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Follow-up with neoadjuvant or primary chemotherapy is usually done by breast Magnetic Resonance Imaging (MRI).Tumour response to treatment is assessed on morphological size criteria.
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Angiomammography (also called CESM : Contrast Enhanced Spectral Mammography) is an innovative and validated imaging technique consisting of dual energy mammography with injection of iodinated contrast medium; two images are generated, one comparable to a standard mammography and a second image highlighting the structures enhanced by the contrast medium. The characteristic neo angiogenesis of the tumour process thus allows good visualisation of the tumour compared to the underlying mammary gland.
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A classical morphological analysis is therefore possible thanks to standard mammographic acquisition coupled with a quantitative functional analysis linked to the study of enhancement.
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During angiomammography, several images are acquired in succession, starting with the cranio caudal view and ending with the profile view. On the same examination, these acquisitions are carried out at different injection times, making it possible to study the type of enhancement of a given area (Progressive/ Plateau/ Wash out).
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Angiomammography has several advantages over breast MRI in the follow-up of chemotherapy: shorter examination time, shorter appointment time, better tolerated by the patients and without injection of Gadolinium chelates, which have recently been shown to cause definitive brain deposits during repeated injections. Currently, angiomammography is validated in the follow-up of breast cancers treated with neoadjuvant or primary chemotherapy, with an analysis of tumour response currently only morphological, as in breast MRI.
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Here, the hypothesis is that the study of tumour enhancement by angiomammography may constitute a new predictive element of histological response: indeed, the performance of an initial angiomammography before treatment (baseline) and then a second angiomammography performed early in relation to the start of chemotherapy, could allow early prediction of which patients will have a complete histological response at the time of the closing surgery. This prospective study is to compare the variation in tumour enhancement, assessed on each of the two examinations using dedicated X-ray consoles, to the final histological result after closure surgery: it is hoped that the relative variation in tumour enhancement would be greater in responding patients. conditions: Breast Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 100 type: ESTIMATED name: Diagnostic test measure: The evolution of the relative tumor enhancement (RTEe) (%) between the baseline and early re-evaluation CESM measure: RTEe according to the 3 categories of RCB score measure: The type of enhancement (TE) % sex: FEMALE minimumAge: 35 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hôpital de la Croix Rousse city: Lyon zip: 69004 country: France name: Dorothée TACONET, MD role: CONTACT phone: 0426109185 phoneExt: +33 email: dorothee.taconet@chu-lyon.fr lat: 45.74848 lon: 4.84669 hasResults: False
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<|newrecord|> nctId: NCT06299189 id: 309264 briefTitle: A Therapist Guided Internet-delivered Treatment for Adults With ADHD (Attention Deficit / Hyperactivity Disorder) - an Open Effectiveness Trial in Routine Care acronym: MinADHD overallStatus: RECRUITING date: 2024-01-01 date: 2027-09 date: 2027-09 date: 2024-03-07 date: 2024-03-07 name: Haukeland University Hospital class: OTHER briefSummary: The primary objective of this study is to explore and evaluate the use and utility of a guided Internet-delivered psychological treatment for adults with ADHD with a combined focus on:
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i) Evaluating the impact of potential predictors to treatment adherence, treatment response, treatment use and utilty. ii) Evaluating the feasibility, clinical benefits and implementation process of the treatment in routine outpatient care. iii) Evaluate the cost-effectiveness of the treatment program. conditions: ADHD conditions: ADHD - Combined Type conditions: ADHD Predominantly Inattentive Type conditions: ADHD, Predominantly Hyperactive - Impulsive studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 200 type: ESTIMATED name: MinADHD measure: The Adult ADHD Self-Rating Scale measure: Adult ADHD Quality of Life Measure measure: The Patient Health Questionnaire measure: Generalized Anxiety Disorder-7 measure: Personality Disorder Severity ICD-11 measure: EuroQoL 5D-5L sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Bjørgvin DPS status: RECRUITING city: Bergen country: Norway name: Gunn Elise Sæthre role: CONTACT phone: 00000000 lat: 60.39299 lon: 5.32415 hasResults: False
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<|newrecord|> nctId: NCT06299176 id: ESHF-WHRT (2024-10362) briefTitle: Whole Heart Radiotherapy for End-stage Heart Failure acronym: ESHF-WHRT overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-12-31 date: 2024-12-31 date: 2024-03-07 date: 2024-03-07 name: McGill University Health Centre/Research Institute of the McGill University Health Centre class: OTHER briefSummary: End-stage heart failure (ESHF) causes recurrent hospitalizations, cardiac arrhythmias, and intolerance to standard HF therapies are common as the disease progresses. Management focuses on controlling symptoms, correcting precipitants, avoiding triggers, and improving quality-of-life. The combination of recent preclinical and clinical data suggests that localized cardiac RT is relatively safe and has positive conductive and anti-proliferative effects in the "sick" heart. In this Phase 1 study, the investigators aim to assess the feasibility and safety of 5 Gy whole heart radiotherapy in six (6) ESHF participants with limited options for further medical therapy to control their disease. The investigators hypothesize that 5 Gy whole heart radiotherapy can improve LVEF and decrease blood markers of heart failure and inflammation including B-type natriuretic peptide (BNP), C-reactive protein (CRP), and troponins, while also having a very tolerable side effect profile. conditions: Heart Failure NYHA Class III conditions: Heart Failure NYHA Class IV conditions: End-stage Heart Failure conditions: Heart Failure With Reduced Ejection Fraction studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: 6 participants with end-stage heart failure (NYHA 3 or 4, LVEF \< 30%) with no other standard of care therapy options to receive whole heart radiation therapy. primaryPurpose: TREATMENT masking: NONE maskingDescription: no masking count: 6 type: ESTIMATED name: Whole Heart Radiation Therapy measure: Change in mean left ventricle ejection fraction measure: Acute adverse events definitely or probably related to radiation therapy at 30 days as per CTCAE v 5.0 measure: Overall survival measure: Hospital stays measure: Subacute adverse events measure: Late adverse events measure: Medication Changes - dose measure: Medication Changes - number measure: Quality of life CHFQOLQ-20 measure: Quality of life - SF-36 measure: Troponin changes measure: Lactate changes measure: Renal Function measure: b-natrurietic peptide sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06299163 id: NB-NM032-2668-101 briefTitle: NM32-2668 in Adult Patients With Selected Advanced Solid Tumors overallStatus: RECRUITING date: 2024-03-29 date: 2027-12-31 date: 2027-12-31 date: 2024-03-07 date: 2024-03-07 name: Numab Therapeutics AG class: INDUSTRY briefSummary: This is a first-in-human, open-label, multi-center, Phase 1, dose-escalation study with expansion cohorts to evaluate NM32-2668 for safety and immunogenicity, to determine the maximal tolerated dose and recommended Phase 2 dose, define the pharmacokinetics, to explore the pharmacodynamics, and to obtain preliminary evidence of the clinical activity in adult patients with selected advanced solid tumors. conditions: Ovarian Carcinoma conditions: Fallopian Tube Carcinoma conditions: Peritoneal Carcinoma conditions: Endometrial Cancer conditions: Adenocarcinoma of Lung conditions: Triple Negative Breast Cancer conditions: Liposarcoma conditions: Leiomyosarcoma conditions: Mesothelioma, Malignant conditions: Adenocarcinoma - Gastroesophageal Junction (GEJ) conditions: Adenocarcinoma of the Stomach conditions: Melanoma, Malignant conditions: Renal Cell Carcinoma studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 180 type: ESTIMATED name: NM32-2668 measure: Incidence of Dose Limiting Toxicities (DLTs) measure: Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) as assessed by CTCAE v5.0 / ASTCT (for Cytokine Release Syndrome [CRS]) measure: Frequency of dose interruptions/reductions measure: Duration of dose interruptions/reductions measure: Assessment of the maximum observed serum concentration (Cmax) measure: Assessment of the the minimum observed serum concentration (Cmin) measure: Time from dosing at which maximum observed serum concentration is apparent (Tmax) measure: Assessment of the terminal phase (apparent elimination) rate constant (λz) measure: Assessment of the elimination half-life (t½) measure: Assessment of the area under the serum concentration-time curve extrapolated from the last quantifiable concentration to infinity (AUC[0-infinity]) measure: Assessment of the area under serum concentration-time curve over dosing interval (AUCtau) measure: Assessment of clearance (CL) of NM32-2668 in serum measure: Assessment of the volume of distribution (Vd) of NM32-2668 in serum measure: Assessment of accumulation ratios of Cmax (ARcmax) of NM32-2668 in serum measure: Assessment of accumulation ratios of Cmin (ARcmin) of NM32-2668 in serum measure: Assessment of accumulation ratios of AUC (ARauc) of NM32-2668 in serum measure: Frequency of specific anti-drug antibodies (ADAs) to NM32-2668 measure: Concentration of specific ADAs to NM32-2668 measure: Incidence of specific ADAs by category to NM32-2668 measure: Best Overall Response (BOR) according to RECIST 1.1 measure: Overall Response Rate (ORR) according to RECIST 1.1 measure: Disease Control Rate (DCR) according to RECIST 1.1 measure: Progression-free Survival (PFS) according to RECIST 1.1 measure: Time to Response (TTR) according to RECIST 1.1 measure: Duration of Response (DOR) according to RECIST 1.1 measure: Overall Survival (OS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Lifespan Cancer Institute at Rhode Island Hospital status: RECRUITING city: Providence state: Rhode Island zip: 02903 country: United States name: Benedito A. Carneiro, MD role: CONTACT name: Benedito A. Carneiro, MD role: PRINCIPAL_INVESTIGATOR lat: 41.82399 lon: -71.41283 facility: Mary Crowley Cancer Research status: RECRUITING city: Dallas state: Texas zip: 75230 country: United States name: Douglas W. Orr, MD role: CONTACT name: Douglas W. Orr, MD role: PRINCIPAL_INVESTIGATOR lat: 32.78306 lon: -96.80667 hasResults: False
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<|newrecord|> nctId: NCT06299150 id: 2023-1 briefTitle: Clinical Evaluation of Three Different Techniques Restoring Ellis Class II Traumatized Central Incisors In Children overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-05-01 date: 2025-02-01 date: 2024-03-07 date: 2024-03-07 name: October University for Modern Sciences and Arts class: OTHER briefSummary: Dental trauma (DT) of the incisors and their supporting tissues, which is one of the most challenging dental emergency situations, requires immediate assessment and management due to psychological and physical reasons. (8) This is especially important for young permanent teeth because of continuing development in order to minimize undesired complications. The treatment of dental trauma is sometimes neglected. (9,10) although it might lead to pain, difficulty in articulation and mastication as well as having considerable negative effects on patient's self-esteem. (11) However, aesthetics of the anterior teeth are very important aspects of human appearance and could be affected by many factors including the presence of fillings, tooth color, position, alignment, shape and number. (12)
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Rasmussen ST et al. discovered in 1981 that most children suffer from tooth trauma. (13) According to their research, 25% of all schoolchildren and 33% of adults have undergone trauma, with the majority of cases occurring before the age of 19. (14)
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As the maxillary incisors are the most commonly injured teeth due to their exposed position, a functional, aesthetic and time-efficient restoration is frequently demanded.(15) According to the current International Association of Dental Traumatology guidelines, crown fractures confined to enamel and dentine may be treated either with a direct composite restoration or with an adhesive reattachment of the fractured fragment.(16) As long as the fragment is intact, reattachment is often preferred in dental practice. This technique facilitates the restoration of the tooth with its original anatomy, color and function in a minimum amount of time. (17,18) Unfortunately, clinical studies regarding the survival of reattached fragments are scarce, and results from laboratory investigations cannot be transferred to clinical settings without limitations. (19) Furthermore, longevity data of direct composite restorations in fractured anterior teeth are restricted to a few clinical studies. (20, 21)
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In addition to the aforementioned restorative alternatives, the use of small partial glassy restorations-partial laminate veneers (PLVs), sectional veneers, or ceramic fragments-has become increasingly popular over the last few years. (22,23) PLVs are thin pieces of glass-matrix ceramic fragments without a defined shape that are used to restore small defects in the anterior teeth. As tooth preparation is not required for this type of restoration, as for conventional laminate veneers, and minimal to no prep is accepted, the maximum amount of enamel surface structure is conserved. (24) Thus, retention relies completely on adhesion, which is primarily achieved by bonding to the conditioned glassy surface. (25,26) Despite their growing popularity, available data in the literature on PLVs are limited to a few in vitro studies (27,28) and case reports (29, 30, 31), without any clinical information available at present.
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Patients in all groups will receive a minimally invasive restoration with high esthetic advantages and long-term success of their fractured incisors (either conventional composite restoration, fragment reattachment or partial laminate veneers) that require minimal to no preparation depends on the type of restoration will receive and doesn't require local anesthesia. conditions: Composites Resins studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The study is a randomized clinical trial (RCT) where 2 arm parallel groups with a 1:1 allocation ratio were compared. The child participants and the legal guardian of each participating child and the statistician were blinded. primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 40 type: ESTIMATED name: IPS e.max CAD measure: Clinical success/ survival sex: ALL minimumAge: 8 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06299137 id: RE2022-0000000349 id: RE2022-0000000349 type: OTHER_GRANT domain: Society of Academic Emergency Medicine briefTitle: Ultrasound Guided Serratus Anterior Plane Block in ED Patients With Rib Fractures overallStatus: NOT_YET_RECRUITING date: 2024-08-01 date: 2025-10 date: 2025-10 date: 2024-03-07 date: 2024-03-12 name: Rhode Island Hospital class: OTHER briefSummary: The goal of this clinical trial is to test the effectiveness of the Serratus Anterior Plane Block in patients with rib fractures. The main questions it aims to answer are:
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* Determine if UG-SAPB results in an improved pain, incentive spirometry, and cough ability (PIC) score when compared to usual care over the first five hours.
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* Evaluate if UG-SAPB results in fewer opioid medications administered when compared to usual care over the first 24 hours.
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Participants will undergo the Serratus Anterior Plane. Researchers will compare this to usual care to see if this intervention improves pulmonary function and reduces opioid requirements for ED patients with rib fractures. conditions: Rib Fractures conditions: Pain Acute conditions: Regional Anesthesia conditions: Opioid Use studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Research Assistants who collect the data will be blinded to which arm of the study the participants are in. whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: Serratus Anterior Plane Block name: Ropivacaine injection measure: PIC Score measure: Total oral morphine equivalents over the first 24 hours sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Rhode Island Hospital city: Providence state: Rhode Island zip: 02903 country: United States name: Leland K Perice, MD role: CONTACT phone: 401-429-3441 email: lperice@lifespan.org name: Leland K Perice, MD role: PRINCIPAL_INVESTIGATOR lat: 41.82399 lon: -71.41283 hasResults: False
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<|newrecord|> nctId: NCT06299124 id: RGT-419B-102 briefTitle: A Phase I Study of RGT-419B in Patients With HR-Positive, HER2-Negative Advanced Breast Cancer or Other Solid Tumors overallStatus: RECRUITING date: 2023-04-17 date: 2024-12-30 date: 2025-06-30 date: 2024-03-07 date: 2024-03-08 name: Regor Pharmaceuticals Inc. class: INDUSTRY briefSummary: This is a Phase 1 dose escalation and dose expansion phase I study to evaluate the safety, tolerability, pharmacokinetic profile and preliminary efficacy of RGT-419B as monotherapy in Chinese patients with HR+/HER2- advanced/metastatic breast cancer and other advanced solid tumors. conditions: Breast Cancer conditions: Advanced Solid Tumor studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: RGT-419B measure: Safety & Tolerability - Number of subjects with Dose-Limiting Toxicities (DLTs) at each cohort dose level measure: Safety & Tolerability - Incidence, Severity, and Causality of all Treatment Emergent Adverse Events (TEAEs) measure: Day 1 and steady-state pharmacokinetics(PK) assessment of RGT-419B and major metabolites - Cmax measure: Day 1 and steady-state PK assessment of RGT-419B and major metabolites - Area Under Concentration-TimeCurve to Infinity (AUC0-inf) measure: Day 1 and steady-state PK assessment of RGT-419B and major metabolites - Plasma Decay Half-Life (t1/2) measure: Day 1 and steady-state PK assessment of RGT-419B and major metabolites - Time to Reach Maximum ObservedPlasma Concentration (Tmax) measure: Day 1 and steady-state PK assessment of RGT-419B and major metabolites - Accumulation rate after multipledoses measure: Day 1 and steady-state PK assessment of RGT-419B and major metabolites - Cumulative urinary excretion measure: Tumor Response assessed by Investigator according to RECIST v1.1 measure: QTc Interval - Changes in corrected QT interval sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fudan University Shanghai Cancer Center status: RECRUITING city: Shanghai state: Shanghai zip: 200032 country: China name: Yan Zhou role: CONTACT phone: 86-021-31168233 lat: 31.22222 lon: 121.45806 hasResults: False
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<|newrecord|> nctId: NCT06299111 id: R9933-DVT-2308 id: 2023-508603-21-00 type: OTHER domain: EU CT Number briefTitle: A Trial to Learn How Well REGN9933 and REGN7508 Work for Preventing Blood Clots, and How Safe They Are, in Adults Who Have a Peripherally Inserted Central Catheter (PICC) acronym: ROXI-CATH overallStatus: NOT_YET_RECRUITING date: 2024-08-31 date: 2026-06-08 date: 2026-06-08 date: 2024-03-07 date: 2024-03-07 name: Regeneron Pharmaceuticals class: INDUSTRY briefSummary: This study is researching 2 different experimental drugs called REGN9933 and REGN7508 (called "study drugs"). The study is focused on adults undergoing a placement of a catheter in your vein, also called a 'PICC line'.
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The aim of the study is to see how effective the study drug is at preventing venous thromboembolism (VTE) and other related disease after catheter placement.
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The study is looking at several other research questions, including:
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* What side effects may happen from taking the study drug
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* How much study drug is in your blood at different times
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* Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects) conditions: Venous Thromboembolism studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 195 type: ESTIMATED name: REGN9933 name: REGN7508 name: Placebo measure: Incidence of confirmed VTE per central reading center (CRC) review measure: Incidence of treatment-emergent adverse event (TEAEs) measure: Severity of TEAEs measure: Incidence of confirmed PICC associated venous thrombosis per CRC review measure: Incidence of major bleeding measure: Incidence of clinically relevant non-major (CRNM) bleeding measure: Concentrations of REGN9933 in serum measure: Concentrations of REGN7508 in serum measure: Change in activated partial thromboplastin time (aPTT) measure: Change in prothrombin time (PT) measure: Incidence of anti-drug antibody (ADA) to REGN9933 over time measure: Titer of ADA to REGN9933 over time measure: Incidence of ADA to REGN7508 over time measure: Titer of ADA to REGN7508 over time sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06299098 id: R1033-OB-2288 briefTitle: A Study to Test if Trevogrumab or Trevogrumab With Garetosmab When Taken With Semaglutide is Safe and How Well They Work in Adult Patients With Obesity for Weight Loss and Fat Loss acronym: COURAGE overallStatus: ACTIVE_NOT_RECRUITING date: 2024-03-13 date: 2026-06-24 date: 2026-06-24 date: 2024-03-07 date: 2024-04-01 name: Regeneron Pharmaceuticals class: INDUSTRY briefSummary: This study is researching experimental drugs called trevogrumab and garetosmab (called "study drugs") in combination with another drug, semaglutide (Wegovy®). Part A of the study, the sponsor is only researching trevogrumab. Part B of the study the sponsor is researching trevogrumab, garetosmab, and Wegovy either alone or in different combinations with each other. Part A of the study is focused on healthy participants. Part B of the study is focused on participants with obesity. The aim of Part A of the study is to see how safe and tolerable the study drug is in healthy participants. The aim of Part B of the study is to see how safe and effective the study drug is when combined with Wegovy.
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Parts A and B of the study are looking at several other research questions, including:
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* What side effects may happen from taking the study drug
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* How much study drug is in the blood at different times
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* Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects) conditions: Obesity studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 624 type: ESTIMATED name: Trevogrumab-Part A name: Trevogrumab-Part B name: Garetosmab name: Semaglutide name: Matching Placebo-Part A name: Matching Placebo-Trevogrumab name: Matching Placebo-Garetosmab measure: Incidence of treatment-emergent adverse events (TEAEs) measure: Severity of TEAEs measure: Percent body weight change measure: Percent change in total fat mass measure: Concentrations of trevogrumab in serum over time measure: Percent body weight change measure: Percent change in total fat mass measure: Percent change in total lean mass measure: Change in waist circumference (cm) measure: Percent change in body weight measure: Percent change in total lean mass measure: Percent change in regional measurements of body composition measure: Percent change in gynoid fat mass measure: Change in total lean mass:total fat mass ratio measure: Proportion of weight loss attributable to fat mass loss measure: Percent change in android (central) fat mass measure: Percent change in thigh muscle volume (TMV) measure: Body weight reduction of ≥5% measure: Body weight reduction of ≥10% measure: Body weight reduction of ≥15% measure: Body weight reduction of ≥20% measure: Body weight reduction of ≥25% measure: Percent change in fasting serum triglycerides measure: Percent change in total cholesterol measure: Percent change in Apolipoprotein B (Apo B) measure: Percent change in low-density lipoprotein cholesterol (LDL-C) measure: Change in physical function domain (5 items) score of Impact of Weight on Quality of Life-Lite for Clinical Trials (IWQoLLite- CT) measure: Change in physical functioning domain score of SF-36 measure: Concentrations of garetosmab in serum over time measure: Incidence of anti-drug antibodies (ADA) to trevogrumab after repeated doses over time measure: Titer of ADAs to trevogrumab after repeated doses over time measure: Incidence of ADAs to garetosmab after repeated doses over time measure: Titer of ADAs to garetosmab after repeated doses over time measure: Incidence of TEAEs measure: Severity of TEAEs sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: ProSciento city: Chula Vista state: California zip: 91911 country: United States lat: 32.64005 lon: -117.0842 facility: Tandem Clinical Research city: Marrero state: Louisiana zip: 70072 country: United States lat: 29.89937 lon: -90.10035 facility: Accellacare of Wilmington city: Wilmington state: North Carolina zip: 28401 country: United States lat: 34.22573 lon: -77.94471 hasResults: False
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<|newrecord|> nctId: NCT06299085 id: OSTEO-BS (L4191) briefTitle: Clinical-functional Effects of Bariatric Surgery on the Musculoskeletal System in Relation to Bone Turnover. overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-10-31 date: 2026-03-01 date: 2024-03-07 date: 2024-03-07 name: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio class: OTHER briefSummary: By studying "in vivo" new possible predictive factors of increased bone turnover and risk of fractures after bariatric surgery, our study aims to improve health not only musculoskeletal but general of patients with severe obesity, a pathology which represents one of the main causes of disability and mortality. conditions: Bariatric Surgery Candidate studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: The minimum sample size was determined by considering the circulating levels of gastro-entero hormones (PYY, ghrelin, GLP-1, GIP), adipokines (leptin and adiponectin) and hormones associated with the anabolism of muscle and bone tissue (insulin). as primary endpoints; the highest calculated sample size obtained for ghrelin levels was used for the purposes of this study.
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The calculation was performed using G\*Power software (v3.1.9.7) assuming a type I error (α error) of 0.05, a Power (1-β error) of 0.8, an effect size of 0.44.
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The resulting minimum sample size is 42 patients. Taking into account the presence of any drop-outs, 20% more patients will be considered, for a total of 50 patients to be enrolled. primaryPurpose: SCREENING masking: NONE count: 50 type: ESTIMATED name: 50 adult patients suffering from severe or morbid obesity, male and female, candidates for bariatric surgery. measure: Study of new predictive markers of possible bone remodeling through specific blood tests before (pre-admission) and 12 months after bariatric surgery. measure: Evaluation of the bone health status of patients pre- and post-bariatric surgery using different methods. sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06299072 id: PEP-2303 briefTitle: A Cross-sectional Online Survey Among Saudi Arabian Population in the Age Group 18-40 Years to Assess Whole Grain (WG) Awareness, Consumption Levels, and Dietary Habits Around Breakfast overallStatus: COMPLETED date: 2023-09-05 date: 2023-09-19 date: 2023-09-19 date: 2024-03-07 date: 2024-03-12 name: PepsiCo Global R&D class: INDUSTRY briefSummary: In this online survey conducted suing the YouGov consumer insights panel, the primary aims of this study are to provide for the first time an estimate of consumer awareness regarding wholegrains; their definitions and knowledge of potential benefits in the Saudi Arabia adult population and the he estimated consumption amongst Saudi consumers.
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Secondary Objectives are to assess the breakfast habit, oat consumption \& health concerns amongst Saudi consumers; identify socio-demographic and consumer characteristics associated with breakfast consumption, the types of foods consumed at breakfast, and fill gaps in knowledge regarding breakfast eating habits, commonly consumed breakfast foods. conditions: Diet, Healthy studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 814 type: ACTUAL name: Survey measure: Consumer awareness regarding wholegrains measure: Consumer definitions of wholegrains measure: Consumer knowledge of potential benefits of wholegrains measure: Wholegrain consumption measure: Breakfast habits measure: Oat consumption measure: Health concerns measure: Socio-demographics associated with breakfast consumption measure: Consumer characteristics associated with breakfast consumption measure: Types of foods consumed at breakfast measure: Fill gaps in knowledge regarding breakfast eating habits measure: Commonly consumed breakfast foods sex: ALL minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: Remote, no facility visits city: Riyadh country: Saudi Arabia lat: 24.68773 lon: 46.72185 hasResults: False
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<|newrecord|> nctId: NCT06299059 id: Compliance briefTitle: Intermittent Oro-esophageal Tube on Rehabilitation Therapy Compliance in Stroke Patients overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-07 date: 2024-07 date: 2024-03-07 date: 2024-03-12 name: Zeng Changhao class: OTHER briefSummary: The aim of this clinical trial is to compare Rehabilitation Therapy Compliance of ischemic stroke patients who receive enteral nutrition support through either Intermittent Oro-esophageal Tube or Nasogastric Tube. Patients will be randomly assigned to either an observation group or a control group, with both groups receiving routine rehabilitation treatment. The observation group will receive enteral nutrition support through Intermittent Oro-esophageal Tube, while the control group will receive it through Nasogastric Tube. Researchers will then compare Rehabilitation Therapy Compliance of the two groups. conditions: Stroke studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Intermittent Oro-esophageal Tube Feeding name: Nasogastric Tube Feeding measure: Rehabilitation Treatment Compliance Questionnaire measure: Patient Health Questionnaire-9 measure: Swallowing Quality of Life questionnaire sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06299046 id: 3235 briefTitle: Bleeding After Robot-assisted Radical Prostatectomy: a Respective Study acronym: UROBLOOD01 overallStatus: COMPLETED date: 2022-12-01 date: 2023-01-01 date: 2023-01-01 date: 2024-03-07 date: 2024-03-08 name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico class: OTHER briefSummary: Nowadays robot-assisted radical prostatectomy (RARP) has become the standard surgical treatment for localised prostate cancer. The robotic approach has been proven superior to open retropubic prostatectomy (ORP) in terms of surgical-related morbidity: RARP has in fact been associated with significantly lower estimated blood loos (EBL), lower transfusion rate, less length of stay, shorter catheterization time, lower risk of Clavien-Dindo grade II and III complications, lower risk of vesicourethral anastomotic stricture and less post-operative pain. The optimal anatomical visualisation and the extraordinary maneuverability, along with the tamponade effect of the pneumoperitoneum, are surely to be deemed responsible of this statistically significant differences.
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However, to this day no study has ever investigated the prognostic significance of haematological parameters in terms of predicting perioperative bleeding risk in patients undergoing RARP.
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Therefore, the investigators conducted a retrospective non-interventional cohort study to gather evidence concerning the impact of anemia and thrombocytopenia on bleeding risk following this surgical procedure. Furthermore, the investigators evaluated associations between demographical, pathological and surgical factors and hemorrhagic complications.
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The investigators retrospectively evaluated all the patients that underwent robot-assisted radical prostatectomy in our Urology Unit from the 1st of January 2017 to the 31th of December 2020. The investigators collected demographic, clinical and pathological data from the medical records of these patients, with particular attention to other known risk-factors for RARP-associated bleeding (e.g.: volume of the prostate, body mass index, smoking status, nerve sparing technique).
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Complications were analyzed according to the Clavien- Dindo classification. Bleeding was assessed by considering both the hemoglobin (Hb) drop after surgery and the fluid intraoperatively collected in the suction canister, with all the due adjustments. Moreover, post-operative haemorrhagic complications were evaluated.
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The investigators included patients not younger than 18 years old, of which records of a pre-operative full blood count in the 30 days prior to the surgery along with a full blood count the day after were available.
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Criteria for exclusion were a history of congenital coagulopathies and/or congenital thrombocytopenia and patients that underwent salvage radical prostatectomy after radiation therapy.
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Statistics: EBL and operative time learning curve is studied. Clinical, pathological, intraoperative risk factors analysis for higher EBL is performed by linear regression modelling. Factors are evaluated independently and jointly. Association between each factor above and post-operative outcomes (i.e. post-op bleeding, need of transfusion and hematuria) is also assessed. conditions: Prostate Cancer conditions: Bleeding conditions: Prostate Adenocarcinoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 194 type: ACTUAL name: robot-assisted radical prostatectomy measure: Influence of hemoglobin value on haemorrhagic complications measure: Influence of hematocrit value on haemorrhagic complications measure: Influence of platelet count on haemorrhagic complications measure: Influence of blood group on haemorrhagic complications measure: Identification of possibile demographic and surgical predictive factors of haemorrhagic complications sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Fondazione Ca' Granda Ospedale Maggiore Policlinico city: Milan zip: 20122 country: Italy lat: 45.46427 lon: 9.18951 hasResults: False
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<|newrecord|> nctId: NCT06299033 id: HPS-NP1-101 briefTitle: A Safety and Tolerability Study of Human Forebrain Neural Progenitor Cells Injection (hNPC01) in Subjects With Chronic Ischemic Stroke overallStatus: RECRUITING date: 2023-11-09 date: 2024-08-30 date: 2025-12-30 date: 2024-03-07 date: 2024-03-07 name: Hopstem Biotechnology Inc. class: INDUSTRY briefSummary: The principal aims of the clinical investigation involve assessing the safety profile and MTD of human forebrain neural progenitor cells (hNPC01) administered at escalated doses via single-dose intracerebral injection to subjects with stable chronic ischemic stroke. conditions: Chronic Ischemic Stroke studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 21 type: ESTIMATED name: hNPC01 measure: Incidence of Treatment-Emergent Adverse Events as assessed by physiological parameters during 6 months after intracerebral injection of hNPC01 measure: Incidence of Treatment-Emergent Adverse Events as assessed by physiological parameters during 12 months after intracerebral injection of hNPC01 measure: Number of participants with motor function improvement as assessed by rating scales of Modified Rankin Scale (mRS) during 12 months of treatment measure: Number of participants with motor function improvement as assessed by rating scales of Fugl-Meyer Motor Scale (FMMS) during 12 months of treatment measure: Number of participants with motor function improvement as assessed by rating scales of NIH Stroke Scale (NIHSS) during 12 months of treatment measure: Number of participants with motor function improvement as assessed by rating scales of Barthel Index (BI) during 12 months of treatment sex: ALL minimumAge: 30 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: XiangYa Hospital status: RECRUITING city: Changsha state: Hunan country: China name: Dan Li role: CONTACT phone: 15074875481 name: Zhiquan Yang, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 28.19874 lon: 112.97087 hasResults: False
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<|newrecord|> nctId: NCT06299020 id: HLaRabta24 briefTitle: Risks of Intermittent Fasting in Patients With Primary Adrenal Insufficiency overallStatus: NOT_YET_RECRUITING date: 2024-03-04 date: 2024-04-20 date: 2024-12 date: 2024-03-07 date: 2024-03-07 name: Hopital La Rabta class: OTHER briefSummary: In primary adrenal insufficiency, there is an increased risk of hypoglycaemia and dehydration. These risks have been little studied particularly during intermittent fasting. The present study aimed to assess these risks in a prospective study of 30 subjects with primary adrenal insufficiency. Patients will undergo a clinical examination, blood sampling and continuous glucose monitoring for fourteen days (one week of fasting and one week of non-fasting). conditions: Primary Adrenal Insufficiency conditions: Intermittent Fasting studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: DIAGNOSTIC masking: NONE count: 30 type: ESTIMATED name: intermittent fasting measure: hypoglycemia measure: Dehydration sex: ALL minimumAge: 20 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06299007 id: HYH EC 052-66-01 id: HYH EC 052-66-01 type: OTHER_GRANT domain: Hatyai Hospital Education Center briefTitle: Awareness of Iron Status Evaluation in UGIB acronym: AISE overallStatus: COMPLETED date: 2023-08-01 date: 2023-12-31 date: 2023-12-31 date: 2024-03-07 date: 2024-03-07 name: Hat Yai Medical Education Center class: OTHER briefSummary: BACKGROUND: Data on the awareness of the need to evaluate iron status and IDA prevalence in acute UGIB are limited.
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OBJECTIVES: This study aimed to investigate the rate of evaluation of iron status and prevalence of iron deficiency anemia (IDA) and the associated factors in patients with anemia hospitalized for acute upper gastrointestinal bleeding (UGIB). conditions: Upper Gastrointestinal Bleeding studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 867 type: ACTUAL measure: iron status measurement measure: Iron deficiency anemia sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hatyai Hospital city: Hat Yai state: Songkhla zip: 90110 country: Thailand lat: 7.00836 lon: 100.47668 hasResults: False
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<|newrecord|> nctId: NCT06298994 id: SBA 23/391 briefTitle: Determination of Body Awareness and the Functional Movement in Patients With COPD overallStatus: NOT_YET_RECRUITING date: 2024-03-08 date: 2025-03-08 date: 2026-03-08 date: 2024-03-07 date: 2024-03-07 name: Hacettepe University class: OTHER briefSummary: The aim of this study is to investigate body awareness and functional movement in patients with Chronic Obstructive Pulmonary Disease (COPD) compared to healthy controls. conditions: Pulmonary Disease, Chronic Obstructive conditions: Postural; Defect conditions: Movement, Abnormal conditions: Pain studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 60 type: ESTIMATED measure: Evaluation of functional movement measure: Evaluation of Body Awareness measure: Functional exercise capacity measure: Respiratory muscle strength measure: Respiratory muscle endurance measure: Pain Severity measure: Pain threshold measure: Posture measure: Daily living activities measure: Severity of disease measure: Dyspnea measure: Symptoms sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Aynur Demirel city: Ankara zip: 06100 country: Turkey lat: 39.91987 lon: 32.85427 facility: Hacettepe University city: Ankara zip: 06100 country: Turkey name: Aynur Demirel role: CONTACT phone: +905545295057 phoneExt: 178 email: aynur.demirel@hacettepe.edu.tr name: hidaye yamikan role: CONTACT phone: +905349898724 email: hidaye.yamikan@hacettepe.edu.tr name: hidaye yamikan role: SUB_INVESTIGATOR name: cansu akkus role: SUB_INVESTIGATOR lat: 39.91987 lon: 32.85427 hasResults: False
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<|newrecord|> nctId: NCT06298981 id: 2301 briefTitle: Pulse Rate and Breathing Rate Accuracy overallStatus: RECRUITING date: 2024-02-12 date: 2024-06-30 date: 2024-06-30 date: 2024-03-07 date: 2024-03-22 name: Nuralogix Corporation class: INDUSTRY briefSummary: The purpose of this study is to conduct a Breathing Rate and Pulse Rate accuracy validation comparing the NuraLogix AMC-SDK to the Reference devices, an FDA cleared End Tidal Carbon Dioxide monitor (GE Datex-Ohmeda) and a standard ECG (GE Datex-Ohmeda) derived heart rate reference. This will be done by manually scoring the collected waveform for data analysis. conditions: Pulse Rate and Breathing Rate studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 60 type: ESTIMATED name: noninvasive and investigational NuraLogix AMC-SDK measure: Breathing rate accuracy validation measure: Pulse rate accuracy validation measure: Pulse rate simulation sex: ALL minimumAge: 18 Years maximumAge: 81 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Element Materials Technology status: RECRUITING city: Louisville state: Colorado zip: 80027 country: United States name: Monica Rabanal role: CONTACT lat: 39.97776 lon: -105.13193 hasResults: False
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<|newrecord|> nctId: NCT06298968 id: NFEC-2024-074 briefTitle: Combined Therapy Using Gemcitabine and Cisplatin Chemotherapy, Lenvatinib and Adebrelimab for Patients With Advanced and Unresectable Intrahepatic Cholangiocarcinoma overallStatus: RECRUITING date: 2024-02-25 date: 2025-02-25 date: 2027-02-25 date: 2024-03-07 date: 2024-03-07 name: Nanfang Hospital, Southern Medical University class: OTHER briefSummary: In this phase 2 study, the investigators aim to evaluate the efficacy and safety of combined therapy using gemcitabine and cisplatin chemotherapy, Lenvatinib and Adebrelimab for patients with advanced and unresectable intrahepatic cholangiocarcinoma conditions: Intrahepatic Cholangiocarcinoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 38 type: ESTIMATED name: combined therapy using gemcitabine and cisplatin chemotherapy, Lenvatinib and Adebrelimab measure: Objective response rate (ORR) measure: The disease control rate (DCR) measure: Duration of response (DOR) measure: The median progression free survival time (mPFS) measure: The median overall survival time (mOS) measure: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Nanfang Hospital of Southern Medical University status: RECRUITING city: Guangzhou state: Guangdong country: China name: Mengya Zang role: CONTACT phone: 86-20-62787430 email: zangmy@163.com lat: 23.11667 lon: 113.25 hasResults: False
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<|newrecord|> nctId: NCT06298955 id: OMS906-PNH-003 briefTitle: Long-Term Safety, Tolerability and Efficacy of OMS906 in Paroxysmal Nocturnal Hemoglobinuria overallStatus: RECRUITING date: 2024-02-19 date: 2026-12 date: 2027-04 date: 2024-03-07 date: 2024-03-07 name: Omeros Corporation class: INDUSTRY briefSummary: The purpose of this study is to assess the long-term safety and tolerability of repeat-dose OMS906 5 mg/kg IV administration at 8-week intervals in patients with PNH. conditions: Paroxysmal Nocturnal Hemoglobinuria studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 25 type: ESTIMATED name: OMS906 study drug measure: To assess overall safety and tolerability of OMS906 administration at 8-week intervals in PNH patients. measure: To assess efficacy measured by hemoglobin (Hgb). measure: To assess efficacy by transfusion requirements. measure: To assess efficacy by measurement of lactate dehydrogenase (LDH). measure: To assess efficacy by measurement of reticulocyte count. measure: To assess efficacy by measurement of clinical breakthrough hemolysis. measure: To assess population PK Cmax of OMS906. measure: To assess population PK AUC of OMS906. measure: To assess population PK terminal half life of OMS906. measure: To assess PD of OMS906 measure: OMS906 anti-drug antibodies (ADA). measure: Assess the change in Functional Assessment of Chronic Illness Therapy (FACIT) fatigue score. sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Omeros Investigational Site status: NOT_YET_RECRUITING city: Aachen country: Germany lat: 50.77664 lon: 6.08342 facility: Omeros Investigational Site status: NOT_YET_RECRUITING city: Ulm country: Germany lat: 48.39841 lon: 9.99155 facility: Omeros Investigational Site status: RECRUITING city: Lausanne country: Switzerland lat: 46.516 lon: 6.63282 facility: Omeros Investigational Site status: NOT_YET_RECRUITING city: Kyiv country: Ukraine lat: 50.45466 lon: 30.5238 facility: Omeros Investigational Site status: NOT_YET_RECRUITING city: Leeds country: United Kingdom lat: 53.79648 lon: -1.54785 hasResults: False
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<|newrecord|> nctId: NCT06298942 id: fac.med.24.9 briefTitle: Naturally Banded Versus Synthetic Banding of Sleeve Gastrectomy overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2025-06-15 date: 2025-07-15 date: 2024-03-07 date: 2024-03-07 name: Minia University class: OTHER briefSummary: to compare banding sleeve gastrectomy using silicone ring Versus using natural flap ( round ligament of the liver) conditions: Obesity, Morbid studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 250 type: ESTIMATED name: natural band name: silicone band measure: total cost measure: food intolerance measure: %EWL measure: complications rate measure: improvement of comorbidities sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06298929 id: 36264PR427/11/23 briefTitle: Medial Rectus Fenestration vs Recession for PAET overallStatus: RECRUITING date: 2023-11-15 date: 2024-09-15 date: 2024-10-15 date: 2024-03-07 date: 2024-03-07 name: Mansoura University class: OTHER name: Tanta University briefSummary: This prospective comparative study aims to compare medial rectus (MR) muscle fenestration and recession in patients with partially accommodative esotropia (PAET). The main question it aims to answer is whether MR fenestration is equally effective as MR recession for PAET.
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All patients will receive complete ophthalmic and orthoptic assessment. Patients will be randomly allocated using a random table to one of two groups; Group 1 will receive conventional MR recession, and Group 2 will receive MR fenestration. conditions: Partially Accommodative Esotropia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: medial rectus fenestration name: medial rectus recession measure: Ocular alignment (measured in prism diopters) measure: ocular motility sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Tanta University status: RECRUITING city: Tanta state: Gharbeya country: Egypt name: Heba M Shafeik, MD role: CONTACT phone: +201227440829 email: heba.saeid@med.tanta.edu.eg lat: 30.78847 lon: 31.00192 hasResults: False
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<|newrecord|> nctId: NCT06298916 id: FAPi-1301 briefTitle: 64Cu-LNTH-1363S in Patients With Sarcoma or Gastrointestinal Tract Cancer acronym: PHANTOM overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-11 date: 2026-04 date: 2024-03-07 date: 2024-03-07 name: Lantheus Medical Imaging class: INDUSTRY briefSummary: This is a multicenter, open-label, prospective Phase 1/2a study to assess safety and tolerability, establish dosimetry and to identify an optimal imaging dose (radioactivity and mass dose) and imaging time window of 64Cu-LNTH-1363S (64Cu Radiolabeled FAPi PET/CT Imaging Agent) and to compare its imaging biodistribution with FAP expression by immunohistochemistry (IHC) in patients with sarcomas or GIT cancers. The study will be conducted in 2 parts (Part 1 and Part 2). conditions: Metastatic Sarcoma conditions: Esophageal Cancer conditions: Gastric Cancer conditions: Pancreatic Cancer conditions: Colorectal Cancer conditions: Sarcoma studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: Part 1: Metastatic Sarcoma Part 2: Non-metastatic sarcoma or gastrointestinal tract (GIT) cancer (esophageal, gastric, pancreatic, colorectal cancer) primaryPurpose: DIAGNOSTIC masking: NONE count: 32 type: ESTIMATED name: 64Cu-LNTH-1363S measure: Primary Part 1 Biodistribution of 64Cu-LNTH-1363S measure: Primary Part 1 - Optimal dose (radioactivity and mass dose) and imaging time window of 64Cu-LNTH-1363S measure: Primary Part 2 - Correlation of 64Cu-LNTH-1363S biodistribution with Immunohistochemistry FAP expression measure: Secondary Parts 1 and 2 Safety and Tolerability measure: Secondary Part 1 FAP expression profile of 64Cu-LNTH-1363S in patients with sarcoma measure: Secondary Part 1 and Part 2 Cardiac Safety measure: Secondary Part 2 Validate optimal radioactivity in patients with sarcoma or GIT cancer measure: Exploratory Part 1 and Part 2 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06298903 id: STUDY00002565 briefTitle: Impact of Hip Activation Compared to Hip Plus Balance Training on the Forward-Step-Down Test overallStatus: ACTIVE_NOT_RECRUITING date: 2024-01-12 date: 2024-03-25 date: 2024-08 date: 2024-03-07 date: 2024-04-29 name: Louisiana State University Health Sciences Center Shreveport class: OTHER briefSummary: The purpose of this research is to determine the impact of a hip activation home exercise program (HEP) compared to a hip activation + single leg balance HEP on performance of the Forward-Step-Down Test (FSDT) in healthy females. Participants will be assigned to the control (hip activation HEP only) or experimental (hip activation + single leg balance HEP). Following the pre-test data collection, participants will complete their HEP for 8 weeks. They will return to the lab for post-test measurements. conditions: Control of Frontal Plane Biomechanics conditions: Patellofemoral Pain Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE maskingDescription: The investigator who will analyze the data will be blinded whoMasked: INVESTIGATOR count: 34 type: ACTUAL name: Hip Activation name: Hip activation + Single leg balance measure: Forward-Step-Down Test measure: surface electromyography (sEMG) peak measure: surface electromyography (sEMG) mean measure: Unipedal Stance Test (UPST) measure: Dose-Response sex: FEMALE minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: LSUHSC-Shreveport city: Shreveport state: Louisiana zip: 71103 country: United States lat: 32.52515 lon: -93.75018 hasResults: False
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<|newrecord|> nctId: NCT06298890 id: SASKAT briefTitle: The Pattern of Dry Eye Disease After Cataract Surgery overallStatus: RECRUITING date: 2024-03 date: 2026-05 date: 2027-09 date: 2024-03-07 date: 2024-03-07 name: Lithuanian University of Health Sciences class: OTHER name: Santen Oy briefSummary: This study is designed to explore dry eye disease (DED) pattern: ocular surface, corneal morphological changes, patients' subjective assessment of DED and their correlations with ocular surface inflammation, pain biomarkers after cataract surgery according to ocular surface lubrication with artificial tears during long-term follow-up. conditions: Dry Eye Disease conditions: Cataract conditions: Ocular Surface Disease studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Artificial tears (sodium hyaluronate 0.2%) measure: Assessment of ocular surface changes following cataract surgery measure: Evaluation of the cornea morphology measure: Evaluation of matrix metalloproteinase-9 (MMP-9) levels in patients' tears measure: Evaluation of tear osmolarity measure: Evaluation of tear cytokine levels measure: Assessment of central corneal sensitivity measure: Evaluation of potential pain biomarkers in patients' saliva measure: Dry Eye Questionnaire-5 (DEQ5) 5-item measure: Ocular surface disease index (OSDI) measure: Visual function (VFQ-25) questionnaire measure: Visual acuity evaluation (LogMAR) sex: ALL minimumAge: 50 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Lithuanian University of Health Sciences status: RECRUITING city: Kaunas zip: LT-44307 country: Lithuania name: Reda Zemaitiene role: CONTACT phone: + 370 37 327 201 email: rektoratas@lsmu.lt lat: 54.90272 lon: 23.90961 hasResults: False
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<|newrecord|> nctId: NCT06298877 id: 2023-04696-01 briefTitle: Frailty, Quality Of Life and Early Reversal of Temporary Defunctioning Stoma in Ovarian Cancer acronym: FOLERO overallStatus: RECRUITING date: 2024-03-11 date: 2029-03-28 date: 2029-03-28 date: 2024-03-07 date: 2024-03-20 name: Sahar Salehi class: OTHER briefSummary: Complete macroscopic surgical resection (CMR) requires extensive surgery and combined with chemotherapy confers best chance of survival in advanced ovarian cancer. During cytoreductive surgery 11% of women require a temporary diverting intestinal stoma.
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Unexpectedly, our results from a unique fully accounted for population demonstrate that survival was not improved when increasing the proportion of women in whom CMR was achieved and in a yet unidentified subgroup of women extensive surgery was detrimental. In these women surgical treatment should be omitted in favor of chemotherapy only. Accordingly, there is an imperative need to improve patient selection to surgical treatment.
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In Sweden, we treat an unselected population of women in a public healthcare system, where 30% of women with are \>75 years. Despite these circumstances guidelines on patient-selection are lacking.
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Age is an imprecise variable to base clinical decisions on but must be considered with an aging population. The dynamics between physiological changes of aging, comorbidity and medical condition are included in the concept of frailty, that has gained little attention in oncology, despite their potential to stratify risk and mortality.
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The FOLERO study is a prospective adequately powered national cohort study with aim to determine if frailty instruments may be used to select patient to surgical treatment. In addition, we test the feasibility of early stoma reversal after index cytoreductive surgery in a small phase I trial and follow our patients Health Related Quality of Life after state of the art surgical treatment. conditions: Ovarian Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 450 type: ESTIMATED name: Frailty and Quality of Life evaluation measure: Overall Survival measure: 1-year mortality measure: Health related quality of life (HRQoL) (QLQ-C30) measure: Health related quality of life (HRQoL) (QLQ-OV28) measure: Health related quality of life (HRQoL) (QLQ-ELD14) measure: Health related quality of life (HRQoL) (EQ-5D-5L) measure: Low anterior resection syndrome (LARS) measure: Postoperative complications measure: Readmissions measure: Length of hospital stay measure: Extent of surgery vs survival measure: Sarcopenia vs post-operative outcome measure: Standard regimen of adjuvant chemotherapy measure: Time interval to adjuvant chemotherapy measure: Total number of hospital days and readmissions within90 days after index surgery measure: Health economics measure: Recurrence or progression free survival sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Karolinska University Hospital status: RECRUITING city: Stockholm state: Solna zip: 171 76 country: Sweden name: Sahar Salehi, MD, Ass Prof role: CONTACT email: sahar.salehi@regionstockholm.se name: Daniel Hunde, MD role: CONTACT email: daniel.hunde@regionstockholm.se name: Daniel Hunde, MD role: SUB_INVESTIGATOR name: Sahar Salehi, MD, Ass Prof role: PRINCIPAL_INVESTIGATOR lat: 59.33258 lon: 18.0649 facility: Sahlgrenska University Hospital and Sahlgrenska Academy status: NOT_YET_RECRUITING city: Gothenburg zip: 41685 country: Sweden name: Pernilla Dahm-Kähler, MD, Prof. role: CONTACT phone: 0313434216 email: pernilla.dahm-kahler@gu.se name: Pernilla Dahm-Kähler, MD, Prof. role: PRINCIPAL_INVESTIGATOR name: Charlotte Palmqvist, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 57.70716 lon: 11.96679 facility: Linköping University Hospital status: RECRUITING city: Linköping zip: 581 85 country: Sweden name: Madelene Wedin, MD, PhD role: CONTACT email: madelene.wedin@regionostergotland.se name: Madelene Wedin, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 58.41086 lon: 15.62157 facility: Skåne University Hospital status: NOT_YET_RECRUITING city: Lund zip: 22185 country: Sweden name: Mihaela Asp, MD, PhD role: CONTACT email: Mihaela.Asp@skane.se name: Mihaela Asp, MD, PhD role: PRINCIPAL_INVESTIGATOR name: Päivi Kannisto, MD, Ass Prof role: SUB_INVESTIGATOR lat: 55.70584 lon: 13.19321 hasResults: False
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<|newrecord|> nctId: NCT06298864 id: ASC-RCT 2 briefTitle: Internet-based Behavioral Intervention Following ACS acronym: ACS-CBT overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2026-01-31 date: 2027-01-31 date: 2024-03-07 date: 2024-03-07 name: Karolinska Institutet class: OTHER name: Karolinska University Hospital briefSummary: The aim of this study is to evaluate if an online Cognitive Behavioral Therapy (CBT) protocol customized for patients following Acute Coronary Syndrome (ACS), reduce cardiac anxiety, enhance Quality of Life (QoL), and promote increased physical activity while controlling for caregiver attention, utilizing an active control group receiving internet-based cardiac lifestyle intervention. conditions: Acute Coronary Syndrome conditions: Online CBT Targeting Cardiac Anxiety studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 260 type: ESTIMATED name: Internet-CBT name: Internet-CL measure: Cardiac anxiety questionnaire modified for weekly assessment measure: Cardiac anxiety questionnaire measure: Cardiac anxiety questionnaire measure: HeartQoL Health-related Quality of Life Questionnaire modified for weekly assessment measure: HeartQoL Health-related Quality of Life Questionnaire measure: HeartQoL Health-related Quality of Life Questionnaire measure: Symptom checklist Severity and Frequency Scale (SCL, adapted to coronary artery disease) modified for weekly assessment measure: Symptom checklist Severity and Frequency Scale (SCL, adapted to coronary artery disease) measure: Symptom checklist Severity and Frequency Scale (SCL, adapted to coronary artery disease) measure: University of Toronto Atrial fibrillation Severity Scale (AFSS) measure: University of Toronto Atrial fibrillation Severity Scale (AFSS) measure: University of Toronto Atrial fibrillation Severity Scale (AFSS) measure: Myocardial infarction behavior questionnaire measure: Myocardial infarction behavior questionnaire measure: Myocardial infarction behavior questionnaire measure: DOSE Non-Adherence questionnaire measure: DOSE Non-Adherence questionnaire measure: DOSE Non-Adherence questionnaire measure: Perceived stress scale 4-item measure: Perceived stress scale 4-item measure: Perceived stress scale 4-item measure: Short Fatigue questionnaire measure: Short Fatigue questionnaire measure: Short Fatigue questionnaire measure: Patient Health Questionnaire-9 measure: Patient Health Questionnaire-9 measure: Patient Health Questionnaire-9 measure: Insomnia Severity Index measure: Insomnia Severity Index measure: Insomnia Severity Index measure: Perceived stress scale 4-item measure: The Godin Leisure-time Exercise and International Physical Activity Questionnaire 1 item on inactivity measure: The Godin Leisure-time Exercise and International Physical Activity Questionnaire 1 item on inactivity measure: The Godin Leisure-time Exercise and International Physical Activity Questionnaire 1 item on inactivity measure: Lifestyle factors: The national Board of health and Welfare questionnaire measure: Lifestyle factors: The national Board of health and Welfare questionnaire measure: Lifestyle factors: The national Board of health and Welfare questionnaire measure: Aversive cognition to medication measure: Adversive cognition to medication measure: Adversive cognition to medication measure: Adverse events measure: Adverse events measure: Adverse events measure: Adverse events measure: Accelerometer (Actigraf®) measure: Accelerometer (Actigraf®) measure: Swedish Prescribed Drug Register measure: Swedish Prescribed Drug Register measure: Swedish Prescribed Drug Register measure: Working Alliance Inventory measure: Treatment Credibility Scale measure: Client satisfaction Questionnaire measure: Follow-up questions on health changes measure: Follow-up questions on health changes measure: Follow-up questions on health changes measure: AFFS/SCL-4 measure: MI-behavior Questionnaire measure: DOSE Non-Adherence questionnaire sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Karolinska University Hospital city: Stockholm zip: 11635 country: Sweden name: Josefin Särnholm, PhD role: CONTACT lat: 59.33258 lon: 18.0649 hasResults: False
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<|newrecord|> nctId: NCT06298851 id: E-10840098-772.02-2026 briefTitle: Comparative Effects of Lower Body Quadrant Neural Mobilization and Stretching in Collegiate Football Players overallStatus: NOT_YET_RECRUITING date: 2024-03-08 date: 2024-03-25 date: 2024-03-31 date: 2024-03-07 date: 2024-03-07 name: Istanbul Medipol University Hospital class: OTHER briefSummary: Neural mobilizations (NM) are defined as interventions that aim to directly or indirectly affect neural structures or surrounding tissue through manual techniques or exercise. Neural mobilizations have been studied in both patients and healthy populations. In the study, individuals in the amateur football team will be divided into three groups and will be given pre-training warm-up periods, including neural mobilization, dynamic and static stretching.After the warm-up period, its effect on flexibility and performance will be examined and compared. conditions: Sports Physical Therapy conditions: Stretch conditions: Stretch Injury studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: Neural Mobilization Group (NMG) name: Dynamic Stretching Group (DSG) name: Static Stretching Group (SSG) measure: Straight Leg Raise Test measure: Y Balance Test measure: One-Leg Forward Jump Test measure: T Test measure: BlazePod Reaction Time Determination Test sex: ALL minimumAge: 18 Years maximumAge: 25 Years stdAges: ADULT facility: Istanbul Medipol University city: Istanbul zip: 34820 country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False
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<|newrecord|> nctId: NCT06298838 id: XEOS study briefTitle: High-resolution Intra-operative PSMA PET-CT in Prostate Cancer overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-03 date: 2025-03 date: 2024-03-07 date: 2024-03-07 name: IRCCS San Raffaele class: OTHER briefSummary: This is a Single-center, diagnostic open-label prospective, pilot study in a total of 10 patients affected by Prostate cancer (PCa) with a risk of lymph node invasion (LNI) higher than 5% and candidates for a robot-assisted radical prostatectomy (RARP) with an extended pelvic lymph node dissection (ePLND) .
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The aim of the trial is to evaluate the feasibility and accuracy and clinical value of a novel high-resolution perioperative PET-CT-scan for intraoperative margin and lymph node invasion assessment, after 18F-PSMA injection, using histopathology as the gold standard. conditions: Prostate Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 10 type: ESTIMATED name: AURA10® Specimen PET/CT imager measure: To investigate the performance characteristics (sensitivity and specificity) of a novel high-resolution perioperative PET-CT-scan for intraoperative margins and lymph node invasion assessment after 18F-PSMA using histopathology as the gold standard measure: Reporting positive lymph nodes detection rate at intraoperative imaging after 18-PSMA injection sex: MALE minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06298825 id: KY2024-148 briefTitle: S-ADHF：Sarcopenia in Patients With ADHF acronym: S-ADHF overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-12-01 date: 2026-06-01 date: 2024-03-07 date: 2024-03-12 name: Guangdong Provincial People's Hospital class: OTHER briefSummary: This is a prospective, multi-center, investigator-initiated observational cohort study. Enrollment with a minimum of of 195 cases each for patients with and without sarcopenia. Each patient is followed up for 6 month, 1 year, 2 years or until the occurrence of death.This study will examine the correlation between sarcopenia and prognosis in different subgroups of patients, and explore the additive effect of different comorbidities and sarcopenia on prognosis in patients with acute decompensated heart failure. conditions: Acute Decompensated Heart Failure studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 500 type: ESTIMATED measure: All-cause mortality measure: All-cause mortality measure: Cardiovascular mortality measure: All-cause hospitalisation measure: HF hospitalisation measure: The frequency and length of hospitalization of patient readmitted measure: Survival time from enrollment to death of deceased patients sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Huan Ma city: Guangdong country: China name: Huan Ma, PhD role: CONTACT phone: +86 15078755932 email: mahuandoctor@163.com hasResults: False
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<|newrecord|> nctId: NCT06298812 id: Protocol Rev 0 11July2023 briefTitle: REFLECT Scoliosis System Post Approval Study overallStatus: NOT_YET_RECRUITING date: 2024-03-31 date: 2027-03-31 date: 2032-03-31 date: 2024-03-07 date: 2024-03-07 name: Globus Medical Inc class: INDUSTRY briefSummary: The purpose of this multi-center, prospective, single-arm registry Post-Approval Study (PAS) is to evaluate the radiographic and clinical outcomes of 100 patients with idiopathic scoliosis treated with the REFLECT™ Scoliosis Correction System, as a condition of HDE approval conditions: Idiopathic Scoliosis studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Patients treated with the REFLECT Scoliosis Correction System primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: REFLECT Scoliosis Correction System measure: Primary Probable Benefit measure: Primary Safety measure: Curve progression measure: Device integrity measure: Composite endpoint analysis measure: Failure analysis measure: SRS score sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Mayo Clinic city: Rochester state: Minnesota zip: 55905 country: United States name: Jana Robinson role: CONTACT name: Noelle Larson, MD role: PRINCIPAL_INVESTIGATOR lat: 44.02163 lon: -92.4699 hasResults: False
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<|newrecord|> nctId: NCT06298799 id: GEN-GE-001-IL briefTitle: GENETIC VARIABILITY TO GLP1 TREATMENT acronym: GLP1 treatment overallStatus: RECRUITING date: 2023-10-01 date: 2025-01-01 date: 2025-01-01 date: 2024-03-07 date: 2024-03-07 name: GENGE class: OTHER briefSummary: The goal of this retrospective study is to assess whether a selection of genetic variants may allow us to identify individuals who will have a satisfactory response after GLP-1 treatment in terms of weight loss, sugar level reduction, and adverse events.
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Participants will The study consists of a single visit at the diabetes unit clinic at the involved study sites. The following will be performed for every subject at the study screening enrollment visit:
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* Informed consent
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* Study eligibility (Inclusion / Exclusion criteria)
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* Collection of demographic data (age (date of birth), gender, ethnic origin)
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* General and T2DM medical history review (per subject file)
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* Concomitant medication review (at enrollment)
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* Physical attributes (Body Weight, Height, BMI)
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* Allocation to study cohort and study subgroup
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* Saliva and blood collection for genetic tests
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* Self-reported questionnaire for Ozempic (Semaglutide) experience conditions: Type 2 Diabetes conditions: Obesity studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: The study population consists of two cohorts:
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A. Type 2 Diabetic participants cohort B. Healthy participants cohort primaryPurpose: OTHER masking: NONE maskingDescription: no masking count: 400 type: ESTIMATED name: DNA Sequencing and Analysis name: differential expression analysis with RNA-sequencing (RNA seq) experiments measure: Genetic variants and miRNA expressions associated with changes in BMI. measure: Genetic variants and miRNA expressions associated with changes in A1c. measure: Genetic variants and miRNA expressions associated with side effects. measure: Demographic parameters that affect GLP1 AG therapy. sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Rambem medical center status: RECRUITING city: Haifa country: Israel name: Irit Hochberg, MD role: PRINCIPAL_INVESTIGATOR lat: 32.81841 lon: 34.9885 hasResults: False
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<|newrecord|> nctId: NCT06298786 id: 6MIMATE012 briefTitle: Validation and Evaluation of the Mastication Function in Adults: The Functional Six-minute Mastication Test (F-6MMT). acronym: F-6MMT overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-06 date: 2024-09 date: 2024-03-07 date: 2024-03-13 name: Fundació Universitària del Bages class: OTHER name: Hospital Universitari Sagrat Cor name: Universitat Internacional de Catalunya name: Clinicas Dr. Emilio López Jiménez briefSummary: Temporomandibular Disorders (TMD) encompass various conditions that affect the temporomandibular joint and associated tissues, often causing or being associated with other symptoms such as jaw pain, myofascial pain, neck pain, and headaches. TMDs are classified according to the DC/TMD instrument in which the joint and pain axes are evaluated. However, there is no evaluation of mandibular function, and TMDs can result in a decrease in jaw strength and resistance. This leads to an increase in the chewing fatigue. Reliable and time-effective diagnostic methods for evaluating masticatory function are crucial in the clinical setting because of the high prevalence of TMD. Chewing efficiency is essential for food preparation and nutrient absorption, and muscle fatigue is a common problem affecting chewing ability. Despite this, there is a lack of validated tests to evaluate chewing fatigue in patients with TMD, which makes its consideration unnoticed in clinical practice.
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The modified six-minute functional chewing test (F-6MMT) was proposed as a tool to evaluate chewing ability and fatigue in patients with TMD. This test is an adaptation of a previously designed test in which subjects with mitochondrial pathology were evaluated; however, the subjects were not instructed to perform functional chewing during the test. In this version, modifications are added so that the test is as functional as possible, allowing chewing to be evaluated in a standardized way, and cut-off points established between healthy subjects and subjects with TMD in terms of chewing capacity in general and fatigue in particular. This study will follow standardized reporting guidelines and recruit participants from diverse clinical settings. conditions: Mastication Disorder conditions: Fatigue conditions: Temporomandibular Disorder conditions: Orofacial Pain conditions: Chewing Problem studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 400 type: ESTIMATED name: Functional 6-minute mastication test measure: Fatigue measure: Self-reported Pain measure: Pain-related TMD diagnosis measure: Self-reported daily fatigue measure: Pain pressure threshold (PPT) measure: Taste of the gum measure: Difficulty in breaking the gum at the beginning of the F-6MMT measure: Preferred side when chewing during the F-6MMT measure: Kinesiofobia related to TMD measure: Health status measure: Comorbidities sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Universitat de Manresa city: Manresa state: Barcelona zip: 08242 country: Spain name: Jordi Padrós, Mr role: CONTACT phone: 613040826 email: jpadros@umanresa.cat name: Jordi Padros-Augé, PhDS role: PRINCIPAL_INVESTIGATOR name: Arnau Cerdà-Ribó, PT role: PRINCIPAL_INVESTIGATOR lat: 41.72815 lon: 1.82399 facility: Universitat Internacional de Catalunya city: Barcelona zip: 08017 country: Spain name: Jordi Tomás-Aliberas, PhD role: CONTACT phone: +34932541800 email: jtomas@uic.es lat: 41.38879 lon: 2.15899 facility: Hospital QuirónSalud Sagrado Corazón city: Barcelona zip: 08029 country: Spain name: Cristian Justribó, Mr role: CONTACT phone: +34672057031 email: cjustribom@uao.es name: Cristian Justribó-Manion, PhDS role: PRINCIPAL_INVESTIGATOR name: José J Bara Casaus, PhD role: PRINCIPAL_INVESTIGATOR lat: 41.38879 lon: 2.15899 facility: Clínicas Dr. Emilio López Jiménez city: Jaén zip: 23280 country: Spain name: Emilio López-Jiménez, PhD role: CONTACT phone: 665842389 email: ddnariz@gmail.com lat: 37.76922 lon: -3.79028 hasResults: False
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<|newrecord|> nctId: NCT06298773 id: 6127 briefTitle: Spatial Profile of Tumors acronym: PROST overallStatus: NOT_YET_RECRUITING date: 2024-03-05 date: 2026-09-30 date: 2028-12-30 date: 2024-03-07 date: 2024-03-07 name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS class: OTHER briefSummary: The research project focuses on analyzing the spatial organization of cells within various solid tumors, utilizing advanced technologies enabling in-depth multi-parametric analysis of tumor and immune cells. The primary objective is to understand the spatial distribution of cellular subpopulations within each type of tumor, while secondary objectives include correlating these data with clinical aspects and identifying potential therapeutic targets. The study involves 1000 patients with primary or metastatic tumors and spans a duration of 5 years, from 2024 to 2028. No experimental treatments are planned; rather, only spatial imaging analyses with multiple markers will be conducted. Data analysis involves descriptive statistical methods and hypothesis testing to generate hypotheses for subsequent studies. The analyses will be performed using SPSS® version 21.0 software for Windows®. conditions: Solid Tumors studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1000 type: ESTIMATED name: Spatial analysis of paraffin samples from solid tumors measure: Spatial analysis of cancer cells measure: Comparison of clinical data measure: Identification of therapeutic targets sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS city: Rome state: RM zip: 00168 country: Italy name: Alessandro Sgambato role: CONTACT phone: +390630154914 email: alessandro.sgambato@policlinicogemelli.it name: Alessandro Sgambato role: PRINCIPAL_INVESTIGATOR lat: 41.89193 lon: 12.51133 hasResults: False
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<|newrecord|> nctId: NCT06298760 id: çörekotu refleksoloji briefTitle: The Effect of Reflexology and Knee Massage With Black Cumin Oil on Pain and Fatigue overallStatus: COMPLETED date: 2019-06-19 date: 2020-02-19 date: 2020-04-19 date: 2024-03-07 date: 2024-03-12 name: Erzurum Technical University class: OTHER briefSummary: In this study, black cumin extract oil was used in elderly individuals with Knee Osteoarthritis (OA). The effects of foot reflexology and knee massage on pain and fatigue symptoms. It is aimed to examine and research which of these two applications is more effective.The study, planned as a randomized controlled experimental study, included a total of 150 participants.
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The data consists of participants who receive outpatient treatment in the Physical Therapy and Rehabilitation Unit at a university hospital, are over 65 years old, and have no problems with their perception after the Mini Mental Test. After randomization, participants were divided into five groups, with 30 participants in each group. Groups; It consisted of 1) Reflexology with Black Cumin, 2) Placebo Reflexology, 3) Knee Massage with Black Cumin, 4) Placebo Knee Massage and 5) Control groups. conditions: Knee Osteoarthritis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: After randomization, participants were divided into 30 participants in each group.
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were divided into five groups:Groups; It consisted of 1) Reflexology with Black Cumin, 2) Placebo Reflexology, 3) Knee Massage with Black Cumin, 4) Placebo Knee Massage and 5) Control groups. "Patient Information Form", "Kellgren and Lawrence", "Pain Visual Analog Scale (A-VAS)", "Fatigue Severity Scale and Western Ontario and McMaster Universities Osteoarthritis Index "WOMAC" were applied to the participants. Participants in the application groups were administered once a week for 6 weeks. The session lasted 30 minutes. The control group was allowed to continue routine treatment and care without any intervention. Data were collected by applying questionnaires to the participants in the 1st and 6th weeks. primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 150 type: ACTUAL name: Knee Massage With Black Cumin Oil Group: name: Foot Reflexology Group With Black Cumin Oil name: placebo group measure: Pain Score measure: fatigue severity sex: ALL minimumAge: 65 Years maximumAge: 90 Years stdAges: OLDER_ADULT facility: Ercan Bakır city: Erzurum state: Yakutiye country: Turkey lat: 39.90861 lon: 41.27694 hasResults: False
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<|newrecord|> nctId: NCT06298747 id: Cervical root PRF briefTitle: Ultrasound-guided Selective Cervical Root Pulsed Radiofrequency Therapy in Patients With Cervical Radicular Pain acronym: pulsedrf overallStatus: COMPLETED date: 2022-11-01 date: 2023-07-01 date: 2023-07-02 date: 2024-03-07 date: 2024-03-15 name: Diskapi Teaching and Research Hospital class: OTHER briefSummary: Chronic cervical pain is a common disorder with a prevalence of approximately 35% in adults. Cervical radicular pain is defined as radiating pain in the upper limb caused by compression or inflammation of the nerve roots ascending from the intervertebral foramen to the spinal cord, due to disc herniation or spinal stenosis. C7 and C6 are the two most commonly affected nerve roots. Various treatment modalities are available, including oral medications, physiotherapy, and epidural steroid injections. However, chronic and persistent pain that develops as a result of some patients not responding to these treatments. Ultrasound-guided selective cervical nerve root block and pulsed radiofrequency are interventional treatments used in patients with radicular cervical pain unresponsive to conservative treatments. Pulsed radiofrequency (PRF) treatment of peripheral nerves may provide long-term pain relief in patients with short-term pain relief with a local anesthetic block. Studies have shown the effectiveness of PRF therapy applied to selective cervical nerve roots in relieving cervical radicular pain. conditions: Cervical Pain studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: RETROSPECTIVE count: 45 type: ACTUAL name: Selective cervical nerve root pulsed radiofrequency measure: VAS measure: Neck Disability Index (NDI) measure: Douleur Neuropathique 4 Questions (DN4) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ankara Etlik City Hospital city: Ankara country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False
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<|newrecord|> nctId: NCT06298734 id: 23-712 briefTitle: Exercise and Diet Interventions During Immunotherapy in Melanoma Patients overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2025-03-31 date: 2026-03-31 date: 2024-03-07 date: 2024-03-07 name: Dana-Farber Cancer Institute class: OTHER name: World Cancer Research Fund International briefSummary: The purpose of this study is to determine whether high-intensity exercise and high-fiber diet are feasible and improve various health outcomes among participants with advanced melanoma receiving immunotherapy.
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The names of the groups in this research study are:
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* High-Intensity Exercise (EX)
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* High-fiber Diet (DT)
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* Combined High-Intensity Exercise and High-Fiber Diet (COMB)
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* Attention Control (AC) conditions: Melanoma (Skin) conditions: Skin Cancer conditions: Advanced Melanoma studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 40 type: ESTIMATED name: Exercise Program name: Diet Program measure: Change in Gut Microbiome Diversity measure: Change in Systemic Immune Function measure: Change in Cardiopulmonary Fitness measure: Change in Short Physical Performance Battery (SPPB) measure: Change in Percent Body Fat measure: Change in Lean mass measure: Change in Hip circumference measure: Change in Waist circumference measure: Change in Health-Related Quality of life (EORTC-QLQ C30) measure: Change in MDASI-Immunotherapy Questionnaire Score measure: Change in Anxiety (HADS) measure: Change in Depression (HADS) measure: Change in Sleep Quality (PSQI) measure: Proportion of Participants Completing the Exercise Intervention Sessions sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Dana-Farber Cancer Institute city: Boston state: Massachusetts zip: 02215 country: United States lat: 42.35843 lon: -71.05977 hasResults: False
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<|newrecord|> nctId: NCT06298721 id: 23-885 briefTitle: Improving Total Knee Arthroplasty Dissatisfaction Through a Personalized Approach Focusing on PROMs Phenotypes overallStatus: RECRUITING date: 2024-03-12 date: 2027-03 date: 2027-03 date: 2024-03-07 date: 2024-04-17 name: The Cleveland Clinic class: OTHER name: American Association of Hip and Knee Surgeons briefSummary: This study is a randomized controlled trial to assess whether the implementation of a TKA Personalized Outcome Prediction Tool to set expectation, in addition to targeted interventions to address patients with poor baseline mental health and poor physical function, improves satisfaction at 1-year (when compared to standard of care). conditions: Knee Osteoarthritis conditions: Knee Arthropathy conditions: Surgery studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 300 type: ESTIMATED name: Personalized outcome prediction tool + targeted interventions name: Standard of Care TKA measure: Satisfaction at 1 year sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cleveland Clinic Foundation status: RECRUITING city: Cleveland state: Ohio zip: 44195 country: United States name: Shujaa T Khan, MD role: CONTACT phone: 419-965-8274 email: khans34@ccf.org lat: 41.4995 lon: -81.69541 hasResults: False
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<|newrecord|> nctId: NCT06298708 id: PED-2566-0634 briefTitle: Immunogenicity and Safety of Inactivated and Live-attenuated HAV Vaccine Among Thai Healthy Children and Adolescents acronym: HAV-RCT overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-03 date: 2025-06 date: 2024-03-07 date: 2024-03-08 name: Chiang Mai University class: OTHER name: Faculty of Medicine, Chiang Mai University briefSummary: Hepatitis A virus (HAV) vaccine is an effective strategy to prevent natural HAV infection. In Thailand, there are 2 types of HAV vaccine available, including inactivated HAV vaccine and live-attenuated HAV vaccine. This study aims to compare the immunogenicity and safety of inactivated and lived-attenuated HAV vaccine among Thai healthy children and adolescents age 18 months to 18 years. conditions: HAV conditions: Hepatitis A conditions: Hep A conditions: Vaccine-Preventable Diseases studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 120 type: ESTIMATED name: Mevac-A vaccine name: Havrix 720 Junior measure: Anti-HAV immunoglobulin G (IgG) seroconversion rate measure: Geometric mean concentration (GMC) of anti-HAV IgG level sex: ALL minimumAge: 18 Months maximumAge: 18 Years stdAges: CHILD stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06298695 id: 2012939 id: 10390022210010 type: OTHER_GRANT domain: ZonMw briefTitle: Schema Therapy for Treatment-resistant Anxiety Disorders acronym: PaDoLA overallStatus: NOT_YET_RECRUITING date: 2024-09-01 date: 2024-09-30 date: 2030-12-31 date: 2024-03-07 date: 2024-03-07 name: Amsterdam UMC, location VUmc class: OTHER name: ZonMw: The Netherlands Organisation for Health Research and Development name: ADF Stichting name: University of Amsterdam name: Maastricht University name: GGZ inGeest name: Pro Persona Mental Health Care Foundation name: Mondriaan name: GGNet name: GGZ Delfland briefSummary: The aim of this study is to assess the cost-effectiveness of schema therapy compared to treatment as usual (TAU) in patients with treatment-resistant anxiety disorders. In a multicenter randomized controlled trial, patients will be assigned to receive individual schema therapy (maximum of 40 sessions) or treatment as usual (control group) within one year. The primary outcome is the difference between ST and TAU conditions in anxiety symptoms as measured with the Beck Anxiety Inventroy (BAI) at post treatment. Secondary outcomes include quality of life, societal costs, general mental health, remission from the anxiety disorders and/or comorbid affective disorders, positive and negative effects of psychotherapy, schemas and schema modes, and satisfaction. Measurements take place at baseline and after 1, 3, 6, 12, 24 and 36 months (follow-up of two years). conditions: Anxiety Disorders studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A multicenter parallel group randomized controlled clinical intervention trial primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 172 type: ESTIMATED name: Individual Schema Therapy name: TAU measure: Changes in the severity of anxiety symptoms measure: Health-related quality of life measure: Mental health quality of life measure: Health care utilization and productivity losses measure: Remission from the primary anxiety disorder and from comorbid disorders measure: Screening for DSM-5 personality disorders measure: Assessment of DSM-5 personality disorders measure: Demographics measure: (Strength of) treatment preference measure: Assessment of childhood trauma measure: Assessment of autistic traits measure: Assessment of general mental health measure: Functioning and recovery in psychiatric patients measure: Early Maladaptive Schemas measure: Schema Modes measure: Positive and negative effects of psychotherapy measure: The level of satisfaction with the psychological treatment sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06298682 id: CCM1421 briefTitle: Characterization of Exosomes Platelets-released acronym: EXOPLT overallStatus: RECRUITING date: 2021-07-08 date: 2026-07-07 date: 2027-07-07 date: 2024-03-07 date: 2024-03-12 name: Centro Cardiologico Monzino class: OTHER name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico briefSummary: Extracellular vesicles (EVs) play a key role in cell-to-cell communication. They are small vesicles that contain rich molecular cargo. Recently, they have been proposed as biomarkers for clinical diagnostics. EVs include three classes: small EVs (exosomes), large EVs (microparticles), and apoptotic bodies. Platelet-derived EVs (PEVs) are the most abundant class in human blood and can actively participate in numerous physiological and pathological processes. The information about the role of platelet exosomes in cardiovascular disease and the effect of antiplatelet agents on their release and content is very limited. conditions: Platelet Thrombus studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: OTHER count: 175 type: ESTIMATED measure: Characterization of exosomes released by activated platelet by Nanoparticle Tracking Analysis (NTA) and proteoma analysis measure: Characterization of exosomes released by activated platelet and exposed to platelet inhibitors by NTA and proteoma analysis measure: Platelet exosome profile emerged by NTA and proteoma analysis will be related with the "biographical" and "anthropometric" data of the subjects. sex: ALL minimumAge: 20 Years maximumAge: 60 Years stdAges: ADULT facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico status: RECRUITING city: Milan country: Italy name: Daniele Prati role: CONTACT lat: 45.46427 lon: 9.18951 hasResults: False
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<|newrecord|> nctId: NCT06298669 id: 10652 briefTitle: Biventricular Versus Right Ventricular Pacing overallStatus: SUSPENDED date: 2023-08-09 date: 2025-02 date: 2025-02 date: 2024-03-07 date: 2024-03-07 name: Indiana University class: OTHER briefSummary: The study is a randomized, single-blind crossover prospective study in which investigators will determine the clinical outcomes of cardiac resynchronization therapy (CRT) pacing modalities in patients with left ventricular assist devices (LVAD). Only patients are blinded. This is a small-scale study from which future larger scale randomized controls can be performed. The primary endpoint will be the effect of BiV and RV pacing setting on the 6-minute walk test. conditions: Heart Failure studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 28 type: ESTIMATED name: Biventricular Pacing name: Right Ventricular Pacing measure: 6 Minute Walk Test Performance measure: Serum NT-PRO-BNP measure: EQ-5D-3L sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Indiana University Health Methodist Hospital city: Indianapolis state: Indiana zip: 46202 country: United States lat: 39.76838 lon: -86.15804 hasResults: False
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