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<|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: cakirgzem@gmail.com 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: tengyu.wang@gohealtharo.com 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: weihui@ihcams.ac.cn 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: jiej0503@163.com 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: heather.b.ward@vumc.org name: Sophia H Blyth, BA role: CONTACT phone: 6154345891 email: sophia.h.blyth@vumc.org 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: f.pezone@studenti.unisr.it 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: pcouroux@cliantha.com 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: joanparera@osteopatiaterrassa.com 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: jlsutcliffe@ucdavis.edu 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: dr.canergenc@gmail.com 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. |
We aim to 1) quantify the impact of PERSEVERE on caregiver knowledge, attitudes, mastery, and strain; 2) identify the intervention and mentor factors determining implementation fidelity; and 3) test the effects of PERSEVERE on PLBD quality of life and healthcare utilization. This will be accomplished in an NIH Behavioral Model Stage II national, randomized, attention-controlled, 12-week trial of PERSEVERE in 502 LBD caregivers in partnership with the Lewy Body Dementia Association, Parkinson's Foundation, and LBD Caregiver Advisors. We will match intervention arm caregivers with a trained peer mentor who will coach them through a modular, theory-based curriculum on LBD knowledge and social support. Attention-control participants will receive weekly, curated links to educational materials. We will identify immediate and delayed intervention effects, including mediators of strain at 12 weeks, and caregiver strain and PLBD outcomes at nine months. Implementation fidelity and PLBD healthcare utilization will be tracked biweekly. Qualitative methods will explore the intervention- and mentor-specific factors predicting fidelity, mentee outcomes, and retention. Remote recruitment, mentoring, and community engagement strategies will maximize accessibility and inclusion of underrepresented caregiver groups. Results will illuminate the extent to which leveraging prior LBD caregivers as expert interventionists can improve current caregiver outcomes, and in turn, PLBD outcomes. These results will inform future adaptation and dissemination of this model for other conditions. conditions: Lewy Body Dementia conditions: Parkinson Disease Dementia conditions: Dementia With Lewy Bodies conditions: Lewy Body Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 622 type: ESTIMATED name: Peer Mentor Support and Caregiver Education name: Caregiver Education measure: Multidimensional Caregiver Strain Index (MCSI) measure: Quality of Life in Alzheimer's Disease ( QoL-AD) measure: Dementia Attitudes Scale (DAS) measure: LBD Knowledge Test ( LBDK) measure: Baseline PLBD Fall Frequency and Healthcare Utilization Questionnaire measure: Fortinsky Caregiver Self-Efficacy Score measure: Multidimensional Scale of Perceived Social Support (MSPSS) measure: Pearlin Mastery Scale measure: Frequency and Duration of Mentoring Calls measure: Study adherence of Mentors and Mentees measure: Coverage of target topics; additional topics discussed sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Rush University Medical Center city: Chicago state: Illinois zip: 60612 country: United States name: Persevere Study Team role: CONTACT phone: 312-563-3300 email: persevere@rush.edu name: Dr. Jori Fleisher, MD MSCE role: PRINCIPAL_INVESTIGATOR lat: 41.85003 lon: -87.65005 hasResults: False |
<|newrecord|> nctId: NCT06389019 id: BLCA_CMUFH id: K2024-187-01 type: OTHER domain: The First Affiliated Hospital of Chongqing Medical University briefTitle: Whole-slide Image and CT Radiomics Based Deep Learning System for Prognostication Prediction in Bladder Cancer overallStatus: RECRUITING date: 2024-01-01 date: 2024-06-01 date: 2024-10-01 date: 2024-04-29 date: 2024-04-29 name: Mingzhao Xiao class: OTHER briefSummary: Bladder cancer (BLCA), with its diverse histopathological features and varying patient outcomes, poses significant challenges in diagnosis and prognosis. Postoperative survival stratification based on radiomics feature and whole slide image feature may be useful for treatment decisions to improve prognosis. In this research, we aim to develop a deep learning-based prognostic-stratification system for automatic prediction of overall and cancer-specific survival in patients with BLCA. conditions: Bladder Cancer studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: RETROSPECTIVE count: 1000 type: ESTIMATED name: Deep learning system for prognostication prediction in bladder cancer measure: Overall survival measure: Recurrence free survival sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Urology, The First Affiliated Hospital of Chongqing Medical University status: RECRUITING city: Chongqing state: Chongqing zip: 400016 country: China name: QuanHao He, PHD role: CONTACT phone: 800-555-5555 email: 2020120460@stu.cqmu.edu.cn name: Mingzhao Xiao, PHD role: CONTACT phone: 023-89012557 email: 2023140134@stu.cqmu.edu.cn lat: 29.56278 lon: 106.55278 hasResults: False |
<|newrecord|> nctId: NCT06389006 id: RC48-C025 briefTitle: To Evaluate the Efficacy and Safety of Disitamab Vedotin Combined With Toripalimab Sequential Chemotherapy as Neoadjuvant Treatment in Patients With HR-positive, HER2-low Breast Cancer overallStatus: NOT_YET_RECRUITING date: 2024-04-30 date: 2025-06-01 date: 2026-12-31 date: 2024-04-29 date: 2024-04-29 name: RemeGen Co., Ltd. class: INDUSTRY briefSummary: The purpose of this study is to evaluate the efficacy and safety of Disitamab Vedotin combined with Toripalimab sequential chemotherapy as in patients with HR-positive, HER2-low breast cancer conditions: HR-positive, HER2-low Breast Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 79 type: ESTIMATED name: Disitamab Vedotin for Injection name: Toripalimab name: Epirubicin name: Cyclophosphamide measure: Total pathological complete response (tpCR) rate measure: Breast pathological complete response（bpCR） measure: Event free survival (EFS) measure: Disease-free survival (DFS) measure: Objective Response Rate (ORR) measure: Adverse events (AEs) measure: Change in cluster of differentiation 8 (CD8) measure: Health-related quality of life - EORTC-QLQ-C30 measure: Residual cancer burden score measure: Change in tumor-infiltrating lymphocytes (TILs) measure: Change in programmed cell death protein L1 (PD-L1) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Jiong Wu city: Shanghai state: Fudan University Shanghai Cancer Center zip: 200032 country: China name: Jiong Wu, Ph.D role: CONTACT lat: 31.22222 lon: 121.45806 hasResults: False |
<|newrecord|> nctId: NCT06388993 id: 2023H0351 briefTitle: Marrow Cellution™ vs. Traditional BMA Harvest Project overallStatus: RECRUITING date: 2024-03-25 date: 2024-12-31 date: 2025-03-31 date: 2024-04-29 date: 2024-04-29 name: Ohio State University class: OTHER briefSummary: Six patients with diagnosed bone loss of the hip who have consented to minimally invasive repair will be approached to participate in the study. Participants will have the liquid portion of bone marrow collected using the Zimmer Biomet Biocue system, which is the standard system used by physicians at The Ohio State University, and the novel Marrow Cellutions system™. Bone marrow liquid will be collected from the surgical hip using the Zimmer Biomet Biocue system, and the Marrow Cellutions system™ will be used to collect bone marrow liquid from the non-surgical hip. Following collection, the bone marrow liquid will be processed using the respective systems to concentrate the cells and molecules found in the bone marrow liquid. As part of the standard of care for this arthroscopic procedure, concentrated bone marrow liquid processed using the Zimmer Biomet Biocue system will be delivered to the surgical site as an adjunct to promote healing. Concentrated bone marrow liquid prepared with the Zimmer Biomet Biocue system is given as part of the standard of care for patients undergoing minimally invasive treatment for bone loss of the hip; therefore, the target population for this study are individuals between the ages of 18-50 years with confirmed bone loss of the hip who have consented to minimally invasive repair. In addition to the concentrated bone marrow liquid prepared using the Zimmer Biomet Biocue system, patients will also have bone marrow liquid collected from the non-surgical hip using the Marrow Cellutions™ system. Only concentrated bone marrow liquid produced with the Zimmer Biomet Biocue system will be given to the patient. All concentrated bone marrow liquid produced with the Marrow Cellutions™ system will be sent to the laboratory for analysis. Additionally, white blood cells will be concentrated into an autologous protein solution (APS) using the Zimmer Biomet Plasmax system from blood collected using a routine blood draw. All protein solution produced will be sent to the laboratory for analysis. No protein solution will be given to the patient. As the bone marrow liquid collection using the Marrow Cellutions™ system and the blood draw to produce protein solution using the Zimmer Biomet Plasmax system are being performed for research, conditions: Hip Arthropathy conditions: Avascular Necrosis of Bone conditions: Subchondral Cysts studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 6 type: ESTIMATED name: Bone Marrow Collection measure: Assess overall number of stem cells collected from each aspiration method measure: Assess overall number of cytokines collected from each aspiration method measure: Assess overall number of growth factors collected from each aspiration method sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Jameson Crane Sports Medicine Institute status: RECRUITING city: Columbus state: Ohio zip: 43202 country: United States name: Michael Keller role: CONTACT phone: 614-293-2410 email: michael.keller@osumc.edu name: Karen Persons role: CONTACT email: andrea.persons@osumc.edu name: William K Vasileff, MD role: PRINCIPAL_INVESTIGATOR lat: 39.96118 lon: -82.99879 hasResults: False |
<|newrecord|> nctId: NCT06388980 id: UFCIN1_2022 briefTitle: Knowledge and Needs of Nursing in Relation to the Treatment Complex Wounds overallStatus: ACTIVE_NOT_RECRUITING date: 2023-05-01 date: 2023-06-01 date: 2024-06-01 date: 2024-04-29 date: 2024-04-29 name: Corporacion Parc Tauli class: OTHER briefSummary: Study with cross-sectional and descriptive mixed methodology. With questionnaires with likert-type questions (0-10) being the 10 with the highest score, and open questions in relation to knowledge in wound care; include all Corporaciló Sanitària Parc Taulí (CCSPT) nurses who voluntarily want to participate in a pseudo-anonymized surv conditions: Nurse's Role conditions: Knowledge, Attitudes, Practice conditions: Wound studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 200 type: ESTIMATED name: Validated questionnaires and ad hoc questions measure: "What not to do in chronic wounds?" measure: ReAc-PUKT (Renobato-Acosta Pressure Ulcer Knowledge Test) measure: Ad hoc open questions sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Corporació Sanitària Parc Taulí city: Sabadell state: Barcelona zip: 08208 country: Spain lat: 41.54329 lon: 2.10942 hasResults: False |
<|newrecord|> nctId: NCT06388967 id: 19288/PCDC briefTitle: Pancreatic Cancer Detection Consortium acronym: PCDC overallStatus: RECRUITING date: 2023-03-15 date: 2025-11-21 date: 2025-11-21 date: 2024-04-29 date: 2024-04-29 name: City of Hope Medical Center class: OTHER briefSummary: This study aims to prospective validate an exosome-based miRNA signature for noninvasive and early detection of pancreatic ductal adenocarcinoma. conditions: Pancreatic Cancer conditions: Pancreatic Carcinoma conditions: Pancreatic Adenocarcinoma conditions: Pancreatic Ductal Adenocarcinoma conditions: Pancreatic Neoplasms conditions: Pancreatic Cancer Stage I conditions: Pancreatic Cancer Stage conditions: Pancreatic Cancer Resectable conditions: Pancreatic Cancer Stage 0 conditions: Pancreatic Cancer Stage II conditions: Pancreatic Cancer Stage III conditions: Pancreatic Cancer, Adult conditions: Pancreatic Cancer Non-resectable studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 2000 type: ESTIMATED name: PANcreatic cancer Exosome Early detectiON (PANXEON) measure: Sensitivity measure: Specificity measure: Accuracy sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Translational Genomics Research Institute status: RECRUITING city: Phoenix state: Arizona zip: 85004 country: United States name: Daniel Von Hoff role: CONTACT email: dvh@tgen.org name: Daniel Von Hoff role: PRINCIPAL_INVESTIGATOR name: Haiyong Han role: SUB_INVESTIGATOR name: Derek Cridebring role: SUB_INVESTIGATOR lat: 33.44838 lon: -112.07404 facility: Honorhealth status: RECRUITING city: Scottsdale state: Arizona zip: 85258 country: United States name: Erkut Borazanci role: CONTACT email: erkut.borazanci@honorhealth.com name: Erkut Borazanci role: SUB_INVESTIGATOR lat: 33.50921 lon: -111.89903 facility: City of Hope Medical Center status: RECRUITING city: Monrovia state: California zip: 91016 country: United States name: Ajay Goel, PhD role: CONTACT phone: 626-218-3452 email: AJGOEL@COH.ORG name: Ajay Goel role: PRINCIPAL_INVESTIGATOR name: Stanley Hamilton role: SUB_INVESTIGATOR name: Vincent Chung role: SUB_INVESTIGATOR name: Caiming Xu role: SUB_INVESTIGATOR name: Alessandro Mannucci role: SUB_INVESTIGATOR lat: 34.14806 lon: -117.99895 facility: Hoag Center status: RECRUITING city: Newport Beach state: California zip: 92663 country: United States name: Michael Demeure role: CONTACT email: michael.demeure@hoag.org name: Michael Demeure role: SUB_INVESTIGATOR lat: 33.61891 lon: -117.92895 facility: OSF HealthCare status: RECRUITING city: Peoria state: Illinois zip: 61637 country: United States name: Chandler Wilfong role: CONTACT email: chandler.d.wilfong@osfhealthcare.org name: Chandler Wilfong role: SUB_INVESTIGATOR lat: 40.69365 lon: -89.58899 facility: Ochsner Medical Center status: RECRUITING city: Jefferson state: Louisiana zip: 70121 country: United States name: John Bolton role: CONTACT email: jbolton@ochsner.org name: John Bolton role: SUB_INVESTIGATOR lat: 29.96604 lon: -90.15313 facility: Atlantic Health System status: RECRUITING city: Morristown state: New Jersey zip: 07960 country: United States name: Angela Alistar role: CONTACT email: angela.alistar@atlantichealth.org name: Angela Alistar role: SUB_INVESTIGATOR name: Eric Whitman role: SUB_INVESTIGATOR lat: 40.79677 lon: -74.48154 facility: Piedmont Medical Center status: RECRUITING city: Rock Hill state: South Carolina zip: 29732 country: United States name: Andrew Page role: CONTACT email: Andrew.Page@piedmont.org name: Andrew Page role: SUB_INVESTIGATOR name: Eyal Meiri role: SUB_INVESTIGATOR lat: 34.92487 lon: -81.02508 facility: Medical College of Wisconsin status: RECRUITING city: Milwaukee state: Wisconsin zip: 53226 country: United States name: Douglas Evans role: CONTACT email: devans@mcw.edu name: Douglas Evans role: SUB_INVESTIGATOR lat: 43.0389 lon: -87.90647 facility: Nagoya University status: RECRUITING city: Nagoya country: Japan name: Yasuhiro Kodera role: CONTACT email: ykodera@med.nagoya-u.ac.jp name: Yasuhiro Kodera role: SUB_INVESTIGATOR name: Masamichi Hayashi role: SUB_INVESTIGATOR lat: 35.18147 lon: 136.90641 facility: Asan Medical Center status: RECRUITING city: Seoul country: Korea, Republic of name: Song Cheol Kim role: CONTACT email: drksc@amc.seoul.kr name: Song Cheol Kim role: SUB_INVESTIGATOR lat: 37.566 lon: 126.9784 hasResults: False |
<|newrecord|> nctId: NCT06388954 id: P.T.REC/012/005107 briefTitle: Plasticity Biomarkers,Interleukin-6 and Motor Performance in Response to Vagus Nerve Stimulation After Stroke overallStatus: RECRUITING date: 2024-02-21 date: 2024-04-23 date: 2024-05-09 date: 2024-04-29 date: 2024-04-29 name: Cairo University class: OTHER briefSummary: Forty-eight clinically verified Egyptian patients from both sexes with ischemic stroke that occurred at least 6 months to 2 years before inclusion will be randomly assigned into 2 groups, control group (GA) and the experimental group (GB). Patients will be randomly assigned into two equal groups: the control group (GA) and the experimental group (GB). Patients in the control group (GA) will be treated with sham Vagus nerve stimulation (taVNS) immediately before a selected physical therapy program, while in the experimental group (GB), patients will receive real transcutaneous auricular Vagus nerve stimulation (taVNS) followed by the same selected physical therapy program as (GA). Plasma level of Brain-Derived Neurotrophic Factors (BDNF) and Interleukin-6 (IL-6), Box and Blocks Test (BBT), and modified Ashworth scale (MAS) will be assessed at baseline and immediately post-treatment. conditions: Stroke conditions: Motor Disorders studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Single-blind, randomized controlled study. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Patients participated will be masked about the type of intervention, where (GA) patients will receive physical therapy program + sham transcutaneous auricular Vagus nerve stimulation, while patients in (GB) will receive true transcutaneous auricular Vagus nerve stimulation in addition to the same physical therapy program as (GA). whoMasked: PARTICIPANT count: 50 type: ESTIMATED name: True Transcutaneous auricular Vagus Nerve Stimulation (TaVNS) name: Sham Trancutaneous auricular Vagus Nerve Stimulation measure: Muscle tone of the upper limb measure: Gross hand dexterity measure: Level of Plasma brain-derived Derived factor (BDNF) measure: Level of Serum Interleukin IL-6 sex: ALL minimumAge: 55 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Faculty of Physical Therapy, Cairo University status: RECRUITING city: Giza state: Ad Doqi, Giza District, Giza Governorate zip: 11432 country: Egypt name: Engy BadrEldin S Moustafa, PhD role: CONTACT phone: 00201099445112 email: engybm.saleh@cu.edu.eg name: Moshera H. Darwish, PhD role: CONTACT phone: 00201015163617 email: dr.moshera11@yahoo.com lat: 30.00808 lon: 31.21093 hasResults: False |
<|newrecord|> nctId: NCT06388941 id: CLNP023R12201 briefTitle: Iptacopan in Patients With ANCA Associated Vasculitis overallStatus: NOT_YET_RECRUITING date: 2024-08-28 date: 2027-08-27 date: 2027-09-22 date: 2024-04-29 date: 2024-04-29 name: Novartis Pharmaceuticals class: INDUSTRY briefSummary: The purpose of this study is to evaluate the efficacy and safety of iptacopan compared to standard of care (SOC) to induce and maintain remission in study participants with active granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA), when used in combination with rituximab (RTX) induction. The trial will also assess the impact of iptacopan on disease relapses, evolution of renal function and proteinuria, GC side effects, patients' immune status, and QoL. conditions: Anti-Neutrophil Cytoplasm Antibodies (ANCA) Associated Vasculitis studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 78 type: ESTIMATED name: Iptacopan name: Placebo name: Rituximab measure: Sustained remission through Week 48 defined as complete remission at Week 24 without major relapse up to Week 48. measure: B cell counts measure: Total IgG levels measure: Complete remission at week 24 measure: Time to reach BVAS=0 measure: Time to major relapse measure: Estimated glomerular filtration rate (eGFR) using the CKD-EPI formula, urinary protein excretion and hematuria over 48 weeks measure: Cumulative dose of glucocorticoid (GC) measure: Glucocorticoid toxicity index over 48 weeks measure: 36-Item short form survey (SF-36) measure: Patient's Global Assessment (PtGA) measure: Physician's global assessment (PhGA) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06388928 id: P.T.REC/012/004596 briefTitle: Effect of Menstrual Cycle on the Manual Dexterity of Female Dentists overallStatus: COMPLETED date: 2023-07-09 date: 2023-12-26 date: 2023-12-26 date: 2024-04-29 date: 2024-04-29 name: Cairo University class: OTHER briefSummary: The aim of this observational study was to investigate the effect of the menstrual cycle on the manual dexterity of female dentists. |
This study was conducted to answer the following question: |
- Is there any effect of the menstrual cycle on the manual dexterity of female dentists? conditions: Menstrual Cycle conditions: Manual Dexterity studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 45 type: ACTUAL measure: Manual dexterity assessment sex: FEMALE minimumAge: 25 Years maximumAge: 35 Years stdAges: ADULT facility: Horus University city: Damietta country: Egypt lat: 31.41648 lon: 31.81332 hasResults: False |
<|newrecord|> nctId: NCT06388915 id: K2202403004 briefTitle: A Retrospective Cohort Study of 15 Cases of Pelvic Fractures Complicated by Morel-Lavallee Lesion overallStatus: COMPLETED date: 2024-03-12 date: 2024-03-20 date: 2024-03-23 date: 2024-04-29 date: 2024-04-29 name: Weikang Chen class: OTHER briefSummary: Some related factors of pelvic fracture and Morel-Lavallee injury (MLL) are preliminarily discussed, which provides some preliminary references for early clinical detection and research of such injuries. conditions: Pelvic Fracture conditions: Morel-Lavallee Lesion studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: RETROSPECTIVE count: 15 type: ACTUAL measure: Site of MLL measure: Site of injury and Classification of pelvic fracture measure: Time to treatment measure: Drainage volume sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Fujian Provincial Hospital city: Fuzhou state: Fujian zip: 350000 country: China lat: 26.06139 lon: 119.30611 hasResults: False |
<|newrecord|> nctId: NCT06388902 id: BR115-101 briefTitle: A Phase I Study of BR115 for Injection Alone in Subjects With Advanced Solid Malignancies overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2028-08 date: 2028-12 date: 2024-04-29 date: 2024-04-29 name: BioRay Pharmaceutical Co., Ltd. class: INDUSTRY briefSummary: This is a Phase I, multicenter, open-label, single-arm and first-in-human clinical study of BR115 for injection. The study objectives are to evaluate the safety, tolerability, pharmacokinetic profile, anti-tumor activity and immunogenicity of BR115 for injection in patients with advanced solid malignancies. |
Patients will receive two doses at the first week of treatment, followed by once per week until intolerable toxicity, disease progression, pregnancy, withdrawal of informed consent, death, study discontinuation, or withdrawal from the study. conditions: Advanced Solid Malignancies studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 120 type: ESTIMATED name: BR115 for injection measure: Treatment-emergent Adverse Events Following Treatment With BR115 measure: Objective Response Rate measure: Progression-free survival (PFS) measure: Overall survival (OS) measure: Disease control rate (DCR) measure: Duration of response (DOR). measure: Pharmacokinetic Parameter Maximum Serum Concentration (Cmax) measure: Pharmacokinetic Parameter Area Under the Concentration-time Curve (AUC) measure: The anti-drug antibody (ADA) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sun Yat-sen University Cancer Center city: Guangzhou state: Guangdong zip: 510060 country: China name: Rui Xu, MD role: CONTACT phone: 86-20-87343468 email: ruihxu@163.com lat: 23.11667 lon: 113.25 hasResults: False |
<|newrecord|> nctId: NCT06388889 id: AR-DEX-22-04 briefTitle: Phase III Long-Term Extension Study With Dexpramipexole acronym: EXHALE-5 overallStatus: ENROLLING_BY_INVITATION date: 2024-05-08 date: 2027-06-01 date: 2027-06-01 date: 2024-04-29 date: 2024-04-29 name: Areteia Therapeutics class: INDUSTRY briefSummary: The goal of this clinical trial\] is to evaluate the long term safety of dexpramipexole treatment in participants with severe asthma, aged ≥12 years, on Global Initiative for Asthma (GINA) 2021 \[GINA, 2021\] Step 4 or 5 therapy and who completed either of the Phase III studies EXHALE-2 or EXHALE-3. conditions: Eosinophilic Asthma studyType: INTERVENTIONAL phases: PHASE3 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 1600 type: ESTIMATED name: Dexpramipexole Dihydrochloride measure: Number and Percentage of Participants with a Treatment Emergent Adverse Event measure: Number and Percentage of Participants with Potentially Clinically Significant Postbaseline Changes in Clinical Laboratory Evaluations measure: Number and Percentage of Participants with Potentially Clinically Significant Postbaseline Changes in Vital Signs and Body Weight measure: Number and Percentage of Participants with Potentially Significant Postbaseline Changes in Electrocardiogram Parameters measure: Severe Asthma Exacerbations measure: Change in Asthma Control Questionnaire-6 (ACQ-6) measure: Change in absolute eosinophil counts (AEC) sex: ALL minimumAge: 12 Years maximumAge: 99 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Research Site 20001-004 city: Tampa state: Florida zip: 33607 country: United States lat: 27.94752 lon: -82.45843 hasResults: False |
<|newrecord|> nctId: NCT06388876 id: AnkaraYBUbk briefTitle: The Effect of Exercise on Post-traumatic Stress Disorder and Sleep Quality in Individuals Affected by the 2023 Kahramanmaraş Earthquakes overallStatus: COMPLETED date: 2023-04-01 date: 2023-06-15 date: 2023-07-30 date: 2024-04-29 date: 2024-04-29 name: Ankara Yildirim Beyazıt University class: OTHER name: TÜBİTAK briefSummary: Natural disasters can have adverse impacts on both physical and mental health. Post-traumatic stress disorder (PTSD) and sleep disorders are among the most common problems seen after natural disasters. Exercise may represent a safe, cost-effective, accessible, non-pharmacological method for treating PTSD and sleep problems. The aim of this study was to investigate the effect of exercise interventions on PTSD and sleep quality in young individuals affected by the 2023 Kahramanmaraş earthquakes in Türkiye. conditions: Earthquake conditions: Stress Disorders, Post-Traumatic studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: there are 2 groups; exercise and control primaryPurpose: TREATMENT masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 38 type: ACTUAL name: Exercise name: lifestyle advice measure: Post-traumatic Stress Disorder Short Scale measure: Pittsburgh Sleep Quality Index sex: ALL minimumAge: 18 Years maximumAge: 30 Years stdAges: ADULT facility: Ankara Yildirim Beyazıt University city: Ankara country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False |
<|newrecord|> nctId: NCT06388863 id: B2024-002 briefTitle: Evaluation of the Efficacy and Safety of FMT for Constipation in Parkinson's Disease overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2026-05-31 date: 2026-05-31 date: 2024-04-29 date: 2024-04-29 name: Shanghai Zhongshan Hospital class: OTHER briefSummary: Participants will be allocated to FMT group or placebo group at a 1:1 ratio. For interventional group, patients will be given six FMT capsules twice a week for 24 weeks. Placebo capsules are identical in appearance and smell but contain milk powder. During visitpoints, participants complete specific scales to assess improvement in constipation, emotion and quality of life. Besides, fecal samples are collected for metagenomics and metabolomics sequencing and blood samples are tested peripheral concentration of levodopa. conditions: Parkinson Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 76 type: ESTIMATED name: Healthy donor-derived FMT capsule name: Placebo capsule measure: Response rate of constipation in Parkinson's Disease (PD) measure: Change from baseline PD symptoms at week 5, week 13 and week 24 measure: Change from baseline anxiety at week 5, week 13 and week 24 measure: Change from baseline depression at week 5, week 13 and week 24 measure: Change from baseline quality of life at week 5, week 13 and week 24 measure: Change from baseline drug concentration of levodopa in peripheral blood at week 13 and week 24 measure: Change from baseline fecal microbiota at week 5, week 13 and week 24 measure: Change from baseline fecal metabolites at week 5, week 13 and week 24 sex: ALL minimumAge: 40 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: 180 Fenglin Road city: Shanghai state: Shanghai zip: 200032 country: China name: Shengdi Wu role: CONTACT phone: (86)13817923359 email: wu.shengdi@zs-hospital.sh.cn name: Shengdi Wu role: PRINCIPAL_INVESTIGATOR lat: 31.22222 lon: 121.45806 hasResults: False |
<|newrecord|> nctId: NCT06388850 id: 5U01CE003393-03 type: NIH link: https://reporter.nih.gov/quickSearch/5U01CE003393-03 briefTitle: Evaluation of HRP Among Pre-K Through 5th Grade overallStatus: ENROLLING_BY_INVITATION date: 2023-03-23 date: 2025-09-30 date: 2025-09-30 date: 2024-04-29 date: 2024-04-29 name: Northeastern University class: OTHER briefSummary: This study is a rigorous experimental evaluation of an existing manualized universal child sexual abuse primary prevention program with a history of 30+ years of implementation across 30 states and robust pilot data. conditions: Child Sexual Abuse studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SINGLE_GROUP interventionModelDescription: A stepped wedge cluster randomized clinical trial design will be used to assess the efficacy of two linked curricula of the Healthy Relationships Project (HRP): Care for Kids (Pre-K through 2nd Grade) and We Care Elementary (3rd through 5th Grade). The HRP includes a 1.5 hour training for school staff prior to implementation, six 30-minute classroom lessons delivered to students once per week for 6 weeks, and 3 caregiver workshops. primaryPurpose: PREVENTION masking: NONE count: 16 type: ESTIMATED name: Healthy Relationships Project measure: Reports of child sexual abuse measure: The Parental Knowledge Scale (PKS) measure: The Parental Discussions about Sex Abuse Scale (PDSAS) measure: The adapted Parenting Self Agency (PSAM) measure: The Parent Knowledge Questionnaire (PKQ) measure: HRP evaluation measure: The CSA Myths Scale measure: The Teachers' Reporting Attitudes Scale for Child Sexual Abuse (TRAS-CSA) sex: ALL minimumAge: 3 Years maximumAge: 11 Years stdAges: CHILD facility: Safe Shores city: Washington state: District of Columbia zip: 20001 country: United States lat: 38.89511 lon: -77.03637 hasResults: False |
<|newrecord|> nctId: NCT06388837 id: RECO6U/20- 2021 briefTitle: Effect of Symphysis Onlay Bone Graft, Injectable Platelet Rich Fibrin (I-PRF) and Xenograft on Horizontal Alveolar Ridge Augmentation in Esthetic Zone overallStatus: COMPLETED date: 2021-02-20 date: 2023-03-01 date: 2023-03-01 date: 2024-04-29 date: 2024-04-29 name: October 6 University class: OTHER briefSummary: The aim of the study: was to evaluate whether mandibular symphysis Onlay autogenous bone graft mixed with Injectable PRF could offer any advantages for patients undergoing horizontal alveolar ridge widening regarding increase alveolar ridge width compared to mandibular symphysis Onlay autogenous bone graft mixed with Xenograft conditions: Symphysis Onlay Bone Graft conditions: Platelet Rich Fibrin conditions: Xenograft conditions: Horizontal Alveolar Ridge Augmentation conditions: Esthetic Zone studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 12 type: ACTUAL name: Injectable Platelet Rich Fibrin name: Xenograft measure: Alveolar ridge width measure: Bone density sex: ALL minimumAge: 20 Years maximumAge: 40 Years stdAges: ADULT facility: October 6 University city: Giza zip: 12511 country: Egypt lat: 30.00808 lon: 31.21093 hasResults: False |
<|newrecord|> nctId: NCT06388824 id: GWang028 briefTitle: The Effect of Esketamine on Sleep Disturbance overallStatus: NOT_YET_RECRUITING date: 2024-05-20 date: 2024-09-30 date: 2024-10-10 date: 2024-04-29 date: 2024-04-29 name: Tianjin Medical University General Hospital class: OTHER briefSummary: To explore the efficacy of a single low dose of esketamine during surgical abortion in patients with sleep disturbance conditions: Sleep Disturbance studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 200 type: ESTIMATED name: normal saline name: Esketamine measure: The incidence of sleep disturbance on the first night after surgery measure: The incidence of sleep disturbance on the second and third postoperative nights measure: The incidence of sleep disturbance on the seventh postoperative nights measure: Postoperative anxiety measure: Postoperative depression measure: Pain intensity measure: Adverse event measure: preoperative hemoglobin concentration measure: Human Chorionic Gonadotropin level measure: The incidence of sleep disturbance on the day before surgery measure: The incidence of sleep disturbance before surgery sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tianjin Medical University General Hospital city: Tianjin zip: 300052 country: China lat: 39.14222 lon: 117.17667 hasResults: False |
<|newrecord|> nctId: NCT06388811 id: 2023/1162 briefTitle: Validity and Reliability Study of the Turkish Version of the Early Osteoarthritis Questionnaire overallStatus: NOT_YET_RECRUITING date: 2024-05-15 date: 2024-11-15 date: 2024-12-15 date: 2024-04-29 date: 2024-04-29 name: Istanbul University class: OTHER briefSummary: The symptoms of early osteoarthritis (OA) are quite similar to established knee OA, they differ, particularly in frequency, intensity, and severity. For this reason, in 2023, the International Symposium of intra-articular treatment (ISIAT) technical experts panel (TEP-technical experts panel) published for the first time a questionnaire designed to assess and monitor the follow-up and clinical progression of patients affected by early knee OA. Early management of knee OA is recommended by various guidelines because this approach may alter the course and clinical features of the disease, especially when considering disease-modifying agents that may delay disease progression. |
Therefore, the assessment of early knee OA with a questionnaire may facilitate the follow-up of OA in the early stages of the disease when treatment is likely to be more effective. This approach will allow to reduce disability and improve patients' quality of life. While creating the Early Osteoarthritis Questionnaire (EOAQ), it was aimed to have a complete, short and easy-to-understand questionnaire and to ensure that the respondents could complete the questionnaire easily and in a short time. The EOAQ consists of 11 questions. The questions were divided into two different groups. While the first two questions were related with clinical characteristics, the other nine questions aimed to investigate the results reported by the patient. For each question, there are three responses depending on the number of episodes: Never, rarely (between one and three episodes) and frequently (more than three episodes) within a 6-month period. Turkish validity and reliability study of the EOAQ has not been conducted yet. |
For the translation of the questionnaire, the guide recommended by Beaton et al. for the cultural adaptation of questionnaires will be used. According to this guideline the original EOAQ will be translated into Turkish by two experts independently of each other, and then a single Turkish version will be created by two experts working together. This Turkish version will then be translated back into English by an expert who can speak both languages at an advanced level. The experts will then evaluate the translation and adapt the questionnaire accordingly. After the completion of the translated form, 110 patients and 110 control group participants who applied to Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation and met the inclusion criteria will be included. The participants will be informed verbally and in writing about the purpose, duration and method of the study and will be asked to sign an "Informed Voluntary Consent Form" after their consent is obtained. Participants will fill in the Turkish version of the questionnaire. Along with the questionnaire, knee pain will be questioned with the Numeric Rating Scale (0=no pain, 10=the most severe pain you experience) and disability will be questioned with the WOMAC Questionnaire, whose Turkish validity and reliability study has been conducted. Test-retest method will be applied for reliability analyses; therefore, at least 30 patients among the patients included in the study will complete the questionnaire twice (the second evaluation will be 2 weeks after the first evaluation). conditions: Early Knee Osteoarthritis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 220 type: ESTIMATED name: Early Osteoarthritis Questionnaire measure: Numeric Rating Scale measure: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06388798 id: Ankara Etlik city hospital briefTitle: Evaluation of the Effectiveness of Psychoeducational Training Given to Nurses Working in a Psychiatric Clinic overallStatus: COMPLETED date: 2023-05-30 date: 2023-07-30 date: 2023-07-30 date: 2024-04-29 date: 2024-04-29 name: Ankara Etlik City Hospital class: OTHER_GOV briefSummary: Summary: |
Background One of the most important roles of psychiatric nurses, who help individuals, families and society in promoting health, preventing diseases and coping with problems, is their educational role. With its educational role, the nurse can help the patient and their family function at the best level in biopsychosocial integrity in preventing and coping with diseases through psychoeducation. |
Goals This research was conducted to evaluate the effectiveness of psychoeducational training given to nurses working in a psychiatric clinic. |
Design This research is a randomized controlled experimental study. Participants Participants were determined using simple randomization. The sample of the study consisted of 78 nurses (intervention = 39; control = 39) working in a psychiatric clinic in a city hospital in Turkey. |
Methods Groups were determined using the simple randomization method. Psychoeducational training was given to the intervention group, nurses working in the Psychiatry clinic, for a total of 4 sessions, with two sessions of 50 minutes each. The data of the research were collected with the ;Personal Information Form; Form for evaluating the knowledge level of nurses working in the psychiatry clinic regarding psychoeducation and Perception of Adequacy Scale in Psychoeducation Program Development and Implementation. Data were analyzed using independent samples t test and two-way repeated measures analysis of variance (ANOVA). conditions: Nursing Education conditions: Psychoeducation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: SINGLE whoMasked: INVESTIGATOR count: 78 type: ACTUAL name: Education measure: Psychoeducation program development and implementation competence perception scale. Data will be collected before and after the training program in the intervention group, and at parallel times to the intervention group in the control group. measure: Form for evaluating the knowledge level of nurses working in a psychiatric clinic regarding psychoeducation sex: ALL minimumAge: 23 Years maximumAge: 45 Years stdAges: ADULT facility: Ankara Etlik City Hospital city: Ankara country: Turkey lat: 39.91987 lon: 32.85427 typeAbbrev: Prot_SAP_ICF hasProtocol: True hasSap: True hasIcf: True label: Study Protocol, Statistical Analysis Plan, and Informed Consent Form date: 2023-05-05 uploadDate: 2024-03-04T06:15 filename: Prot_SAP_ICF_000.pdf size: 163176 hasResults: False |
<|newrecord|> nctId: NCT06388785 id: TAK-003-5001 briefTitle: A Study to Monitor the Adverse Events of QDENGA Vaccine in Participants in Malaysia acronym: PRIME-Q overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2027-09-01 date: 2027-09-01 date: 2024-04-29 date: 2024-04-29 name: Takeda class: INDUSTRY briefSummary: The main aim of this study is to collect the number and type of medical problems (adverse events) after vaccination with QDENGA in Malaysia and to learn more about such medical problems after vaccination. Another aim of this study is to collect the number of persons vaccinated with QDENGA who need to stay in the hospital because of severe dengue fever. |
No vaccination will be given as part of this study. The study will only collect data of persons already vaccinated with QDENGA who agree to participate. conditions: Dengue Fever studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 10000 type: ESTIMATED name: No Intervention measure: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) measure: Number of Participants who Require Hospitalization for Severe Dengue Diagnosed by Healthcare Provider (HCP) sex: ALL minimumAge: 4 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Universiti Putra Malaysia city: Serdang state: Selangor zip: 43400 country: Malaysia name: Study Contact role: CONTACT phone: +603-9769 1000 email: zamberi@upm.edu.my name: Zamberi Sekawi, Dr role: PRINCIPAL_INVESTIGATOR facility: Universiti Malaya city: Kuala Lumpur state: Wilayah Persekutuan Kuala Lumpur zip: 50603 country: Malaysia name: Study Contact role: CONTACT phone: +60379493641 email: sfaridah@ummc.edu.my name: Sharifah Faridah binti Syed Omar, Dr role: PRINCIPAL_INVESTIGATOR lat: 3.1412 lon: 101.68653 hasResults: False |
<|newrecord|> nctId: NCT06388772 id: HJG-CZQH-QHRD106 briefTitle: Study to Assess PK, Safety and Tolerability Early in Healthy Subjects overallStatus: COMPLETED date: 2021-07-05 date: 2022-07-22 date: 2023-01-06 date: 2024-04-29 date: 2024-04-29 name: Changzhou Qianhong Bio-pharma Co., Ltd. class: INDUSTRY briefSummary: The purpose of this study is to assess the safety, tolerability and pharmacokinetics (PK) of QHRD106 early in Chinese healthy subjects with single doses. conditions: Acute Ischemic Stroke studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 74 type: ACTUAL name: QHRD106 Injection name: placebo measure: Safety as assessed by incidence, severity, and causality of adverse events measure: Plasma measurements of QHRD106 sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Nanjing Drum Tower Hospital city: Nanjing state: Jiangsu zip: 210008 country: China lat: 32.06167 lon: 118.77778 hasResults: False |
<|newrecord|> nctId: NCT06388759 id: TQ05105-Ib-03 briefTitle: TQ05105 Tablet for Myelofibrosis Treatment in Ruxolitinib-Resistant or Intolerant Patients overallStatus: ACTIVE_NOT_RECRUITING date: 2022-08-01 date: 2024-12 date: 2024-12 date: 2024-04-29 date: 2024-04-29 name: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. class: INDUSTRY briefSummary: This is an open, single-arm, multi-center clinical study designed to evaluate the efficacy of TQ05105 Tablets in patients with intermediate-risk and high-risk myelofibrosis. conditions: Myelofibrosis studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 9 type: ACTUAL name: TQ05105 Tablets measure: Spleen volume reduction (SVR35)≥35% from baseline measure: Optimum effective rate measure: Onset time of splenic response measure: Duration of maintenance of spleen response (DoMSR) ≥35% reduction measure: Myeloproliferative neoplasm- Symptom Assessment Form- Total Symptom Score (MPN-SAF TSS) : ≥ 50% Reduction from Baseline measure: The total symptom score of MPN-SAF TSS decreased compared with baseline measure: Progression-free survival (PFS) measure: Leukemia free survival (LFS) measure: Overall Survival (OS) measure: Incidence of adverse events (AEs) measure: Severity of AEs sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Anhui Provincial Hospital city: Hefei state: Anhui zip: 230001 country: China lat: 31.86389 lon: 117.28083 facility: The First Affiliated Hospital of Wannan Medical College city: Wuhu state: Anhui zip: 241001 country: China lat: 31.33728 lon: 118.37351 facility: Union Hospital Tongji College Huazhong University of Science And Technology city: Wuhan state: Hubei zip: 430071 country: China lat: 30.58333 lon: 114.26667 facility: The Affiliated Hospital of Xuzhou Medical University city: Xuzhou state: Jiangsu zip: 221000 country: China lat: 34.18045 lon: 117.15707 facility: The First Hospital of Jilin University city: Changchun state: Jilin zip: 130021 country: China lat: 43.88 lon: 125.32278 facility: Shanghai Sixth People's Hospital city: Shanghai state: Shanghai zip: 200233 country: China lat: 31.22222 lon: 121.45806 hasResults: False |
<|newrecord|> nctId: NCT06388746 id: NKUA briefTitle: Arresting Carious Lesions With Minimal Intervention Techniques overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-06 date: 2025-12 date: 2024-04-29 date: 2024-04-29 name: National and Kapodistrian University of Athens class: OTHER briefSummary: A single-blinded randomized clinical trial with a split-mouth design that will assess the 12-month clinical and radiographic success of two minimally invasive treatment techniques, one using a chemo-mechanical caries removal agent and one using a caries arresting agent, for the treatment of deep caries in primary molars. conditions: Caries,Dental studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: BRIX3000® name: Riva Star Aqua, SDI Limited, Australia measure: clinical success measure: radiographic success measure: Longevity and the quality of the final restoration measure: Patient's acceptance sex: ALL minimumAge: 4 Years maximumAge: 8 Years stdAges: CHILD hasResults: False |
<|newrecord|> nctId: NCT06388733 id: IVY P3-24-021 briefTitle: A Study Comparing Niraparib With Temozolomide in Adult Participants With Newly-diagnosed, MGMT Unmethylated Glioblastoma overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2027-12 date: 2028-03 date: 2024-04-29 date: 2024-04-29 name: Ivy Brain Tumor Center class: OTHER name: GlaxoSmithKline briefSummary: The goal of this Phase 3 clinical trial is to compare the efficacy of niraparib versus temozolomide (TMZ) in adult participants with newly-diagnosed, MGMT unmethylated glioblastoma multiforme (GBM). The main questions it aims to answer are: |
Does niraparib improve progression-free survival (PFS) compared to TMZ? |
Does niraparib improve overall survival (OS) compared to TMZ? |
Participants will be randomly assigned to one of two treatment arms: niraparib or TMZ. |
* study drug (Niraparib) or |
* comparator drug (Temozolomide - which is the standard approved treatment for MGMT unmethylated glioblastoma). |
The study medication will be taken daily while receiving standard of care radiation therapy (RT) for 6-7 weeks. |
Participants may continue to take the niraparib or TMZ adjuvantly as long as the cancer does not get worse or completion of 6 cycles of treatment (TMZ). A total of 450 participants will be enrolled in the study. |
Participants' tasks will include: |
* Complete study visits as scheduled |
* Complete a diary to record study medication conditions: Glioblastoma conditions: GBM conditions: Brain Neoplasms, Adult, Malignant conditions: Brain Tumor studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE maskingDescription: Blinded Independent Central Review is composed of independent radiologists and will be utilized to assess progression of disease count: 450 type: ESTIMATED name: Niraparib name: Temozolomide measure: Progression-free survival (PFS) assessed by Blinded Independent Central Review (BICR) measure: Overall survival measure: Overall response rate measure: Compare symptoms, function, and Health-related quality of life (HRQoL) and symptoms by EORTC QLQ-C30-item Core module (EORTC QLQ-C30) (Scores on a scale) measure: Compare symptoms, function, and Health-related quality of life (HRQoL) and symptoms by EORTC QLQ-BN20-item Core module (EORTC QLQ-BN20) (Scores on a scale) measure: Changes from baseline in neurocognitive function assessed by Hopkins Verbal Learning Test measure: Changes from baseline in neurocognitive function assessed by Controlled Oral Word Association measure: Changes from baseline in neurocognitive function assessed by Trail Making Test Parts A and B measure: Number of participants with adverse events (AEs), serious adverse events (SAEs) and adverse events of special interest (AESIs) measure: Number of treatment discontinuations, dose interruptions, and dose reductions due to AEs, SAEs, or AESIs, changes in Karnofsky performance status, changes in clinical laboratory results, and vital sign measurements measure: Frequency and severity of symptomatic AEs based on PRO-CTCAE sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06388720 id: NCC2024-0026 briefTitle: The Clinical Effectiveness and Safety of Intravesical Mitomycin-C and Gemcitabine Sequential Therapy acronym: IMGeS overallStatus: RECRUITING date: 2024-04-30 date: 2025-06-30 date: 2027-12-31 date: 2024-04-29 date: 2024-04-29 name: National Cancer Center, Korea class: OTHER_GOV briefSummary: The aim of this study is to evaluate the effectiveness and safety of mitomycin-c and gemcitabine sequential instillation in BCG unresponsive high risk non-muscle invasive bladder cancer patients. conditions: Bladder Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 82 type: ESTIMATED name: Mitomycin-c 40mg/20ml and Gemcitabine 2000mg/50ml measure: Recurrent free survival in sequential treatment group. measure: Progression free survival in sequential treatment group. measure: Cystectomy free survival in sequential treatment group. measure: cancer specific survival in sequential treatment group. measure: Overall survival in sequential treatment group. measure: Safety of sequential treatment. sex: ALL minimumAge: 20 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National Cancer Center status: RECRUITING city: Goyang-si country: Korea, Republic of name: Ho Kyung Seo role: CONTACT phone: 82-31-920-1678 email: seohk@ncc.re.kr name: Ho Kyung Seo, MD role: PRINCIPAL_INVESTIGATOR name: Eui Hyun Jung, Ph.D role: SUB_INVESTIGATOR lat: 37.65639 lon: 126.835 hasResults: False |
<|newrecord|> nctId: NCT06388707 id: NF-2022-01 briefTitle: A Safety, Tolerability, and Preliminary Efficacy of Low-intensity Focused Ultrasound Neuromodulation in Patients With Drug-resistant Epilepsy overallStatus: NOT_YET_RECRUITING date: 2024-08-01 date: 2025-07-31 date: 2025-12-31 date: 2024-04-29 date: 2024-04-29 name: NaviFUS Corporation class: INDUSTRY name: NaviFUS US LLC briefSummary: This will be a prospective, open-label, single-arm, multi-center, pilot study to evaluate the safety, tolerability, and preliminary efficacy of low-intensity focused ultrasound (LIFU) neuromodulation using NaviFUS System in patients with drug-resistant unilateral or bilateral temporal lobe epilepsy (DR-TLE). conditions: Drug Resistant Epilepsy conditions: Epilepsy studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 8 type: ESTIMATED name: NaviFUS System measure: Adverse events (AEs) measure: Change from baseline in seizure frequency measure: Change from baseline in electroencephalography (EEG) epileptiform discharges measure: Days of seizure-free measure: Changes from baseline in Beck Anxiety Inventory (BAI) measure: Changes from baseline in Beck Depression Inventory (BDI-II) measure: Changes from baseline in Personal Impact of Epilepsy Scale (PIES) measure: Change from baseline in subjective seizure strength sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Stanford University School of Medicine city: Palo Alto state: California zip: 94305 country: United States name: Robert Fisher, M.D., Ph.D. role: CONTACT lat: 37.44188 lon: -122.14302 facility: Brigham and Women's Hospital city: Boston state: Massachusetts zip: 02115 country: United States name: Ellen Bubrick, M.D. role: CONTACT lat: 42.35843 lon: -71.05977 facility: University of Virginia School of Medicine city: Charlottesville state: Virginia zip: 22903 country: United States name: Nathan Fountain, M.D. role: CONTACT lat: 38.02931 lon: -78.47668 hasResults: False |
<|newrecord|> nctId: NCT06388694 id: RDO KPNC 24-056 briefTitle: Pharmacist Management of Attention Deficit Hyperactivity Disorder Medication Refill Requests overallStatus: NOT_YET_RECRUITING date: 2024-05-02 date: 2024-06-28 date: 2024-07-31 date: 2024-04-29 date: 2024-04-29 name: Kaiser Permanente class: OTHER briefSummary: This cluster randomized trial will compare pharmacist management of secure message requests for refills of attention deficit hyperactivity medications with primary care physician management regarding quality of care, timeliness of service, and parent care experience. conditions: Attention-deficit Hyperactivity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: SINGLE whoMasked: INVESTIGATOR count: 315 type: ESTIMATED name: Pharmacist Care name: Primary Care Physician Care measure: Percentage of participants appropriately referred for a follow-up weight check measure: Timeliness of care measure: Parent perception of effectiveness of care sex: ALL minimumAge: 2 Years maximumAge: 17 Years stdAges: CHILD facility: Kaiser Permanente Northern California city: Oakland state: California zip: 94612 country: United States lat: 37.80437 lon: -122.2708 hasResults: False |
<|newrecord|> nctId: NCT06388681 id: HMKU-KMY-SA-02 briefTitle: Stress Ball Use in Patients Undergoing Coronary Angiography overallStatus: RECRUITING date: 2024-04-24 date: 2024-04-26 date: 2024-06-26 date: 2024-04-29 date: 2024-04-29 name: Mustafa Kemal University class: OTHER briefSummary: One of the nonpharmacologic interventions included in the NIC-Nursing Interventions Classification is the use of stress balls. Stress balls are one of the cognitive distraction methods used especially in reducing pain and increasing the comfort level of patients. On the other hand, there are studies showing that stress balls have a positive effect not only on pain but also on vital signs, anxiety and comfort level of the patient. conditions: Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 72 type: ESTIMATED name: The Effect of Stress Ball Use on Immobilization Comfort, Pain Level and Vital Signs in Patients Undergoing Coronary Angiography measure: Patient Identifying Information Form measure: Immobilization Comfort Scale measure: Visual Benchmarking Scale measure: Vital Signs Monitoring Form sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hatay Mustafa Kemal University status: RECRUITING city: Hatay country: Turkey name: SÜMEYYE AKÇOBAN role: CONTACT lat: 38.40227 lon: 27.10486 hasResults: False |
<|newrecord|> nctId: NCT06388668 id: ICM 2025-3428 briefTitle: Lipid Testing After Myocardial Infarction at the Montreal Heart Institute overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-07 date: 2025-09 date: 2024-04-29 date: 2024-04-29 name: Montreal Heart Institute class: OTHER name: Novartis Pharmaceuticals briefSummary: Because treatment decisions are usually based on a single measurement of the lipid panel at the time of an admission for an MI, the overarching objective of this project is to evaluate whether the measurement of LDL, non-HDL, and apoB values are reliable through all the duration of the hospitalization. |
It will be a single-center, prospective, observational study will be conducted, including consecutive patients hospitalized for myocardial infarction at the Montreal Heart Institute. |