Record
stringlengths 1
197k
|
|---|
<|newrecord|> nctId: NCT06285149 id: AKLD-22 briefTitle: Tace With Icaritin in First-line Treatment of Middle and Advanced HCC in Child Grade B Patients overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-12-01 date: 2025-06-01 date: 2024-02-29 date: 2024-02-29 name: Henan Cancer Hospital class: OTHER_GOV briefSummary: Icaritin is a drug that has been approved by the National Medical Products Administration (NMPA) based on a multicenter, randomized, double-blind, parallel-controlled Phase III clinical trial - SNG1705 ICR-1. It is used for patients with unresectable hepatocellular carcinoma who are not suitable for or refuse standard treatment and have not previously received systemic therapy. According to numerous studies, in tumor cells, Icaritin can downregulate the expression of TNF-α, IL-6, PD-L1 and exert anti-tumor effects. At the same time, it regulates the tumor immune microenvironment by reducing the secretion of TNFa and IL-6 as well as inhibiting PD-L1 expression through decreasing MDSC cell proportion. Importantly, Icaritin has excellent safety profile and greatly ensure patients' quality of life clinically. Rare grade 3-4 TRAEs were observed in clinical trials which is uncommon among existing standard drugs. Good safety is a prerequisite for combination therapy; therefore, further exploration of optimal drug combinations is worth considering. Thus, TACE+Icaritin may potentially optimize treatment strategies for patients with poor liver function reserve. conditions: HCC studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 80 type: ESTIMATED name: Icaritin measure: ORR measure: PFS measure: Overall survival，OS sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
|
<|newrecord|> nctId: NCT06285136 id: SHEN-PJ-KE-2024-15 briefTitle: Safety and Efficacy of Venetoclax Combination With Decitabine(DEC3-VEN) in the Treatment of AML in the Adult overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2026-03-01 date: 2026-03-01 date: 2024-02-29 date: 2024-02-29 name: The Second Affiliated Hospital of Kunming Medical University class: OTHER name: Institute of hematology hospital,Chinese Academy of Medical Sciences name: Handan Central Hospital name: Taian City Central Hospital name: Tianjin People's Hospital name: Guizhou Provincial People's Hospital name: Central South University name: Western Theater General Hospital name: First Affiliated Hospital of Guangxi Medical University name: Chengdu Jingdongfang Hospital briefSummary: This study proposes to conduct a prospective, multicenter, single-arm study to explore the efficacy and safety of venetoclax in combination with high-dose decitabine (DEC3-VEN) in new diagnosed adult patients with AML, and to provide evidence for the optimal selection of clinical treatment regimens, which is planned to be conducted in 10 research centers across the country. conditions: Acute Myeloid Leukemia, Adult studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: DEC3-VEN measure: ORR measure: Overall survival (OS) sex: ALL minimumAge: 16 Years maximumAge: 65 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: The Second Affiliated Hospital of Kunming Medical University. city: Kunming state: Yunnan country: China lat: 25.03889 lon: 102.71833 hasResults: False
|
<|newrecord|> nctId: NCT06285123 id: HUM00248235 and HUM00248331 id: 1U01FD007803-01 type: FDA link: https://reporter.nih.gov/quickSearch/1U01FD007803-01 briefTitle: Implementing the COMFORT Guidelines for Postpartum Pain Management overallStatus: ACTIVE_NOT_RECRUITING date: 2024-01-26 date: 2025-07 date: 2026-04 date: 2024-02-29 date: 2024-02-29 name: University of Michigan class: OTHER name: Food and Drug Administration (FDA) briefSummary: A new national clinical practice guideline (CPG) for pain management after childbirth aims to mitigate peripartum opioid-related risks without compromising or exacerbating existing inequities in pain management in the United States. Standard dissemination approaches are often insufficient to change clinical practice-more active implementation efforts are generally required. Replicating Effective Programs (REP) is a theory-driven implementation intervention that is publicly available and highly scalable, but REP alone may be insufficient for effectively embedding the CPG across all maternity sites. For sites needing more support, REP can be augmented with facilitation (e.g., individualized consultation with site champions to overcome local barriers to CPG adoption, "Enhanced-REP" \[E-REP\]). Because E-REP is more expensive and difficult to scale than REP, it is essential to identify those settings where REP alone is effective versus those where REP may need augmentation, but this has not been evaluated in maternity contexts. Our objective is to determine the effect of a new postpartum pain management CPG, as implemented by REP and E-REP, on postpartum opioid prescribing (primary outcome: rate and amount of opioid prescribed within three days of childbirth), overall, by hospital, and among key subgroups.
|
This is a non-responder randomized trial within the Obstetrics Initiative (OBI), a perinatal collaborative quality initiative funded by Blue Cross Blue Shield of Michigan that includes 68 member hospitals serving more than 120,000 postpartum people over an approximately 15-month study time period. Hospitals not initially responding to REP (defined by performance below the top 15th percentile of all OBI hospitals for a) inpatient order for opioid-sparing postpartum pain management, \[e.g., scheduled acetaminophen and ibuprofen\], or b) amount of opioid prescribed at discharge, or c) provision of non-medication pain management interventions) will be allocated, via block randomization, to either continue REP vs. augment REP with facilitation (E-REP).
|
The primary analysis will evaluate the rate of postpartum opioid-sparing prescribing metrics at the time of discharge (primary outcome) and opioid prescription refills and high-risk prescribing (secondary outcomes) before and after CPG implementation with REP, using interrupted time series analyses. Inequities in outcomes by patient, procedure, prescriber, and hospital factors will be evaluated. Exploratory analyses will examine temporal trends in patient-reported outcomes. The effects of continued REP vs. E-REP among non-responder sites will also be examined. Finally, implementation outcomes will be characterized using clinician and patient surveys and qualitative methods. conditions: Postpartum Pain conditions: Opioid Stewardship conditions: Maternity Care conditions: Obstetric Care studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 68 type: ESTIMATED name: REP name: Facillitation measure: Postpartum opioid prescribing - Rate measure: Postpartum opioid prescribing - Amount measure: Refill opioid prescribing measure: High-risk opioid prescribing measure: Patient-reported outcomes measure: Implementation outcomes - reach measure: Implementation outcomes - adoption measure: Implementation outcomes - feasibility measure: Implementation outcomes - acceptability measure: Implementation outcomes - appropriateness measure: Implementation outcomes - fidelity measure: Implementation outcomes - potential mechanisms of implementation measure: Implementation outcomes - costs of delivering implementation sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Michigan city: Ann Arbor state: Michigan zip: 48109 country: United States lat: 42.27756 lon: -83.74088 hasResults: False
|
<|newrecord|> nctId: NCT06285110 id: DTG Resist briefTitle: HIV-1 Subtype-specific Drug Resistance in Patients Failing Dolutegravir (DTG) Based Regimen acronym: DTG-Resist overallStatus: RECRUITING date: 2022-06-13 date: 2025-08-31 date: 2025-08-31 date: 2024-02-29 date: 2024-02-29 name: University of Bern class: OTHER name: University of Zurich name: ETH Zurich name: University of KwaZulu name: University of Bristol briefSummary: This is a prospective observational study enrolling People Living with HIV (PLHIV) who are on a Dolutegravir-based AntiRetroviral Treatment (ART) regimen and experiencing virologic failure. Virologic failure is defined as two consecutive viral load measurements of \>1000 copies/mL of blood. The main aim of the study is to identify the drug-resistance mutations in the viral genome that are associated with this failure.
|
To achieve this goal, patients fulfilling the eligibility criteria will be invited for a single study visit for the collection of blood. The extracted HIV virus will be sequenced through whole genome sequencing methods to identify the drug-resistance mutations. The study is conducted in 15-20 countries within six regions of the IeDEA cohort (International epidemiology Databases to Evaluate AIDS). conditions: Hiv studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 2600 type: ESTIMATED measure: Type of Integrase Drug Resistance Mutations (INSTI DRMs) at the time of failing a DTG-based regimen. measure: Prevalence of Integrase Drug Resistance Mutations (INSTI DRMs) at the time of failing a DTG-based regimen. measure: Time to virologic failure measure: Number of INSTI DRMs per patient measure: DTG drug resistance measure: Phenotypic resistance levels of novel DRMs sex: ALL minimumAge: 10 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Centro Medico Huesped status: RECRUITING city: Buenos Aires country: Argentina lat: -34.61315 lon: -58.37723 facility: Instituto Nacional de Infectiologia Evandro Chagas - Fiocruz status: RECRUITING city: Rio De Janeiro country: Brazil lat: -22.90278 lon: -43.2075 facility: Hopital de Jour du Centre Hospitalier Universitaire (CHU Souro Sanou) status: RECRUITING city: Bobo-Dioulasso country: Burkina Faso lat: 11.17715 lon: -4.2979 facility: National Centre for HIV/AIDS, Dermatology and STDs (NCHADS) status: RECRUITING city: Phnom Penh country: Cambodia lat: 11.56245 lon: 104.91601 facility: Regional Hospital Limbe status: RECRUITING city: Limbe country: Cameroon lat: 4.02356 lon: 9.20608 facility: Hospital Jamot status: RECRUITING city: Yaounde country: Cameroon lat: 3.86667 lon: 11.51667 facility: Centre de Traitement Ambulatoire status: RECRUITING city: Brazzaville country: Congo lat: -4.26613 lon: 15.28318 facility: Centre de Traitement Ambulatoire status: RECRUITING city: Pointe Noire country: Congo lat: -4.77609 lon: 11.86352 facility: ACONDA Centre de Prise en Charge et de Formation (CePReF) status: RECRUITING city: Abidjan country: Côte D'Ivoire lat: 5.30966 lon: -4.01266 facility: Centre médical de suivi des donneurs de sang, CNTS status: RECRUITING city: Abidjan country: Côte D'Ivoire lat: 5.30966 lon: -4.01266 facility: Moi University, AMPATH status: RECRUITING city: Eldoret country: Kenya lat: 0.52036 lon: 35.26993 facility: Lighthouse clinic status: RECRUITING city: Lilongwe country: Malawi lat: -13.96692 lon: 33.78725 facility: Martin Preuss Centre status: RECRUITING city: Lilongwe country: Malawi lat: -13.96692 lon: 33.78725 facility: Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán status: RECRUITING city: Mexico City country: Mexico lat: 19.42847 lon: -99.12766 facility: Research for Development, Einstein-Rwanda Research and Capacity Building Program status: RECRUITING city: Kigali country: Rwanda lat: -1.94995 lon: 30.05885 facility: National Institute for Medical Research (NIMR) status: RECRUITING city: Kisesa country: Tanzania lat: -3.08333 lon: 34.15 facility: HIV-NAT/Thai Red Cross AIDS Research Center (TRCARC) status: RECRUITING city: Bangkok country: Thailand lat: 13.75398 lon: 100.50144 facility: Ramathibodi Hospital, Mahidol University status: RECRUITING city: Bangkok country: Thailand lat: 13.75398 lon: 100.50144 facility: Masaka Regional Referral Hospital / AHF Uganda Cares status: RECRUITING city: Masaka country: Uganda lat: -0.33379 lon: 31.73409 facility: Mbarara University of Science and Technology / Mbarara ISS Clinic (MUST) status: RECRUITING city: Mbarara country: Uganda lat: -0.60467 lon: 30.64851 facility: Centre for Infectious Disease Research Zambia (CIDRZ) status: RECRUITING city: Lusaka country: Zambia lat: -15.40669 lon: 28.28713 facility: Newlands Clinic status: RECRUITING city: Harare country: Zimbabwe lat: -17.82772 lon: 31.05337 hasResults: False
|
<|newrecord|> nctId: NCT06285097 id: C5391001 briefTitle: A Study of PF-07820435 as a Single Agent and in Combination in Participants With Advanced Solid Tumors overallStatus: RECRUITING date: 2024-02-08 date: 2027-01-31 date: 2028-01-31 date: 2024-02-29 date: 2024-04-04 name: Pfizer class: INDUSTRY briefSummary: This study aims to evaluate the safety, and early signals of anti-tumor activity of PF-07820435 when administered alone (Part 1A) or in combination with sasanlimab (Part 1B; Part 2) in patients with selected advanced or metastatic solid tumors. Part 1 will be dose-finding and Part 2 of the study will further evaluate PF-07820435 at the recommended dose for combination expansion in patients with selected advanced solid tumors. conditions: Neoplasms conditions: Non-small-cell Lung Cancer conditions: Melanoma conditions: Squamous Cell Carcinoma of the Head and Neck conditions: Renal Cell Carcinoma conditions: Urothelial Carcinoma conditions: Colorectal Carcinoma conditions: Ovarian Carcinoma studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 140 type: ESTIMATED name: PF-07820435 name: Sasanlimab measure: Number of patients with dose limiting toxicities (DLTs) in dose escalation (Part 1A and Part 1B) measure: Number of patients with adverse events (AEs) measure: Number of patients with clinically significant lab abnormalities measure: Objective response rate (ORR) in Part 2 Expansion measure: Objective response rate (ORR) in dose escalation (Part 1A and Part 1B) measure: Duration of tumor response measure: Progression free survival (PFS) measure: Cmax (maximum concentration) of PF-07820435 and its active metabolite measure: Tmax (time to maximal plasma concentration) of PF-07820435 and its active metabolite measure: AUClast (area under the curve from time 0 to the last measurable timepoint) of PF-07820435 and its active metabolite measure: Cmin (minimum concentration) of PF-07820435 and its active metabolite after multiple dosing only measure: Change from baseline of immune markers within biopsied tumor tissue measure: Pre-dose trough concentrations of sasanlimab (Part 1B and Part 2) measure: Incidence and titers of ADA and NAb against sasanlimab (Part 1B and Part 2) measure: Cmax of PF-07820435 and its active metabolite under fasted and fed conditions (Part 2 subset) subset of participants in Part 2 measure: Tmax of PF-07820435 and its active metabolite under fasted and fed conditions (Part 2 subset) subset of participants in Part 2 measure: AUC of PF-07820435 and its active metabolite under fasted and fed conditions (Part 2 subset) subset of participants in Part 2 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Corewell Health (reference non-engagement letter) status: NOT_YET_RECRUITING city: Grand Rapids state: Michigan zip: 49503 country: United States lat: 42.96336 lon: -85.66809 facility: START Midwest status: NOT_YET_RECRUITING city: Grand Rapids state: Michigan zip: 49546 country: United States lat: 42.96336 lon: -85.66809 facility: National Cancer Center Hospital East status: NOT_YET_RECRUITING city: Kashiwa state: Chiba zip: 277-8577 country: Japan lat: 35.86224 lon: 139.97732 facility: The Cancer Institute Hospital of JFCR status: NOT_YET_RECRUITING city: Koto state: Tokyo zip: 135-8550 country: Japan lat: 35.66667 lon: 139.81718 facility: Hospital Oncologico Dr. Isaac Gonzalez-Martinez status: RECRUITING city: Rio Piedras zip: 00935 country: Puerto Rico lat: 18.39745 lon: -66.04989 facility: Pan American Center for Oncology Trials, LLC status: RECRUITING city: Rio Piedras zip: 00935 country: Puerto Rico lat: 18.39745 lon: -66.04989 hasResults: False
|
<|newrecord|> nctId: NCT06285084 id: VALETUDO Trial (L4195) briefTitle: Deep Learning ECG Evaluation and Clinical Assessment for Competitive Sport Eligibility acronym: VALETUDO overallStatus: RECRUITING date: 2024-02-02 date: 2025-11-02 date: 2027-02-02 date: 2024-02-29 date: 2024-02-29 name: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio class: OTHER briefSummary: The goal of this observationl study is to evaluate the possibility of building a Deep Learning (DL) model capable of analyzing electrocardiographic traces of athletes and providing information in the form of a probability stratification of cardiovascular disease.
|
Researchers will enroll a training cohort of 455 participants, evaluated following standard clinical practice for eligibility in competitive sports. The response of the clinical evaluation and ECG traces will be recorded to build a DL model.
|
Researchers will subsequently enroll a validation cohort of 76 participants. ECG traces will be analyzed to evaluate the accuracy of the model to discriminate participants cleared for sports eligibility versus participants who need further medical tests conditions: Sports Cardiology conditions: Preventive Cardiology conditions: Electrocardiogram conditions: Artificial Intelligence studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 531 type: ESTIMATED measure: DL model accuracy sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Ospedale Galeazzi-Sant'Ambrogio status: RECRUITING city: Milano state: Lombardy zip: 20157 country: Italy name: davide marchetti, MD role: CONTACT phone: +390283506734 email: davide.marchetti@grupposandonato.it lat: 45.46427 lon: 9.18951 hasResults: False
|
<|newrecord|> nctId: NCT06285071 id: NN7415-7557 id: U1111-1274-4740 type: OTHER domain: World Health Organization (WHO) briefTitle: Post-Marketing Surveillance (All Case Surveillance) on Treatment With Alhemo® in Patients With Haemophilia A or Haemophilia B With Inhibitors overallStatus: ENROLLING_BY_INVITATION date: 2024-04-30 date: 2030-04-30 date: 2030-04-30 date: 2024-02-29 date: 2024-04-01 name: Novo Nordisk A/S class: INDUSTRY briefSummary: The purpose of the study is to investigate the safety and effectiveness of Alhemo® in all participants under real-world clinical practice in Japan. Participants will get Alhemo® as prescribed by the study doctor. The study will last for about 2 years. conditions: Haemophilia A conditions: Haemophilia B studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 23 type: ESTIMATED name: Concizumab measure: Number of adverse reaction (AR) measure: Number of serious adverse reaction (SAR) measure: Number of serious adverse event (SAE) measure: Number of thromboembolic adverse event (AE) measure: Number of shock/anaphylaxis AE measure: Number of treated spontaneous and traumatic bleeding episodes measure: Number of treated spontaneous and traumatic target joint bleeding episodes measure: Number of all treatment requiring bleeding episode sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Novo Nordisk Investigational Site city: Toshima state: Tokyo country: Japan hasResults: False
|
<|newrecord|> nctId: NCT06285058 id: LUNAI briefTitle: Deep Learning Model Predicts Pathological Complete Response of Lung Cancer Following Neoadjuvant Immunochemotherapy overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-12 date: 2026-03 date: 2024-02-29 date: 2024-03-13 name: Wuhan Union Hospital, China class: OTHER briefSummary: This study presents the development and validation of an artificial intelligence (AI) prediction system that utilizes pre-neoadjuvant immunotherapy plain scans and enhanced multimodal CT scans to extract deep learning features. The aim is to predict the occurrence of pathological complete response in non-small cell lung cancer patients undergoing neoadjuvant immunochemotherapyy. conditions: Deep Learning Model conditions: Pathological Complete Response conditions: Non-small Cell Lung Cancer conditions: Neoadjuvant Chemoimmunotherapy studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 1000 type: ESTIMATED name: No interventions measure: the accuracy, sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of predicting model sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
|
<|newrecord|> nctId: NCT06285045 id: 2060302-1703-05 briefTitle: Study on Roujin Formula in the Treatment of Fibromyalgia Syndrome With Blood Deficiency and Liver Depression overallStatus: COMPLETED date: 2018-10-01 date: 2019-08-31 date: 2019-08-31 date: 2024-02-29 date: 2024-03-05 name: Guang'anmen Hospital of China Academy of Chinese Medical Sciences class: OTHER briefSummary: To evaluate the efficacy and safety of Roujin Formula in the treatment of fibromyalgia syndrome(FMS)patients with blood deficiency and liver depression through a randomized,single-blind,placebo-parallel controlled exploratory clinical trial study,and to provide reliable clinical evidence for the treatment of fibromyalgia syndrome with Roujin Formula. 48 eligible participants with FMS of blood deficiency and liver depression syndrome were selected and randomly divided into treatment group(n=24)and control group(n=24). The treatment group was given Roujin Foumula 150mL,twice a day; The control group was given Roujin Foumula placebo 150mL,twice a day,the study period was 8 weeks. The evaluation points were 0 weeks,4 weeks,and 8 weeks of treatment,and follow-up to 12 weeks. To evaluate the effect changes before and after treatment,FIQR score、VAS score、PSQI score、BDI score and SF-36 PCS、MCS score were used as secondary efficacy evaluation indexes. SPSS23.0 was used to analyze the data. conditions: Fibromyalgia Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 48 type: ACTUAL name: Roujin Formula measure: The change of the revised Fibromyalgia Impact Questionnaire (FIQR) from baseline measure: The change of the Visual Analogue Scale (VAS) for pain from baseline measure: The change of the Pittsburgh Sleep Quality Index(PSQI) from baseline measure: The change of the Beck depression inventory(BDI) from baseline measure: The change of the Short Form-36 Health Status Questionnaire(SF-36) from baseline sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Juan Jiao city: Beijing state: Beijing zip: 100053 country: China lat: 39.9075 lon: 116.39723 hasResults: False
|
<|newrecord|> nctId: NCT06285032 id: STUDY00017244 id: R34DA058325 type: NIH link: https://reporter.nih.gov/quickSearch/R34DA058325 briefTitle: Decreasing Loneliness to Optimize Pain Care acronym: DLoop overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-03 date: 2026-05 date: 2024-02-29 date: 2024-03-01 name: University of Washington class: OTHER name: National Institute on Drug Abuse (NIDA) briefSummary: Loneliness, which is the perceived feeling of insufficient personal relationships, is related to higher risk for inappropriate opioid use and opioid use disorders in patients who are taking opioids long-term. The study seeks to pilot test the evidence-based loneliness interventions of psychological therapy and social navigation in patients on chronic opioids treated in primary care practices to determine if reducing loneliness can lower opioid misuse. conditions: Loneliness conditions: Opioid Use studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 102 type: ESTIMATED name: Cognitive Behavior Therapy (CBT) name: Social Navigation Group name: Controlled Group measure: Opioid Misuse measure: Determine Functional Outcome measure: Loneliness sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Washington city: Seattle state: Washington zip: 98105 country: United States lat: 47.60621 lon: -122.33207 hasResults: False
|
<|newrecord|> nctId: NCT06285019 id: GWK-2023-004 briefTitle: Modified TOMOX-HAIC in Combination With Sintilimab and Bevacizumab Biosimilar for First-line Treatment of Advanced Hepatocellular Carcinoma overallStatus: RECRUITING date: 2023-12-01 date: 2024-12-31 date: 2025-12-31 date: 2024-02-29 date: 2024-02-29 name: Fudan University class: OTHER briefSummary: This is a single-center, single-arm, phase II clinical study, to explore the efficacy and safety of modified TOMOX-HAIC combined with sintilimab and bevacizumab biosimilar as first line treatment in patients with advanced hepatocellular carcinoma. conditions: Hepatocellular Carcinoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 65 type: ESTIMATED name: TOMOX-HAIC name: Sintilimab name: Bevacizumab measure: objective response rate (ORR) measure: disease control rate (DCR) measure: Progression-Free Survival (PFS) measure: Time to progression (TTP) measure: Duration of response (DOR) measure: overall survival (OS) measure: adverse event (AE) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fudan University Shanghai Cancer Center status: RECRUITING city: Shanghai state: Shanghai zip: 200062 country: China name: Lu Wang, M.D. role: CONTACT phone: +86-18121299357 email: w.lr@hotmail.com lat: 31.22222 lon: 121.45806 hasResults: False
|
<|newrecord|> nctId: NCT06285006 id: MScAZASTPED025/23/202/12/2021 briefTitle: Desmopressin Monotherapy for Monosymptomatic Nocturnal Enuresis overallStatus: RECRUITING date: 2024-02-23 date: 2024-05-01 date: 2024-05-12 date: 2024-02-29 date: 2024-04-23 name: Al-Azhar University class: OTHER briefSummary: Nocturnal Enuresis (NE) is defined as the involuntary passage of urine during sleep past the age of usual control, which is considered a developmental age of 5 to 7 years.
|
NE is a common problem that causes distress to both children and their families. It has an adverse impact on behavior and social life, affects self-esteem, and can result in poor emotional well-being. In Egypt, the prevalence of NE in primary school children is about 15.4%. The family history was seen to have had a markedly significant impact on the occurrence of NE in the studied children. The mainstay of treatment is urotherapy with information and psychoeducation about normal lower urinary tract function, the underlying cause of MNE, disturbed bladder dysfunction in the child with NMNE, and instructions about therapeutic strategies. Alarm therapy and desmopressin are effective in randomized trials. Children with NMNE first need treatment of the underlying daytime functional bladder problem before treatment of nocturnal enuresis. conditions: Nocturnal Enuresis studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 50 type: ESTIMATED name: Desmopressin measure: The number of episodes per week after desmopressin treatment sex: ALL minimumAge: 7 Years maximumAge: 14 Years stdAges: CHILD facility: Alazhar university status: RECRUITING city: Assiut zip: 11884 country: Egypt name: Omnia Nassar, Dr role: CONTACT phone: 01010112054 email: omnianassar835@gmail.com name: Hosny Elmasry, Prof role: CONTACT phone: 01010112054 email: omnianassar835@gmail.com lat: 27.18096 lon: 31.18368 hasResults: False
|
<|newrecord|> nctId: NCT06284993 id: 2023-214-KY briefTitle: Acupuncture of Different Treatment Frequency in Chronic Plantar Fasciitis overallStatus: RECRUITING date: 2024-02-20 date: 2026-09-30 date: 2026-12-30 date: 2024-02-29 date: 2024-02-29 name: Guang'anmen Hospital of China Academy of Chinese Medical Sciences class: OTHER briefSummary: Plantar fasciitis (PF) is one of the most common causes of heel pain, typically characterized by a sharp pain in the plantar aponeurosis, specifically near the insertion site close to the medial process of the calcaneal tuberosity. It has been reported that 1 in 10 people are expected to be affected by PF in their lifetime. A comprehensive internet-panel survey conducted among the adult United States population revealed the population-based prevalence of self-reported PF with pain in the last month was 0.85 percent. Approximately 1 million patients are diagnosed with this disease each year in the United States. PF was believed to be an acute inflammatory disease, but patient samples show it is actually a chronic degenerative process caused by various factors such as repetitive stresses, vascular and metabolic disorders, excess free radicals, high temperatures, genetic factors, and conditions like rheumatoid arthritis and spondyloarthropathies. PF may be associated with impaired health-related quality of life, including reduced life functioning, poor perceived health status and social isolation. Additionally, a recent study indicates that the annual cost associated with PF is $284 million.
|
The first-line treatments recommended by guidelines for PF encompass physical therapy (including manual therapy, stretching, and others), pharmacological therapy (involving corticosteroids or platelet-rich plasma), and surgical treatment. However, the definite effects of physical therapy still require confirmation. Pharmacological treatments, such as local corticosteroid injections, exhibit a short maintenance period. Some studies indicate that the relief provided by corticosteroid injections lasts up to one month, yet its efficacy diminishes after 6 months. Surgical treatment is generally advised 6 to 12 months after unsuccessful conservative treatment, albeit with the drawback of higher costs, post-surgery recovery time, and patient apprehension.
|
Acupuncture is one of the most common complementary alternative therapy for the treatment of pain-related diseases such as musculoskeletal muscle, and recent guidelines recommend dry needling as a treatment for relief of plantar fasciitis, with a level of evidence of B. Dry acupuncture is different from acupuncture in terms of theoretical basis, therapeutic apparatus, technical operation and scope of indications, however, the American Alliance for Professional Acupuncture Safety also believes that dry needling falls under the umbrella of acupuncture, but under a different name. In addition, there are systematic evaluations that suggest acupuncture can be a safe and effective treatment for PF, and most of the trials in the systematic evaluations used 4-week treatment courses. Our prior study demonstrated that a 4-week intervention of both electroacupuncture and manual acupuncture resulted in improved pain outcomes among patients with PF.
|
The frequency of acupuncture stands as a crucial factor influencing its efficacy. A study revealed that needling trials with negative results had a significantly lower frequency compared to those yielding positive results. Furthermore, several studies indicate that acupuncture once a week can be help in conditions such as simple obesity, functional dyspepsia, and overactive bladder in women. There is no universally accepted standard of frequency of treatment for many conditions, including PF. In China, patients with chronic diseases usually receive 3-5 acupuncture treatments per week. However, in most previous trials, individuals with chronic diseases received 1-2 needling sessions per week. An increase in the frequency of acupuncture means an increase in the pain, time, and financial investment associated with the acupuncture process. Therefore, it is critical to optimize the frequency of acupuncture to ensure the effectiveness and feasibility of the treatment while avoiding increasing the burden on the patient. Accordingly, we designed the current trial to compare the effects of different acupuncture sessions (1 session per week versus 3 sessions per week) in a randomized controlled trial (RCT) of chronic PF. The hypothesis is that 1 session per week compared with 3 sessions per week of electroacupuncture treatment over a total of 4 weeks of treatment will provide a similar effect on pain relief in chronic PF. conditions: Plantar Fasciitis, Chronic studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: electroacupuncture(more frequent) name: electroacupuncture(less frequent) measure: The response rate measure: The response rate measure: Change from baseline in the VAS score for worst pain intensity during the first steps in the morning measure: Change from baseline in the VAS score for mean pain intensity during the day measure: Change from baseline in the duration of heel pain during the day measure: Change from baseline in heel pressure pain threshold (PPT) measure: Change from baseline in ankle range of motion (AROM) measure: Change from baseline in Foot and Ankle Ability Measure (FAAM) total score and subscale scores measure: Participant global assessment of improvement measure: Participants' expectation towards acupuncture measure: Safety assessment measure: Adherence assessment measure: Number of cases and number of times painkillers and other treatments sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences Guang'anmen Hospital status: RECRUITING city: Beijing country: China name: Jiaxiang Shi role: CONTACT phone: +8618396129770 email: 476605704@qq.com lat: 39.9075 lon: 116.39723 hasResults: False
|
<|newrecord|> nctId: NCT06284980 id: 2369 briefTitle: Gestional Trophoblastic Neoplasia Ultrasound Assessment: Titanium Study acronym: TITANIUM overallStatus: RECRUITING date: 2019-01-24 date: 2024-12-30 date: 2025-12-31 date: 2024-02-29 date: 2024-02-29 name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS class: OTHER briefSummary: Gestational trophoblast diseases are characterized by abnormal proliferation of trophoblastic tissue, which can occur consequent to any pregnancy event. Pre-malignant forms (partial hydatiform mola and complete mola) and malignant forms are distinguished, the latter also known as gestational trophoblast neoplasms (invasive hydatiform mola, choriocarcinoma, placental site trophoblastic tumor, and epithelioid trophoblastic tumor).
|
These are neoplasms associated with good prognosis, amenable to conservative treatment and highly sensitive to chemotherapy.
|
The identification of ultrasonographic and echofluximetric features typical of malignant forms as well as the identification of ultrasonographic parameters predictive of chemoresistance to single-drug treatments could help improve their management. conditions: Describe Typical Gray Scale/Color Doppler Ultrasound Features of Gestational Trophoblastic Neoplasia at the US Examination conditions: To Assess if There Are Differences at the Baseline US Scan Between Low-risk and High-risk Patients conditions: To Identify Ultrasound Predictors of Resistance to First-line Single Drug Chemotherapy in Low-risk GTN Patients conditions: To Investigate if Machine Learning (ML) Algorithms (Radiomics, Deep Neural Networks (DNN), and Other Machine Learning Algorithms studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 120 type: ESTIMATED measure: typical features of Gestational Trophoblastic Neoplasia measure: differences at the baseline US scan between low-risk and high-risk patients measure: changes characteristics of Gestational Trophoblastic Neoplasia during treatment sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fondazione Policlinico Universitario Agostino Gemelli, IRCCS status: RECRUITING city: Rome zip: 00168 country: Italy name: Floriana Mascilini role: CONTACT phone: 0630156399 email: floriana.mascilini@policlinicogemelli.it lat: 41.89193 lon: 12.51133 hasResults: False
|
<|newrecord|> nctId: NCT06284967 id: Vitamin D In Spondylolysis briefTitle: Association Of Serum Vitamin D Level With Isthmic Spondylolysis overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-08-01 date: 2025-09-01 date: 2024-02-29 date: 2024-03-08 name: Assiut University class: OTHER briefSummary: The aim of this study is to compare vitamin D level between young adults with isthmic spondylolysis and a matched healthy control group. conditions: Spondylolysis studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 184 type: ESTIMATED measure: Mean serum vitamin D in both groups. measure: Mean serum calcium level sex: ALL minimumAge: 20 Years maximumAge: 45 Years stdAges: ADULT hasResults: False
|
<|newrecord|> nctId: NCT06284954 id: ARGX-117-2301 id: 2023-508337-14 type: OTHER domain: CTIS number briefTitle: A Study to Evaluate Safety and Efficacy of Empasiprubart in Adults With Dermatomyositis acronym: empacific overallStatus: NOT_YET_RECRUITING date: 2024-05-10 date: 2025-07-18 date: 2028-01-20 date: 2024-02-29 date: 2024-03-15 name: argenx class: INDUSTRY briefSummary: This study will evaluate the safety and efficacy of empasiprubart compared with placebo in adult participants with dermatomyositis (DM). conditions: Dermatomyositis conditions: Myositis studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Empasiprubart IV name: Placebo IV measure: Incidence and severity of adverse events (AEs) measure: Percentage of participants discontinuing investigational medicinal product (IMP) due to an adverse event (AE) measure: Mean TIS sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
|
<|newrecord|> nctId: NCT06284941 id: KY 2023-001-001 briefTitle: A Study of Ropivacaine Complex Methylene Blue Fascia Iliaca Compartment Block on Analgesia in Patients Undergoing Hip Arthroplasty overallStatus: ENROLLING_BY_INVITATION date: 2023-06-20 date: 2024-06-20 date: 2024-06-20 date: 2024-02-29 date: 2024-02-29 name: Wang wanxia class: OTHER briefSummary: Total hip arthroplasty is currently the most effective method for treating hip joint lesions and improving quality of life, but postoperative severe pain is not conducive to rapid recovery of patients. In recent years, the widespread application of ultrasound has achieved good clinical results in iliac fascia block for postoperative analgesia in THA. However, the use of high-dose local anesthetics can increase the risk of local anesthetic poisoning, and the single block analgesia time is generally less than 24 hours. Methylene blue, as a long-acting analgesic drug, can block the pain transmission of nerve fibers for a long time, achieving analgesic effects without damaging neurons. This study used ultrasound-guided ropivacaine combined with methylene blue to perform iliac fascia block on patients undergoing total hip replacement, with the aim of prolonging pain relief time, reducing complications, and promoting postoperative recovery on the basis of traditional methods. conditions: Femoral Neck Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 90 type: ESTIMATED name: Ropivacaine combined with methylene blue for iliac fascia block measure: Neutrophil lymphocyte ratio measure: visual analogue scale（VAS） measure: Procalcitonin measure: Hypersensitive C-reactive protein measure: Mean arterial pressure measure: Heart rate measure: Duration of surgery measure: Number of postoperative salvage analgesia measure: Walking distance for the first time getting out of bed measure: The number of activities of getting out of bed 48 hours after surgery sex: ALL minimumAge: 65 Years maximumAge: 85 Years stdAges: OLDER_ADULT facility: Jiangyan District Hospital of traditional Chinese medicine attached to the Nanjing University of Chinese Medicine city: Taizhou state: Jiang Su zip: 225500 country: China lat: 32.49069 lon: 119.90812 hasResults: False
|
<|newrecord|> nctId: NCT06284928 id: 20240104-01 briefTitle: Gut Microbiota and New Hypertension acronym: MIPHYP-CROSS overallStatus: COMPLETED date: 2019-12-01 date: 2020-06-01 date: 2020-12-01 date: 2024-02-29 date: 2024-02-29 name: Xinjiang Medical University class: OTHER briefSummary: This study aims to explore the gut microbiota patterns in patients newly diagnosed with hypertension, comparing them to those in non-hypertensive individuals. Utilizing cross-sectional analysis, it seeks to identify specific microbial profiles associated with hypertension, which could provide insights into the disease's pathogenesis and potential new avenues for treatment. The research focuses on analyzing fecal samples collected from both groups, using advanced genomic techniques to assess the diversity and abundance of gut bacteria. This investigation could contribute significantly to our understanding of the role gut microbiota plays in cardiovascular health and disease. conditions: Hypertension conditions: Gut Microbiota studyType: OBSERVATIONAL observationalModel: CASE_CROSSOVER timePerspective: CROSS_SECTIONAL count: 100 type: ACTUAL name: Gut Microbiota Analysis measure: Change in Gut Microbiota Composition sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The First Affiliated Hospital of Xinjiang Medical University city: Ürümqi state: Xinjiang zip: 630000 country: China lat: 43.80096 lon: 87.60046 hasResults: False
|
<|newrecord|> nctId: NCT06284915 id: MEQ00089 id: MEQ00089 type: OTHER domain: Sanofi Identifier id: 2023-508177-85 type: REGISTRY domain: CTIS id: U1111-1280-6981 type: REGISTRY domain: ICTRP briefTitle: Study on Immunogenicity and Safety of a Meningococcal ACYW Conjugate Vaccine in Healthy Infants and Toddlers overallStatus: RECRUITING date: 2024-03-19 date: 2025-03-10 date: 2025-03-11 date: 2024-02-29 date: 2024-04-17 name: Sanofi Pasteur, a Sanofi Company class: INDUSTRY briefSummary: This study is conducted to support a 2-dose series (1+1 vaccination schedule) for immunization of individuals from 6 months of age. The study is designed to evaluate the non-inferiority of the immunological response of MenACYW conjugate vaccine to Nimenrix® after the completion of the 2-dose series (1+1 vaccination schedule), with the first dose (priming dose) being given at 6-7 months of age to MenACWY- naïve healthy infants and the second dose (booster dose) given at 12-13 months of age. This study will also describe additional immunogenicity parameters and safety of MenACYW conjugate vaccine and Nimenrix® in the same population of participants. conditions: Meningococcal Immunisation conditions: Healthy Volunteers studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: TRIPLE maskingDescription: The study will be performed in a modified double-blind fashion:
|
* Investigators and study staff who conduct the safety assessment, and the participants parent/ legally acceptable representative will not know which study intervention is administered
|
* Only the study staff who prepare and administer the study intervention and are not involved with the safety evaluation will know which study intervention is administered whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 840 type: ESTIMATED name: MenACYW conjugate vaccine name: MenACYW conjugate vaccine measure: Geometric mean titers (GMTs) of Antibodies against meningococcal serogroups A, C, Y and W measure: hSBA antibody titers ≥ 1:8 against meningococcal serogroups A, C, Y, and W measure: hSBA antibody titers against meningococcal serogroups A, C, W, and Y measure: hSBA antibody titers ≥ several pre-defined thresholds against meningococcal serogroups A, C, Y, and W measure: Percentage of Participants who achieved ≥4-fold rise in antibody titers over baseline measured by hSBA measure: hSBA meningococcal serogroups A, C, Y, and W vaccine seroresponse measure: Rabbit complement (rSBA) antibody titers against meningococcal serogroups A, C, W, and Y measure: rSBA antibody titers ≥ several pre-defined thresholds against meningococcal serogroups A, C, Y, and W measure: Percentage of Participants who achieved ≥4-fold rise in antibody titers over baseline measured by rSBA measure: rSBA meningococcal serogroups A, C, Y, and W vaccine seroresponse measure: Number of participants with immediate adverse events (AEs) measure: Number of participants with solicited injection site reactions or systemic reactions measure: Number of participants with unsolicited AEs measure: Number of participants with serious adverse events (SAEs) sex: ALL minimumAge: 6 Months maximumAge: 14 Months stdAges: CHILD facility: Investigational Site Number: 2030001 status: RECRUITING city: Ceske Budejovice country: Czechia lat: 48.97447 lon: 14.47434 facility: Investigational Site Number: 2030005 status: RECRUITING city: Prague country: Czechia lat: 50.08804 lon: 14.42076 facility: Investigational Site Number: 2080004 status: RECRUITING city: Aarhus country: Denmark lat: 56.15674 lon: 10.21076 facility: Investigational Site Number: 2460006 status: RECRUITING city: Jaarvenpa country: Finland facility: Investigational Site Number: 2460007 status: RECRUITING city: Oulu country: Finland lat: 65.01236 lon: 25.46816 facility: Investigational Site Number: 2460004 status: RECRUITING city: Tampere country: Finland lat: 61.49911 lon: 23.78712 facility: Investigational Site Number: 2460012 status: RECRUITING city: Turku country: Finland lat: 60.45148 lon: 22.26869 facility: Investigational Site Number: 2760007 status: RECRUITING city: Erfurt country: Germany lat: 50.9787 lon: 11.03283 facility: Investigational Site Number: 2760001 status: RECRUITING city: Moenchengladbach country: Germany lat: 51.18539 lon: 6.44172 facility: Investigational Site Number: 2760005 status: RECRUITING city: Schoenau Am Koenigssee country: Germany facility: Investigational Site Number: 6160017 status: RECRUITING city: Bydgoszcz country: Poland lat: 53.1235 lon: 18.00762 facility: Investigational Site Number: 6160015 status: RECRUITING city: Krakow country: Poland lat: 50.06143 lon: 19.93658 facility: Investigational Site Number: 6160021 status: RECRUITING city: Krakow country: Poland lat: 50.06143 lon: 19.93658 facility: Investigational Site Number: 6160016 status: RECRUITING city: Leczna country: Poland lat: 51.30121 lon: 22.88135 facility: Investigational Site Number: 6160012 status: RECRUITING city: Lubon country: Poland lat: 52.34705 lon: 16.89267 facility: Investigational Site Number: 6160007 status: RECRUITING city: Torun country: Poland lat: 53.01375 lon: 18.59814 facility: Investigational Site Number: 6160014 status: RECRUITING city: Trzebnica country: Poland lat: 51.31076 lon: 17.06331 facility: Investigational Site Number: 6160010 status: RECRUITING city: Wroclav country: Poland facility: Investigational Site Number: 6420005 status: RECRUITING city: Calarasi country: Romania lat: 44.2051 lon: 27.31356 hasResults: False
|
<|newrecord|> nctId: NCT06284902 id: BDR17987 briefTitle: Bioavailability Study of Fexofenadine HCl New Formulation Tablet overallStatus: RECRUITING date: 2024-02-23 date: 2024-05-08 date: 2024-05-23 date: 2024-02-29 date: 2024-03-21 name: Opella Healthcare Group SAS, a Sanofi Company class: INDUSTRY briefSummary: The purpose of the study is to assess the relative bioavailability of a new galenic form of fexofenadine HCl new formulation tablet (test drug) taken with or without water compared to fexofenadine HCl film-coated tablets (reference form) taken with water under fasting conditions. conditions: Healthy Volunteers studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: NONE count: 25 type: ESTIMATED name: Fexofenadine HCl Coated tablet name: Fexofenadine HCl New Formulation Tablet measure: Area Under the Concentration-time Curve From Time Zero Until the Last Observed Concentration (AUC0-t) of Fexofenadine measure: Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) (AUC0-inf) of Fexofenadine measure: Maximal Observed Concentration (Cmax) of Fexofenadine measure: Time When the Maximal Concentration is Observed (Tmax) of Fexofenadine measure: Time of Observation Prior to the First Observation with a Measurable (non-zero) Concentration (Tlag) of Fexofenadine measure: Terminal Half-life Associated with the Terminal Slope (T1/2z) of Fexofenadine measure: Terminal Elimination Rate Constant (Kel) of Fexofenadine measure: Percentage of Participants with Treatment Emergent Adverse Events (TEAEs) sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Syneos Health Clinic inc. status: RECRUITING city: Quebec zip: G1P 0A2 country: Canada lat: 46.81228 lon: -71.21454 hasResults: False
|
<|newrecord|> nctId: NCT06284889 id: DepActive briefTitle: Behavioral Activation for the Treatment of Depression in Older Adults acronym: DepActive overallStatus: NOT_YET_RECRUITING date: 2024-03-04 date: 2027-12-31 date: 2028-12-31 date: 2024-02-29 date: 2024-02-29 name: Uppsala University class: OTHER name: Västmanland County Council, Sweden name: Sormland County Council, Sweden name: Uppsala County Council, Sweden briefSummary: Depression affects between 5-15% of adults ≥ 65 years in Sweden. Depression in older adults reduces functional ability and quality of life, and increases the risk for morbidity, loneliness, and suicide. Psychological treatment is recommended as a first-line treatment for depression, which about 3% of older adults with depression in Sweden report receiving. One effective psychological treatment is behavioral activation, which reduces depressive symptoms by increasing enjoyable, meaningful and important activities, for example exercise and social activities. The research group conducted a pilot study of telephone based behavioral activation for isolated older adults with depression during the COVID-19 pandemic. The intervention consisted of four telephone calls, and the results showed a significant decrease in depressive symptoms, with maintained effects for six months.
|
250 individuals will participate in the study. Half of the participants will be randomised to start the intervention immediately, while the other half of the participants will be randomized to a control group receiving treatment as usual at their respective primary care center. Participants will be asked to fill in questionnaires before, after treatment. Questionnaires will also be sent 3- and 6 months after treatment to follow up on the results. Patients will be asked to wear an accelerometer for 5-7 days to record their activity level at baseline, post-intervention and after 3-months. A smaller group of participants (10-15) will be asked to participate in a more detailed interview about how they experienced the treatment. conditions: Depression studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomised controlled multi-center trial primaryPurpose: TREATMENT masking: NONE count: 250 type: ESTIMATED name: Behavioural activation name: Treatment as usual (TAU) measure: Change from baseline in depressive symptoms using the Montgomery-Asberg Depression Rating Scale, MADRS-S measure: Change from baseline in depression diagnosis assessed using the Mini International Neuropsychiatric Interview, MINI measure: Change from baseline in Physical Activity level measure: Change from baseline in anxiety symptoms using the Geriatric Anxiety Scale - 10 item (GAS-10) is a self-rating scale designed to capture anxiety specifically in older adults, with items reflecting affective-, cognitive- and somatic anxiety symptoms. measure: Change from baseline in health and disability using The WHO Disability Assessment Schedule 12-item, WHODAS measure: Change from baseline in self rated quality of life using the EuroQol-5 Dimensions-5 Level Scale, EQ-5D-5L measure: Changes from baseline in Self Efficacy measured with the New General Self-Efficacy Scale, S-GSE. measure: Changes from baseline in loneliness measured with the UCLA Loneliness Scale version 3, UCLA-LS-3. measure: Diagnostic accuracy sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: Uppsala university city: Uppsala state: Uppland zip: 753 10 country: Sweden name: Mattias Damberg, MD role: CONTACT phone: +46739480910 email: mattias.damberg@pubcare.uu.se lat: 59.85882 lon: 17.63889 hasResults: False
|
<|newrecord|> nctId: NCT06284876 id: IY-NTNS03 briefTitle: Study to Evaluate the Efficacy and Safety of Ilaprazole 10 mg in Prevention NSAIDs Associated Peptic Ulcer overallStatus: NOT_YET_RECRUITING date: 2024-08-30 date: 2026-08-30 date: 2027-02-28 date: 2024-02-29 date: 2024-02-29 name: Il-Yang Pharm. Co., Ltd. class: INDUSTRY briefSummary: To demonstrate the non-inferiority of Ilaprazole 10 mg to the active control in prevention of NSAIDs-associated peptic ulcer, as assessed by the proportion of subjects with peptic ulcer by Week 24 conditions: Peptic Ulcer studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 416 type: ESTIMATED name: Ilaprazole name: Lansoprazole name: Ilaprazole Placebo name: Lansoprazole Placebo measure: Ilaprazole, Lansoprazole peptic ulcer measure: Ilaprazole, Lansoprazole peptic ulcer measure: Ilaprazole, Lansoprazole GI bleeding sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Chung Ang University Hospital city: Seoul country: Korea, Republic of lat: 37.566 lon: 126.9784 hasResults: False
|
<|newrecord|> nctId: NCT06284863 id: 04-2023-200315 briefTitle: Impact Of Nutritional Education Program In Hemodialysis Patients overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-03 date: 2026-04 date: 2024-02-29 date: 2024-02-29 name: Assiut University class: OTHER briefSummary: The study aims to improve the health status of chronic renal failure patients on hemodialysis using nutritional education program on quality of life anserum d electrolytes level by application of physical and clinical evaluation and some biochemical analysis before and after a specified nutritional program conditions: Hemodialysis Complication studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 100 type: ESTIMATED name: Natritional Education Program In Hemodialysis Patients measure: The percentage patients responded to nutritional education program on hemodialysis patients. sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT hasResults: False
|
<|newrecord|> nctId: NCT06284850 id: Christina Trakatelli briefTitle: Empagliflozin and Red Blood Cell 2,3-biphosphoglycerate Levels overallStatus: RECRUITING date: 2023-11-30 date: 2025-11 date: 2025-11 date: 2024-02-29 date: 2024-02-29 name: Aristotle University Of Thessaloniki class: OTHER briefSummary: The aim of this study is to investigate the hypothesis that treatment with empagliflozin may have an impact on red blood cell 2,3-biphosphoglycerate levels affecting tissue oxygen supply and thus mediating part of the cardio- and reno- protective effect of SGLT-2 inhibitors. conditions: Hematocrit Change conditions: Cardiovascular Prevention conditions: Empagliflozin conditions: SGLT2-Inhibitors conditions: Tissue Oxygenation studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 40 type: ESTIMATED name: Empagliflozin10Mg Tab measure: Mean change in red blood cell 2,3-biphosphoglycerate levels (μmol/ml) measure: Mean change in Hct (%) measure: Hb (mg/dl) measure: RBC (x1000000/μl) measure: MCV (fl), measure: HbA1c (%, mmol/mol), measure: erythropoietin (mU/ml) measure: eGFR (ml/min/1.73m2), measure: Urine Albumin to Creatinine Ratio (mg/g) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Papageorgiou General Hospital status: RECRUITING city: Thessaloniki state: Central Macedonia zip: 56403 country: Greece name: KONSTANTINOS KITSIOS, MD,MSc,PhD role: CONTACT phone: +306977295744 email: kitsios_k@yahoo.gr lat: 40.64361 lon: 22.93086 hasResults: False
|
<|newrecord|> nctId: NCT06284837 id: HREC/99382/Alfred-2023 briefTitle: Secondary Access - FEmoral or Radial in Transcatheter Aortic Valve Implantation? acronym: SAFER-TAVI overallStatus: RECRUITING date: 2023-12-04 date: 2025-07 date: 2025-08 date: 2024-02-29 date: 2024-03-04 name: The Alfred class: OTHER name: Epworth Healthcare name: Cabrini Health briefSummary: Transcatheter aortic valve implantation (TAVI) is a well known safe treatment for severe aortic stenosis. To perform TAVI safely, there is a need for two vascular entry (access) sites: the primary and secondary access sites. While the femoral approach remains the most common site for primary access, secondary access (which is needed for guidance during the procedure) has drawn little attention in trials of TAVI. The two secondary access sites most commonly used are the radial (through an artery in the wrist) and femoral (through an artery in the groin) access sites. Observational studies comparing the two have shown a lower risk of complications with radial access compared to femoral access, but there are no randomized controlled data to confirm these findings. Accordingly, investigators aim to undertake a multicenter, randomized controlled trial among patients who are undergoing transfemoral TAVI, to assess if radial access is superior to femoral access as a secondary access site. conditions: Valve Stenoses, Aortic studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 560 type: ESTIMATED name: Access site measure: All bleeding and vascular complications measure: All bleeding measure: All vascular complications measure: All-cause death measure: Stroke measure: Myocardial infarction measure: Major adverse cardiovascular events measure: Length of stay post-procedure measure: Overall procedure duration measure: Radiation dose measure: Conversion rate to alternative vascular access site measure: Tertiary site utilised to treat vascular complication measure: Failure to perform angiogram of primary access site at completion of TAVI sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Alfred Health status: RECRUITING city: Melbourne state: Victoria zip: 3004 country: Australia name: Jennifer Zhou, MBBS, BMedSc role: CONTACT email: je.zhou@alfred.org.au name: Antony Walton, MBBS role: PRINCIPAL_INVESTIGATOR name: Dion Stub, MBBS, PhD role: PRINCIPAL_INVESTIGATOR lat: -37.814 lon: 144.96332 facility: Epworth Healthcare status: NOT_YET_RECRUITING city: Melbourne state: Victoria zip: 3121 country: Australia name: Jennifer Zhou, MBBS, BMedSc role: CONTACT email: je.zhou@alfred.org.au name: Antony Walton, MBBS role: PRINCIPAL_INVESTIGATOR lat: -37.814 lon: 144.96332 facility: Cabrini Health status: NOT_YET_RECRUITING city: Melbourne state: Victoria zip: 3144 country: Australia name: Jennifer Zhou, MBBS, BMedSc role: CONTACT email: je.zhou@alfred.org.au name: Dion Stub, MBBS, PhD role: PRINCIPAL_INVESTIGATOR lat: -37.814 lon: 144.96332 hasResults: False
|
<|newrecord|> nctId: NCT06284824 id: DPS-JMP-2022-040 briefTitle: Comparison of Two Robotic-Assisted Total Knee Arthroplasty Systems overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-05 date: 2027-05 date: 2024-02-29 date: 2024-04-17 name: Southeast Orthopedic Specialists class: NETWORK name: DePuy Orthopaedics name: Stryker Orthopaedics briefSummary: The goal of this prospective study is to compare two different knee replacement robots. This study will look at patient reported outcome measures and data collected during the operation. The main questions this study aims to answer include:
|
* Will the patient reported outcomes differ between the two groups?
|
* Will the intraoperative data differ between the two groups? Participants will undergo total knee replacement with one of the two robots, complete standardized surveys, and have x-rays taken. conditions: Knee Osteoarthritis conditions: Knee Arthritis conditions: Knee Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 120 type: ESTIMATED name: Stryker Triathlon with MAKO Robotic-Arm name: DePuy Attune with VELYS Robotic-Assistance measure: KSS measure: KSS measure: KSS measure: KSS measure: KOOS JR measure: KOOS JR measure: KOOS JR measure: KOOS JR measure: FJS-12 Knee measure: FJS-12 Knee measure: FJS-12 Knee measure: Operative step time measure: Bone resected measure: Costs for surgery sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
|
<|newrecord|> nctId: NCT06284811 id: 050.06.04/155 briefTitle: Massage and Percussion Therapy on Muscle and Performance Parameters overallStatus: RECRUITING date: 2023-12-31 date: 2024-04-15 date: 2024-04-20 date: 2024-02-29 date: 2024-02-29 name: Acibadem University class: OTHER name: Istanbul Aydın University name: Biruni University briefSummary: DOMS, muscle viscoelastic properties, quadriceps strength and vertical jump performance will be evaluated in physically active individuals before the exercise and after the exercise and intervention which is either Swedish massage or Percussion therapy conditions: Healthy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 24 type: ESTIMATED name: Exercise program focusing on quadriceps measure: Muscle tone/tension(Hz) measure: Muscle dynamic stiffness (N/m) measure: Muscle elasticity (log) measure: DOMS measure: Vertical Jump Performance measure: Quadriceps isometric strength sex: ALL minimumAge: 18 Years maximumAge: 30 Years stdAges: ADULT facility: Acibadem University status: RECRUITING city: Istanbul state: Ataşehir zip: 34752 country: Turkey name: Özge Haklı, Research Assisstant role: CONTACT phone: +902165004221 email: ozge.kocaer@acibadem.edu.tr lat: 41.01384 lon: 28.94966 hasResults: False
|
<|newrecord|> nctId: NCT06284798 id: NN9650-5027 id: 2023-506134-79 type: OTHER domain: European Medical Agency (EMA) id: U1111-1291-7535 type: OTHER domain: World Health Organization (WHO) briefTitle: A Research Study of a New Medicine (NNC0650-0013) in Healthy Men overallStatus: RECRUITING date: 2024-01-30 date: 2025-03-22 date: 2025-03-22 date: 2024-02-29 date: 2024-02-29 name: Novo Nordisk A/S class: INDUSTRY briefSummary: This study is testing a new study medicine which may be used to treat people with type 2 diabetes. NNC0650-0013 is a new medicine, which cannot be prescribed by doctors. The purpose of the study is to see if the new study medicine is safe, and how it works in participants body. Participants will get a single dose of the study medicine either as injection(s) under the skin or into a vein. The injection will be given by the study staff. If participants are chosen to get the study medicine as injections under the skin, participants will either get NNC0650-0013 or placebo (a "dummy medicine" without any active ingredients). Which treatment participants get is decided by chance. Participants will be required to fast overnight 3 times during the study. The study will last between 11 and 17 weeks. conditions: Healthy Participants studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: Sponsor staff involved in the clinical trial is masked according to company standard procedures. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 52 type: ESTIMATED name: NNC0650-0013 A name: Placebo measure: S.C. Cohort: Number of treatment emergent adverse events (TEAEs) measure: S.C. Cohort: AUC0-∞,0188,SD: Area under the NNC0519-0188 plasma concentration time curve from time 0 to infinity after a single dose measure: S.C. Cohort: Cmax,0188,SD: Maximum plasma concentration of NNC0519-0188 after a single dose measure: S.C. Cohort: AUC0-∞,0013,SD: Area under the NNC0650-0013 plasma concentration-time curve from time 0 to infinity after a single dose measure: S.C. Cohort: Cmax,0013,SD: Maximum observed plasma concentration of NNC0650-0013 after a single dose measure: S.C. Cohort: AUC0-∞,0031,SD: Area under the NNC0650-0031plasma concentration time curve from time 0 to infinity after a single dose measure: S.C. Cohort: Cmax,0031,SD: Maximum observed plasma concentration of NNC0650-0031 after a single dose measure: I.V. Cohort: AUC0-∞,0188,SD: Area under the NNC0519-0188 plasma concentration-time curve from time 0 to infinity after a single dose measure: I.V. Cohort: AUC0-∞,0013,SD: Area under the NNC0650-0013 plasma concentration-time curve from time 0 to infinity after a single dose measure: I.V. Cohort: AUC0-∞,0031,SD: Area under the NNC0650-0031 plasma concentration-time curve from time 0 to infinity after a single dose measure: S.C. and I.V. Cohort: AUC0-∞,0013,SD/dose: Area under the NNC0650-0013 plasma concentration-time curve from time 0 to infinity after a single dose divided by the dose administered sex: MALE minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Profil Institut für Stoffwechselforschung GmbH status: RECRUITING city: Neuss zip: 41460 country: Germany lat: 51.19807 lon: 6.68504 hasResults: False
|
<|newrecord|> nctId: NCT06284785 id: 2023.0121 briefTitle: The Effects of Bariatric Surgery on Kidney Oxygenation in Obese Adults With Type 2 Diabetes and Hyperfiltration acronym: ECSTASY overallStatus: RECRUITING date: 2023-08-01 date: 2026-01-01 date: 2026-03-01 date: 2024-02-29 date: 2024-02-29 name: Amsterdam UMC, location VUmc class: OTHER name: Dutch Kidney Foundation name: Dutch Diabetes Research Foundation briefSummary: In this study the investigators will examine the effects of VAT reduction by bariatric surgery on kidney hypoxia and compare kidney oxygenation before- and after surgery in both sexes using BOLD-MRI and measures of kidney hemodynamic function. Furthermore, the investigators will assess whether kidney oxygenation is reduced in obese T2D men and women versus various controls as described below. This will determine whether kidney hypoxia can be appointed as a modifiable pathogenic factor in early DKD and non-surgical interventions targeting kidney hypoxia can be designed to slow DKD progression. conditions: Kidney Hypoxia conditions: Diabetes Mellitus, Type 2 studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Bariatric surgery measure: Difference in kidney oxygenation before and after bariatric surgery measure: Difference in kidney oxygenation between men and women measure: Difference in kidney oxygenation between obese, hyperfiltering men and women with T2D versus non-diabetic lean controls sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: VU University Medical Center status: RECRUITING city: Amsterdam state: Noord-Holland zip: 1081HV country: Netherlands name: Daniel H van Raalte, MD role: CONTACT phone: +31 204442974 email: d.vanraalte@vumc.nl name: Daniel H van Raalte, MD role: PRINCIPAL_INVESTIGATOR lat: 52.37403 lon: 4.88969 hasResults: False
|
<|newrecord|> nctId: NCT06284772 id: 4457/2023 briefTitle: FINRISK 2002 Re-examination overallStatus: ENROLLING_BY_INVITATION date: 2023-11-13 date: 2024-06-25 date: 2024-06-25 date: 2024-02-29 date: 2024-02-29 name: University of Turku class: OTHER name: Finnish Institute for Health and Welfare briefSummary: The project aims to fill in the existing gaps in the study of the microbiome as a cardiometabolic driver 1) by determining the key demographic, environmental, genetic, dietary, and metabolic correlates of long-term within-individual microbiome and microbial metabolite changes; and 2) by assessing how the gut microbiome, microbial metabolites, and their long-term changes are prospectively related to the risk factors, surrogate markers, and overt outcomes of CMD. To achieve this goal, repeat stool samples will be collected of \~2300 Finnish individuals who gave stool samples in the year 2002. In addition, \~300 individuals will undergo a in-depth health examination in 2024. conditions: Cardiometabolic Syndrome conditions: Cardiovascular Diseases studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 2300 type: ESTIMATED name: Questionnaire and fecal sampling name: Health examination measure: Gut microbiome change between 2002-2024 measure: Correlates of gut microbiome change between 2002-2024 sex: ALL minimumAge: 47 Years maximumAge: 96 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Turku city: Turku zip: 20100 country: Finland lat: 60.45148 lon: 22.26869 hasResults: False
|
<|newrecord|> nctId: NCT06284759 id: E-77082166-302.08.01-380534 briefTitle: The Effect of Tele-Nursing Application on Self-Care Ability and Daily Living Activities in Fracture Surgery Patients overallStatus: ACTIVE_NOT_RECRUITING date: 2023-09-15 date: 2024-03-28 date: 2024-03-28 date: 2024-02-29 date: 2024-02-29 name: Gazi University class: OTHER name: Lokman Hekim Üniversitesi name: Ankara City Hospital Bilkent briefSummary: This study aims to determine the effect of tele-nursing application based on Orem's Self-care Theory on self-care agency and daily living activities in trauma-related lower extremity fracture surgery patients. conditions: Lower Extremity Fracture studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE maskingDescription: In the study, the statistician was blinded using the blind technique. whoMasked: OUTCOMES_ASSESSOR count: 52 type: ACTUAL name: post-discharge telenursing intervention measure: Self Care, Assessed using the Self-Care Agency scale. measure: Activities of daily living, Assessed using the Katz index of independence in activities of daily living (ADL) scale. measure: Instrumental activities of daily living, Assessed using the The Lawton instrumental activities of daily living scale. sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Lokman Hekim University city: Ankara zip: 06510 country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False
|
<|newrecord|> nctId: NCT06284746 id: 301Qiaoz briefTitle: Tirelizumab Combined With Chemotherapy in the Treatment of HER-2 Negative Locally Advanced Gastric Cancer overallStatus: RECRUITING date: 2023-10-01 date: 2025-04-30 date: 2025-07-30 date: 2024-02-29 date: 2024-02-29 name: Lin Chen class: OTHER briefSummary: This study objectively analyzes the safety and survival evaluation of perioperative immunotherapy combined with chemotherapy in locally advanced gastric cancer patients through a prospective randomized controlled trial research method; By comparing the pathological response rate, disease-free survival rate, and incidence of adverse events between the combination therapy and chemotherapy alone group, we aim to verify the efficacy and safety of tirelizumab combined with SOX/XELOX chemotherapy in disease control of locally advanced gastric cancer patients, laying the foundation and providing a basis for large-scale multicenter clinical research. conditions: Locally Advanced Gastric Carcinoma conditions: HER2 Negative conditions: Efficacy conditions: Safety studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Tirolizumab+SOX/XELOX name: SOX/XELOX measure: Pathological complete response (pCR) measure: Objective Response Rate（ORR） measure: Disease-free survival（DFS） measure: Overall survival（OS） measure: Major Pathologic Response（MPR） measure: The incidence of adverse events during treatment sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: General Surgery Institute, China PLA General Hospital status: RECRUITING city: Beijing state: Beijing zip: 100853 country: China name: Yunhe Gao, Ph.D. role: CONTACT phone: 86-010-66937164 email: gaoyunhe@301hospital.org lat: 39.9075 lon: 116.39723 hasResults: False
|
<|newrecord|> nctId: NCT06284733 id: P.T.REC/012/004874 briefTitle: Whole-body Vibration Without Visual Feedback on Postural Steadiness in Unilateral Trans-femoral Traumatic Amputees overallStatus: COMPLETED date: 2023-11-05 date: 2024-04-08 date: 2024-04-20 date: 2024-02-29 date: 2024-04-23 name: MTI University class: OTHER briefSummary: This study will investigate the effects of Whole-body vibration without visual feedback on postural steadiness in unilateral trans-femoral traumatic amputees. This study will be carried out at the outpatient clinic of the faculty of physical therapy, modern university for technology and information, and El Wafaa wel Amal hospital.
|
All participants will sign a written consent form after receiving full information about the purpose of the study, procedure, possible benefits, privacy, and use of data. conditions: Amputation; Traumatic, Leg, Lower studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: They will be assigned into three equal groups: primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Double blinded whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 115 type: ACTUAL name: Whole-body vibration plus conservative care name: conservative care measure: Prosthetic leg stability test measure: Sway Index measure: Limits of Stability Test sex: ALL minimumAge: 40 Years maximumAge: 55 Years stdAges: ADULT facility: Ahmed Mohamed Ahmed Abdelhady city: Cairo country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False
|
<|newrecord|> nctId: NCT06284720 id: Project number 144 briefTitle: Transcranial Alternating Current Stimulation for the Improvement of Episodic Memory in Healthy Older Adults overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-10-31 date: 2024-10-31 date: 2024-02-29 date: 2024-03-12 name: Universidade Católica Portuguesa class: OTHER name: Clínica NeuroVida (Portugal) briefSummary: Memory complaints are a common symptom among Subjective Cognitive Decline, Mild Cognitive Impairment and Alzheimer disease. Indeed, episodic memory and Alzheimer disease are highly sensitive to aging. Many brain areas become active when we remember an event from the past. The precuneus, part of the posterior system of default mode network, has been identified as a central node of episodic memory retrieval and a central node in various psychiatric and neurological disorders, such as Alzheimer disease. Age-related changes have been consistently found in the default mode network connectivity, occurring within its posterior areas and with the reduction of connectivity between anterior and posterior subnetwork. It has also been found that aging is associated with decreased functional connectivity in the precuneus and posterior cingulate of the default mode network. Furthermore, γ-Aminobutyric acid (GABA), which plays an essential role in regulating brain activity and modulating the default mode network, shows a decrease throughout the normal course of aging, in Mild Cognitive Impairment and Alzheimer disease. It was also verified a link between cognitive decline and the dysfunction of the inhibitory activity of GABAergic interneurons, particularly parvalbumin-positive interneurons, that play a role in control local circuitry, brain networks and memory processing. Parvalbumin interneurons are the fast-spiking interneurons that generate and maintain gamma frequency. Gamma band has been associated with the encoding and retrieval of episodic memory. Impairments of gamma oscillations have been observed in healthy aging, Mild Cognitive Impairment and Alzheimer disease.
|
By identifying these functional connectivity changes, non-invasive neuromodulation techniques may offer a new strategy for improving cognitive functions. Transcranial Alternating Current Stimulation (tACS) is a form of non-invasive brain stimulation that modulates cortical activity by applying weak, oscillating electrical currents to the cortex via two or more scalp electrodes. By using alternating currents, it is possible to simulate the rhythmic pattern of electrophysiological activity of the brain. tACS can interact with neural firing at behaviorally relevant frequencies linked to memory.
|
In this randomized, double-blind, sham-controlled, cross-over study, the investigators will evaluate whether stimulation with gamma tACS on the precuneus can improve episodic memory in healthy older adults. conditions: Healthy Older Adults studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: PREVENTION masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 16 type: ESTIMATED name: Gamma tACS (40 Hz) over the precuneus name: Sham tACS over the precuneus measure: Changes in immediate and delayed free recall Auditory Verbal Learning Test scores measure: Changes in immediate free recall and delayed recognition Face-Name Memory Test scores measure: Change in functional connectivity sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: Filipa Ribeiro city: Lisbon country: Portugal name: Filipa Ribeiro, PhD role: CONTACT phone: +351 217214147 email: filipa.nc.ribeiro@ucp.pt name: Joana Macedo, MSc role: PRINCIPAL_INVESTIGATOR name: Filipa Ribeiro, PhD role: PRINCIPAL_INVESTIGATOR lat: 38.71667 lon: -9.13333 hasResults: False
|
<|newrecord|> nctId: NCT06284707 id: Rhythmic_PAU_2024 briefTitle: Effect of Rhythmic Gymnastics Training in Children With Down Syndrome overallStatus: RECRUITING date: 2024-03-01 date: 2024-03-08 date: 2024-05-05 date: 2024-02-29 date: 2024-03-08 name: University of Castilla-La Mancha class: OTHER briefSummary: Some of the clinical characteristics of people with Down syndrome (DS) are orthopedic, cardiovascular, neuromuscular, visual, cognitive and perceptual disorders, which directly affect the quality of their movements. Children with DS often have a sedentary lifestyle or low levels of physical activity which exacerbates problems related to obesity and overall physical health. Therefore, the practice of physical exercise in this type of population is essential to improve their health-related physical fitness. The aim of this study was to analyze the influence of an adapted rhythmic gymnastics training program on body composition, tendon architecture and stiffness, and physical capacity in children with DS. conditions: Physical Conditioning, Human studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: CROSSOVER primaryPurpose: OTHER masking: TRIPLE maskingDescription: The care provider will be responsible for administering the training program. Two different people will develop swimming training and rhythmic gymnastics training. Each participant will be assigned a code. The researcher will process the data with the code of each participant. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 20 type: ESTIMATED name: swimming training name: rhythmic gymnastics training measure: Body composition measure: Tendon thickness measure: Stiffness tendon measure: Hamstrings flexibility measure: body mass index measure: visceral fat area measure: metabolism measure: tendon elastography measure: balance measure: functional capacity sex: ALL minimumAge: 6 Years maximumAge: 20 Years stdAges: CHILD stdAges: ADULT facility: Universidad de Castilla La Mancha status: RECRUITING city: Toledo zip: 45071 country: Spain name: Paula Esteban-García, PhD role: CONTACT phone: 925 26 88 00 email: paula.esteban@uclm.es lat: 39.8581 lon: -4.02263 hasResults: False
|
<|newrecord|> nctId: NCT06284694 id: REB23-0120 briefTitle: Treatment of Neuropathic Pain Following Spinal Cord Injury - a rTMS Approach overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-06-30 date: 2025-06-30 date: 2024-02-29 date: 2024-02-29 name: University of Calgary class: OTHER briefSummary: This study aims to determine if repetitive transcranial magnetic stimulation (rTMS) can improve pain symptomology in adults with neuropathic pain (NP) following a spinal cord injury (SCI). conditions: Neuropathic Pain studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: All participants will receive active rTMS treatment. primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: Repetitive Transcranial Magnetic Stimulation (rTMS) measure: International Spinal Cord Injury Pain Basic Data Set (ISCIPBDS) v3.0 measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Scale Neuropathic Pain Quality 5a measure: Quality of Life Index Spinal Cord Injury version (QLI-SCI) measure: Pain Catastrophizing Scale (PCS) measure: World Health Organization Disability Assessment Schedule (WHODAS) 2.0 measure: Generalized Anxiety Disorder scale-7 (GAD-7) measure: Patient Health Questionnaire-9 (PHQ-9) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Foothills Medical Centre city: Calgary state: Alberta zip: T2N 2T9 country: Canada lat: 51.05011 lon: -114.08529 hasResults: False
|
<|newrecord|> nctId: NCT06284681 id: IRB-300012557 id: 3P50MD017338-03S1 type: NIH link: https://reporter.nih.gov/quickSearch/3P50MD017338-03S1 briefTitle: Weight Inclusive and Adaptive Strategies to Enhance Cardiometabolic Health in Black Adults acronym: WISE Health overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-12-31 date: 2025-12-31 date: 2024-02-29 date: 2024-03-21 name: University of Alabama at Birmingham class: OTHER name: National Institute on Minority Health and Health Disparities (NIMHD) briefSummary: The proposed 6-month pilot Sequential Multiple Assignment Randomize Trial (SMART) has two aims. The first and primary aim is to determine the feasibility of conducting a full-scale SMART to compare weight-focused (i.e., weight loss) and weight-neutral (i.e., weight loss is not an explicit goal) adaptive biobehavioral interventions for improving cardiometabolic health in Black adults with overweight or obesity (BMI ≥27 kg/m2) plus at least one weight-related cardiometabolic condition (high blood pressure, prediabetes or diabetes, and/or high cholesterol). Biobehavioral interventions are treatment strategies that combine lifestyle-based behavioral interventions such as eating a healthy diet and exercise with medications. In this study, participants will be randomly assigned to receive either weight-focused or weight-neutral health coaching for 7 weeks. At week 8, participants will be identified as either "responders" or "nonresponders" to the initial interventions. The threshold for response in the weight-focused condition is greater than or equal to 3% weight loss. The threshold for response in the weight-neutral condition is engaging in greater than or equal to 150 minutes of moderate physical activity for the 7 days prior to the week 8 study visit. Responders to the initial interventions will continue with health coaching on a biweekly basis for weeks 9-26 of the intervention. Nonresponders will be re-randomized to either intensify the lifestyle-based intervention by receiving a membership to the YMCA and enrolling in group fitness classes or augmenting the health coaching with enhanced medical management in partnership with their established primary care provider. The second aim is to use clinical data from the pilot SMART to estimate treatment effects and the between-person variability in these effects. Because this is a pilot study, these estimates will not be used to make comparisons or draw conclusions on the comparative effectiveness of intervention conditions. Rather, these data will be used to generate preliminary effect sizes that can be used to estimate the sample size required for a full-scale trial. Clinical trial feasibility data will be collected on an ongoing basis throughout the study and clinical data will be collected prior to initiating the intervention (baseline) and at week 8 (response visit) and week 26 (post-intervention visit). conditions: Obesity conditions: Prehypertension conditions: Hypertension conditions: PreDiabetes conditions: Type 2 Diabetes conditions: Dyslipidemia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: SINGLE whoMasked: INVESTIGATOR count: 60 type: ESTIMATED name: Weight-focused health coaching name: Weight-neutral health coaching name: Intensify lifestyle approach name: Augment with enhanced medical management measure: Recruitment rate measure: Retention rate measure: Response/Non-response rate to initial interventions measure: Attendance to health coaching sessions measure: Treatment Credibility and Expectancy Questionnaire (CEQ) measure: Treatment Credibility and Expectancy Questionnaire (CEQ) measure: Treatment Preference measure: Treatment Preference measure: Family medicine clinic capacity for research measure: Study visit duration measure: Time required for surveys completion measure: Response to weight-focused health coaching measure: Response to weight-neutral health coaching measurement measure: Change in blood pressure measure: Change in glucose measure: Change in insulin measure: Change in insulin sensitivity measure: Change in HbA1c measure: Change in total cholesterol measure: Change in LDL-cholesterol measure: Change in HDL-cholesterol measure: Change in triglycerides measure: Change in Metabolic Syndrome Severity Score measure: Change in blood pressure measure: Change in glucose measure: Change in insulin measure: Change in HbA1c measure: Change in total cholesterol measure: Change in LDL-cholesterol measure: Change in HDL-cholesterol measure: Change in triglycerides measure: Change in body weight measure: Change in physical activity measure: Change in fat mass measure: Change in fat mass measure: Change in lean mass measure: Change in lean mass measure: Change in waist circumference measure: Change in waist circumference measure: Dietary intake measurement measure: Dietary intake measurement measure: Change in insulin sensitivity measure: Change in Metabolic Syndrome Severity Score sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
|
<|newrecord|> nctId: NCT06284668 id: GWang027 briefTitle: Esketamine vs Remimazolam for Postoperative Sleep Disturbance and Anxiety overallStatus: RECRUITING date: 2024-03-04 date: 2024-06-20 date: 2024-07-10 date: 2024-02-29 date: 2024-03-05 name: Tianjin Medical University General Hospital class: OTHER briefSummary: To explore and compare the effects of esketamine and remimazolam on postoperative sleep disturbance in patients undergoing oocyte retrieval conditions: Sleep Disturbance studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 300 type: ESTIMATED name: normal Saline name: Esketamine name: Remimazolam measure: The incidence of postoperative sleep disturbance on the first night after surgery measure: The incidence of sleep disturbance one day before surgery measure: The incidence of postoperative sleep disturbance on the second and third postoperative nights measure: Postoperative anxiety measure: Postoperative depression measure: Pain Score (NRS) measure: Mean intraoperative blood pressure measure: Oxygen saturation measure: Somatokinetic reaction measure: Operation time measure: Duration of anesthesia measure: Time to walking down measure: Adverse event sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Tianjin Medical University General Hospital status: RECRUITING city: Tianjin zip: 300052 country: China name: Guolin Wang role: CONTACT phone: +8618604755166 email: wangguolinghad@hotmail.com lat: 39.14222 lon: 117.17667 hasResults: False
|
<|newrecord|> nctId: NCT06284655 id: 635362 a briefTitle: The Effect of a Brief Educational Intervention for Adults With ADHD overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2027-01 date: 2030-12 date: 2024-02-29 date: 2024-02-29 name: St. Olavs Hospital class: OTHER name: Norwegian University of Science and Technology briefSummary: This RCT-study proposes the evaluation of an intensive educational intervention tailored for adults with Attention Deficit Hyperactivity Disorder (ADHD) in community mental health centers (CMHCs). Given the prevalent challenges of prolonged waiting lists and low patient engagement in CMHCs, the research seeks to assess the efficacy of this intervention in enhancing patient engagement, self-efficacy, satisfaction with the information and overall health outcomes. The intervention, developed collaboratively with user representatives, combines a brief group-based educational sessions with standard clinical care. The primary hypotheses posit that this approach will lead to increased patient satisfaction with the treatment, patient self-efficacy, and activation compared to conventional treatment. Additionally, it aims to improve patients' satisfaction with information received. The study will employ a ITT analysis to assess the intervention's effects against usual treatment practices in outpatient settings. The anticipated outcome is a significant improvement in level of patient satisfaction, level of self-efficacy and level of satisfaction with the received information for patients with ADHD, potentially informing clinical practices and optimizing care for adults with ADHD. conditions: ADHD studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Parallel two-arms randomized control trial primaryPurpose: OTHER masking: SINGLE maskingDescription: Blinded statistician whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: group-based combined with innovative technology education name: Standard treatment measure: Change in client satisfaction using CSQ measure: Change in general self-efficacy using GSE-6 measure: Change in satisfaction with the information measure: Knowledge and treatment preferences measure: Change in patient activation using PAM measure: Change in ADHD-related symptoms using ASRS measure: Change in ADHD-related symptoms using SCL-9 measure: Change in depression and anxiety symptoms using PHQ-4 measure: Change in patient enablement using PEN-13 measure: Change in stress level using PSS-4 measure: Change in level of functioning using WSAS measure: Change in ADHD Quality of life using AAQoL measure: Change in Health-related Quality of life using EQ-5D-5L measure: Cost measure: Health care usage sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: St Olav's Hospital city: Trondheim country: Norway name: Mariela Loreto Lara-Cabrera, PhD role: CONTACT email: mariela.lara@ntnu.no lat: 63.43049 lon: 10.39506 hasResults: False
|
<|newrecord|> nctId: NCT06284642 id: LD-ITUK-2024-001 briefTitle: Early Lumbar Drainage Combined With Intrathecal Urokinase Injection for Treatment of Severe Aneurysmal SAH (LD-ITUK) overallStatus: RECRUITING date: 2024-03-28 date: 2026-01-30 date: 2026-06-30 date: 2024-02-29 date: 2024-04-15 name: Second Affiliated Hospital of Nanchang University class: OTHER name: Changhai Hospital briefSummary: The LD-ITUK is a multicenter, prospective, randomized, double-blind, blind endpoint, placebo-control design trial. All eligible patients with the diagnosis of severe aSAH will be randomly assigned to the treatment group or the placebo group. Patients in the treatment group will receive standard treatment with the addition of lumbar drainage combined with intrathecal urokinase injection started within 24 hours after aneurysm treatment with 30000 IU urokinase, once a day for 3 consecutive days. Patients in the control group will receive standard treatment with the addition of lumbar drainage combined with intrathecal placebo (0.9%NaCl) injection. The primary outcome measure is favorable functional outcome, defined as a score of 0 to 2 on the modified Rankin Scale (mRS), at 6 months after aneurysmal SAH. Primary outcome will be determined by a member of the Independent Committee on Terminal events. conditions: Aneurysmal Subarachnoid Hemorrhage studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 424 type: ESTIMATED name: Urokinase name: Placebo measure: Modified Rankin Scale (mRS) measure: Modified Rankin Scale (mRS) measure: Relative Modified Rankin Scale (mRS) measure: Modified Rankin Scale (mRS) distribution measure: Glasgow Outcome Scale (GOS） measure: Questionnaire EuroQol Five Dimensions Questionnaire (EQ-5D) measure: Barthel Index for Activities of Daily Living (BI) measure: Total hospitalized time measure: Total hospitalized costs measure: Cerebral vasospasm (CV) measure: Delayed cerebral ischemia (DCI) measure: Death measure: Hydrocephalus measure: Rebleeding measure: Subarachnoid hemorrhage volume clearance measure: Correlationship between cerebralspinal fluid pressure with subarachnoid hemorrhage volume measure: Correlationship between clinical grades and subarachnoid hemorrhage volume sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Second Affiliated Hospital of Nanchang University status: RECRUITING city: Nanchang state: Jiangxi zip: 330006 country: China name: Xingen Zhu, MS role: CONTACT email: zxg2008vip@163.com lat: 28.68396 lon: 115.85306 hasResults: False
|
<|newrecord|> nctId: NCT06284629 id: PD-DigiCare briefTitle: Enhancing Referral Decision-making for Advanced Treatment in Parkinson's Disease Through Objective Measurements and Patient Reported Outcomes. acronym: PD-DigiCare overallStatus: NOT_YET_RECRUITING date: 2024-09-01 date: 2026-09-01 date: 2026-09-01 date: 2024-02-29 date: 2024-04-22 name: Rigshospitalet, Denmark class: OTHER name: Odense University Hospital name: Zealand University Hospital briefSummary: The overall aim of the trial is to compare the efficacy of using wearables and patient-reported outcome measures versus standard care in enhancing the timeliness of referrals to advanced monitoring of treatments for people with Parkinson's Disease. conditions: Parkinson Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE maskingDescription: Participants and physicians will be blinded to device and app data in the control group. Blinding of the group allocation is not possible due to the investigated device. count: 90 type: ESTIMATED name: Neptune name: Standard clinical care measure: Differences between groups in algorithm-based motor symptom burden (time spent in the ON state without dyskinesias) at referral to evaluation for advanced treatment. measure: Differences in questionnaire data from baseline (inclusion visit) to end-of-intervention. measure: Differences in questionnaire data from baseline (inclusion visit) to end-of-intervention. measure: Changes in type of, frequency and dose of medication (calculated Levodopa Equivalent Dose, LED, by use of Tomlinson's scale) measure: Differences in questionnaire data from baseline (inclusion visit) to end-of-intervention. measure: Differences in questionnaire data from baseline (inclusion visit) to end-of-intervention. measure: Differences in questionnaire data from baseline (inclusion visit) to end-of-intervention. measure: Differences in questionnaire data from baseline (inclusion visit) to end-of-intervention. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Rigshospitalet Glostrup city: Glostrup zip: 2600 country: Denmark name: Nikolaj la Cour Karottki, MD role: CONTACT phone: 40432773 email: nikolaj.folke.la.cour.karottki.01@regionh.dk lat: 55.6666 lon: 12.40377 facility: Odense University Hospital city: Odense country: Denmark name: Morten Blaabjerg, MD role: CONTACT lat: 55.39594 lon: 10.38831 facility: Zealand University Hospital, Roskilde city: Roskilde country: Denmark name: Helle Thagesen, MD role: CONTACT lat: 55.64152 lon: 12.08035 hasResults: False
|
<|newrecord|> nctId: NCT06284616 id: K2019-0392 briefTitle: JASP-1 for Children Recently Diagnosed and Their Parents acronym: JASP-1 overallStatus: COMPLETED date: 2019-08-15 date: 2023-04-15 date: 2023-12-31 date: 2024-02-29 date: 2024-03-06 name: Region Stockholm class: OTHER_GOV briefSummary: To implement and evaluate a patient-and family-centered Juvenile Arthritis Support Program during one year (JASP-1) for children recently diagnosed with JIA and their parents and after 12 months compare satistaction with care and health outcomes with a control group receiving standard care. conditions: JIA conditions: Support Program conditions: Patient Satisfaction conditions: Patient Outcome Assessment studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The study is a non-randomized intervention study with 2 groups receiving either a Support program (JASP-1) or standard care primaryPurpose: SUPPORTIVE_CARE masking: NONE maskingDescription: All patient receiving a JIA diagnose was offered to participate in JASP-1. The controls had received diagnose before the start of the study. count: 82 type: ACTUAL name: JASP-1 measure: Rate of Patient Reported Experienced Measures (PREM) measure: Rate of Overall perceived health measure: Rate of Child Health Activity Questionnaire (CHAQ) measure: Number of active joints sex: ALL minimumAge: 1 Year maximumAge: 16 Years stdAges: CHILD facility: Astrid Lindgren Children´s Hospital city: Stockholm state: Region Stockholm zip: 17176 country: Sweden lat: 59.33258 lon: 18.0649 hasResults: False
|
<|newrecord|> nctId: NCT06284603 id: AWF_LA_HBOT briefTitle: Effectiveness of Hyperbaric Oxygen Therapy in Adults overallStatus: COMPLETED date: 2022-03-01 date: 2023-12-20 date: 2023-12-20 date: 2024-02-29 date: 2024-02-29 name: Poznan University of Physical Education class: OTHER briefSummary: The goal of this controlled, experimental study is to learn about the effects of 10 sessions of hyperbaric oxygen therapy on physical performance, vascular circulation, biochemical parameters, and composition of the intestinal microbiota in young healthy men depending on the frequency of single treatments.
|
The main questions it aims to answer are:
|
1. Do 10 treatments of hyperbaric oxygen therapy induce significant changes in physical performance levels, vascular circulation, and concentrations of biochemical parameters in young, healthy men?
|
2. Does the body's response to 10 treatments of hyperbaric oxygen therapy differ depending on the frequency of treatments?
|
3. Does a series of hyperbaric oxygen therapy treatments induce significant changes in the composition of the intestinal microbiota, metabolome, and functional status of the intestines?
|
Participants are exposed to hyperoxia under hyperbaric conditions or form a control group with no treatment. conditions: Healthy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Two study groups (dependent on frequency of HBOT treatments) and control group primaryPurpose: TREATMENT masking: NONE count: 80 type: ACTUAL name: Hyperbaric Oxygen Therapy - HBOT measure: Volume of oxygen and carbon dioxide measure: Heart rate measure: Vascular circulation measures measure: Body composition (body mass, fat mass, lean body mass, muscle mass) measure: Inflammatory cytokine profile measure: Oxidative stress indicators measure: F2-Isoprostanes (F2-IsoP) measure: Brain-derived neurotrophic factor concentration (BDNF) measure: Nicotinamide (NAD) metabolites measure: Gut microbiome and metabolome measure: Indicators of intestinal inflammation (fecal calprotectin, claudin, occludin, zonulin, sIgA) measure: endothelial nitric oxide synthase (eNOS) measure: Vascular endothelial growth factor (VEGF) measure: Hypoxia inducible factor-1 (HIF-1alfa) sex: MALE minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: Poznan University of Physical Education city: Poznan state: Wielkopolska zip: 61-871 country: Poland lat: 52.40692 lon: 16.92993 hasResults: False
|
<|newrecord|> nctId: NCT06284590 id: PH-ICKPD1-02/21 id: MK-3475-F20 type: OTHER domain: Merck Sharp & Dohme LLC id: KEYNOTE-F20 type: OTHER domain: missing briefTitle: Study of the Efficacy of Intratumoral L19IL2 or L19TNF or L19IL2/L19TNF, in Combination With Pembrolizumab, in Unresectable Melanoma Patients acronym: INTACT/MeRCI overallStatus: ACTIVE_NOT_RECRUITING date: 2023-12-19 date: 2028-07 date: 2028-07 date: 2024-02-29 date: 2024-04-08 name: Philogen S.p.A. class: INDUSTRY name: Merck Sharp & Dohme LLC briefSummary: The trial aims to evaluate the efficacy of single agent L19IL2, single agent L19TNF, and combination L19IL2+L19TNF given concurrently with anti-PD1 therapy compared to historical control of anti-PD-1 re-challenge alone for anti-PD1 refractory unresectable stage III-IV melanoma. conditions: Melanoma Stage III conditions: Melanoma Stage IV studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: 162 patients. Patients enrolled will be randomized in a 1:1:1 ratio. i) systemic pembrolizumab in combination with intralesional L19IL2 (Arm 1): 54 patients.
|
ii) systemic pembrolizumab in combination with intralesional L19TNF (Arm 2): 54 patients iii) systemic pembrolizumab in combination with intralesional L19IL2/L19TNF (Arm 3): 54 patients primaryPurpose: TREATMENT masking: NONE count: 162 type: ESTIMATED name: L19IL2 name: L19TNF name: L19IL2/L19TNF name: KEYTRUDA® measure: Confirmed Objective Response Rate (ORR) measure: Best overall response (BOR) measure: Duration of Response (DoR) measure: Pathological response measure: Confirmed ORR measure: Progression-free survival (PFS) measure: Overall survival (OS) measure: Serious Adverse Event (SAEs) measure: Drug-Induced Liver Injury (DILI) measure: Number of patients with Adverse Events of Special Interest (AESI) measure: Number of patients with Immune-Related Adverse Events (IRAEs) measure: Number of participants with abnormal hematology laboratory tests results measure: Number of participants with abnormal hematology laboratory tests results measure: Number of participants with abnormal hematology laboratory tests results measure: Number of participants with abnormal hematology laboratory tests results measure: Number of participants with abnormal serum chemistry laboratory tests results measure: Number of participants with abnormal serum chemistry laboratory tests results measure: Number of participants with abnormal serum chemistry laboratory tests results measure: Number of participants with abnormal serum chemistry laboratory tests results measure: Number of participants with abnormal serum chemistry laboratory tests results measure: Number of participants with abnormal coagulation laboratory tests results measure: Number of participants with abnormal body temperature measure: Number of participants with abnormal blood pressure measure: Number of participants with abnormal Electrocardiogram (ECG) readings measure: Number of participants with abnormal Echocardiogram (ECHO) readings measure: Number of participants with abnormal physical examination results measure: Concomitant medication usage measure: Assessment of the formation of human anti-fusion protein antibodies (HAFA) against L19IL2 and L19TNF sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Memorial Sloan Kettering Cancer Center city: New York state: New York zip: 10065 country: United States lat: 40.71427 lon: -74.00597 hasResults: False
|
<|newrecord|> nctId: NCT06284577 id: 677186 briefTitle: Quality of Life and Gut Health in Pediatric Patients With Cystic Fibrosis overallStatus: RECRUITING date: 2024-01-02 date: 2027-06-01 date: 2027-07-01 date: 2024-02-29 date: 2024-02-29 name: Oslo University Hospital class: OTHER briefSummary: The aim of the present study is to investigate the effect of probiotic supplementation on GI related quality of life, through a randomised placebo-controlled clinical trial. Moreover, the invetigators wish to study CF microbiota and intestinal inflammation in the setting of probiotic supplementation and newly started treatment with a highly effective CF-specific treatment, elexacaftor-tezacaftor-ivacaftor (ETI). The proposed project has the potential to increase QoL and decrease GI morbidity in children with CF. If successful, the results of this study can contribute to alter the care of CF patients by including supplementation of probiotics in routine CF care. Morever, the study can provide much needed insights to GI microbiota and inflammation in pediatric CF patients. conditions: Cystic Fibrosis in Children studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 40 type: ESTIMATED name: Multistrain Probiotic name: Placebo - maltodextrin measure: Changes in GI related QoL using the questionnaire PedsQL GI measure: Changes in microbiota measure: Changes in intestinal inflammation sex: ALL minimumAge: 2 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Oslo University Hospital status: RECRUITING city: Oslo country: Norway name: Magnhild P Kolsgaard, PhD role: CONTACT phone: 0047 41514045 email: uxpoma@ous-hf.no name: Camilla Styffe Sæland, Master role: CONTACT phone: 004793257798 email: casael@ous-hf.no name: Magnhild P Kolsgaard, PhD role: PRINCIPAL_INVESTIGATOR name: Camilla Styffe Sæland, Master role: SUB_INVESTIGATOR name: Linh Dieu Ngo, Master role: SUB_INVESTIGATOR lat: 59.91273 lon: 10.74609 hasResults: False
|
<|newrecord|> nctId: NCT06284564 id: 2023-0538 id: NCI-2024-03604 type: OTHER domain: NCI-CTRP Clinical Registry briefTitle: A Phase II Study Bolstering Outcomes by Optimizing Immunotherapy Strategies With Evolocumab and Nivolumab in Patients With Metastatic Renal Cell Carcinoma (BOOST-RCC) overallStatus: NOT_YET_RECRUITING date: 2024-09-30 date: 2024-10-01 date: 2026-10-01 date: 2024-02-29 date: 2024-04-26 name: M.D. Anderson Cancer Center class: OTHER name: Bristol-Myers Squibb name: Cancer Prevention Research Institute of Texas name: United States Department of Defense briefSummary: To learn if evolocumab and nivolumab can control metastatic and refractory renal cell carcinoma. The safety of this drug combination will also be studied. conditions: Metastatic Renal Cell Carcinoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: Evolocumab name: Nivolumab measure: Safety and adverse events (AEs) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: MD Anderson Cancer Center city: Houston state: Texas zip: 77030 country: United States name: Eric Jonasch, MD role: CONTACT phone: 713-563-7232 email: ejonasch@mdanderson.org name: Eric Jonasch, MD role: PRINCIPAL_INVESTIGATOR lat: 29.76328 lon: -95.36327 hasResults: False
|
<|newrecord|> nctId: NCT06284551 id: 202111069RINB briefTitle: The Relationship Between Internet-use Behavior and Mental Health in Youth overallStatus: ENROLLING_BY_INVITATION date: 2022-02-08 date: 2024-02-15 date: 2025-01-27 date: 2024-02-29 date: 2024-02-29 name: National Taiwan University Hospital class: OTHER briefSummary: Introduction: WHO defines youth as 15-24 years age group. At this stage, the brain is still under development, with high impulsiveness, being fond of stimulation and yearning for peer life. Compared with traditional interpersonal interaction, modern youths use the Internet as a main interpersonal interaction platform and conduct lots of leisure activities on the Internet. Poor cognitive emotion regulation strategies and personal traits may extend to new types of mental health issues; and are associated with depression, anxiety, suicidal/self-injurious behaviors, and cyberbullying.
|
Objectives: (1) To investigate whether emotion regulation strategies while facing stressful events are highly related to with cyberbullying, social media, and internet gaming disorder. (2) To investigate the relation between cyberbullying and depression, anxiety, suicide/self-injury among Taiwanese youths. (3) To investigate the probability of cyberbullying, social media addiction, and internet gaming disorder occurring at the same time.
|
Method: This cross-sectional study recruits cases of youths from 15 to 24 years old and collects data through questionnaires survey. In addition to collection of basic data, Internet using habits, and medical history, self-rated questionnaires include Suicide/Self-Injury Ideation Questionnaire, The Beck Depression Inventory 2nd Edition, Multidimensional Anxiety Scale for Children-Taiwan version, Cognitive Emotion Regulation Questionnaire, Cyberbullying Questionnaire, and Internet Gaming Disorder Scale-Short Form. conditions: Mental Health Issue studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 50 type: ESTIMATED measure: Cyberbullying Questionnaire measure: Beck's Depression Inventory (BDI-II) sex: ALL minimumAge: 15 Years maximumAge: 24 Years stdAges: CHILD stdAges: ADULT facility: National Taiwan University Hospital city: Taipei country: Taiwan lat: 25.04776 lon: 121.53185 hasResults: False
|
<|newrecord|> nctId: NCT06284538 id: NA-01-23 briefTitle: Study to Evaluate the Effectiveness of a Medical Device Based on Hyaluronic Acid in Wounds acronym: WOUND-H overallStatus: RECRUITING date: 2024-01-15 date: 2024-07-31 date: 2024-09-30 date: 2024-02-29 date: 2024-02-29 name: Nova Argentia S.r.l. class: INDUSTRY briefSummary: The primary objective of the study is to evaluate the safety and performance of a Class IIB medical device based on linear hyaluronic acid used in the treatment of post-surgical wounds. The outcomes of the study are the improvement of wound healing assessed through the Clinical Healing score (score from 0 to 5), which includes the evaluation of: redness, edema, suppuration, healthy granulation tissue and signs of re-epithelialization; the percentage of patients with completely healed wounds at day 30 post-treatment; the pain perceived by the patient when changing the dressing; the frequency of adverse events. conditions: Wound Healing Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 112 type: ESTIMATED name: NOVA.EMOSTOP RE-EPITHELIZING measure: improvement in Clinical Healing score at visit 3 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Casa di cura riabilitativa Villa Sofia status: RECRUITING city: Acireale state: Catania zip: 95024 country: Italy name: Marco Daniele, PI role: CONTACT phone: 0957631997 email: marcodaniele@email.it name: Salvatore Balsamo role: SUB_INVESTIGATOR lat: 37.60886 lon: 15.16577 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2023-06-26 uploadDate: 2024-02-13T04:55 filename: Prot_SAP_000.pdf size: 2091803 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2023-04-02 uploadDate: 2024-02-21T04:35 filename: ICF_001.pdf size: 95177 hasResults: False
|
<|newrecord|> nctId: NCT06284525 id: 2137420 briefTitle: Ankle Assistance and Resistance in Older Adults overallStatus: RECRUITING date: 2023-02-01 date: 2025-01 date: 2025-01 date: 2024-02-29 date: 2024-02-29 name: Northern Arizona University class: OTHER briefSummary: The goal of this research protocol is to improve mobility in older individuals through advances in wearable assistive devices by focusing on two specific aims. The first aim is to study if targeted ankle resistance gait training improves walking performance in older individuals. The second aim is to evaluate the potential of wearable assistance at the ankle, knee, and/or hip joints to increase walking performance in older individuals. conditions: Sarcopenia studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 8 type: ESTIMATED name: Ankle resistance and biofeedback measure: 6MWT measure: Metabolic power measure: Plantar flexor strength sex: ALL minimumAge: 65 Years maximumAge: 85 Years stdAges: OLDER_ADULT facility: Northern Arizona University status: RECRUITING city: Flagstaff state: Arizona zip: 86011 country: United States name: Zach Lerner, PhD role: CONTACT phone: 928-523-1787 email: zachary.lerner@nau.edu lat: 35.19807 lon: -111.65127 hasResults: False
|
<|newrecord|> nctId: NCT06284512 id: Uveal Melanoma 1942/2022 briefTitle: Uveal Melanoma - Comparative Study overallStatus: RECRUITING date: 2023-10-15 date: 2024-12-31 date: 2024-12-31 date: 2024-02-29 date: 2024-02-29 name: Medical University of Vienna class: OTHER briefSummary: The progress of uveal melanoma is typically monitored with sonography by experienced onco-ophthalmologists. However, there is evidence that twodimensional measurements in color fundus photography match precisely with sonography measurements. This study aims to compare sonography and color fundus photography measurements in order to evaluate the feasibility of monitoring of uveal melanoma with color fundus photography. conditions: Uveal Melanoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 50 type: ESTIMATED name: Sonography, color fundus photography measure: Largest Basal Diameter sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Medical University of Vienna, Department of Ophthalmology and Optometry status: RECRUITING city: Vienna zip: 1090 country: Austria name: Judith Kreminger, MD role: CONTACT phone: +4314040048470 email: judith.kreminger@meduniwien.ac.at name: Reinhard Told, MD, PhD, Priv.-Doz. role: CONTACT phone: +434040079690 email: reinhard.told@meduniwien.ac.at name: Adrian Reumueller, MD, Priv.-Doz role: SUB_INVESTIGATOR name: Roman Dunavölgyi, Assoc.-Prof. Priv.-Doz. Dr. role: SUB_INVESTIGATOR lat: 48.20849 lon: 16.37208 hasResults: False
|
<|newrecord|> nctId: NCT06284499 id: 26308819120 briefTitle: Effect of Different Fixed Lingual Retainers on Tooth Stability overallStatus: WITHDRAWN date: 2020-01-16 date: 2023-01-15 date: 2023-10-13 date: 2024-02-29 date: 2024-02-29 name: Mustafa Kemal University class: OTHER briefSummary: Objective: The aim of this study was to compare the effect of different fixed lingual retainers (LRs) on tooth stability after orthodontic treatment using a Periotest® device.
|
Materials and methods: A total of 82 patients (43 females and 39 males; mean age = 18.61 ± 3.71 years) with no missing teeth in the lower inter-canine region were treated with fixed orthodontic mechanics. At the completion of the orthodontic treatment, each patient was fitted with either Ortho FlexTech (Reliance; Group I), dead soft 8-braided (Bond-A-Braid, Reliance; Group II), or 5-stranded (PentaOne, Masel; Group III) LR wire. A control group consisting of people with a healthy periodontal condition and no bone loss was included (Control; Group C). The mobility of the lower anterior teeth on the right and left sides was measured using a Periotest® device before (T0), immediately after (T1), and 10 months after (T2) the application of the LR. Statistical analyses were performed using one-way ANOVA followed by post hoc LSD, repeated ANOVA with Bonferroni post hoc test, and Pearson χ2 tests. conditions: Effect of Lingual Retainers on Tooth Stability studyType: OBSERVATIONAL observationalModel: CASE_CROSSOVER timePerspective: PROSPECTIVE count: 0 type: ACTUAL name: measuring tooth stability after orthodontic treatment using a Periotest® device. measure: Assessment of tooth stability after orthodontic lingual retainer wire application using periotest device sex: ALL minimumAge: 14 Years maximumAge: 20 Years stdAges: CHILD stdAges: ADULT facility: Hatay Mustafa Kemal University, Faculty of Dentistry city: Hatay zip: 31060 country: Turkey lat: 38.40227 lon: 27.10486 hasResults: False
|
<|newrecord|> nctId: NCT06284486 id: 2023-0794 id: NCI-2024-01721 type: OTHER domain: NCI-CTRP Clinical Registry briefTitle: A Multi-Site Break Through Cancer Trial: Phase II Study Investigating Dual Inhibition of BCL2 and Menin in AML MRD Using the Combination of Venetoclax and Revumenib overallStatus: NOT_YET_RECRUITING date: 2024-07-31 date: 2026-12-30 date: 2028-12-30 date: 2024-02-29 date: 2024-03-27 name: M.D. Anderson Cancer Center class: OTHER name: Syndax Pharmaceuticals name: Break Through Cancer name: AbbVie briefSummary: To learn if the combination of venetoclax and revumenib can help to control MRD-positive AML. conditions: Acute Myeloid Leukemia studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 8 type: ESTIMATED name: Venetoclax name: Revumenib measure: Safety and adverse events (AEs) sex: ALL minimumAge: 12 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: MD Anderson Cancer Center city: Houston state: Texas zip: 77030 country: United States name: Ghayas Issa, MD role: CONTACT phone: 713-745-6798 email: gcissa@mdanderson.org name: Ghayas Issa, MD role: PRINCIPAL_INVESTIGATOR lat: 29.76328 lon: -95.36327 hasResults: False
|
<|newrecord|> nctId: NCT06284473 id: 212154 briefTitle: Ketamine as a Supplement to Local Anesthesia for Minor Procedures acronym: INK-MP overallStatus: RECRUITING date: 2022-05-25 date: 2025-05-31 date: 2025-05-31 date: 2024-02-29 date: 2024-03-15 name: Loyola University class: OTHER briefSummary: This trial is a double-blind randomized controlled clinical trial of adults and children (ages 7 to less than 70 years). Patients who present to the ED and who undergo minor bedside procedures that require local anesthesia will be divided into two groups: The first group will be treated with 0.7 mg/kg intranasal ketamine as well as standard local anesthesia for the procedure (treatment cohort). The second group will be treated with a volume-based dose of intranasal saline solution as well as standard local anesthesia for the procedure (control cohort). The primary aim is to assess whether patients in the treatment cohort report lower pain scores on the Numerical Rating Scale (NRS-100) when compared to patients in the control cohort. For adult patients, a secondary aim is to compare agitation between the two cohorts using the Richmond Agitation Sedation Scale (RASS) and, for pediatric patients, a secondary aim is to compare alertness between the two cohorts using the University of Michigan Sedation Scale (UMSS).
|
Results obtained from specific procedures will be analyzed on a spectrum of complexity and general length of recovery time. Scientific achievements may include finding a safe and effective way to reduce pain and discomfort during minor procedures in the Emergency Department. Additionally, it would provide opportunities for more research on sub-dissociative doses of ketamine during minor procedures: a topic in which there is still a gap in the published research conditions: Pain, Procedural conditions: Minor Laceration conditions: Abscess studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Patients presenting to the emergency department at Loyola University Medical Center for a minor medical procedure requiring local anesthesia will be randomly assigned to receive either standard local anesthesia with 0.7 mg/kg intranasal ketamine before the procedure or to standard local anesthesia with volume-based dose saline before the procedure using a 1:1 random block allocation. primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: All participants and study personnel are blinded except for the clinical pharmacist who prepares the intervention. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 108 type: ESTIMATED name: Ketamine name: Saline measure: Immediate pain measure: Acute pain measure: Delayed pain measure: Immediate agitation measure: Acute agitation measure: Delayed agitation measure: Immediate alertness measure: Acute alertness measure: Delayed alertness sex: ALL minimumAge: 7 Years maximumAge: 70 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Loyola University Medical Center status: RECRUITING city: Maywood state: Illinois zip: 60153 country: United States name: Shannon Lovett, MD role: CONTACT phone: 847-951-2936 email: slovett@lumc.edu name: Trent Reed, DO role: CONTACT phone: 708-216-4117 email: treed1@lumc.edu lat: 41.8792 lon: -87.84312 hasResults: False
|
<|newrecord|> nctId: NCT06284460 id: 2022-0622 id: NCI-2024-01692 type: OTHER domain: NCI-CTRP Clinical Registry briefTitle: Phase I/II Study of a Combination of Decitabine and Cedazuridine (ASTX727) and ASTX029, an ERK Inhibitor, for Patients With RAS Pathway Mutant Myelodysplastic Syndromes and Myelodysplastic/Myeloproliferative Neoplasms overallStatus: NOT_YET_RECRUITING date: 2024-07-31 date: 2025-12-01 date: 2027-12-01 date: 2024-02-29 date: 2024-04-03 name: M.D. Anderson Cancer Center class: OTHER briefSummary: The goal of Part 1 of this clinical research study is to find the highest tolerable dose of ASTX029 that can be given in combination with ASTX727 to participants who have RAS-mutant MDS or MDS/MPN. The goal of Part 2 of this clinical research study is to learn if the dose of ASTX029 found in Part 1 can help to control the disease when used in combination with ASTX727. conditions: Pathway Mutant Myelodysplastic Syndromes conditions: Myelodysplastic Neoplasm conditions: Myeloproliferative Neoplasm studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 36 type: ESTIMATED name: ASTX029 name: ASTX727 measure: Safety and adverse events (AEs) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: MD Anderson Cancer Cente city: Houston state: Texas zip: 77030 country: United States name: Guillermo Montalban Bravo, MD role: CONTACT phone: 713-794-3604 email: gmontalban1@mdanderson.org name: Guillermo Montalban Bravo, MD role: PRINCIPAL_INVESTIGATOR lat: 29.76328 lon: -95.36327 hasResults: False
|
<|newrecord|> nctId: NCT06284447 id: 22-004500 id: NCI-2024-00181 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: 22-004500 type: OTHER domain: Mayo Clinic Institutional Review Board briefTitle: Barriers to Cervical Cancer Screening overallStatus: RECRUITING date: 2023-03-23 date: 2025-03-31 date: 2025-03-31 date: 2024-02-29 date: 2024-02-29 name: Mayo Clinic class: OTHER briefSummary: This study evaluates barriers to cervical cancer screening among non-compliant women. conditions: Cervical Carcinoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 200000 type: ESTIMATED name: Non-Interventional Study measure: Identify barriers to cervical cancer screening sex: FEMALE minimumAge: 21 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mayo Clinic in Rochester status: RECRUITING city: Rochester state: Minnesota zip: 55905 country: United States name: Clinical Trials Referral Office role: CONTACT phone: 855-776-0015 email: mayocliniccancerstudies@mayo.edu name: Brittany A. Strelow, DSMc, PA-C role: PRINCIPAL_INVESTIGATOR lat: 44.02163 lon: -92.4699 hasResults: False
|
<|newrecord|> nctId: NCT06284434 id: CHI2311 briefTitle: Liposomal Bupivacaine Use in Alveolar Bone Graft Patients overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2026-03 date: 2026-03 date: 2024-02-29 date: 2024-03-04 name: Kerry O'Rourke class: OTHER name: Shriners Hospitals for Children briefSummary: The goal of this clinical trial is to learn if a pain medication called liposomal bupivacaine (brand name EXPAREL®) with epinephrine will provide better pain control, increased activity, and reduced use of opioids compared with the standard treatment for patients age 6 years and older with cleft lip and palate who have had an alveolar bone graft surgery. Investigators will look at:
|
* pain scores at hip and jaw sites
|
* opioid use in amount and frequency
|
* scores on activity questionnaires Researchers will compare the results of these items with those of patients who had the standard treatment of bupivacaine with epinephrine. conditions: Cleft Lip and Palate studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The design of this study is a randomized control trial, double-blinded. Patients who meet criteria and consent will be randomized to receive LB or standard bupivacaine. primaryPurpose: SUPPORTIVE_CARE masking: TRIPLE maskingDescription: Surgeons and patients will be unaware of which cohort the subject will be randomized to be part of. The pharmacist, anesthesiologist, and research coordinator may all be aware of which drug is administered. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 60 type: ESTIMATED name: Liposomal Bupivacaine name: Bupivacain name: Epinephrine measure: Visual Analog Pain Scores measure: Opioid Use measure: PROMIS Pediatric Mobility Questionnaire sex: ALL minimumAge: 6 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
|
<|newrecord|> nctId: NCT06284421 id: IRB23-1068 briefTitle: Durometer for Measuring Uterine Tone overallStatus: RECRUITING date: 2024-02-08 date: 2024-06-30 date: 2024-09-30 date: 2024-02-29 date: 2024-03-01 name: University of Chicago class: OTHER briefSummary: This study will evaluate the use of a durometer to measure uterine tone in parturients undergoing cesarean delivery. conditions: Uterine Tone Disorders conditions: Cesarean Section Complications studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DEVICE_FEASIBILITY masking: NONE count: 20 type: ESTIMATED name: Shore durometer measure: feasibility of a durometer measure: durometer reading measure: durometer reading measure: durometer reading measure: correlation of durometer reading with a 0-10 uterine tone rating score (0= "no tone"; 10= "excellent tone") measure: correlation of durometer reading with a 0-10 uterine tone rating score (0= "no tone"; 10= "excellent tone") measure: correlation of durometer reading with a 0-10 uterine tone rating score (0= "no tone"; 10= "excellent tone") sex: FEMALE minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: University of Chicago status: RECRUITING city: Chicago state: Illinois zip: 60637 country: United States name: Naida M Cole, MD role: CONTACT phone: 773-702-6700 email: nmcole@bsd.uchicago.edu name: Somayeh Mohammadi role: CONTACT phone: 17738343274 email: mohammadis@bsd.uchicago.edu lat: 41.85003 lon: -87.65005 hasResults: False
|
<|newrecord|> nctId: NCT06284408 id: 2024-15683 briefTitle: Centralized Screening Unit (CSU) at Montefiore-Einstein overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2028-12 date: 2028-12 date: 2024-02-29 date: 2024-03-04 name: Albert Einstein College of Medicine class: OTHER name: American Cancer Society, Inc. briefSummary: This study proposes to increase Lung-cancer screening (LCS) in the Bronx, New York. Despite strong evidence that Lung-cancer screening (LCS) can reduce Lung cancer (LCa) deaths, low-dose computed tomography (LDCT) referral rates by clinicians are very low and there is poor adherence with LCS by patients. Both provider and patient barriers may be amenable to systemic improvements in support, coordination and infrastructure for screening. The investigator team hypothesizes that the implementation of a Central Screening Unit (CSU) that shifts routine workflow attributed to LCS (e.g., collection of smoking history, determination of eligibility, shared decision making and arranging follow-up) away from busy practices (usual care) and that offers patients an array of navigation and support services will increase the uptake of LCS guidelines and subsequent low-dose computed tomography (LDCT) screening scans in a low-income, predominately Hispanic and Black catchment area. The proposed study represents a unique opportunity to test this hypothesis in the context of the roll out of a CSU as a significant new component of the Montefiore-Einstein health system. The investigator team will examine whether and how the CSU facilitates LCS uptake and retention of patients. This study is powered to test whether CSU reduces proportion of late-stage lung cancer diagnoses in the Bronx, New York. conditions: Lung Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Systems-level intervention which using a mixed study design including stepped-wedge with a cluster randomized arm within the stepped-wedge. The implementation and evaluation of the CSU will be accomplished using cluster randomization to select 24 sites to be phased-into the CSU intervention according to a stepped-wedge design. Randomization will take place at the clinic level. The clinic clusters will be brought 'online' in a graded manner over the study period. 24 of the 35 NYC RING sites will be selected to enter the experimental (CSU) condition in three waves: Month 6, Month 12, or Month 18 after the start of the study. The remaining 11 sites will receive CSU support after completion of the third randomized group of clinics primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 9460 type: ESTIMATED name: Centralized Screening Unit Implementation measure: Participant Referrals measure: Proportion of participants with early stage lung cancer (LCa) sex: ALL minimumAge: 50 Years maximumAge: 77 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Montefiore Medical Center's New York City Research and Improvement Networking Group (NYC RING) city: Bronx state: New York zip: 10467 country: United States name: Yocheved Halberstam, MPH role: CONTACT phone: 917-833-1070 email: yocheved.halberstam@einsteinmed.edu name: H. Dean Hosgood, PhD role: CONTACT phone: 203-215-3275 email: dean.hosgood@einsteinmed.edu lat: 40.84985 lon: -73.86641 hasResults: False
|
<|newrecord|> nctId: NCT06284395 id: HGM1471-002/24 briefTitle: Two Schemes Response in Multiple Myeloma overallStatus: RECRUITING date: 2023-11-20 date: 2024-03-20 date: 2024-03-30 date: 2024-02-28 date: 2024-02-28 name: Hospital General de Mexico class: OTHER_GOV briefSummary: Retrospective study based on medical records of patients with multiple myeloma, eligible for stem cell transplantation, who received, first-line, the VTD or TD combination. conditions: Response, Acute Phase conditions: Survivorship studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 83 type: ESTIMATED name: Bortezomib measure: Favorable Response measure: Time to next treatment measure: Overall survival sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital General de Mexico Dr. Eduardo Liceaga status: RECRUITING city: Mexico City state: Cdmx zip: 06720 country: Mexico name: Christian O Ramos Peñafiel, PhD role: CONTACT phone: 5523351588 email: leukemiachop33@gmail.com name: Adan G Gallardo Rodriguez role: CONTACT phone: +525584005072 email: nutriologo.agallardo8@gmail.com name: Juan M Cano Calderón, MD role: SUB_INVESTIGATOR name: Juan F Zazueta Pozos, MD role: SUB_INVESTIGATOR name: Adán G Gallardo Rodriguez, PhD role: SUB_INVESTIGATOR name: Carlos Martínez Murillo, PhD role: SUB_INVESTIGATOR name: Irma Olarte Carrillo, PhD role: SUB_INVESTIGATOR name: Adolfo Martínez Tovar, PhD role: SUB_INVESTIGATOR name: Christian O Ramos Peñafiel, PhD role: PRINCIPAL_INVESTIGATOR lat: 19.42847 lon: -99.12766 hasResults: False
|
<|newrecord|> nctId: NCT06284382 id: 2022-A02736-37 briefTitle: Interaction Between Early Trauma and Odor-induced Dopamine Release acronym: T-ODOR overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2026-06-01 date: 2027-06-01 date: 2024-02-28 date: 2024-02-28 name: Hôpital le Vinatier class: OTHER briefSummary: This prospective, double-blind, parallel-group controlled trial aims to investigate the consequence of early trauma on dopamine release evoked by positive valence odors. conditions: Trauma, Psychological studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a prospective, single-center, double-blind, parallel-group controlled trial with two arms. primaryPurpose: BASIC_SCIENCE masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 30 type: ESTIMATED name: High score at Childhood Trauma Questionnaire. name: Low score at Childhood Trauma Questionnaire. measure: Dopamine transmission measured with positron emission tomography measure: Odor hedonic appreciation. measure: Functional brain connectivity. measure: Effective brain connectivity sex: ALL minimumAge: 18 Years maximumAge: 30 Years stdAges: ADULT hasResults: False
|
<|newrecord|> nctId: NCT06284369 id: Mongolia briefTitle: Video Messages for Smoking Cessation Campaign overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-03 date: 2025-04 date: 2024-02-28 date: 2024-03-04 name: Loma Linda University class: OTHER briefSummary: 240 adult smokers will be recruited. Subjects will be asked to view video messages that encourage smoking cessation. The effect of these videos will be assessed. conditions: Smoking Cessation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE maskingDescription: Participants don't know which video each subject is randomized to whoMasked: PARTICIPANT count: 240 type: ESTIMATED name: Developing, Evaluating and Testing Video Messages for a Smoking Cessation Campaign name: Health Message Framing measure: Message Engagement measure: Readiness to Quit Smoking sex: ALL minimumAge: 18 Years maximumAge: 64 Years stdAges: ADULT hasResults: False
|
<|newrecord|> nctId: NCT06284356 id: IRB Session 2022/14 Protocol 6 briefTitle: Pan Immune Inflammation Value for Perioperative Complications of Laparoscopic Sleeve Gastrectomy overallStatus: COMPLETED date: 2022-05-01 date: 2023-05-01 date: 2023-05-01 date: 2024-02-28 date: 2024-03-01 name: Kahramanmaras Sutcu Imam University class: OTHER name: Elazig Special Eastern Anatolian Hospital briefSummary: Morbid obesity emerges as a problem that causes serious complications and increased mortality rates. The most effective treatment for morbid obesity today is surgical treatment. The most preferred type of surgery in morbid obesity surgery in Turkey and around the world is Laparoscopic Sleeve Gastrectomy (LSG).
|
While postoperative complications are divided into early and late complications, complications that develop during surgery and in the postoperative period before discharge are defined as perioperative complications. Early surgical complications after LSG include complications such as staple line bleeding, leaks, pulmonary thromboembolism, and torsion of the remnant stomach. It is important to detect these complications, which can be controlled with early intervention in the perioperative period.
|
Monitoring blood parameters and monitoring inflammation are methods that are easily accessible and provide rapid evaluation. Platelet lymphocyte ratio (PLR) and neutrophil-lymphocyte ratio (NLR), which are used in the evaluation and detection of postoperative complications, have shed light on studies in this direction. Pan immune inflammation value (PIV) is calculated from blood parameters and has been used to evaluate prognosis and chemotherapy results in colorectal cancer.
|
In this study, the diagnostic importance of changes in NLR, PLR, and PIV values in the preoperative and postoperative periods will be investigated in detecting complications that develop in the perioperative period before discharge in patients who underwent LSG. conditions: Morbid Obesity conditions: Laparoscopic Sleeve Gastrectomy conditions: Post Operative Complicaiton studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 159 type: ACTUAL name: Laparoscopic Sleeve Gastrectomy measure: Complication prediction after LSG with complete blood cell parameters sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Kahramanmaras SIU city: Kahramanmaraş zip: 46000 country: Turkey lat: 37.5847 lon: 36.92641 hasResults: False
|
<|newrecord|> nctId: NCT06284343 id: 6414 briefTitle: Development and Validation of a Risk Prediction Model for Venous Thromboembolism in Gynecological Cancer Patients Undergoing Systemic Antineoplastic Treatment: The Gynecological Cancer Associated Thrombosis (GynCAT) Study acronym: GynCAT overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-09-30 date: 2026-09-30 date: 2024-02-28 date: 2024-02-28 name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS class: OTHER name: Fondazione Umberto Veronesi briefSummary: Cancer patients are burdened by an increased risk of venous thromboembolism (VTE), which has a significant impact on morbidity and mortality. Existing Risk Prediction Models (RPMs), including the widely accepted Khorana Risk Score (KRS), have some limitations when used in certain tumor site populations, such as gynecological cancers. Notably, gynecological patients exhibit a variable risk of VTE based on their specific tumor sites, with ovarian cancer representing the highest risk. Moreover, currently available RPMs lack validation in a broad gynecological population and may fail to effectively stratify VTE risk.
|
GynCAT is a prospective cohort study that will be conducted on female patients with gynecologic malignancies scheduled for systemic antineoplastic treatment. During the screening phase, symptomatic VTE will be excluded, and KRS will be assessed. Pharmacological thromboprophylaxis will be considered and prescribed at clinical judgement, for patients with a KRS score of 3 or higher. Clinical, hematological, biochemical, coagulation, and genetic variables will be collected. Follow-up will last for the entire duration of the antineoplastic treatment line, and VTE events, bleeding events, and mortality will be recorded.
|
The primary objective is the development and validation of an RPM for VTE in gynecologic cancer patients undergoing systemic antineoplastic treatment. Secondary objectives are evaluation of the predictive value of the identified model, comparing it with existing general oncology RPMs; assessment of its performance in predicting mortality; evaluation of VTE incidence in patients with KRS≥3 receiving thromboprophylaxis; identification of risk factors for bleeding in this patient population.
|
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.