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<\|newrecord\|> nctId: NCT06298656 id: ILBS-ACLF-17 briefTitle: Acute hemodynamiC Response To Carvedilol Predicts Survival in ACLF Patients overallStatus: NOT_YET_RECRUITING date: 2024-03-10 date: 2026-02-28 date: 2026-02-28 date: 2024-03-07 date: 2024-03-07 name: Institute of Liver and Biliary Sciences, India class: OTHER briefSummary: Clinically significant portal hypertension (CSPH) is defined as HVPG \>10 mmHg. Patients with CSPH are at risk of developing esophageal varices and clinical decompensation (variceal bleeding, ascites, jaundice, encephalopathy), which mark the transition from compensated stage to a stage of the disease (decompensated) associated with higher mortality (1). HVPG is calculated by subtracting the free hepatic venous pressure (FHVP), a measure of systemic pressure, from the wedged hepatic venous pressure (WHVP), a measure of hepatic sinusoidal pressure. HVPG is surrogate marker in many clinical applications such as gold standard test to evaluate presence and severity of portal hypertension (PHT) diagnosis, risk stratification, monitoring of the patients on beta blockers (2). Non selective beta-blockers like propranolol and carvedilol are indicated in adults for primary and secondary prophylaxis of variceal hemorrhage. Acute hemodynamic response to intravenous propranolol with HVPG values coming down to \<12 mm Hg or reduction to \>20% from baseline have been shown to be associated with reduced long term risk of variceal bleed. Hence we are planning the current work to study the Acute hemodynamiC response To Carvedilol predicts survival in ACLF patients - "ACT - C ACLF study conditions: Acute-On-Chronic Liver Failure studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: No intervention measure: Predictive value of acute HVPG change by carvedilol for 28 day transplant free survival in patients of ACLF measure: Complications [PHT related bleed, AKI, infections, HE, Hypotension, Cardiac side effect] within 90 days measure: Transplant-free survival rate at 90 days measure: Correlation with evolution of AARC score by 2 week sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Institute of Liver & Biliary Sciences (ILBS) city: New Delhi state: Delhi zip: 110070 country: India name: Garvit Mundra, MD role: CONTACT phone: 01146300000 email: garvitmundrailbs@gmail.com lat: 28.63576 lon: 77.22445 hasResults: False
<\|newrecord\|> nctId: NCT06298643 id: CA056-1094 briefTitle: Real-World Practice Patterns and Outcomes of Lower-Risk Myelodysplastic Syndrome Patients in Japan overallStatus: ACTIVE_NOT_RECRUITING date: 2023-12-22 date: 2024-12-31 date: 2024-12-31 date: 2024-03-07 date: 2024-03-07 name: Bristol-Myers Squibb class: INDUSTRY briefSummary: The purpose of this study is to describe the treatment patterns, clinical outcomes, healthcare resource utilization (HCRU) and medical costs of lower-risk myelodysplastic syndromes patients in Japan. conditions: Lower-risk Myelodysplastic Syndromes studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 300 type: ACTUAL name: Red blood cell transfusion name: Red blood cell transfusion measure: Participant age measure: Participant sex measure: Participant weight measure: Participant height measure: Participant comorbidities calculated using the Charlson Comorbidity Index (CCI) method measure: Participant Eastern Cooperative Oncology Group (ECOG) score measure: Participant International Prognostic Scoring System (IPSS) or Revised International Prognostic Scoring System (IPSS-R) risk category measure: Percentage of ring sideroblasts present in participants measure: Percentage of bone marrow blasts present in participants measure: Histopathology results measure: Number of red-blood cell transfusions received by participants measure: Treatment prescribed by line of therapy measure: Duration of treatment by line of therapy measure: Time between date of diagnosis and treatment measure: Time between date of treatment initiation to treatment discontinuation measure: Time between date of diagnosis to date of first red-blood cell transfusion measure: Number of participants that achieved red-blood cell transfusion independence during first-line of therapy treatment measure: Mean hemoglobin change of participants during first-line of therapy measure: Number of transfusion dependant participants achieving re-blood cell transfusion independence for ≥12 weeks with associated concurrent mean hemoglobin increase of ≥1.5 g/dL during first-line of therapy measure: Number of non-transfusion dependant participants achieving red-blood cell transfusion independence during first-line therapy for ≥24, 48 and 72 weeks measure: Time to red-blood call transfusion independence of ≥12 weeks for transfusion dependant participants receiving first line therapy measure: Hematologic Improvement - Erythroid (HI-E) response of transfusion dependant participants receiving first line therapy measure: Modified Hematologic Improvement - Erythroid (mHI-E) of transfusion dependant participants receiving first line therapy measure: Hematologic Improvement - Erythroid (HI-E) response of non-transfusion dependant participants receiving first line therapy measure: Modified Hematologic Improvement - Erythroid (mHI-E) of non-transfusion dependant participants receiving first line therapy measure: Time to Hematologic Improvement - Erythroid (HI-E) or Modified hematologic improvement - Erythroid (mHI-E) during first-line therapy measure: Duration of Hematologic Improvement - Erythroid (HI-E) or Modified hematologic improvement - Erythroid (mHI-E) during first-line therapy measure: Duration of red-blood call transfusion independence of ≥12 weeks for transfusion dependant participants receiving first line therapy measure: Number of participants diagnosed with Acute Myeloid Leukemia measure: Time to Acute Myeloid Leukemia diagnosis measure: Overall survival (OS) of participants measure: Number of red-blood cell transfusion days per participant measure: Number of red-blood cell units used per transfusion measure: Number of outpatient visits per month measure: Number of hospital admissions measure: Length of hospitalization measure: Reason for hospitalization measure: Number of emergency department visits measure: Number of Intensive care unit admissions (ICU) measure: Number of outpatient/inpatient medication claims measure: Supplemental medication use: Iron chelation use measure: Supplemental medication use: Granulocyte-colony stimulating factors (G-CSF) measure: Number of hematology tests ordered measure: Medical costs sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mebix, Inc city: Tokyo state: Minato-ku zip: 107-0052 country: Japan lat: 35.6895 lon: 139.69171 hasResults: False
<\|newrecord\|> nctId: NCT06298630 id: 2022-LTF-BRL-101 briefTitle: Long-term Follow-up Study of BRL-101 for TDT overallStatus: NOT_YET_RECRUITING date: 2024-12-08 date: 2038-08-20 date: 2038-10-15 date: 2024-03-07 date: 2024-03-22 name: Bioray Laboratories class: INDUSTRY name: First Affiliated Hospital of Guangxi Medical University name: Xiangya Hospital of Central South University name: Chinese Academy of Medical Sciences name: Nanfang Hospital, Southern Medical University name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University name: The 923rd Hospital of Joint Logistics Support Force of People's Liberation Army name: Shenzhen Children 's Hospital briefSummary: Observe long-term safety risk and long-term efficacy after intravenous infusion of BRL-101 in TDT subjects. conditions: Thalassemia, Beta studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 45 type: ESTIMATED name: Assessments measure: Incidence of hematologic malignancies measure: Frequency, grade, and relationship of SAEs sex: ALL minimumAge: 3 Years maximumAge: 35 Years stdAges: CHILD stdAges: ADULT facility: Nanfang Hospital, Southern Medical University city: Guangzhou state: Guangdong zip: 510006 country: China name: Xiaoqin Feng, phD role: CONTACT lat: 23.11667 lon: 113.25 facility: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University city: Guangzhou state: Guangdong zip: 510006 country: China name: Jianpei Fang, phD role: CONTACT lat: 23.11667 lon: 113.25 facility: Shenzhen Children 's Hospital city: Shenzhen state: Guangdong zip: 510006 country: China name: Sixi Liu, phD role: CONTACT lat: 22.54554 lon: 114.0683 facility: No. 923 Hospital of Joint Support Force of Chinese People 's Liberation Army Hospital city: Nanning state: Guangxi zip: 530021 country: China name: Xinhua Zhang, phD role: CONTACT lat: 22.81667 lon: 108.31667 facility: Xiangya Hospital of Central South University city: Changsha state: Hunan zip: 510510 country: China name: Bin Fu, PhD role: CONTACT lat: 28.19874 lon: 112.97087 facility: Tianjin Institute of Hematology city: Tianjin state: Tianjin zip: 300000 country: China name: Jun shi, PhD role: CONTACT lat: 39.14222 lon: 117.17667 facility: The First Affiliated Hospital of GUANGXI MEDICAL UNIVERSITY city: Guangxi zip: 530021 country: China name: Yongrong Lai, PhD role: CONTACT hasResults: False
<\|newrecord\|> nctId: NCT06298617 id: RC 27.1.2024 briefTitle: Systemic Inflammatory Indices as a Non-invasive Grading Modality for Endometriosis overallStatus: COMPLETED date: 2023-01-01 date: 2023-07-30 date: 2023-12-25 date: 2024-03-07 date: 2024-03-12 name: Benha University class: OTHER briefSummary: Endometriosis (EMs) is one of the commonest chronic inflammatory disorder affecting women and is characterized by the presence and growth of endometrial-like glandular epithelial and stromal cells outside the uterus leading to multiple clinical symptoms affecting patients quality of life and fertility with high recurrence rate . The systemic immune inflammatory index (SII) and systemic inflammatory response index (SIRI) are documented as prognostic serum biomarker in many kinds of cancer and for the need and outcomes of adjuvant therapies for various cancers . conditions: Endometriosis studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 88 type: ACTUAL name: Diagnostic laparoscopy name: Full Blood Count (FBC) measure: Indices' ability to predict EM stage sex: FEMALE minimumAge: 25 Years maximumAge: 50 Years stdAges: ADULT facility: Benha University city: Banhā state: Al Qalyobia zip: 13511 country: Egypt lat: 30.45906 lon: 31.17858 hasResults: False
<\|newrecord\|> nctId: NCT06298604 id: IECED-12112023 briefTitle: Motorized Fine Needle Biopsy vs Standard Needles overallStatus: RECRUITING date: 2023-12-09 date: 2024-10-09 date: 2024-12-09 date: 2024-03-07 date: 2024-03-22 name: Instituto Ecuatoriano de Enfermedades Digestivas class: OTHER briefSummary: Recent improvements in punctures techniques and needles now allow for the collection of high-quality specimens comparable to core needle biopsy. A newly developed motorized fine needle biopsy (mFNB), the Precision-GI (Limaca, Israel) promises intact tissue acquisition without sample damage, relying on controlled axial tissue cutting and high-speed rotational coring for optimized tissue acquisition.
Given the advancement mentioned, the investigators aim to compare the performance of the mFNB with the standard needle during the acquisition of endoscopic ultrasound (EUS)-guided pancreatic and liver specimens through a prospective, interventional, single-center trial. The study will consist of two groups of patients: one assigned to the standard fine needle biopsy (FNB) and the other to the mFNB. The primary study outcomes will include sample quality (core integrity), and diagnostic accuracy. conditions: Pancreas Disease conditions: Liver Diseases studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Prospective, diagnostic,, cross-sectional study primaryPurpose: DIAGNOSTIC masking: SINGLE maskingDescription: Single masking, the pathologist will be blinded to the needle used for sample collection. whoMasked: CARE_PROVIDER count: 60 type: ESTIMATED name: EUS-guided standard fine needle biopsy name: EUS-guided motorized fine needle biopsy measure: Endoscopic ultrasound fine needle biopsy sample quality measure: Diagnostic accuracy according to histological analysis measure: Tissue blood contamination measure: Time efficiency during tissue acquisition measure: Rate of liver specimen adequacy measure: Rate of adverse events associated with the procedure measure: Quality of cytologic sample sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Instituto Ecuatoriano de Enfermedades Digestivas (IECED) status: RECRUITING city: Guayaquil zip: 090505 country: Ecuador name: Carlos Robles-Medranda, MD FASGE role: CONTACT phone: +593989158865 email: carlosoakm@yahoo.es name: Carlos Robles-Medranda, MD FASGE role: PRINCIPAL_INVESTIGATOR name: Raquel Del Valle, MD role: SUB_INVESTIGATOR name: Maria Egas-Izquierdo, MD role: SUB_INVESTIGATOR name: Jorge Baquerizo-Burgos, MD role: SUB_INVESTIGATOR name: Domenica Cunto, MD role: SUB_INVESTIGATOR name: Juan Alcivar-Vasquez, MD role: SUB_INVESTIGATOR name: Daniela Tabacelia, MD role: SUB_INVESTIGATOR name: Martha Arevalo-Mora, MD role: SUB_INVESTIGATOR name: Miguel Puga-Tejada, MD role: SUB_INVESTIGATOR name: Gustavo Rubio, MD role: SUB_INVESTIGATOR name: Hannah Pitanga-Lukashok, MD role: SUB_INVESTIGATOR lat: -2.20584 lon: -79.90795 hasResults: False
<\|newrecord\|> nctId: NCT06298591 id: atrophic scar treatment briefTitle: The Efficacy of Combination Therapy in Atrophic Scars overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2027-03-15 date: 2027-03-15 date: 2024-03-07 date: 2024-03-07 name: Assiut University class: OTHER briefSummary: There are more than 100 million patients who develop scar formation caused by various factors, such as post-inflammatory acne and trauma (1). They often have physical, aesthetic, psychological, and social barriers. Scar tissue is naturally a stage of wound healing. Abnormal wound healing produces a spectrum of scar tissue types such as atrophic, hypertrophic, and keloid scars (2).
Atrophic scars are dermal depressions, which are commonly caused by the destruction of collagen following inflammatory process. This permanent disfiguring sequelae correlates with the duration of pathology, severity of lesion, and delay in therapy (3).
Treatment of atrophic acne scars remains a therapeutic challenge, yet there is no standard option as the most effective treatment (4). A range of possible options has been investigated including surgical techniques (subcision, non-ablative laser treatment, resurfacing techniques (ablative laser treatment, dermabrasion), and injection or dermal fillers or fat, and a combination of two or more modalities (5).
Ultrasound is a unique non-invasive and non-radiating medical imaging tool in the investigation of dermatological diseases by providing detailed anatomic and physiologic data of skin lesions and deeper soft tissue changes. Lesion size in three dimensions-lengths, width, and depth, morphology, the detailed anatomic information provided by sonography is useful to assessment of effect of different types of treatment modality to improve atrophic scar and avoid invasive assessment tools as punch biopsy for histopathological examination (6) conditions: Atrophic Scar studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 45 type: ESTIMATED name: co2 laser measure: change of dermal thickness in sonar and Vancouver scale sex: ALL minimumAge: 12 Years maximumAge: 70 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06298578 id: Mobile Based Application briefTitle: The Utility of Mobile Based Application for Patient Reported Outcome Measures In Patients With Acetabular Fractures : A Randomized Clinical Trial overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-12-01 date: 2026-01-01 date: 2024-03-07 date: 2024-03-07 name: Assiut University class: OTHER briefSummary: The primary objective of this study is to validate the feasibility of a remote patient monitoring (RPM) system using Mobile App in terms of the frequency of data interruptions and patient acceptance.
The secondary objective is to Improve quality of life and early prediction of the complications. conditions: Acetabular Fracture studyType: OBSERVATIONAL observationalModel: ECOLOGIC_OR_COMMUNITY timePerspective: PROSPECTIVE count: 126 type: ESTIMATED measure: percentage of missed follow up data in both groups postoperatively through assessing the patient-reported outcome measures (PROMS) after surgery for a fracture of the acetabulum using the Arabic validated form of (SF-36) measure: Quality of life scoring (Arabic validated form of (SF-36) and early prediction of the complications sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06298565 id: ARGX-113-PASS-2208 briefTitle: A Non-interventional, Post-authorisation Safety Study of Patients Treated With Efgartigimod Alfa overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2034-06 date: 2034-06 date: 2024-03-07 date: 2024-03-07 name: argenx class: INDUSTRY briefSummary: This is a non-interventional, prospective, post authorization safety study. Patients with gMG who are expected to start treatment with efgartigimod at enrolment or are within their first cycle of efgartigimod at enrolment will be eligible to enroll into the efgartigimod cohort. Patients with gMG who have not been exposed to efgartigimod and for whom it is not planned to start treatment with efgartigimod at enrolment will be eligible to enroll into the non-efgartigimod cohort. conditions: Myasthenia Gravis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 680 type: ESTIMATED name: efgartigimod measure: The overall long-term safety of efgartigimod including the occurrence of serious infections in generalized myasthenia gravis (gMG) patients treated with efgartigimod compared to gMG patients not exposed to efgartigimod sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06298552 id: ARGX-113-2308 id: 2024-511796-15-00 type: OTHER domain: CTIS number briefTitle: A Phase 3 Study to Evaluate the Efficacy and Safety of Efgartigimod IV in Patients With Acetylcholine Receptor Binding Antibody Seronegative Generalized Myasthenia Gravis acronym: ADAPT SERON overallStatus: RECRUITING date: 2024-04-16 date: 2025-07-25 date: 2027-07-23 date: 2024-03-07 date: 2024-04-23 name: argenx class: INDUSTRY briefSummary: The primary purpose of this study is to measure the efficacy and safety of efgartigimod intravenously (IV) compared to placebo in participants with Acetylcholine Receptor Binding Antibody (AChR-Ab) seronegative Generalized Myasthenia Gravis (gMG). Other objectives are to assess long-term efficacy, safety, and tolerability of efgartigimod.
Study will consist of:
* Screening
* Part A: participants will be randomized to receive either efgartigimod IV or placebo
* Part B: participants completing part A will receive open-label efgartigimod IV conditions: Generalized Myasthenia Gravis studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 110 type: ESTIMATED name: Efgartigimod IV name: Placebo IV measure: Myasthenia Gravis Activities of Daily Living (MG-ADL) total score change from baseline measure: Quantitative myasthenia gravis (QMG) total score change from baseline measure: Proportion of participants who are both MG-ADL and QMG responders sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: First Choice Neurology Boca Raton status: RECRUITING city: Boca Raton state: Florida zip: 33428 country: United States name: Brian Costell, MD role: CONTACT phone: 857-350-4834 email: clinicaltrials@argenx.com lat: 26.3669 lon: -80.13033 hasResults: False
<\|newrecord\|> nctId: NCT06298539 id: 21C308 briefTitle: Auditory Sensory Attenuation in Obesity acronym: Ud_SA_OB overallStatus: ACTIVE_NOT_RECRUITING date: 2023-03-01 date: 2024-12-31 date: 2024-12-31 date: 2024-03-07 date: 2024-03-12 name: Istituto Auxologico Italiano class: OTHER name: University of Turin, Italy briefSummary: The goal of this observational cross-sectional study is to test the sensory attenuation effect with auditory stimuli comparing women with obesity and healthy-weight women. Specifically, the study aims to test whether the sensory attenuation effect (i.e., the perceived loudness of a self-generated sound is weaker than when another person produces the same sound):
i) is observed in obesity ii) it can be modulated in interactive action contexts, as was previously observed in healthy participants.
Participants will compare the loudness of target sound with a comparison tone, which can be prompt by the participant by pressing a button on their own will (i.e., individual context) or upon the experimenter\'s signal (i.e., interactive context); externally-generated sounds are produced in the opposite way. conditions: Obesity studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 36 type: ESTIMATED measure: point of subjective equality (PSE) measure: cognitive empathy measure: interpersonal pleasure sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Istituto Auxologico Italiano, San Giuseppe Hospital city: Piancavallo state: VCO zip: 28824 country: Italy hasResults: False
<\|newrecord\|> nctId: NCT06298526 id: 21C307 briefTitle: Auditory Sensory Attenuation in Anorexia Nervosa acronym: UdSA_AN overallStatus: ACTIVE_NOT_RECRUITING date: 2023-03-01 date: 2024-02-29 date: 2024-12-31 date: 2024-03-07 date: 2024-03-12 name: Istituto Auxologico Italiano class: OTHER briefSummary: The goal of this observational cross-sectional study is to test the sensory attenuation effect with auditory stimuli comparing women affected by anorexia nervosa and healthy-weight women. Specifically, the study aims to test whether the sensory attenuation effect (i.e., the perceived loudness of a self-generated sound is weaker than when another person produces the same sound):
i) is observed in anorexia nervosa ii) it can be modulated in interactive action contexts, as was previously observed in healthy participants.
Participants will compare the loudness of target sound with a comparison tone, which can be prompt by the participant by pressing a button on their own will (i.e., individual context) or upon the experimenter\'s signal (i.e., interactive context); externally-generated sounds are produced in the opposite way. conditions: Anorexia Nervosa studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 36 type: ESTIMATED measure: point of subjective equality (PSE) measure: cognitive empathy measure: interpersonal pleasure sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Istituto Auxologico Italiano, San Giuseppe Hospital city: Piancavallo state: VCO zip: 28824 country: Italy hasResults: False
<\|newrecord\|> nctId: NCT06298513 id: 09C338 briefTitle: Autonomic and Metabolic Response to Cardiac Rehabilitation After Acute MI acronym: RIABILITOMICA overallStatus: RECRUITING date: 2023-05-02 date: 2025-04 date: 2025-12 date: 2024-03-07 date: 2024-03-07 name: Istituto Auxologico Italiano class: OTHER briefSummary: Ischemic heart disease remains the leading cause of death in the western world. The beneficial effects of cardiac rehabilitation on the evolution of ischemic heart disease are known, but the effects of rehabilitation on the metabolic processes of the patients are so far poorly understood. Metabolomics is the qualitative/quantitative analysis of the body's metabolic responses to pathophysiological stimuli or genetic alterations. Metabolic changes caused by physical activity have been demonstrated in obese and diabetic patients and in athletes. Aim of the study is to evaluate whether cardiac rehabilitation after a first myocardial infarction induces changes in the metabolic state of patients, and whether these changes may be related with changes in the usual risk factors (i.e. glyco-lipidic profile, natriuretic peptides, homocysteine). conditions: Acute Myocardial Infarction: Rehabilitation Phase studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 25 type: ESTIMATED name: Cardiac rehabilitation measure: Changes in purine after rehabilitation measure: Changes in histidine after rehabilitation measure: Changes in galactose after rehabilitation sex: MALE minimumAge: 25 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Istituto Auxologico Italiano status: RECRUITING city: Milan zip: 20149 country: Italy name: Lia Crotti, MD PhD role: CONTACT phone: 39 0261911 phoneExt: 2903 email: lia.crotti@unimib.it lat: 45.46427 lon: 9.18951 hasResults: False
<\|newrecord\|> nctId: NCT06298500 id: AAG-O-H-2115 briefTitle: Clinical Performance of HISTOACRYL® LAPFIX - CANNULA for Laparoscopic Inguinal Hernia Repair acronym: HISTOLAP overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-06 date: 2024-09 date: 2024-03-07 date: 2024-03-08 name: Aesculap AG class: INDUSTRY name: B.Braun Surgical SA briefSummary: The goal of this retrospective study is to identify the incidence of hernia recurrence following the application of Histoacryl® Lapfix - Cannula for laparoscopic mesh fixation in patients undergoing hernia repair surgery. All adult patients who underwent laparoscopic inguinal hernia repair with Histoacryl® Lapfix - Cannula in the period June 2018 - March 2021 at Hospital San Juan de Dios will be analysed. The investigator team will access electronical medical records for the cohort of patients identified. conditions: Inguinal Hernia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 448 type: ESTIMATED name: hernia repair surgery measure: Hernia recurrence rate measure: Delayed tissue adhesive polymerization measure: Intraoperative bleeding requiring therapeutic measures measure: Organ injury measure: Hernia recurrence measure: Mesh migration measure: Adhesions measure: Erosion measure: Meshoma formation measure: Tack hernias measure: Surgical Site Infection (superficial, deep, intraabdominal) measure: Hematoma measure: Seroma measure: Hemorrhage measure: Orchitis measure: Other Adverse Event measure: Reintervention measure: Mesh repositioning or removal measure: Acute or chronic pain sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital San Juan de Dios city: Santa Cruz De Tenerife state: Tenerife zip: 38001 country: Spain name: José Miguel Del Pino Monzón, Dr. role: CONTACT lat: 28.46824 lon: -16.25462 hasResults: False
<\|newrecord\|> nctId: NCT06298487 id: CHRD 1023 briefTitle: Evaluation of the Impact of Therapeutic Education Workshops for COPD Patients in the North-West Val d'Oise Area acronym: MPSAT-ETP overallStatus: RECRUITING date: 2024-03-11 date: 2024-09 date: 2024-09 date: 2024-03-07 date: 2024-04-04 name: Hôpital NOVO class: OTHER briefSummary: The aim of this study is to assess the impact of the Patient Therapeutic Education (PTE) workshops offered by the Maison de Prévention de la Santé et d'Accompagnement Thérapeutique (MPSAT) on the follow-up and feelings of the COPD patients who take part. These workshops are organised outside the hospital environment and supervised by hospital and town professionals in the NOVO zone. conditions: COPD studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 100 type: ESTIMATED name: Patient questionnaires measure: Evaluation of the overall impact of the PTE workshops offered by the MPSAT on patients' knowledge, skills, attitudes and behaviours with regard to COPD management and care measure: Measure of the impact of PTE workshops on quality of life (comparison of PTE group versus Control group) measure: Comparison of anxiety/depression levels in patients in the PTE group versus Control group measure: Comparison of levels of motivation towards physical activity during free time in the PTE group versus Control group measure: Comparison of the number of hospital admissions for COPD exacerbations in patients in the PTE group versus Control group measure: Comparison of the perception/feelings of patients in the PTE group versus Control group, concerning PTE workshops organised in a city/hospital setting sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Pneumology, respiratory rehabilitation and follow-up and rehabilitation care department - Hôpital NOVO status: RECRUITING city: Pontoise zip: 95300 country: France name: Dr Bruno PHILIPPE role: CONTACT phone: +33 1 30 75 47 75 email: bruno.philippe@ght-novo.fr name: Mme Anne-Charlotte TAUVERON role: CONTACT phone: +33 6 75 08 36 60 email: anne-charlotte.tauveron@valdoise.fr lat: 49.05 lon: 2.1 hasResults: False
<\|newrecord\|> nctId: NCT06298474 id: 2R44AG071105-03 type: NIH link: https://reporter.nih.gov/quickSearch/2R44AG071105-03 briefTitle: The BRAIN App (Phase 2 SBIR) overallStatus: NOT_YET_RECRUITING date: 2025-02-15 date: 2025-11-15 date: 2025-11-30 date: 2024-03-07 date: 2024-03-26 name: Hopeful Aging class: INDUSTRY briefSummary: There are currently 6.7 million Americans living with dementia and, without significant breakthroughs, this figure will double to 12.7 million by 2050. There are about 46,000 long-term care (LTC) facilities in the U.S. More than half of LTC residents have some form of dementia (Alzheimer's Association, 2018). Responsive behaviors and dysfunction of the dementia care triad-i.e., the PLWD, professional Care Partner (CP), and Family Member (FM)-are inexorably linked. The emergence of responsive behaviors can lead to disruption of the triad's function. Thus, it is imperative to maintain positive relationships and a high quality of life (QoL) within the triad to reduce BPSD. Cognitive Stimulation Therapy (CST) has demonstrated improvements in QoL and relationships for PLWD. CST is a psychosocial intervention that promotes communication and engagement in PLWD via a structured program of meaningful and enjoyable theme. While clinical trials have shown improvement in cognition and QoL, the potential large-scale impact of CST has been hampered by low adherence, with less than 40% completing trials. One likely reason for the low adherence to CST is the reliance on generic and non-digital tools (e.g., paper-based agendas, tools, DVDs, and board games) in facilitating the intervention. That is, even though CST aims to be personalized, the specific interventions used in the field tend to be generic and not tailored to each PLWD's specific interests. The use of digital technology to implement CST would offer considerable advantages to expand and personalize the range of stimulation content and provide a means for monitoring responses, optimizing protocols, and promoting adherence.
The proposed Phase II study will involve the continued development and evaluation of a multi-faceted software platform called "Building Relationships using Artificial Intelligence and Nostalgia" or BRAIN. The BRAIN Platform will be the first-ever Artificial Intelligence (AI) powered CST digital therapy platform for PLWD. The platform, which has been shown to be effective in an initial Phase I clinical trial, has three main goals: to improve the quality of life of PLWD, to reduce BPSD in PLWD, and to foster positive relationships between members of the care triad. The proposed Phase II project has the following Specific Aims: 1. Create an improved Beta version of the BRAIN Platform's eight components: (1) the Admin Management Dashboard, (2) the Annotation Dashboard, (3) the Log Viewer, (4) the Content Management System (CMS), (5) the Private CMS, (6) the Control App, (7) the Home App, and (8) the Training Dashboard. 2. Fine-tune the different classes of AI algorithms-i.e., behavioral analytics, personalized content recommendation, and personalized program generation-in the BRAIN app such that they can (a) recognize and track 12 distinct behaviors and indicators of PLWD, (b) use these behavioral traits as a basis for automatically rating the relative success of each activity, and (c) automatically recommend personalized activities that are likely to be successful for individual PLWD. 3. Conduct a Cluster Randomized Trial (CRT) of the BRAIN App to examine the app's impact on engagement/affect, quality of life, and responsive behaviors. 4. Examine satisfaction and ease of use of the app for PLWD, LTC staff, and FMs. conditions: Dementia conditions: Alzheimer Disease conditions: Vascular Dementia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A Cluster Randomized Trial (CRT) will be conducted with each LTC facility being considered a cluster. All PLWD at an Experimental facility will be invited to use the intervention twice per week for 3 months, while all PLWD at a Control facility will receive standard care/programming for 3 months. Individual random assignment is not feasible, due to the high likelihood of contamination in a study involving the facilitation of activities in a LTC environment. LTC Facilities Eight (8) LTC facilities will participate in the study-i.e., 4 NHs and 4 ALFs. Half of the sites will be randomly assigned to the Experimental Group and the other half to the Control Group. So, 2 NHs and 2 ALFs will be assigned to the Experimental Group, while 2 NHs and 2 ALFs will be assigned to the Control Group. primaryPurpose: TREATMENT masking: NONE count: 120 type: ESTIMATED name: The BRAIN App measure: Menorah Park Engagement Scale (MPES) measure: Menorah Park Engagement Scale (MPES) measure: Engagement for Persons with Dementia Scale (EPWDS) measure: Engagement for Persons with Dementia Scale (EPWDS) measure: Dementia Related Quality of Life (DEMQOL) measure: Dementia Related Quality of Life (DEMQOL) measure: Neuropsychiatric Inventory--Nursing Home (NPI-NH) measure: Neuropsychiatric Inventory--Nursing Home (NPI-NH) measure: Quality of Carer-Patient Relationship (QCPR) measure: Quality of Carer-Patient Relationship (QCPR) measure: Mini-Mental Status Examination (MMSE) Mini-Mental Status Examination (MMSE)Mini-Mental Status Examination (MMSE) measure: Mini-Mental Status Examination (MMSE) Mini-Mental Status Examination (MMSE)Mini-Mental Status Examination (MMSE) sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: Hopeful Aging city: Winchester state: Massachusetts zip: 01890 country: United States lat: 42.45232 lon: -71.137 hasResults: False
<\|newrecord\|> nctId: NCT06298461 id: BowelPrep briefTitle: Bowel Preparation for Colonoscopy Among Individuals With Crohn's and Ulcerative Colitis Disease. overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-03 date: 2025-06 date: 2024-03-07 date: 2024-03-07 name: University of Manitoba class: OTHER name: Canadian IBD Research Consortium (CIRC) briefSummary: The purpose of this study is to compare how effective and how tolerable two different bowel preparation laxatives are for colonoscopy. The aim is to compare oral sulfate solution (OSS) to another laxative called 2L polyethylene glycol (PEG) solution to see which is more effective and more tolerable by individuals with IBD (Crohn's disease or Ulcerative colitis). conditions: Crohn Disease conditions: Ulcerative Colitis studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: INVESTIGATOR count: 418 type: ESTIMATED name: KleanLyte name: Bi-PegLyte measure: Quality of bowel cleanliness measure: Quality of bowel cleanliness measure: Volume of laxative intake measure: Endoscopic Outcomes measure: Endoscopic Outcomes measure: Endoscopic Outcomes measure: Endoscopic Outcomes measure: Patient experience data measure: Crohn's disease or ulcerative colitis flares after colonoscopy measure: Endoscopic Outcomes sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06298448 id: NL83176.042.23 briefTitle: eGPA and Local Inflammation Within the Ear, Nose and Throat Area overallStatus: RECRUITING date: 2024-02-14 date: 2027-12 date: 2028-12 date: 2024-03-07 date: 2024-03-07 name: University Medical Center Groningen class: OTHER name: GlaxoSmithKline briefSummary: Rationale: Eosinophilic Granulomatosis with Polyangiitis (eGPA), eosinophilic asthma and chronic rhinosinusitis with nasal polyps (CRSwNP) are airway diseases where eosinophils and interleukine-5 are involved in the pathogenesis. eGPA differs from the other diseases with respect to involvement of other organs. The investigators hypothesize that nasal microbiome dysbiosis with a central augmenting role for S. Aureus plays an important role in disease expression. The investigators expect that anti-interleukin-5 treatment with mepolizumab restores the changes of the nasal microbiome and immune responses to a healthy control phenotype. To study this, the nasal microbiome, the local and systemic immune response and the effect of mepolizumab treatment will be assessed. conditions: EGPA - Eosinophilic Granulomatosis With Polyangiitis studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 150 type: ESTIMATED name: laboratory experiments before and after mepolizumab treatment measure: The effect mepolizumab treatment has on the nasal microbiome profiles measure: Exploratory evaluation of between group differences measure: Mepolizumab effect on outcome 2 measure: s there a correlation between the disease activity, the quality of life and the microbiome and immune parameters? sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UMC Groningen status: RECRUITING city: Groningen zip: 9700RB country: Netherlands name: Abraham Rutgers, MD-PhD role: CONTACT phone: +31503616161 email: a.rutgers@umcg.nl lat: 53.21917 lon: 6.56667 hasResults: False
<\|newrecord\|> nctId: NCT06298435 id: 17536 briefTitle: Optimising Ventilatory Strategies by Using Positive Respiratory Integer Measurements acronym: OPTIMVSPRIME overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-04-01 date: 2025-04-01 date: 2024-03-07 date: 2024-03-07 name: University Medical Center Groningen class: OTHER briefSummary: • Background Intermittent Positive Pressure Ventilation is used during general anesthesia but can lead to serious complications. Respiratory parameter settings can be adjusted to minimize the detrimental effects of this unphysiological artificial respiration. Determining optimal ventilator settings is a multifactorial problem with many possible realisations. Knowledge of the relationship of patient outcomes with mathematically identifiable integer sets of ventilator setting parameters may help to understand which effects ventilator settings have on patient outcomes. An exploratory database study can provide a basis for further, prospective, interventional studies to find the optimal combination of ventilator settings.
Main research question
* To determine the relationship between the use of mathematically identifiable integer ventilator parameter sets and patient outcomes
* Design (including population, confounders/outcomes) Retrospective database study of all cases of adult patients undergoing procedures in the UMCG under general anesthesia with IPPV between 01-01-2018 and 01-04-2023. Multivariate and mixed-model analyses, where appropriate, will be corrections for patient specific characteristics such as ASA PS, age, BMI, sex.
* Expected results Using mathematically identifiable integer ventilatory parameter sets improves respiratory and/or hemodynamic patient outcomes. conditions: Hypoxemia conditions: Hypercapnia conditions: Ventilator Associated Pneumonia conditions: Complication of Anesthesia conditions: Postoperative Complications studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 20000 type: ESTIMATED name: Intermittent Positive pressure ventilation measure: SpO2/FiO2 ratio measure: SpO2 measure: etCO2 measure: Blood Pressure measure: Heart Rate measure: Positive end Expiratory Pressure measure: Plateau Pressure measure: Respiration rate sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UMCG city: Groningen zip: 9700RB country: Netherlands name: Rob Spanjersberg role: CONTACT phone: +31503616161 email: r.spanjersberg@umcg.nl lat: 53.21917 lon: 6.56667 hasResults: False
<\|newrecord\|> nctId: NCT06298422 id: 806433 briefTitle: Oxygen Saturations Across Tones of Skin acronym: O2SATS overallStatus: RECRUITING date: 2024-03-01 date: 2025-03-01 date: 2025-06-30 date: 2024-03-07 date: 2024-03-07 name: University of California, San Diego class: OTHER briefSummary: Pulse oximetry, or SpO2, is a vital sign used across healthcare systems to gauge how much oxygen blood is carrying as a percentage of the maximum it could carry. Recent research has suggested that current SpO2 monitors may inaccurately report high SpO2 in patients with darker skin tones when the actual oxygenation is at unsafe, low levels. Additionally, this new research suggests as the SpO2 levels decrease, the risk of occult hypoxia rises. The investigators hypothesize melanin interferes with the pulse oximetry accuracy. Investigators will use spectrophotometry to measure melanin indices and other variables to test this hypothesis. conditions: Generalised Melanin Pigmentation conditions: Pulse Oximetry studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 20 type: ESTIMATED measure: Difference observed between SpO2 and SaO2. measure: Melanin Index sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UCSD Health status: RECRUITING city: San Diego state: California zip: 92103 country: United States name: Pamela DeYoung role: CONTACT phone: 858-232-0343 email: pdeyoung@health.ucsd.edu lat: 32.71533 lon: -117.15726 hasResults: False
<\|newrecord\|> nctId: NCT06298409 id: EB04 briefTitle: Evaluating the Effect Of Rifaximin on the Gut Microbiota and Metabolome in SIBO Using CapScan® overallStatus: RECRUITING date: 2024-02-15 date: 2024-09-15 date: 2024-12-15 date: 2024-03-07 date: 2024-03-07 name: Envivo Bio Inc class: INDUSTRY briefSummary: We will sample intestinal microbiota using a microbiome sampling capsule in patients with Small Intestinal Bacterial Overgrowth (SIBO) conditions: Small Intestinal Bacterial Overgrowth studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 34 type: ESTIMATED name: CapScan collection capsule measure: Sampling of gut microbiota measure: Sampling of gut metabolome measure: Effect of rifaximin on gut microbiota measure: Effect of rifaximin on gut metabolome sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Silicon Valley Gastroenterology status: RECRUITING city: Mountain View state: California zip: 94040 country: United States name: Jennifer Taufui role: CONTACT email: svgistaff@gmail.com lat: 37.38605 lon: -122.08385 hasResults: False
<\|newrecord\|> nctId: NCT06298396 id: CLTD5853 briefTitle: Investigating Stimulation Parameter and Electrode Mode Changes on Speech Perception in Experienced Adult Cochlear Implant Recipients acronym: DUAL overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-04 date: 2025-04 date: 2024-03-07 date: 2024-03-07 name: Cochlear class: INDUSTRY name: Avania briefSummary: This study aims to investigate the effect of stimulation parameters and different electrode modes on speech perception in adult cochlear implant recipients. conditions: Hearing Loss, Sensorineural studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE maskingDescription: There is no masking in this study as all participants receive all MAPs (single group study model). The term "single-blinded" in the official title refers to the fact that participants are blinded to the order in which they receive the MAPs. count: 20 type: ESTIMATED name: Program using default MAP name: Program using low-power 1 (LP1) MAP name: Program using low-power 2 (LP2) MAP name: Program using low-power 3 (LP3) MAP measure: Paired difference in percentage CNC words correct between default and LP1 MAPs in quiet setting measure: Paired difference in dB SRT (AuSTIN) between default and LP1 MAPs in noise measure: Paired difference in percentage CNC words correct between LP1 MAP and LP2 MAP in quiet setting measure: Paired difference in dB SRT (AuSTIN) between LP1 and LP2 MAPs in noise measure: Paired difference in percentage CNC words correct between LP1 and LP3 MAPs in quiet setting sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cochlear Macquarie city: Macquarie Park state: New South Wales zip: 2109 country: Australia name: Esti Nel role: CONTACT phone: +61448495008 email: Enel@cochlear.com lat: -33.7751 lon: 151.11272 hasResults: False
<\|newrecord\|> nctId: NCT06298383 id: ERU1 briefTitle: The Effect of Three Different Medications on Anesthetic Success and Postoperative Pain overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2024-07-15 date: 2024-09-15 date: 2024-03-07 date: 2024-03-07 name: Cairo University class: OTHER name: Egyptian Russian University briefSummary: Pain is a very important factor in Endodontic treatment, Both intra- and Post-operatively. In case of symptomatic Irreversible pulpitis, a build up of inflammatory mediators makes it very difficult for the operator to reach the desired level of anesthesia in order to deliver a pain free treatment as well as to eliminate or at least reduce post-operative pain incidence and severity. therefore, a number of pre- medications was suggested with variable success rates. Therefore this trial aims at the use of a new category of anti-inflammatory medications which would be less harmful than the standard NSAIDs or steroids. conditions: Symptomatic Irreversible Pulpitis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 120 type: ESTIMATED name: Trypsin, Bromelain and Rutoside name: Diclofenac Potassium name: Prednisolone Oral Tablet name: Placebo measure: Success of Anesthesia measure: Post-operative pain sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06298370 id: PENG study briefTitle: The Efficacy of Combined Intrathecal Morphine and PENG Block on Postoperative Pain in Hip Arthroplasty acronym: PENG overallStatus: RECRUITING date: 2024-03-18 date: 2024-06-08 date: 2024-07-08 date: 2024-03-07 date: 2024-03-07 name: Bezmialem Vakif University class: OTHER briefSummary: This study aims to compare the postoperative 48-hour period in terms of morphine consumption, postoperative pain, and quality of recovery scores by combining the Pericapsular Nerve Group (PENG) block with low-dose intrathecal morphine in hip arthroplasty, as opposed to PENG alone and intrathecal morphine alone. conditions: Postoperative Pain Management studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: prospective, double-blind, randomized clinical trial primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 3 type: ESTIMATED name: Pericapsular nerve group block plus intrathecal bupivacaine name: Intrathecal bupivacaine and morphine name: Pericapsular nerve group block plus intrathecal bupivacaine and morphine measure: Morphine consumption measure: Postoperative pain scores measure: The quality of recovery score sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Bezmialem Vakif University status: RECRUITING city: Istanbul state: Fatih zip: 34093 country: Turkey lat: 41.01384 lon: 28.94966 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2023-11-01 uploadDate: 2024-02-03T12:32 filename: Prot_SAP_000.pdf size: 160574 hasResults: False
<\|newrecord\|> nctId: NCT06298357 id: 300012601 id: LAIKPRI02012024 type: OTHER_GRANT domain: Kaul Pediatric Research Institute Pilot Grant briefTitle: Virtual Reality Gaming for Exercise and Mindfulness Among Pediatric Cancer Rehabilitation overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-12-31 date: 2026-03-31 date: 2024-03-07 date: 2024-04-03 name: University of Alabama at Birmingham class: OTHER briefSummary: This study will explore the potential benefits of a virtual reality gaming program that focuses on mindfulness and exercise among pediatric cancer rehabilitation patients. The program will last 8 weeks outside of the hospital. Participants will start immediately in the hospital (immediate start group) or wait 8 weeks after hospital discharge to start the program (waitlist control group). conditions: Pediatric Cancer studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: There will be 2 parallel groups, immediate start group and waitlist control group. Once control participants finish the wait period (8 weeks), they will start the intervention (8 weeks). Participants in the immediate start group will start exercise and mindfulness in the hospital and continue the program for 8 weeks outside of the hospital. primaryPurpose: TREATMENT masking: NONE count: 16 type: ESTIMATED name: Immediate Start - Virtual Reality name: Delayed Start - Virtual Reality measure: Physical activity measure: Minutes of gameplay measure: Global Health measure: Forced Expiratory Volume in the first second (FEV1) sex: ALL minimumAge: 8 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Children's Hospital of Alabama city: Birmingham state: Alabama zip: 35233 country: United States lat: 33.52066 lon: -86.80249 hasResults: False
<\|newrecord\|> nctId: NCT06298344 id: 002 briefTitle: The Role of Thiamine After Transcatheter Closure in Children With Left-to-Right Shunt Congenital Heart Disease overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-12-31 date: 2025-01-01 date: 2024-03-07 date: 2024-03-07 name: Universitas Sumatera Utara class: OTHER briefSummary: Currently, research on the effect of thiamine administration during transcatheter closure on the structure and function of the left ventricle by examining levels of matrix metalloproteinase-9 and tissue inhibitor of metalloproteinase-1 in children with left to right shunt congenital heart disease has never been carried out in Indonesia, so it is necessary carried out this research. This research was carried out by administering 100 mg of thiamine once per day to patients post transcatheter closure for 28 days. The parameters assessed were MMP-9, TIMP-1, and echocardiography to assess the structure and function of the left ventricle in CHD patients with left to right shunt lesions. conditions: Congenital Heart Disease conditions: Thiamine Deficiency conditions: Patent Ductus Arteriosus conditions: Ventricular Septal Defect conditions: Atrial Septal Defect studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Double blind primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 88 type: ESTIMATED name: Thiamine measure: Correlation between transcatheter closure and left ventricular structure change after thiamine treatment measure: Correlation between transcatheter closure and left ventricular function change after thiamine treatment measure: Correlation between transcatheter closure and serum matrix metalloproteinase-9 level change after thiamine treatment measure: Correlation between transcatheter closure and serum tissue inhibitor of metalloproteinase-1 level change after thiamine treatment sex: ALL minimumAge: 6 Months maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Universitas Sumatera Utara city: Medan state: North Sumatera zip: 20155 country: Indonesia name: Putri Amelia role: CONTACT phone: +6285261000273 email: putri.amelia@usu.ac.id lat: 3.58333 lon: 98.66667 hasResults: False
<\|newrecord\|> nctId: NCT06298331 id: KA-23073 briefTitle: Investigation of the Additional Effects of Aerobic Exercise Training to Abdominal Massage in Functional Constipation overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2026-03-15 date: 2026-03-15 date: 2024-03-07 date: 2024-03-07 name: Hacettepe University class: OTHER briefSummary: The aim of this study was to investigate the additional effects of aerobic exercise to abdominal massage in patients with functional constipation. There are several studies investigating the effects of massage and aerobic exercise separately in functional constipation. However, to the best of our knowledge, there are no studies combining abdominal massage and aerobic exercise to demonstrate additional effects. By combining these two approaches, we believe that a higher and broader effect (local and systemic) and perhaps a cure for constipation (reaching the ideal defecation frequency or asymptomatic status) can be achieved. Therefore, this study will include individuals between the ages of 18-65 who have a diagnosis of functional constipation and who agree to participate in the study. This study is designed as a randomized controlled trial. conditions: Constipation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 44 type: ESTIMATED name: Aerobic Exercise name: Abdominal Massage name: Patient Education measure: Weekly defecation frequency measure: Average weekly defecation time measure: Average weekly frequency of laxative use measure: Average weekly stool consistency score measure: The severity of constipation and associated discomfort measure: The severity of constipation measure: Gastrointestinal symptom level measure: Constipation-related quality of life measure: Patient perception of global change measure: Abdominal muscle strength measure: Functional exercise capacity sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ceren Gursen city: Ankara zip: 06100 country: Turkey name: Serap ÖZGÜL role: CONTACT phone: +905339390803 email: serapky@yahoo.com name: Hatice Yasemin Balaban role: SUB_INVESTIGATOR name: Türkan Akbayrak role: SUB_INVESTIGATOR name: Halis Şimşek role: SUB_INVESTIGATOR name: Beyza Atay role: SUB_INVESTIGATOR name: Ege Nur Atabey Gerlegiz role: SUB_INVESTIGATOR name: İrem Gül Doğan role: SUB_INVESTIGATOR lat: 39.91987 lon: 32.85427 hasResults: False
<\|newrecord\|> nctId: NCT06298318 id: Acute Binge Drink briefTitle: Metabolic Changes in Healthy Subjects With Acute Binge Drink acronym: MeABD overallStatus: ENROLLING_BY_INVITATION date: 2024-04-18 date: 2024-07-19 date: 2026-07-18 date: 2024-03-07 date: 2024-04-17 name: Zhejiang Chinese Medical University class: OTHER_GOV briefSummary: The goal of this double-blinded, randomized trial is to investigate the effects of acute binge drink on liver function, liver fat content and lipid metabolism in healthy young subjects. The main questions it aims to answer are:
1. if acute binge drink could alleviate liver injury and hepatic steatosis. conditions: Binge Drinking conditions: Liver Injury conditions: Hepatic Steatosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: vodka name: water measure: Hepatic fibrosis change measure: hepatic function change measure: hepatic injury change measure: Lipid metabolism change measure: Laboratory markers of inflammation measure: Fecal metabolites measure: Ethanol concentration measure: Acetaldehyde concentration measure: hangover cognition assessment tools after drinking sex: MALE minimumAge: 18 Years maximumAge: 30 Years stdAges: ADULT facility: Zhejiang Chinese Medical University city: Hangzhou state: Zhejiang zip: 310053 country: China lat: 30.29365 lon: 120.16142 hasResults: False
<\|newrecord\|> nctId: NCT06298305 id: QUANTIB briefTitle: Artificial Intelligence & Prostate Cancer acronym: QUANTIB overallStatus: ACTIVE_NOT_RECRUITING date: 2022-09-01 date: 2023-10-10 date: 2024-12 date: 2024-03-07 date: 2024-03-07 name: IRCCS San Raffaele class: OTHER briefSummary: This is a single center, blinded (the mpMRI will be read by expert personnel not aware of the patient's diagnosis ), retrospective study. A total of 200 patients with suspicious prostate cancer (PCa) who underwent, between January 2014 and January 2022, mpMRI of the prostate and subsequent prostate biopsy will identified. All mpMRI images will be retrospectively collected and evaluated using the Quantib Prostate software. In particular, 200 mpMRI with endorectal coil will be read by the expert radiologist and by the Quantib prostate (Quantib B.V. Rotterdam, The Netherlands) software, thus evaluating the predictive characteristics of Quantib Prostate for the identification of suspicious lesions. The sensitivity, specificity, negative predictive value, positive predictive value and accuracy of Quantib Prostate vs. radiologist in detecting csPCa will be evaluated using the biopsy report as reference standard. conditions: Prostate Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 200 type: ACTUAL name: Quantib prostate (Quantib B.V. Rotterdam, The Netherlands) software measure: To evaluate the sensitivity, specificity, positive predictive value, negative predictive value, and accuracy in detecting csPCa of Quantib Prostate vs. traditional radiologist reading of mpMRI measure: To assess the impact of Quantib Prostate in predicting pathologic outcomes in patients who received radical prostatectomy measure: To report time reduction in the diagnosis of suspicious PCa sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Ospedale San Raffaele city: Milan state: MI zip: 20132 country: Italy lat: 45.46427 lon: 9.18951 hasResults: False
<\|newrecord\|> nctId: NCT06298292 id: ZerominisCT01 briefTitle: Acceptability/Tolerance of Protein Substitutes in Tablet Form for the Dietary Management of Rare Aminoacidopathies acronym: ZeroMinisMR overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-03-31 date: 2026-06-30 date: 2024-03-07 date: 2024-03-07 name: metaX Institut fuer Diatetik GmbH class: INDUSTRY name: Birmingham Women's and Children's NHS Foundation Trust name: Great Ormond Street Hospital for Children NHS Foundation Trust briefSummary: The purpose of this prospective, observational study is to evaluate the tolerability and acceptability of Zero minis, a range of protein substitute tablets for use in the dietary management of children with either TYROSINAEMIA Type I, II, III or ALKAPTONURIA, HOMOCYSTINURIA, or MAPLE SYRUP URINE DISEASE (MSUD) over the age of 7 years. conditions: Tyrosinemia, Type I conditions: Tyrosinemia, Type II conditions: Tyrosinemia, Type III conditions: Alkaptonuria conditions: Homocystine; Metabolic Disorder conditions: MSUD (Maple Syrup Urine Disease) studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 15 type: ESTIMATED name: Zero minis (range of protein substitutes in tablet form) measure: Daily compliance measure: Treatment-Emergent tolerability measure: Patient Acceptability measure: Metabolic control measure: Incidence of study product emergent events. sex: ALL minimumAge: 7 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT hasResults: False
<\|newrecord\|> nctId: NCT06298279 id: 2023-436 briefTitle: Assessing Social Learning and Course Delivery Timing in Internet-delivered Cognitive Behaviour Therapy for Public Safety Personnel overallStatus: NOT_YET_RECRUITING date: 2024-03-12 date: 2025-04-30 date: 2025-04-30 date: 2024-03-07 date: 2024-03-07 name: University of Regina class: OTHER name: Government of Canada briefSummary: This study is a randomized factorial trial designed to evaluate unguided (i.e., purely self-help), transdiagnostic internet delivered cognitive behaviour therapy tailored for public safety personnel with tunneled of personalized course delivery and with or without the incorporation of social learning resources. conditions: Depression conditions: Anxiety conditions: Stress Disorders, Post-Traumatic studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: FACTORIAL interventionModelDescription: Factor 1: Tunneled or Personalized Course Delivery Factor 2: Standard or Enhanced Social Learning Resources Participants will be randomly assigned to one of four treatment conditions (tunneled delivery of ICBT with standard resources, tunneled delivery of ICBT with enhanced social learning resources, personalized delivery ICBT with standard resources, personalized delivery of ICBT with enhanced social learning resources) primaryPurpose: TREATMENT masking: NONE maskingDescription: Participants cannot be blinded to condition because ICBT (like other psychotherapies) cannot be both provided to and concealed from a participant. However, the difference between the four conditions (i.e., presence or absence of social learning resources, tunneled versus personalized course navigation) will be concealed from all participants. Because outcomes will be assessed via self-report questionnaire measures, outcomes assessor masking is not applicable. count: 164 type: ESTIMATED name: Tunneled Delivery name: Personalized Delivery name: Standard Resources name: Enhanced Social Learning Resources name: Transdiagnostic Self-Guided ICBT measure: Generalized Anxiety Disorder 7-item (GAD-7) measure: Patient Health Questionnaire-9 (PHQ-9) measure: PTSD Checklist for the DSM-5 (PCL-5) measure: Engagement measure: Work and Social Adjustment Scale (WSAS) measure: Brief Resilience Scale (BRS) measure: Healthcare Use Questionnaire measure: Case Story Questionnaire measure: Treatment Satisfaction Questionnaire measure: Digital Behavior Change Interventions Engagement Scale (DCBI) measure: Post-treatment Semi-structured interview sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Psychology, University of Regina city: Regina state: Saskatchewan zip: S4S 0A2 country: Canada name: Heather D Hadjistavropoulos, PhD role: CONTACT phone: 306-585-5133 email: heather.hadjistavropoulos@uregina.ca name: Caeleigh A Landry, MSc role: CONTACT phone: 306-337-2473 email: caeleigh.landry@uregina.ca name: Heather D Hadjistavropoulos, PhD role: PRINCIPAL_INVESTIGATOR lat: 50.45008 lon: -104.6178 hasResults: False
<\|newrecord\|> nctId: NCT06298266 id: GD2H-XYK-001 briefTitle: To Assess Safety, Tolerability, and Efficacy of Anti-GPRC5D-CD19-CAR-T in Relapsed/Refractory Multiple Myeloma overallStatus: NOT_YET_RECRUITING date: 2024-03-29 date: 2026-05-31 date: 2026-12-31 date: 2024-03-07 date: 2024-03-07 name: Guangdong Second Provincial General Hospital class: OTHER briefSummary: To evaluate the safety and tolerability of anti-GPRC5D-CD19 CAR-T cells infusion in subjects with relapsed and refractory multiple myeloma conditions: Relapsed or Refractory Multiple Myeloma studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 15 type: ESTIMATED name: infusion of GPRC5D-CD19 CAR T injection measure: Objective Response Rate sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Guangdong Second Provincial General Hospital city: Guangzhou state: Guangdong zip: 510317 country: China name: Qing Zhang role: CONTACT phone: +862089169186 email: zhqing@vip.163.com lat: 23.11667 lon: 113.25 hasResults: False
<\|newrecord\|> nctId: NCT06298253 id: 2024P000832 briefTitle: Behavioral Economics to Implement a Traffic Light Nutrition Ranking System: Study 2 acronym: BeWell overallStatus: NOT_YET_RECRUITING date: 2024-09 date: 2027-06 date: 2028-06 date: 2024-03-07 date: 2024-04-09 name: Massachusetts General Hospital class: OTHER briefSummary: This is a cluster randomized controlled trial of 30 food pantries affiliated with the Greater Boston Food Bank to test the use of behavioral economics (BE) tools to encourage food pantries to implement the Supporting Wellness at Pantries (SWAP) program, with the goal of fostering accurate use of SWAP traffic light labels on pantry shelves and increasing the healthfulness of foods chosen by pantry clients. Primary outcomes will be assessed at 6 and 12 months to compare the implementation and effectiveness of the SWAP program in the intervention vs. control pantries. conditions: Food Insecurity conditions: Implementation Science conditions: Diet, Healthy conditions: Behavioral Economics studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 3750 type: ESTIMATED name: Behavioral economics-enhanced SWAP implementation name: Basic SWAP implementation measure: Pantry SWAP implementation measure: Percent items (by weight) ordered by pantry that are labeled green or red measure: Percent of pantry clients' selected food that is green or red measure: Client dietary quality score measure: Skin carotenoid level sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06298240 id: 4R22/074 briefTitle: Implementation of Nursing Demand Management as a Factor for Improvement in a Primary Care Emergency Center. overallStatus: ACTIVE_NOT_RECRUITING date: 2022-10-01 date: 2024-01-05 date: 2024-09-01 date: 2024-03-07 date: 2024-04-15 name: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina class: OTHER briefSummary: Background: Nurse Demand Management was born in 2009 out of the need to address the growth of spontaneous acute demand in primary care. But it is not until 2013 that guidelines for the exercise of nursing actions in demand management were established in Catalonia, Spain. Nurses trained specifically to solve acute and low complexity health problems generate a quality of care comparable to that provided by family medicine doctors. On the other hand, it is worth highlighting the need to rationalise medical resources in primary care centres, primary care emergency centres or points of continuous care (different emergency facilities in the territory in terms of size and services) in order to give priority to doctors being able to dedicate more time to medium or high complexity pathology. Although nurse demand management has been implemented in primary care teams for years, it is being carried out in different intensities according to the needs or priorities of each health territory.
The promotion of the autonomous role of nursing through the implementation of nurse demand management in the urgent spontaneous demand of low complexity can be transcendent, both in the optimisation of health resources in primary care and in the management of the demand for care.
Hypothesis: The implementation of nurse demand management is a factor of improvement in the efficiency and quality of care in the Primary Care Emergency Centre of the city of Mataró (Barcelona, Spain). Objectives: The main objective of this study was to determine whether the implementation of nurse demand management is a factor in improving efficiency and quality of care in the CUAP of Mataró. Methodology: Non-randomised controlled experimental intervention study. Application of a consensual guide with 5 reasons for health consultations where demand management nursing can be applied. conditions: Nurse's Role conditions: Disease, Acute studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 312 type: ACTUAL name: nursing procedure for acute health problems of low complexity measure: Waiting time and resolution of the visit measure: Number of reconsultations measure: patient experience measure: Prescribed drugs measure: Processed labour disabilities measure: Diagnoses change sex: ALL minimumAge: 16 Years maximumAge: 65 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Mataró primary care emergency center city: Mataró state: Barcelona zip: 08301 country: Spain lat: 41.54211 lon: 2.4445 hasResults: False
<\|newrecord\|> nctId: NCT06298227 id: Medipol Hospital 1 briefTitle: Erector Spinae Plane Block vs Quadratus Lumborum Block for Laparoscopic Nephrectomy overallStatus: RECRUITING date: 2024-03-11 date: 2024-07-20 date: 2024-07-30 date: 2024-03-07 date: 2024-03-15 name: Istanbul Medipol University Hospital class: OTHER briefSummary: Ultrasound (US) guided Quadratus Lumborum Block (QLB) is performed at the level of the 12th rib, in the parasagittal oblique plane, at the L1-L2 level. As there are modifications of the block generally local anesthetic is given between quadratus lumborum (QL) and psoas major (PM) muscles (Anterior QLB). The QLB provides a sensory block between T7 - L1. Therefore, QLBs are used to provide postoperative analgesia for abdominal, obstetric, gynecologic, and urologic surgeries.
US-guided erector spinae plane block (ESPB) is performed at the level of the T11 transverse process. After visualization of the erector spinae (ES) muscle and the transverse process, local anesthetic is injected under the ES muscle. ESPB provides a sensory block of the anterior, posterior, and lateral thoracic and abdominal walls accordingly it's used for postoperative analgesia after thoracal wall repairs, thoracotomies, percutaneous nephrolithotomies, nephrectomies, and ventral hernia repairs.
This study aims to compare the effectiveness of US-guided ESPB and QLB on postoperative pain control after laparoscopic nephrectomy. conditions: Kidney Diseases conditions: Kidney Failure studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Sixty patients aged 18-65 years old with American Society of Anesthesiologists (ASA) classification I-II and scheduled for laparoscopic nephrectomy surgery will be included in the study. Patients will be randomly divided into two groups (Group ESPB = ESPB group, Group QLB = QLB group) including 30 patients each, before entering the operating room. primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Outcomes assessor and participants will be blinded to the study whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Postoperative analgesia management with Paracerol® and IV PCA with Talinat® name: Erector spinae plane block name: Quadratus lumborum plane block measure: Amount of total opioid consumption (Fentanyl PCA) at the first 24 hours period postoperatively measure: Pain scores (Numerical rating scale-NRS) measure: Need for rescue analgesia (meperidine) measure: Adverse events sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Istanbul Medipol University Mega Hospital Complex status: RECRUITING city: Istanbul state: Bağcılar country: Turkey name: Ayşe İnce, Assist Prof role: CONTACT lat: 41.01384 lon: 28.94966 hasResults: False
<\|newrecord\|> nctId: NCT06298214 id: RP-23-019 briefTitle: Testing the Effectiveness of the Her Health Program to Add Healthcare Value in the Fourth Trimester acronym: Her Health overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-01-01 date: 2026-06-01 date: 2024-03-07 date: 2024-03-07 name: Elizabeth F Sutton, PhD class: OTHER name: Donaghue Medical Research Foundation briefSummary: The goal of this clinical trial is to learn if a program Woman's Hospital has made, called the Her Health Program, can help women be healthy and get healthcare in the first year after having a baby.
The main question\[s\] the study aims to answer are:
* Can the Her Health program increase access to healthcare in the first year postpartum?
* Can the Her Health program increase knowledge about healthcare and change feelings toward the healthcare system?
Participants will complete one research visit in which they will be enrolled and told which group they will be in- "Her Health Program" group or "Usual Care" group. If they are placed in the "Her Health Program" group, they will receive their usual care + the addition of an extra healthcare team member(called a community health navigator) to to work with patients and care team for a year postpartum.
Researchers will compare those who receive the Her Health Program and those who do not receive the program to see if the Her Health Program can help women get healthcare in the first year after having a baby. conditions: Postpartum conditions: Pregnancy Related studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 500 type: ESTIMATED name: Her Health Program measure: Postpartum visit attendance measure: Medical trust measure: Health literacy measure: Self-efficacy measure: Healthcare costs sex: FEMALE minimumAge: 16 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Woman's Hospital city: Baton Rouge state: Louisiana zip: 70817 country: United States lat: 30.45075 lon: -91.15455 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2023-12-05 uploadDate: 2024-02-02T12:19 filename: Prot_SAP_000.pdf size: 458232 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2023-12-06 uploadDate: 2024-02-02T12:21 filename: ICF_001.pdf size: 188057 hasResults: False
<\|newrecord\|> nctId: NCT06298201 id: IMAGINE2024 briefTitle: E-Based Physical Exercise in Patients With Multiple Sclerosis and Comorbidity acronym: COMPACT overallStatus: RECRUITING date: 2024-04 date: 2024-11 date: 2025-07 date: 2024-03-07 date: 2024-03-07 name: University of Southern Denmark class: OTHER briefSummary: Background: Physical exercise (PE) improves symptoms and quality of life in patients with multiple sclerosis (pwMS). Comorbidity is prevalent among pwMS and may contribute to disease progression. Integrating and sustaining PE is challenging and E-based PE solutions have been proposed as a tool to support the integration of PE into daily life.
Aims: To assess the effect of e-based PE in addition to usual care in pwMS on clinical outcome and the levels of inflammatory, metabolic, and neurodegenerative mediators. Furthermore, to determine whether PE plays a role in the modification of comorbidities with a focus on vascular comorbidity and related risk factors, i.e., type 2 diabetes mellitus.
Method: This study will be prospective with longitudinal follow-up of pwMS with and without comorbidities. The physical activity of pwMS will be measured at baseline and after six months by accelerometers. In a randomized controlled trial (RCT) patients will be randomly assigned in a 1:1 ratio to receive either usual care or usual care plus an e-based PE program. The exercise program consists of resistance training with resistance bands targeting the lower extremities, including leg press, knee extension, hip flexion, hamstring curl, and hip extension. The sessions will enable participants to engage in group exercises from their homes through a secure online platform, supervised virtually by physiotherapists. The primary endpoints are walking capacity using the 6-meter walk test and the NEDA-3 scale, focusing on the absence of clinical relapses and disease progression, as indicated by an increase in the Expanded Disability Status Scale score and the absence of new disease activity on MRI (including new T2 lesions or enhancing lesions). Secondary outcomes will encompass measures of quality of life and fatigue, as well as levels of potential biomarkers like neurofilament light chain in blood and cerebrospinal fluid.
Conclusion: This study will contribute to the rehabilitation and improved quality of life of pwMS particularly of patients with comorbidities. The potential for e-based PE at home to encourage sustained exercise engagement among pwMS will be evaluated, offering a significant contribution to the field of digital healthcare solutions. conditions: Multiple Sclerosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized controlled trial (RCT) with prospective longitudinal follow up primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Due to the nature of the intervention, it is not feasible to blind participants or physiotherapists delivering the program. Nonetheless, to preserve the integrity of the trial, outcome assessors (researchers) will remain blinded to the allocation of treatments. whoMasked: PARTICIPANT count: 300 type: ESTIMATED name: E-Based Physical Exercise Intervention measure: 6-meters' walk test measure: "no evidence of disease activity" (NEDA-3) score measure: Cognitive function, evaluated using the Montreal Cognitive Assessment (MoCA), measure: Fatigue levels, assessed using the short-form Neuro-QOL Fatigue Scale measure: Neurofilament Light Chain (NfL) determination sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Southern Denmark status: ENROLLING_BY_INVITATION city: Odense zip: 5000 country: Denmark lat: 55.39594 lon: 10.38831 facility: University of Southern Denmark status: RECRUITING city: Odense zip: 5230 country: Denmark name: Nasrin Asgari, Professor role: CONTACT phone: +4530700612 email: nasgari@health.sdu.dk name: Ulrik Dalgas, Professor role: CONTACT email: dalgas@ph.au.dk lat: 55.39594 lon: 10.38831 hasResults: False
<\|newrecord\|> nctId: NCT06298188 id: RisaKids briefTitle: Risankizumab in Children With Crohn's Disease (RisaKids) overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2026-10 date: 2026-10 date: 2024-03-07 date: 2024-03-07 name: Shaare Zedek Medical Center class: OTHER briefSummary: The goal of this observational study is to to prospectively explore the real life short (12 weeks) and longer term (54 weeks) clinical, biochemical and endoscopic outcomes of risankizumab in pediatric CD.
This is a 1-year prospective multi-center cohort study of children commencing on risankizumab for pediatric CD with 2 years extension for long-term follow-up. The investigators will record clinical manifestations, blood markers and fecal calprotectin, with monitoring for safety signals including infusion and injection site reactions, pyrexia and infections at various intervals as outlined below. The investigators will also include calprotectin monitoring and fecal sample collection for microbiome and serum samples for drug levels. According to available budget, the investigators will also collect fecal and serum samples for metabolome. Samples collection is optional, thus failure of bio-samples collection will not exclude patients from the study. conditions: Crohn Disease studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 90 type: ESTIMATED name: Risankizumab measure: Co-primary outcomes: Complete remission at end of remission (weeks 12 and week 54) sex: ALL minimumAge: 6 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT hasResults: False
<\|newrecord\|> nctId: NCT06298175 id: 2021-157 briefTitle: Self-Management Training With Online Intervention Process for Young Adults With Chronic Conditions overallStatus: COMPLETED date: 2021-04-15 date: 2021-04-15 date: 2021-08-15 date: 2024-03-07 date: 2024-03-07 name: Saglik Bilimleri Universitesi class: OTHER briefSummary: The study was conducted from 15th April 2021 to 15th August 2021. It employed a pretest-posttest design with control and training groups. In this study, a pretest-posttest design including control and training groups was used. Pre-assessments were taken from young adults who reported that they wanted to participate in the study via social media accounts and e-mail and who met the study criteria, and two groups were formed by the simple randomization method. The study group received 8 weeks of self-management training. The control group was informed about self-management for 1 week. Final evaluations were conducted for both groups after eight weeks. conditions: Chronic Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Pre-post test, randomized controlled study primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 72 type: ACTUAL name: Self management training measure: Self-Control Self-Management Scale (SCMS) measure: Cognitive Emotion Regulation Questionnaire (CERQ) measure: The Occupational Balance Questionnaire (OBQ) sex: ALL minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: Saglik Bilimleri Universitesi city: Ankara country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False
<\|newrecord\|> nctId: NCT06298162 id: 2018-1279 briefTitle: Assessment of Pouch Emptying With MRI After Roux-en-Y Gastric Bypass acronym: MRI pouch overallStatus: COMPLETED date: 2019-07-25 date: 2020-02-01 date: 2020-02-01 date: 2024-03-07 date: 2024-03-07 name: Rijnstate Hospital class: OTHER briefSummary: A cross-sectional observational study in which pouch emptying rate is measured with MRI in good (TWL\>35%) and bad responders (TWL\<25%) two years after Laparoscopic Roux-en-Y Gastric Bypass (LRYGB). conditions: Bariatric Surgery Candidate conditions: Gastric Bypass conditions: Obesity, Morbid conditions: Pouch Emptying studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 10 type: ACTUAL name: 2 years after RYGB, no intervention. MRI measurement. Observational. measure: Pouch emptying rate measured with MRI measure: subjective ratings of fullness measure: subjective ratings of wellbeing sex: FEMALE minimumAge: 20 Years maximumAge: 55 Years stdAges: ADULT facility: Yonta Burgh city: Arnhem zip: 6815 AD country: Netherlands lat: 51.98 lon: 5.91111 hasResults: False
<\|newrecord\|> nctId: NCT06298149 id: 2023-650-EXEMPT id: 1U54CA280812-01 type: NIH link: https://reporter.nih.gov/quickSearch/1U54CA280812-01 briefTitle: Reach Through Equitable Implementation of Turtle Island Tales overallStatus: ENROLLING_BY_INVITATION date: 2023-11-01 date: 2028-04-30 date: 2028-04-30 date: 2024-03-07 date: 2024-03-07 name: Montana State University class: OTHER name: National Institutes of Health (NIH) name: University of Utah name: National Cancer Institute (NCI) briefSummary: Reach Through Equitable Implementation of Turtle Island Tales is a family-level obesity prevention intervention that aims to reinforce AI cultural values of family interaction and holistic wellness. The long-term objective of this research program is to increase the reach of existing evidence-based interventions (EBIs) for cancer and obesity prevention among American Indian (AI) families who live in persistent poverty census tracts. conditions: Obesity, Childhood conditions: Obesity conditions: Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Each participating family will receive a monthly lesson targeting a healthy behavior (increase fruit/vegetable intake, decrease added sugar intake, increase physical activity, decrease sedentary/screen time, promote healthy sleep, and promote emotional regulation) over the course of one year. primaryPurpose: PREVENTION masking: NONE count: 200 type: ESTIMATED name: Turtle Island Tales measure: 20-item Family Nutrition and Physical Activity Survey measure: Food insecurity screener measure: Mental Health screening sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Montana State University city: Bozeman state: Montana zip: 59717 country: United States lat: 45.67965 lon: -111.03856 hasResults: False
<\|newrecord\|> nctId: NCT06298136 id: 15610923 briefTitle: The Effects of an Online Mindfulness-based Intervention for Children With Attention-Deficit/Hyperactivity Disorder acronym: MindADHD overallStatus: RECRUITING date: 2024-02-01 date: 2026-12-31 date: 2026-12-31 date: 2024-03-07 date: 2024-03-07 name: The Hong Kong Polytechnic University class: OTHER briefSummary: This study will investigate the effects of an online mindfulness-based intervention with a randomized controlled trial. conditions: ADHD studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This study will investigate the effects of an online mindfulness-based intervention (MBI) on outcomes in children with ADHD. The effects of the MBI (arm 1) will be investigated in comparison with the effects of psychoeducation (arm 2). primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: The participants will be informed that an intervention (program A or program B) will be assigned to them randomly. For research team who will be in contact with participants for outcome assessment, whether the participants have been allocated to arm 1 or arm 2 will be blinded. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 208 type: ESTIMATED name: mindfulness-based intervention name: child behavior management measure: Child ADHD symptoms measure: Parent depressive symptoms measure: Parent anxiety symptoms measure: Parent sleep quality measure: Parent well-being measure: Child executive functioning measure: Parental Stress measure: Expressed emotion sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Herman Hay Ming Lo status: RECRUITING city: Hong Kong country: Hong Kong name: Christine Wing Tung Yeung, MSsc role: CONTACT phone: +85266279904 email: wing-tung.yeung@polyu.edu.hk lat: 22.27832 lon: 114.17469 hasResults: False
<\|newrecord\|> nctId: NCT06298123 id: adjuvant-03 briefTitle: Postoperative Adjuvant Immunotherapy for Hepatocellular Carcinoma: Risk Factor Analysis and Prognostic Modelling overallStatus: COMPLETED date: 2019-02-01 date: 2023-02-01 date: 2023-02-01 date: 2024-03-07 date: 2024-03-07 name: Chen Xiaoping class: OTHER briefSummary: The aim of this study was to analyse the independent risk factors for hepatocellular carcinoma (HCC) patients undergoing adjuvant immunotherapy after liver resection surgery, and to develop a prognostic model based on these factors. conditions: Hepatocellular Carcinoma conditions: Adjuvant Immunotherapy conditions: Checkpoint Inhibitor studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 304 type: ACTUAL name: Anti-PD-1 monoclonal antibody measure: Recurrence-Free Survival (RFS) measure: Overall Survival (OS) measure: Imaging data (enhanced CT and MRI） and histopathology data, if available. sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology city: Wuhan state: Hubei zip: 430030 country: China lat: 30.58333 lon: 114.26667 hasResults: False
<\|newrecord\|> nctId: NCT06298110 id: PRP in Abdominal hysterectomy briefTitle: The Effect of PRP on Wound Healing in High Risk Patients Undergoing Abdominal Hysterectomy overallStatus: NOT_YET_RECRUITING date: 2024-03-10 date: 2024-08-25 date: 2024-09-25 date: 2024-03-07 date: 2024-03-08 name: Helwan University class: OTHER briefSummary: To evaluate the effect of PRP on wound healing in high risk patients undergoing abdominal hysterectomy. conditions: Wound Heal conditions: Abdominal Wound conditions: PRP studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 80 type: ESTIMATED name: Platelets Rich plasma of the same patient measure: changes in wound healing measure: Vancouver scar scale changes measure: Visual Analog Scale changes measure: Hospital readmission measure: Infection sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06298097 id: 2019.11 briefTitle: Brain Connectivity Measured With High-density Electroencephalography acronym: NEUROCONN overallStatus: RECRUITING date: 2020-06-11 date: 2025-02-02 date: 2025-02-02 date: 2024-03-07 date: 2024-03-07 name: IRCCS San Camillo, Venezia, Italy class: OTHER briefSummary: Emerging scientific results show that disrupted functional connectivity in stroke can explain behavioral impairments and predict their recovery over time. However, no technique is yet available for widespread use in clinics to examine how neural synchronization in brain networks is altered in stroke patients. This is crucial to determine favorable prognostic factors and to define individualized rehabilitation protocols. Importantly, the investigators have successfully used high-density electroencephalography (hdEEG) in healthy individuals to measure neural synchronization in brain networks. In this project, the investigators will develop methods and tools based on hdEEG for assessing functional connectivity in stroke patients. These methods and tools will be employed to examine how neural changes occurring after brain lesions explain behavioral impairments. The project will open the way for the use of hdEEG at the patient's bedside, as a neurodiagnostic tool for stroke as well as other brain disorders. conditions: Stroke studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: NONE count: 170 type: ESTIMATED name: Connectivity measures measure: High-density electroencephalography measurements (work package 1, 2, and 3) measure: High-density electroencephalography measurements (work package 1, 2, and 3) measure: High-density electroencephalography measurements (work package 1, 2, and 3) measure: High-density electroencephalography measurements (work package 1, 2, and 3) measure: High-density electroencephalography measurements (work package 1, 2, and 3) measure: Magnetic Resonance Imaging measurement (work package 1, 2, and 3) measure: Magnetic Resonance Imaging measurement (work package 1, 2, and 3) measure: Magnetic Resonance Imaging measurement (work package 1, 2, and 3) measure: Magnetic Resonance Imaging measurement (work package 1, 2, and 3) measure: Magnetic Resonance Imaging measurement (work package 1, 2, and 3) measure: Muscle strength measurement (work package 3) measure: Muscle strength measurement (work package 3) measure: Muscle strength measurement (work package 3) measure: Muscle strength measurement (work package 3) measure: Muscle strength measurement (work package 3) measure: Sensorimotor impairment measurement (work package 3) measure: Sensorimotor impairment measurement (work package 3) measure: Sensorimotor impairment measurement (work package 3) measure: Sensorimotor impairment measurement (work package 3) measure: Sensorimotor impairment measurement (work package 3) measure: Spasticity measurement (work package 3) measure: Spasticity measurement (work package 3) measure: Spasticity measurement (work package 3) measure: Spasticity measurement (work package 3) measure: Spasticity measurement (work package 3) measure: Funtional skills measurement (work package 3). measure: Funtional skills measurement (work package 3). measure: Funtional skills measurement (work package 3). measure: Funtional skills measurement (work package 3). measure: Funtional skills measurement (work package 3). measure: Activities of daily living measurement (work package 3) measure: Activities of daily living measurement (work package 3) measure: Activities of daily living measurement (work package 3) measure: Activities of daily living measurement (work package 3) measure: Activities of daily living measurement (work package 3) measure: Pain measurement (work package 3) measure: Pain measurement (work package 3) measure: Pain measurement (work package 3) measure: Pain measurement (work package 3) measure: Pain measurement (work package 3) measure: Cognitive performance measurements (work package 3) measure: Cognitive performance measurements (work package 3) measure: Cognitive performance measurements (work package 3) measure: Cognitive performance measurements (work package 3) measure: Cognitive performance measurements (work package 3) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS San Camillo Hospital status: RECRUITING city: Venice country: Italy role: CONTACT email: n.ricercaclinica@hsancamillo.it lat: 45.43713 lon: 12.33265 hasResults: False
<\|newrecord\|> nctId: NCT06298084 id: 2023-505925-15-00 id: 2023/3668 type: OTHER domain: CSET number briefTitle: Dose-Expansion Modular Study To Explore the Safety, Tolerability, and Anti-tumor Activity of HER3- DXd Monotherapy and Combinations in Patients With Inoperable Advanced Breast Cancer (ABC) After Progression on T-DXd acronym: ICARUSBREAST02 overallStatus: RECRUITING date: 2024-03-21 date: 2027-09 date: 2029-06 date: 2024-03-07 date: 2024-03-29 name: Gustave Roussy, Cancer Campus, Grand Paris class: OTHER name: Daiichi Sankyo briefSummary: ICARUS-BREAST02 is an open-label, multicenter, phase 1b/2, platform study that aims to evaluate the safety, tolerability, and efficacy of HER3-DXd monotherapy and in combination with other anti-cancer agents in patients with ABC.
The first 2 modules will evaluate: i. safety and efficacy of HER3-DXd with olaparib in patients with HER2-low and HER2-positive ABC progressed on T-DXd (Module 1) and HER3-DXd monotherapy in patients with HER2-low ABC progressed on T-DXd (Module 0).
The main objective of Part 1 is to assess the safety and tolerability of HER3-DXd monotherapy and combination and to determine the recommended phase 2 dose (RP2D) of the combination containing HER3-DXd.
The main objective of Part 2 is to assess the efficacy of study therapies in each module based on investigator assessment as evaluated by the objective response rate (ORR) at 6 months. conditions: Breast Cancer Metastatic conditions: HER2-positive Metastatic Breast Cancer conditions: HER2 Low Breast Carcinoma conditions: Advanced Breast Cancer studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 152 type: ESTIMATED name: Patritumab deruxtecan name: Olaparib measure: DLTs (dose-limiting toxicity) for part 1a and 1b measure: Frequency of safety event for part 1a and 1b measure: Severity of safety event for part 1a and 1b measure: Proportion of treatment modification due to AEs for part 1a and 1b measure: frequency of laboratory abnormalities for part 1a and 1b measure: Severity of laboratory abnormalities for part 1a and 1b measure: radiographic changes potentially consistent with ILD/pneumonitis or any other pulmonary signs/symptoms for part 1a and 1b measure: ORR for part 2 measure: DOR for part 2 measure: PFS for part 2 measure: CBR for part 2 measure: ORR for part 1 measure: DOR for part 1 measure: PFS for part 1 measure: CBR for part 1 measure: PK analysis for part 1 measure: ADA analysis for part 1 measure: DLTs for part 2 measure: Frequency of safety event for part 2 measure: Severity of safety event for part 2 measure: proportion of treatment modification event for part 2 measure: frequency of laboratory abnormalities for part 2 measure: Severity of laboratory abnormalities for part 2 measure: radiographic changes potentially consistent with ILD/pneumonitis or any other pulmonary signs/symptoms for part 2 measure: PK analysis for part 2 measure: ADA analysis for part 2 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Gustave Roussy Institut status: RECRUITING city: Villejuif zip: 94805 country: France name: Barbara Pistilli role: CONTACT phone: +33 (0)1 42 11 61 62 email: barbara.pistilli@gustaveroussy.fr name: Fernanda Mosele role: CONTACT phone: +33 (0)1 42 11 61 43 email: Mariafernanda.MOSELE@gustaveroussy.fr lat: 48.7939 lon: 2.35992 hasResults: False
<\|newrecord\|> nctId: NCT06298071 id: SIBP-R002-Ib briefTitle: A Phase Ib Clinical Trial of Peguricase for Injection With Methotrexate in Patients With Uncontrolled Gout. overallStatus: RECRUITING date: 2023-03-03 date: 2024-12-30 date: 2025-12-30 date: 2024-03-07 date: 2024-03-07 name: Shanghai Institute Of Biological Products class: INDUSTRY name: First Affiliated Hospital Bengbu Medical College name: The First Affiliated Hospital of Henan University of Science and Technology name: Chengdu Fifth People's Hospital briefSummary: To evaluate the safety and tolerability of peguricase for injection with methotrexate in patients with gout who remain uncontrolled after standardized treatment with conventional uric acid-lowering drugs, to determine the recommended dose for phase II clinical trials, and to provide basis for formulation of administration regimen for phase II clinical trials. conditions: Gout studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: According to the sequence from low-dose group to high-dose group, there are 12 participants in each group, totaling 36 participants. primaryPurpose: TREATMENT masking: NONE count: 36 type: ESTIMATED name: SIBP-R002 name: SIBP-R002 name: SIBP-R002 name: Methotrexate measure: AE(Adverse Events) measure: SAE(Serious Adverse Events) measure: AUC(Area Under The Plasma Concentration Versus Time Curve) measure: Cmax(Peak Plasma Concentration) measure: Tmax(Peak Time) measure: T ½ (Terminal elimination half-life) measure: CL (Clearance Rate) measure: ADA (Anti-uricase Antibody, Anti-PEG Antibody, Anti-PEG-uricase Antibody) measure: NAb (Anti-PEG-uricase Neutralizing Antibody) sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The First Affiliated Hospital of Bengbu Medical College status: RECRUITING city: Bengbu state: Anhui country: China name: Huan Zhou, Master role: CONTACT phone: 86-13665527160 email: zhouhuanbest@hotmail.com lat: 32.94083 lon: 117.36083 hasResults: False
<\|newrecord\|> nctId: NCT06298058 id: SIBP-A13-I briefTitle: A Clinical Trial of SIBP-A13 Injection in the Treatment of Advanced Malignant Solid Tumor Patients. overallStatus: NOT_YET_RECRUITING date: 2024-03-12 date: 2026-04-30 date: 2026-06-30 date: 2024-03-07 date: 2024-03-07 name: Shanghai Institute Of Biological Products class: INDUSTRY name: Shanghai Pulmonary Hospital, Shanghai, China briefSummary: To evaluate the safety, tolerability, and pharmacokinetic characteristics of SIBP-A13 and determine the maximum tolerable dose (MTD) and phase II recommended dose (RP2D). conditions: Advanced Solid Tumor studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: This study is an open, multi-dose increasing single and multiple dose study. primaryPurpose: TREATMENT masking: NONE count: 144 type: ESTIMATED name: SIBP-A13 formulation for injection measure: AE (Adverse Events) measure: SAE (Serious Adverse Events) measure: AUC (Area Under The Plasma Concentration Versus Time Curve) measure: Cmax (Peak Plasma Concentration) measure: Tmax (Peak Time) measure: T ½ (Terminal elimination half-life) measure: CL (Clearance Rate) measure: ORR (Objective Response Rate) measure: DCR (Disease control rate) measure: PFS (Progression-free survival) measure: OS (overall survival) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06298045 id: DIM-06790-002 briefTitle: Effectiveness of a Combination of Trimetazidine With One Hemodynamic Agent in Patients Recently Diagnosed With Stable Angina and Still Symptomatic Despite First Line Hemodynamic Therapy overallStatus: RECRUITING date: 2023-07-15 date: 2025-03-31 date: 2025-03-31 date: 2024-03-07 date: 2024-03-07 name: Servier Affaires Médicales class: INDUSTRY briefSummary: The purpose of this study is to assess in recently diagnosed stable Angina patients symptomatic despite first line hemodynamic therapy, the effect of a combination of this hemodynamic agent with a metabolic one (trimetazidine). The treatment effect will be measured by the reduction of patients' angina symptoms, physical limitation and an improvement of quality of life using the Seattle Angina Questionnaire-7 items (SAQ-7) Patients will be also proposed to complete a BEAMER (BEhavioral and Adherence Model for improving quality, health outcomes and cost-Effectiveness of healthcaRe) questionnaire which will contribute to a separate research project developed by the Innovative Medicines Initiative (IMI). Analysis of the BEAMER questionnaires will be performed outside the study by the IMI BEAMER Consortium for BEAMER purposes only. conditions: Stable Angina studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 600 type: ESTIMATED measure: Assessment of angina symptoms via the summary score of SAQ-7 measure: CCS angina grading post-inclusion measure: Tolerance ( Adverse Events) measure: Tolerance ( Serious Adverse Events) measure: Adherence to the antianginal treatment combination under evaluation sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Thera Card Srl status: RECRUITING city: Braşov zip: 500091 country: Romania name: Zara Cornelia, Dr role: CONTACT phone: +40723733774 email: cornelia.zara@theracardia.ro lat: 45.64861 lon: 25.60613 hasResults: False
<\|newrecord\|> nctId: NCT06298032 id: 000414 briefTitle: A Study Investigating the Safety, Tolerability, Immunogenicity and Pharmacokinetics of Olamkicept in Healthy Persons overallStatus: RECRUITING date: 2024-02-20 date: 2024-11-12 date: 2024-11-12 date: 2024-03-07 date: 2024-03-07 name: Ferring Pharmaceuticals class: INDUSTRY briefSummary: Interleukin (IL)-6 is a cytokine produced in response to infection and tissue damage. IL-6 is believed to act as a key mediator in chronic inflammation and autoimmune diseases such as inflammatory bowel diseases. IL-6 is known to be involved in at least two distinct signalling pathways, classical and trans-signalling. The hypothesis is that classical signalling by IL-6 infers some beneficial effects (e.g. on gut barrier function), while excessive IL-6 trans-signalling may have detrimental effects. Olamkicept (FE 999301) has been shown in vitro to be a selective IL-6 trans-signalling inhibitor, and administered at lower doses (600 mg every 2nd week for 12 weeks) it has proven to induce clinical improvement for patients with ulcerative colitis. The aim of this trial is to investigate safety, tolerability, immunogenicity and pharmacokinetics of Olamkicept at higher doses (up to 2400 mg) to support the clinical development program. Our hypothesis is that treatment with higher doses of Olamkicept will result in greater clinical improvement for patients with inflammatory bowel diseases. conditions: Inflammatory Gastrointestinal Diseases studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 48 type: ESTIMATED name: Olamkicept Part A name: Olamkicept Part B name: Placebo measure: Number of treatment-emergent adverse events, including type, intensity, and causality measure: Change in vital signs from baseline to Day 36 after a single dose infusion measure: Change in vital signs from baseline to Day 64 after multiple dose infusions measure: Change in 12-lead electrocardiogram (ECG) from baseline to Day 36 after a single dose infusion measure: Change in 12-lead electrocardiogram (ECG) from baseline to Day 64 after multiple dose infusions measure: Change in haematology from baseline to Day 36 after a single dose infusion measure: Change in haematology from baseline to Day 64 after multiple dose infusions measure: Change in clinical chemistry from baseline to Day 36 after a single dose infusion measure: Change in clinical chemistry from baseline to Day 64 after multiple dose infusions measure: Change in haemostasis parameters from baseline to Day 36 after a single dose infusion measure: Change in haemostasis parameters from baseline to Day 64 after multiple dose infusions measure: Change in urinalysis parameters from baseline to Day 36 after a single dose infusion measure: Change in urinalysis parameters from baseline to Day 64 after multiple dose infusions measure: Single-dose PK of FE 999301: Area under the concentration-time curve from dosing to infinity (AUCinf) measure: Single-dose PK of FE 999301: Area under the concentration-time curve to last measurable concentration (AUClast) measure: Single-dose PK of FE 999301: Observed plasma concentration at end of infusion (AUCeoi) measure: Single-dose PK of FE 999301: Baseline adjusted maximum observed concentration; also referred to as maximum exposure (Cmax) measure: Single-dose PK of FE 999301: Time of maximum observed concentration (tmax) measure: Single-dose PK of FE 999301: Terminal half-life (t1/2) measure: Single-dose PK of FE 999301: Mean residence time (MRT) measure: Single-dose PK of FE 999301: Total clearance (CL) measure: Single-dose PK of FE 999301: Apparent volume of distribution at steady-state (Vss) measure: Multiple-dose PK of FE 999301: Area under concentration-time curve from dosing up to time τ, where τ is the dosing interval (AUCτ) measure: Multiple-dose PK of FE 999301: Area under the concentration-time curve to last measurable concentration (AUClast) measure: Multiple-dose PK of FE 999301: Observed accumulation index (Rac) measure: Multiple-dose PK of FE 999301: Observed plasma concentration at end of infusion (Ceio) measure: Multiple-dose PK of FE 999301: Baseline adjusted maximum observed concentration; also referred to as maximum exposure (Cmax) measure: Multiple-dose PK of FE 999301: Time of maximum observed concentration (tmax) measure: Multiple-dose PK of FE 999301: Terminal half-life (t½) measure: Multiple-dose PK of FE 999301: Mean residence time (MRT) measure: Multiple-dose PK of FE 999301: Total clearance (CL) measure: Multiple-dose PK of FE 999301: Apparent volume of distribution at steady-state (Vss) measure: Presence of anti-FE 999301 antibodies on Days 1, 15, and 57 after multiple dose infusions sex: MALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Ferring Investigational Site status: RECRUITING city: Berlin country: Germany lat: 52.52437 lon: 13.41053 hasResults: False
<\|newrecord\|> nctId: NCT06298019 id: 73464 briefTitle: Study of KYV-101 Anti-CD19 CAR T Therapy in Adult Dermatomyositis overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2027-04 date: 2039-04 date: 2024-03-07 date: 2024-03-07 name: Stanford University class: OTHER briefSummary: The goal of this clinical trial is to characterize to understand the effects of a type of cell therapy called Chimeric Antigen Receptor T lymphocyte (CAR T) therapy in adult patients with the autoimmune disease dermatomyositis. This study will utilize a technology that modifies a type of white blood cell called the cytotoxic T lymphocyte-this T cell normally functions in the immune system to kill infected or potentially harmful cells in the body. In CAR T therapy, the patients' white blood cells are harvested and the cytotoxic T cells are isolated and modified such that they are programmed to kill any cell that has a protein structure called "CD19" on its outer surface (membrane). Since the CD19 protein is only present on a type of white blood cell called the B lymphocyte, when these "re-engineered" cytotoxic T lymphocytes are then given back to the patient (by an infusion), these cells will seek out and kill essentially all of the patient's B cells. B cells are an important part of a person's immune system and have many functions, including the production of antibodies. It is thought that, in dermatomyositis and other autoimmune diseases, a tiny subset of these B cells plays a large role in making autoantibodies (antibodies directed against the patient's own tissues) and causing disease. The idea is that the therapy will "wipe out" all/most of the B cells in the patient so that they can make an entirely new set of B cells to recreate a functional immune system without the autoimmune disease.
The main questions the study intends to answer are:
* Understanding how well patients tolerate undergoing this therapy in terms of side effects;
* Getting an early idea if this therapy can help certain aspects of the autoimmune disease, including inflammation in the skin, muscles, and lungs; conditions: Dermatomyositis studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SEQUENTIAL interventionModelDescription: Patients will be enrolled in a sequential manner with respect to the aggressiveness of the conditioning regimen used prior to receiving the CAR T infusion therapy. The first 3 patients will undergo standard conditioning--daily cyclophosphamide (IV, 300 mg/m2) and fludarabine (30 mg/m2) x 3 days. If this regimen is found to allow sufficient engraftment of the CAR T cells, participants will be enrolled in sequential groups (of 3-5) representing milder doses or alternative medications that overall represent gentler cytoreduction, which advancement to each sequential group contingent upon satisfactory number and function of infused CAR T cells. primaryPurpose: TREATMENT masking: NONE count: 21 type: ESTIMATED name: KYV-101 measure: Number of participants experiencing adverse events sex: ALL minimumAge: 25 Years maximumAge: 72 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Stanford University city: Stanford state: California zip: 94305 country: United States lat: 37.42411 lon: -122.16608 hasResults: False
<\|newrecord\|> nctId: NCT06298006 id: 275025 briefTitle: A Two Year Longitudinal Clinical Study of Neurocognitive and Psychiatric Symptoms in Post COVID-19 Patients acronym: PASC24 overallStatus: RECRUITING date: 2022-02-22 date: 2026-12-31 date: 2027-06-30 date: 2024-03-07 date: 2024-03-07 name: Region Örebro County class: OTHER name: Örebro University, Sweden name: Karolinska Institutet name: Karolinska University Hospital name: Sahlgrenska University Hospital, Sweden briefSummary: The prospective, longitudinal, open observational study monitors patients with cognitive and neuropsychological symptoms after COVID-19 infection, in a longitudinal manner to see how the disease has affected their physical, psychological and cognitive function, their ability to be active, return to work, their health-related quality of life in correlation with potential diagnostic and prognostic markers. conditions: COVID-19 studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Follow-up measure: Change in cognitive functions measured with Mindmore and change in cognitive profile in Mindmore. measure: Symptom improvement in depression measure: Self-reported symptom improvement in depression measure: Grade of self-reported mental fatigue measure: Rate of self-reported symptoms suggestive of post-traumatic stress disorder (PTSD) measure: Grade of self-reported stress measure: Grade of self-reported cognitive failures in everyday life measure: Occurence of activity limitations and changes in health-related quality of life (QoL) measure: Grade of work incapacity/sick leave and time to return to work measure: Changes in body size measure: Waist size measure: Rate of peak expiratory flow (PEF) measure: Grade of physical exercise capacity measure: Concetration of Beta-Amyloid 42 in cerebrospinal fluid (CSF) as a CSF biomarker of neurodegeneration. measure: Beta Amyloid Ratio 42/40 in cerebrospinal fluid (CSF) as a CSF biomarker of neurodegeneration linked to Alzheimer's disease measure: Concentration of neurogranin in cerebrospinal fluid (CSF) as a CSF biomarker of neurodegeneration linked to Alzheimer's disease measure: Concentration of Tau (P-Tau) protein in cerebrospinal fluid (CSF) as a CSF biomarker of cortikal damage/neurodegeneration measure: Concentration of phosphorylated Tau (P-Tau) in cerebrospinal fluid (CSF) as a CSF biomarker of neurodegeneration/taupathy measure: Concentration of neurofilament light (NFL) in cerebrospinal fluid (CSF) as a CSF biomarker of neurodegeneration measure: Concentration of neurofilament light (NFL) in plasma as a blood biomarker of neurodegeneration measure: Occurence of APOE4 allele as biomarker of genetic predisposition to Alzheimer's disease and susceptibility to more severe course of COVID-19 infection measure: Brain volumes and signal abnormalities in white and gray matter measure: Changes in functional and structural brain connectivity measure: Changes in gut microbiome sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Geriatrics, University Hospital Örebro status: RECRUITING city: Örebro country: Sweden name: Yvonne Freund-Levi, MD, PhD role: CONTACT phone: +46 736841130 email: yvonne.freund@oru.se name: Zbigniew Dzialanski, MD role: SUB_INVESTIGATOR lat: 59.27412 lon: 15.2066 hasResults: False
<\|newrecord\|> nctId: NCT06297993 id: WIND-PSC-01 briefTitle: Adult Patients With Primary Sclerosing Cholangitis acronym: WIND-PSC overallStatus: RECRUITING date: 2024-04 date: 2029-01 date: 2031-01 date: 2024-03-07 date: 2024-04-09 name: Arbor Research Collaborative for Health class: OTHER briefSummary: Develop an appropriate real-world data comparator cohort to support the design, execution, and serve as an external control for interventional clinical trials in PSC. conditions: PSC studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 2000 type: ESTIMATED measure: Develop interventional clinical trial external control using clinical and biomarker data. measure: Identify alternative endpoints to predict clinical benefit using large clinical and biomarker data. measure: Changes in patient reported outcomes over time as assessed by Patient Reported Outcomes surveys. sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Schiff Center for Liver Diseases / University of Miami status: RECRUITING city: Miami state: Florida zip: 33136 country: United States name: Cynthia Levy, MD role: CONTACT phone: 306-243-4615 email: clevy@med.miami.edu name: Cynthia Levy, MD role: PRINCIPAL_INVESTIGATOR lat: 25.77427 lon: -80.19366 hasResults: False
<\|newrecord\|> nctId: NCT06297980 id: 23-1513 briefTitle: Impact of MEnstruation on Glycemic Response and Exercise In Females With Type 1 Diabetes acronym: MERIT overallStatus: RECRUITING date: 2024-03-15 date: 2026-10-31 date: 2026-10-31 date: 2024-03-07 date: 2024-03-07 name: University of Colorado, Denver class: OTHER name: The Leona M. and Harry B. Helmsley Charitable Trust briefSummary: The objectives of this study are to examine how sex hormones (use of hormonal birth control, menstrual cycle phase) impact glycemic control among women with type 1 diabetes (T1D), and to test adjustments to insulin dosing and food intake to ameliorate cycle-related glycemic variability. A secondary aim is to examine how the menstrual cycle and use of hormonal birth control impact patient-reported outcomes and glycemic responses to physical activity. conditions: Type 1 Diabetes conditions: Hypoglycemia conditions: Hyperglycaemia Due to Type 1 Diabetes Mellitus conditions: Menstruation Disturbances studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This will be a parallel group randomized control trial of a personalized glucose control intervention to target changes in glycemic control related to the menstrual cycle that are identified during a 3 month observational period. primaryPurpose: TREATMENT masking: NONE count: 150 type: ESTIMATED name: Personalized modifications to treatment to address menstrual cycle effects on glycemia measure: Glucose time in range measure: Glucose standard deviation measure: Mean glucose (mg/dL) pre-exercise measure: Mean glucose (mg/dL) while exercising measure: Mean glucose (mg/dL) over 24 hours after exercise measure: Glucose standard deviation measure: Glucose standard deviation sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: University of Colorado status: RECRUITING city: Aurora state: Colorado zip: 80045 country: United States name: JANET K SNELL-BERGEON, PhD role: CONTACT phone: 303-724-6762 email: Janet.Snell-Bergeon@cuanschutz.edu name: Catherine Chartier-Logan, MPH role: CONTACT phone: 3037247505 email: Catherine.Chartier-Logan@cuanschutz.edu name: Sarit Polsky, MD role: SUB_INVESTIGATOR name: Cristy Geno, PhD role: SUB_INVESTIGATOR name: Bryan Bergman, PhD role: SUB_INVESTIGATOR name: Laura Pyle, PhD role: SUB_INVESTIGATOR lat: 39.72943 lon: -104.83192 hasResults: False
<\|newrecord\|> nctId: NCT06297967 id: CSAPG-33 briefTitle: Acetic Acid 2% Solution for Skin Ulcers acronym: ECA-AA overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-04 date: 2026-06 date: 2024-03-07 date: 2024-03-12 name: Consorci Sanitari de l'Alt Penedès i Garraf class: OTHER briefSummary: The objective of this clinical trial is to assess the effectiveness of acetic acid in patients suffering from chronic cutaneous ulcers with biofilm. The primary question it seeks to address is whether acetic acid (as a 2% topical solution) is superior to the current standard treatment for chronic cutaneous ulcers with biofilm at our center (Prontosan®).
Participants will be randomly assigned to receive either the acetic acid solution treatment or the standard current treatment. conditions: Ulcer, Skin studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 104 type: ESTIMATED name: Acetic Acid name: Prontosan measure: Change in ulcer area compared to baseline (percentage) at 8 weeks of treatment measure: Percentage of participants with ulcer healing at 4 weeks from the start of treatment. measure: Percentage of participants with ulcer healing at 12 weeks from the start of treatment. measure: Time (days) to ulcer healing from the start of treatment. measure: Changes in the wound bed at 8 weeks according to score of section 6 of the RESVECH2.0 ("Expected Results of the Assessment and Evaluation of Healing of Chronic Wounds" scale. measure: Number of adverse reactions associated with the treatment, collected from the medical record. measure: The healthcare expenditure associated with each branch of the study sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Consorci Sanitari Alt'Pènedes i Garraf city: Barcelona state: Cataluña zip: 08810 country: Spain name: Marta De Vicente role: CONTACT phone: +34 938931616 email: mdevicente@csapg.cat name: Noemí Casaponsa role: CONTACT phone: +34 938960025 phoneExt: 43197 email: recerca@csapg.cat name: Marta De Vicente role: PRINCIPAL_INVESTIGATOR lat: 41.38879 lon: 2.15899 hasResults: False
<\|newrecord\|> nctId: NCT06297954 id: GA22-00011 briefTitle: Usefulness of Metoclopramide to Improve Endoscopic Visualization in Upper Gastrointestinal Bleeding overallStatus: RECRUITING date: 2023-03-16 date: 2024-06 date: 2024-06 date: 2024-03-07 date: 2024-03-07 name: Universidad Autonoma de Nuevo Leon class: OTHER briefSummary: A prospective, randomized, double-blind study will be conducted, including all patients with upper gastrointestinal bleeding, defined as vomiting blood or black bowel movements, within 12 hours prior to admission. Patients will be randomized to receive intravenous metoclopramide 20 mg or placebo, a placebo is a look-alike substance that contains no active drug. Then endoscopy will be performed in the following 120 minutes, evaluating endoscopic visualization with the modified Avgerinos scale. conditions: Upper Gastrointestinal Bleeding studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Patients will be randomized to receive metoclopramide 20 mg IV or placebo, this randomization will be performed by means of a computer sequence to receive each of the treatment sequences. The sequence of treatment (metoclopramide) and placebo in which they will be distributed to patients will be determined using randomization software. A folio number will be assigned and depending on the sequence the treatment or placebo will be administered. Subsequently, the upper endoscopy will be performed in the following 120 minutes, and the endoscopic visualization will be evaluated by the physician performing the procedure by means of the modified Avgerinos scale primaryPurpose: DIAGNOSTIC masking: DOUBLE maskingDescription: As it is double-blind, both physician and patient will not know the treatment they are receiving and it will only be revealed later at the end of the protocol. Following the previous folios, both the treatment and the placebo will be distributed in boxes by default by the research staff, delivering them to the personnel who will apply the drug or placebo, indicating the doses and frequencies of these when administered. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 50 type: ESTIMATED name: Metoclopramide name: Placebo measure: To determine the usefulness of metoclopramide in improving endoscopic visualisation in patients with upper gastrointestinal bleeding. measure: To determine whether the use of metoclopramide avoids repeating the endoscopic procedure. measure: To determine whether the use of metoclopramide shortens the length of hospital stay. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital Universitario Dr. José Eleuterio González, UANL status: RECRUITING city: Monterrey state: Nuevo León zip: 64460 country: Mexico name: José Luis Herrera Elizondo, Physician role: CONTACT phone: +528180182968 email: here_herrera_11@hotmail.com name: José Alberto González González, Physician role: CONTACT phone: +528183668061 email: jalbertogastro@gmail.com lat: 25.67507 lon: -100.31847 hasResults: False
<\|newrecord\|> nctId: NCT06297941 id: REM-422-102 briefTitle: Study of REM-422 in Patients With AML or Higher Risk MDS overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2026-03-15 date: 2027-06-15 date: 2024-03-07 date: 2024-04-23 name: Remix Therapeutics class: INDUSTRY briefSummary: The goal of this study is to determine the safety and antitumor effects of REM-422, a MYB mRNA degrader, in people with Higher Risk MDS and relapsed/refractory AML conditions: Myelodysplastic Syndromes conditions: Higher Risk Myelodysplastic Syndromes conditions: Acute Myeloid Leukemia conditions: Acute Myeloid Leukemia Refractory studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: REM-422 measure: Frequency and severity of Treatment Emergent Adverse Events (TEAEs) measure: Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) measure: AML: Rate of Complete Response (remission) (CR) measure: AML: Rate of CR with partial hematologic recovery (CRh) measure: AML: Duration of CR measure: AML: Duration of CRh measure: AML: Overall response rate (ORR) (CR + CRh + CRi + PR) with incomplete hematologic recovery [CRi] + partial response [PR]) per modified IWG response criteria 2003 based on Investigator assessment measure: AML: Duration of response (DOR) measure: MDS: Rate of Compete Response (CR) measure: MDS: Duration of Complete Response (CR) measure: MDS: Overall Response Rate (ORR) measure: MDS: Duration of Response (DOR) measure: Determine pharmacokinetic profile (Cmax) of REM-422 measure: Determine pharmacokinetic profile (Cmin) of REM-422 measure: Determine pharmacokinetic profile (Tmax) of REM-422 measure: Determine pharmacokinetic profile (AUC) of REM-422 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: City of Hope city: Duarte state: California zip: 91010 country: United States name: Anthony S Stein, MD role: PRINCIPAL_INVESTIGATOR lat: 34.13945 lon: -117.97729 facility: Memorial Sloan Kettering city: New York state: New York zip: 10065 country: United States name: Eytan M Stein, MD role: PRINCIPAL_INVESTIGATOR lat: 40.71427 lon: -74.00597 facility: MD Anderson Cancer Center city: Houston state: Texas zip: 77030 country: United States name: Courtney D DiNardo, MD role: PRINCIPAL_INVESTIGATOR lat: 29.76328 lon: -95.36327 hasResults: False
<\|newrecord\|> nctId: NCT06297928 id: 2023/11238/I briefTitle: Metabolomics and Bariatric Surgery in Patients With Metabolically Unhealthy Obesity overallStatus: RECRUITING date: 2024-01-01 date: 2025-06-01 date: 2026-12-31 date: 2024-03-07 date: 2024-03-07 name: Parc de Salut Mar class: OTHER briefSummary: The goal of this observational study is to investigate metabolic changes in individuals undergoing bariatric surgery, specifically focusing on those with obesity and varying metabolic health statuses. The main questions it aims to answer are:
* Can metabolic markers predict the transition from metabolically unhealthy obesity to metabolically healthy obesity after bariatric surgery?
* How do metabolic profiles change in individuals with metabolically healthy obesity after bariatric surgery?
* What are the metabolic differences between individuals with metabolically healthy and unhealthy obesity before and after bariatric surgery?
Participants will undergo routine evaluations and blood tests before and after bariatric surgery. These tests will include assessments of metabolic health markers and sampling of blood plasma for metabolomic analysis. The study will study changes in metabolic profiles between individuals who transition to metabolically healthy obesity and those who remain metabolically unhealthy after surgery. conditions: Bariatric Surgery Candidate conditions: Obesity, Morbid conditions: Obesity, Metabolically Benign studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 145 type: ESTIMATED name: baratric surgery measure: Identification of Metabolic Signatures Using Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) Analysis Predicting Transition from Metabolically Unhealthy Obesity (MUO) to Metabolically Healthy Obesity (MHO) Status measure: Comparison of Metabolomic Changes Using Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) between Patients with Persistent Metabolically Unhealthy Obesity (MUO) and Those Transitioning to Metabolically Healthy Obesity (MHO) Status measure: Comparison of Baseline Metabolomic Profile and Its Evolution Using Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) after Surgery between Patients with Metabolically Healthy Obesity (MHO) and Metabolically Unhealthy Obesity (MUO) sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Hospital del Mar status: RECRUITING city: Barcelona zip: 08003 country: Spain name: David Benaiges Boix, PhD role: CONTACT phone: 0034932483902 email: dbenaiges@psmar.cat name: David Benaiges, PhD role: PRINCIPAL_INVESTIGATOR name: Joan Pedro-Botet, PhD role: SUB_INVESTIGATOR name: Albert Goday, PhD role: SUB_INVESTIGATOR name: Carme Serra role: SUB_INVESTIGATOR name: Elisenda Climent, PhD role: SUB_INVESTIGATOR name: Helena Julià, PhD role: SUB_INVESTIGATOR name: Miguel Olano, MD role: SUB_INVESTIGATOR name: Oscar Pozo, PhD role: SUB_INVESTIGATOR lat: 41.38879 lon: 2.15899 hasResults: False

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