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<|newrecord|> nctId: NCT06302855 id: 2024-00124 briefTitle: Exploring Adherence and Knowledge Among Diabetic Individuals in Periodontal Care overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2026-03-01 date: 2026-09-01 date: 2024-03-12 date: 2024-03-12 name: Karim Gariani class: OTHER briefSummary: Objective(s) The primary objective is to evaluate the adherence of diabetic patients to periodontal care, accomplished either through oral communication (group A, control) or through a photograph of their smile, and focusing on their gum health evaluated by a periodontist (group B, test).
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Secondary objectives include assessing the prevalence of periodontal disease (PD) in this diabetic sample population and evaluating the presence of specific biomarkers related to it.
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The final objective is to assess the agreement between the diagnosis of periodontitis based on the photographs and the diagnosis given after the dental visit, based on the clinical examination. The aim is to determine if the photos could potentially serve as a reliable indicator for periodontal risk assessment. conditions: Periodontitis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: NONE count: 180 type: ESTIMATED name: dental expertise measure: adherence of diabetic patients to periodontal measure: calculate the prevalence of periodontitis sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06302842 id: 20J201 briefTitle: Pilot Open Label Study With Commercial Supplementation in Healthy Subjects acronym: AUXNUTRIMMUN overallStatus: ACTIVE_NOT_RECRUITING date: 2023-07-01 date: 2023-10-15 date: 2024-04-30 date: 2024-03-12 date: 2024-03-19 name: Istituto Auxologico Italiano class: OTHER briefSummary: A bidirectional relationship among nutrition, infection and immunity exists: changes in one component affect the others. Various micronutrients are essential for immunocompetence, particularly vitamins A, C, D, E, B2, B6, and B12, folic acid, iron, selenium, and zinc. Micronutrient deficiencies are a recognized global public health issue, and poor nutritional status predisposes to certain infections. Immune function may be improved by restoring deficient micronutrients to recommended levels, thereby increasing resistance to infection and supporting faster recovery when infected. Diet alone may be insufficient and tailored micronutrient supplementation based on specific age-related needs is necessary.
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Aim of the study is to investigate whether nutrient supplementation may affect different functional parameters of the innate and adaptive immunity. conditions: Supportive Care studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 15 type: ACTUAL name: Bioritmon Immuno Defend measure: Change in neutrophil chemotaxis measure: Change in neutrophil phagocytosis measure: Change in neutrophil oxidative burst measure: Change in mononuclear CD4pos69pos measure: Change in mononuclear CD56pos69pos granzymepos measure: Change in plasma cytokine levels sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Istituto Auxologico Italiano IRCCS city: Milan zip: 20145 country: Italy lat: 45.46427 lon: 9.18951 hasResults: False
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<|newrecord|> nctId: NCT06302829 id: RiphahIU Shafia Anjum briefTitle: Comparison of IMES Versus DN on ATrPs of AC overallStatus: RECRUITING date: 2024-01-21 date: 2024-06-30 date: 2024-07-30 date: 2024-03-12 date: 2024-03-12 name: Riphah International University class: OTHER briefSummary: The aim of our study to compare DN and IMES for pressure pain threshold, ROM and the shoulder function in active trigger points with adhesive capsulitis. This study will add to the growing body of knowledge that if these two techniques yield comparable outcomes and if one technique is superior to the other, which should be the alternative of therapy. Moreover, it would add to the society as there are very limited researches done in Pakistan using needling for trigger points in adhesive capsulitis. conditions: Shoulder Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE maskingDescription: randomized whoMasked: PARTICIPANT count: 44 type: ESTIMATED name: Dry needling name: intramusuar electrical stimulation measure: Algometer (pressure pain threshold) measure: ROM Shoulder (Flexion) measure: ROM Shoulder (Abduction) measure: ROM Shoulder (External rotation) measure: ROM Shoulder (Internal Rotation) measure: ASES Questionnaire; (American shoulder and elbow surgeons scale) sex: ALL minimumAge: 30 Years maximumAge: 60 Years stdAges: ADULT facility: Railway general hopsital status: RECRUITING city: Rawalpindi state: Punjab zip: 46000 country: Pakistan name: Aneela zia, MS-OMPT role: CONTACT phone: +923365869031 email: aneela.zia@riphah.edu.pk name: Shafia Anjum, MS-OMPT role: PRINCIPAL_INVESTIGATOR lat: 33.6007 lon: 73.0679 hasResults: False
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<|newrecord|> nctId: NCT06302816 id: REC/RCR&AHS/23/0580 briefTitle: Effects of Tupler and Scoop Exercises in Diastasis Recti overallStatus: RECRUITING date: 2023-02-23 date: 2024-08-01 date: 2024-09-01 date: 2024-03-12 date: 2024-03-12 name: Riphah International University class: OTHER briefSummary: To compare the effects of tupler and scoop exercises on inter recti distance, low back pain, abdominal strength and urogynecological symptoms in diastasis. conditions: Diastasis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 30 type: ESTIMATED name: TUPLER exercises name: SCOOP EXERCISES measure: Digital nylon calipers for inter recti distance (IRD) measure: NPRS for low back pain measure: Manual muscle testing for intra-abdominal strength measure: Short form Pelvic Floor Distress Inventory for Urogynaecological symptoms sex: FEMALE minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: Innovative Health Concepts status: RECRUITING city: Lahore zip: 05499 country: Pakistan name: hina gul gul role: CONTACT phone: 03214979172 email: hina.gul@riphah.edu.pk name: Rutaba Hussain, MSPT(WH) role: PRINCIPAL_INVESTIGATOR lat: 31.558 lon: 74.35071 hasResults: False
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<|newrecord|> nctId: NCT06302803 id: NFEC-2024-033 briefTitle: Modified Intermittent Eating on Weight Loss (INTEREST-3 Trial) acronym: INTEREST-3 overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-12-31 date: 2027-07-01 date: 2024-03-12 date: 2024-04-02 name: Nanfang Hospital, Southern Medical University class: OTHER briefSummary: Calorie restriction (CR) is the most important treatment for weighting loss. In recent years, two novel types of intermittent fasting recently have gained more attention: the 5:2 diet and time-restricted eating (TRE). TRE requires individuals to eat in a specified number of hours per day (typically 4 to 10 hours) without energy intake restriction. The 5:2 diet involves 5 feast days and 2 fast days per week; participants eat ad libitum without restriction on feast days while 25% of energy needs (approximately 500-800 kcal per day) are consumed on fast days. However, the effects of dietary strategy of intermittent fasting plus time-restricted eating (modified time-restricted eating: TRE 5 days and fasting 2days per week) on weight loss and cardiometabolic risk factors in obese adults have not been proved. This randomized controlled trial aimed to evaluate the effect of modified time-restricted eating (mTRE) and CR on weight loss and cardiometabolic risk factors in obese adults compared to usual health care over 12 months. conditions: Obesity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 225 type: ESTIMATED name: Intermittent fasting plus time-restricted eating name: Calorie restriction measure: Change in body weight over 12 months measure: Change in body mass index （BMI） measure: Change in waist circumference measure: Change in body fat composition meassured by DEXA measure: Change in liver fat measure: Change in systolic blood pressure measure: Change in diastolic blood pressure measure: Change in concentration of serum triglyceride measure: Change in concentration of serum total cholesterol measure: Change in concentration of serum LDL-c measure: Change in concentration of HbA1c measure: Change in insulin sensitivity measure: Change in β cell function measure: Change in arterial stiffness measured by pulse wave velocity measure: Change in depression score measured by the Patient Health Questionnaire-9 measure: Change in quality of sleep score measured by the Pittsburgh sleep quality index measure: Change in quality of life score measured by the 12-item Short-Form Health Survey Questionnaire sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Nanfang Hospital of Southern Medical University city: Guangzhou state: Guangdong zip: 510515 country: China lat: 23.11667 lon: 113.25 hasResults: False
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<|newrecord|> nctId: NCT06302790 id: AcuteMolliiSuitEffects briefTitle: Examination of the Acute Effect of Mollii Suit in Children With Cerebral Palsy overallStatus: RECRUITING date: 2024-03-01 date: 2025-03-01 date: 2025-05-01 date: 2024-03-12 date: 2024-03-12 name: Kırıkkale University class: OTHER name: Gazi University briefSummary: The aim of our study is to examine the acute effect of Mollii Suit application on balance and muscle tone problems in children with spastic cerebral palsy. conditions: Mollii Suit conditions: Cerebral Palsy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: The statistician in the study and the physiotherapist performing the evaluation will be blinded. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: Molli Suit Apply measure: Gross Motor Function Classification System (GMFCS) measure: Modified Tardiue Scale (MTS) measure: Modifiye Modified Ashworth Scale (MAS) measure: NMC Tests with Seansamove Sensbalance sex: ALL minimumAge: 4 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Gazi University status: RECRUITING city: Ankara country: Turkey name: Kübra Uğurlu role: CONTACT phone: +905077295353 email: kubra.ozdamar06@gmail.com lat: 39.91987 lon: 32.85427 hasResults: False
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<|newrecord|> nctId: NCT06302777 id: 2023-1184 briefTitle: MAIN-IMAGE Registry acronym: MAIN-IMAGE overallStatus: RECRUITING date: 2023-09-26 date: 2028-09-26 date: 2031-09-26 date: 2024-03-12 date: 2024-03-12 name: Goethe University class: OTHER briefSummary: All comers registry with patients with chronic coronary syndrome or acute coronary syndrome who underwent intracoronary imaging during cardiac catherization. The aim is to identify plaque characteristics on OCT or IVUS that are associated with adverse cardiac events including myocardial infarction and atherosclerotic progression. conditions: Coronary Artery Disease studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 500 type: ESTIMATED measure: Major adverse cardiovascular Events (MACE) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Frankfurt University Hospital status: RECRUITING city: Frankfurt state: Hesse zip: 60590 country: Germany name: Lena Seegers role: CONTACT phone: +496963016666 lat: 50.11552 lon: 8.68417 facility: Frankfurt University Hospital status: RECRUITING city: Frankfurt country: Germany name: Lena Seegers role: CONTACT lat: 50.11552 lon: 8.68417 hasResults: False
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<|newrecord|> nctId: NCT06302764 id: WZiKS.4.1.2023.2 id: WZiKS.4.1.2023 type: OTHER_GRANT domain: Jagiellonian University in Kraków briefTitle: Emergency Medical Staff Workload Analysis overallStatus: RECRUITING date: 2023-10-01 date: 2024-04-20 date: 2024-06-30 date: 2024-03-12 date: 2024-04-16 name: Jagiellonian University class: OTHER briefSummary: The aim of this study is to identify trauma determinants and leverage this understanding to develop solutions applicable to the prevention and treatment of PTSD among emergency medical personnel. By categorizing stimuli associated with traumatic professional experiences, the study aims to enhance existing therapeutic protocols through exposure therapy. The specific objectives are as follows:
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1. Analysis and characterization of occupational workloads among doctors and emergency medical personnel, focusing on the scale of burdens associated with PTSD symptoms.
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2. Development of categories for aggravating and potentially traumatizing stimuli within the medical staff of rescue teams.
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3. Examination of the feasibility of incorporating the obtained results into cognitive-behavioral therapy protocols.
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4. Assessment of the potential for implementing the results in solutions utilizing virtual reality technology.
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5. Formation of an interdisciplinary international research team. conditions: Stress conditions: Work Related Stress conditions: PTSD conditions: Mental Stress conditions: Medical Emergencies studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: CROSS_SECTIONAL count: 400 type: ESTIMATED name: Qualitative & Quantitative Research measure: Focused Interview measure: Posttraumatic Stress Disorder Checklist (PCL-5) measure: Patient Health Questionnaire (PHQ-9) measure: Depersonalization Mechanism Scale (DMS) sex: ALL minimumAge: 21 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Institute of Applied Psychology, Jagiellonian University in Krakow, Poland status: RECRUITING city: Krakow state: Małopolska zip: 30-348 country: Poland name: Krystyna Golonka, Prof role: CONTACT email: krystyna.golonka@uj.edu.pl name: Katarzyna Sitnik-Warchulska, PhD role: CONTACT email: katarzyna.sitnik-warchulska@uj.edu.pl name: Krystyna Golonka, Prof role: PRINCIPAL_INVESTIGATOR name: Katarzyna Sitnik-Warchulska, PhD role: SUB_INVESTIGATOR name: Dominika Fortuna, MS role: SUB_INVESTIGATOR lat: 50.06143 lon: 19.93658 facility: University of Coimbra status: RECRUITING city: Coimbra country: Portugal name: João Ferreira, PhD role: CONTACT email: naquelepordosol@gmail.com name: João Ferreira, PhD role: SUB_INVESTIGATOR lat: 40.20564 lon: -8.41955 facility: Bogomolets National Medical University status: RECRUITING city: Kyiv country: Ukraine name: Sergii Tukaiev, PhD role: CONTACT email: tsv.serg.69@gmail.com name: Borys Palamar, Prof role: CONTACT email: palamar.bi@ukr.net name: Borys Palamar, Prof role: SUB_INVESTIGATOR name: Sergii Tukaiev, PhD role: PRINCIPAL_INVESTIGATOR lat: 50.45466 lon: 30.5238 hasResults: False
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<|newrecord|> nctId: NCT06302751 id: 3647 briefTitle: A Mobile Application to Improve Postoperative Outcomes in Colorectal Cancer acronym: RAISe-Care overallStatus: RECRUITING date: 2024-02-26 date: 2026-02-26 date: 2026-08-31 date: 2024-03-12 date: 2024-03-15 name: Istituto Clinico Humanitas class: OTHER briefSummary: The unplanned readmission rate after colorectal cancer surgery is still high, despite the implementation of enhanced recovery programs. The use of a mobile-based application for perioperative remote monitoring may improve the postoperative outcomes and reduce the unplanned postoperative readmissions. conditions: Colorectal Cancer conditions: Surgery studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Single-center, prospective, interventional case-series study with a historical cohort of comparison primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 600 type: ESTIMATED name: Care 4 Today ® (Johnson and Johnson) mobile app measure: Unplanned hospital readmissions measure: Severity of postoperative complications measure: Length of hospital stay measure: Time from symptoms onset to diagnosis measure: Healthcare costs sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Humanitas Research Hospital status: RECRUITING city: Rozzano state: MI zip: 20089 country: Italy name: Annalisa Maroli, PhD role: CONTACT phone: 02 8224 7776 phoneExt: 0039 email: colorapp@humanitas.it name: Stefano De Zanet, MS role: CONTACT phone: 02 8224 4623 phoneExt: 0039 email: colorapp@humanitas.it lat: 45.38193 lon: 9.1559 hasResults: False
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<|newrecord|> nctId: NCT06302738 id: 09C221 briefTitle: Phenotypisation of Sleep Pattern in Hypertensive Patients With Non Dipper Pattern acronym: INTO-DIP overallStatus: RECRUITING date: 2023-05-04 date: 2024-12-31 date: 2024-12-31 date: 2024-03-12 date: 2024-04-16 name: Istituto Auxologico Italiano class: OTHER briefSummary: High blood pressure is the most common modifiable risk factor for cardiovascular diseases (CV). The large interindividual variability in clinical expression of the disease and response to treatment, however, makes the management of the hypertensive patient complex.Therefore, identifying phenotypes of hypertensive patients associated with a specific CV outcome or who tend to respond/not respond to treatment is of paramount importance for improving CV prevention.
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It has been shown that the phenotype of hypertensive patient with poor control of nighttime blood pressure values, especially when associated with a "non-dipper" profile, was associated with an increased risk of developing CV and cerebrovascular complications.
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The non-dipper profile and nocturnal hypertension are caused by several factors including excessive salt intake and dysautonomia. However, they are also inevitably influenced by sleep duration and the presence of sleep disorders: obstructive sleep apnea (OSA), but also insomnia and periodic movements of the lower limbs,such as those frequently seen in restless legs syndrome, are among the the main determinants related to altered nighttime pressure pattern. However, such disturbances are not systematically assessed during the performance of monitoring 24h pressor and their impact in the outcome of the hypertensive patient is unknown.
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The primary objective of this study is to phenotype non-dipper patients with or without nocturnal hypertension to determine the prevalence of sleep disorders such as sleep apnea syndrome, insomnia, and restless legs syndrome (RLS) (OSA diagnosed considering AHI\>5 events/hour, insomnia and RLS according to ICSD 3 criteria) and correlate the presence of various sleep disorders with cardiac organ damage, vascular, and renal damage mediated by hypertension. conditions: Hypertension conditions: Sleep Disorder studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 143 type: ESTIMATED name: polysomnography measure: Prevalence of sleep disorders sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UOSD Ipertensione Arteriosa "A.M. Pirrelli" - AUOC Policlinico di Bari, University of Bari, status: RECRUITING city: Bari state: Italy, Bari zip: 70120 country: Italy name: Sebastiano Cicco, MD role: CONTACT email: sebastiano.cicco@uniba.it lat: 41.11148 lon: 16.8554 facility: Azienda Sanitaria Locale della provincia di Brindisi status: RECRUITING city: Brindisi state: Italy, Brindisi zip: 72100 country: Italy name: Luigi Vernaglione, MD role: CONTACT phone: 003908311882006 lat: 40.63215 lon: 17.93607 facility: Medicina Interna 1, Ambulatorio Ipertensione e Malattie Metaboliche AOU "Maggiore della carità"- Novara status: RECRUITING city: Novara state: Italy, Novara zip: 28100 country: Italy lat: 45.44694 lon: 8.62118 facility: Padova 1- Clinica Medica 3 · Dipartimento di Medicina · Azienda Ospedaliera di Padova, Italy status: RECRUITING city: Padova state: Italy, Padova zip: 35128 country: Italy name: Maria Teresa Seccia, MD, PhD role: CONTACT phone: 00390498212263 email: teresamaria.seccia@unipd.it lat: 45.40797 lon: 11.88586 facility: Padova 2 - UOC Medicina d'urgenza, Centro Regionale Specializzato per l'ipertensione arteriosa OSA - Azienda ospedaliera Università di Padova, Italy status: RECRUITING city: Padova state: Italy, Padova zip: 35128 country: Italy name: Giuseppe Maiolino, MD role: CONTACT phone: 00390498212872 email: giuseppe.maiolino@gmail.com lat: 45.40797 lon: 11.88586 facility: UO Cardiologia, UO Pneumologia, Presidio Ospedaliero Cittadella, Azienda ULSS 6 Euganea, Cittadella, Italy. status: NOT_YET_RECRUITING city: Cittadella state: Italy, PD zip: 35013 country: Italy name: Francesca Saladini, MD role: CONTACT phone: 00390499424531 email: francesca.saladini@alss6.veneto.it lat: 45.64523 lon: 11.78453 facility: Azienda Unità Sanitaria Locale-IRCCS di Reggio Emilia- S.O.S Centro per la Cura dell'Ipertensione Arteriosa- Medicina II Cardiovascolare status: NOT_YET_RECRUITING city: Reggio Emilia state: Italy, RE zip: 42122 country: Italy name: Chiara Grasselli, MD role: CONTACT email: chiara.grasselli@ausl.re.it lat: 44.69825 lon: 10.63125 facility: Azienda Provinciale per i Servizi Sanitari, Provincia Autonoma di Trento- UO Medicina interna - Rovereto status: NOT_YET_RECRUITING city: Rovereto state: Italy, Trento zip: 38068 country: Italy name: Francesco Dalle Vedove, MD role: CONTACT lat: 45.8904 lon: 11.04053 facility: Azienda sanitaria universitaria Giuliano-Isontina (ASU-GI)- SC (UCO) Medicina Clinica status: NOT_YET_RECRUITING city: Trieste state: Italy, Trieste zip: 34128 country: Italy name: Andrea Grillo, MD, PhD role: CONTACT phone: 00390403994619 email: andrea.grillo@asugi.sanita.fvg.it lat: 45.64953 lon: 13.77679 facility: Department of Medicine, University of Verona, Verona, Italy status: RECRUITING city: Verona state: Italy, Verona zip: 37126 country: Italy name: Cristiano Fava, MD, PhD role: CONTACT phone: 00390458124732 email: cristiano.fava@univr.it lat: 45.4299 lon: 10.98444 facility: Istituto Auxologico Italiano IRCCS status: RECRUITING city: Milano state: MI zip: 20149 country: Italy name: Martino Pengo, MD, PhD role: CONTACT phone: 00390261911 email: m.pengo@auxologico.it name: Elisa Nardin role: CONTACT phone: 00390261911 email: e.nardin@auxologico.it name: Gianfranco Parati, MD role: PRINCIPAL_INVESTIGATOR lat: 45.46427 lon: 9.18951 hasResults: False
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<|newrecord|> nctId: NCT06302725 id: APHP231514 id: 2023-A02623-42 type: OTHER domain: IDRCB briefTitle: Vaginal Self-sampling for Detecting High-risk Human Papillomavirus Cervical Infection in Patients With Immune-mediated Inflammatory Diseases acronym: APOSY overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2026-03 date: 2027-03 date: 2024-03-12 date: 2024-03-12 name: Assistance Publique - Hôpitaux de Paris class: OTHER briefSummary: Main objective: -To determine Human Papilloma Virus (HPV) prevalence in patients with immune-mediated inflammatory diseases (IMID) using vaginal self-sampling (VSS), one year after VSS was proposed Primary endpoint: - To determine the prevalence of HPV infection (yes/no) after VSS proposal Secondary objectives: - To describe the HPV typology and the rate of co-infection (with several high-risk HPV (HR-HPV)) in this population - To describe the factors associated with the presence of HPV infection - To determine the rate of HPV clearance after one year, during the second screening at 12 months- To determine the percentage of pre-cancerous cervical lesions and cervical cancer in the event of subsequent cervical smear - To determine the factors associated with persistence (or non-clearance ) of HPV infection - To determine the factors associated with the presence of pre-cancerous and cancerous cervical lesions - To determine the characteristics, tolerance and acceptability of VSS - To determine the rate of cervical cancer screening carried out following French Health Authorities guidelines -To determine the HPV vaccination coverage Secondary endpoints: 1/ HPV typology and presence of co-infection (Yes/No, type) or HPV multi-infection (more than 2 HPV, Yes/No) identified on samples at inclusion and at 1 year. 2/ Explanatory variables: demographic, clinical, biological factors and treatments (corticoids, immunosuppressive treatments); variable to be explained: presence of HPV infection during follow-up. 3/ Characteristics, acceptability, obstacles and tolerance of VPA reported by self-questionnaire (including procedure failures, bleeding and pain). 4/ Up-to-date cervical cancer screening rate in accordance with HAS recommendations at 12 months post-procedure. 5/ Proportion of cervical cytological abnormalities and cervical cancer authenticated on cervico-vaginal smear, if performed (histological confirmation if available) during follow-up. 6/ Explanatory variables: demographic, clinical, biological factors and treatments (corticoids, immunosuppressants; variable to be explained: presence of cervical precancerous lesions and cervical cancer, authenticated on cervico-vaginal smear, if performed (histological confirmation if available) during follow-up. 7/ HPV vaccination coverage rate (measured on initial self-questionnaire) 8/ Prevalence of HR-HPV(s) at second screening at one year, in the case of initial positivity (Persistence of HPV infection (Yes/No). 9/ Explanatory variables: demographic, clinical, biological factors and treatments (corticoids, immunosuppressive treatments); variable to be explained: persistence of cervical HPV infection at one year (in the case of initial positivity). conditions: HPV Infection conditions: Systemic Disease studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE count: 300 type: ESTIMATED name: Vaginal self sampling detecting HPV measure: prevalence of HPV infection (yes/no) after VSS proposal measure: the HPV typology of co-infection (with several high-risk HPV (HR-HPV)) in this population measure: The rate of co-infection (with several high-risk HPV (HR-HPV)) in this population measure: Presence of HPV infection during follow-up (yes/no) measure: description of demographic factor measure: description of clinical factor measure: description of biological factor measure: description of treatment (corticoids, immunosuppressive treatments) measure: description of characteristics of VPA reported by self-questionnaire (including procedure failures, bleeding and pain). measure: description of acceptability of VPA reported by self-questionnaire (including procedure failures, bleeding and pain). measure: description of tolerance of VPA reported by self-questionnaire (including procedure failures, bleeding and pain). measure: description obstacles of VPA reported by self-questionnaire (including procedure failures, bleeding and pain). measure: Up-to-date cervical cancer screening rate in accordance with HAS recommendations measure: Proportion of cervical cytological abnormalities if performed (histological confirmation if available) measure: proportion of cervical cancer authenticated on cervico-vaginal smear, if performed (histological confirmation if available) measure: presence of cervical precancerous lesions and cervical cancer measure: HPV vaccination coverage rate measure: Persistence of HPV infection sex: FEMALE minimumAge: 30 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Service de Médecine Interne - Hôpital Bichat Claude Bernard city: Paris zip: 75018 country: France name: Tiphaine Goulenok, MD role: CONTACT phone: 00 33 1 40 25 72 89 email: tiphaine.goulenok@aphp.fr lat: 48.85341 lon: 2.3488 hasResults: False
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<|newrecord|> nctId: NCT06302712 id: TIIP briefTitle: Traditional Islamically Integrated Psychotherapy for Muslims With OCD in Pakistan overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-10-01 date: 2024-11-30 date: 2024-03-12 date: 2024-03-18 name: International Islamic University Malaysia class: OTHER name: Foundation University Islamabad briefSummary: The current study aims to determine the effectiveness of the first culturally adapted Traditional Islamically Integrated Psychotherapy (TIIP) for Muslims with OCD in Pakistan along with the module effectiveness in reducing OCD symptoms with comorbidities like anxiety, depression, stress, thought control, thought-action fusion, and enhancing the spiritual quality of life of participants. conditions: Obsessive-Compulsive Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 60 type: ESTIMATED name: Traditional Islamically Integrated Psychotherapy measure: Yale Brown Obsessive Compulsive Scale measure: Depression, Stress, Anxiety measure: Thought Action Fusion measure: Thought Control measure: Spiritual Quality sex: ALL minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06302699 id: UCAD-MM-001 briefTitle: Detecting Minimal Residual Diseases (MRD) and Monitoring Clonal Evolution Using Ultrasensitive Chromosomal Aberrations Detection (UCAD) in Multiple Myeloma overallStatus: RECRUITING date: 2023-05-01 date: 2024-05-01 date: 2026-03-01 date: 2024-03-12 date: 2024-03-12 name: Institute of Hematology & Blood Diseases Hospital, China class: OTHER briefSummary: The presence of minimal residual disease (MRD) is an important prognostic factor for multiple myeloma, while copy number variation (CNV) is a widely accepted biomarker used for multiple myeloma (MM). Detecting MRD and monitoring clonal evolution by monitoring CNV using low-pass whole genome sequencing is promising due to its high analytical sensitivity. To evaluate the correlation between MRD detected by flow cytometry and low-pass whole genome sequencing, nearly 200 samples were collected for this study. We applied ultrasensitive chromosomal aberrations detection to detect CNV for each patient. The follow-up samples were then collected and sequencing used the same method. conditions: Multiple Myeloma studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: RETROSPECTIVE count: 80 type: ESTIMATED measure: Detection of copy number variation measure: Serial monitoring of treatment response sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06302686 id: INRCA_004_2023 briefTitle: engAGE: Managing cognitivE decliNe throuGh Theatre Therapy, Artificial Intelligence and Social Robots drivEn Interventions acronym: engAGE overallStatus: RECRUITING date: 2023-10-09 date: 2024-06-24 date: 2024-06-24 date: 2024-03-12 date: 2024-03-12 name: Istituto Nazionale di Ricovero e Cura per Anziani class: OTHER name: European Union briefSummary: The objectives of the engAGE project are to counteract and slow down cognitive decline progression, to enhance the intrinsic capacity of the users, and to support the wellbeing of older persons with mild cognitive impairment (MCI) by providing an ecosystem of services based on an innovative system that integrates social robots. conditions: Mild Cognitive Impairment conditions: Older Adults studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 78 type: ESTIMATED name: engAGE system name: Group practicing with only the support of a booklet measure: Change in perceived stability of cognitive status by the older adults measure: Change in cognitive impairment in older adults measure: Change in depression in older adults measure: Change in frailty status in older adults measure: Change in mental well being in older adults measure: Change in quality of life in older adults measure: Change in acceptability of the engAGE system in older adults measure: Change in quality of life in informal caregivers measure: Change in mental well being in informal caregivers measure: Change in caregiver burden sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: IRCCS INRCA Hospital status: RECRUITING city: Ancona zip: 60127 country: Italy name: Elvira Maranesi role: CONTACT name: Roberta Bevilacqua role: PRINCIPAL_INVESTIGATOR lat: 43.5942 lon: 13.50337 facility: Karde A/S status: RECRUITING city: Oslo country: Norway name: Terje Grimstad role: CONTACT name: Terje Grimstad role: PRINCIPAL_INVESTIGATOR lat: 59.91273 lon: 10.74609 facility: HUG status: RECRUITING city: Geneva country: Switzerland name: Christian Lovis role: CONTACT name: Christian Lovis role: PRINCIPAL_INVESTIGATOR lat: 46.20222 lon: 6.14569 hasResults: False
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<|newrecord|> nctId: NCT06302673 id: 23081229 briefTitle: The Role Of Laserpuncture For Prevention Of Nausea And Vomiting Post Strabismus Surgery With General Anesthesia In Adult Patients overallStatus: RECRUITING date: 2023-10-09 date: 2024-10 date: 2024-10 date: 2024-03-12 date: 2024-03-12 name: Indonesia University class: OTHER briefSummary: This study to determine the effectiveness of a combination of pre-surgical laserpuncture with standard anti-emetic therapy for PONV symptoms in adult patients after strabismus surgery under general anesthesia compared to a combination of pre-surgical placebo laserpuncture with standard anti-emetic therapy. Research design using a double blinded randomized controlled trial (RCT) where research subjects and data takers who will be disguised. The research will be carried out in the Operation and Inpatient Room, Kirana Building, RSUPN Dr. Cipto Mangunkusumo (RSCM) with research subjects as adult patients undergoing strabismus surgery under general anesthesia. Assessment of nausea and vomiting using AVS ( Analog Visual Scale) consists of scoring using a score from 1-5 which indicates the severity of nausea and vomiting. conditions: Nausea and Vomiting, Postoperative studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Double blinded randomized controlled trial (RCT) primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 32 type: ESTIMATED name: Laserpuncture and anti emetic standar therapy name: Sham Laserpuncture and anti emetic standar therapy measure: Analog Visual Scale for nausea vomitting sex: ALL minimumAge: 18 Years maximumAge: 59 Years stdAges: ADULT facility: RSUPN Dr. Cipto Mangunkusumo status: RECRUITING city: Jakarta Pusat state: Jakarta country: Indonesia name: Yossie Faudina Putri, MD role: CONTACT phone: 6281290371481 email: yossie.dina2@gmail.com lat: -6.1818 lon: 106.8223 hasResults: False
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<|newrecord|> nctId: NCT06302660 id: 22/LO/0169 briefTitle: Profiling Microbiome Associated Metabolic Pathways in Oesophageal Cancer Survivors acronym: MAPLES overallStatus: RECRUITING date: 2022-03-09 date: 2024-06-01 date: 2025-06-01 date: 2024-03-12 date: 2024-04-18 name: Imperial College London class: OTHER name: Imperial College Healthcare NHS Trust name: West Hertfordshire Teaching Hospitals NHS Trust name: Barking, Havering and Redbridge University Hospitals NHS Trust briefSummary: The goal of this observational study is to learn about long term symptoms in oesophageal cancer survivors. The main question it aims to answer is are:
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* Study the changes in gut bacteria by examining saliva, stool and blood.
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* Investigate the products of bacteria in breath to develop a non-invasive breath test to detect the changes in gut bacteria.
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* Develop new strategies to treat this change and trial new treatments to improve quality- of-life in oesophageal cancer survivors.
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Participants will attend an outpatient clinic, fasted for at least 4 hours for collection of breath, saliva, blood, urine, stool and complete validated healthy-related quality-of-life questionnaires.
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Researchers will compare symptomatic and asymptomatic participants to detect the changes stated above. conditions: Oesophageal Cancer conditions: Quality of Life conditions: Bacterial Overgrowth studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 100 type: ESTIMATED name: Breath test name: Saliva sample name: Blood sample name: Urine sample name: Stool sample name: Health-related Quality of life questionnaires measure: Identify microbiome dysbiosis in saliva associated with long-term functional symptoms. measure: Identify microbiome dysbiosis in stool associated with long-term functional symptoms. measure: Identify underlying metabolic pathways associated with microbiome derived metabolites. measure: Develop a breath test to detect volatile biomarkers associated with microbiome dysbiosis. measure: Propose a strategy for treatment of long-term symptoms in oesophageal adenocarcinoma survivors. sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Barking, Havering and Redbridge University Hospitals NHS Trust status: RECRUITING city: London country: United Kingdom name: Munir Tarazi, MB BCh BAO MRCS MCh role: CONTACT phone: +44 (0)20 7594 8197 email: m.tarazi@imperial.ac.uk lat: 51.50853 lon: -0.12574 facility: Imperial College Healthcare NHS Trust status: RECRUITING city: London country: United Kingdom name: Munir Tarazi, MB BCh BAO MRCS MCh role: CONTACT phone: +44 (0)20 7594 8197 email: m.tarazi@imperial.ac.uk lat: 51.50853 lon: -0.12574 facility: West Hertfordshire NHS Teaching Hospitals status: RECRUITING city: London country: United Kingdom name: Munir Tarazi, MB BCh BAO MRCS MCh role: CONTACT phone: +44 (0)20 7594 8197 email: m.tarazi@imperial.ac.uk lat: 51.50853 lon: -0.12574 hasResults: False
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<|newrecord|> nctId: NCT06302647 id: PI-6022 briefTitle: Assessing Interest in Web/App Platforms for Early Phase Clinical Trial Recruitment overallStatus: NOT_YET_RECRUITING date: 2024-03-14 date: 2024-06-15 date: 2024-06-30 date: 2024-03-12 date: 2024-03-15 name: Instituto de Investigación Hospital Universitario La Paz class: OTHER briefSummary: Study objective:
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To assess whether the different stakeholders (volunteers, patients, doctors and industry) involved in early phase trials would be interested in using a platform to facilitate recruitment and engagement in this type of trials. In addition, we will also evaluate the degree of awareness existing in society about clinical trials.
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Study subjects: General population, patient, physicians, pharmaceutical-biotechnological industry.
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Keywords: healthy volunteer, patient, pharma industry, patient associaiton, questionnaire, clinical trial, platform, recruitment, engagement. conditions: Assessing Interest in a Platform for Early Phase Clinical Trial Recruitment studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Questionnaires measure: percentage of each of the three groups that would find the platform useful sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06302634 id: ReCO id: 2022/137 type: OTHER domain: Comité de Ética de la Investigación de Santiago-Lugo briefTitle: Cardio-Oncology Rehabilitation Care Process acronym: ReCO overallStatus: RECRUITING date: 2022-06-22 date: 2027-06-22 date: 2027-06-22 date: 2024-03-12 date: 2024-03-15 name: Hospital Clinico Universitario de Santiago class: OTHER briefSummary: The objective of this observational study is to assess the outcomes of a hospital-based Cardio-Oncology Rehabilitation (CORe) program focused on exercise in cancer patients undergoing cardiotoxic treatment. This evaluation will be conducted by analyzing disease-related health indicators, functional capacity, and quality of life. Patients at risk of cardiotoxicity attending the Cardio-Onco-Hematology Unit will be offered the exercise program, which includes two modalities: in-person (center-based) and remote (home-based) options. The assignment to either modality is non randomized, based on the functional assessment conducted in the Rehabilitation Unit and the agreement between healthcare professional and patient. All participants will perform a 3-month supervised exercise intervention. There are 3 time points for assessment: at baseline (T0), 3-month after the exercise program (T1) and follow-up at 9 months from baseline (T2). conditions: Cardio-Oncology conditions: Rehabilitation conditions: Cardiovascular Diseases conditions: Exercise studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 300 type: ESTIMATED name: Exercise-based cardio-oncology rehabilitation measure: Change in left ventricular systolic function quantified by left ventricular ejection fraction and global longitudinal strain by transthoracic echocardiography measure: Increased cardiac biomarkers (Troponin I and BNP/NT-proBNP) measure: Decrease in functional capacity assessed by estimated VO2peak measure: Change in cardiovascular risk profile as assessed by the presence or absence of classic cardiovascular risk factors. measure: Changes in fasting blood glucose measure: Changes in total low-density lipoprotein (LDL) and total cholesterol (TC) levels measure: Change in haemoglobin measure: Significant cardiovascular and non-cardiovascular adverse effects during treatment. measure: Change in health-related quality of life assessed by the Functional Assessment of Cancer Therapy - Breast plus Arm Morbidity (FACT-B+4) questionnaire. measure: Change in localized lower limb functional capacity assessed by number of repetitions performed within 30 seconds in the sit-to-stand test. measure: Change in lower limb strength measured by squat dynamometry (kg). measure: Change in biceps strength by dynamometry (kg). measure: Change in perimeter (cm) of the right thigh 5cm above the upper edge of the patella measure: Changes in peak expiratory flow measure: Change in upper limb strength measured by dynamometry (kg). measure: Change in anthropometric parameters: weight in kg. measure: Change in anthropometric parameters: Body mass index (BMI) in kg/m^2 measure: Change in anthropometric parameters: abdominal circumference in cm. measure: Change in resting heart rate measured by pulse oximetry (beats per min). measure: Change in resting blood pressure (mmHg) measured by a blood pressure monitor. measure: Change in physical activity assessed by the score in the Godin Leisure Test Exercise Questionnaire (GLTEQ). measure: Change in cardiovascular treatment by its presence or absence. measure: Adherence and compliance to cardiac rehabilitation program (CBCORe) assessed by number of training sessions attended/number of sessions planned. measure: Compliance to home-based cardiac rehabilitation program (HBCORe) assessed by the total number of telephone calls during the Physiotherapy follow-up and the total time of telephone calls. measure: Security of the cardiac rehabilitation program assessed by number of adverse events during training (CBCORe). measure: Satisfaction with the CORe program measure: Follow-up of the exercise performed after participation in the CORe program measure: Presence or absence of lymphoedema. sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital Clínico Universitario de Santiago status: RECRUITING city: Santiago de Compostela state: A Coruña zip: 15706 country: Spain name: Carlos Peña-Gil, MD, PhD role: CONTACT phone: +34 981 950 778 email: carlos.pena.gil@sergas.es name: Estíbaliz Díaz-Balboa role: CONTACT phone: +34 981950747 email: estibaliz.diaz.balboa@sergas.es lat: 42.88052 lon: -8.54569 hasResults: False
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<|newrecord|> nctId: NCT06302621 id: 21-725 briefTitle: Pemigatinib + Afatinib in Advanced Refractory Solid Tumors overallStatus: RECRUITING date: 2024-07-01 date: 2024-12-01 date: 2025-12-01 date: 2024-03-12 date: 2024-04-26 name: Massachusetts General Hospital class: OTHER name: Boehringer Ingelheim name: Incyte Corporation briefSummary: This study is researching whether the combination of Afatinib and Pemigatinib is safe and effective in FGFR altered unresectable or metastatic advanced solid tumors.
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The study is also trying to discover the highest doses of the study drugs that can be administered without causing any intolerable side effects.
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This research study involves the study drugs Afatinib and Pemigatinib. conditions: Advanced Solid Tumor conditions: Unresectable Solid Tumor conditions: Metastatic Solid Tumor conditions: Cholangiocarcinoma studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 70 type: ESTIMATED name: Afatinib name: Pemigatinib measure: Maximum tolerated dose (MTD) measure: Objective response rate (ORR) measure: Disease Control Rate measure: Duration of Response measure: Overall Survival measure: Progression-free Survival measure: Best Overall Response measure: Time to response measure: Treatment Related Adverse Events measure: Maximum Plasma Concentration [Cmax]) and C trough of pemigatinib and afatinib measure: Molecular correlates of response sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Massachusetts General Hospital status: RECRUITING city: Boston state: Massachusetts zip: 02115 country: United States name: Andreas Varkaris, MD role: CONTACT phone: 617-724-4000 email: AVARKARIS@MGH.HARVARD.EDU name: Andreas Varkaris, MD role: PRINCIPAL_INVESTIGATOR lat: 42.35843 lon: -71.05977 hasResults: False
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<|newrecord|> nctId: NCT06302608 id: NGGT-BCD-P-2203 briefTitle: Safety and Efficacy Study of NGGT001 in Bietti Crystalline Corneoretinal Dystrophy overallStatus: ACTIVE_NOT_RECRUITING date: 2023-02-08 date: 2024-05-29 date: 2028-05-29 date: 2024-03-12 date: 2024-03-12 name: Xiamen Ophthalmology Center Affiliated to Xiamen University class: OTHER briefSummary: Evaluate the safety and tolerability of NGGT001 subretinal injection for the treatment of crystalline retinal degeneration (BCD) conditions: Bietti's Crystalline Dystrophy studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 6 type: ESTIMATED name: NGGT001 measure: BCVA measure: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Xiuju Chen city: Xiamen state: Fujian zip: 361000 country: China lat: 24.47979 lon: 118.08187 hasResults: False
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<|newrecord|> nctId: NCT06302595 id: 2022P001093 id: 5R44CA224853 type: NIH link: https://reporter.nih.gov/quickSearch/5R44CA224853 briefTitle: MRI Guided Prostate Biopsy overallStatus: RECRUITING date: 2023-08-24 date: 2024-05-31 date: 2024-08-31 date: 2024-03-12 date: 2024-03-12 name: Brigham and Women's Hospital class: OTHER name: National Cancer Institute (NCI) name: Physical Sciences Inc. briefSummary: This study aims to assess the feasibility of magnetic resonance (MR) guided prostate biopsy using a needle holder frame. This frame is used to help position the needle used for the biopsy. The feasibility in this study is defined as whether the needle holder frame enables accurate tissue sampling from a suspicious region in the prostate found on an MR image. If it does, a biopsy can be carried out with the needle holder frame safely in a clinical routine. The study will be conducted during a routine MR-guided prostate biopsy procedure with an investigational needle holder frame instead of a conventional needle-guiding template. conditions: Suspected Prostate Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DEVICE_FEASIBILITY masking: NONE count: 15 type: ESTIMATED name: MRI-guided prostate biopsy using the needle holder frame. measure: Accuracy of needle placement sex: MALE minimumAge: 30 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Brigham and Women's Hospital status: RECRUITING city: Boston state: Massachusetts zip: 02115 country: United States name: Kemal Tuncali, MD role: CONTACT phone: 617-732-7631 email: ktuncali@bwh.harvard.edu lat: 42.35843 lon: -71.05977 hasResults: False
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<|newrecord|> nctId: NCT06302582 id: stress injury briefTitle: Platelet Rich Plasma Combined With Human Umbilical Cord Mesenchymal Stem Cells for Stage 3 and 4 Stress Injury overallStatus: RECRUITING date: 2024-02-29 date: 2024-11-25 date: 2024-11-25 date: 2024-03-12 date: 2024-03-12 name: Liaocheng People's Hospital class: OTHER briefSummary: This study is an open-label, single-center trial which aim to evaluate of efficacy and safety of human umbilical cord-derived mesenchymal stem cells (hUC-MSCs) combined with platelet-rich plasma (PRP) in stage 3 and 4 stress injury. conditions: Pressure Injuries - Stage 3 conditions: Pressure Injuries - Stage 4 studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: Platelet-rich plasma (PRP) combined with human umbilical cord mesenchymal stem cells (huMSCs) name: Control group measure: Change From Baseline in Pressure Ulcer Scale for Healing (PUSH) measure: Change from baseline in Determination of growth factor content measure: Wound healing time measure: Positive rate of bacterial culture measure: Safety evaluation sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Central laboratory status: RECRUITING city: Liaocheng state: Shandong zip: 252000 country: China name: changhui Zhou, postgraduate role: CONTACT phone: 13562078772 email: zhouchanghui008@163.com lat: 36.45596 lon: 115.97766 hasResults: False
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<|newrecord|> nctId: NCT06302569 id: Bellini INT 2024-511587-93-00 briefTitle: Pembrolizumab Plus Enfortumab Vedotin in Collecting Duct and Renal Medullary Carcinoma acronym: REPRINT overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-10 date: 2028-05 date: 2024-03-08 date: 2024-03-08 name: Giuseppe Procopio class: OTHER briefSummary: This is a single-arm, monocentric, phase II trial, enrolling patients with histological diagnosis of collecting duct carcinoma and renal medullary carcinoma with locally advanced or metastatic disease who will be treated with Pembrolizumab plus Enfortumab Vedotin.
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Approximately, 23 patients will be enrolled. At screening, pre-existing archival primary and metastatic FFPE tumor specimen will be collected and submitted for central pathology review and translational analysis. All participants will undergo baseline screening imaging for clinical staging. Patients will be treated with Pembrolizumab q21 plus Enfortumab Vedotin 1,8q21 for 3 cycles (3 infusion of Pembrolizumab and 6 infusion of Enfortumab Vedotin) then radiological imaging will be repeated and patients with SD, PR or CR will continue pembrolizumab until disease progression, unacceptable toxicities or completion of treatment (17 cycles). Patients with progressive disease after 3 cycles of study intervention will be treated as per clinical practice.
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Patients who will experience progressive disease during pembrolizumab monotherapy treatment could restart Enfortumab Vedotin.
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The study will also involve collection of a blood sample taken at the commencement of treatment, at the first cycle, after cycle 3 and at the end of treatment or progression of disease, to be used for research purposes. conditions: Bellini Carcinoma conditions: Collecting Duct Carcinoma conditions: Renal Medullary Carcinoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 23 type: ESTIMATED name: Pembrolizumab + Enfortumab Vedotin measure: ORR in patients treated with Pembrolizumab plus Enfortumab Vedotin measure: Progression-free survival (PFS) in patients treated with Pembrolizumab plus Enfortumab Vedotin measure: Overall-survival (OS) in patients treated with Pembrolizumab plus Enfortumab Vedotin measure: Number of Participants treated with Pembrolizumab + Enfortumab Vedotin who experience AEs/SAEs sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fondazione Irccs Istituto Dei Tumori Di Milano city: Milan zip: 20133 country: Italy lat: 45.46427 lon: 9.18951 hasResults: False
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<|newrecord|> nctId: NCT06302556 id: 2022XJ9W4F id: G53D2300526 0006 type: OTHER_GRANT domain: Ministry of University and Research. NextGenetationUE briefTitle: The Role of Immune Checkpoints in Lung Transplant (ILTRA) acronym: ILTRA overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-01 date: 2026-02 date: 2024-03-08 date: 2024-03-08 name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico class: OTHER name: University of Milan name: University of Padova name: University of Turin, Italy briefSummary: The goal of this observational study is to learn about rejection in lung transplantation.
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The main question it aims to answer is:
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• what is the role of immune checkpoints in lung transplantation? Participants will describe pathways of rejection in lung transplantation analyzing the immune checkpoints on explanted lungs as well as trans-bronchial biopsies. conditions: Lung Transplant Rejection studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 280 type: ESTIMATED name: Immune checkpoints analysis name: Gene expression analysis measure: Lung-tissue immune-checkpoint profile and bronchoalveolar immune-cells mRNA signature in acute rejection after lung transplantation. measure: Lung-tissue immune-checkpoint profile in chronic rejection after lung transplantation. sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fondazione IRCCS Cà Granda, Ospedale Maggiore Policlinico city: Milan zip: 20122 country: Italy name: Mario Nosotti, Medicine role: CONTACT phone: 3393924679 email: mario.nosotti@unimi.it name: Ilaria Righi, Medicine role: CONTACT phone: +393470556707 email: ilaria.righi78@gmail.com name: Mario Nosotti, Medicine role: PRINCIPAL_INVESTIGATOR name: Ilaria Righi, Medicine role: SUB_INVESTIGATOR name: Lorenzo Rosso, Medicine role: SUB_INVESTIGATOR name: Valentina Vaira, Biology role: SUB_INVESTIGATOR name: Mario Clerici, Medicine role: SUB_INVESTIGATOR name: Daria Trabattoni, Biology role: SUB_INVESTIGATOR lat: 45.46427 lon: 9.18951 facility: University of Modena and Reggio Emilia city: Modena zip: 41121 country: Italy name: Marcello Pinti, Biology role: CONTACT phone: +390592055386 email: marcello.pinti@unimore.it lat: 44.64783 lon: 10.92539 facility: University of Padua city: Padova zip: 35131 country: Italy name: Marco Schiavon, Medicine role: CONTACT phone: +39 3475642901 email: marco.schiavon@unipd.it lat: 45.40797 lon: 11.88586 facility: University of Turin city: Torino zip: 10124 country: Italy name: Massimo Boffini, Medicine role: CONTACT phone: +39 3474267034 email: massimo.boffini@unito.it lat: 45.07049 lon: 7.68682 hasResults: False
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<|newrecord|> nctId: NCT06302543 id: POI bone marrow briefTitle: Treatment of Premature Ovarian Insufficiency Using Bone Marrow Cells acronym: alfarah overallStatus: RECRUITING date: 2024-03-01 date: 2024-09-10 date: 2024-10-24 date: 2024-03-08 date: 2024-03-08 name: abdulmajeed hammadi class: INDUSTRY briefSummary: investigator is doing single armed clinical interventional study to treat premature ovarian insufficiency with autologous bone marrow derived mononuclear cells to be given systematically and locally to the ovaries under ultrasound guidance with experienced gynecologist and to look for the results including: laboratory evidence through hormonal study ultrasound proof of ovarian follicle development. premature ovarian insufficiency is characterized by early loss of ovarian function (less than 40 years of age) manifested by menstrual irregularity or amenorrhea with elevated levels of gonadotropin hormones and low estrogen and anti-Mullerian hormone.
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Autologous use of stem cells from bone marrow are alternative safe minimal manipulative products that can provide a solution to this clinical problem without the need for oocyte donation program. conditions: Premature Ovarian Insufficiency studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: single armed interventional study primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: autologous bone marrow cells injection measure: change in gonadotropin levels sex: FEMALE minimumAge: 30 Years maximumAge: 60 Years stdAges: ADULT facility: Ministry of Health status: RECRUITING city: Baghdad zip: 964 country: Iraq name: abdulmajeed Hammadi, MD role: CONTACT phone: +9647902268105 email: alzaitounhospital@gmail.com lat: 33.34058 lon: 44.40088 hasResults: False
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<|newrecord|> nctId: NCT06302530 id: UCV/2022-2023/155 briefTitle: "Effectiveness of the Ultrasound - Guided Lengthening of the Gastrocsoleus Complex" acronym: EUGLGC overallStatus: RECRUITING date: 2024-03-15 date: 2024-08-30 date: 2025-03-15 date: 2024-03-08 date: 2024-04-23 name: Fundación Universidad Católica de Valencia San Vicente Mártir class: OTHER briefSummary: This research project compares the effectiveness of different surgical techniques for lengthening the gastrocnemius-soleus system in patients with equinus deformity. The study will compare 2 techniques: gastrocnemius tendon recession (Strayer) and plantaris resection. Increased ankle range of motion, complications, operative time, recovery time, pain scales and function will be measured. The results will help determine which technique is most effective and safe for correcting equinus deformity. conditions: Gastrocnemius Equinus studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: To reduce bias, the study will use double-blind blinding. Patients will not know the group to which they have been assigned. In addition, the assessors performing the ankle range of motion measurements by goniometry will be blinded to each patient's treatment group.
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Randomization to each group will be performed using opaque sealed envelopes that will be opened in the operating room just prior to surgery. Neither the surgeon nor the patient will know the assignment until that time.
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The statistical analysis will also be performed in a blinded manner, without the statistician knowing the intervention received by each group. Only after the analysis will the groups be unblinded.
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In this way, the aim is to reduce the possibility of knowledge of the assigned treatment influencing the evaluation of the results, both on the part of the patients and of the evaluators and analysts. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 48 type: ESTIMATED name: Stayer name: Plantar transection measure: Ankle range of motion measure: Visual Analog Scale. measure: American Orthopedic Foot and Ankle Score measure: Complications sex: ALL minimumAge: 10 Years maximumAge: 90 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Podologia Avançada status: RECRUITING city: Granollers state: Barcelona zip: 08401 country: Spain name: Lluis Castillo-Sanchez, Dr role: CONTACT phone: 610143173 email: info@podologiaavanzadabcn.com name: Lluis Castillo, Dr role: SUB_INVESTIGATOR name: Cristina Razzano role: PRINCIPAL_INVESTIGATOR name: Simone Moroni role: SUB_INVESTIGATOR lat: 41.60797 lon: 2.28773 facility: Clinica Mayral foot center status: RECRUITING city: Barcelona state: Barcelon zip: 08029 country: Spain name: Jordi Mayral role: CONTACT phone: (+34) 93 339 78 41 email: barcelona@clinicamayral.com name: Jordi Mayral role: SUB_INVESTIGATOR name: Cristina Razzano role: PRINCIPAL_INVESTIGATOR name: Simone Moroni role: SUB_INVESTIGATOR lat: 41.38879 lon: 2.15899 facility: Clinica Pasito a pasito status: RECRUITING city: Valencia zip: 46008 country: Spain name: Javier Ferrer-Torregrosa, Dr role: CONTACT phone: 963855535 email: clinicaspasitoapasito@gmail.com name: Javier Ferrer-Torregrosa, Dr role: CONTACT phone: 644733882 email: javier.ferrer@ucv.es name: JAVIER Ferrer- TORREGROSA, Dr role: PRINCIPAL_INVESTIGATOR lat: 39.46975 lon: -0.37739 hasResults: False
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<|newrecord|> nctId: NCT06302517 id: K2020097 briefTitle: Bis Monitoring Effect on Delirium Occurrence and Nursing Quality Improvement Recovering From General Anesthesia overallStatus: COMPLETED date: 2020-09-01 date: 2022-05-31 date: 2022-08-29 date: 2024-03-08 date: 2024-03-08 name: The Fourth Affiliated Hospital of Zhejiang University School of Medicine class: OTHER briefSummary: ①Effects of BIS Index (BIS) monitoring on delirium incidence in Post-anesthesia care unit (PACU) in patients undergoing general anesthesia
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②Effects of BIS BIS Index (BIS) monitoring on the quality of nursing care in the Post-anesthesia care unit (PACU) conditions: Delirium, Postoperative studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 134 type: ACTUAL name: BIS-guided measure: Ricker sedation-agitation scale measure: The nursing activity score (NAS) measure: vital signs （Mean arterial pressure, heart rate, pulse oxygen saturation ） measure: Comparison of complications during the PACU period measure: The comprehensive satisfaction score sex: ALL minimumAge: 20 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Fourth Affiliated Hospital, School of Medicine, Zhejiang University city: Jinhua state: Zhejiang zip: 322000 country: China lat: 29.10678 lon: 119.64421 hasResults: False
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<|newrecord|> nctId: NCT06302504 id: Nature briefTitle: Nature-based Mindfulness Intervention Program for Family Carers overallStatus: RECRUITING date: 2023-04-15 date: 2024-03-31 date: 2024-03-31 date: 2024-03-08 date: 2024-03-08 name: The Hong Kong Polytechnic University class: OTHER briefSummary: The program integrates ordinary mindfulness exercise with nature environment. Participants will be able to practice mindfulness in a natural environment in some of the program sessions. The study will study the effects of nature-based mindfulness program in reducing caregiving stress. The program will last for 4 session, 8 hours in total. conditions: Mental Health Issue studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE count: 60 type: ESTIMATED name: Nature-based mindfulness program measure: depression measure: anxiety measure: stress measure: family functioning measure: family conflict measure: well-being sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Hong Kong Polytechnic University status: RECRUITING city: Hong Kong zip: 852 country: Hong Kong name: Hay-ming Herman Lo, PhD role: CONTACT phone: +852-27665769 email: herman.lo@polyu.edu.hk lat: 22.27832 lon: 114.17469 hasResults: False
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<|newrecord|> nctId: NCT06302491 id: AND017-BTH-205 briefTitle: A Study of Safety and Efficiency of AND017 in Patients With Transfusion Dependent and Non-transfusion Dependent β-thalassemia overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-12 date: 2026-07 date: 2024-03-08 date: 2024-03-08 name: Kind Pharmaceuticals LLC class: INDUSTRY briefSummary: This is a phase II, randomized, double-blinded, placebo-controlled study to treat patients with transfusion-dependent and non-transfusion dependent β -thalassemia with AND017 and optimal supportive care, including blood transfusion and iron removal, based on the clinician's judgment and practice. conditions: β -Thalassemia studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 64 type: ESTIMATED name: AND017 capsules name: AND017 Placebo measure: Evaluate the safety and tolerability of different oral doses of AND017 in the treatment of β-thalassemia subjects measure: Change in mean Hb levels relative to baseline at weeks 8-12 and week 20-24 post-treatment compared to baseline (mean Hb values during the 4 weeks prior to the first dose). measure: The level of Hb and the change from baseline at each visit throughout the treatment period. measure: Proportion of patients with mean Hb elevation ≥1.0 g/dL from baseline to weeks 8-12 after dosing. measure: Levels of and changes from baseline in red blood cell count throughout the treatment period measure: Levels of and changes from baseline in reticulocyte count throughout the treatment period measure: Levels of and changes from baseline in mean corpuscular volume (MCV) throughout the treatment period measure: Levels of and changes from baseline in mean corpuscular hemoglobin (MCH) throughout the treatment period measure: Levels of and changes from baseline in mean corpuscular hemoglobin concentration (MCHC) throughout the treatment period measure: Throughout the treatment period, changes in the levels and relative baseline of transferrin will be assessed. measure: Throughout the treatment period, changes in the levels and relative baseline of transferrin saturation (TSAT) will be assessed. measure: Throughout the treatment period, changes in the levels and relative baseline of ferritin will be assessed. measure: Throughout the treatment period, changes in the levels and relative baseline of serum iron level will be assessed. measure: Throughout the treatment period, changes in the levels and relative baseline of total iron binding capacity (TIBC) will be assessed. measure: Change in transfusion load (units transfused) at 12-24 weeks post-dose compared to baseline (12 weeks to W0 before first dose). measure: Change in number of transfusions at 12-24 weeks post-dose compared to baseline (12 weeks to W0 before first dose). measure: Proportion of subjects with ≥33% reduction in transfusion load (transfusion units) relative to baseline (12 weeks prior to first dose to W0) from baseline to any consecutive 12-week period after dosing. measure: Duration (days) of maintenance below this transfusion dose after a 33% reduction in transfusion load from baseline has been achieved. sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06302478 id: KhonKaenU001 briefTitle: 5E Program for Preventing Venous Thromboembolism in Patients With Spinal Cord Disorders overallStatus: RECRUITING date: 2024-03-12 date: 2024-05-30 date: 2024-10-31 date: 2024-03-08 date: 2024-03-13 name: Khon Kaen University class: OTHER briefSummary: The goal of this quasi-experimental study is to examine the effects of a venous thromboembolism prevention program, or "5E" program, on the rates of venous thromboembolism in patients with spinal cord disorders. The main questions it aims to answer are:
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* Will participants receiving the 5E program have lower rates of venous thromboembolism compared to those receiving the usual care?
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* Will participants receiving the 5E program have lower scores of venous thromboembolism signs and symptoms compared to those receiving the usual care?
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* Will the average thigh and calf circumferences of participants before and after receiving the 5E program be different?
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Participants in the intervention group will receive the 5E program, including
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* Education: health education regarding venous thromboembolism prevention
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* Elevation: leg elevation of 10-20 degrees
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* Exercise: ankle exercises
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* Enough fluid: adequate fluid uptake
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* Early application of intermittent pneumatic compression (IPC): IPC use within 48 hours after admission conditions: Venous Thromboembolism conditions: Spinal Cord Diseases conditions: Spinal Cord Injuries conditions: Nurse's Role studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: A quasi-experimental research (two group pretest-posttest design) primaryPurpose: PREVENTION masking: SINGLE whoMasked: PARTICIPANT count: 42 type: ESTIMATED name: 5E program measure: The rate of venous thromboembolism measure: Signs and symptoms of deep venous thrombosis and pulmonary embolism measure: Thigh and calf circumference sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Chaiyaphum Hospital status: RECRUITING city: Chaiyaphum zip: 36000 country: Thailand name: Suchada Chindamart, BNS role: CONTACT phone: +66619411828 email: suchada.chi@kkumail.com lat: 15.81047 lon: 102.02881 hasResults: False
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<|newrecord|> nctId: NCT06302465 id: PKUPH-sarcoma 18 briefTitle: Narlumosbartmab Combined With Neoadjuvant Chemotherapy in Bone-derived Malignancies With Osteolytic Lesions and Multinucleated Giant Cells overallStatus: RECRUITING date: 2024-05-01 date: 2026-11-01 date: 2026-12-31 date: 2024-03-08 date: 2024-03-29 name: Peking University People's Hospital class: OTHER briefSummary: Malignant tumor of bone is rare with poor prognosis. Surgery is the main treatment for non- metastatic bone tumor. Although neoadjuvant chemotherapy for non-metastatic bone tumor cannot improve survival rate based on adjuvant chemotherapy, it can reduce and clarify tumor boundary. Control of local recurrence rate is the core objective of oncotherapy. Surgery way and boundary have a significant effect on prognosis of non- metastatic bone tumor. Narlumosbartmab, a RANKL inhibitor, can make tumor boundary clear and reduce surgical difficulty by inhibiting osteoclast. This is a prospective, randomized, controlled, two-arm, open, single-center clinical trial to compare the efficacy and safety of narlumosbartmab combined with neoadjuvant chemotherapy and neoadjuvant chemotherapy alone in bone-derived malignancies with bone lytic lesions and multinucleated giant cells. Investigators mainly observe the local recurrence rate to evaluate the survival benefit for patients with poor prognosis. conditions: Malignant Bone Tumor studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: narlumosbartmab plus doxorubicin、cisplatin、methotrexate、ifosfamide name: doxorubicin、cisplatin、methotrexate、ifosfamide measure: local recurrence rate measure: tumor necrosis rate measure: R0 removal rate measure: Event-free survival measure: Overall survival sex: ALL minimumAge: 8 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Peking University People's Hospital status: RECRUITING city: Beijing state: Beijing zip: 100044 country: China name: Lu Xie, M.D. role: CONTACT phone: +8613401044719 email: xie.lu@hotmail.com lat: 39.9075 lon: 116.39723 hasResults: False
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<|newrecord|> nctId: NCT06302452 id: IRB00433605 id: R01MD019173 type: NIH link: https://reporter.nih.gov/quickSearch/R01MD019173 briefTitle: Adult Trauma Centers RE-AIM at Gun Safety (ACTFAST) Prevention overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2028-02 date: 2028-02 date: 2024-03-08 date: 2024-03-08 name: Johns Hopkins University class: OTHER name: National Institute on Minority Health and Health Disparities (NIMHD) name: Rhode Island Hospital briefSummary: The goal of this interventional study is to evaluate the implementation and effectiveness of a comprehensive a universal firearm injury prevention program, ACTFAST (Adopting Comprehensive Training for FireArm Safety in Trauma centers), in level 1 trauma centers. The main aims of the study are:
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1. (Primary Aim 1) Increase the adoption, implementation, and maintenance of a universal firearm injury prevention intervention at three participating trauma centers in the mid-Atlantic states;
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2. (Primary Aim 2) Assess firearm injury prevention knowledge, attitudes, and safe storage practices among trauma patients treated within participating trauma centers. conditions: Firearm Injury conditions: Safety Issues studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: The trial uses a unidirectional crossover stepped wedge design with a sequential roll-out of the intervention, ACTFAST, RE-AIM implementation framework, over several discrete time points or "steps." Each of the three trauma centers will be randomly assigned to one step that will determine when they crossover from control to implementation.
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Data are collected over multiple wedges, each 4-6 months in length. During the first wedge, none of the participating trauma centers will receive ACTFAST. During the second wedge, the first trauma center completes the Adoption and Implementation period. Over the third wedge, the first center shifts to the Maintenance period, the second trauma center enters the Adoption and Implementation period, and the remaining cohort stays in the control condition. This pattern continues until all trauma centers have progressed from control condition through the active implementation period. primaryPurpose: OTHER masking: NONE count: 1776 type: ESTIMATED name: Adopting Comprehensive Training for FireArm Safety in Trauma Centers measure: Proportion of admitted injured patients receiving each element of the ACTFAST Program measure: Percentage of admitted injured patients receiving elements of the ACTFAST Program measure: Patient firearm safety attitudes and behaviors as assessed by survey measure: Clinician firearm safety knowledge and confidence as assessed by survey sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Johns Hopkins Bayview Medical Center city: Baltimore state: Maryland zip: 21224 country: United States lat: 39.29038 lon: -76.61219 facility: Johns Hopkins Hospital city: Baltimore state: Maryland zip: 21287 country: United States lat: 39.29038 lon: -76.61219 hasResults: False
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<|newrecord|> nctId: NCT06302439 id: INZ701-007 briefTitle: PROPEL - A Prospective Observational Patient Registry to Evaluate ENPP1 and ABCC6 Deficiency overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2034-05 date: 2034-05 date: 2024-03-08 date: 2024-03-18 name: Inozyme Pharma class: INDUSTRY name: GACI Global briefSummary: The purpose of this prospective registry is to characterize the natural history of ectonucleotide pyrophosphatase/phosphodiesterase1(ENPP1) Deficiency and the infantile-onset form of adenosine triphosphate (ATP) binding cassette transporter protein subfamily C member 6 (ABCC6) Deficiency longitudinally. The registry will prospectively gather information about the genetic, biochemical, physiological, anatomic, radiographic, and functional manifestations (including patient reported outcomes \[PROs\]) of each disease during routine, standard-of-care visits, with the aim of developing a comprehensive understanding of the burden of illness and progressive nature of the disease. conditions: Ectonucleotide Pyrophosphatase/Phosphodiesterase 1 Deficiency conditions: ATP-Binding Cassette Subfamily C Member 6 Deficiency studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 1000 type: ESTIMATED name: No Intervention for this observational study measure: Characterization of the natural history of ENPP1 Deficiency and the infantile-onset form of ABCC6 Deficiency longitudinally measure: Assessment of Patient Functional changes through a validated Patient Reported Outcomes (PROs) tool measure: Assessment of Health-Related Quality-of-Life (HRQoL) changes through validated Patient Reported Outcomes (PROs) tools measure: Measurement of inorganic phosphate (PPi) levels in patients' venous blood sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06302426 id: INI-4001-101 briefTitle: Trial of INI-4001 in Patients With Advanced Solid Tumours overallStatus: NOT_YET_RECRUITING date: 2024-03-29 date: 2024-08-01 date: 2026-04-30 date: 2024-03-08 date: 2024-03-08 name: Inimmune Corporation class: INDUSTRY name: Avance Clinical Pty Ltd. briefSummary: Phase 1 open-label, dose-escalation and dose-expansion study of INI-4001 as a single agent and in combination with approved checkpoint inhibitors in subjects with advanced solid tumors. conditions: Advanced Solid Tumor studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: This is a Phase Ia/Ib, open-label, dose-escalation and dose expansion study. This study will be conducted in two parts: Phase Ia (dose escalation) and Phase Ib (dose expansion). primaryPurpose: TREATMENT masking: NONE count: 50 type: ESTIMATED name: INI-4001 name: Nivolumab name: Pembrolizumab name: Cemiplimab name: Avelumab name: Atezolizumab name: Durvalumab measure: Incidence of dose-limiting toxicities (DLTs) during Cycle 1 to determine the maximum tolerated dose of INI-4001 Monotherapy measure: Incidence, type, and severity of treatment-emergent adverse events (TEAEs) leading to discontinuation of study treatment after multiple ascending doses measure: Incidence and nature of dose-limiting toxicities (DLTs) and regimen-limiting toxicities (RLTs) leading to discontinuation of study treatment after multiple ascending doses measure: Number of Participants with a Change from baseline in Vital signs measurements after multiple ascending doses measure: Number of Participants with a Change from baseline in body weight after multiple ascending doses measure: Number of Participants with a Change from baseline in clinical laboratory parameters (haematology) after multiple ascending doses measure: Number of Participants with a Change from baseline in clinical laboratory parameters (serum chemistry) after multiple ascending doses measure: Number of Participants with a Change from baseline in clinical laboratory parameters (urinalysis) after multiple ascending doses measure: Change from baseline in measurements of HR in beats per minute after multiple ascending doses measure: Change from baseline in measurements of PR interval via 12-lead electrocardiogram after multiple ascending doses measure: Change from baseline in measurements of QT interval via 12-lead electrocardiogram after multiple ascending doses measure: Change from baseline in measurements of RR interval in breaths per minute via 12-lead electrocardiogram after multiple ascending doses measure: Change from baseline in measurements of QRS duration via 12-lead electrocardiogram after multiple ascending doses measure: Change from baseline in measurements of QTcF via 12-lead electrocardiogram after multiple ascending doses measure: Change from baseline in Eastern Cooperative Oncology Group (ECOG) score after multiple ascending doses measure: Single dose PK Parameters - maximum observed concentration (Cmax) measure: Multiple dose PK Parameters - maximum observed concentration (Cmax) measure: Single dose PK Parameters - Time to Cmax (Tmax) measure: Multiple dose PK Parameters - Time to Cmax (Tmax) measure: Single dose PK Parameters - Area under the concentration-time curve from time 0 to 24 hours post-dose (AUC0-24) measure: Single dose PK Parameters - Total amount excreted in urine (Ae) measure: Single dose PK Parameters - Fraction excreted in the urine (Fe) measure: Single dose PK Parameters - Renal clearance (CLr) measure: Multiple dose PK Parameters - Area under the concentration-time curve from time 0 to 24 hours post-dose (AUC0-24) measure: Single dose PK Parameters - Area under the concentration-time curve (AUC0-t) measure: Multiple dose PK Parameters - Area under the concentration-time curve (AUC0-t) measure: Single dose PK Parameters - Half-life (t1/2) measure: Multiple dose PK Parameters - Half-life (t1/2) measure: Single dose PK Parameters - Clearance (Cl) measure: Multiple dose PK Parameters - Clearance (Cl) measure: Single dose PK Parameters - Volume of distribution (Vz) measure: Multiple dose PK Parameters - Volume of distribution (Vz) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Border Cancer Hospital city: Albury state: New South Wales zip: 2640 country: Australia name: Reenu Arora role: CONTACT email: AroraReenu@ramsayhealth.com.au name: Kay Xu, Dr role: PRINCIPAL_INVESTIGATOR lat: -36.07482 lon: 146.92401 facility: Cabrini Hospital city: Malvern state: Victoria zip: 3144 country: Australia name: Prachi Bhave role: CONTACT email: PBhave@cabrini.com.au name: Prachi Bhave, Dr role: PRINCIPAL_INVESTIGATOR lat: -32.02849 lon: 151.32225 hasResults: False
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<|newrecord|> nctId: NCT06302413 id: 1805574553; Aims 9-10 id: 1R01AA029396-01 type: NIH link: https://reporter.nih.gov/quickSearch/1R01AA029396-01 briefTitle: Enhancing Prospective Thinking in Early Recovery acronym: HOME overallStatus: RECRUITING date: 2024-02-15 date: 2027-07-31 date: 2027-07-31 date: 2024-03-08 date: 2024-03-08 name: Indiana University class: OTHER name: National Institute on Alcohol Abuse and Alcoholism (NIAAA) briefSummary: The goal of this clinical trial is to use a novel virtual reality intervention to test for efficacy in reducing alcohol use and increasing abstinence, with concomitant increases in future self-identification, future time perspective, and delay-of-reward, in early recovering alcohol use disorder (AUD) persons. The main question\[s\] this trial aims to answer are:
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Will the Virtual Reality (VR) intervention decrease the number of stimulant use days? Will the VR intervention produce longer abstinence periods during follow-up visits? Will the VR intervention increase alcohol abstinence rates? Will the VR intervention increase future self-identification? Will the VR intervention increase self-reported future time perspective? Will the VR intervention increase preference for delayed rewards in a laboratory delay discounting task on the study day? Will the VR intervention produce gains in the behavioral effects of future self-identification, future time perspective, and delayed rewards at the 30-day and 6-month follow-ups? Researchers will compare the experimental and control groups to see if there are differences in the results for the questions outlined above. conditions: Alcohol Use Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: SINGLE maskingDescription: All study participants are randomly assigned to a group prior to study enrollment. Participants will not be made aware of their group assignment. whoMasked: PARTICIPANT count: 500 type: ESTIMATED name: Virtual Reality name: Virtual Reality measure: Reduced Use of Drug Using Days measure: Increased Length of Abstinence measure: Increased (overall) Abstinence measure: Future Self-identification with Future Self Continuity Questionnaire measure: Future Time Perspective with the Delayed Discounting Behavioral Task and Future Self Continuity Questionnaire measure: Delayed Reward Preference with the Delayed Discounting Behavioral Task sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Indiana University School of Medicine - Goodman Hal status: RECRUITING city: Indianapolis state: Indiana zip: 46202 country: United States name: Sarah Turo, BA role: CONTACT phone: 317-963-7220 email: sturo@iu.edu name: Brandon G Oberlin, PhD role: PRINCIPAL_INVESTIGATOR lat: 39.76838 lon: -86.15804 hasResults: False
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<|newrecord|> nctId: NCT06302400 id: RS-IC04 briefTitle: Individualized Dosimetry for Holmium-166 Radioembolization in Patients With Unresectable Hepatocellular Carcinoma acronym: RHEPaiR overallStatus: RECRUITING date: 2024-02-22 date: 2027-02 date: 2027-02 date: 2024-03-08 date: 2024-03-08 name: Imperial College London class: OTHER name: Terumo Europe N.V. briefSummary: The goal of this clinical trial is to test the safety and effectiveness of a medical device called 166-Holmium microspheres (QuiremSpheres®) in patients with hepatocellular carcinoma (HCC) . The main questions it aims to answer are:
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* What is the safety and toxicity profile of the 166-Holmium microspheres?
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* Is the device effective in treating HCC?
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Participants will undergo a range of screening procedures to confirm they are eligible and to record their baseline results, including:
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* A Computed Tomography (CT) scan
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* A Magnetic Resonance Imaging (MRI) scan
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* Blood tests
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* Quality of life questionnaires
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Before receiving treatment with QuiremSpheres® the participant will receive a 'scout' dose of the microspheres, to check whether there is distribution of the radioactivity to other non-target areas of the body. This is measured using Single-Photon Emission Computed Tomography-CT imaging. If the distribution to non-target areas is deemed to not be too high, the participant will go on to receive the individualised therapeutic dose of QuiremSpheres®. Follow-up visits will occur 3 and 6 weeks post-treatment dose, and then at 3 and 6 months. conditions: Carcinoma, Hepatocellular studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 15 type: ESTIMATED name: 166Holmium microspheres (QuiremSpheres®) measure: The incidence of adverse and serious adverse events in patients receiving individualized treatment with 166Ho- microspheres, using National Cancer Institute CTCAE v5.0. measure: The rate of efficacy as defined as overall response rate (ORR) in patients receiving individualized treatment with 166Ho- microspheres, using modified RECIST (mRECIST) response evaluation criteria. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Imperial College Healthcare NHS Trust status: RECRUITING city: London zip: W12 0HS country: United Kingdom name: Rohini Sharma, Professor role: CONTACT phone: 02033133720 email: r.sharma@imperial.ac.uk lat: 51.50853 lon: -0.12574 hasResults: False
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<|newrecord|> nctId: NCT06302387 id: BEC-LSMU(R)-27 briefTitle: Acellular Dermal Matrix Versus Tenting Technique in Peri-implant Soft Tissue Augmentation and Crestal Bone Stability overallStatus: COMPLETED date: 2018-01-01 date: 2020-04-01 date: 2023-02-01 date: 2024-03-08 date: 2024-03-08 name: Harvard Medical School (HMS and HSDM) class: OTHER briefSummary: This study looks at two ways to make gums thicker and bones stable around dental implants for people with thin gums. It compares two methods in 40 people: one method uses a special graft, and the other uses a technique called tenting. The goal is to see which method might work better for making the gums and bones around implants healthier. The check-ups are planned when the implant is put in and again after one year. The study focuses on how these methods are done without talking about what the results are. conditions: Soft Tissue Augmentation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The interventional study model for this trial is a two-arm, double-blind, randomized, prospective controlled clinical trial. primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: double-blind, where neither the patients nor the clinicians responsible for treatment know the specific treatment modality whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 40 type: ACTUAL name: Acellular Dermal Matrix name: Soft Tissue Expansion using Tenting Technique measure: Crestal Bone Levels measure: Vertical soft tissue thickness measure: PPD measure: BOP measure: PI sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: VIC Clinic city: Vilnius zip: 01362 country: Lithuania lat: 54.68916 lon: 25.2798 hasResults: False
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<|newrecord|> nctId: NCT06302374 id: GR2001-001 briefTitle: Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of GR2001 in Chinese Healthy Adults overallStatus: COMPLETED date: 2023-03-04 date: 2023-11-01 date: 2024-02-19 date: 2024-03-08 date: 2024-03-08 name: Genrix (Shanghai) Biopharmaceutical Co., Ltd. class: INDUSTRY briefSummary: The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and Immunogenicity characteristics of GR2001 and compare the anti-tetanus neutralizing antibody titers of GR2001 with human tetanus immunoglobulin (HTIG)in healthy adult subjects. conditions: Tetanus studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: In the phase I part of the study, a total of 94 healthy subjects will be enrolled. The 94 healthy adult subjects will be enrolled into 7 cohorts sequentially. Each participant will receive a single IM dose of GR2001 or placebo or HTIG according to the cohort in which they were enrolled. After injection (Day 0), participants will remain in the study site for observation up to Day 1. The phase I part will last for 105 days following the assessments of safety, PK, PD and ADA.
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In the phase II part of the study, a total of 108 healthy subjects will be enrolled. The 108 healthy subjects will be randomly assigned to the experimental group and the control group based on a ratio of 1:1:1:2:2:2.The phase II part will last for 105 days following the assessments of safety, PK, PD and ADA. primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Double Blind whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 202 type: ACTUAL name: GR2001 name: Placebo name: HTIG name: Tetanus Toxoid measure: Incidence of AEs(Phase I) measure: Tetanus-antibody titer(Phase II) measure: Tetanus-antibody titer(Phase I/II) measure: Incidence of ADA(Phase I/II) measure: Incidence of AEs(Phase II) measure: Peak plasma concentration(Cmax) measure: Area under the plasma concentration versus time curve (AUC) measure: Time of maximum plasma concentration (Tmax) measure: Terminal half-life (T1/2) measure: Apparent total body clearance (CL/F) measure: Apparent volume of distribution (Vd/F) measure: The elimination rate constant (Kel) measure: Mean Residence Time (MRT) sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Huashan Hospital affiliated of Fudan University city: Shanghai state: Shanghai zip: 200040 country: China lat: 31.22222 lon: 121.45806 hasResults: False
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<|newrecord|> nctId: NCT06302361 id: 23/54225 briefTitle: Lymphovenous Anastomosis for Breast Cancer Lymphedema overallStatus: RECRUITING date: 2024-03-01 date: 2026-06-30 date: 2026-06-30 date: 2024-03-08 date: 2024-03-08 name: Odense University Hospital class: OTHER name: Vejle Hospital name: Zealand University Hospital name: Herlev and Gentofte Hospital briefSummary: This multi-center cohort study focuses on evaluating the efficacy of lymphovenous anastomosis (LVA) for treating pitting lymphedema in female breast cancer survivors. Conducted across multiple centers in Denmark, including Odense University Hospital, Herlev Hospital, Lillebaelt Hospital Vejle, and Zealand University Hospital, it aims to assess LVA's impact on reducing arm volume and improving quality of life in patients with upper extremity lymphedema secondary to breast cancer treatment.
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Eligible participants are adult women with unilateral arm lymphedema who show active pitting and identifiable lymphatic vessels via indocyanine green lymphography. Inclusion involves informed consent and the ability to complete Danish questionnaires.
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Patients are recruited from the outpatient clinics of the participating hospitals and will undergo LVA surgery under either local or general anesthesia. Following the intervention, patients are seen for data collection up to twelve months.
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The study measures outcomes like arm volume changes through water displacement volumetry and arm circumferential measurements, body composition via bioimpedance, health-related quality of life through LYMPH-Q, general quality of life through SF-36, arm function via DASH, and anastomosis patency via ICG lymphography. Additionally, changes in ICG lymphography images, arm fibrosis via SkinFibroMeter, and surgery duration are evaluated.
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The study adheres to ethical guidelines, ensuring patient safety and the integrity of the research. conditions: Lymphedema conditions: Lymphedema Arm conditions: Breast Cancer Lymphedema conditions: Lymphedema, Secondary conditions: Lymphedema; Surgical conditions: Lymphedema of Upper Limb conditions: Lymphedema, Breast Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Multi-center cohort study primaryPurpose: TREATMENT masking: NONE count: 47 type: ESTIMATED name: Lymphovenous anastomosis (LVA) measure: Arm volume (Water Displacement) measure: Arm volume (Arm Circumferences) measure: Health-related quality of life (LYMPH-Q) measure: General quality of life (SF-36) measure: Arm and shoulder function (DASH) measure: L-Dex measure: LVA patency measure: Skin Fibrosis measure: Surgery duration measure: Body composition sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Plastic Surgery, Odense University Hospital status: RECRUITING city: Odense state: Region Of Southern Denmark zip: 5000 country: Denmark name: Caroline Lilja, MD role: CONTACT phone: +4560555340 email: caroline.lilja@rsyd.dk lat: 55.39594 lon: 10.38831 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2024-02-07 uploadDate: 2024-03-04T05:57 filename: Prot_SAP_000.pdf size: 934504 hasResults: False
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<|newrecord|> nctId: NCT06302348 id: PTC923-PKU-401 briefTitle: A Study of Sepiapterin in Participants With Phenylketonuria (PKU) acronym: EPIPHENY overallStatus: NOT_YET_RECRUITING date: 2024-02-29 date: 2031-02-28 date: 2031-02-28 date: 2024-03-08 date: 2024-03-08 name: PTC Therapeutics class: INDUSTRY briefSummary: The main purpose of this trial is to evaluate the long-term efficacy of sepiapterin on preserving neurocognitive functioning in children with PKU when treatment is initiated in early childhood. conditions: Phenylketonuria studyType: INTERVENTIONAL phases: PHASE3 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 56 type: ESTIMATED name: Sepiapterin measure: Mean Change From Baseline in Full-scale Intelligence Quotient (FSIQ) Weschler Preschool and Primary Scale of Intelligence - Fourth Edition (WPPSI-IV) Score measure: Mean Change From Baseline in FSIQ Weschler Intelligence Scale for Children - Fifth Edition (WISC-V) Score measure: Change From Baseline in Phenylketonuria-Quality of Life (PKU-QOL) Questionnaire Score measure: Change From Baseline in the European Quality of Life - 5 Dimensions (EQ-5D) Score measure: Mean Change From Baseline in FSIQ (WPPSI-IV) Score measure: Mean Change From Baseline in FSIQ (WISC-V) Score measure: Change From Baseline in Mean Blood Phe Levels sex: ALL maximumAge: 12 Years stdAges: CHILD facility: Indiana University city: Indianapolis state: Indiana zip: 46202 country: United States name: Susan Romie role: CONTACT name: Melissa Lah role: PRINCIPAL_INVESTIGATOR lat: 39.76838 lon: -86.15804 hasResults: False
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<|newrecord|> nctId: NCT06302335 id: 2022-0442 briefTitle: Povidone-iodine vs Saline Solution in Colorectal Surgeries and Its Effects on the Surgical Site Infection overallStatus: RECRUITING date: 2023-01-02 date: 2027-12-31 date: 2027-12-31 date: 2024-03-08 date: 2024-03-08 name: Hospital de Clinicas de Porto Alegre class: OTHER briefSummary: Considering the relatively high incidence of surgical site infection (SSI) in colorectal surgery, this trial will compare rates of SSI in patients undergoing colorectal resections followed by surgical wound irrigation with povidone-iodine versus the group of patients undergoing surgical wound irrigation with saline solution. The trial will be conducted in a large university hospital in Southern Brazil. conditions: Surgical Site Infection studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This a randomized clinical trial involving patients undergoing colorectal surgeries who will submitted to the application of povidone-iodine versus saline solution in their surgical sites. primaryPurpose: PREVENTION masking: SINGLE maskingDescription: Participants will not know what kind of substance will be used during the surgery. whoMasked: PARTICIPANT count: 228 type: ESTIMATED name: Povidone-iodine name: Saline solution measure: Surgical site infection measure: Intracavitary surgical infection sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital de Clinicas de Porto Alegre status: RECRUITING city: Porto Alegre state: RS zip: 90.035-903 country: Brazil name: Daniel C Damin role: CONTACT phone: +5551996020442 email: damin@terra.com.br lat: -30.03306 lon: -51.23 hasResults: False
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<|newrecord|> nctId: NCT06302322 id: 158200-07-512-149 briefTitle: Long-term Follow up of Mucosal Tissue Height Influence on Peri-implant Bone Levels. overallStatus: COMPLETED date: 2021-01-07 date: 2022-08-15 date: 2022-10-01 date: 2024-03-08 date: 2024-03-08 name: Harvard Medical School (HMS and HSDM) class: OTHER briefSummary: Our study looks into how the thickness of the gum tissue affects the health of the bone around dental implants over ten years. We include 59 people and divide them into three groups based on their gum tissue thickness. Some have naturally thin gums, some have thin gums that were made thicker with a special procedure, and some already had thick gums. We try to find out if having thicker gums, whether naturally or through enhancement, can help keep the bone around dental implants healthy in the long run. conditions: Edentulous Alveolar Ridge studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: SCREENING masking: NONE count: 59 type: ACTUAL name: Thin Tissues name: Thick Tissues name: Surgically augmented thin tissues measure: Crestal Bone Levels measure: PPD measure: BOP measure: PI sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: VIC Clinic city: Vilnius zip: 01362 country: Lithuania lat: 54.68916 lon: 25.2798 hasResults: False
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<|newrecord|> nctId: NCT06302309 id: NL85217.091.23 briefTitle: Tackling Anxiety-related Freezing of Gait in People With Parkinson's Disease acronym: TACKLING-FOG overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-09 date: 2025-09 date: 2024-03-08 date: 2024-03-08 name: Radboud University Medical Center class: OTHER briefSummary: The purpose of this study is to investigate whether personalized strategies that target anxiety and stress surrounding freezing of gait can alleviate freezing of gait in people with Parkinson's Disease. conditions: Freezing of Gait studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: NONE maskingDescription: Randomization will be performed in CastorEDC, a web-based data management system for academic studies (www.castoredc.com). Breaking of the randomization code is not applicable, since researchers and trainers cannot be blinded. count: 40 type: ESTIMATED name: Psychological intervention measure: % time frozen during a personalized gait trajectory measure: subjective impact of anxiety and stress on FOG, as measured with a Visual Analogue Scale measure: Heart Rate Variability measure: The Parkinson Anxiety Scale (PAS) measure: Gait-Specific Attention Profile measure: he Updated Perceived Control over Falling Scale (UP-COF) measure: New Freezing of Gait Questionnaire measure: The Parkinson's Disease Questionnaire measure: The Rosenberg self-esteem score measure: Perceived Stress Scale measure: Montreal Cognitive Assessment measure: Unified Parkinson's Disease Rating Scale Part III sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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