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Several studies have shown the possibility of identifying the tissue origin of DNA circulating in the blood, in healthy subjects, on the basis of the epigenetic properties of circulating DNA. In addition, in kidney transplant subjects, an increase in the quantity of circulating DNA originating from the graft in the blood and urine has been shown as well as an increase in urinary chemokine levels during renal dysfunction (notably dismiss). Thus, the company CGenetix in partnership with INSERM units 1155 and 1151 is developing a method to identify and characterize kidney transplant rejection early, through the detection of epigenetic biomarkers on circulating DNA targeting different fractions of the kidney (glomerular, tubular, peritubular capillary and vascular). The main objective is to study the diagnostic performance of the quantity of DNA of renal origin in kidney transplant patients in the blood and in the urine (expressed in copies/ml) for the diagnosis of type Rejection mediated by kidneys. antibody (ABMR) established by kidney graft biopsy (gold standard) and according to the Banff 2022 classification. conditions: Kidney Transplant Patients Eligible for a Solid Biopsy studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 319 type: ESTIMATED measure: The area under the ROC curve of ABMR rejection prediction models according to kidney biopsy and with renal circulating DNA quantities as variables of interest measure: The area under the ROC curve of TCMR rejection prediction models according to kidney biopsy and with renal circulating DNA quantities as variables of interest measure: The area under the ROC curve of mixed rejection prediction models according to kidney biopsy and with renal circulating DNA quantities as variables of interest measure: The area under the ROC curve of glomerulitis-type rejection prediction models (≥g1) according to kidney biopsy and with renal circulating DNA quantities as variables of interest measure: The area under the ROC curve of tubulitis-type rejection prediction models (≥t1) according to kidney biopsy and with renal circulating DNA quantities as variables of interest measure: The area under the ROC curve of vascularitis-type rejection prediction models (≥v1) according to kidney biopsy and with renal circulating DNA quantities as variables of interest measure: The area under the ROC curve of capillaritis-type rejection prediction models (≥ptc1) according to kidney biopsy and with renal circulating DNA quantities as variables of interest measure: Areas under the ROC curve of rejection prediction models according to renal biopsy and with as covariates of interest the quantities of urinary chemokines (CXCL9 and CXCL10) determined by ELISA and expressed in pg/mL in urine sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06351475 id: APHP230864 briefTitle: Efficacy of Intraoperative Use of 20% Albumin Combined With Ringer Lactate Versus Ringer Lactate During Cytoreductive Surgery With Hyperthermic Intraperitoneal Chemotherapy acronym: ALBUCHIP overallStatus: NOT_YET_RECRUITING date: 2024-09 date: 2026-10 date: 2026-10 date: 2024-04-08 date: 2024-04-23 name: Assistance Publique - Hôpitaux de Paris class: OTHER briefSummary: Introduction Cytoreductive surgery (CRS) with hyperthermic intraperitoneal chemotherapy (HIPEC) is considered as the standard of care for the treatment of peritoneal metastases. Cytoreductive surgery with HIPEC is characterized by large intra operative fluid shift secondary to surgical resection, peritoneal inflammation and capillary shifts, requesting high volume of intra operative fluid therapy. Previous studies found a strong association between intra operative hypovolemia or volume overload with post operative outcomes. Albumin as an intravenous fluid has been widely studied in critical ill patients, but evaluation of its efficacy during major surgery on post operative clinical outcomes are lacking. We hypothesize that a reduction of intra operative crystalloid volume infusion by using 20% albumin during CRS with HIPEC could improve patients' prognosis. The aim of this study will be to assess the efficacy of 20% albumin combined with Ringer Lactate versus Ringer Lactate for fluid therapy during CRS with HIPEC on post operative outcome at 28 day.
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Methods and analysis The study protocol has been designed and written in accordance with the Prospective randomised, comparative, controlled, prospective, open-label, with parallel group and multicentre clinical trial.
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Recruitment, randomisation and allocation Information on the study and screening of patients will be conducted during the consultation of anaesthesia (= selection visit), 2 months at 3 days before the surgery. Information notice and consent form will be delivered. The day before the surgery, anaesthesiologist who will conduct the pre anaesthetic visit will be able to include patients in the study (=inclusion visit). Randomisation will be done at the inclusion visit after information and signature of consent form of voluntary patients. A randomization number will be assigned. The 1:1 randomisation will be centralized via an online interface ensuring secret group assignment, and based on predefined randomisation lists with variable-size permutation blocks, stratified by center. Randomisation will be accomplished using a computer-generated random sequence.
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Randomized Open, Blinded endpoint (PROBE) design. This study is a randomised, comparative, controlled, prospective, open-label, with parallel group and multicentre clinical trial.
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Intervention
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* 20% Albumin + Ringer Lactate group (intervention group) Per-operative fluid therapy consisting in Ringer Lactate combined with 20% albumin. Patients will receive a bolus of 3 mL/kg on one hour of 20% albumin from anaesthetic induction. Then, infusion of 20% albumin (100 mL, 20g) will be administered for each 1200 mL of vascular filling by Ringer Lactate. Dosage of intra operative albuminemia will be realized 2 hours after the end of the bolus or infusion to ensure albuminemia is within the target concentrations (35-45 g/L). Use of 20% albumin will be realized for the entire duration of the surgery and stopped at the end of the surgery.
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* Control group Ringer Lactate for intra operative fluid management based on the latest scientific recommendations. As the the study is an open labelled randomized clinical trial, placebo use is not planned.
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Outcome measures The primary outcome will be the Comprehensive Complication Index (CCI score) at day 28 after CRS with HIPEC. Secondary outcomes are mortality at day 28, CCI score at day 7, volume of intra operative and post operative (48h) post operative fluid therapy, cumulated incidence of surgical post operative complications, cumulated incidence of medical post operative complications, need for mechanical ventilation, renal replacement therapy between surgery and day 28, SOFA score variation between pre operative period and 48h after surgery, number of days alive out of intensive care unit and out of hospital until day 28
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Sample size calculation To ensure a power of 80%, a number of patients 130 (65 patients by group) will be necessary with a reduction of 13.6 (SD 24) points of the CCI score at day 28 in the intervention group. Because of a risk of neoplastic evolution between anaesthetic consultation and randomisation (10% of early cancellation), a total of 146 patients (73 by group) will be included in the study.
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Discussion In summary, ALBUCHIP study will be the first randomized clinical trial assessing efficacy of intraoperative use of 20% albumin combined with Ringer Lactate versus Ringer Lactate during CRS with HIPEC. Results yielded from this study will be helpful for vascular filling during CRS with HIPEC but, thanks to ancillary studies, to improve pathophysiological understanding of this surgery. conditions: Peritoneal Neoplasms conditions: Hyperthermic Intraperitoneal Chemotherapy conditions: Intraoperative Care conditions: Fluid Therapy conditions: Postoperative Complications studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 146 type: ESTIMATED name: Intra-operative albumin administration name: Control measure: Comprehensive Complication Index score measure: Mortality measure: Comprehensive Complication Index score measure: Volume of intra operative and post operative fluid therapy measure: Cumulative incidence of surgical post operative complications measure: Cumulative incidence of medical post operative complications measure: Need for mechanical ventilation measure: Need for renal replacement therapy measure: Sequential organ failure assessment (SOFA) score variation measure: Number of days alive out of intensive care unit measure: Number of days alive out of hospital sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06351462 id: APHP200008 briefTitle: Comparative Health Status and Quality of Life of Patients With Sickle Cell Disease (SCD) Who Underwent Matched-sibling Hematopoietic Stem Cell Transplantation Versus Non Transplanted SCD Case-control Patients acronym: TRANSPLANTORN2 overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2027-05-01 date: 2027-05-01 date: 2024-04-08 date: 2024-04-19 name: Assistance Publique - Hôpitaux de Paris class: OTHER briefSummary: The long term burden of morbidity and mortality in the natural history of sickle cell disease has not been compared up to date to the risks and mortality of a curative option like bone marrow transplantation in severe sickle-cell disease patients. Given this lack of data, primary-care Sickle Cell Disease (SCD) physicians and transplant physicians are prevented from a factual debate over the benefit/risk ratio for each patient and refining indications of transplant in patients. Therefore, the present study seeks to describe and compare the very long-term outcomes after either Human Leukocyte Antigen (HLA) -matched sibling transplantation (study arm) and "non-transplant care" for severe sickle cell disease SCA patients in order to yield robust comparative data regarding both arms.
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The main objective is to assess the benefit of Hematopoietic stem cell transplantation (HSCT) regarding quality of life compared to standard care after 10 years, in patients with severe Sickle Cell Disease (SCD). conditions: Sickle Cell Disease studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 220 type: ESTIMATED name: Spermogram name: Hospital Anxiety and Depression Scale (HADS) name: SF36 Quality of life questionnaire name: Psychologist interview name: Optional sera banking name: Optional DNA banking measure: Evaluation of quality of life assessed by SF36 measure: Evaluation of gonadal function measure: Evaluation of quality of life measure: Proportion of patients with anxiety and depression sex: ALL minimumAge: 15 Years maximumAge: 80 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06351449 id: 69HCL22_0489 briefTitle: Characterization of Visual Characteristics in Allergic Contact Dermatitis Using the Skincam® Tool acronym: PatchCam overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2027-04-15 date: 2027-04-30 date: 2024-04-08 date: 2024-04-08 name: Hospices Civils de Lyon class: OTHER briefSummary: Contact dermatitis (CD) is a common inflammatory skin disease, affecting approximately 15-20% of the general population in industrialized countries and ranking first among occupational diseases in many European countries.
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The patch test method aims at reproducing the eczematous lesions by applying occlusive patches containing the suspected allergens to the patient's healthy skin. It requires experienced medical staff to read the reaction.
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Newtones Technologies society has developed a new tool, the SkinCam®, able to capture high resolution cross and parallel images, allowing a quantification of color and relief of skin.
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This study aims to illustrate patch test results, describing skin appearance (color, roughness, shine), using photographs taken by the SkinCam®. conditions: Allergic Contact Dermatitis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 500 type: ESTIMATED name: The patch under study is photographed using the SkinCam® measure: To highlight characteristics of allergic contact dermatitis (ACD) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06351436 id: TBC20240402 briefTitle: Virtual Reality Cave Experience With Mindfulness for Mental Wellbeing overallStatus: NOT_YET_RECRUITING date: 2024-08 date: 2025-08 date: 2025-08 date: 2024-04-08 date: 2024-04-08 name: The Hong Kong Polytechnic University class: OTHER briefSummary: The aim of this study is to investigate the effectiveness of a mindfulness-based intervention using a virtual reality cave system for promoting mental wellbeing in youths. The mindfulness-based intervention will last for three months, with 6-8 weekly sessions lasting 1.5 hours each. Participants will attend the sessions in a group format, and the sessions will be administered by registered social worker who are specialized in counselling. The intervention content is designed by a registered clinical psychologist accredited for delivering mindfulness-based intervention and nurses who are experienced in mindfulness training.
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A single-group pre-post uncontrolled design will be employed. Evaluations will be conducted at baseline (0 weeks) and post-intervention (3 months). conditions: Anxiety studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Single-group non-randomized uncontrolled trial primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 20 type: ESTIMATED name: Mindfulness measure: Mental Well-Being in Youths measure: Stress Level in Youths measure: Feasibility of Eligibility and Enrollment measure: Feasibility of Attendance Rate measure: Feasibility of Retention Rate sex: ALL minimumAge: 11 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06351423 id: HE-NHS2023/03 briefTitle: The Effectiveness of MIND Diet and Forest Bathing on Stress Reduction overallStatus: NOT_YET_RECRUITING date: 2024-04-29 date: 2024-08-31 date: 2024-11-30 date: 2024-04-08 date: 2024-04-23 name: Hong Kong Metropolitan University class: OTHER briefSummary: This clinical trial aims to explore the effectiveness of the Mediterranean DASH Intervention for Neurodegenerative Delay (MIND) diet and Forest Bathing (FB) in reducing psychological stress among older Chinese individuals. The main questions it aims to answer are:
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1. what is the effect of FB on stress reduction
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2. what is the effect of MIND on stress reduction
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Participants of the MIND-FB group will participate will receive
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1. FB: a two-hour FB session on four consecutive weekends in a country park,
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2. MIND: four nutrition sessions, and adhere to the MIND diet for 12 weeks
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Researchers will compare the FB and routine care groups to compare the effectiveness of MIND and FB in reducing psychological stress. conditions: Anxiety conditions: Depression conditions: Stress conditions: Psychological Stress studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: a 3-arm randomized controlled study in a parallel design. Eligible participants will be randomly assigned into 3 interventions: (1) FB-MIND, (2) FB and (3) routine care-control. primaryPurpose: PREVENTION masking: NONE count: 30 type: ESTIMATED name: Forest Bathing (FB) name: MIND diet measure: Emotional states measure: Systolic Blood Pressure (SBP) measure: Salivary Cortisol sex: ALL minimumAge: 50 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hong Kong Metropolitan University city: Hong Kong country: Hong Kong name: Fabian Ling Ngai Tung, PhD role: CONTACT phone: 85239708732 email: [email protected] name: Fabian Ling Ngai Tung, PhD role: PRINCIPAL_INVESTIGATOR name: Queenie Pui Sze Law, PhD role: SUB_INVESTIGATOR name: Katherine Ka Yin Yau, DHsC role: SUB_INVESTIGATOR name: Sam Kit San Yuen role: SUB_INVESTIGATOR name: Eric Tsz Fai Chan role: SUB_INVESTIGATOR lat: 22.27832 lon: 114.17469 hasResults: False
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<|newrecord|> nctId: NCT06351410 id: JEP 2023-679 briefTitle: Assessment of Tear Production, Corneal Staining, and Comfort Level Wearing Different Types of Contact Lenses overallStatus: NOT_YET_RECRUITING date: 2024-05-02 date: 2024-07-30 date: 2025-02-28 date: 2024-04-08 date: 2024-04-19 name: National University of Malaysia class: OTHER briefSummary: This research assesses the tear performance of five distinct types of soft contact lenses commonly found in the market. The study involves contact lens participants, all of whom are students enrolled at UKM. Before the study, participants were instructed to discontinue wearing their usual contact lenses for two weeks. The lenses utilized in this clinical trial all possess current refractive power. Participants are required to wear the lenses for an entire day only. Upon completion of the study, participants will be requested to complete a brief questionnaire. conditions: Dry Eye conditions: Dry Eye Syndromes conditions: Contact Lens-induced Corneal Fluorescein Staining studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: 18 participants will be fitted with 2 types of lenses on either eye at one time. There will be a 2-week wash-off period before another 2 set of fittings with another 4 types of lenses. primaryPurpose: DIAGNOSTIC masking: NONE maskingDescription: The 6 types of Contact Lenses used will be labeled as A, B, C, D, E, and F by a co-investigator and will be fitted on the participant's eye randomly. count: 18 type: ESTIMATED name: Eye Wearing Contact Lens measure: To assess the quantity of tears in eyes wearing contact lenses measure: To asess the quality of tears in eyes wearing contact lenses measure: To assess corneal staining in eyes wearing contact lenses measure: To assess comfort level of participants using CL Discomfort Index Questionaire sex: ALL minimumAge: 19 Years maximumAge: 29 Years stdAges: ADULT facility: Optometry Clinic city: Kuala Lumpur zip: 50300 country: Malaysia lat: 3.1412 lon: 101.68653 typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2024-04-02 uploadDate: 2024-04-01T23:49 filename: Prot_000.pdf size: 837117 hasResults: False
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<|newrecord|> nctId: NCT06351397 id: 75021 briefTitle: Immersive Mixed Reality Simulation to Evoke Empathy acronym: Empathy overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2025-06-30 date: 2025-06-30 date: 2024-04-08 date: 2024-04-12 name: Stanford University class: OTHER briefSummary: This is a quantifiable study evaluating the ability of a mixed reality (MR), immersive simulation experience to evoke empathy in anesthesiology trainees. Quantitative methodologies will be employed using standardized questionnaires including the The Jefferson Scale of Physician Empathy for Health Professions Students, (HP-version). Trainees will assess their preliminary, baseline empathy using the Jefferson Scale and after the simulation and debrief, will reassess empathy scores, once again using the Jefferson Scale. A satisfaction survey to assess simulated patient embodiment as a valuable exercise and contributor to empathy education curriculum. conditions: Educational Problems studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 250 type: ESTIMATED name: Mixed Reality (MR) measure: Changes in self-reported empathy from before and after the simulation measure: Satisfaction of Design Features of the Simulation measure: Evaluation of the CHARM system's usability measure: Evaluation of the CHARM system's ergonomics sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Lucile Packard Children's Hospital Stanford city: Palo Alto state: California zip: 94303 country: United States name: Astrid Suen, MMedSc role: CONTACT email: [email protected] name: Thomas Caruso, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 37.44188 lon: -122.14302 hasResults: False
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<|newrecord|> nctId: NCT06351384 id: 20230744 briefTitle: Early Detection and Risk Stratification of Colorectal Cancer Based on miRNA Platform overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-10-01 date: 2025-12-31 date: 2024-04-08 date: 2024-04-08 name: Sir Run Run Shaw Hospital class: OTHER briefSummary: This is a prospective, observational cohort study to establish the minimal residual disease (MRD) model for predicting relapse risk and identifying disease recurrence in patients with colorectal adenocarcinoma based on the miRNA platform.
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Blood miRNA markers will be evaluated. The study will enroll approximately 600 participants, including participants with malignancies or benign diseases, and healthy participants. conditions: Colorectal Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 600 type: ESTIMATED name: miRNA detection test measure: Correlation between post-surgery 1 month MRD status and recurrence-free survival (RFS) in colorectal patients sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06351371 id: NCI-2024-01153 id: NCI-2024-01153 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: EAY131-K2 type: OTHER domain: ECOG-ACRIN Cancer Research Group id: EAY131-K2 type: OTHER domain: CTEP id: U10CA180820 type: NIH link: https://reporter.nih.gov/quickSearch/U10CA180820 briefTitle: Testing JNJ-42756493 (Erdafitinib) as Potentially Targeting Treatment in Cancers With FGFR Mutations or Fusions (MATCH - Subprotocol K2) overallStatus: ACTIVE_NOT_RECRUITING date: 2018-06-19 date: 2024-06-30 date: 2024-06-30 date: 2024-04-08 date: 2024-04-08 name: National Cancer Institute (NCI) class: NIH briefSummary: This phase II MATCH treatment trial tests how well erdafitinib (JNJ-42756493) works in treating patients with tumors that have FGFR mutations or fusions. Erdafitinib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal FGFR protein that signals cancer cells to multiply. This may help keep cancer cells from growing and may kill them. conditions: Malignant Solid Neoplasm studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 35 type: ESTIMATED name: Biopsy name: Biospecimen Collection name: Computed Tomography name: Erdafitinib name: Magnetic Resonance Imaging measure: Objective response rate (ORR) measure: Overall survival (OS) measure: 6-month progression-free survival (PFS) rate measure: Progression free survival sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: ECOG-ACRIN Cancer Research Group city: Philadelphia state: Pennsylvania zip: 19103 country: United States lat: 39.95233 lon: -75.16379 hasResults: False
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<|newrecord|> nctId: NCT06351358 id: GLI.04.US.SL.036 briefTitle: Evaluation of the Effects of a Biostimulator and Dermal Fillers for Cheek Augmentation and Contour Deficiencies overallStatus: RECRUITING date: 2024-02-19 date: 2024-10-31 date: 2024-10-31 date: 2024-04-08 date: 2024-04-11 name: Galderma R&D class: INDUSTRY briefSummary: Adult subjects with a history of or currently taking glucagon-like peptide-1 (GLP-1) receptor agonist medication and moderate-to-severe cheek wrinkles and midface contour deficiencies will be treated with Sculptra correction of fine lines and wrinkles in the cheek area and Restylane Lyft or Restylane Contour for cheek augmentation and correction of midface contour deficiencies. conditions: Photoaging conditions: Weight Loss conditions: Skin Laxity conditions: Photodamaged Skin conditions: Volume Deficiency of the Midface studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: Sculptra treatment name: Restylane Treatment measure: Change in skin hydration from baseline measure: Change in skin radiance from baseline measure: Change in skin elasticity from baseline measure: Change in skin thickness from baseline measure: Subject Treatment Satisfaction sex: ALL minimumAge: 22 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Somenek + Pittman MD: Advanced Plastic Surgery status: ENROLLING_BY_INVITATION city: Washington state: District of Columbia zip: 20037 country: United States lat: 38.89511 lon: -77.03637 facility: Lorenc Aesthetic Plastic Surgery Center status: RECRUITING city: New York state: New York zip: 10028 country: United States name: Paul Lorenc, MD role: CONTACT phone: 212-472-2900 email: [email protected] name: Allison Bonugli role: CONTACT email: [email protected] name: Paul Z Lorenc, MD role: PRINCIPAL_INVESTIGATOR lat: 40.71427 lon: -74.00597 hasResults: False
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<|newrecord|> nctId: NCT06351345 id: Pro00115215 briefTitle: 129 Xenon Imaging in Patients Treated With Sotatercept acronym: Sox-PH overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-08-01 date: 2025-08-01 date: 2024-04-08 date: 2024-04-08 name: Bastiaan Driehuys class: OTHER name: Merck Sharp & Dohme LLC briefSummary: Determine the ability of 129Xe MRI/MRS biomarker signatures to non-invasively monitor pulmonary vascular reverse remodeling induced by sotatercept in pulmonary arterial hypertension (PAH). conditions: Pulmonary Hypertension conditions: Pulmonary Arterial Hypertension studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 14 type: ESTIMATED name: 129Xe Hyperpolarized measure: Change in Xenon MRI Red Blood Cell (RBC) percentage measure: Change in cardiogenic oscillation amplitudes sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Duke University Medical Center city: Durham state: North Carolina zip: 27710 country: United States lat: 35.99403 lon: -78.89862 hasResults: False
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<|newrecord|> nctId: NCT06351332 id: 24-005 briefTitle: A Phase I/II Single-arm Trial of Azenosertib (ZN-c3) Combined With Carboplatin and Pembrolizumab in Patients With Metastatic Triple-negative Breast Cancer (ZAP-IT) overallStatus: NOT_YET_RECRUITING date: 2024-09 date: 2027-03-01 date: 2029-09-01 date: 2024-04-08 date: 2024-04-08 name: Filipa Lynce, MD class: OTHER name: Merck Sharp & Dohme LLC name: Zentalis Pharmaceuticals briefSummary: This research is being done to evaluate the safety and effectiveness of a drug currently known as Azenosertib (ZN-C3) in combination with the drugs carboplatin and pembrolizumab in metastatic triple-negative breast cancer.
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The names of the study drugs involved in this study are:
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* Azenosertib (a type of WEE1 inhibitor)
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* Carboplatin (a type of platinum compound)
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* Pembrolizumab (a type of monoclonal antibody) conditions: Breast Cancer conditions: Breast Cancer Female conditions: Triple Negative Breast Cancer conditions: Hormone Receptor Negative Malignant Tumor Breast Triple conditions: HER2-negative Breast Cancer studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 78 type: ESTIMATED name: Azenosertib name: Carboplatin name: Pembrolizumab measure: Number of Participants Experiencing Dose Limiting Toxicity (DLT) measure: Maximum Tolerated Dose (MTD) measure: Objective Response Rate (ORR) measure: Clinical Beneficial Rate (CBR) measure: Median Progression Free Survival (PFS) measure: Median Overall Survival (OS) measure: Duration of Response (DOR) measure: Grade 3-5 Treatment-Related Toxicity Rate sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Dana-Farber Cancer Institute city: Boston state: Massachusetts zip: 02215 country: United States name: Filipa Lynce, MD role: CONTACT phone: 617-632-3800 email: [email protected] name: Filipa Lynce, MD role: PRINCIPAL_INVESTIGATOR lat: 42.35843 lon: -71.05977 hasResults: False
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<|newrecord|> nctId: NCT06351319 id: HenanPPH-zhangquncheng briefTitle: Endobronchial Ultrasound-based SVM Model for Differentiating Benign and Malignant Mediastinal and Hilar Lymph Nodes overallStatus: COMPLETED date: 2018-01-01 date: 2023-12-01 date: 2024-04-01 date: 2024-04-08 date: 2024-04-08 name: Quncheng Zhang class: OTHER briefSummary: ABSTRACT Background and objective: To establish a ultrasound radiomics machine learning model based on endobronchial ultrasound (EBUS)to assistdoctors in distinguishing between benign and malignant diagnoses ofmediastinal and hilar lymph nodes.
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Methods: The clinical and ultrasonic image data of 197 patients wereretrospectively analyzed. The radiomics features were extracted by EBUS.based radiomics and dimensionality reduction was performed on thesefeatures by the least absolute shrinkage and selection operator (LASSO)EBUS-based radiomics model was established by support vector machine(SVM).205 lesions were randomly divided into a training group (n=143)and a validation group (n=62). The diagnostic efficiency was evaluated byreceiver operating characteristic (ROC).Results: A total of 13 stable features with non-zero coefficients wereselected. The support vector machine (SV) model exhibited promisingperformance in both the training and verification groups. In the traininggroup, the SVM model achieved an area under the curve (AUC) of 0.892(95% CI: 0.885-0.899), with an accuracy of 85.3%, sensitivity of 93.2%and specificity of 79.8%.In the verification group, the SVM modeldemonstrated an AUC of 0.906 (95% C: 0.890-0.923),along with anaccuracy of 74.2%,sensitivity of 70.3%, and specificity of 74.1% Conclusion:EBUS-based radiomics model can be used to differentiatemediastinal and hilar benign and malignant lymph nodes. The SVM modeldemonstrates superiority and holds potential as a diagnostic tool in clinical practice conditions: Benign and Malignant Lymph Nodes studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: RETROSPECTIVE count: 197 type: ACTUAL name: SVM model measure: AUC measure: accuracy measure: sensitivity measure: specificity sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Respiratory and Critical Care Medicine city: Zhengzhou state: Henan zip: 450000 country: China lat: 34.75778 lon: 113.64861 hasResults: False
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<|newrecord|> nctId: NCT06351306 id: AAAU5915 briefTitle: DEC-C and Thioguanine for R/R AML overallStatus: RECRUITING date: 2024-01-30 date: 2027-12 date: 2027-12 date: 2024-04-08 date: 2024-04-08 name: Joseph Jurcic class: OTHER briefSummary: The purpose of this study is to find out if oral decitabine-cedazuridine (Inqovi®) is effective, safe, and able to be tolerated without severe side effects when given with thioguanine (Tabloid®) in patients with acute myeloid leukemia (AML) whose disease has returned or did not respond to treatment (relapsed or refractory).
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This is a "phase II trial with a safety lead-in." The goal of the lead-in portion of the study is to make sure participants are getting the highest dose of medications that are safe. If too many serious side effects are seen with the dose previously studied, some additional patients may be treated with a lower dose to make sure that this dose is safe. conditions: Acute Myeloid Leukemia studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 48 type: ESTIMATED name: Thioguanine (Tabloid ®) name: DecitabineCedazuridine (Inqovi ®) measure: Composite Complete Remission (CRc) Rate measure: Duration of Remission measure: Time to Complete Remission (CR) measure: Overall Survival (OS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Columbia University status: RECRUITING city: New York state: New York zip: 10032 country: United States name: Research Nurse Navigator role: CONTACT phone: 212-342-5162 email: [email protected] name: Joseph G. Jurcic, MD role: PRINCIPAL_INVESTIGATOR lat: 40.71427 lon: -74.00597 hasResults: False
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<|newrecord|> nctId: NCT06351293 id: GLI.04.US.SL.034 briefTitle: A Comparative Analysis of Two Hyaluronic Acid Fillers for Nasolabial Fold Correction overallStatus: ENROLLING_BY_INVITATION date: 2024-02-21 date: 2025-02-28 date: 2025-02-28 date: 2024-04-08 date: 2024-04-11 name: Galderma R&D class: INDUSTRY briefSummary: This is a randomized, split-face, subject-blinded, comparative study. Subjects will receive initial treatment with Defyne on one of the NLFs and with RHA3 on the other based on the pre-determined randomization.
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4 weeks after the initial treatment, subjects will receive optional touch-up on one side or both sides at the Investigator's discretion for optimal correction.
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Subjects to return to the site at Month 3, 6, and 12 for follow-ups. conditions: Wrinkle studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Subjects will be blinded to the treatment assignment, in which randomization and treatment side will be concealed in order to avoid bias in subjective assessment. The clinic staff will mask the product identity by covering the packaging and product name (e.g., using tape, marker, wipe-out, etc.) so that it is not visible to the subjects. The Investigator will not be blinded. whoMasked: PARTICIPANT count: 15 type: ESTIMATED name: Defyne Treatment in Nasolabial Fold name: RHA3 Treatment in Nasolabial Fold measure: Visual Comparison of Nasolabial Fold Ultrasounds measure: Volume Change Imaging Analysis sex: ALL minimumAge: 22 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Aesthetic Clinique city: Santa Rosa Beach state: Florida zip: 32459 country: United States lat: 30.39603 lon: -86.22883 hasResults: False
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<|newrecord|> nctId: NCT06351280 id: Sana Nasir Zaidi briefTitle: Evaluation of Performance-based Functional Outcome Measures After Open Abdominal Surgery overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-06 date: 2024-07 date: 2024-04-08 date: 2024-04-08 name: Riphah International University class: OTHER briefSummary: A laparotomy is a surgical technique, the increasing rate of this surgical interventions and the subsequent need to evaluate the post-surgical recovery and rehabilitation process comprehensively. This study aims to provide essential insights into the reliability, validity, and responsiveness of such tests, enabling healthcare professionals to make informed decisions about patient recovery progress and the optimization of rehabilitation protocols. conditions: Laparotomy studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 50 type: ESTIMATED name: Standardised Physiotherapy Plan measure: 6MWT (Six-Minute Walk Test) measure: 5 Times Sit to Stand measure: 2MWT (Two-Minute Walk Test) measure: Timed Up and GO (TUG) sex: ALL minimumAge: 20 Years maximumAge: 60 Years stdAges: ADULT facility: Fauji Foundation Hospital city: Rawalpindi state: Punjab zip: 00666 country: Pakistan name: Suman Sheraz, PhD* role: CONTACT phone: 03335646361 email: [email protected] name: Sana Nasir, MS-CPPT* role: SUB_INVESTIGATOR name: Suman Sheraz, PhD* role: PRINCIPAL_INVESTIGATOR lat: 33.6007 lon: 73.0679 hasResults: False
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<|newrecord|> nctId: NCT06351267 id: REC/RCR & AHS/23/0568 briefTitle: Combined Effects of Core Stability Exercises and Back Strengthening Exercises on Pregnancy-Induced Back Pain. overallStatus: NOT_YET_RECRUITING date: 2024-04-05 date: 2024-10-01 date: 2024-10-15 date: 2024-04-08 date: 2024-04-08 name: Riphah International University class: OTHER briefSummary: The study will be a Randomized controlled trial to check the combined effects of Core Stability Exercises with and without Back strengthening exercises in females with pregnancy-induced back pain, disability, and function so that we can examine the effect of the above techniques on pain, disability and function in pregnant females Non-probability convenience sampling technique will be used, subject following eligibility criteria from Society Hospital Nabipura Lahore will be randomly allocated in two groups. Group A participants will be given core stability exercises with back strengthening exercises, Group B participants will be given core stability exercises for 4 weeks. Assessment will be done via, Numeric Pain Rating Scale, Oswestry disability index questionnaire and Back pain Functional Scale. conditions: Low Back Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 34 type: ESTIMATED name: Core Stability Exercises name: Back Strengthening exercises measure: Numeric Pain Rating Scale measure: Oswestry Disability Index Questionnaire measure: Back Pain Functional Scale (BPFS): sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Society Hospital Nabipura city: Lahore state: Punjab zip: 54700 country: Pakistan name: Ghulam Fatima, PhD* role: CONTACT phone: +923034073057 email: [email protected] lat: 31.558 lon: 74.35071 hasResults: False
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<|newrecord|> nctId: NCT06351254 id: REC/RCR & AHS/23/01101nayab briefTitle: Kinesthetic Exercises and Sine Sound Waves in Cervical Spondylosis overallStatus: RECRUITING date: 2023-11-20 date: 2024-06-01 date: 2024-06-01 date: 2024-04-08 date: 2024-04-08 name: Riphah International University class: OTHER briefSummary: The goal of this Randomized control trial is to determine the Effect of kinesthetic exercises and sound waves on pain, ROM, shoulder alignment and disability in cervical spondylosis. The main question it aims to answer is:
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Weather sine sound and kinesthetic exercise are effective in management of pain, rom, alignment, and disability in patients that are suffering from cervical spondylosis conditions: Cervical Spondylosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 24 type: ESTIMATED name: Sine sound waves name: Kinesthetic exercises name: Sine sound waves plus kinesthetic exercises measure: NPRS measure: Inclinometer measure: Goniometer measure: NDI sex: ALL minimumAge: 45 Years maximumAge: 60 Years stdAges: ADULT facility: Riphah international university status: RECRUITING city: Lahore state: Punjab zip: 54000 country: Pakistan name: Muhammad Sanaullah role: CONTACT phone: 03224819253 email: [email protected] lat: 31.558 lon: 74.35071 hasResults: False
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<|newrecord|> nctId: NCT06351241 id: E.222840/280 briefTitle: Hemodynamic Effects of Steep Trendelenburg Position and Pneumoperitoneum overallStatus: COMPLETED date: 2022-11-29 date: 2023-04-14 date: 2023-04-14 date: 2024-04-08 date: 2024-04-08 name: Ege University class: OTHER briefSummary: BACKGROUND: The steep Trendelenburg position and pneumoperitoneum are used to improve surgical visibility in robot-assisted laparoscopic radical prostatectomy (RALRP). However, these procedures can lead to hemodynamic changes. This study aimed to investigate the effects of these interventions on the perfusion index (PI) and the Pleth variability index (PVI) in patients undergoing RALRP under general anesthesia.
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METHODS: Fifty-three patients scheduled for RALRP underwent standard monitoring; PI and PVI values were monitored using a finger probe. PI, PVI, hemodynamic and respiratory parameters, and intraabdominal pressure were recorded before and after anesthesia induction, after adopting the Trendelenburg position, after pneumoperitoneum, after pneumoperitoneum and the Trendelenburg position, at 15 min, 30 min, in the supine position, after carbon dioxide (CO2) desufflation, and after extubation. conditions: Perfusion Index conditions: Pleth Variability Index studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 53 type: ACTUAL measure: Hemodynamic effects of steep trendelenburg position and pneumoperitoneum in urologic robotic surgery sex: MALE minimumAge: 25 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Nursen Karaca city: Bornova state: İzmir zip: 35040 country: Turkey lat: 38.47921 lon: 27.2399 hasResults: False
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<|newrecord|> nctId: NCT06351228 id: 5720 briefTitle: Fertility-sparing in Early-stage Cervcial Cancer: The ETERNITY Project acronym: Eternity overallStatus: NOT_YET_RECRUITING date: 2024-03-30 date: 2024-12-31 date: 2024-12-31 date: 2024-04-08 date: 2024-04-08 name: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano class: OTHER briefSummary: The ETERNITY project is a retrospective analysis of outcomes of patients undergoing fertility-sparing treatment for cervcial cancer.
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The primary aim is to report outcomes of those patients.
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Other aims included:
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1. Evaluation about the effectiveness of different treatment modalities;
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2. Evaluation of outcomes according to different stages of disease;
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3. Evaluation of the impactof neoadjuvant chemotherapy in patients undergoing conservative surgery conditions: Cervical Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 400 type: ESTIMATED name: Conization plus nodal evaluation measure: oncological outcomes sex: FEMALE minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Fondazione IRCCS Istituto Nazionale dei Tumori di Milano city: Milano state: Lombardia zip: 20133 country: Italy lat: 45.46427 lon: 9.18951 hasResults: False
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<|newrecord|> nctId: NCT06351215 id: APP-24-00554 briefTitle: PO Methadone Ortho Outpatient overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2024-12-01 date: 2024-12-15 date: 2024-04-08 date: 2024-04-08 name: Keck School of Medicine of USC class: OTHER briefSummary: The goal of this clinical trial is to learn if oral methadone given before surgery works to minimize post-operative pain and opioid usage. The main questions it aims to answer are:
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Does oral methadone improve post-operative pain scores as compared to standard treatment? Does oral methadone lead to reduced use of post-operative and post-discharge opioid usage as compared to the current standard treatment?
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Researchers will compare oral methadone to a placebo (a look-alike substance that contains no drug) to assess the questions above.
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Participants will:
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Receive either oral methadone or a look-alike placebo before surgery Receive standard intraoperative and immediate post-operative pain control at the anesthesiologist's discretion Be asked about their pain levels in the recovery area Keep a diary of pain and opioid usage over the first 2 days after surgery conditions: Arthroscopic Knee Repair conditions: Arthroscopic Hip Repair studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: Methadone group name: Placebo measure: Post-op opioid usage measure: Post-op Pain Score sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: USC Healthcare Consultation 3 city: Los Angeles state: California zip: 90033 country: United States name: Alexander Chen, M.D. role: CONTACT phone: 323-442-7400 email: [email protected] name: Abigail Song, B.S. role: SUB_INVESTIGATOR name: Benjamin Liu, M.D. role: SUB_INVESTIGATOR name: Paul Lee, M.D., M.S. role: SUB_INVESTIGATOR lat: 34.05223 lon: -118.24368 hasResults: False
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<|newrecord|> nctId: NCT06351202 id: RBGP 2023 COLNE id: 2023-A02256-39 type: OTHER domain: ANSM briefTitle: Impact Assessment of Abdominal Massage on Feeding Tolerance of Preterms acronym: PREMABDO overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-02 date: 2026-06 date: 2024-04-08 date: 2024-04-10 name: University Hospital, Clermont-Ferrand class: OTHER briefSummary: Every year in France, 60,000 children are born prematurely (before 37 weeks of amenorrhea - WA), and present an immaturity of their various systems, in particular the digestive system. This can result in feeding intolerance, expressed by abdominal distension, regurgitation, irregular transit and abdominal discomfort. It can influence the length of hospitalization and lead to necrotising enterocolitis, a major complication.
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At the Clermont-Ferrand University Hospital Center, abdominal massages have been performed by physiotherapist for several years in order to improve the state of the digestive system of preterm infants. The indication for abdominal massages are very dependent on the caregivers in charge of the newborns because the evaluation of feeding intolerance remains subjective.
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In this context, the investigators carried out a first study to validate a scale that they created (ECAP scale : Clinical Assessment Scale for Abdominal state of Preterm infant) to assess in a rapid, reliable and reproductible manner the abdominal state of preterm infant - data currently being published). This scale can pose the indications for abdominal massage more objectively.
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