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<|newrecord|> nctId: NCT06389448 id: pCLE vs EB 2024tj briefTitle: Comparison of pCLE and EB in Gastric Lesion Diagnosis overallStatus: RECRUITING date: 2024-04-11 date: 2026-04 date: 2026-10 date: 2024-04-29 date: 2024-04-29 name: Huazhong University of Science and Technology class: OTHER briefSummary: This is a prospective multicenter comparative study, aiming to compare probe-based confocal laser endomicroscopy (pCLE) and endoscopic biopsies in the diagnosis of the whole specific gastric lesion especially for distinguishing low grade intraepithelial neoplasia (LGIN) from high grade intraepithelial neoplasia (HGIN) and create an endoscopic image database for the follow-up research. conditions: Low Grade Intraepithelial Neoplasia conditions: High Grade Intraepithelial Neoplasia conditions: Early Gastric Cancer conditions: Gastric Intraepithelial Neoplasia studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Participants undergo pCLE after pre-ESD assessment and before ESD resection. primaryPurpose: DIAGNOSTIC masking: NONE count: 366 type: ESTIMATED name: pCLE-gastr measure: Diagnostic accuracy of pCLE and endoscopic biopsy in diagnosing the whole gastric lesion measure: The histological upstaging rate of pCLE and endoscopic biopsy in diagnosing the whole gastric lesion sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tongji hospital, Tongji Medical College, Huazhong University of Science and Technology status: RECRUITING city: Wuhan state: Hubei zip: 430030 country: China name: Bin Cheng, Professor role: CONTACT phone: 86-027-8366-3333 email: [email protected] name: Yilin Gu role: CONTACT phone: 86-19884836004 email: [email protected] lat: 30.58333 lon: 114.26667 hasResults: False |
<|newrecord|> nctId: NCT06389435 id: 2024DS id: Knee type: OTHER domain: Danderyds sjukhus briefTitle: RObotic-assisted Versus Conventional Knee Endoprosthetic Techniques acronym: ROCKETS overallStatus: RECRUITING date: 2024-03-04 date: 2027-01 date: 2028-01 date: 2024-04-29 date: 2024-04-29 name: Danderyd Hospital class: OTHER name: Karolinska Institutet name: Stockholm South General Hospital briefSummary: Rationale for conducting the study: |
The study aims to systematically evaluate the clinical and economic impacts of Robotic-Assisted Total Knee Replacement (RTKR) compared to conventional Total Knee Replacement (TKR). It focuses on the potential benefits of RTKR, including improved precision in surgery, potentially leading to better patient outcomes and reduced healthcare costs. Our primary endpoint is the Forgotten Joint Score (FJS), aimed at measuring patients awareness of their knee joint in everyday life, indicating the success of the knee replacement surgery in restoring natural joint function. Secondary endpoints include patient-reported outcome measures (PROMs), patient activity levels, the accuracy of implant positioning on x-ray, and the incidence of adverse events. |
Study design: |
Multicentre,, preference-tolerant, randomized, controlled, superiority trial with two treatment arms that compares the outcomes of RTKR with traditional TKR techniques. |
Study population: |
Adult patients aged 18 years and older who are eligible for TKR as per local guidelines and who have given informed consent to participate in the study. |
Number of patients: |
400 |
Inclusion criteria: |
Patients must be adults aged 18 years and older, eligible for TKR according to local guidelines, and willing to participate in the study. |
Exclusion criteria: |
Patients with extreme malalignment requiring special implants or techniques, patients unfit for surgery due to medical reasons, and those deemed unsuitable to participate in the study for other reasons. |
Primary outcome variables: |
The Forgotten Joint Score (FJS) at 2 years after surgery conditions: Knee Arthroplasty, Total conditions: Robotic-assisted conditions: Osteoarthritis of the Knee studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 250 type: ESTIMATED name: Patients will be randomized to undergo TKR or RTKR measure: The Forgotten Joint Score (FJS) measure: KOOS measure: ADLS knee instability measure: The Forgotten Joint Score (FJS) measure: EQ-5D measure: Knee alignment measure: Adverse events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Danderyds Sjukhus status: RECRUITING city: Stockholm zip: 18288 country: Sweden name: Olof Skoldenberg, Md, PhD role: CONTACT phone: 800-555-5555 email: [email protected] name: Olof Skoldenberg, MD, PhD role: PRINCIPAL_INVESTIGATOR name: Karl Erikson, MD, PhD role: SUB_INVESTIGATOR lat: 59.33258 lon: 18.0649 hasResults: False |
<|newrecord|> nctId: NCT06389422 id: NCC4620 briefTitle: Phase II Study of Moderate-dose Hypofractionated RT Combined With Pembrolizumab for HCC With Diffuse Tumor Thrombosis overallStatus: RECRUITING date: 2024-05-01 date: 2026-04-30 date: 2027-04-30 date: 2024-04-29 date: 2024-04-29 name: Cancer Institute and Hospital, Chinese Academy of Medical Sciences class: OTHER briefSummary: This is a single-center, single-arm, open-label study that includes patients meeting the inclusion criteria (liver-GTV volume \< 700ml or estimated liver-GTV V5 \< 300ml) with hepatocellular carcinoma with diffuse tumor thrombosis involving both left and right lobes. All lesions receive moderate-dose hypofractionated intensity-modulated radiotherapy, with a gross tumor dose of 25Gy/5f, and a maximum dose of 35Gy/5f at the tumor center. One week before or during the radiotherapy, patients receive concurrent Pembrolizumab at a dose of 200mg. Subsequently, Pembrolizumab is administered intravenously every 3 weeks. Follow-up examinations are conducted 1-3 months post-radiotherapy. Lenvatinib 4mg may be used for maintenance therapy with Pembrolizumab if there are no contraindications. Maintenance therapy is continued until disease progression or intolerance. The primary endpoint is median overall survival (mOS), and secondary endpoints include objective response rate (ORR), progression-free survival (PFS), and toxicity. conditions: Hepatocellular Carcinoma conditions: Radiotherapy conditions: Pembrolizumab conditions: Tumor Thrombosis studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Moderate-dose Hypofractionated Intensity-modulated Radiotherapy name: Pembrolizumab measure: Median Overall Survival measure: Objective Response Rate measure: Progression-free Survival measure: Toxicity sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciecnces and Peking Union Medical College status: RECRUITING city: Beijing state: Beijing country: China name: Bo Chen, MD role: CONTACT phone: 0086-13240000876 email: [email protected] lat: 39.9075 lon: 116.39723 hasResults: False |
<|newrecord|> nctId: NCT06389409 id: Protocollo N.2009 Testicolo briefTitle: Study on the Quality of Life and Functional/Oncological Outcome of Testicular Cancer Patients overallStatus: RECRUITING date: 2010-08-24 date: 2030-09-01 date: 2040-08-31 date: 2024-04-29 date: 2024-04-29 name: IRCCS San Raffaele class: OTHER briefSummary: The research aims to collect data in order to report the main problems related to the testicular cancer; To reach this aim, this study proposes to create a database of the testicular cancer condition. |
From this perspective, the aim of this project is the improving of scientific knowledge of the disease and develop appropriate and effective procedures for the diagnosis and treatment of the patient. conditions: Testicular Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 3000 type: ESTIMATED name: Observation of testicular cancer patients measure: Clinical data measure: Adjuvant therapy measure: lactate dehydrogenase measure: Testicular objective examination measure: Testicular objective examination - cysts measure: Testicular objective examination - nodules measure: Testicular objective examination - varicocele measure: Testicular objective examination - hydrocele measure: α-feto protein measure: β human Chorionic Gonadotropin measure: carcinoembryonic antigen sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Ospedale San Raffaele status: RECRUITING city: Milan state: Lombardy zip: 20132 country: Italy name: Alessia d'Arma, PhD role: CONTACT phone: 02 2643 5506 email: [email protected] lat: 45.46427 lon: 9.18951 hasResults: False |
<|newrecord|> nctId: NCT06389396 id: CP362 briefTitle: Investigation of a New Rectal Catheter for Users of Transanal Irrigation overallStatus: RECRUITING date: 2024-04-08 date: 2024-06-30 date: 2024-06-30 date: 2024-04-29 date: 2024-04-29 name: Coloplast A/S class: INDUSTRY briefSummary: The clinical investigation is an exploratory, randomised controlled, open-labelled, crossover investigation. |
The clinical investigation will be conducted as a multi-centre clinical investigation in two different clinical investigation sites in Denmark. conditions: Bowel Management studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: PREVENTION masking: NONE count: 20 type: ESTIMATED name: CP362 Test Catheter measure: The primary endpoint is: Was it possible to perform transanal irrigation (assessed after irrigation at V1 and V2) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Århus Universitetshospital status: RECRUITING city: Århus state: Jutland zip: 8200 country: Denmark name: Peter Christensen role: CONTACT lat: 56.15674 lon: 10.21076 facility: Amager Hvidovre Hospital status: RECRUITING city: Hvidovre state: Zealand zip: 2650 country: Denmark name: Michael Sørensen role: CONTACT lat: 55.65719 lon: 12.47364 hasResults: False |
<|newrecord|> nctId: NCT06389383 id: 22-0182 briefTitle: Pilot Study - Monitoring the Nasal Microbiome and Viral Respiratory Infections in Newborn Hospitalized in Neonatalogy. acronym: NEONATMICROBIO overallStatus: ACTIVE_NOT_RECRUITING date: 2022-12-21 date: 2023-06-30 date: 2024-12 date: 2024-04-29 date: 2024-04-29 name: University Hospital, Caen class: OTHER briefSummary: The objective of our study is therefore to study the evolution of the respiratory microbiome of hospitalized newborns, its interaction with viral infections and their impacts on the evolution of newborns. conditions: Newborn; Infection studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: BASIC_SCIENCE masking: NONE count: 38 type: ACTUAL name: Nasal Swab measure: rate of viral infections sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: CAEN University Hospital city: Caen country: France lat: 49.18585 lon: -0.35912 hasResults: False |
<|newrecord|> nctId: NCT06389370 id: knowledge, Attitude, Behaviour briefTitle: ASSESSMENT OF ORAL HEALTH KNOWLEDGE, ATTITUDE AND BEHAVIOUR AND ITS ASSOCIATION WITH SOCIODEMOGRAPHIC FACTORS OF PRECLINICAL AND CLINICAL DENTAL STUDENTS IN CAIRO UNIVERSITY: A CROSS-SECTIONAL STUDY overallStatus: NOT_YET_RECRUITING date: 2024-11-04 date: 2024-11-18 date: 2024-12-03 date: 2024-04-29 date: 2024-04-29 name: Cairo University class: OTHER briefSummary: The knowledge, behaviour and attitude of oral health professionals reflects their awareness and understanding of oral preventive measures, which will have significant impact on their delivery of public oral health promotion in the future. They are expected to set an example for positive oral health behaviour among other college students, family members and their patients. Various external factors like sociodemographic factors like age, gender, marital state, occupation, and number of family members play a major role in oral hygiene. The relationships between various modifiable factors needs to be assesses in a vast manner. |
There were some researches about oral health knowledge, behaviour and attitude in correlation to socio-demographic data, of dental students in other countries, but little was known in Egypt. Dental students are expected to play a critical role in instructing public oral health for improving their patient's, families, and friends. In addition, it may pave the way to develop new programs to encourage needful oral health practices. conditions: Oral Health Knowledge, Attitude and Behaviour of Dental Students studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 535 type: ESTIMATED name: HU-DBI questionnaire measure: Increase of dental students KAB by preceding through higher academic levels sex: ALL minimumAge: 17 Years maximumAge: 27 Years stdAges: CHILD stdAges: ADULT hasResults: False |
<|newrecord|> nctId: NCT06389357 id: 1305G2024 briefTitle: Return to School Adaptation Programme for Children With Cancer acronym: web-based overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2024-09-06 date: 2024-11-30 date: 2024-04-29 date: 2024-04-29 name: Gazi University class: OTHER briefSummary: This study is planned to evaluate the effect of back-to-school adaptation programme on social anxiety score, coping score and back-to-school readiness score in children aged 8-17 years who are followed up with a diagnosis of cancer. |
H1: Is there a significant difference in children's social anxiety scores before and after the back-to-school adaptation programme? H2: Is there a significant difference in children's coping scores before and after the back-to-school adaptation programme? H3: Is there a significant difference in children's readiness to return to school scores before and after the back-to-school adaptation programme? conditions: Childhood Cancer conditions: ALL, Childhood conditions: AML, Childhood conditions: Lymphoma conditions: Solid Tumor, Childhood studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: The research is a technical/scientific/collaborative action research design. primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 35 type: ESTIMATED name: training and counselling measure: social anxiety measure: coping measure: back to school readiness measure: process evaluation sex: ALL minimumAge: 8 Years maximumAge: 17 Years stdAges: CHILD facility: Gizem Cakir city: Ankara state: Cankaya zip: 06490 country: Turkey name: Gizem Cakir, PhD(c) role: CONTACT phone: +905300858879 email: [email protected] lat: 39.91987 lon: 32.85427 hasResults: False |
<|newrecord|> nctId: NCT06389344 id: lk20240401 briefTitle: Effect of Esketamine on Conscious State in Patients With pDoC overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-12-31 date: 2026-06-30 date: 2024-04-29 date: 2024-04-29 name: Beijing Tiantan Hospital class: OTHER briefSummary: The goal of this clinical trial is to learn about the effect of intraoperative infusion of subanesthetic dose of esketamine on conscious status in patients with prolonged disorders of consciousness under sevoflurane anesthesia. |
Participants will be patients with prolonged disorders of consciousness undergoing surgery with general anesthesia at Beijing Tiantan Hospital. 0.3mg/kg esketamine or saline will be infused will be infused intravenously at a constant speed within 30 min after tracheal intubation/pneumatectomy fixation. Coma recovery scale-revised, Glasgow coma scale, Full Outline of UnResponsiveness scores, SedLine multi-channel electroencephalogram and perioperative adverse events after surgery will be investigated. conditions: Esketamine conditions: Consciousness Disorders studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 116 type: ESTIMATED name: Esketamine name: normal saline measure: Coma recovery scale-revised(CRS-R) measure: Coma recovery scale-revised(CRS-R) measure: Full Outline of UnResponsiveness(FOUR) measure: Glasgow coma scale(GCS) measure: Original EEG measure: Patient state index(PSI) measure: Power spectral density measure: Burst-suppression ratio measure: Spectral edge frequency measure: The incidence of perioperative adverse events sex: ALL minimumAge: 16 Years maximumAge: 65 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06389331 id: IRC/1971/020 briefTitle: Study on Effects of Defect Closure in Laparoscopic Repair of Direct Inguinal Hernia overallStatus: COMPLETED date: 2020-09-01 date: 2021-06-30 date: 2021-08-31 date: 2024-04-29 date: 2024-04-29 name: B.P. Koirala Institute of Health Sciences class: OTHER briefSummary: The defect closure was found to have higher pain and less seroma formation at various intervals of time following TEP for moderate-large direct inguinal hernia. Although these findings were statistically insignificant, they may be clinically significant, and further studies with a larger sample size are suggested. conditions: Hernia conditions: Direct Inguinal Hernia conditions: Seroma Following Procedure studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 88 type: ACTUAL name: closed the defect with barbed suture measure: seroma sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Vijay Pratap Sah city: Malangwa state: Madhesh Pradesh country: Nepal lat: 26.85679 lon: 85.55811 typeAbbrev: Prot_ICF hasProtocol: True hasSap: False hasIcf: True label: Study Protocol and Informed Consent Form date: 2020-09-01 uploadDate: 2024-04-24T12:06 filename: Prot_ICF_000.pdf size: 190465 hasResults: False |
<|newrecord|> nctId: NCT06389318 id: RC 29-11-2023 briefTitle: Buccal Midazolam Versus Intranasal Dexmedetomidine Plus Oral Chloral Hydrate in Inguinal Hernia Repair overallStatus: COMPLETED date: 2023-03-26 date: 2024-03-26 date: 2024-04-24 date: 2024-04-29 date: 2024-04-29 name: Benha University class: OTHER briefSummary: Inguinal hernia surgery is one of the most common surgical procedures in early infancy. Preoperative anxiety remains a vexing issue, and it exists in nearly 50% of pediatric patients conditions: Inguinal Hernia Repair studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Group A (40 patients): Children received oral placebo syrup, Group B (40 patients): Children received oral chloral hydrate (Chloral Hydrate mixture) primaryPurpose: PREVENTION masking: DOUBLE maskingDescription: Both participant and the care-provider in this trial were blinded. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 80 type: ACTUAL name: buccal midazolam +oral placebo syrup name: oral chloral hydrate,intranasal dexmedetomidine and buccal normal saline measure: Ramsay sedation score measure: Parental separation anxiety scale sex: ALL minimumAge: 2 Years maximumAge: 7 Years stdAges: CHILD facility: Benha University city: Banha zip: 13511 country: Egypt lat: 30.45906 lon: 31.17858 hasResults: False |
<|newrecord|> nctId: NCT06389305 id: BJGBYY-IIT-LCYJ-2024-012 briefTitle: CIK Cell Therapy for Relapsed or Refractory Acute B-Lymphoblastic Leukemia: Prognostic Impact on Patients With Early CAR-T Cell Dysfunction overallStatus: RECRUITING date: 2024-05-01 date: 2025-04-30 date: 2026-04-30 date: 2024-04-29 date: 2024-04-29 name: Beijing GoBroad Hospital class: OTHER briefSummary: This is a single-center, double-blind, randomized trial. Patients with r/r B-ALL experiencing early functional exhaustion of CAR-T cells will be randomly allocated into three groups: the control cell group, the CIK treatment group, and the mRNA-CIK treatment group. The primary objective of the study is to evaluate the prognostic impact of CIK cell therapy on the early functional exhaustion of CAR-T cells in children and adolescent and young adult (AYA) with r/r B-ALL. The primary endpoint of the study is the event-free survival rate of these patient in the CIK cell therapy group.A total number of 213 subjects will be enrolled. conditions: B-cell Acute Lymphoblastic Leukemia conditions: Acute Lymphoblastic Leukemia, in Relapse conditions: Refractory Acute Lymphoid Leukemia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: a prospective cohort study primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 213 type: ESTIMATED name: peripheral blood lymphocytes name: CIK cell measure: EFS in CIK infusion group measure: PFS in CIK infusion group measure: DOR in CIK infusion group measure: OS in CIK infusion group measure: EFS in mRNA-CIK infusion group sex: ALL minimumAge: 1 Year maximumAge: 39 Years stdAges: CHILD stdAges: ADULT facility: Beijing GoBroad Hospital status: RECRUITING city: Beijing state: Beijing zip: 102206 country: China name: Tengyu Wang role: CONTACT phone: 86+18333186020 email: [email protected] lat: 39.9075 lon: 116.39723 hasResults: False |
<|newrecord|> nctId: NCT06389292 id: APG2575AG301 briefTitle: A Pivotal Phase 3 Study of APG-2575 (Lisaftoclax) Combined With Azacytidine in the Treatment of Acute Myeloid Leukemia overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2028-05-25 date: 2029-03-26 date: 2024-04-29 date: 2024-04-29 name: Ascentage Pharma Group Inc. class: INDUSTRY briefSummary: An international multicenter, randomized, double-blind, placebo-controlled, phase III pivotal registration study, to evaluate the efficacy of APG-2575 (Lisaftoclax) combined with azacitidine (AZA) versus placebo combined with azacitidine in newly diagnosed acute myeloid leukemia who are not eligible for standard induction chemotherapy. conditions: Acute Myeloid Leukemia studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 486 type: ESTIMATED name: Lisaftoclax (APG-2575) name: Placebo name: Azacitidine Injection measure: Overall Survival（OS） measure: Percentage of Participants with Objective Response Rate (ORR) measure: Safety evaluation based on the adverse event concurrence sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hematology Hospital of the Chinese Academy of Medical Sciences city: Tianjin state: Tianjin zip: 300020 country: China name: Hui Wei, M.D. role: CONTACT phone: 022-23909120 email: [email protected] name: Hui Wei, M.D. role: PRINCIPAL_INVESTIGATOR lat: 39.14222 lon: 117.17667 facility: The First Affiliated Hospital of Zhejiang University School of Medicine city: Hangzhou state: Zhejiang zip: 310003 country: China name: Jie Jin, M.D. role: CONTACT email: [email protected] role: CONTACT phone: 0571-87236896 name: Jie Jin, M.D. role: PRINCIPAL_INVESTIGATOR lat: 30.29365 lon: 120.16142 hasResults: False |
<|newrecord|> nctId: NCT06389279 id: 2023-18/11 briefTitle: The Effect of Facial Plane Blocks on Postoperative Recovery Quality in Hip Surgery overallStatus: NOT_YET_RECRUITING date: 2024-04-24 date: 2024-09-24 date: 2024-10-24 date: 2024-04-29 date: 2024-04-29 name: Antalya Training and Research Hospital class: OTHER_GOV briefSummary: The aim of this study was to evaluate the effect of ultrasound-guided pericapsular nerve block, fascia iliaca compartment block, and femoral block on the quality of recovery as part of multimodal analgesia before hip surgery under spinal anesthesia. conditions: Hip Fracture studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 80 type: ESTIMATED name: PENG block group name: FIC block group name: Femoral block group name: Control group measure: recovery quality measure: postoperative Numeric Rating Scale (NRS) pain score measure: postoperative opioid consumption sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Health Sciences, Antalya Training and Researh Hospital city: Antalya country: Turkey name: Antalya Training and Research Hospital role: CONTACT lat: 36.90812 lon: 30.69556 hasResults: False |
<|newrecord|> nctId: NCT06389266 id: 221550 briefTitle: Network-Targeted Neuromodulation for Nicotine Dependence in Schizophrenia overallStatus: RECRUITING date: 2023-06-15 date: 2029-01-10 date: 2029-01-10 date: 2024-04-29 date: 2024-04-29 name: Vanderbilt University Medical Center class: OTHER briefSummary: The goal of this clinical trial is to compare two active types of transcranial magnetic stimulation in two nicotine-using populations: nicotine-using people with psychosis and nicotine-using people without a diagnosis of a psychotic disorder. The main questions it aims to answer are: |
1. Can rTMS change functional connectivity in brain circuits associated with nicotine use? |
2. Are those rTMS-induced changes in functional connectivity related to craving? |
Participants will complete tasks assessing their cognitive performance and craving before and after each week of TMS. Researchers will compare the effect of each TMS intervention on participants with and without psychosis to see if one type of TMS has an effect on nicotine craving. conditions: Schizophrenia conditions: Nicotine Dependence studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: All participants receive five days of DMN-targeted cTBS and five days of L DLPFC-targeted iTBS. The order in which participants receive the two types of TMS is randomized. primaryPurpose: BASIC_SCIENCE masking: NONE maskingDescription: The study is not sham-controlled, as both arms are active TMS treatments. The type of TMS is not masked from the participant or the investigator. Statistician will be blinded to intervention. count: 100 type: ESTIMATED name: Repetitive Transcranial Magnetic Stimulation (rTMS) measure: Resting-state functional connectivity measure: Cue-induced craving measure: Tiffany Brief Questionnaire of Smoking Urges (QSU) measure: Self-reported craving measure: Wisconsin Smoking Withdrawal Scale (WSWS) measure: Fagerstrom Test for Nicotine Dependence (FTND) measure: Self-reported nicotine use sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Vanderbilt University Medical Center status: RECRUITING city: Nashville state: Tennessee zip: 37232 country: United States name: Heather B Ward, MD role: CONTACT phone: 615-327-7000 email: [email protected] name: Sophia H Blyth, BA role: CONTACT phone: 6154345891 email: [email protected] name: Stephan Heckers, MD, MSc role: SUB_INVESTIGATOR name: Hilary A Tindle, MD, MPH role: SUB_INVESTIGATOR lat: 36.16589 lon: -86.78444 hasResults: False |
<|newrecord|> nctId: NCT06389253 id: HTSW1 briefTitle: Subtalar Extra-articular Screw Arthroereisis overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-05 date: 2025-05 date: 2024-04-29 date: 2024-04-29 name: Università Vita-Salute San Raffaele class: OTHER briefSummary: The aim of the study is to investigate the effect of subtalar extra-articular calcaneo-stop screw on the proprioceptive and nociceptive pathways of the ankle before and after implantation. The hypothesis of the study is that an increased number of receptors related to proprioception will be detected in the sinus tarsi. conditions: Flatfoot, Flexible conditions: Ankle Proprioception studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 40 type: ESTIMATED name: Histological Analysis measure: Primary Endpoint (%) measure: Secondary Endpoint sex: ALL minimumAge: 10 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Ircss Ospedale San Raffaele city: Milan state: Lombardy zip: 20149 country: Italy lat: 45.46427 lon: 9.18951 facility: Università Vita-Salute San Raffaele city: Milan zip: 20132 country: Italy name: Francesco Pezone role: CONTACT role: CONTACT email: [email protected] lat: 45.46427 lon: 9.18951 hasResults: False |
<|newrecord|> nctId: NCT06389240 id: 160848 briefTitle: Early Weight Bearing in Unicondylar Tibial Plateau Fractures overallStatus: ACTIVE_NOT_RECRUITING date: 2022-12-21 date: 2025-12 date: 2025-12 date: 2024-04-29 date: 2024-04-29 name: University of Utah class: OTHER briefSummary: The investigators aim of the study is to assess the effects of early mobilization after surgically treated unicondylar tibia plateau fractures (6 weeks without weight bearing) on gait, patient satisfaction, return to work/sports and complication rate. The data will be compared to a 10-12 week non-weight bearing group (standard of care). |
It is assumed that earlier mobilization does not lead to an increase in the complications - in particular osteosynthesis failure and infections -, but leads to improved patient satisfaction, reduced return to work/sports times, and has a positive impact on the overall outcome conditions: Early Mobilization studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 60 type: ESTIMATED name: 6 weeks post-operatively early weight bearing name: 10 weeks post-operatively weight bearing (standard of care) measure: Average peak load (Newtons (N)) measure: Average peak load (Newtons (N)) measure: Average peak load (Newtons (N)) measure: Average peak load (Newtons (N)) measure: Average peak load (Newtons (N)) measure: Average peak load (Newtons (N)) measure: Average peak load (Newtons (N)) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Utah Orthopedics city: Salt Lake City state: Utah zip: 84108 country: United States lat: 40.76078 lon: -111.89105 hasResults: False |
<|newrecord|> nctId: NCT06389227 id: 0433611 briefTitle: Developing the Physical Performance in Youth Soccer: Short-term Effect of Dynamic-Ecological Versus Traditional Training Approach for Sub-élite U13 Players: An Ecological Exploratory Cluster Randomised Trial overallStatus: COMPLETED date: 2023-10-15 date: 2023-10-30 date: 2024-02-15 date: 2024-04-29 date: 2024-04-29 name: University of Turin, Italy class: OTHER briefSummary: Therefore, this study aims to verify the effects of a soccer training program based on the dynamic-ecological approach on U13 sub-elité players' physical efficiency by analysing explosive strength, speed, resistance to speed and muscle flexibility. This study hypothe-sises that the dynamic-ecological approach can consistently help players develop adequate physical efficiency and motor coordination. conditions: Verify the Effects of a Soccer Training Program Based on the Dynamic-ecological Approach on U13 Sub-elité Players' Physical Efficiency studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 35 type: ACTUAL name: dynamic ecological approach (DEA) name: traditional training group measure: Number of participants evaluated on physical efficiency sex: MALE minimumAge: 12 Years maximumAge: 13 Years stdAges: CHILD facility: Cit Turin LDE city: Turin zip: 10100 country: Italy lat: 45.07049 lon: 7.68682 hasResults: False |
<|newrecord|> nctId: NCT06389214 id: ADX-102-DED-030 briefTitle: A Phase 3 Clinical Trial to Assess the Efficacy and Safety of Subjects With Dry Eye Disease overallStatus: RECRUITING date: 2024-04-09 date: 2024-12-31 date: 2024-12-31 date: 2024-04-29 date: 2024-04-29 name: Aldeyra Therapeutics, Inc. class: INDUSTRY briefSummary: A Randomized, Double-Masked, Vehicle-Controlled Parallel Group Clinical Trial to Assess Efficacy and Safety of 0.25% Reproxalap Ophthalmic Solution Compared to Vehicle in Subjects with Dry Eye Disease conditions: Dry Eye Disease studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 110 type: ESTIMATED name: Reproxalap Ophthalmic Solution (0.25%) name: Vehicle Ophthalmic Solution measure: Ocular discomfort symptom score over 100 minutes in the dry eye chamber at Visit 2 and Visit 4 sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cliantha Research status: RECRUITING city: Mississauga state: Ontario country: Canada name: Patricia Couroux, MD role: CONTACT phone: (888) 989-1808 email: [email protected] lat: 43.5789 lon: -79.6583 hasResults: False |
<|newrecord|> nctId: NCT06389201 id: 2024HCQ briefTitle: Pretreatment With HCQ Before Radiotherapy and Chemotherapy in Advanced NPC Patients overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-12-31 date: 2026-12-31 date: 2024-04-29 date: 2024-04-29 name: Affiliated Hospital of Nantong University class: OTHER briefSummary: Dormant cancer cells that survive anti-cancer therapy can lead to cancer recurrence and disseminated metastases that prove fatal in most cases. Recently, specific dormant polyploid giant cancer cells (PGCC) have drawn our attention because of their association with the clinical risk of nasopharyngeal carcinoma (NPC) recurrence, as demonstrated by previous clinical data. In study, we report the biological properties of PGCC, and reveal that autophagy is a critical mechanism of PGCC induction. Moreover, pharmacological inhibition of autophagy greatly impaired PGCC formation, significantly suppressing metastasis and improving survival in a mouse model. Mechanistically, chemotherapeutic drugs partly damaged mitochondria, and activated autophagy to promote PGCC formation. High numbers of PGCCs correlated with shorter recurrence time and worse survival outcomes in NPC patients. Collectively, these findings suggest a therapeutic approach of targeting dormant PGCCs in cancer. |
Pretreatment with an autophagy inhibitor (HCQ) before chemotherapy and radiotherapy could prevent formation of therapy-induced dormant polyploid giant cancer cells, thereby reducing recurrence and metastasis of nasopharyngeal carcinoma. conditions: Nasopharyngeal Carcinoma studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 30 type: ESTIMATED name: HCQ name: Placebo measure: Recurrence and metastasis sex: ALL minimumAge: 20 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Bo You city: Nantong state: Jiangsu zip: 226000 country: China lat: 32.03028 lon: 120.87472 hasResults: False |
<|newrecord|> nctId: NCT06389188 id: JVT003 briefTitle: Effectiveness of Cervical Osteopathic Manipulation in Patients With Whiplash overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-09-01 date: 2024-10-01 date: 2024-04-29 date: 2024-04-29 name: Universidad Miguel Hernandez de Elche class: OTHER name: Consorci Sanitari de Terrassa briefSummary: To determine the mid- and long-term efficiency (15, 30 and 120 days after starting sessions) of the SAT technique in patients with grade II acute WL, comparing it with a conventional rehabilitation program. conditions: Whiplash studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: RHB Group measure: Subjective pain intensity measure: Neck specific disability measure: Cervical range of motion (CROM) measure: Cervical lordosis Cobb angle measure: Hospital anxiety and depression scale sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Consorci Sanitari de Terrassa. city: Terrassa state: Barcelona zip: 08227 country: Spain name: Joan Parera-Turull, PhD role: CONTACT phone: 937310007 phoneExt: 0007 email: [email protected] lat: 41.56667 lon: 2.01667 hasResults: False |
<|newrecord|> nctId: NCT06389175 id: BON001 id: KR 4555/10-1 type: OTHER_GRANT domain: Deutsche Forschungsgemeinschaft (DFG) briefTitle: Non-invasive Vagus Nerve Stimulation as a Tool to Modulate Stomach-Brain Coupling in Depression overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-12 date: 2026-12 date: 2024-04-29 date: 2024-04-29 name: University of Bonn class: OTHER name: University Hospital Tuebingen briefSummary: The overarching goal of the project is to determine whether differences in stomach-brain coupling contribute to key symptoms of major depressive disorder (MDD) and whether transcutaneous non-invasive vagus nerve stimulation (tVNS) may serve as a non-invasive intervention to improve aberrant interoceptive signaling in participants suffering from MDD. conditions: Depressive Disorder, Major studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: BASIC_SCIENCE masking: SINGLE whoMasked: PARTICIPANT count: 80 type: ESTIMATED name: Transcutaneous non-invasive vagus nerve stimulation (tVNS) name: Sham stimulation measure: Stimulation-induced acute changes in stomach-brain coupling measure: Stimulation-induced acute changes in gastric motility measure: Stimulation-induced mid-term changes in gastric motility measure: Stimulation-induced mid-term changes in self-reported interoception measure: Stimulation-induced mid-term changes in somatic symptoms measure: Stimulation-induced mid-term changes in depressive symptoms measure: Stimulation-induced acute neural changes in food cue reactivity measure: Stimulation-induced acute behavioral changes in invigoration measure: Stimulation-induced acute neural changes during foraging measure: Stimulation-induced acute behavioral changes in foraging decisions measure: Stimulation-induced mid-term changes in positive and negative affect measure: Stimulation-induced mid-term changes in self-reported interoception measure: Stimulation-induced mid-term changes in motivation measure: Stimulation-induced mid-term changes in physical activity measure: Stimulation-induced mid-term changes in heart rate measure: Stimulation-induced acute changes in blood parameters measure: Stimulation-induced mid-term changes in blood parameters measure: Stimulation-induced mid-term changes in composition of microbiome measure: Stimulation-induced mid-term changes in discounting-related decision-making measure: Stimulation-induced mid-term changes in reward learning measure: Stimulation-induced mid-term changes in loneliness sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT hasResults: False |
<|newrecord|> nctId: NCT06389162 id: UNLV-2024-115 briefTitle: Dorsolateral Prefrontal Cortex Transcranial Direct Current and Muscle Fatigue Stimulation on Muscle Fatigue overallStatus: ENROLLING_BY_INVITATION date: 2024-04-04 date: 2024-08-31 date: 2024-09-30 date: 2024-04-29 date: 2024-04-29 name: University of Nevada, Las Vegas class: OTHER briefSummary: The goal of this clinical trial is to learn if transcranial direct current stimulation (tDCS) of the dorsolateral prefrontal cortex (DLPFC) can impact muscle fatigue. The main questions it aims to answer are: |
1. Does tDCS of the left DLPFC increase the time that a fatiguing contraction can be maintained? |
2. Does tDCS of the left DLPFC decrease the rate of increase of muscle activity, force error, and standard deviation of force during a fatiguing contraction. |
Researchers will compare tDCS of the left DLPFC to a SHAM stimulation (a type of stimulation that feels like real tDCS but does not elicit physiological effects) to see if tDCS of the left DLPFC works to reduce the progression of muscle fatigue. |
Participants will: |
Performing two experimental sessions held 3-10 days apart (usually 7 days) Perform a 9 hole pegboard test, maximum voluntary contractions, and a fatiguing contraction. conditions: Fatigue studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: Double-blind whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 20 type: ESTIMATED name: transcranial direct current stimulation measure: Time to Task Failure measure: Fatigue Index measure: Average EMG activity measure: Force error measure: Standard deviation of force measure: 9 Hole Pegboard Test sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: University of Nevada Las Vegas city: Las Vegas state: Nevada zip: 89154 country: United States lat: 36.17497 lon: -115.13722 hasResults: False |
<|newrecord|> nctId: NCT06389149 id: 0165-24-FB briefTitle: Leg Exercise Assistive Paddling (LEAP) Therapy for Peripheral Artery Disease overallStatus: NOT_YET_RECRUITING date: 2024-08 date: 2025-08 date: 2025-08 date: 2024-04-29 date: 2024-04-29 name: University of Nebraska class: OTHER briefSummary: 1) The purpose of this study is to test the effects of leg exercise assistive paddling (LEAP) therapy during prolonged sitting (PS) on vascular and functional performance in those with peripheral artery disease (PAD) and age-matched controls. LEAP therapy is a novel application of passive limb movement to enhance blood flow through the legs without muscular contractions. Specifically, LEAP therapy is the rotational passive movement of the lower leg about the knee from 90 to 180 degrees of rotation at a cadence of 1Hz. Previous literature has indicated that this movement pattern can produce robust increases in blood flow in the passively moved limb in healthy individuals, and passive limb movement may protect vascular function during PS. However, the impact of LEAP therapy to improve blood flow in the legs of those with PAD during PS is unknown. 2) To be eligible for this study, those with PAD must be between the ages of 50-85 years, women must be postmenopausal, must have a history of exercise-limiting claudication, have an ankle brachial index (ABI) 0.9. 3) Subjects will participate in a randomized cross-over design study with 2 visits (LEAP therapy and no LEAP therapy). For the first visit, subjects will be randomly allocated to receive LEAP therapy during 2.5 hours of PS or not. For the second visit, subjects will sit for 2.5 hours and will receive the condition that they did not previously receive. Before and after PS, the following measurements will be made: flow-mediated dilation of the popliteal and brachial arteries, arterial stiffness with tonometry techniques, microvascular vasodilatory capacity and skeletal muscle metabolic rate with near-infrared spectroscopy, autonomic nervous system function, and there will be blood drawn from the antecubital vein. After PS, subjects will participate in a graded exercise test to assess functional walking capacity. Finally, during PS, near-infrared spectroscopy on the calf muscles and electrocardiogram will be collected continuously to monitor muscle oxygen availability and autonomic activity, respectively. 4) There will be no follow-up. conditions: Peripheral Arterial Disease conditions: Peripheral Vascular Disease conditions: Peripheral Artery Occlusive Disease conditions: Peripheral Artery Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: There will be a peripheral artery disease (PAD) group and an age-matched healthy control group. Within each of these groups will be a 1:1 randomized, crossover study design. primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 24 type: ESTIMATED name: LEAP therapy name: no LEAP therapy measure: Macrovascular Endothelial Function measure: Microvascular Vasodilatory Capacity measure: Femoral and Popliteal Artery Blood Flow measure: Walking capacity measure: Autonomic Function measure: Autonomic Activity measure: Arterial Stiffness measure: Muscle Oxygenation measure: Peripheral blood mononuclear cell mitochondrial function sex: ALL minimumAge: 55 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Nebraska - Omaha city: Omaha state: Nebraska zip: 68182 country: United States lat: 41.25626 lon: -95.94043 hasResults: False |
<|newrecord|> nctId: NCT06389136 id: M24-601 briefTitle: A Study of Upadacitinib in Adult Participants With Moderate-to-Severe Atopic Dermatitis and Inadequate Response to Dupilumab acronym: Switch-Up overallStatus: NOT_YET_RECRUITING date: 2024-05-24 date: 2025-08-22 date: 2026-03-09 date: 2024-04-29 date: 2024-04-29 name: AbbVie class: INDUSTRY briefSummary: Atopic dermatitis (AD) is a skin condition that may cause a rash and itching due to inflammation of the skin. Therapies spread over the skin may not be enough to control the AD in trial participants who require systemic anti-inflammatory treatment. This study aims to provide data on the efficacy and safety of upadacitinib at different doses in adult participants with moderate to severe AD. |
Upadacitinib is an approved drug for the treatment of moderate to severe atopic dermatitis (AD). This study is conducted in 2 periods. During Period 1, participants are randomly assigned into 1 of 2 groups called treatment arms to receive upadacitinib Dose A or dupilumab Dose A. Based on the participants response to upadacitinib Dose A, they may have their dose increased to upadacitinib Dose B after 2 weeks. In Period 2, participants that completed Period 1 will either remain on their assigned dose or be reassigned to a different dose based on their Eczema Area and Severity Index (EASI) response. Approximately 300 adult participants ages 18 to 64 with moderate to severe AD who are current users of dupilumab and had a history of inadequate response to dupilumab will be enrolled at up to 94 sites worldwide. |
The study is comprised of a 35-day Screening Period, an 8-week Open-Label Period 1 and a 24-week Open-Label Period 2 for participants that completed Period 1. Participants will receive upadacitinib oral tablets once daily or dupilumab subcutaneous (SC) injection every other week for 32 weeks and followed for 30 days. |
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires. conditions: Atopic Dermatitis studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 300 type: ESTIMATED name: Upadacitinib Dose A name: Dupilumab Dose A name: Upadacitinib Dose B measure: Participants who achieve a composite endpoint of both a 90% reduction in Eczema Area and Severity Index from Baseline (EASI 90) and Worst Pruritus Numerical Rating Scale of 0 or 1 (WP-NRS 0/1) measure: Percentage of participants who achieve EASI 90 measure: Percentage of participants achieving worst pruritus numerical rating scale (WP-NRS) 0/1 measure: Percentage of participants achieving worst pruritus numerical rating scale (WP-NRS) 0/1 sex: ALL minimumAge: 18 Years maximumAge: 63 Years stdAges: ADULT hasResults: False |
<|newrecord|> nctId: NCT06389123 id: 1788760 briefTitle: Molecularly Targeted Theranostic Approach for the Detection and Treatment of Metastatic Carcinomas overallStatus: RECRUITING date: 2024-04-01 date: 2027-03-31 date: 2028-03-31 date: 2024-04-29 date: 2024-04-29 name: University of California, Davis class: OTHER name: National Institutes of Health (NIH) briefSummary: This is a Phase I study to evaluate the safety and efficacy of the \[68Ga\]Ga DOTA-5G and \[177Lu\]Lu DOTA-ABM-5G theranostics pair in patients with metastatic cancer. conditions: Metastatic Cancer studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Single treatment primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: [68Ga]Ga DOTA-5G and [177Lu]Lu DOTA-ABM-5G. measure: [68Ga]Ga DOTA-5G PET/CT imaging measure: [177Lu]Lu DOTA-ABM-5G treatment measure: [177Lu]Lu DOTA-ABM-5G treatment efficacy sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The University of California Davis Comprehensive Cancer Center status: RECRUITING city: Sacramento state: California zip: 95817 country: United States name: Julie L Sutcliffe, PhD role: CONTACT phone: 916-734-5536 email: [email protected] lat: 38.58157 lon: -121.4944 hasResults: False |
<|newrecord|> nctId: NCT06389110 id: SOPH201-1023/III briefTitle: Study to Evaluate the Efficacy of Alleance® (Atropine Sulfate 0.01%) as a Treatment to Delay Myopia and Axial Ocular Elongation in Children. overallStatus: NOT_YET_RECRUITING date: 2024-12-30 date: 2027-06-30 date: 2027-06-30 date: 2024-04-29 date: 2024-04-29 name: Laboratorios Sophia S.A de C.V. class: INDUSTRY briefSummary: Phase III clinical study to evaluate the efficacy of Alleance® (atropine sulfate 0.01%) ophthalmic solution through the incidence of unexpected adverse events, changes in Best Corrected Visual Acuity (BCVA), changes in intraocular pressure, changes in the amplitude of accommodation, compared to placebo, as a treatment to delay the progression of myopia and axial ocular elongation in children. conditions: Myopia conditions: Myopia, Progressive studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a study to demonstrate superiority, double-blind, randomized, controlled, comparative, and multicenter phase III clinical trial. primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 123 type: ESTIMATED name: Alleance® name: Placebo measure: Changes in the spherical equivalent measure: Changes in axial eye length measure: Incidence of unexpected adverse events related to the interventions measure: Incidence of photophobia between interventions measure: Changes in pupillary diameter between the interventions measure: Changes in Best Corrected Visual Acuity (BCVA) measure: Changes in near best-corrected visual acuity measure: Changes in the amplitude of accommodation (AA) between interventions measure: Changes in intraocular pressure (IOP) sex: ALL minimumAge: 3 Years maximumAge: 12 Years stdAges: CHILD hasResults: False |
<|newrecord|> nctId: NCT06389097 id: J23152 id: IRB00411454 type: OTHER domain: JHM IRB id: P01CA272222 type: NIH link: https://reporter.nih.gov/quickSearch/P01CA272222 briefTitle: SPECT Imaging for Pharmacokinetics and dosimEtry Towards TREATment Optimization acronym: (SEEtoTREAT) overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2028-05 date: 2029-05 date: 2024-04-29 date: 2024-04-29 name: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins class: OTHER name: National Cancer Institute (NCI) briefSummary: The investigators will study SPECT imaging of radiopharmaceutical therapies given as standard of care or as part of other compatible research protocols. The goal is to validate the quantitative SPECT image reconstruction methods developed in this proposal, and to investigate the relation between dosimetry calculated from SPECT images and the outcomes. Patients will be recruited for SPECT/CT imaging during treatment. This is an observational study no additional new drugs or activities will be administrated. The investigators will perform SPECT imaging on a total of 80 patients (\~20 each from year 2 to year 5). Each participant will be imaged 3 times after the first and last cycles of planned radiopharmaceutical therapy. conditions: Prostate Cancer conditions: Advanced Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 80 type: ESTIMATED name: Radium-223 name: 177Lu-DOTATATE name: 177Lu-PSMA-617 measure: Mean absorbed dose to normal organs compared using different quantitative methods measure: Variability of intra-patient and inter-patient mean absorbed dose to normal organs compared using SPECT images measure: Mean absorbed dose to normal organs correlated with toxicity sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06389084 id: 179939 briefTitle: Parents Together: Supporting Parents to Promote Healthy Behaviours in Children overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-03-31 date: 2025-12-31 date: 2024-04-29 date: 2024-04-29 name: The Hospital for Sick Children class: OTHER briefSummary: The Parents Together trial aims to determine if the Parents Together program consisting of virtual parent group sessions and coaching calls, will result in better health outcomes for children. The program which is facilitated by a Public Health Nurse seeks to encourage healthy lifestyle behaviours, help build strong family relationships, and promote child development and mental health. conditions: Child Eating Behaviours conditions: Child Nutrition conditions: Early Child Development conditions: Parenting studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized control trial primaryPurpose: PREVENTION masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 128 type: ESTIMATED name: Parents Together parenting course measure: Child eating behaviours measure: Dietary intake and food environment measure: Nutritional risk measure: Physical Activity, Sedentary Time, Sleep Duration measure: Physical activity measure: Social and emotional development measure: Child development measure: Family psychosocial health measure: Parenting measure: Parenting sense of competence measure: sociodemographic, maternal and child characteristics measure: zBMI measure: Waist circumference measure: Blood pressure sex: ALL minimumAge: 2 Years maximumAge: 5 Years stdAges: CHILD facility: The Hospital for Sick Children city: Toronto state: Ontario country: Canada lat: 43.70011 lon: -79.4163 hasResults: False |
<|newrecord|> nctId: NCT06389071 id: PLS001 briefTitle: Laser Treatment for Lichen Sclerosus overallStatus: RECRUITING date: 2024-03-01 date: 2025-12-20 date: 2025-12-30 date: 2024-04-29 date: 2024-04-29 name: Sciton class: INDUSTRY briefSummary: Fractional ablative laser treatment for Lichen Sclerosus lesion conditions: Lichen Sclerosus Lesion studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 50 type: ESTIMATED name: Fractional 2940 nm Laser measure: Histological clearance sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Clinique Medicale Uro-Gyneco de l'Abitibi status: RECRUITING city: Val-d'Or state: Quebec zip: J9P1W1 country: Canada name: Josee Parent, MD role: CONTACT phone: 819-825-3800 lat: 48.0974 lon: -77.79737 hasResults: False |
<|newrecord|> nctId: NCT06389058 id: G00014538 briefTitle: Using NLP and Neural Networks to Autonomously Identify Severe Asthma and Determine Study Eligibility in a Large Healthcare System overallStatus: ACTIVE_NOT_RECRUITING date: 2023-05-01 date: 2024-07-01 date: 2026-11 date: 2024-04-29 date: 2024-04-29 name: San Diego State University class: OTHER name: GlaxoSmithKline name: Scripps Health name: Modena Allergy + Asthma, La Jolla, CA name: University of California, San Diego briefSummary: The study aims to to use new technologies (ML, AI, NLP), to autonomously identify moderate to severe asthma populations within an EHR system, describe differences in treatment patterns across different populations, and determine trial eligibility. |
Primary Objectives Please ensure you detail primary objectives Aim 1. Determine and validate a diagnosis of severe asthma (SA) using predictive features obtained from the Scripps Health EHR. |
* Aim 1a: Use ML applied to structured EHR data to predict SA. Use the opinion of 2 specialty-trained physicians and ATS guidelines to determine model accuracy. |
* Aim 1b: Use NLP applied to unstructured text to predict SA. Determine model accuracy as above in Aim 1a. |
* Aim 1c: Use a combination of ML applied to structured data to predict SA. Determine model accuracy as above in Aim 1a. conditions: Severe Asthma studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 31795 type: ACTUAL name: Recommendation for the diagnoses and treatment of Severe Athma measure: Identification of Patients with Severe Asthma sex: ALL minimumAge: 6 Years maximumAge: 85 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: San Diego State University city: San Diego state: California zip: 92182-1309 country: United States lat: 32.71533 lon: -117.15726 hasResults: False |
<|newrecord|> nctId: NCT06389045 id: EUS briefTitle: Profopol and Remifentanil Sedation in Endoscopic Ultrasonography overallStatus: RECRUITING date: 2024-04-24 date: 2024-06-24 date: 2024-07-01 date: 2024-04-29 date: 2024-04-29 name: Samsun University class: OTHER briefSummary: Endoscopic ultrasonography (EUS) is an endoscopic procedure performed to investigate conditions affecting the stomach, liver, and bile ducts, as well as for therapeutic interventions. The complexity of EUS can vary significantly, with increased complexity affecting procedure duration, technical success, and the occurrence of adverse events. For the comfort of patients and the success of the procedure, these interventions are typically performed under anesthesia with procedural sedation. To enhance the success rate of the procedure, reduce the risk of side effects, and maximize patient comfort, EUS is generally performed under sedation according to the recommendations of the American Society of Anesthesiologists (ASA). During sedation, the aim is for the patient to be more relaxed and comfortable while maintaining spontaneous respiratory function. Preserving spontaneous respiratory parameters is crucial for procedural safety. conditions: Sedation Complication conditions: Endoscopic Ultrasonography conditions: Procedural Sedation studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 70 type: ESTIMATED name: Procedural Sedation measure: Anesthesia related major complications measure: The prevalence of symptoms of inadequate sedation sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Samsun University Faculty of Medicine status: RECRUITING city: Samsun country: Turkey name: Caner Genc, M.D. role: CONTACT phone: 5444846865 phoneExt: +90 email: [email protected] lat: 41.27976 lon: 36.3361 hasResults: False |
<|newrecord|> nctId: NCT06389032 id: 21041503 id: 1R01AG079128-01A1 type: NIH link: https://reporter.nih.gov/quickSearch/1R01AG079128-01A1 briefTitle: PERSEVERE in Lewy Body Dementia: A Randomized, Controlled Trial of Peer Mentor Support and Caregiver Education overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2027-10-15 date: 2028-06-30 date: 2024-04-29 date: 2024-04-29 name: Rush University Medical Center class: OTHER name: National Institute on Aging (NIA) briefSummary: Lewy Body Dementia (LBD) is the second most common form of degenerative dementia, affecting at least 2.4 million US adults, and the overwhelming majority of persons living with LBD (PLBD) are cared for by family caregivers. LBD caregiver strain: 1) exceeds that of non-LBD dementia caregivers; 2) worsens caregiver physical and mental health; and 3) increases the risk of PLBD hospitalization and institutionalization. LBD progression is complicated by combined motor, cognitive, and neuropsychiatric decline, and is punctuated by falls, infections, dehydration, and neuropsychiatric symptoms leading to acute healthcare utilization. Although family caregivers are uniquely positioned to identify and manage these challenges, which may avert emergency department visits and reduce morbidity, many caregivers lack the knowledge, skills, confidence, resources, and support to do so. |