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<\|newrecord\|> nctId: NCT06324162 id: JagiellonianU Gibas-Stanek briefTitle: Does the Pain Experienced During Orthodontic Treatment and Bracket Removal Depend on the Architecture of the Bracket? acronym: Debonding overallStatus: COMPLETED date: 2021-10-01 date: 2023-05-01 date: 2023-05-01 date: 2024-03-21 date: 2024-03-21 name: Piotr Fudalej class: OTHER briefSummary: The present research aimed to thoroughly investigate the impact of bracket architecture on pain perception during active treatment, debonding, and adhesive removal. conditions: Debonding conditions: Orthodontic Brackets studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: NONE count: 100 type: ACTUAL name: bracket removal pliers, LODI measure: Pain during active treatment measure: Pain during brackets removal measure: Pain on adhesive removal sex: ALL minimumAge: 12 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Jagiellonian University Collegium Medicum city: Kraków zip: 31-008 country: Poland lat: 50.06143 lon: 19.93658 hasResults: False
<\|newrecord\|> nctId: NCT06324149 id: AGE-IT-FRAILTY briefTitle: Age-related Conditions in the Context of Multimorbidity and Frailty: Relative Weight of Frailty in Determining the Course and Outcomes of Different Chronic Diseases and Viceversa acronym: AGE-IT-FRAILTY overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-02-28 date: 2026-04-30 date: 2024-03-21 date: 2024-03-21 name: IRCCS San Raffaele class: OTHER briefSummary: Observational study. Participants of the FRASNET study (9th March 2017, Protocol No. 24/INT/2017) who were evaluated in 2016 and 2017 will be contacted to be re-evaluated with multidimensional visits as part of the present study in order to assess trajectories and biomarkers of frailty and sarcopenia. Moreover, are going to evaluate with the same multidimensional visits patients with mild cognitive impairment and dementia followed up at the Neurologic Unit of the San Raffaele Hospital. conditions: Frailty conditions: Sarcopenia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 500 type: ESTIMATED name: completion of scales and questionnaires; venous blood sampling; muscle ultrasound; cardiac ultrasound; electrocardiogram; bioelectrical impedance analysis measure: identify new molecular markers of frailty and sarcopenia measure: evaluate the ability of new markers for frailty, sarcopenia, cognitive impairment sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: San Raffaele Hospital city: Milan country: Italy lat: 45.46427 lon: 9.18951 hasResults: False
<\|newrecord\|> nctId: NCT06324136 id: KIDNEY-PNRR briefTitle: Validation, Implementation, and Cost-analysis of a Strategy for Personalized Diagnosis of Rare Kidney Diseases overallStatus: RECRUITING date: 2023-07-06 date: 2026-07-31 date: 2026-12-30 date: 2024-03-21 date: 2024-03-21 name: Meyer Children's Hospital IRCCS class: OTHER briefSummary: Chronic kidney disease (CKD) affects about 10% of the world population, with high morbidity and mortality. Genetic kidney diseases are increasingly recognized across all age groups and represent over 20% of all the causes of CKD. Accurate diagnosis allows necessary and unnecessary diagnostic procedures to be defined, avoids unnecessary treatments, improves prognosis prediction, identifies other family members for genetic counseling, and defines risks for living donor kidney transplantation. The research group coordinated by the Principal Investigator has recently developed an algorithm for the genetic diagnosis in pediatric and adult patients with CKD. The application of this personalized diagnostic algorithm on a local study led to a global diagnostic yield of 70%, suggesting that this strategy has the potential to substantially improve the diagnostic approach to patients with rare kidney disorders. The aim of this study is to validate and implement these results by extending its application in a multicentric study involving nephrology units that are referral centers for rare kidney diseases at national level. conditions: Chronic Kidney Diseases studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 300 type: ESTIMATED name: Implementation of the diagnostic algorithm measure: Implementation of a diagnostic algorithm for personalized diagnosis of rare kidney diseases measure: Analysis of the functional role of variant of unknown clinical significance (VUS) measure: Identification of immunological and/or structural factors in genetic and nongenetic forms. measure: Cost-effectiveness of the diagnostic algorithm. sex: ALL minimumAge: 0 Years maximumAge: 70 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Meyer Children's Hospital IRCCS status: RECRUITING city: Firenze country: Italy name: Paola Romagnani role: CONTACT lat: 43.77925 lon: 11.24626 facility: Azienda Ospedaliero Universitaria Vanvitelli status: RECRUITING city: Napoli country: Italy name: Miriam Zacchia role: CONTACT lat: 40.85216 lon: 14.26811 facility: Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone status: RECRUITING city: Palermo country: Italy name: Santina Cottone role: CONTACT lat: 38.13205 lon: 13.33561 hasResults: False
<\|newrecord\|> nctId: NCT06324123 id: 23C304 briefTitle: Observational Study Aimed at Evaluating the Trend of Neuropathic Pain acronym: NEURATIL overallStatus: RECRUITING date: 2023-06-09 date: 2024-12-31 date: 2024-12-31 date: 2024-03-21 date: 2024-03-25 name: Istituto Auxologico Italiano class: OTHER briefSummary: The present study aims to evaluate the trend of neuropathic pain in patients treated with Peacetil for a period of two months.
Neuropathic pain will me assessed through the Numeric Rating Scale (NRS) questionnaire score. conditions: Neuropathic Pain studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 400 type: ESTIMATED name: Peacetil measure: Change in neuropathic pain after two months of treatment with Peacetil measure: Change in neuropathic pain after one month of treatment with Peacetil sex: ALL minimumAge: 18 Years maximumAge: 82 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Istituto Auxologico Italiano status: RECRUITING city: Milan state: Lombardy zip: 20149 country: Italy name: Luca Maderna, MD role: CONTACT phone: 0261911 email: l.maderna@auxologico.it name: Alberto Doretti, MD role: CONTACT phone: 0261911 phoneExt: 2937 email: neurotrial@auxologico.it lat: 45.46427 lon: 9.18951 facility: ASST Fatebenefratelli Sacco status: NOT_YET_RECRUITING city: Milano zip: 20157 country: Italy name: Fabrizio Gervasoni, MD role: CONTACT email: fabrizio.gervasoni@asst-fbf-sacco.it lat: 45.46427 lon: 9.18951 facility: Fondazione Don Carlo Gnocchi ONLUS status: NOT_YET_RECRUITING city: Milano country: Italy name: Angela Comanducci, MD role: CONTACT email: acomanducci@dongnocchi.it lat: 45.46427 lon: 9.18951 hasResults: False
<\|newrecord\|> nctId: NCT06324110 id: RG1124119 id: NCI-2024-01763 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: 20250 type: OTHER domain: Fred Hutch/University of Washington Cancer Consortium id: R01CA284032 type: NIH link: https://reporter.nih.gov/quickSearch/R01CA284032 briefTitle: Evaluating the Impact of Centralized Interventions on Lung Cancer Screening Adherence in Community Settings, ACCELL Trial overallStatus: NOT_YET_RECRUITING date: 2024-08-01 date: 2027-06-30 date: 2027-06-30 date: 2024-03-21 date: 2024-04-10 name: Fred Hutchinson Cancer Center class: OTHER name: National Cancer Institute (NCI) briefSummary: This clinical trial tests the impact of lung cancer screening care coordination interventions implemented at the system-level on lung cancer screening adherence in community settings. Lung cancer remains the leading cause of cancer death in the United States. Although lung cancer screening (LCS) with yearly low-dose chest computed tomography has the potential to decrease lung deaths, the use of this screening technique remains low. In addition, studies have shown that adherence to lung cancer screening in clinical settings is far lower that those found in clinical trials. Improved care coordination services that include comprehensive, system-wide tracking of screening outcomes for all LCS participants, results reporting with direct-to-patient information, direct patient and physician communication, and active reviews of non-adherent patients and stepped support interventions may increase patient adherence to LCS. Coordination services at the system-level may decrease barriers and improve adherence to lung cancer screening in community settings. conditions: Lung Carcinoma studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SCREENING masking: NONE count: 8658 type: ESTIMATED name: Electronic Health Record Review name: Interview name: Patient Navigation measure: Adherence to appropriate follow-up measure: Characteristics associated with adherence to follow up sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fred Hutch/University of Washington Cancer Consortium city: Seattle state: Washington zip: 98109 country: United States name: Tinnie Louie role: CONTACT phone: 206-667-3323 email: tlouie@fredhutch.org name: Matthew Triplette role: PRINCIPAL_INVESTIGATOR lat: 47.60621 lon: -122.33207 hasResults: False
<\|newrecord\|> nctId: NCT06324097 id: 2024-357 briefTitle: Diagnostic Value of Endocytoscopy for Colorectal Lesions overallStatus: RECRUITING date: 2024-04-01 date: 2024-05 date: 2024-05 date: 2024-03-21 date: 2024-04-18 name: Hong Xu class: OTHER briefSummary: Colorectal cancer (CRC) is the third most common malignancy and the second leading cause of cancer-related death worldwide. Colonoscopy is considered the preferred method of screening for colorectal cancer, and resection of colorectal lesions can significantly reduce the incidence and mortality of colorectal cancer. In order to improve the qualitative and quantitative diagnosis of colorectal lesions, many endoscopic techniques, such as image-enhanced endoscopy (IEE), including narrowband imaging (NBI), magnifying endoscopy, pigment endoscopy, confocal laser endoscopy, and endocytoscopy (EC) are applied clinically. The application of EC is intended to achieve the purpose of real-time histopathological endoscopic diagnosis without biopsy. Several studies have shown that EC is effective in identifying the nature of colorectal lesions and judging the depth of invasion in CRC. Based on the endoscopic diagnosis, the endoscopist can determine the treatment plan for the colorectal lesions. The latest EC is an integrated endoscope with a contact light microscopy system with a maximum magnification of 520 x. EC may demonstrate the atypical of gland structure and cells after staining (EC staining mode, along with the use of the EC-NBI mode. The endoscopic diagnosis of the EC staining mode is based on the EC classification (EC-C), used to predict the histopathological diagnosis of colorectal lesions. A prospective randomized trial showed that the diagnostic accuracy was 94.1% by EC-C. However, the diagnostic value of EC-C depends on the operator and may be influenced by the quality of the staining. Meanwhile, the high-quality staining process is time-consuming and tedious. Therefore, EC-NBI seems to be the first choice for EC diagnosis with the advantages of convenient operation and efficient diagnosis. EC-NBI can display the super-amplified surface microvessels of the lesion and provide pathological prediction according to the vessel classification (EC-V). EC-V achieved 99% diagnostic accuracy for hyperplastic polyps and 88.6% for invasive carcinoma. In EC examination, the investigators usually use EC-NBI and EC staining successively to diagnose colorectal lesions, which is believed to improve the diagnostic performance. However, the diagnostic value of increasing EC-staining after EC-NBI examination for predicting the pathological nature of colorectal lesions is still unclear. Therefore, this retrospective study aimed to evaluate the diagnostic value of two different modalities of cell endoscopy for colorectal lesions and to clarify whether additional EC staining after EC-NBI could improve the diagnostic performance of predicting the pathological diagnosis of colorectal lesions.
In the study, the investigators collect clinical information of colorectal lesions which were diagnosed by endoscopic diagnosis (including EC-NBI and EC-staining) and pathological diagnosis. Then, the investigators calculate the accuracy, sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and high confidence diagnosis rate of EC-C and EC-V classification, respectively. Inter-and intra-observer agreement in the diagnosis of EC-C and EC-V will be calculated. conditions: Colorectal Neoplasms studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: RETROSPECTIVE count: 500 type: ESTIMATED name: endocytoscopy measure: sensitivity measure: specificity measure: accuracy measure: positive predictive value measure: negative predictive value measure: inter-observer agreement measure: intra-observer agreement sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: the Department of Gastroenterology and Endoscopy Center, First Hospital of Jilin University status: RECRUITING city: Changchun state: Jilin zip: 130021 country: China name: Mingqing Liu, Doctor role: CONTACT phone: +8613204300453 email: liumq23@mails.jlu.edu.cn name: Hong Xu, Doctor role: PRINCIPAL_INVESTIGATOR name: Mingqing Liu, Doctor role: SUB_INVESTIGATOR name: Nan Zhang, Doctor role: SUB_INVESTIGATOR lat: 43.88 lon: 125.32278 hasResults: False
<\|newrecord\|> nctId: NCT06324084 id: 05M201 briefTitle: PATHophysiology of OSteoporosis: Role of Hidden Cortisol Excess and Its Predictors in Bone Fragility acronym: PATHOS overallStatus: RECRUITING date: 2023-04-24 date: 2024-10-24 date: 2025-04-24 date: 2024-03-21 date: 2024-03-21 name: Istituto Auxologico Italiano class: OTHER briefSummary: Osteoporosis is a chronic skeletal disease which leads to a decrease in bone strength which increases the risk of fractures.
Clinically overt hypercortisolism leads to hypertension, central obesity, diabetes and osteoporosis. More recently, even the condition of mild and asymptomatic hypercortisolism has been associated with increased prevalence of chronic complications of cortisol excess and mortality. In patients with osteoporosis this form of hypercortisolism may remain occult (hidden hypercortisolism, HidHyCo).
Although asymptomatic, however, this subtle cortisol excess is associated with an increased risk of osteoporosis and fragility fractures.
Moreover, HidHyCo prevalence seems to be increased in osteoporotic patients. The HidHyCo case finding is of utmost importance. However, given the high prevalence of bone fragility and the relatively low diagnostic accuracy of the currently available tests for the HidHyCo detection, a mass screening for HidHyCo is considered unthinkable. As now, no guidelines are available for addressing the HidHyCo screening in osteoporosis.
Therefore, the aims of the present study are the following: i) to assess the HidHyCo prevalence in a sample of osteoporotic patients; ii) to compare the clinical characteristics between osteoporotic/osteopenic patients with HidHyCo and those without HidHyCo in order to determine the clinical characteristics more frequently associated with the HidHyCo presence and to identify those osteoporotic patients worthy of HidHyCo screening; iii) to further investigate bone quality and turnover in HidHyCo patients, to characterize HidHyco patients from a molecular and genetic point of view and to evaluate the pathogenetic mechanisms explaining the negative effects of endogenous cortisol excess on bone health in these patients and the potential role of the genetic background and of the gut microbiome.
The HidHyCo could be present in a not negligible percentage of osteopenic/osteoporotic patients. In these patients, osteoporosis and, if present, other comorbidities can improve by the surgical resection of the adrenal or pituitary adenoma if feasible, or by the use of drugs able to modulate cortisol secretion or glucocorticoid sensitivity. Moreover, the case-finding could be reserved in those patients at higher risk of having HidHyCo, therefore, reducing the costs of a scarcely specific mass screening. conditions: Osteoporosis conditions: Bone Fracture conditions: Cortisol Excess studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 1500 type: ESTIMATED measure: Prevalence of hidden hypercortisolism in osteoporosis measure: Statistical comparison of the clinical and biochemical characteristics of osteoporotic/osteopenic patients with HidHyCo and those without HidHyCo to identify the characteristics predictive of the presence of HidHyCo in osteoporosis measure: Further investigation of bone turnover in HidHyCo patients, as assessed by serum osteocalcin, CrossLaps, bone alkaline phosphatase and amino-terminal propeptide of type 1 procollagen (P1NP) and additional new potential serum markers of bone status. measure: Further investigation of bone quality as assessed by Radiofrequency Echographic Multi Spectrometry (REMS) measure: Characterization of HidHyco patients from a molecular and genetic point of view by the determination of circulating microRNAs, peripheral glucocorticoid activity and the polymorphic variants of the 11ßHSD1, GR and B2AR gene. measure: Assessment of gut microbiome composition by the analysis of fecal samples sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Azienda Ospedaliera Universitaria Policlinico "G. Rodolico-San Marco" status: NOT_YET_RECRUITING city: Catania country: Italy name: Agostino Gaudio, Professor role: CONTACT lat: 37.49223 lon: 15.07041 facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico status: RECRUITING city: Milan country: Italy name: Cristina Eller-Vainicher, MD role: CONTACT name: Giorgia Grassi, MD role: SUB_INVESTIGATOR lat: 45.46427 lon: 9.18951 facility: Istituto Auxologico Italiano IRCCS status: RECRUITING city: Milan country: Italy name: Elisa Cairoli, MD role: CONTACT name: Carmen Aresta, MD role: SUB_INVESTIGATOR lat: 45.46427 lon: 9.18951 facility: Ospedale "Casa Sollievo della Sofferenza" IRCCS status: RECRUITING city: San Giovanni Rotondo country: Italy name: Alfredo Scillitani, MD role: CONTACT name: Flavia Pugliese, MD role: SUB_INVESTIGATOR lat: 41.70643 lon: 15.7277 facility: Azienda Ospedaliera Universitaria Senese status: NOT_YET_RECRUITING city: Siena country: Italy name: Luigi Gennari, Professor role: CONTACT lat: 43.31822 lon: 11.33064 hasResults: False
<\|newrecord\|> nctId: NCT06324071 id: 2022_TSOD_125 briefTitle: Study to Verify the Efficacy of a Product Containing 125 mg of TetraSOD® for the Treatment of Male Infertility overallStatus: RECRUITING date: 2024-01-08 date: 2025-01 date: 2025-04 date: 2024-03-21 date: 2024-03-22 name: Fitoplancton Marino, S.L. class: INDUSTRY name: Fundacio Clinic Barcelona name: Fertypharm briefSummary: TetraSOD® is a unique marine phytoplankton (Tetraselmis chuii) SOD-rich ingredient that is grown under patent-protected technology exclusively designed by the company Fitoplancton Marino, S.L. (Spain). In a previous pilot trial, the ability of TetraSOD® (dose: 250 mg/day) to improve semen characteristics in idiopathic infertile men after three months of treatment was assessed, revealing significant improvements in almost all of the analyzed parameters. In a further clinical trial close to finish (ClinicalTrials.gov Identifier: NCT04864314) using the same dose, such positive results have been tested again in a higher number of patients, and additional parameters have been included in order to gain insights into the sperm physiological changes that underpin the improvement in semen quality. In this new clinical trial, an intermediate dose (125 mg/day) is going to be tested in an attempt to determine a range of TetraSOD® dosage being clinically active for the treatment of male infertility. conditions: Male Infertility studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 50 type: ESTIMATED name: Sham name: Marine microalgae Tetraselmis chuii with high Superoxide Dismutase (SOD) activity measure: Sperm motility measure: Sperm concentration measure: Sperm oxidative stress measure: DNA integrity measure: sORP by MiOXSYS measure: Adverse effects sex: MALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Hospital Clinic status: RECRUITING city: Barcelona zip: 08036 country: Spain name: Juan M Corral role: CONTACT phone: +34 932275545 email: jmcorral@clinic.cat name: Meritxell Jodar role: CONTACT phone: +34 932275510 email: mjodar@clinic.cat name: Marta Guimerà role: SUB_INVESTIGATOR name: Juan M Mayorga-Torres role: SUB_INVESTIGATOR name: Antonio Alcaraz role: SUB_INVESTIGATOR name: Dolors Manau role: SUB_INVESTIGATOR name: Rafael Oliva role: SUB_INVESTIGATOR lat: 41.38879 lon: 2.15899 hasResults: False
<\|newrecord\|> nctId: NCT06324058 id: Huashan_H briefTitle: Cryoablation Versus BCG Instillation Therapy for High-risk NMIBC overallStatus: NOT_YET_RECRUITING date: 2024-03-18 date: 2025-03-18 date: 2026-03-18 date: 2024-03-21 date: 2024-03-21 name: Huashan Hospital class: OTHER briefSummary: This trial plans to enroll 190 eligible patients and randomize them into two groups with a 1:1 ratio, with 95 patients in each group. The experimental group will receive immediate cryoablation therapy at the resection site after TUR, while the control group will only undergo TUR and receive conventional BCG instillation therapy postoperatively. Both groups of subjects will undergo Re-TURBT or cystoscopy 10-12 weeks after surgery to compare the tumor-free residual rates and adverse events between the two groups. conditions: Bladder Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 190 type: ESTIMATED name: Transurethral cryoablation name: Transurethral resection of bladder tumor name: Bcg Intravesical measure: Tumor residual rate measure: Recurrence measure: Progression sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06324045 id: MRC-01-22-314 briefTitle: Deprescribing Intervention for Patients With Chronic Kidney Disease overallStatus: RECRUITING date: 2024-02-19 date: 2025-08-31 date: 2025-08-31 date: 2024-03-21 date: 2024-03-21 name: Hamad Medical Corporation class: INDUSTRY name: Qatar University name: Winchester District Memorial Hospital briefSummary: Chronic Kidney Disease (CKD) is recognized as a leading health problem globally. It is associated with multiple consequences such as cardiovascular diseases, infections, reduced cognitive function, and higher mortality rates. In Qatar, it is estimated that 13% of the population suffers from CKD. Management of CKD is associated with polypharmacy (the use of multiple medications), which burdens the patients and leads to adverse health and economic outcomes. As documented by previous studies, CKD setting is associated with a high medication burden, which leads to non-adherence, reduced quality of life, and other negative sequelae. These consequences can be minimized or averted by implementing a deprescribing program. Deprescribing is defined as the supervised process of intentionally stopping a medication, altering the dose or introducing a safer alternative to improve a person's clinical and quality of life outcomes. Previous deprescribing initiatives in inpatient and outpatient hospital settings were successfully implemented.
In general, there are limited deprescribing initiatives in CKD settings. There is a need to provide evidence of the impact of deprescribing programs on improving clinical and economic outcomes in this setting. In Qatar, there is no evidence of the effectiveness of implementing deprescribing programs in clinical settings. Therefore, we have built a team of researchers, clinicians, and stakeholders, and initiated a collaboration with deprescribing experts to fit into the Qatar healthcare system. This project aims to initiate a deprescribing multidisciplinary team and to evaluate the impact of providing such services on the clinical and economic outcomes among CKD patients in Qatar using a randomized controlled trial approach. The findings could have a potential positive impact on the professional practice and patient safety represented by health and economic outcomes. conditions: Chronic Kidney Diseases studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: CKD patients will be screened using medical records. Eligible patients will be approached during their routine visits to FBJ Kidney Center and other ambulatory kidney centers. Due to feasibility and practicality issues, selecting the patients will be consecutive case series as per their availability during the time of the recruitment (nonprobabilistic).
After obtaining informed consent, patients will be randomized into one of the two study arms. Randomization will be stratified by dialysis dependency (dialysis vs. pre-dialysis); randomly permuted balanced block sizes of 4 for dialysis patients and 1 for pre-dialysis will be used. Neither the practitioners nor the patients will be blinded to the patients' allocated groups due to the nature of the intervention. Due to feasibility and practicalities, selecting the patients will be consecutive as per their availability during the time of the recruitment (non-probabilistic). primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 424 type: ESTIMATED name: Deprescribing measure: Percentage of participants with at least one Potentially inappropriate medications (PIMs) measure: Number of Potentially inappropriate medications (PIMs) measure: Pill burden measure: Health-related quality of life (HRQoL) measure: Treatment burden measure: Self-reported adherence measure: Medication Refills adherence measure: Emergency department visits and hospitalizations measure: Unanticipated adverse effects measure: Cost avoidance measure: Cost savings sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hamad Medical Corporation status: RECRUITING city: Doha state: Unlisted (UL) zip: 00000 country: Qatar name: Abdulla Hamad, MD role: CONTACT phone: +97444394804 email: ahamad9@hamad.qa name: Rania Ibrahim, MSc. role: CONTACT phone: +9744394808 email: ribrahim4@hamad.qa name: Abdulla Hamad, MD role: PRINCIPAL_INVESTIGATOR name: Ahmed Awaisu, Ph.D. role: PRINCIPAL_INVESTIGATOR name: Daoud Al-Badriyeh, Ph.D. role: PRINCIPAL_INVESTIGATOR name: Muhammad Abdul Hadi, Ph.D. role: PRINCIPAL_INVESTIGATOR name: Ali Elbeddini, Pharm D role: SUB_INVESTIGATOR name: Rania Ibrahim, MSc. role: SUB_INVESTIGATOR name: Amani Zidan, MSc. role: SUB_INVESTIGATOR name: Kheloud Khaled, Pharm D role: SUB_INVESTIGATOR lat: 25.28545 lon: 51.53096 hasResults: False
<\|newrecord\|> nctId: NCT06324032 id: 021-FPO20 briefTitle: SUNNYDAY: SUbepithelialgastroiNtestiNal Tumors Detection,accuracYDiAgnosis,ElastographY and Contrast-enhanced EUS acronym: SunnyDay021 overallStatus: RECRUITING date: 2020-12-17 date: 2025-06-30 date: 2025-12-31 date: 2024-03-21 date: 2024-03-21 name: Fondazione del Piemonte per l'Oncologia class: OTHER briefSummary: This will be a longitudinal, prospective, observational multicenter study where the role of EUS-E will be examined in differentiating subepithelial gastrointestinal tumors in 138 patients conditions: Subepithelial Gastrointestinal Tumors studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 138 type: ESTIMATED name: EUS Elastography (EUS-E) measure: Evaluation of EUS-E accuracy qualitative measure: Evaluation of EUS-E accuracy quantitative measure: Evaluation of diagnostic accuracy of EUS-biopsy with fine needle biopsy (FNB) measure: Evaluation of gene mutations in EUS-guided specimen measure: Correlation of elastographic and contrastographic characteristics of SETs with the pathological risk stratification. measure: Complication rate (perforations, bleeding) of the procedure sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ospedale Santa Maria della Scaletta status: RECRUITING city: Imola state: Bologna country: Italy name: Pietro Fusaroli, MD role: CONTACT lat: 44.35916 lon: 11.7132 facility: Istituto Clinico Humanitas status: RECRUITING city: Rozzano state: Milano country: Italy name: Silvia Carrara, MD role: CONTACT lat: 45.38193 lon: 9.1559 facility: Fondazione del Piemonte per l'Oncologia-IRCCS Candiolo status: RECRUITING city: Candiolo state: Turin, zip: 10060 country: Italy name: Teresa Staiano, MD role: CONTACT phone: +390119933413 email: teresa.staiano@ircc.it lat: 44.95858 lon: 7.59812 facility: Ospedale Humanitas Mater Domini status: RECRUITING city: Castellanza state: Varese country: Italy name: Benedetto Mangiavillano, MD role: CONTACT lat: 45.61079 lon: 8.89616 facility: AOU Maggiore della Carità status: RECRUITING city: Novara zip: 28100 country: Italy name: Pietro Occhipinti, MD role: CONTACT lat: 45.44694 lon: 8.62118 facility: Istituto Oncologico Veneto status: RECRUITING city: Padova country: Italy name: Alberto Fantin, MD role: CONTACT lat: 45.40797 lon: 11.88586 facility: AOU Città della Salute e della Scienza di Torino, Ospedale Molinette status: RECRUITING city: Turin zip: 10126 country: Italy name: Claudio G. De Angelis, MD role: CONTACT lat: 45.07049 lon: 7.68682 hasResults: False
<\|newrecord\|> nctId: NCT06324019 id: Ethics number E.405221 briefTitle: Gynaecological Examination Gown and Patient Satisfaction overallStatus: COMPLETED date: 2022-02-01 date: 2022-04-30 date: 2022-06-22 date: 2024-03-21 date: 2024-03-21 name: ayşegül muslu class: OTHER briefSummary: The attitude of the health personnel before, during and after the examination and the positive examination experience of the person have a significant impact on ensuring the continuity of the subsequent examination and increasing the quality of the service provided. The use of different clothes in the patient during the examination will ensure that the patient\'s physical privacy is ensured from the moment of application, during diagnosis and treatment, and that the examination experience will be positively affected by preventing the use of additional covers to protect the privacy of all patients during examination and intervention. This will contribute to the maintenance of health by eliminating the intense stress and embarrassment experienced by patients during the examination and ensuring that they regularly attend health checks. In addition, meeting the privacy expectations of the patients will ensure that they are satisfied with the health service they receive, thus increasing the quality of the health service provided.
The attitude of the health personnel before, during and after the examination and the positive examination experience of the person have an important effect on ensuring the continuity of the subsequent examination and increasing the quality of the service provided. With the examination suit, it will be ensured that the patient\'s bodily privacy is ensured from the moment of application, during diagnosis, treatment and care, the use of the same cover to protect the privacy of all patients during examination and intervention will be prevented to prevent infection transmission and the examination experience will be positively affected. Thus, the intense stress and embarrassment experienced by patients during the examination will be eliminated and will contribute to the maintenance of health through regular visits to health checks. In addition, meeting the privacy expectations of patients will ensure that they are satisfied with the health service they receive, thus increasing the quality of the health service provided. In order to ensure patient privacy, to protect and improve women\'s health and to provide convenience in gynecological examination, the gynecological examination garment to be used in the examination can be designed as disposable, perineum and thigh open for the examination to be performed. In order to protect privacy, extra parts can be used to ensure that the open parts remain closed outside the examination process. Properties of the fabric used in the examination garment;
* Grama: 32,07 g/m\^2
* Explosion.: 135,77 kpç
* Detachment: Ȼ: 115NȺ: 120 N
* Air permeability: 1750
* Type of material: Polypropylene
The study was carried out as a post-test control group design from randomised controlled studies. The intervention group of the study was dressed in gynaecological examination clothes, while the control group used the drape given to the patient during the examination, which is a routine practice in the health institution where the study was conducted. conditions: Gynecology conditions: Gynecology/Obstetrics Conditions studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: The study was carried out as a post-test control group design from randomised controlled studies. The intervention group of the study was dressed in gynaecological examination clothes, while the control group used the drape given to the patient during the examination, which is a routine practice in the health institution where the study was conducted.
Hypotheses of the Study
1. Ho: There is no difference between the perception of privacy in the experimental and control group women.
H1: There is a difference between the perception of privacy in the experimental group and control group women.
2. Ho: There is no difference between the perception of satisfaction in the experimental group and control group women.
H1: There is a difference between the satisfaction perception of women in the experimental group and the control group. primaryPurpose: OTHER masking: NONE count: 150 type: ACTUAL name: putting on an examination gown measure: Gynaecological examination gown sex: FEMALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: EGE city: İzmir state: Konak country: Turkey lat: 38.41273 lon: 27.13838 hasResults: False
<\|newrecord\|> nctId: NCT06324006 id: DCT3934 briefTitle: A Phase 1 Trial of LIB-01 in Healthy Participants. overallStatus: ACTIVE_NOT_RECRUITING date: 2023-08-25 date: 2024-05-30 date: 2024-05-30 date: 2024-03-21 date: 2024-03-27 name: Dicot AB class: INDUSTRY briefSummary: The goal of this clinical trial is to learn about the safety, tolerability and pharmacokinetics of LIB-01 in healthy male participants. The main questions it aims to answer are:
* How safe and tolerable is LIB-01 when given once or repeatedly at different dose levels.
* What are the pharmacokinetic characteristics of LIB-01
Participants will receive LIB-01 and be followed up for safety and pharmacokinetics by:
* Adverse events
* ECG
* Blood sampling for laboratory parameters and pharmacokinetic analysis conditions: Erectile Dysfunction studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a Phase I, double-blind, parallel-group, placebo-controlled, randomized first-in-human trial. primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 64 type: ACTUAL name: LIB-01 name: Placebo measure: To evaluate the incidence of treatment-emergent adverse events as assessed by CTCAE in healthy male participants, following a single oral dose of LIB-01. measure: To evaluate changes in vital signs in healthy male participants, following a single oral dose of LIB-01. measure: To evaluate changes in ECG in healthy male participants, following a single oral dose of LIB-01. measure: To evaluate the incidence of treatment-emergent adverse events as assessed by CTCAE in healthy male participants, following multiple oral dosing of LIB-01. measure: To evaluate changes in vital signs in healthy male participants, following a multiple oral dosing of LIB-01. measure: To evaluate changes in ECG in healthy male participants, following multiple oral dosing of LIB-01. measure: To characterise the maximum plasma concentration of LIB-01, following a single oral dose. measure: To characterise the plasma concentration half life of LIB-01, following a single oral dose. measure: To characterise the plasma concentration area under curve of LIB-01, following a single oral dose. measure: To characterise the maximum plasma concentration of LIB-01 following multiple oral dosing. measure: To characterise the plasma concentration half life of LIB-01 following multiple oral dosing. measure: To characterise the plasma concentration half life of LIB-01 following multiple oral dosing. sex: MALE minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Clinical Trial Consultants city: Uppsala zip: 75237 country: Sweden lat: 59.85882 lon: 17.63889 hasResults: False
<\|newrecord\|> nctId: NCT06323993 id: 2021-115 briefTitle: The Effect of Different Window-preparation Approaches on the Clinical Outcomes of Lateral Sinus Floor Elevation overallStatus: COMPLETED date: 2022-03-01 date: 2022-05-01 date: 2023-06-15 date: 2024-03-21 date: 2024-03-21 name: The Dental Hospital of Zhejiang University School of Medicine class: OTHER briefSummary: This study retrospectively evaluated the effect of two different lateral window preparation techniques on peri-implant bone augmentation for patients who underwent lateral sinus floor elevation with simultaneous implant placement using two-dimensional and three-dimensional radiographic results, with special emphasis placed on the stability of the graft material after surgery. conditions: Dental Implantation conditions: Cone-Beam Computed Tomography conditions: Surgical Procedure, Unspecified conditions: Maxillary Sinus Floor Augmentation studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 34 type: ACTUAL name: Piezoelectric osteotomy measure: Apical bone height measure: Endo-sinus bone gain measure: Palatal bone height measure: Buccal bone height measure: Augmentation volume measure: Perforation incidence measure: Early implant loss measure: Lateral window length measure: Lateral bone length sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Stomatology Hospital, School of Stomatology, Zhejiang University School of Medicine city: Hangzhou state: Zhejiang zip: 310000 country: China lat: 30.29365 lon: 120.16142 hasResults: False
<\|newrecord\|> nctId: NCT06323980 id: DSM202108 briefTitle: INHANCE Stemless Reverse Shoulder IDE overallStatus: NOT_YET_RECRUITING date: 2024-09-15 date: 2027-11-10 date: 2028-04-10 date: 2024-03-21 date: 2024-04-24 name: DePuy Orthopaedics class: INDUSTRY briefSummary: 2:1 Randomized, Controlled, Multi-Center, Prospective, Pre-Market Study of the INHANCE Stemless Reverse Cementless Total Shoulder. conditions: Arthroplasty conditions: Replacement conditions: Shoulder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: 2:1 Randomized (Stemless to Stemmed) primaryPurpose: TREATMENT masking: NONE count: 168 type: ESTIMATED name: Reverse Total Shoulder measure: Constant Murley Score (CMS) measure: Removal of any system component measure: Revision of any system component measure: Reoperation of any system component measure: Supplemental Fixation of any system component measure: Radiolucent Lines (Humeral & Glenoid) measure: Migration and Tilt (Humeral & Glenoid) measure: Constant Murley Score (CMS) measure: EQ-5D-5L and EQ-VAS measure: Simple Shoulder Test measure: Single Assessment Numeric Evaluation (SANE) Score measure: Survivorship measure: Complications measure: Constant Murley Score (CMS) measure: EQ-5D-5L and EQ-VAS measure: Simple Shoulder Test measure: Single Assessment Numeric Evaluation (SANE) Score measure: Range of Motion sex: ALL minimumAge: 22 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hoag Orthopedic Institute city: Irvine state: California zip: 92618 country: United States lat: 33.66946 lon: -117.82311 facility: Atlantis Orthopaedics city: Lake Worth state: Florida zip: 33463 country: United States lat: 26.61708 lon: -80.07231 facility: Boston Sports & Shoulder Center city: Waltham state: Massachusetts zip: 02451 country: United States lat: 42.37649 lon: -71.23561 facility: Trinity Health Grand Rapids city: Grand Rapids state: Michigan zip: 49503 country: United States lat: 42.96336 lon: -85.66809 facility: Missouri Orthopaedic Institute (MOI) city: Columbia state: Missouri zip: 65201 country: United States lat: 38.95171 lon: -92.33407 facility: Lindner Research Center city: Cincinnati state: Ohio zip: 45219 country: United States lat: 39.12713 lon: -84.51435 facility: Cleveland Clinic city: Cleveland state: Ohio zip: 44195 country: United States lat: 41.4995 lon: -81.69541 facility: Slocum Center for Orthpaedics and Sports Medicine city: Eugene state: Oregon zip: 97401 country: United States lat: 44.05207 lon: -123.08675 facility: Rothman Orthopaedics Institute city: Philadelphia state: Pennsylvania zip: 19107 country: United States lat: 39.95233 lon: -75.16379 facility: TOSH- The Orthopedic Specialty Hospital city: Murray state: Utah zip: 84107 country: United States lat: 40.66689 lon: -111.88799 facility: University of Utah city: Salt Lake City state: Utah zip: 84108 country: United States lat: 40.76078 lon: -111.89105 hasResults: False
<\|newrecord\|> nctId: NCT06323967 id: 231981 briefTitle: Growing Strong Study of Unconditional Cash Transfers Plus Peer Support for Families With Babies in Homeless Shelters overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2027-03 date: 2027-03 date: 2024-03-21 date: 2024-03-21 name: Vanderbilt University class: OTHER name: Women in Need (Win) name: The Samuels Group name: New York City Center for Innovation through Data Intelligence (CIDI) briefSummary: The Growing Strong program tests a novel approach to helping families with young children living in homeless shelters, namely offering guaranteed, unconditional cash gifts that families can use as they wish plus voluntary peer support. The assumption behind this approach is that families know best how to allocate resources to meet their own individual needs. While there are a number of Direct Cash Transfer studies taking place around the country, the investigator(s) are unaware of any that have tested the relationship of receiving cash on homelessness among families specifically. To be eligible to participate in the study, families must reside in a homeless shelter and have at least one child under two years of age living with them in shelter. The investigator(s) have tied eligibility to the age of the youngest child in the household because rates of shelter use are highest among this population and because the costs associated with young children increase such families' financial burdens.
A total of 200 families will be enrolled in the study. One hundred families in the active intervention group will receive $1,500 per month ("substantial cash") for 24 months ($18,000 annually) and may also elect to receive peer support services. One hundred families in the active comparison group will receive $50 per month ("nominal cash") for 24 months ($600 annually) and will not have access to the peer support services. A third, passive comparison group will receive usual care within the homeless shelter system in the same metropolitan area (New York City) as participants in both cash gift groups. This group of families will be followed only in administrative records.
The main research questions are: does providing substantial, unconditional cash transfers plus access to voluntary peer support services over 24 months a) reduce the length of time in shelter for families with young children and/or b) improve other aspects of family and child well-being relative to providing nominal cash transfers alone or usual care. conditions: Time to Shelter Exit conditions: Family Well-being conditions: Child Well-being studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Parallel assignment to 1) active treatment and 2) active comparison. A third, passive comparison group will be constructed and followed anonymously via administrative records. primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: Participants will be blind to condition at the baseline assessment but will be unmasked immediately afterwards (they will receive debit cards and learn whether they are eligible for peer support). At baseline, interviewers will likely be aware of study conditions because they will interview respondents at shelters and shelter is associated with condition. At subsequent assessments interviewers will remain blind to study condition to the extent possible, but may well learn the condition from respondents, especially those who complete qualitative interviews. Win staff who provide usual care to both groups will be blind to the study condition. Participants in the passive comparison group will be unaware of the study. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 200 type: ESTIMATED name: Large unconditional cash transfers plus voluntary peer support. name: Nominal cash transfers name: Passive comparison group measure: Time to shelter exit measure: Housing: Total time in shelter* measure: Housing: Housing Stability measure: Target Child Development: Child Behavior Problems* measure: Target Child Development: Child Prosocial Behavior* measure: Target Child Development: Child Verbal Development measure: Parenting: Chaos in the Home* measure: Parenting: Early Learning Activities with Target Child* measure: Parenting: Target-Child-Focused Expenditure Index measure: Parenting: Household Routines measure: Parenting: Parenting Stress measure: Family Separation: Separation of Parent and Target Child (Cumulative at any time point)* measure: Family Separation: Indicated Investigations, Preventive services, or Child Placement of Target Child by Child Protective Services (No/Yes) measure: Adult Well-Being: Adult Psychological Distress* measure: Adult Well-Being: Adult Alcohol or Drug Abuse measure: Adult Well-Being: Hope measure: Domestic Violence: Adult Domestic Violence* measure: Financial Well-Being: Food Insecurity* measure: Financial Well-Being: Adult Economic Stress measure: Financial Well-Being: Financial Well-Being as Measured by the Consumer Financial Protection Bureau Financial Well-Being Scale measure: Financial Well-Being: Financial Hardship as Measured by the Urban Institute Well-Being and Basic Needs Survey measure: Employment: Income from Employment in Most Recent Period* measure: Employment: Adult Work for Pay measure: Health Care: Family Use of Emergency Medical Care or Hospitalization (Cumulative at any point)* measure: Health Care: Proportion of Target Child Immunizations Recommended by Age by the American Academy of Pediatrics measure: Health Care: Proportion of Well-Child Visits by Target Child Recommended by Age by the American Academy of Pediatrics sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Win NYC Shelter System city: New York state: New York zip: 10004 country: United States name: Kirsten Cafarella, B.A. role: CONTACT phone: 646-899-6943 email: kcafarella@winnyc.org name: Marybeth Shinn, Ph.D. role: PRINCIPAL_INVESTIGATOR lat: 40.71427 lon: -74.00597 hasResults: False
<\|newrecord\|> nctId: NCT06323954 id: H24110 briefTitle: tVNS During Motor Training in Older Adults overallStatus: NOT_YET_RECRUITING date: 2024-09-01 date: 2026-05-31 date: 2026-06-30 date: 2024-03-21 date: 2024-04-01 name: Georgia Institute of Technology class: OTHER name: University of Florida briefSummary: The goal of this study is to learn about the effect of applying transcutaneous vagus nerve stimulation (tVNS) during motor training on motor learning in older adults. The main question it aims to answer is whether applying tVNS after successful motor trials (post-success tVNS) will facilitate the rate of motor learning. Participants will be randomly assigned to tVNS or sham group and receive tVNS or sham, respectively, at the outer ear during finger control training sessions. Finger control performance will be tested before and after the training sessions without outer ear stimulation. conditions: Older Adults studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 32 type: ESTIMATED name: tVNS stimulation name: Sham stimulation measure: Rate of error reduction sex: ALL minimumAge: 65 Years maximumAge: 84 Years stdAges: OLDER_ADULT facility: Human Neuromuscular Physiology Lab city: Atlanta state: Georgia zip: 30332 country: United States name: Minoru Shinohara, Ph.D. role: CONTACT phone: 404-894-1030 email: shinohara@gatech.edu name: Minoru Shinohara, Ph.D. role: PRINCIPAL_INVESTIGATOR lat: 33.749 lon: -84.38798 hasResults: False
<\|newrecord\|> nctId: NCT06323941 id: UV0003 briefTitle: Motor Imagery and Isometric Exercises on Pelvic Floor Sensorimotor Condition overallStatus: COMPLETED date: 2023-11-01 date: 2024-03-01 date: 2024-03-14 date: 2024-03-21 date: 2024-03-22 name: University of Valencia class: OTHER briefSummary: Mental practice (both in isolation and also in combination with real practice) has been shown to improve somatosensory and motor variables but so far no study has taken it into the study of women's health. Through the present study the investigators want to offer some interesting data regarding the effectiveness of mental practice combined with physical practice. conditions: Isometric Exercise conditions: Motor Imagery conditions: Women's Health studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 30 type: ACTUAL name: Motor Imagery plus therapeutic exercise name: Therapeutic exercises measure: Skin conductance (for asessing electrodermal activity) measure: Algometry for assessing pressure pain thresholds (Pain sensitivity) measure: maximal pelvic floor muscle strength (measured in grams and with the phenix device) sex: FEMALE minimumAge: 18 Years maximumAge: 30 Years stdAges: ADULT facility: Ferran Cuenca Martínez city: Valencia zip: 46017 country: Spain lat: 39.46975 lon: -0.37739 hasResults: False
<\|newrecord\|> nctId: NCT06323928 id: 20297A id: 2023-508821-28-00 type: OTHER domain: EU Trial briefTitle: A Dose-finding Trial With Lu-AG09222 in Adults With Migraine Who Have Not Been Helped by Prior Preventive Treatments acronym: PROCEED overallStatus: RECRUITING date: 2024-04-01 date: 2025-07-31 date: 2025-09-30 date: 2024-03-21 date: 2024-04-17 name: H. Lundbeck A/S class: INDUSTRY briefSummary: The purpose of this trial is to determine which doses of Lu AG09222 are recommended to help prevent migraines. People who join this trial have already tried 2 to 4 other available medications to prevent their migraines, but these medications have not helped them. conditions: Migraine studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 498 type: ESTIMATED name: Lu AG09222 name: Placebo measure: Change From Baseline in the Number of Monthly Migraine Days (MMDs) measure: Change From Baseline in MMDs measure: Percentage of Participants With ≥50% Reduction From Baseline in MMDs measure: Percentage of Participants With ≥75% Reduction From Baseline in MMDs measure: Change from Baseline in the Number of Monthly Headache Days measure: Number of Participants with Treatment-emergent Adverse Events (TEAEs) measure: Number of Participants with Anti-drug Antibodies (ADA) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Accellacare of Charleston status: RECRUITING city: Mount Pleasant state: South Carolina zip: 29464 country: United States lat: 32.79407 lon: -79.86259 hasResults: False
<\|newrecord\|> nctId: NCT06323915 id: 2020_03_C3M briefTitle: Comparative Study of 3 Multifocal Intraocular Lenses in Murcia acronym: C3M overallStatus: RECRUITING date: 2021-04-20 date: 2025-06-20 date: 2025-09-20 date: 2024-03-21 date: 2024-03-21 name: Cristalens Industrie class: INDUSTRY briefSummary: The goal of this clinical trial is to compare the performance of 3 intraocular lenses (IOLs): FineVision (comparator), ARTIS SYMBIOSE (study lenses), and Tecnis Synergy (comparator) through binocular distance-corrected defocus curve.
This main objective will be to show superiority of the ARTIS SYMBIOSE system through binocular distance-corrected defocus curve.
The patient population to be included is patient suffering from cataract who requires cataract surgery procedure that meet the inclusion and non-inclusion criteria and provide written informed consent.
Participants will attend a total of 5 study visits: 1 preoperative visit, 1 surgery visit and 3 postoperative visits. conditions: Cataract studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 84 type: ESTIMATED name: intraocular lens implantation in cataract surgery measure: defocus curve comparison sex: ALL minimumAge: 50 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Vista Clinic Ircovision Murcia status: RECRUITING city: Murcia zip: 30008 country: Spain name: Juan Zapata role: CONTACT phone: +34 968 27 17 35 email: juanf.zapata.diaz@gmail.com lat: 37.98704 lon: -1.13004 hasResults: False
<\|newrecord\|> nctId: NCT06323902 id: PT-CO39 briefTitle: Autologous Platelet-rich Plasma as a Treatment for Macular Holes overallStatus: COMPLETED date: 2022-10-25 date: 2023-06-08 date: 2024-02-29 date: 2024-03-21 date: 2024-03-21 name: Clinica Oftalmologica Paredes class: OTHER briefSummary: For a series of patients with full-thickness macular hole, an autologous plasma rich in growth factors was developed in the form of a clot and applied to the retinal defect. These patients were followed up for a period of one year, obtaining substantial improvement both anatomically and functionally. conditions: Macular Holes conditions: Macular Hole of Left Eye (Disorder) conditions: Macular Hole of Right Eye (Disorder) studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 13 type: ACTUAL name: Pars plana vitrectomy, with or without epiretinal membrane peeling, plus PRGF membrane implantation measure: Macular hole closure sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Clinica Ofalmologica Paredes city: Pasto state: Nariño zip: 520002 country: Colombia lat: 1.21361 lon: -77.28111 hasResults: False
<\|newrecord\|> nctId: NCT06323889 id: LIMITFOOD2 briefTitle: Longitudinal Monitoring During Intermittent Fasting Protocols in Obese Adults acronym: LIMITFOOD2 overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2026-01 date: 2027-01 date: 2024-03-21 date: 2024-04-19 name: University of Zurich class: OTHER briefSummary: LIMITFOOD2 is a randomized clinical intervention study that investigates the effects of two different intermittent fasting protocols compared to a control group on the health of obese adults. A total of 90 participants will be randomized into three equally sized groups: a modified alternate day fasting, a time-restricted eating and a control group, receiving general weight-loss counseling. conditions: Intermittent Fasting conditions: Obesity conditions: Time Restricted Eating studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 90 type: ESTIMATED name: Modified Alternate Day Fasting name: Time-Restricted Eating name: Weight-loss counseling measure: Fat Volume measure: Distribution of fat volume measure: Concentration of Leptin measure: Changes in Insulin Sensitivity measure: Changes in Fasting Lipids measure: Changes in Inflammatory Markers measure: Free triiodothyronine (fT3) measure: Correlation of longitudinally measured parameters measure: Serum Metabolomics measure: Genetic Analysis measure: LDL Particle Size measure: Fecal Microbiome sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Department of Endocrinology, Diabetology and Clinical Nutrition city: Zürich zip: 8091 country: Switzerland lat: 47.36667 lon: 8.54999 hasResults: False
<\|newrecord\|> nctId: NCT06323876 id: HSR301252 id: R01HL171918 type: NIH link: https://reporter.nih.gov/quickSearch/R01HL171918 briefTitle: The Role of Quantitative CT and Radiomic Biomarkers for Precision Medicine in Pulmonary Fibrosis overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2028-05 date: 2029-05 date: 2024-03-21 date: 2024-03-21 name: University of Virginia class: OTHER name: National Heart, Lung, and Blood Institute (NHLBI) briefSummary: This observational study involves obtaining 2 chest CT scans; a historical baseline CT within ±1 year of enrollment into PRECISIONS, and a follow-up CT (either historical or prospective) 12 months ± 180 days after the baseline CT. Many IPF patients will have a CT scan every 12 months for disease monitoring and cancer screening. Participants will have the option to share historical CTs only or they can choose to have a research CT done for the follow-up scan, if a scan for clinical purposes is not available. conditions: Idiopathic Pulmonary Fibrosis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 160 type: ESTIMATED name: HRCT name: Blood Draw measure: Derivation of DTA in IPF only cases from the PFF-PR and its associations with disease severity and outcomes. measure: Determine whether known IPF-risk genetic variants are associated with DTA score. measure: Identify novel genetic variants that associate with DTA score progression. measure: Determine if DTA or any constituent radiomic features correlate with select plasma proteins. measure: Determine if DTA or any of constituent radiomic features correlate with transcriptomic measure: Determine the best combination of markers (DTA, proteins and transcriptome) for machine learning algorithms for AUC evaluation of ROCs on all 3 cohorts. measure: Determine associations of changes in DTA scores with 12-month changes in FVC and DLCO. measure: Determine associations of changes in DTA scores with drug treatment (i.e., antifibrotics) sex: ALL minimumAge: 40 Years maximumAge: 101 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06323863 id: N°4-RCB/EUDRACT briefTitle: Ultra-high Resolution CT: the End of Stapes Prosthesis Measurement Misestimation overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-06-01 date: 2024-12-01 date: 2024-03-21 date: 2024-03-21 name: Central Hospital, Nancy, France class: OTHER briefSummary: Actual CT scanners overestimate stapes piston size, and do not represent a valuable technique for their follow-up, especially in case of complication. Ultra-high resolution has not yet been evaluated in this setting. conditions: Otosclerosis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 20 type: ESTIMATED name: stapedectomy name: ultra high resolution CT measure: length sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Chu Nancy city: Nancy zip: 54000 country: France name: romain gillet, md role: CONTACT phone: 00383851811 email: r.gillet@chru-nancy.fr lat: 48.68439 lon: 6.18496 hasResults: False
<\|newrecord\|> nctId: NCT06323850 id: HM20028878 briefTitle: Improving Access to Community-Based Occupations Via a Rideshare Training Program overallStatus: RECRUITING date: 2024-05-15 date: 2025-02 date: 2025-02 date: 2024-03-21 date: 2024-04-04 name: Virginia Commonwealth University class: OTHER name: Organization for Autism Research briefSummary: Community mobility is critical for living independently and engaging in one's community. It is especially important for people in their early adult years, as this is often a time of transition to employment and living independently. Community mobility can be particularly challenging for adults with Autism Spectrum Disorders (ASD) (henceforth referred to as autistic adults based on the preferred identity-first language of our autistic partners). Some autistic adults are unable to meet the demands of driving. Public transportation is an option for autistic adults; and autistic adults are more likely to use public transportation than their non-autistic counterparts. However, using public transportation may be just as challenging as driving for the autistic population. Rideshare (also called ride-hailing) is a relatively new form of transportation in which passengers get from point A to point B in private vehicles driven by their owners. A digital app, usually accessed on a smartphone, matches passengers and drivers, coordinates routes using a GPS system, and facilitates payment through a linked financial account. Rideshare has the potential to address many of the issues autistic adults have accessing the community. It is faster and more direct than the public train or bus, there is limited social interaction required, and rides can be scheduled at any time. Despite it's potential to increase transportation in autistic adults, there are no evidence-based training programs to support Rideshare use in this population. conditions: Autism studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: A hybrid type-2 effectiveness-implementation randomized wait-list control design . The experimental group will receive the intervention first, while the waitlist group receives no intervention (Phase 1). After the 2-month intervention period, the waitlist group will receive the intervention, while the experimental group participates in a 2-month follow-up (Phase 2). During phase three, the waitlist group will participate in the 2-month follow up. primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 12 type: ESTIMATED name: Intervention Phase name: Virtual Training Sessions name: Ride-Along Training Sessions measure: Evaluate the intervention by conducting an effectiveness-implementation waitlist-controlled trial using our Safe Rideshare Program (SRP) , evaluate autistic adults participating in the SRP intervention find the intervention acceptable? measure: Evaluate if the trainers conducting the SRP intervention find the intervention to be appropriate measure: Autistic adults who have participated in the SRP program display greater independence in using Rideshare compared to autistic adults who did not participate in the SRP program (wait-list group) measure: Autistic adults who have participated in the SRP program display greater safety in using Rideshare compared to autistic adults who did not participate in the SRP program (wait-list group)? measure: In the wait-list group, is there a change in community engagement, social participation, and employment from the waitlist phase (no intervention) to the 2-month follow-up period (after the intervention) measure: How do SRP participants use of Rideshare for community, social, and/or employment activities after the intervention sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Virginia Commonwealth University status: RECRUITING city: Richmond state: Virginia zip: 23298 country: United States name: Stacey Reynolds role: CONTACT phone: 410-241-2140 email: reynoldsse3@vcu.edu name: Alissa Brooke role: CONTACT phone: 804-827-0746 email: admolinelli@vcu.edu lat: 37.55376 lon: -77.46026 hasResults: False
<\|newrecord\|> nctId: NCT06323837 id: 20383 briefTitle: Mirtazapine for the Treatment of Methamphetamine Use in Opioid Use Disorder Patients Receiving Medication Assisted Treatment acronym: MIRROM overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-04-01 date: 2026-04-01 date: 2024-03-21 date: 2024-03-21 name: Washington State University class: OTHER briefSummary: This project will evaluate the ability of Mirtazapine (MZP), a pharmacologically unique medication with a growing body of evidence to support its efficacy and safety for the treatment of methamphetamine (MA) use among medication for opioid use disorder (MOUD) patients, to significantly decrease MA use and related health-impairing behaviors. MZP has already successfully been used in the treatment of methamphetamine (detailed further below and in the Appendices).
The investigators hypothesize that those assigned to the MZP plus treatment as usual (TAU) MZP+TAU arm will demonstrate significantly increased rates of biochemically verified abstinence from MA and other substances of abuse and experience improvements in health impairing behaviors relative to the placebo (PLO)+TAU arm across the 10-week treatment and follow-up periods. conditions: Stimulant Use Disorder studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 60 type: ESTIMATED name: Mirtazapine name: Placebo measure: Urinanalysis Verified Increased Days of MA Abstinence measure: Actigraphy Verified Improved Sleep Patterns measure: Self Reported Quantity of Adverse Events measure: Urinanalysis Verified Increased Days of Abstinence from Other Substances sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06323824 id: 2000033271 id: CTN-0131 type: OTHER domain: Clinical Trials Network id: 5UG1DA015831-21 type: NIH link: https://reporter.nih.gov/quickSearch/5UG1DA015831-21 briefTitle: Office-based Methadone Versus Buprenorphine to Address Retention in Medication for Opioid Use Disorder Treatment. overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2028-12 date: 2029-05 date: 2024-03-21 date: 2024-03-21 name: Yale University class: OTHER name: National Institutes of Health (NIH) name: National Institute on Drug Abuse (NIDA) name: The Emmes Company, LLC name: University of California, San Francisco name: Boston Medical Center (BMC) name: Hennepin Healthcare Research Institute name: Alameda Health System name: Marshall Health name: Kaiser Permanente briefSummary: The purpose of this clinical trial is to compare the effectiveness of office-based methadone with pharmacy administration and/or dispensing to office-based buprenorphine for the treatment of opioid use disorder. This study will also examine factors influencing the implementation of office-based methadone. conditions: Opioid Use Disorder studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The comparative effectiveness of two strategies to address retention in medication for opioid use disorder (MOUD) treatment will be tested over a 168-day period. Behavioral treatments offered to patients are designed to be similar across the two medication conditions.
Office-based methadone where the clinician prescribes methadone and oral methadone is administered and/or dispensed at a pharmacy. Providers and Randomized Control Trial (RCT) participants will have flexibility to use behavioral and pharmacological services as clinically indicated.
Office-based buprenorphine (BUP) where the clinician prescribes BUP formulations that are dispensed at a pharmacy or administered in the office (e.g., extended-release formulations). Providers and RCT participants will have flexibility to use behavioral and pharmacological services as clinically indicated. primaryPurpose: TREATMENT masking: NONE count: 600 type: ESTIMATED name: Methadone name: Buprenorphine (BUP) measure: Number of days of continuous treatment with study site clinician-prescribed methadone or buprenorphine, as randomized, during the 168 days post-randomization among RCT participants. measure: Number of self-reported days in any FDA-approved formulation of MOUD treatment (e.g., buprenorphine, methadone or naltrexone) during the 168 days post-randomization. measure: Number of self-reported days in formal OUD treatment, according to American Society of Addiction Medicine (ASAM) levels of care 1-4, during the 168 days post-randomization. measure: Number of days prescribed any FDA-approved MOUD formulation during the 168 days post-randomization. measure: Number of days of self-reported non-prescribed opioid use per month. measure: Number of days of self-reported non-prescribed stimulant use per month. measure: Number of days of self-reported non-prescribed benzodiazepine use per month. measure: Urine toxicology measure: Participant satisfaction with MOUD measure: Total number of self-reported overdose events per total number of participant days at risk. measure: Total number of self-reported injection drug use related events per total number of participant days at risk. measure: Pain measured using PEG-3: "Pain average," "interference with Enjoyment of life," and "interference with General activity." measure: Number of self-reported days with acute care utilization (ED or hospitalization) events during the 168 days post-randomization per month. sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06323811 id: COPE CMR briefTitle: Comparison of Free-breathing 3D Quantitative Perfusion in Patients With MINOCA and MINOCA-mimics acronym: COPE-CMR overallStatus: RECRUITING date: 2023-06-15 date: 2025-06-30 date: 2025-12-31 date: 2024-03-21 date: 2024-03-21 name: University of Zurich class: OTHER name: ETH Zurich briefSummary: This clinical study examines patients presenting with acute myocardial infarction and no significant coronary artery disease on coronary angiography (MINOCA) and patients with MINOCA-mimics with advanced CMR.
The present study aims to:
* assess the microvascular function with a novel quantitative 3D myocardial perfusion imaging approach in the acute phase and post-convalescence
* refine the role and diagnostic potential of advanced quantitative CMR imaging
* assess the potential prognostic significance of microvascular dysfunction and epicardial adipose tissue on cardiovascular outcomes
Participants will undergo advanced CMR imaging in the acute setting (within 10 days after event) and post convalescence (after 3 months). conditions: Myocardial Infarction With Non-Obstructive Coronary Artery conditions: Myocarditis Acute conditions: Takotsubo Cardiomyopathy conditions: Spontaneous Coronary Artery Dissection conditions: Non ST Elevation Myocardial Infarction studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: 5 groups of patients (MINOCA, myocarditis, Takotsubo cardiomyopathy, SCAD, NSTEMI) will undergo CMR with 3D perfusion in the acute setting (within 10 days after the event) and post convalescence (after 3 months) primaryPurpose: DIAGNOSTIC masking: SINGLE whoMasked: INVESTIGATOR count: 75 type: ESTIMATED name: CMR measure: Myocardial perfusion reserve index measure: epicardial adipose tissue (EAT) measure: cardiovascular events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital Zurich status: RECRUITING city: Zürich zip: 8091 country: Switzerland name: Robert Manka role: CONTACT lat: 47.36667 lon: 8.54999 hasResults: False
<\|newrecord\|> nctId: NCT06323798 id: 2024PI035 briefTitle: Diffusion Weighted MRI Enables Differential Diagnosis Between Pyocele and Mucocele overallStatus: NOT_YET_RECRUITING date: 2024-04-28 date: 2024-07-28 date: 2024-12-28 date: 2024-03-21 date: 2024-03-21 name: Central Hospital, Nancy, France class: OTHER briefSummary: Diffusion MRI should allow for differentation of pus and simple retention in the paranasal sinuses, but this remained to be determined conditions: Pyocele; Sinus studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 20 type: ESTIMATED name: MRI measure: apparent diffusion coefficient sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06323785 id: 2022-D0067 briefTitle: Whole-body Hyperthermia for Depression overallStatus: RECRUITING date: 2024-04-30 date: 2026-03-01 date: 2026-03-01 date: 2024-03-21 date: 2024-04-24 name: University of Zurich class: OTHER briefSummary: The goal of this clinical trial is to test the efficacy of whole-body hyperthermia in major depression. The main question it aims to answer is:
• Does whole-body hyperthermia alleviate symptoms of depression?
Participants will be randomised to sham or active whole-body hyperthermia. The study will last 6 weeks during which five visits will take place. Depression will be measured repeatedly and biological mechanisms will be investigated. conditions: Major Depressive Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: Active whole-body hyperthermia name: Sham whole-body hyperthermia measure: Hamilton Rating Scale for Depression (HAMD-17; minimum: 0, maximum: 68, higher scores indicate higher depression) measure: Beck Depression Inventory (BDI; minimum: 0, maximum: 63; higher scores indicate higher depression) measure: Medical Outcomes Study 36-item short-form health survey (MOS-SF; minimum: 0, maximum: 100, higher scores indicate better health status) measure: Hamilton Rating Scale for Depression (HAMD-17; minimum: 0, maximum: 68, higher scores indicate higher depression) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Zurich, Institute of Psychology status: RECRUITING city: Zurich zip: 8050 country: Switzerland name: Susanne Fischer, PhD role: CONTACT phone: +41446357460 email: s.fischer@psychologie.uzh.ch lat: 47.36667 lon: 8.54999 hasResults: False
<\|newrecord\|> nctId: NCT06323772 id: RDC-RP-01 briefTitle: Natural History Study in Patients With PDE6A-, PDE6B- and RHO-linked Retinitis Pigmentosa overallStatus: RECRUITING date: 2023-11-17 date: 2027-03 date: 2027-03 date: 2024-03-21 date: 2024-03-21 name: University Hospital Tuebingen class: OTHER briefSummary: The aim of the study is to apply a novel clinical investigation protocol in patients with Phosphodiesterase 6A (PDE6A), PDE6B and Rhodopsin (RHO)-based retinitis pigmentosa. This novel, multimodal clinical examination protocol describes and correlates structural, functional and metabolic aspects during natural disease development.
Test-retest variability of new measurements as well as correlations of the structural, functional, and metabolic changes will be defined to be able to define well-suited readouts for safety and efficacy of future treatment developments before they reach the clinical phase. conditions: Retinitis Pigmentosa studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 40 type: ESTIMATED measure: Optical coherence tomography (OCT) measure: Fundus autofluorescence imaging measure: Wide-field fundus photography measure: Adaptive optics imaging measure: V1 morphology (MRI) measure: Diffusion Tensor Imaging (DTI) measure: flavoprotein fluorescence (FPF) measure: Retinal oxymetry measure: Local dark adapted adaptation curves measure: best corrected visual acuity (BCVA) measure: Static cone perimetry and dark adapted perimetry measure: chromatic pupil campimetry (CPC) measure: electroretinogram (ERG) measure: Virtual reality (VR) functional test sex: ALL minimumAge: 5 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Institute for Ophthalmic Research, University Tübingen status: RECRUITING city: Tübingen state: Baden-Württemberg zip: 72076 country: Germany name: Katarina Stingl, Prof role: CONTACT phone: 070712988088 email: katarina.stingl@med.uni-tuebingen.de lat: 48.52266 lon: 9.05222 hasResults: False
<\|newrecord\|> nctId: NCT06323759 id: 2022-14 briefTitle: Perinatal EDucation: Pedagogical Strategy and Facilitators for the PROMotion of BreastFeeding acronym: PED-PROM-BF overallStatus: COMPLETED date: 2023-02-06 date: 2024-03-01 date: 2024-03-01 date: 2024-03-21 date: 2024-03-21 name: Lépine Alexandra class: OTHER briefSummary: Breastfeeding up to 6 months of a child's life, for its benefits to mother and child, has become a global public health goal. However, there is a disparity in the prevalence of breastfeeding (BF) in different regions of the world. According to French perinatal surveys, the rate of BF at birth decreased significantly between 2010 and 2016. Even if that figure remains stable according to the last perinatal survey in 2021, it decreases sharply, to 34.4%, at 2 months.While many plans at the national level advocate for BF, it is rare to see an action plan or an education intervention for women and couples aimed at promoting BF. However, women's needs to educate about BF and the need for professionals to reflect on their practices are highlighted by numerous perinatal surveys. It should be noted that despite the importance given to the promotion of BF found in all National Nutrition and Health Programs, none of them provide pedagogical means or an education program to achieve the objectives set. At present, in France, there is no breastfeeding education program and professionals accompany women by implementing experimental actions without considering the complexity of the promotional dimension (producing a behavioral change) and the educational dimension (understanding the pedagogy of the proposed actions) conditions: Breast Feeding studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: This intervention is based on a pedagogical engineering that proposes a favorable learning environment more adapted than the courses already offered in preparing for parenthood and promoting breastfeeding primaryPurpose: OTHER masking: NONE count: 128 type: ACTUAL name: educational intervention measure: To find out the contribution of educational engineering to the choice and continuation of breastfeeding from the point of view of women until 4 months after the birth of the child. measure: To explain contexts and generative mechanisms of pedagogical design that influence breastfeeding management up to 4 months afther birth. measure: To explain interactions between existing contexts, generative mechanisms and effects on women's breastfeeding management skills. measure: To determine contexts and generative mechanisms of pedagogical design that influence women's knowledge of breastfeeding up to 4 months afther birth. measure: To evaluate the level of satisfaction about the educational intervention among nursing mothers. sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Université Sorbonne Paris Nord - Laboratoire d'Educations et Promotion de la Santé - UR 3412 city: Bobigny zip: 93017 country: France lat: 48.9 lon: 2.45 hasResults: False
<\|newrecord\|> nctId: NCT06323746 id: HR-EEG-CSAR briefTitle: Exploring Heart Rate Variability, EEG Pattern, and Corticomuscular Coherence After Cervical Sagittal Alignment Restoration overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2026-03 date: 2026-12 date: 2024-03-21 date: 2024-03-21 name: University of Sharjah class: OTHER briefSummary: The goal of this Randomized clinical trial is to learn about how fixing neck curvature and head posture right away affects heart rate, brainwaves, and muscle coordination in college athletes. The main question it aims to answer:
- Whether forward head posture (FHP) may play a crucial role in affecting heart rate variability, brainwaves, and muscle coordination. conditions: Cervical Lordosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Permuted block randomization to ensure an equal number of allocations in each of the two groups (intervention and wait list group). Each random block will be stored in opaque sealed envelopes consecutively numbered with a third researcher. Once each participant officially joins the study the researcher will open the subsequent envelop. whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Denneroll cervical traction orthodontic measure: Cervical Sagittal Alignment Radiographs measure: Cervical Sagittal Alignment Radiographs measure: Heart rate Variability (HRV) physiological parameter measure: Corticomuscular Coherence sex: ALL minimumAge: 18 Years maximumAge: 30 Years stdAges: ADULT facility: University of Sharjah city: Sharjah zip: 0000 country: United Arab Emirates name: Ibrahim Mostafa Abuamr, professor role: CONTACT email: iabuamr@sharjah.ac.ae name: Shima Zadeh, Research Assistant role: SUB_INVESTIGATOR name: Ibrahim Mostafa Abuamr, Professor role: PRINCIPAL_INVESTIGATOR lat: 25.33737 lon: 55.41206 hasResults: False
<\|newrecord\|> nctId: NCT06323733 id: 2CAPA briefTitle: Exercise Intervention for Patients With Cancer Cachexia: Effects of a 12-week Program and One-year Follow-up. acronym: 2CAPA overallStatus: ENROLLING_BY_INVITATION date: 2024-01-01 date: 2026-01 date: 2026-01 date: 2024-03-21 date: 2024-03-21 name: Peyrachon Romane class: OTHER briefSummary: The prevalence of cancer with cachexia is rising sharply. More than 80% of digestive cancer patients are affected by cancer cachexia. Cachexia leads to weight loss, and reduces quality of life (QoL), cancer treatment response and survival. Exercise could counteract the deleterious effects of cachexia. The 2CAPA study aims to assess the effectiveness of a 12-week exercise program on various symptoms associated with cancer cachexia, including Health-Related QoL (HRQoL), fatigue, appetite, body composition, physical fitness, and physical activity levels. Additionally, it seeks to examine compliance with the exercise program, identify barriers to regular exercise and determine how compliance influences physical and psychological effects. Furthermore, this study aims to determine the maintenance of physical activity levels and the effects post-program for one year follow-up on cachexia-related symptoms.
Methods: This study will include 31 cancer patients with cachexia. Participants will receive a supervised exercise program lasting 12-weeks with two sessions per week combining endurance and resistance training. Outcomes include HRQoL, fatigue, appetite, anthropometric parameters, physical performances, and physical activity levels at baseline, at the end of the 12-week exercise program, and at 3-, 6- and 12- months post-intervention. conditions: Cachexia-Anorexia Syndrome studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 31 type: ESTIMATED name: Exercise Intervention measure: Health-Related Quality of Life measure: Body weight measure: Body mass index measure: Lean mass measure: Fat mass measure: Aerobic fitness measure: Muscular strength of the lower limbs measure: Handgrip strength measure: Static balance ability measure: Appetite measure: Cancer-related Fatigue measure: Physical Activity and Sedentary Levels measure: Stages of change for exercise measure: Exercise beliefs measure: Compliance to exercise intervention measure: Reasons for absence measure: Timing of absences measure: Fidelity to session duration measure: Fidelity to session intensity measure: Reasons to modify exercise sessions measure: Incidence of Adverse Events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: SPORMED city: Rennes state: Bretagne zip: 35000 country: France lat: 48.11198 lon: -1.67429 hasResults: False
<\|newrecord\|> nctId: NCT06323720 id: ONZ-2023-0442 briefTitle: Signs of Central Sensitization in Tension-type Headache acronym: CSTTH overallStatus: RECRUITING date: 2024-02-23 date: 2025-07 date: 2025-12 date: 2024-03-21 date: 2024-04-01 name: University Ghent class: OTHER briefSummary: The goal of this observational study is to assess the pain sensitivity in tension-type headache patients. The main question it aims to answer is:
- Are signs of central sensitization present in tension-type headache?
Participants will be asked to fill out baseline questionnaires and they will be assessed during 1 test moment (static and dynamic quantitative sensory testing).
Researchers will compare tension-type headache patients with healthy controls to see if signs of central sensitization are only present in the tension-type headache group. conditions: Tension-Type Headache studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 66 type: ESTIMATED name: Quantitative Sensory Testing measure: Pain sensitivity for heat stimuli measure: Pain sensitivity for cold stimuli measure: Pain sensitivity for electrical stimuli measure: Pain sensitivity for pressure measure: Function of the pain facilitating pathways measure: Function of the pain inhibiting pathways sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ghent University status: RECRUITING city: Ghent state: East-Flanders zip: 9000 country: Belgium name: Jessica Van Oosterwijck, Prof. role: CONTACT lat: 51.05 lon: 3.71667 hasResults: False
<\|newrecord\|> nctId: NCT06323707 id: IMPACT briefTitle: The IMPACT Implementation-Effectiveness Trial acronym: IMPACT overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2027-03-15 date: 2027-03-15 date: 2024-03-21 date: 2024-03-21 name: McMaster University class: OTHER name: Canadian Cancer Society (CCS) name: Hamilton Health Sciences Corporation name: Niagara Health System briefSummary: More Canadians are surviving cancer, however, individuals with cancer live with side effects for years after treatments have ended. The physical and psychosocial benefits of regular physical activity (PA) during and after cancer treatment are well established. However, less than 30% of individuals with cancer meet current PA recommendations and PA levels decline significantly during treatment. PA services within the cancer institution to support well-being during treatment are not available for survivors across Ontario. Strategies are needed within cancer centres to close the gap between the evidence and clinical practice.
What is the purpose? To evaluate the effectiveness of a novel exercise and education strategy for individuals with cancer during treatment.
What are we proposing to do? This project includes two parts. In Part 1 participants will be put into one of three groups. Group 1 (Exercise \& self-management) will include eight sessions of supervised, institution-based exercise and self-management education. Group 2 (self-management only) will include eight virtual self-management education sessions with an exercise professional. Group 3 will receive usual care (i.e., no intervention).
In Part 2 participants who attended less than 75% of their sessions will be asked to complete an interview on the barriers to continuing with the study during cancer treatment.
Why is this work important? Findings from this trial will inform the way PA services are provided within cancer institutions across Ontario. This novel strategy incorporates both institution-based and home-based exercise strategies during treatment and highlights the importance of individuals with cancer taking an active role in managing their condition during treatment. This can prevent future complications and decrease burden on the individual and the healthcare system. Results will inform future decisions on PA implementation strategies for cancer survivors with diverse needs across Ontario. conditions: Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 129 type: ESTIMATED name: Exercise name: Self-management e-module measure: Physical activity level measure: Physical activity level measure: Physical activity level measure: Quality of life measure: Quality of life measure: Quality of life measure: Level of exercise knowledge measure: Level of exercise knowledge measure: Level of exercise knowledge measure: Health status measure: Health status measure: Health status measure: Aerobic capacity measure: Aerobic capacity measure: Aerobic capacity measure: Cardiovascular outcomes - Blood pressure measure: Cardiovascular outcomes - Blood pressure measure: Cardiovascular outcomes - Blood pressure measure: Cardiovascular outcomes - Heart rate measure: Cardiovascular outcomes - Heart rate measure: Cardiovascular outcomes - Heart rate measure: Health care utilization measure: Health care utilization measure: Health care utilization sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06323694 id: Attesa chirurgia-1 briefTitle: Quality of Life, Expectations, Thoughts and Fears of Patients on the Waiting List for Spinal Surgery acronym: chirurgia-1 overallStatus: COMPLETED date: 2022-05-15 date: 2024-01-25 date: 2024-02-16 date: 2024-03-21 date: 2024-04-16 name: Istituto Ortopedico Rizzoli class: OTHER name: University of Bologna briefSummary: The objective of this qualitative prospective observational study is to analyze the cognitive aspect, the emotional-behavioral state and the quality of life of patients during their stay on the waiting list for two categories of lumbar spinal surgery: arthrodesis and percutaneous vertebroplasty.
Hypothesis:
Considering the existing evidence that associates some peculiar psychological components (expectations, beliefs, fears, coping strategies) of the patient and the outcome of spinal surgery, as well as the importance that the waiting time for the intervention assumes for recovery post-operative, this study aims to investigate the subjective perception of one's condition and the waiting period prior to the expected spinal surgery.
This is a qualitative prospective observational study, monocentric with variable sample up to the level of saturation. The blind members are the staff who will listen to the recordings of the interviews and prepare the summary table of the same and the statistical researcher who will perform the analyzes.
The selection of the participants will be carried out in such a way as to ensure a heterogeneous sample in terms of age, sex and experience and as representative as possible of the population studied.
The number of participants in qualitative studies is usually determined by intentional sampling, based on the need to understand the full range of possible responses, to obtain the so-called data saturation.
All patients on the waiting lists of the Department of Spinal Surgery, for vertebral arthrodesis or percutaneous vertebroplasty are considered eligible.
The two types of surgery differ both in the surgical procedure and in the duration of the wait before surgery, which is 1-2 months for vertebroplasty and more than one year for spinal arthrodeses which are not of urgency or priority. conditions: Spinal Surgery studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 15 type: ACTUAL name: quality of life measure: Descriptive survey for vertebroplasty patients measure: Descriptive survey for spinal arthrodeses patients sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Istituto Ortopedico Rizzoli city: Bologna zip: 40136 country: Italy lat: 44.49381 lon: 11.33875 hasResults: False
<\|newrecord\|> nctId: NCT06323681 id: Leading Study briefTitle: Pegylated Interferon α in Previously Interferon-treated CHB（Leading Study） overallStatus: RECRUITING date: 2024-02-04 date: 2027-02 date: 2027-08 date: 2024-03-21 date: 2024-03-21 name: Qing XIe class: OTHER briefSummary: Previous clinical practice and exploratory studies suggest that some patients who have not achieved functional cure in the first round of interferon therapy can achieve HBsAg clearance by interferon retreatment (intermittent therapy), which can reduce the occurrence of complications such as liver fibrosis, liver cirrhosis and liver cancer, and its clinical benefit is expected to be higher than that of NAs monotherapy.
This study is aimed to conduct a large-scale, multicenter, prospective study to confirm the benefit of peginterferon-based therapies in these populations. It expected to enroll about 2000 patients with chronic hepatitis B who have received prior interferon therapy and achieved a good response but without function cure, patients receive either interferon-based therapy or NAs monotherapy, according to their wishes and doctors' professional recommendations, with a ratio of 2:1 between the two groups, and all patients treated for 48 weeks. The HBsAg clearance rate before and after treatment, safety, etc. will be analyzed. conditions: Chronic Hepatitis b studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 2016 type: ESTIMATED name: Peginterferon α-2b based treatment group name: NAs monotherapy group measure: Proportion of patients with HBsAg below the lower limit of detection. measure: Decrease of HBV DNA levels at week 48 compared to baseline. measure: Proportion of patients with HBV DNA below the lower limit of detection. measure: Decrease of HBsAg levels at week 48 compared to baseline. measure: Proportion of patients with HBsAg seroconversion. measure: Proportion of patients with HBeAg below the lower limit of detection for patients with baseline HBeAg positive. measure: Proportion of patients with HBeAg seroconversion for patients with baseline HBeAg positive. measure: Serious adverse events. sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Infectious Diseases , Ruijin Hospital, Shanghai Jiao Tong University School of Medicine status: RECRUITING city: Shanghai state: Shanghai country: China name: Qing Xie, MD, PhD. role: CONTACT phone: 0086-021-64370045 phoneExt: 680403 email: xieqingrjh@163.com name: Honglian Gui, MD,PhD role: CONTACT phone: 0086-021-64370045 phoneExt: 680419 email: lillian_ghl@163.com name: Qing Xie, MD, PhD. role: PRINCIPAL_INVESTIGATOR lat: 31.22222 lon: 121.45806 hasResults: False
<\|newrecord\|> nctId: NCT06323668 id: H-23067693 briefTitle: Cardiac Implantable Electronic Device remOval Versus Full coUrse Medical Treatment acronym: CIEDOUT overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2028-06 date: 2038-01-31 date: 2024-03-21 date: 2024-03-21 name: Rigshospitalet, Denmark class: OTHER briefSummary: The CIEDOUT study is an open label randomized trial in patients with possible cardiac implantable electronic device (CIED) infection.
The hypothesis is that CIED removal + guideline antibiotic therapy is better than 6-weeks antibiotic therapy alone in preventing death or relapse of bacteremia in patients with bacteremia and possible CIED infection (not definite CIED infection).

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