidemia overallStatus: RECRUITING date: 2024-03-20 date: 2024-06-20 date: 2024-07-30 date: 2024-03-12 date: 2024-04-09 name: Wecare Probiotics Co., Ltd. class: INDUSTRY briefSummary: This study aims to investigate the effects of Bifidobacterium breve BBr60 on key health indicators in overweight and obese adults. Specifically, it will assess the probiotic's impact on body composition metrics such as BMI, body fat percentage, WHR, and BMR. The inclusion criteria for participants are a BMI of ≥28 kg/m\^2, targeting individuals who stand to benefit significantly from metabolic and body composition improvements. conditions: Overweight or Obesity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Double（Participant,Investigator） whoMasked: PARTICIPANT count: 72 type: ESTIMATED name: Probiotic measure: Effect on body mass index (BMI) values. sex: ALL minimumAge: 19 Years maximumAge: 45 Years stdAges: ADULT facility: Henan University of Science and Technology status: RECRUITING city: Luoyang state: Henan zip: 471000 country: China name: Ying Wu, Dr. role: CONTACT phone: +86 18639283502 email: wuying2000@126.com lat: 34.68361 lon: 112.45361 hasResults: False
<\|newrecord\|> nctId: NCT06305637 id: KTCS-2302 briefTitle: A Study Comparing Ketoconazole Shampoo, 2% and Ketoconazole 2% Shampoo (RS) in the Treatment of Tinea Versicolor. overallStatus: COMPLETED date: 2023-12-04 date: 2024-02-10 date: 2024-02-10 date: 2024-03-12 date: 2024-03-12 name: Taro Pharmaceuticals USA class: INDUSTRY briefSummary: To demonstrate the efficacy, therapeutic equivalence and safety of Ketoconazole Shampoo, 2% (Taro Pharmaceuticals U.S.A., Inc.) and Ketoconazole 2% Shampoo (Reference Standard) in the treatment of tinea versicolor. conditions: Tinea Versicolor studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 430 type: ACTUAL name: Ketoconazole Shampoo, 2% name: Ketoconazole Shampoo, 2% (Reference Standard) name: Placebo measure: To demonstrate the therapeutic equivalence and safety of the Investigational Product sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Taro city: Hawthorne state: New York zip: 10532 country: United States lat: 41.10732 lon: -73.79597 hasResults: False
<\|newrecord\|> nctId: NCT06305624 id: 2024-0130 id: 1R01DA047279-01 type: NIH link: https://reporter.nih.gov/quickSearch/1R01DA047279-01 id: A532000 type: OTHER domain: UW Madison id: Protocol Version 2/21/2024 type: OTHER domain: UW Madison briefTitle: Implementation of Mobile-based Programs for Alcohol Cessation in Treatment of Alcohol-associated Liver Disease acronym: IMPACT-ALD overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2027-10 date: 2027-10 date: 2024-03-12 date: 2024-03-15 name: University of Wisconsin, Madison class: OTHER name: National Institute on Drug Abuse (NIDA) briefSummary: This protocol describes a randomized controlled trial testing the effectiveness and implementability of the CHESS Health Connections smartphone application among patients with alcohol-associated liver disease (ALD) at two medical centers in Michigan and Wisconsin, in two types of clinics: general hepatology and multidisciplinary that offers care for advanced ALD alongside co-located, integrated mental health and substance abuse treatment. The long-term goal of this and future work is to prevent disease progression and promote healthy behaviors by improving the rate of abstinence among patients with ALD earlier in the course of their disease. 298 participants will be enrolled and can expect to be on study for up to 6 months. conditions: Alcohol Use Disorder conditions: Alcohol-related Liver Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized, controlled, Type 1 hybrid implementation-effectiveness trial. primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 298 type: ESTIMATED name: Connections App measure: Days of Alcohol Abstinence in ALD Participants measure: Number of Standard Drinks Consumed in ALD Participants measure: Change in Patient Health Questionnaire (PHQ-8) Score measure: Change in PROMIS Global Health Score measure: Change in Generalized Anxiety Disorder (GAD-7) Score measure: Change in Insomnia Severity Index (ISI) Score measure: Change in Pain Interference (PEG) Score measure: Change in Drinking Motivations Questionnaire - Adult (DMQ-A) Score measure: Change in CHESS Bonding Scale Score measure: Change in Drug-Taking Confidence Questionnaire (DTCQ-8A) Score measure: Change in Treatment Self-Regulation Questionnaire (TSRQ) Score sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UM General Hepatology Clinic city: Ann Arbor state: Michigan zip: 48109 country: United States lat: 42.27756 lon: -83.74088 facility: UM Multidisciplinary ALD Clinic city: Ann Arbor state: Michigan zip: 48109 country: United States lat: 42.27756 lon: -83.74088 facility: UW General Hepatology Clinic city: Madison state: Wisconsin zip: 53705 country: United States lat: 43.07305 lon: -89.40123 facility: UW Multidisciplinary ALD Clinic city: Madison state: Wisconsin zip: 53705 country: United States lat: 43.07305 lon: -89.40123 hasResults: False
<\|newrecord\|> nctId: NCT06305611 id: KIWI briefTitle: European and North Indian Cohort of KaWasaki dIsease overallStatus: RECRUITING date: 2021-07-13 date: 2024-07-15 date: 2024-10-30 date: 2024-03-12 date: 2024-03-12 name: Meyer Children's Hospital IRCCS class: OTHER briefSummary: Kawasaki disease (KD) is currently the leading cause of acquired heart diseases in children in developed countries. Cardiac involvement is the main determinant of the long-term prognosis of these patients, as coronary aneurisms (CAAs) may lead to ischemic heart disease and even sudden death. The current standard of care for KD has consistently reduced CAAs frequency from 25-30% to about 5%. Unfortunately, 10-20% of KD patients results resistant to standard treatment leading to a major risk of cardiac complications. Thus, scoring systems have been constructed in order to identify patients likely to be resistant to IVIG and who may benefit from more aggressive initial therapy. Different scoring scales developed by Kobayashi, Egami et Sano had shown a good sensitivity (77-86%) and specificity (67-86%) in predicting IVIG unresponsiveness in Japanese populations. However, their predictive value was not confirmed by subsequent studies in different ethnic populations. Recently, the French Kawanet group have proposed a IVIG unresponsiveness score that provided good sensitivity and acceptable specificity in a non-Asian KD population even if it was not subsequent validated by an external study. In our study population, the achievement of specificity and sensitivity values for both scores consistent with those reported by the original studies (sensitivity 70% and specificity 80% for Kobayashi and sensitivity 77% and specificity 60% for Kawanet), will be considered a success. conditions: Kawasaki Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 103 type: ESTIMATED measure: IVIG resistance rate measure: percentage of IVIG-resistant patients sex: ALL minimumAge: 1 Year maximumAge: 17 Years stdAges: CHILD facility: Universidade Federal do Rio de Janeiro status: RECRUITING city: Rio de Janeiro country: Brazil name: Adriana Fonseca role: CONTACT lat: -22.90278 lon: -43.2075 facility: Children's Hospital Zagreb status: RECRUITING city: Zagreb country: Croatia name: Alenka Gagro role: CONTACT lat: 45.81444 lon: 15.97798 facility: University Hospital Centre Zagreb, University School of Medicine status: RECRUITING city: Zagreb country: Croatia name: Marija Jelusic role: CONTACT lat: 45.81444 lon: 15.97798 facility: Le Kremlin-Bicetre University Hospital, Paris-Sud University - CEREMAI status: NOT_YET_RECRUITING city: Le Kremlin-Bicêtre country: France name: Isabelle Koné-Paut role: CONTACT lat: 48.81471 lon: 2.36073 facility: Manipal Hospital status: NOT_YET_RECRUITING city: Bangalore country: India name: Anand Prahalad Rao role: CONTACT lat: 12.97194 lon: 77.59369 facility: Postgraduate Institute of Medical Education and Research status: RECRUITING city: Chandigarh country: India name: Vignesh Pandiarajan role: CONTACT lat: 30.73629 lon: 76.7884 facility: Sri Ramachandra Medical Centre status: NOT_YET_RECRUITING city: Chennai country: India name: Mahesh Janarthanan role: CONTACT lat: 13.08784 lon: 80.27847 facility: Amrita Institute of Medical Sciences status: NOT_YET_RECRUITING city: Kochi country: India name: Suma Balan role: CONTACT lat: 9.93988 lon: 76.26022 facility: Institute of Child Health status: RECRUITING city: Kolkata country: India name: Priyankar Pal role: CONTACT lat: 22.56263 lon: 88.36304 facility: Vivekananda Institute of Medical Sciences status: NOT_YET_RECRUITING city: Kolkata country: India name: SUPARNA GUHA role: CONTACT lat: 22.56263 lon: 88.36304 facility: Meir Medical Centre status: NOT_YET_RECRUITING city: Kfar Saba country: Israel name: Ruby Haviv role: CONTACT lat: 32.175 lon: 34.90694 facility: ASST Papa Giovanni XXIII status: RECRUITING city: Bergamo country: Italy name: Lucio Verdoni role: CONTACT lat: 45.69601 lon: 9.66721 facility: Spedali Civili status: RECRUITING city: Brescia country: Italy name: Marco Cattalini role: CONTACT lat: 45.53558 lon: 10.21472 facility: Meyer Children's Hospital IRCCS status: RECRUITING city: Florence country: Italy name: Gabriele Simonini role: CONTACT email: gabriele.simonini@meyer.it lat: 43.77925 lon: 11.24626 facility: IRCCS Istituto Giannina Gaslini status: RECRUITING city: Genova country: Italy name: Silvia Rosina role: CONTACT lat: 44.40478 lon: 8.94438 facility: Fondazione IRCCS Ca' Granda-Ospedale Maggiore Policlinico status: NOT_YET_RECRUITING city: Milano country: Italy name: Giovanni Filocamo role: CONTACT lat: 45.46427 lon: 9.18951 facility: P.O. "Giovanni Di Cristina" status: NOT_YET_RECRUITING city: Palermo country: Italy name: Maria Cristina Maggio role: CONTACT lat: 38.13205 lon: 13.33561 facility: Università di Torino status: RECRUITING city: Torino country: Italy name: Francesco Licciardi role: CONTACT lat: 45.07049 lon: 7.68682 facility: IRCCS Burlo Garofolo status: RECRUITING city: Trieste country: Italy name: andrea Taddio role: CONTACT lat: 45.64953 lon: 13.77679 facility: Beatrix Kinderkliniek, University Medical Center status: NOT_YET_RECRUITING city: Groningen country: Netherlands name: Wineke Armbrust role: CONTACT lat: 53.21917 lon: 6.56667 facility: Hospital de Sabadell status: RECRUITING city: Barcellona country: Spain name: Judith Sanchez Manubens role: CONTACT lat: 41.38879 lon: 2.15899 facility: Hospital Sant Joan de Déu status: RECRUITING city: Barcellona country: Spain name: Jordi Anton role: CONTACT lat: 41.38879 lon: 2.15899 facility: Chiang Mai University Hospital status: RECRUITING city: Chiang Mai country: Thailand name: Watchareewan Sontichai role: CONTACT lat: 18.79038 lon: 98.98468 facility: Hacettepe University Children's Hospital status: RECRUITING city: Ankara country: Turkey name: Seza Ozen role: CONTACT lat: 39.91987 lon: 32.85427 facility: Health Sciences University, Umraniye Education and Research Hospital status: RECRUITING city: Istanbul country: Turkey name: Betul Sozeri role: CONTACT lat: 41.01384 lon: 28.94966 facility: Istanbul Uni. Istanbul Med.Fac status: NOT_YET_RECRUITING city: Istanbul country: Turkey name: Nuray Aktay Ayaz role: CONTACT lat: 41.01384 lon: 28.94966 facility: Royal Hospital for Children status: RECRUITING city: Bristol country: United Kingdom name: Athimalaipet Ramanan role: CONTACT lat: 51.45523 lon: -2.59665 hasResults: False
<\|newrecord\|> nctId: NCT06305598 id: I-3298823 id: NCI-2024-01390 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: I-3298823 type: OTHER domain: Roswell Park Cancer Institute briefTitle: Bipolar Androgen Therapy to Restore Sensitivity to Androgen Deprivation Therapy for Patients With Metastatic Castration Resistant Prostate Cancer overallStatus: RECRUITING date: 2024-06-01 date: 2026-04-01 date: 2027-04-01 date: 2024-03-12 date: 2024-04-25 name: Roswell Park Cancer Institute class: OTHER briefSummary: This phase I trial tests the change in androgen receptor sensitivity, side effects and effectiveness of bipolar androgen therapy, using testosterone, in patients with castration resistant prostate cancer that has spread to other places is the body (metastatic). Bipolar androgen therapy is the regulation of testosterone between castration levels (lower than what would be normally present) and supraphysiological levels (amounts greater than normally found in the body). This may suppress cancer cell growth, which reduces prostate-specific antigen (PSA) levels and may delay cancer progression. conditions: Castration-Resistant Prostate Carcinoma conditions: Metastatic Prostate Carcinoma conditions: Stage IVB Prostate Cancer AJCC v8 studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 14 type: ESTIMATED name: Biopsy name: Bone Scan name: Computed Tomography name: Leuprolide Acetate name: Magnetic Resonance Imaging name: Survey Administration name: Testosterone Cypionate measure: Androgen receptor (AR) activity measure: Incidence of adverse events measure: Incidence of serious adverse events measure: Prostate specific antigen (PSA) 50 measure: Measurable disease response measure: Progression free survival measure: Overall survival measure: Assess Quality of life measure: Assess Quality of Life measure: Assess Fatigue measure: Assess change in Fatigue sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Roswell Park Cancer Institute status: RECRUITING city: Buffalo state: New York zip: 14263 country: United States name: Gurkamal S. Chatta role: CONTACT phone: 716-845-3117 email: Gurkamal.Chatta@RoswellPark.org name: Gurkamal S. Chatta role: PRINCIPAL_INVESTIGATOR lat: 42.88645 lon: -78.87837 hasResults: False
<\|newrecord\|> nctId: NCT06305585 id: IRB# 23-214 briefTitle: Can a Novel Manual Therapy Technique Help Relieve Stress? Assessing Effects of Primal Reflex Release on the Body's Stress Response overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-03 date: 2025-03 date: 2024-03-12 date: 2024-03-12 name: University of Idaho class: OTHER name: CJ Brush name: Jayme Baker name: Sydney Leverett briefSummary: Stress, when left unmanaged, can have detrimental effects on both physical and mental health, contributing to conditions such as high blood pressure, anxiety, and even cardiovascular disease. Effective stress management therapies may help maintain overall well-being and reduce the risk of long-term health complications. The Primal Reflex Release Technique (PRRT) is a novel manual therapy that may reduce markers related to stress such as heart rate variability (HRV) and patient-reported outcomes (PROs). Therefore, the purpose of this study is to elucidate the potential for PRRT to improve HRV and PROs. conditions: Psychological Stress studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Primal Reflex Release Technique (PRRT) measure: ECG Data measure: ICG Data measure: Depression Anxiety Stress Scale-21 (DASS-21) - Depression measure: Depression Anxiety Stress Scale-21 (DASS-21) - Anxiety measure: Depression Anxiety Stress Scale-21 (DASS-21) - Stress measure: Simple Physical Activity Questionnaire (SIMPAQ) measure: Self Assessment Manikin (SAM) - Valence measure: Self Assessment Manikin (SAM) - Arousal sex: ALL minimumAge: 18 Years maximumAge: 64 Years stdAges: ADULT facility: ISMaRT Clinic city: Moscow state: Idaho zip: 83843 country: United States name: Jayme Baker, DPT role: CONTACT phone: 208-885-1055 email: jaymeb@uidaho.edu lat: 46.73239 lon: -117.00017 hasResults: False
<\|newrecord\|> nctId: NCT06305572 id: H-1903-013-1014 briefTitle: Diagnostic Accuracy of Quantitative Flow Ratio overallStatus: COMPLETED date: 2019-07-30 date: 2023-03-25 date: 2023-09-26 date: 2024-03-12 date: 2024-03-12 name: Seoul National University Hospital class: OTHER name: Inje University Ilsan Paik Hospital name: Keimyung University Dongsan Medical Center name: Ulsan Medical Center name: Bucheon Sejong Hospital name: Chosun University Hospital name: Severance Hospital name: Ulsan University Hospital name: Uijeongbu Eulji Medical Center briefSummary: The aim of this study was to investigate the accuracy of quantitative flow ratio (QFR) for predicting fractional flow reserve (FFR) ≤0.80 in an independent core laboratory. conditions: Coronary Artery Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 280 type: ACTUAL name: QFR measure: Diagnostic accuracy of QFR measure: Sensitivity of QFR measure: Specificity of QFR measure: Correlation sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Seoul National University Hospital city: Seoul zip: 03080 country: Korea, Republic of lat: 37.566 lon: 126.9784 hasResults: False
<\|newrecord\|> nctId: NCT06305559 id: OBEZ-302 briefTitle: A CCTA Imaging Trial to Evaluate the Effect of Obicetrapib/Ezetimibe on Coronary Plaque acronym: REMBRANDT overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2026-12 date: 2027-03 date: 2024-03-12 date: 2024-03-12 name: NewAmsterdam Pharma class: INDUSTRY briefSummary: This placebo-controlled, double-blind, randomized, Phase 3 study is being conducted in adult participants with high-risk atherosclerotic cardiovascular disease (ASCVD) who are not adequately controlled by their maximally tolerated lipid-modifying therapy, to assess the impact of the obicetrapib 10 mg + ezetimibe 10 mg FDC daily on coronary plaque and inflammation characteristics, evaluated using cardiovascular computed tomography angiography (CCTA). conditions: Lipidemia conditions: Coronary Artery Disease conditions: Plaque, Atherosclerotic studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: QUADRUPLE maskingDescription: Double blind set-up; post randomization LDL values are not provided to sites (alert triggers are programmed for urgent follow-up) whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 300 type: ESTIMATED name: obicetrapib 10 mg + ezetimibe 10 mg FDC daily name: Placebo measure: • To evaluate the effect of obicetrapib 10 mg + ezetimibe 10 mg fixed dose combination (FDC) daily on total non-calcified coronary atherosclerotic plaque volume (NCPV) at 18 months. measure: Absolute change from baseline to 18 months in total NCPV in all major epicardial coronary arteries, as measured by CCTA, in participants treated with obicetrapib 10 mg + ezetimibe 10 mg FDC therapy compared with placebo. measure: Percent change from baseline to 18 months in LDL-C in participants treated with obicetrapib 10 mg + ezetimibe 10 mg FDC therapy compared to placebo. measure: Percent change from baseline to 18 months in non-calcified coronary atherosclerotic plaque volume in the most diseased coronary segment (NCPVMD), as measured by CCTA, in participants treated with FDC therapy vs placebo measure: Absolute change from baseline to 18 months in NCPVMD, as measured by CCTA, in participants treated with obicetrapib 10 mg + ezetimibe 10 mg FDC therapy compared with placebo. measure: Change in perivascular fat attenuation index (FAI), FAI score and its age- and gender specific centile in the principal epicardial coronary arteries as measured by CCTA in participants treated with FDC therapy compared with placebo. sex: ALL minimumAge: 45 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06305546 id: 2911 briefTitle: Comparisons Of Different Antiplaque Agents On Gingivitis In Orthodontic Patients overallStatus: COMPLETED date: 2023-04-01 date: 2023-10-31 date: 2023-10-31 date: 2024-03-12 date: 2024-03-13 name: Anam Sattar class: OTHER briefSummary: Fixed orthodontic treatment affects the periodontium by allowing plaque accumulation on teeth if the oral ecosystem is unfavorable which initially causes gingivitis to progress into periodontitis, and later enamel demineralization occurs. Yáñez-Vico et al observed that regular modifications per checkups were painful and unpleasant for the patient thus the patients undergoing fixed orthodontic treatments compromised their oral hygiene. This creates plaque retention sites which can lead to developing white spot lesions, caries, and periodontitis conditions: Gingivitis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: TRIPLE maskingDescription: The trial was a double blinded (patients and investigators). We were helped from a member of our department who is not a part of the study, to transfer the gels from commercial tubes to blank containers. The randomization codes remained unknown until data analysis was completed. Randomization was done by computer-generated software. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 80 type: ACTUAL name: Chlorhexidine Gluconate name: Metronidazole name: combination gel (chlorhexidine and metronidazole) name: Placebo measure: gingival index measure: bleeding index measure: orthodontic plaque index sex: ALL minimumAge: 16 Years maximumAge: 35 Years stdAges: CHILD stdAges: ADULT facility: Dow University of Health Sciences city: Karachi state: Sindh country: Pakistan lat: 24.8608 lon: 67.0104 hasResults: False
<\|newrecord\|> nctId: NCT06305533 id: 854623 briefTitle: Efficacy of Photodynamic Therapy and LASER Disinfection in Periodontal Therapy for Treatment of Periodontitis overallStatus: RECRUITING date: 2024-03-01 date: 2024-09 date: 2024-10 date: 2024-03-12 date: 2024-03-12 name: University of Baghdad class: OTHER briefSummary: The goal of this clinical trial is to Investigate the clinical and microbiological efficacies of Laser disinfection and ICG-mediated aPDT as adjunct to RSD for patients with periodontitis. The main question it aims to answer is:
Does the use of laser disinfection or ICG-mediated aPDT as adjunct to RSD are effective in improving clinical parameters and reducing the load of periodontal pathogens.
Participants will undergo full-mouth supragingival debridement by using ultrasonic device at baseline.
All patients will be instructed to brush their teeth twice daily and will be supplied with the same type of tooth paste and toothbrush, with suitable interdental aids.
All the patients will be instructed to attend again after 7 days. One week later, sites randomly allocated to control (Ctrl) group and test groups which will receive, in addition to RSD, either aPDT or periodontal pocket disinfection (Biolase). For all groups, sites with initial PPD 4-6 mm will be treated with RSD using area specific (Graecy) curettes. conditions: Periodontitis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This study is 3 arm, split-mouth, double blinded, randomized clinical trial. The first group will receive RSD only, the second group will be treated with RSD + aPDT with ICG as a PS, and the last group will receive RSD + Laser disinfection. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Sites will randomly be assigned to test or control groups according to a computer-generated list. Allocation concealment will be assured by opaque, sealed envelopes prepared and sequentially numbered by a person not otherwise involved in the study. The person responsible for delivering treatment will be aware about allocation of the groups, while the assessor will be blinded. whoMasked: OUTCOMES_ASSESSOR count: 18 type: ESTIMATED name: LASER disinfection name: Photodynamic therapy name: Root surface debridement measure: Probing Pocket Depth (PPD) measure: Bleeding on probing (BOP) measure: Plaque index (PI) measure: Clinical attachment loss (CAL) measure: Change in bacterial load of F. nucleatum and Fretibacterium fastidiosum sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: College of Dentistry, University of Baghdad status: RECRUITING city: Baghdad zip: 10047 country: Iraq role: CONTACT phone: +964 14169394 email: master@codental.uobaghdad.edu.iq lat: 33.34058 lon: 44.40088 hasResults: False
<\|newrecord\|> nctId: NCT06305520 id: BPLUS-NASAL-02 id: CRIS NO. : KCT0008113 type: REGISTRY domain: The Clinical Research Information Service (CRIS) in KOREA briefTitle: Medical Device Pivotal Study to Injection With SkinPlus-HYAL Implant Lidocaine vs RESTYLANE Lidocaine in of Nasolabial Folds acronym: BPLUS-02 overallStatus: ENROLLING_BY_INVITATION date: 2023-03-10 date: 2024-09-30 date: 2024-10-31 date: 2024-03-12 date: 2024-03-15 name: Bioplus class: INDUSTRY name: Seoul National University Hospital name: Asan Medical Center name: Soonchunhyang University Hospital briefSummary: Purpose : This investigation intends to demonstrate that the investigational device, SkinPlus-HYAL Implant Lidocaine, is non-inferior to the comparator device, RESTYLANE Lidocaine, in terms of temporary wrinkle reduction effect, safety, and injection site pain when applied on nasolabial folds in adults.
Design : 24-week efficacy and safety evaluation and additional 48-week long-term safety and efficacy evaluation with a multi-center, randomized, subject- \& evaluator-blind, matched pairs, active controlled, none-inferiority, confirmatory design
Treatment Group: Application of the investigational medical device (SkinPlus-HYAL Implant Lidocaine) Control Group: Application of the comparator device (RESTYLANE Lidocaine)
Population: Number of subject 100
\* In this investigation, the same subject receives both test and control treatments, one on each side of the nasolabial folds (matched pairs design). conditions: Nasal Disease conditions: Nasal Surgery studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Medical Device primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 100 type: ESTIMATED name: Investigational medical device (SkinPlus-HYAL Implant Lidocaine) name: Active Comparator: Active Comparator Medical Device (RESTYLANE Lidocaine) measure: Difference in the mean values of the Wrinkle Severity Rating Scale (WSRS) between the treatment and control groups as evaluated by an independent evaluator at 24 weeks after the application of the investigational medical device measure: Difference in the mean values of the WSRS between the treatment and control groups as evaluated by the investigator at 8, 16, 24, and 48 weeks after device application measure: Difference in the mean Global Aesthetic Improvement Scale (GAIS) values between the treatment and control groups as evaluated by the investigator at weeks 8, 16, 24, and 48 of the first post-device application phase compared to before application measure: Difference in the mean values of the WSRS between the treatment and control groups as evaluated by an independent evaluator at 48 weeks after device application. sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Seoul National University Hospital city: Seoul state: Jongnogu zip: 03080 country: Korea, Republic of lat: 37.566 lon: 126.9784 hasResults: False
<\|newrecord\|> nctId: NCT06305507 id: 30923-N briefTitle: Differents Laser Applications on Plantar Fasciitis overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-06 date: 2024-07 date: 2024-03-12 date: 2024-03-13 name: University of Seville class: OTHER briefSummary: The objective of this randomized controlled clinical trial (RCT) with a double-blind technique and longitudinal chronology, entitled \"Effect of different laser applications on Plantar Fasciitis\", is to evaluate and compare the effectiveness of laser therapy low-level (LLLT) in local spot mode versus sweep mode in the reduction of pain associated with plantar fasciitis.
The main questions it seeks to answer are:
* What is the comparative effectiveness between low-level laser therapy in local spot mode and sweep mode in reducing pain in patients with plantar fasciitis?
* What are the optimal therapeutic parameters (session duration, frequency and power) for LLLT in both modes, maximizing pain reduction in patients with plantar fasciitis?
Participants in this study will perform the following tasks:
* Undergo low-level laser therapy sessions in local spot mode or sweep mode.
* Comply with the instructions on the duration and frequency of the sessions.
* Record the pain levels experienced before and after each session.
The investigators will compare the group undergoing local spot mode low-level laser therapy with the group undergoing sweeping mode low-level laser therapy to evaluate whether there are significant differences in pain reduction effects. conditions: Fasciitis, Plantar studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 62 type: ESTIMATED name: Focussed laser therapy name: Shower laser therapy measure: Pain Reduction in Patients with Plantar Fasciitis Treated with Laser Therapy (LLLT): Comparison between Local Spot Mode and Sweep Mode" measure: Fascia thickness sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Área Clínica de Podología city: Sevilla state: Andalucía zip: 41004 country: Spain lat: 37.38283 lon: -5.97317 facility: Facultad de Podologia city: Sevilla zip: 41009 country: Spain name: Aurora Castro, Prof titular role: CONTACT phone: 954486500 lat: 37.38283 lon: -5.97317 hasResults: False
<\|newrecord\|> nctId: NCT06305494 id: HE671008 briefTitle: Genitourinary Syndrome of Menopause in Thai Gynecologic Cancer Survivors overallStatus: RECRUITING date: 2024-03-14 date: 2024-12 date: 2024-12 date: 2024-03-12 date: 2024-04-25 name: Khon Kaen University class: OTHER briefSummary: Women often face common cancers like ovarian, uterine, and cervical cancers. Improvements in cancer detection and treatment mean more women survive. However, survivors can encounter challenges like ongoing pain, treatment complications, and fertility issues.
Treating these cancers often involves surgeries that might include removing ovaries or using pelvic radiation. This can trigger menopause in younger women, causing problems like vaginal dryness, itching, and urinary issues.
Women who've gone through menopause often deal with these symptoms, affecting their daily lives, confidence, and intimate relationships. Though treatments are available, lack of awareness, embarrassment, and not discussing these issues with doctors can make managing them difficult.
The main treatment for these symptoms is using vaginal estrogen, but it might not be suitable for some cancer survivors. Non-hormonal options like lubricants and moisturizers are alternatives. This study in Thailand aiming to explore how common these issues are among gynecological cancer survivors, their feelings about it, and how it affects their quality of life. conditions: Atrophic Vaginitis conditions: Gynecologic Cancer conditions: Lower Urinary Tract Symptoms studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 425 type: ESTIMATED measure: Prevalence of genitourinary syndrome of menopause measure: Severity of genitourinary syndrome of menopause measure: Quality of life of gynecologic cancer survivor measure: Attitude toward genitourinary syndrome of menopause in gynecologic cancer survivor sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Faculty of Medicine, Khon Kaen University status: RECRUITING city: Khon Kaen zip: 40002 country: Thailand name: Apiwat Jongjakapun, MD role: CONTACT email: apiwjo@kku.ac.th lat: 16.44671 lon: 102.833 hasResults: False
<\|newrecord\|> nctId: NCT06305481 id: OPT1099 briefTitle: Glaucoma Evaluation With the P200TE overallStatus: RECRUITING date: 2024-02-13 date: 2024-09-30 date: 2024-09-30 date: 2024-03-12 date: 2024-03-12 name: Optos, PLC class: INDUSTRY briefSummary: Images captured on the P200TE device on glaucoma patients conditions: Glaucoma studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 75 type: ESTIMATED name: P200TE measure: Number of images collected sex: ALL minimumAge: 22 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Werner Optometry status: RECRUITING city: Cajon state: California zip: 92019 country: United States name: Kristen Mendenhall role: CONTACT phone: 619-937-1056 email: kristen@wernerod.com lat: 34.29889 lon: -117.45644 facility: Specialty Eyecare Centre status: RECRUITING city: Bellevue state: Washington zip: 98004 country: United States name: Renee Cook role: CONTACT phone: 425-454-3937 email: rcook@specialtyeyecarecentre.com lat: 47.61038 lon: -122.20068 hasResults: False
<\|newrecord\|> nctId: NCT06305468 id: APHP240055 briefTitle: Prognosis of Disseminated and Cerebral Toxoplasmosis Hospitalized in Intensive Care in the Era of PCR Diagnosis acronym: TOXIC overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-04-01 date: 2026-04-01 date: 2024-03-12 date: 2024-03-12 name: Assistance Publique - Hôpitaux de Paris class: OTHER briefSummary: Toxoplasmosis is a common infection whose clinical severity can sometimes justify admission to intensive care, especially in immunocompromised patients.
This study should make it possible to evaluate the impact of different anti-infective treatment regimens and to highlight clinical-biological and prognostic differences depending on the type of underlying immunosuppression. conditions: Toxoplasmosis studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: RETROSPECTIVE count: 200 type: ESTIMATED measure: Mortality rate in intensive care. measure: Hospital mortality rate measure: Length of stay in intensive care measure: Duration of mechanical ventilation sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cochin hospital city: Paris zip: 75014 country: France lat: 48.85341 lon: 2.3488 hasResults: False
<\|newrecord\|> nctId: NCT06305455 id: HSD135 briefTitle: Resistance Profile of Escherichia Coli in Infections of Community Origin: The Importance of Antimicrobial Stewardship overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-07 date: 2024-10 date: 2024-03-12 date: 2024-03-12 name: José Raimundo Araujo de Azevedo class: OTHER briefSummary: The main objective of the study is to describe the antimicrobial resistance profile of E. coli isolated in patients from the community - defined as those with cultures collected within 48 hours of hospital admission - and admitted to the intensive care unit. conditions: Antimicrobial Resistance studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 200 type: ESTIMATED name: Escherichia coli ESBL measure: Prevalence of Escherichia coli resistance sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06305442 id: PR-24031 briefTitle: Microbiota Directed Food for Children With Moderate Acute Malnutrition overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2025-10-31 date: 2026-02-28 date: 2024-03-12 date: 2024-04-24 name: International Centre for Diarrhoeal Disease Research, Bangladesh class: OTHER name: Washington University School of Medicine briefSummary: Moderate acute malnutrition (MAM) refers to a condition characterized by a significant deficit in weight-for-length measurements in children aged 6 to 59 months. It is a crucial public health concern with detrimental effects on child growth, development, and overall well-being. Addressing MAM is crucial to prevent its progression to severe acute malnutrition (SAM) and to ensure healthy child development. To meet the nutritional requirement of MAM children, icddr,b have come up with a novel intervention named microbiota-directed food (MDF), a ready-to-use supplementary food. The investigator propose this efficacy trial to establish the evidence on the effect of this novel intervention on ponderal growth, microbial and proteomic recovery among the children with MAM in comparison to the standard RUSF. conditions: Moderate Acute Malnutrition studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Double blind, randomized, parallel group, clinical trial primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: Double blind whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 230 type: ESTIMATED name: Microbiota-Directed Food name: Ready-to-Use Supplementary Food measure: Mean change in Weight-for-Length Z-score (WLZ) measure: Microbial community repair measure: Validated plasma and faecal biomarkers of health status (prioritized Luminex/ELISA panel including mediators of growth, systemic inflammation, gut inflammation/entero-pathogen burden) measure: Mean change in Weight-for-Age Z-score (WAZ) measure: Mean change in Length-for-Age Z-score (LAZ) measure: Mean change in body composition (% body fat mass and % fat-free mass) measure: Bayley Scales of early childhood development (cognitive, motor, language development) sex: ALL minimumAge: 6 Months maximumAge: 24 Months stdAges: CHILD facility: Mirpur Study site city: Dhaka country: Bangladesh name: Dr. Jinat Alam, MPH, MBBS role: CONTACT phone: +8801676742255 email: jinat.alam@icddrb.com lat: 23.7104 lon: 90.40744 hasResults: False
<\|newrecord\|> nctId: NCT06305429 id: HABITE briefTitle: Encouraging Positive Parenting Habits acronym: HABITE overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-07 date: 2024-09 date: 2024-03-12 date: 2024-04-02 name: D'Or Institute for Research and Education class: OTHER name: Okinawa Institute of Science and Technology Graduate University briefSummary: This study evaluates the feasibility and preliminary impacts of a new parenting program consisting of a series of educational videos, automatically delivered via a popular texting platform. The program content for the feasibility study is focused on teaching parents strategies to better manage one of the commonly reported challenges that children face, a transition to a non-preferred activity. Parents with young children experiencing behavior difficulties with daily transition routines are invited to participate in the study. conditions: ADHD studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Open, single-group trial primaryPurpose: TREATMENT masking: NONE count: 200 type: ESTIMATED name: HabitE (effective parenting habit) program (in Brazilian Portuguese) measure: Number of videos viewed measure: Percentage of completed daily ratings measure: Participant satisfaction measure: Parent-rated child's difficulties with daily transitions measure: Parent-rated child's impairment related to transition difficulties measure: Inconsistent parenting measure: Use of physical control measure: Hostility toward child measure: Parent Stress measure: ADHD symptoms measure: ODD symptoms measure: Irritability measure: Proactive parenting measure: Use of positive reinforcement sex: ALL minimumAge: 4 Years maximumAge: 10 Years stdAges: CHILD hasResults: False
<\|newrecord\|> nctId: NCT06305416 id: 2023/CT/01 briefTitle: A Efficacy and Safety Study of Ranibizumab 10mg/ml Injection (Incepta) in Patients With Diabetic Macular Edema overallStatus: RECRUITING date: 2024-03-20 date: 2025-02 date: 2025-04 date: 2024-03-12 date: 2024-03-13 name: Incepta Pharmaceuticals Ltd class: INDUSTRY name: Institute for Developing Science and Health Initiatives, Bangladesh briefSummary: Macular edema in diabetes, defined as retinal thickening within two disc diameters of the center of the macula, results from retinal microvascular changes that compromise the blood-retinal barrier, causing leakage of plasma constituents into the surrounding retina and consequently retinal edema. Thickening of the basement membrane and reduction in the number of pericytes are believed to lead to increased permeability and incompetence of the retinal vasculature. This compromise of the blood-retinal barrier leads to the leakage of plasma constituents into the surrounding retina with subsequent retinal edema. Hypoxia produced by this mechanism can also stimulate the production of vascular endothelial growth factor (VEGF). Vascular endothelial growth factor (VEGF) increases retinal vascular permeability, causes breakdown of the blood-retina barrier and results in retinal edema.
Diabetic macular edema (DME) is the most common cause of visual reduction in patients with Diabetes Mellitus. The prevalence of DME globally is around 6.8 %. Diabetic Retinopathy (DR) is the most common microvascular complication of diabetes and the leading cause of blindness worldwide. DME is a complication of diabetic retinopathy that affects the macula, which is located at the center of the retina and responsible for central vision. Bangladesh is the 10th country in the world for the number of adults living with diabetes with some 7.1 million (5.3-12.0). In Bangladesh, it is therefore expected that diabetic secondary complications, like DR, will increase along with the rising trend of diabetes mellitus.
The use of therapeutic monoclonal antibodies has revolutionized in the treatment of many diseases. In recent years, millions of patients have been successfully treated with these biological agents. Ranibizumab is one such therapeutic monoclonal antibody for intraocular use. Ranibizumab is a humanized, recombinant, immunoglobulin G1 monoclonal antibody fragment against vascular endothelial growth factor A (VEGF-A) and thus prevents choroidal neovascularization. The small size of ranibizumab allows for enhanced diffusion into the retina and choroid. conditions: Diabetic Macular Edema conditions: Diabetic Retinopathy conditions: Macular Edema conditions: Macular Degeneration conditions: Retinal Disease conditions: Retinal Degeneration studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 70 type: ESTIMATED name: Ranibizumab 10mg/ml Injection name: Lucentis measure: Changes in Best Corrected Visual Acuity (BCVA) from Baseline measure: Changes in Central Subfield Thickness (CST) from Baseline measure: Proportion of patients who lost fewer than 15 letters (approximately 3 lines) from baseline visual acuity measure: Proportion of patients who gained ≥15 letters (approximately 3 lines) from baseline visual acuity measure: Evaluation and comparison of safety between reference vs. test drug. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Bangladesh Eye Hospital & Institute status: RECRUITING city: Dhaka zip: 1209 country: Bangladesh name: Dr. Niaz Abdur Rahman role: CONTACT phone: +8801711590333 email: drniazrahman@gmail.com name: Dr. Niaz Abdur Rahman role: PRINCIPAL_INVESTIGATOR lat: 23.7104 lon: 90.40744 hasResults: False
<\|newrecord\|> nctId: NCT06305403 id: VEXUS1 briefTitle: VEXUS and NGAL in the Diagnosis and Prognosis of Sepsis-associated Acute Kidney Injury overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-03-18 date: 2025-05-18 date: 2024-03-12 date: 2024-04-23 name: Inonu University class: OTHER briefSummary: In this prospective observational study, patients hospitalized in mixed intensive care unit, aged between 18 and 80, and diagnosed with sepsis and septic shock according to sepsis-3 criteria will be included.
To determine whether patients develop AKI during the first five days of ICU admission, creatinine and urine output will be monitored daily for the first five days of ICU admission according to KDIGO criteria. Clinical diagnosis and treatment of AKI will be made according to KDIGO.
According to KDIGO, patients will be divided into two groups: those who develop AKI and those who do not.
By comparing plasma NGAL and VEXUS scores between groups, the sensitivity and specificity of the VEXUS score in determining AKI will be determined. conditions: Sepsis conditions: Acute Kidney Injury studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: serum creatinin level measure: ngal measure: VEXUS measure: MORTALİTY sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06305390 id: 2022-003905-31 briefTitle: Fully Hybrid 18F-PSMA PET/MRI as One-stop Approach for the Diagnosis of Clinically Significant Prostate Cancer. acronym: RF2021-1237227 overallStatus: RECRUITING date: 2023-12-04 date: 2024-07 date: 2025-07 date: 2024-03-12 date: 2024-04-12 name: IRCCS San Raffaele class: OTHER briefSummary: This project aims to evaluate the role of fully hybrid PET/MRI with 18FPSMA and multiparametric MR imaging (mpMRI) as one-stop approach for the diagnosis of clinically significant prostate cancer (csPCa).
Our main hypothesis is that adding 18F-PSMA PET to mpMRI prior to biopsy, will reduce the number of false negative findings, while at the same time, allowing also to reduce the number of unnecessary prostate biopsies in patients with low-risk, clinically indolent PCa. conditions: Clinical Suspicion of Prostate Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 167 type: ESTIMATED name: PET/MRI measure: To assess the accuracy and the predictive value of fully hybrid 18F-PSMA PET/MRI for the diagnosis of clinically significant prostate cancer (csPCa) measure: To compare the proportion of csPCa missed by 18F-PSMA PET scan or mpMRI alone To report the reduction in the detection of clinically insignificant PCa when combining mpMRI and 18F-PSMA PET sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: U.O. of Nuclear Medicine, ,Ospedale San Raffaele status: RECRUITING city: Milano zip: 20132 country: Italy name: Maria Picchio, MD role: CONTACT phone: 02-26436117 email: Picchio.maria@hsr.it lat: 45.46427 lon: 9.18951 hasResults: False
<\|newrecord\|> nctId: NCT06305377 id: DESPED-T1 study briefTitle: Achieving Rapid, Safe and Sustained Glucose Control in Adolescents With Suboptimally Controlled Type 1 Diabetes Using Advanced Hybrid Closed Loop Systems overallStatus: NOT_YET_RECRUITING date: 2024-03-11 date: 2024-03-30 date: 2024-03-30 date: 2024-03-12 date: 2024-03-13 name: Giulio Frontino class: OTHER briefSummary: The rational of this study is to assess if AHCL systems are able to achieve a better metabolic control (better glucometric data) after 2 weeks, 1 months. 6 months and 1 year after the start, in adolescents in not good glycaemic control. conditions: Diabetes Mellitus, Type 1 studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: RETROSPECTIVE count: 20 type: ESTIMATED name: Tandem Control IQ measure: Glucometric data sex: ALL minimumAge: 12 Years maximumAge: 17 Years stdAges: CHILD hasResults: False
<\|newrecord\|> nctId: NCT06305364 id: CL-1001 briefTitle: Predicting Adenomatous Polyps in the Colon Using Images of a Human Tongue overallStatus: RECRUITING date: 2023-08-01 date: 2024-12-01 date: 2024-12-01 date: 2024-03-12 date: 2024-03-20 name: Jubaan Ltd. class: INDUSTRY briefSummary: This is a prospective, multicenter, single-arm clinical investigation designed to evaluate the accuracy of the Gixam™ System in identifying subjects with colorectal adenomas compared to optical colonoscopy. Subjects arriving for a standard of care colonoscopy at the investigation site will be offered to participate in the study. Following an informed consent process, images of the subjects' tongue will be obtained with the Gixam™ System and a prediction score will be generated by the Gixam™ AI model. Subjects will thereafter proceed to their SOC colonoscopy, and the Gixam™ score will be compare with colonoscopy findings to evaluate its performance. conditions: Colorectal Neoplasms conditions: Gastrointestinal Microbiome studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SCREENING masking: NONE maskingDescription: Gastroenterologist performing standard of care colonoscopy post Gixam test will be blinded to the Gixam prediction score. count: 800 type: ESTIMATED name: Gixam measure: Primary Safety Endpoint - Number of device related adverse events and serious adverse events measure: Primary Efficacy Endpoint - Gixam's diagnostic accuracy sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Westside GI status: RECRUITING city: New York state: New York zip: 10019 country: United States name: Theodore Bortz role: CONTACT lat: 40.71427 lon: -74.00597 facility: NewYork-Presbyterian / Columbia University Irving Medical Center status: RECRUITING city: New York state: New York zip: 10032 country: United States name: Elissa Lynch role: CONTACT name: Daniel Freedberg, MD role: PRINCIPAL_INVESTIGATOR lat: 40.71427 lon: -74.00597 hasResults: False
<\|newrecord\|> nctId: NCT06305351 id: K-757 P008 briefTitle: A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of K-757 and K-833 in Overweight/Obese Patients With Type 2 Diabetes overallStatus: RECRUITING date: 2023-12-07 date: 2024-07 date: 2024-07 date: 2024-03-12 date: 2024-03-12 name: Kallyope Inc. class: INDUSTRY briefSummary: This is a multiple dose study to evaluate the safety, tolerability, PK, and PD of K-757 and K-833 when co-administered in overweight/obese patients with Type 2 diabetes mellitus (T2DM) conditions: Obesity conditions: Type 2 Diabetes Mellitus (T2DM) studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 32 type: ESTIMATED name: K-757 and K-833 QD name: K-757 and K-833 BID name: Matching placebo to K-757 and K-833 QD name: Matching placebo to K-757 and K-833 BID measure: Proportion of participants who experienced 1 or more treatment-emergent AEs measure: Proportion of participants who discontinued study medication due to an AE measure: Area under the concentration-time curve [AUC] of plasma K-757 measure: AUC of plasma K-833 measure: Maximum concentration [Cmax] of plasma K-757 measure: Cmax of plasma K-833 measure: Time of maximum concentration [Tmax] of plasma K-757 measure: Tmax of plasma K-833 measure: Clearance [Cl] of plasma K-757 measure: Cl of plasma K-833 measure: Volume of distribution at steady-state [Vdss] of plasma K-757 measure: Vdss of plasma K-833 measure: Half-life [t1/2] of plasma K-757 measure: t1/2 of plasma K-833 sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: QPS Miami status: RECRUITING city: Miami state: Florida zip: 33143 country: United States lat: 25.77427 lon: -80.19366 hasResults: False
<\|newrecord\|> nctId: NCT06305338 id: KUK-Ophthalmology-009 briefTitle: Predicting Intraocular Lens Tilt Using OCT Measurements and Partial Least Squares Regression Modelling acronym: Tilt overallStatus: COMPLETED date: 2022-04-12 date: 2023-04-01 date: 2023-04-26 date: 2024-03-12 date: 2024-03-12 name: Johannes Kepler University of Linz class: OTHER briefSummary: During cataract surgery an artificial intraocular lens (IOL) is implanted in the eye to replace the lens and to correct the refraction for distance vision. Misalignment of IOLs can cause severe loss of visual quality. Different types of misalignment are known. Tilt, one type of IOL misalignment is thought to play a negative role for the optical performance in eyes with IOL designs, especially, if they have aspheric, toric, or multifocal optics.
Various methods to measure IOL misalignments have been described. Studies assessing the IOL position have used subjective grading methods at the slit lamp examination or a Scheimpflug camera to assess IOL decentration and tilt. The subjective grading at the slitlamp may display considerable variability between examiners. This method is more qualitative than quantitative and does not allow fine resolution when reporting IOL tilt. The fact that the patient has no standardized target to focus on makes the method even less reliable. Scanning methods such as Scheimpflug photos require a very well dilated pupil exceeding 6mm to assess the IOL position. Additionally, it can be difficult to identify the anatomical structures of the eye that need to be used as points of reference. Scheimpflug camera images have been used for assessing IOL tilt previously, but erroneous results, often due to corneal magnification, have diminished their widespread use. Another possibility to assess tilt is the use of Purkinje reflexes. The light reflections of Purkinje images at ocular surfaces to evaluate ocular alignment have recently been utilized. Since light is reflected at all interfaces of media with a difference in refractive index, these reflections, called Purkinje images, can be used to assess tilt and decentration of IOLs. Two different clinically applicable Purkinjemeter system provide the measurement of IOL decentration and tilt. The main problem with Purkinje meters is accessibility, as there are only a few prototypes available worldwide.
The most recently developed method for tilt quantification is the use of optical coherence tomography. This method has several advantages compared to the previous methods: OCT based devices are available in most clinics, the resolution of modern OCT devices is high, and the measurements are reproducible.
Aim of this study is to measure tilt with two modern OCT based devices and one Scheimpflug camera and to predict the post-operative tilt using partial least squares regression. This method was developed by Wold and introduced to ophthalmology previously. conditions: Intraocular Lens conditions: Cataract studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 110 type: ACTUAL name: Optical Coherence Tomography measure: post operative IOL tilt measure: Comparison of tilt prediction measure: comparion of three measurement methods measure: Comparison of tilt pre- versus post operative sex: ALL minimumAge: 21 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Matthias Bolz city: Linz state: Oberösterreich zip: 4020 country: Austria lat: 48.30639 lon: 14.28611 hasResults: False
<\|newrecord\|> nctId: NCT06305325 id: 35957 briefTitle: Coparenting Intervention to Prevent Postpartum Depression overallStatus: COMPLETED date: 2018-09-23 date: 2019-11-22 date: 2020-02-22 date: 2024-03-12 date: 2024-03-12 name: Brock University class: OTHER name: University of Toronto briefSummary: The goal of this pilot randomized controlled trial was to examine the feasibility and acceptability of an ehealth antenatal coparenting intervention (eACoP) in primiparous Pakistani women. The secondary purpose of the study was to see the effectives of the intervention in prevention postpartum depression in women. Two hundred and twelve primiparous couples were randomized into an intervention or a control group from the Aga Khan University Hospital. Couples were randomized using consecutively numbered sealed envelopes. Couples in the intervention group received the eACoP intervention during pregnancy, consist of eight online videos in addition to the standard care provided at the center. Both the intervention group and control group received standard care. conditions: Postpartum Depression conditions: Anxiety studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: coparenting framework: it has 3 levels. First is the individual level, which consists of the parent's individual characteristics, which comprises of attitudes, parental beliefs, and emotional and mental health. It has a bidirectional relationship with coparenting and the overall inter-parental relationship. Individual child factors, such as temperament may also play a role in shaping the coparenting relationship. The second level is the family level. It comprises the overall interpersonal relationship, referring to the existing ability of couples to demonstrate support and respect for each other. It could influence the coparental relationship or in reverse, the coparental relationship may influence the overall inter-parental relationship. The third level is the extra-familial level. It has two components: support and stress that are based on a stress-coping perspective. The role of environmental support is viewed as enhancing the coparenting relationship primaryPurpose: PREVENTION masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 106 type: ACTUAL name: eHealth Antenatal Coparenting Intervention measure: feasibility-recruitment rate, adherence, and follow-up rate measure: Acceptability- Participants satisfaction measure: Depressive Symptoms measure: anxiety measure: Coparenting Relationship measure: Relationship Satisfaction- couple relationship satisfaction to discriminate between distressed and non-distressed relationship. measure: Postpartum Childcare Stress measure: Infant Development measure: partner support sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Aga Khan University city: Karachi state: SinDH country: Pakistan lat: 24.8608 lon: 67.0104 hasResults: False
<\|newrecord\|> nctId: NCT06305312 id: HCI166685 id: 1R01CA282409-01 type: NIH link: https://reporter.nih.gov/quickSearch/1R01CA282409-01 briefTitle: Community Services Navigation to Advance Health Equity in Breast Cancer Screening acronym: B-SINCERE overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2028-09 date: 2028-09 date: 2024-03-12 date: 2024-04-17 name: University of Utah class: OTHER name: National Institutes of Health (NIH) name: National Cancer Institute (NCI) briefSummary: The goal of this study is to evaluate if adding community services navigation to the standard referral process for social needs is an effective and scalable strategy for addressing disparities in follow-up to abnormal breast cancer screening results. The investigators will determine the effectiveness of social needs referrals combined with a community services navigation intervention in the screening mammography setting to improving breast screening outcomes in underserved women. conditions: Breast Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 1450 type: ESTIMATED name: Community Service Navigation name: Usual Care measure: Change in participants' level of social needs as measured by the B-SINCERE (Breast-Screener for Intensifying Community Referrals for Health) screener measure: Episode Completion (EC). EC is the name of a dichotomous scale, reported on a 2-point scale that is calculated from patient electronic health record (EHR), with 0=No Breast Cancer Screening completed, 1=Breast Cancer Screening completed. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Utah Health Hospitals/Huntsman Cancer Institute Population Sciences city: Salt Lake City state: Utah zip: 84112 country: United States name: Elissa Ozanne, PhD role: CONTACT phone: 801-213-4130 email: Elissa.Ozanne@hsc.utah.edu name: Tracy Onega, PhD role: SUB_INVESTIGATOR lat: 40.76078 lon: -111.89105 hasResults: False
<\|newrecord\|> nctId: NCT06305299 id: LCCC2152-ATL briefTitle: Autologous CAR-T Cells Targeting B7H3 in Ovarian Cancer iC9-CAR.B7-H3 T Cells overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2026-03 date: 2026-03 date: 2024-03-12 date: 2024-04-23 name: UNC Lineberger Comprehensive Cancer Center class: OTHER briefSummary: The purpose of this study is to test the safety and tolerability of using a new treatment called autologous T lymphocyte chimeric antigen receptor cells against the B7-H3 antigen (iC9-CAR.B7-H3 T cells) in patients with ovarian cancer that came back after receiving standard therapy for this cancer. The iC9.CAR.B7-H3 treatment is experimental and has not been approved by the Food and Drug Administration. The study team wants to know how much (dose) of the iC9-CAR.B7-H3 T cells are safe to use in patients without causing too many side effects and what is the maximum dose could be tolerated.
There are two parts to this study. In part 1, approximately blood will be collected from subjects to prepare the iC9.CAR.B7-H3 T cells. The study team will collect disease-fighting T cells from the blood and modify them to prepare the iC9.CAR.B7-H3 T cells. In part 2, the iC9.CAR.B7-H3 T cells will be given to eligible subjects by infusion three days after completion of lymphodepletion chemotherapy. conditions: Ovary Neoplasm conditions: Ovarian Cancer conditions: Epithelial Ovarian Cancer conditions: Recurrent studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 27 type: ESTIMATED name: iC9-CAR.B7-H3 T cells name: Cyclophosphamide name: Fludarabine measure: Toxicity: NCI-CTCAE measure: Toxicity: Cytokine Release Syndrome (CRS) measure: Toxicity: Immune effector cell-associated neurotoxicity syndrome (ICANS) measure: The recommended phase 2 dose (RP2D) measure: Progression Free Survival (PFS) measure: Overall Survival (OS) measure: The disease control rate (DCR) sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Lineberger Comprehensive Cancer Center city: Chapel Hill state: North Carolina zip: 27599 country: United States name: Caroline Babinec role: CONTACT email: Caroline_babinec@med.unc.edu name: Linda Van Le role: PRINCIPAL_INVESTIGATOR lat: 35.9132 lon: -79.05584 hasResults: False
<\|newrecord\|> nctId: NCT06305286 id: IRB23-1367 briefTitle: Safety, Tolerability, and Efficacy of Immunomodulation With A Monoclonal Antibody Against CD40L in Combination With Transplanted Islet Cells in Adults With Brittle Type 1 Diabetes Mellitus (T1D) overallStatus: RECRUITING date: 2024-03-04 date: 2029-03 date: 2029-03 date: 2024-03-12 date: 2024-03-27 name: University of Chicago class: OTHER name: Juvenile Diabetes Research Foundation name: Cure Alliance briefSummary: AT-1501 is a monoclonal antibody. Antibodies are Y-shaped proteins that are produced naturally by the subject's immune system to attack and fight foreign substances that cause illness. Monoclonal antibodies are man-made proteins manufactured to serve as substitute antibodies to fight diseases. Monoclonal antibodies can restore, enhance, or mimic (copy) the immune system's attack process; they can also tone down the immune system. AT-1501 is thought to work by dampening down the immune system so that it will be less likely to attack the transplanted cells. For other types of transplants, like kidney, a drug called a calcineurin inhibitor is usually used to prevent rejection. That class of drugs can be toxic to islet cells. AT-1501 is an experimental agent that is anticipated to prevent rejection without harming the islet cells. conditions: Diabetes Mellitus studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 3 type: ESTIMATED name: AT-1501 measure: Number of Participants who are insulin-independent post- first and final transplant measure: Number of Participants with glycosylated hemoglobin (HbA1c) <7.0% measure: Number of Participants with free of serious hypoglycemic events (SHEs) post-first and final transplant measure: Number of Participants with HbA1c ≤6.5% AND free from SHEs post-first and final transplant. measure: Number of Participants with graft failure post final transplant. measure: Number of participants with impaired awareness of hypoglycemia after final islet cell transplant and after discontinuation of AT-1501. measure: Change in glycemic lability after final islet cell transplant and years after discontinuation of AT-1501 measure: Change in albumin excretion ratio (AER) post-first and final transplant. measure: Change in estimated glomerular filtration rate (eGFR) post-first and final transplant. measure: Change in percent new macroalbuminuria post-first and final transplant. measure: Change in variability after final islet cell transplant and years after discontinuation of AT-1501 sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Chicago status: RECRUITING city: Chicago state: Illinois zip: 60637 country: United States name: Piotr Witkowski, MD PhD role: CONTACT phone: 773-702-2447 email: pwitkowski@surgery.bs.uchicago.edu lat: 41.85003 lon: -87.65005 hasResults: False
<\|newrecord\|> nctId: NCT06305273 id: 23-0150-A briefTitle: Effectiveness of Two Different Body Positions During Facemask Ventilation in Obese Patients overallStatus: NOT_YET_RECRUITING date: 2024-03-25 date: 2025-03-01 date: 2025-03-01 date: 2024-03-12 date: 2024-03-20 name: Mount Sinai Hospital, Canada class: OTHER briefSummary: It is important to provide enough oxygen to the patients who are asleep during surgery. One way to do this is by using a mask placed over the face to help them breathe. When it becomes difficult getting enough oxygen into the patient's body using the mask, it's called difficult mask ventilation. There can be different reasons for this, and having a higher BMI is one of them. Body physique is assessed by Body Mass Index (BMI). This calculation gives an indication of a person's weight relative to their height.

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