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No intervention will be performed during the study since no treatment is yet available within Europe. As soon as treatment is approved in the EU, patients in this cohort might receive treatment according to availability in their respective country and standard of care. If treatment will be performed, it will be as standard of care outside the study according to each country's standard of care and by EMA label. conditions: Age-Related Macular Degeneration conditions: Geographic Atrophy studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 200 type: ESTIMATED measure: To characterise and quantify focal and global changes of the retina by retinal imaging to identify patients at risk for fast geographic atrophy (GA) progression measure: To identify and quantify disease progression-related biomarkers measure: To evaluate monitoring AMD progression using approved AI algorithms. sex: ALL minimumAge: 55 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06351644 id: STUDY-24-00244 briefTitle: ON 123300 (Narazaciclib) and Dexamethasone in Patients With Relapsed and/or Refractory Multiple Myeloma overallStatus: NOT_YET_RECRUITING date: 2024-06-03 date: 2028-06-05 date: 2028-06-05 date: 2024-04-08 date: 2024-04-08 name: Adriana Rossi class: OTHER briefSummary: Multiple myeloma (MM) is a malignancy characterized by uncontrolled proliferation of plasma cells for which there is an urgent and unmet need to develop new, effective therapeutics. Onconova Therapeutics has developed a first-in-class oral inhibitor of CDK4 and ARK5 ON 123300 (NARAZACICLIB) which shows potent anti-myeloma activity in vitro and in vivo in preclinical models, and is undergoing evaluation in Phase 1-2 trials worldwide.
In this study, the researchers will test the safety and preliminary efficacy of inhibition of CDK4 and ARK5 by ON 123300 (NARAZACICLIB) in combination with dexamethasone in myeloma patients in a Phase I/II clinical trial. conditions: Relapsed and/or Refractory Multiple Myeloma studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: This is a single arm optimal biologic dose finding phase I/II clinical trial. primaryPurpose: TREATMENT masking: NONE count: 36 type: ESTIMATED name: ON 123300 name: Dexamethasone measure: Phase I: The optimal biological dose (OBD) of the combination of ON 123300 (NARAZACICLIB) and dexamethasone measure: Phase I: Dose-Limiting Toxicity (DLT) rate measure: Phase II: Overall response rates (ORR) measure: Number of Adverse events of Special Interest (AESI) measure: HbA1c measure: Fasting insulin levels measure: Lipid profiles measure: Free fatty acids measure: Best overall response (BOR) measure: Duration of Response (DOR) measure: Time to Progression (TTP) measure: Progression-Free Survival (PFS) measure: Disease Control Rate (DCR) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mount Sinai Health System city: New York state: New York zip: 10029 country: United States name: Adriana Rossi, MD role: CONTACT name: Katherine Vandris role: CONTACT email: Katherine.Vandris@mssm.edu name: Adriana Rossi role: PRINCIPAL_INVESTIGATOR lat: 40.71427 lon: -74.00597 hasResults: False
<\|newrecord\|> nctId: NCT06351631 id: 3543-017 id: 2023-506996-89 type: OTHER domain: EU CT id: U1111-1294-8621 type: OTHER domain: UTN id: MK-3543-017 type: OTHER domain: Merck ID briefTitle: A Study to Evaluate Safety and Efficacy of Bomedemstat (MK-3543-017) overallStatus: NOT_YET_RECRUITING date: 2024-05-21 date: 2034-12-04 date: 2034-12-04 date: 2024-04-08 date: 2024-04-08 name: Merck Sharp & Dohme LLC class: INDUSTRY briefSummary: The primary purpose of the study is to transition participants into an extension study to collect long-term safety and efficacy data. The study will include participants who are safely tolerating bomedemstat, receiving clinical benefit from its use in estimation of the investigator, and have shown the following criteria:
* Participants from the IMG-7289-202/MK-3543-005 (NCT05223920) study must have received at least 6 months of treatment with bomedemstat;
* Essential thrombocythemia (ET) and polycythemia vera (PV) participants from studies other than IMG-7289-202/MK-3543-005 must have achieved confirmed hematologic remission.
No hypothesis testing will be conducted in this study. conditions: Thrombocythemia, Essential conditions: Primary Myelofibrosis conditions: Myelofibrosis conditions: Post-polycythemia Vera Myelofibrosis conditions: Post-essential Thrombocythemia Myelofibrosis conditions: Polycythemia Vera studyType: INTERVENTIONAL phases: PHASE3 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 400 type: ESTIMATED name: Bomedemstat measure: Percentage of participants with one or more adverse events (AEs) measure: Percentage of participants who discontinued study treatment due to an AE measure: For participants with ET or PV: Duration of clinicohematologic response measure: For participants with ET or PV: Duration of hematologic remission measure: For participants with ET or PV: Percentage of participants with transformation to MF or MDS/AML measure: For participants with MF: Percentage of participants with worsening of splenomegaly or transformation to MDS/AML measure: For participants with MF, ET, or PV: Percentage of participants with thrombotic events measure: For participants with MF, ET, or PV: Percentage of participants with major hemorrhagic events measure: For participants with MF, ET, or PV: Event-Free Survival (EFS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06351618 id: 2023-06114-01 briefTitle: Epidemiology of Injuries in the Professional Women's Swedish National IceHockey League Permitted to Body-Checking overallStatus: RECRUITING date: 2023-12-01 date: 2024-03-26 date: 2028-01-01 date: 2024-04-08 date: 2024-04-08 name: Lund University class: OTHER briefSummary: This research project can contribute to a deeper understanding of injury patterns among professional female ice-hockey players allowed to body check. An understanding of common injury types and mechanisms aids the clinician in diagnosis and management. This information can guide preventative strategies in the areas of education, coaching, rule enforcement, rule modifications, equipment improvement, and sportsmanship. Today, ice hockey is a sport associated with many severe injuries that not only causes suffering and lower quality of life for the athlete, but also costs society a lot of money. Reducing the number and severity of sport-related injuries is therefore of importance. Knowledge of the injury epidemiology of women's hockey could also contribute to better preventive training programs and other injury preventive actions in the sport. Currently, only a minority of all sports medicine research is made on female study participants (26). This research project has the possibility to gain more knowledge about the female athlete, not only applicable for elite hockey-players, but also for female athletes in different disciplines and in youth teams. Knowledge of factors associated with injury could also contribute to better injury preventive actions and highlight subgroups in extra need of future preventive interventions. conditions: Sport Injury conditions: Ice-Skates Accident conditions: Sports Accident conditions: Female Athlete Triad conditions: Female studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 225 type: ESTIMATED name: No intervention will be conducted. measure: Injuries per 1000 training hours measure: Injuries per 1000 game hours sex: FEMALE minimumAge: 16 Years maximumAge: 110 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: The Faculty of Medicine at Lund University status: RECRUITING city: Malmö zip: 20213 country: Sweden name: Amanda Lahti role: CONTACT phone: 0704854798 email: amanda.lahti@med.lu.se lat: 55.60587 lon: 13.00073 hasResults: False
<\|newrecord\|> nctId: NCT06351605 id: CSP006 briefTitle: A Registry Study to Assess Photobiomodulation in Dry Age-Related Macular Degeneration (EUROLIGHT) (EUROLIGHT) overallStatus: RECRUITING date: 2023-09-01 date: 2026-09 date: 2026-12 date: 2024-04-08 date: 2024-04-08 name: LumiThera, Inc. class: INDUSTRY briefSummary: The EUROLIGHT study is being conducted to collect real life data for the safety and effectiveness of PBM in dry AMD, in routine clinical practice both retrospectively and prospectively. conditions: Dry Age-related Macular Degeneration studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: OTHER count: 500 type: ESTIMATED name: Valeda Light Delivery System measure: Best-Corrected Visual Acuity (BCVA) measure: OCT Imaging measure: FAF Imaging sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Oslo University Hospital status: RECRUITING city: Oslo country: Norway name: Øygunn Utheim, MD role: CONTACT phone: +47 93692578 email: outheim@gmail.com lat: 59.91273 lon: 10.74609 hasResults: False
<\|newrecord\|> nctId: NCT06351592 id: ALN-SOD-ALS-2351 id: 2023-510344-20-00 type: REGISTRY domain: EU CT Number briefTitle: First in Human (FIH) Study of ALN-SOD in Adult Participants With Amyotrophic Lateral Sclerosis Associated With Mutation in the SOD1 Gene (SOD1-ALS) overallStatus: NOT_YET_RECRUITING date: 2024-06-28 date: 2029-04-28 date: 2029-04-28 date: 2024-04-08 date: 2024-04-08 name: Regeneron Pharmaceuticals class: INDUSTRY briefSummary: This study is researching an experimental drug called ALN-SOD (called "study drug"). This study is focused on people with amyotrophic lateral sclerosis (ALS) who have a mutation in a gene called the superoxide dismutase-1 (SOD1) gene. This type of ALS is known as "SOD1-ALS". This is the first time that ALN-SOD will be given to people. The aim of the study is to see how safe and tolerable the study drug is.
The study is looking at several other research questions, including:
* The effect the study drug has on specific biomarkers, which are molecules in the blood or in the fluid that surrounds the brain and spinal cord, known as cerebrospinal fluid (CSF)
* How much study drug is in the blood and in the CSF, at different times
* Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)
* What effects the study drug has on ALS symptoms conditions: Amyotrophic Lateral Sclerosis (ALS) conditions: Mutation in the Superoxide Dismutase-1 (SOD1) Gene studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: No masking during Open-Label Treatment Period after 4-week Double-Blind Treatment Period. This part of the study consists of a crossover design. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 42 type: ESTIMATED name: ALN-SOD name: Diluent name: Placebo (PB) measure: Incidence of treatment-emergent adverse event (TEAEs) in participants treated with ALN-SOD measure: Severity of TEAEs in participants treated with ALN-SOD measure: Concentration of SOD1 protein in cerebrospinal fluid (CSF) over time measure: Change in concentration of SOD1 protein in CSF over time measure: Concentration of neurofilament light chain (NfL) in plasma over time measure: Change in concentration of NfL in plasma over time measure: Concentration of NfL in CSF over time measure: Change in concentration of NfL in CSF over time measure: Concentration of ALN-SOD in plasma over time measure: Concentration of ALN-SOD in CSF over time measure: Incidence of anti-drug antibodies (ADAs) to ALN-SOD in serum over time measure: Titer of ADAs to ALN-SOD in serum over time sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06351579 id: 1010159 briefTitle: Data Collection Post Radical Prostatectomy acronym: ALTO overallStatus: NOT_YET_RECRUITING date: 2024-06-15 date: 2025-12-30 date: 2026-03-15 date: 2024-04-08 date: 2024-04-08 name: Levee Medical, Inc. class: INDUSTRY name: RQMplus briefSummary: The study is to collect information on patients undergoing radical prostatectomy (RP), with a primary focus on the occurrence, duration, and severity of post-prostatectomy incontinence. Data will be collected at multiple time points, allowing for a dynamic understanding of urinary incontinence patterns at post RP. conditions: Stress Urinary Incontinence conditions: Radical Prostatectomy conditions: BPH studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 30 type: ESTIMATED name: Control measure: The change in average 24-hour pad weight over time measure: Change in pad weight during a 1-hour provocative pad weight test measure: Expanded Prostate Index Composite (EPIC-26) score. sex: MALE minimumAge: 45 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06351566 id: VD3, Prebiotics in Diabetes briefTitle: Effects of Vitamin D3 and Prebiotics Supplementation on Cardiovascular Risk Factors in Patients With Type 2 Diabetes overallStatus: NOT_YET_RECRUITING date: 2024-04-24 date: 2024-12-31 date: 2025-12-31 date: 2024-04-08 date: 2024-04-22 name: Huazhong University of Science and Technology class: OTHER briefSummary: The goal of this randomized, double-blind, placebo-controlled, 6-month supplementation study in individuals with type 2 diabetes is to investigate whether taking daily dietary supplements of vitamin D3 (1600 IU) or prebiotics (inulin, 10 gram) has beneficial effects on cardiovascular disease risk factors. conditions: Diabetes Mellitus, Type 2 studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: FACTORIAL primaryPurpose: PREVENTION masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 200 type: ESTIMATED name: Vitamin D3 name: Prebiotics name: Vitamin D3 placebo name: Prebiotics placebo measure: Glycated hemoglobin (HbA1c) measure: Concentration of blood lipids measure: Metagenomic analysis of the gut microbiota measure: Concentration of fasting glucose measure: Concentration of fasting insulin measure: Systolic and diastolic blood pressure measure: Estimated glomerular filtration rate (eGFR) measure: Concentration of C-reactive protein (CRP) measure: Concentration of procalcitonin measure: Concentration of interleukin-6 (IL-6) measure: Concentration of serum 25(OH)D measure: Body weight measure: Waist circumference measure: Hip circumference sex: ALL minimumAge: 40 Years maximumAge: 69 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06351553 id: 2023-169 briefTitle: Effect of the Autonomic Nervous System on the Outcomes of PULSEd Field Ablation to Treat Atrial Fibrillation acronym: EASy-PULSE AF overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2026-06 date: 2026-06 date: 2024-04-08 date: 2024-04-08 name: Hospital General Universitario de Alicante class: OTHER briefSummary: Pulmonary vein (PV) isolation is considered the therapeutic strategy of choice to maintain sinus rhythm (SR) in symptomatic patients with atrial fibrillation (AF). The most commonly used energy modality is radiofrequency (RF). However, this type of energy presents notable challenges, such as its lack of selectivity for myocardial tissue, which increases the risk of serious complications such as atrioesophageal fistula, PV stenosis, and vagus nerve injuries. In this context, PV isolation using pulsed field ablation (PFA) emerges as a promising alternative due to its greater myocardial selectivity. However, this selectivity presents additional challenges. Preliminary studies indicate that PFA may not damage the autonomic nervous system (ANS) involved in the initiation and maintenance of AF in certain patients, although stronger evidence is needed to support this claim.
The investigators propose to carry out a single-center clinical trial, although with the possibility in the future of including other centers. Patients will be randomized to three research groups: PV isolation with RF, PV isolation with PFA, and PV isolation combining PFA and RF (using RF on the anterior wall and PFA on the posterior wall). This assignment will be open to the operator who performs the procedure, but blind for the researcher responsible for monitoring and for the data analyst. The objective is to compare the impact of different energy sources during PV isolation on the ability to produce a permanent alteration in the ANS. The hypothesis is that combined PF isolation will be capable of producing a permanent alteration of autonomic function parameters superior to ablation using exclusive PFA. conditions: Atrial Fibrillation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 156 type: ESTIMATED name: Pulmonary vein isolation exclusively with radiofrequency name: Pulmonary vein isolation exclusively with pulsed field ablation name: Combined pulmonary vein isolation measure: Efficacy primary outcome: Alteration of autonomic function parameters measure: Efficacy secondary outcome: Alteration of autonomic function parameters measure: Efficacy secondary outcome: Alteration of autonomic function parameters measure: Efficacy secondary outcome: Alteration of autonomic function parameters measure: Efficacy secondary outcome: Procedure duration. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Laura García Cano city: Alicante zip: 03010 country: Spain lat: 38.34517 lon: -0.48149 hasResults: False
<\|newrecord\|> nctId: NCT06351540 id: IRB00332797 id: R21DA056687 type: NIH link: https://reporter.nih.gov/quickSearch/R21DA056687 briefTitle: Examining the Role of Tolerance on Dose-dependent Effects of Acute THC on Oculomotor and Cognitive Performance overallStatus: NOT_YET_RECRUITING date: 2024-08-01 date: 2025-08-01 date: 2025-12-01 date: 2024-04-08 date: 2024-04-08 name: Johns Hopkins University class: OTHER name: National Institute on Drug Abuse (NIDA) briefSummary: The purpose of this research is to determine the extent to which oculomotor function accurately detects THC-impairment, if cannabis use experience impacts this detection threshold, and to examine how the oculomotor index corresponds to a measure of sustained attention. A double-blind, placebo-controlled, within-subjects crossover design will be used to examine the dose-effects of THC (0, 5mg, 30mg) on oculomotor performance tasks and a sustained attention task in frequent and infrequent cannabis users. Results from the study will advance the investigators' understanding of the effect of THC and cannabis use frequency on oculomotor function and sustained attention, and will directly inform the validity of the investigators' oculomotor platform for identifying acute THC- induced impairment in frequent and infrequent users. conditions: Cannabis Use conditions: Impaired Driving conditions: Cognitive Impairment studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: double-blind, placebo-controlled, within-subjects crossover design primaryPurpose: BASIC_SCIENCE masking: DOUBLE maskingDescription: placebo controlled, double-blind whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 40 type: ESTIMATED name: Cannabis measure: Commission Errors measure: Omission Errors measure: Reaction Time measure: Reaction Time Standard Error measure: Visuomotor Index measure: Saccade Speed measure: Visually Guided Oculomotor Performance measure: Antisaccade measure: Memory-Guided sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Johns Hopkins Behavioral Pharmacology Research Unit city: Baltimore state: Maryland zip: 21224 country: United States lat: 39.29038 lon: -76.61219 hasResults: False
<\|newrecord\|> nctId: NCT06351527 id: ICP-CL-01202 briefTitle: Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ICP-248 in Mature B-cell Malignancies overallStatus: NOT_YET_RECRUITING date: 2024-04-25 date: 2027-06-25 date: 2027-10-25 date: 2024-04-08 date: 2024-04-08 name: InnoCare Pharma Inc. class: INDUSTRY briefSummary: Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of ICP-248 in Mature B-cell Malignancies conditions: Mature B-cell Malignancies studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: ICP-248 measure: Maximum tolerated dose and/or recommended Phase 2 dose measure: To investigate the incidence, nature and severity of adverse events (AE) according to NCI-CTCAE V5.0 evaluation criteria. sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06351514 id: 2023/00745 briefTitle: An Open-Label, Single Arm Study of the Efficacy of Accelerated Intermittent Theta Burst Stimulation in Schizophrenia Patients With Persistent Negative Symptoms acronym: NOBLE-TMS overallStatus: RECRUITING date: 2024-04-01 date: 2026-09 date: 2026-09 date: 2024-04-08 date: 2024-04-08 name: Institute of Mental Health, Singapore class: OTHER briefSummary: Schizophrenia patients commonly present with persistent negative symptoms which remain the main reason for dysfunction after recovery from an acute episode of psychotic symptoms. Negative symptoms in schizophrenia exact significant burden with no effective pharmacological or behavior treatment options thus far. Neuromodulatory modalities present a novel and alternative treatment approach and recent trials have shown preliminary evidence for the efficacy of intermittent Theta Burst Stimulation (iTBS) to treat negative symptoms in schizophrenia. In this study, we aim to examine the effectiveness of an accelerated iTBS treatment protocol as an augmentation treatment regime for patient in rehabilitation care with persistent negative symptoms.
We propose a pragmatic, open label and single arm clinical trial. Forty patients with diagnosis of schizophrenia, who had been stabilized from psychotic symptoms and currently suffering from dominant negative symptoms will be recruited and undergo accelerated iTBS treatment for 5 consecutive sessions each day for 5 working days. Participants will be followed up immediately, 1 month and 3 months after the end of treatment. Clinical assessment includes, BNSS, The Brief Negative Symptom Scale; SANS, Scale for the assessment of negative symptoms; SAPS, Scale for the assessment of positive symptoms; PANSS, Positive and Negative Symptoms Scale; MoCA, Montreal Cognitive Assessment scale; CDSS, Calgary Depression Scale for Schizophrenia: SDS, Sheehans' disability scale and EQ-5D. The primary endpoint of the trial is the change of negative symptoms as assessed by PANSS, negative symptoms subscale immediately after the treatment.
This study will determine whether accelerated iTBS is effective to be delivered as an augmentation therapy for patients with persistent negative symptoms. The optimal treatment system for this population can be immediately translated to clinical practice and benefit patients in need. conditions: Schizophrenia; Negative Type studyType: INTERVENTIONAL phases: PHASE3 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: Accelerated iTBS measure: Change of Negative symptoms measure: Trend of Negative symptoms sex: ALL minimumAge: 21 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Institute of Mental Health status: RECRUITING city: Singapore zip: 539747 country: Singapore name: Jenny Tay role: CONTACT email: jenny_am_tay@imh.com.sg lat: 1.28967 lon: 103.85007 hasResults: False
<\|newrecord\|> nctId: NCT06351501 id: P170923J id: 2019-000300-16 type: EUDRACT_NUMBER briefTitle: Evaluation of the Effectiveness of Hormonal Treatment in Adolescents Suffering From Gender Dysphoria acronym: TRANSADO overallStatus: NOT_YET_RECRUITING date: 2024-06-06 date: 2029-06-06 date: 2031-06-06 date: 2024-04-08 date: 2024-04-08 name: Assistance Publique - Hôpitaux de Paris class: OTHER briefSummary: Gender dysphoria (GD) is a significant suffering lasting more than 6 months in a subject, regarding the gap felt between gender identity of someone and birth sex. From the start of puberty, most of these adolescents who identify as transgender will persist in this sense and will engage in hormonal-surgical reassignment at some stage. For these adolescents, International recommendations for good practice recommend early treatment at the beginning of pubertal development (Tanner 2) to block pubertal progression, with the possibility of hormonal transition by administration of sex hormones of the desired sex at the age of 16. However, in order to reduce the psychosocial consequences of GD, more and more reference teams are practicing this hormonal transition from the age of 14 without any randomized study showing its benefit compared to a transition at the age of 16 years old. Indeed, in the absence of treatment, comorbidities among adolescents suffering from gender dysphoria is very high, with anxiety and depression, suicidal risk and school dropout.
Our hypothesis is that when hormonal transition is started at an age closer to what physiological puberty would be, it will reduce comorbidities and improve quality of life of these adolescents. This is the first therapeutic randomized study in France on this transgender adolescent population, a field where international recommendations based on "Evidence Based Medicine" principles are scared. We hope that results of this study will guide transgender youth health care allowing them, if the study is positive, to access hormonal treatments earlier and improve their overall functioning, their anxious and depressive symptoms, their quality of life. conditions: Cross Sex Hormonal Treatment in Adolescents With Gender Dysphoria studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: multicentric, controlled, randomized, open trial with blinded assessment of the primary outcome measure (Prospective Open Blinding Endpoint PROBE study) primaryPurpose: TREATMENT masking: SINGLE maskingDescription: The evaluation of the main criterion by the CGAS will be administered by a psychologist trained on this scale who will not have knowledge of the adolescent's attribution group and will not have participated in their care, based on elements keys to the patient's file which will be provided to him without any element that could indicate his group to which he belongs or his original sex, and a telephone interview with the adolescent and with his parents where they will have been previously informed not to not reveal the group to which they belong or the sex of origin. whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: hormonal treatment with cross sex hormones (testosterone or oestrogenes) started at 14 years old +/- 6 months name: Cross sex hormones ( œstrogenes or testosterone) started at 16 years old +/- 6 months measure: Global functionning using the Children's Global Assessment Scale (CGAS) measure: DEP-ADO measure: WISC-V (weschler Test) measure: UGDS (Utrecht Gender Dysphoria Scale ) measure: Beck Depression Inventory (BDI) measure: Body Image Scale (BIS) measure: State and Anxiety Inventory for Children (STAI-C) measure: CBCL (Youth Self Report YSR) Child Behaviour Chekcklist measure: World Health Organization Quality Of Life (WHO QOL) measure: Satisfaction With Life Scale (SWLS) measure: Adolescent Depression Rating Scale (ADRS) measure: Mini International Neuropsychiatric Interview (MINI) measure: Inventory of Parents and Peers Attachment (IPPA) sex: ALL minimumAge: 14 Years maximumAge: 14 Years stdAges: CHILD hasResults: False
<\|newrecord\|> nctId: NCT06351488 id: APHP231661 briefTitle: Detection of Circulating Kidney DNA in Kidney Transplant Patients Facing an Episode of Graft Rejection acronym: DART-RREGREF overallStatus: NOT_YET_RECRUITING date: 2024-06-10 date: 2026-02-11 date: 2026-02-11 date: 2024-04-08 date: 2024-04-08 name: Assistance Publique - Hôpitaux de Paris class: OTHER name: CGenetix name: Institut National de la Santé Et de la Recherche Médicale, France briefSummary: In France, 3,500 kidney transplants are carried out per year; and 40,000 people succeed in 2019 with a kidney transplant. Despite regular medical monitoring, nearly 30% of transplant patients will develop rejection. Currently, only solid biopsy of the graft makes it possible to establish the diagnosis of graft rejection, and to characterize its cellular origin based on the Banff classification.
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
<\|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.
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.
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.
Randomized Open, Blinded endpoint (PROBE) design. This study is a randomised, comparative, controlled, prospective, open-label, with parallel group and multicentre clinical trial.
Intervention
* 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.
* 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.
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
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.
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
<\|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.
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
<\|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.
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.
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.
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
<\|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.
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
<\|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:
1. what is the effect of FB on stress reduction
2. what is the effect of MIND on stress reduction
Participants of the MIND-FB group will participate will receive
1. FB: a two-hour FB session on four consecutive weekends in a country park,
2. MIND: four nutrition sessions, and adhere to the MIND diet for 12 weeks
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: ftung@hkmu.edu.hk 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
<\|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
<\|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: msuen@stanfordchildrens.org name: Thomas Caruso, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 37.44188 lon: -122.14302 hasResults: False
<\|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.
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
<\|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
<\|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: lorenc@lorenc.com name: Allison Bonugli role: CONTACT email: allison@lorenc.com name: Paul Z Lorenc, MD role: PRINCIPAL_INVESTIGATOR lat: 40.71427 lon: -74.00597 hasResults: False
<\|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
<\|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.
The names of the study drugs involved in this study are:
* Azenosertib (a type of WEE1 inhibitor)
* Carboplatin (a type of platinum compound)
* 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: Filipa_Lynce@DFCI.HARVARD.EDU name: Filipa Lynce, MD role: PRINCIPAL_INVESTIGATOR lat: 42.35843 lon: -71.05977 hasResults: False
<\|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.
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
<\|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).
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: cancerclinicaltrials@cumc.columbia.edu name: Joseph G. Jurcic, MD role: PRINCIPAL_INVESTIGATOR lat: 40.71427 lon: -74.00597 hasResults: False
<\|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.
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.
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
<\|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: suman.sheraz@riphah.edu.pk name: Sana Nasir, MS-CPPT* role: SUB_INVESTIGATOR name: Suman Sheraz, PhD* role: PRINCIPAL_INVESTIGATOR lat: 33.6007 lon: 73.0679 hasResults: False
<\|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: ghulam.fatima@riphah.edu.pk lat: 31.558 lon: 74.35071 hasResults: False
<\|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:
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: muhammad.sanaullah@riphah.edu.pk lat: 31.558 lon: 74.35071 hasResults: False
<\|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.
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
<\|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.
The primary aim is to report outcomes of those patients.
Other aims included:
1. Evaluation about the effectiveness of different treatment modalities;
2. Evaluation of outcomes according to different stages of disease;
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
<\|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:
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?
Researchers will compare oral methadone to a placebo (a look-alike substance that contains no drug) to assess the questions above.
Participants will:
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: painmed@usc.edu 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
<\|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.
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.
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.
The hypothesis is that abdominal massage improves feeding tolerance (decrease ECAP score), allows faster weight gain and reaching the full ration and therefore reduces the length of hospitalization of preterm infants.
The aim of the study is to assess the effectiveness of abdominal massage, over a period of 14 days, on the feeding tolerance of preterm infants (under 34 weeks of amenorrhea), defined by the achievement and maintenance of an ECAP score less than 4 during 3 days. conditions: Preterm Birth Complication conditions: Digestive System Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 120 type: ESTIMATED name: Abdominal massage measure: Clinical Abdominal assessment scale for Preterm infants score (ECAP score) measure: Variation of the ECAP score (Clinical Abdominal assessement scale for preterms score) between t0 minute and t10 minutes measure: Weight gain of preterm infants with feeding intolerance measure: Duration to reach the full ration measure: Duration of hospitalization in level 3 measure: 6-hour fasting windows measure: Incidence of occurrence of necrotizing enterocolitis measure: Evolution of digestive tolerance over time sex: ALL minimumAge: 3 Days maximumAge: 60 Days stdAges: CHILD facility: CHU clermont-ferrand city: Clermont-Ferrand country: France lat: 45.77966 lon: 3.08628 hasResults: False
<\|newrecord\|> nctId: NCT06351189 id: CIVI/2022/AD-01 briefTitle: NETTI Wheelchair: Does Dynamic Mode or Static Mode Affect the Sitting Position in Patients With Involuntary Movements ? acronym: DYNAMIC SYSTEM overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2025-06-01 date: 2026-08-01 date: 2024-04-08 date: 2024-04-08 name: Centre Hospitalier Universitaire de Nīmes class: OTHER briefSummary: This study compares two modes of the NETTI wheelchair (dynamic or sitting) for patients with hyperkinetic syndromes, to discover which mode is the most comfortable and best suited to these patients.
It is a prospective, single-center pilot study comparing two medical devices evaluated using SCED (Single Case Experimental Design) ABAB methodology: NETTI DYNAMIC chair in dynamic mode (intervention group; phase B) versus the same chair in static mode (control group; phase A). The subject will be his/her own control conditions: Hyperextension Spasms conditions: Involuntary Movements studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 5 type: ESTIMATED name: Observation measure: Forward slippage in static mode (PHASE A) measure: Forward slippage in static mode (PHASE A) measure: Forward slippage in static mode (PHASE A) measure: Forward slippage in static mode (PHASE A) measure: Forward slippage in dynamic mode (PHASE B) measure: Forward slippage in dynamic mode (PHASE B) measure: Forward slippage in dynamic mode (PHASE B) measure: Forward slippage in dynamic mode (PHASE B) measure: Peak force in static mode (PHASE A) measure: Peak force in static mode (PHASE A) measure: Peak force in static mode (PHASE A) measure: Peak force in static mode (PHASE A) measure: Peak force in dynamic mode (PHASE B) measure: Peak force in dynamic mode (PHASE B) measure: Peak force in dynamic mode (PHASE B) measure: Peak force in dynamic mode (PHASE B) measure: Maximum downward force in static mode (PHASE A) measure: Maximum downward force in static mode (PHASE A) measure: Maximum downward force in static mode (PHASE A) measure: Maximum downward force in static mode (PHASE A) measure: Maximum downward force in dynamic mode (PHASE B) measure: Maximum downward force in dynamic mode (PHASE B) measure: Maximum downward force in dynamic mode (PHASE B) measure: Maximum downward force in dynamic mode (PHASE B) measure: Patient's comfort in static mode (PHASE A) measure: Patient's comfort in static mode (PHASE A) measure: Patient's comfort in static mode (PHASE A) measure: Patient's comfort in static mode (PHASE A) measure: Patient's comfort in dynamic mode (PHASE B) measure: Patient's comfort in dynamic mode (PHASE B) measure: Patient's comfort in dynamic mode (PHASE B) measure: Patient's comfort in dynamic mode (PHASE B) measure: Caregiver's comfort in static mode (PHASE A) measure: Caregiver's comfort in dynamic mode (PHASE B) measure: Caregiver's comfort in dynamic mode (PHASE B) measure: Caregiver's comfort in dynamic mode (PHASE B) measure: Number of repositionings required in static mode (PHASE A) measure: Number of repositionings required in static mode (PHASE A) measure: Number of repositionings required in static mode (PHASE A) measure: Number of repositionings required in static mode (PHASE A) measure: Number of repositionings required in dynamic mode (PHASE B) measure: Number of repositionings required in dynamic mode (PHASE B) measure: Number of repositionings required in dynamic mode (PHASE B) measure: Number of repositionings required in dynamic mode (PHASE B) measure: Discomfort perceived by the caregiver in static mode (PHASE A) measure: Discomfort perceived by the caregiver in static mode (PHASE A) measure: Discomfort perceived by the caregiver in static mode (PHASE A) measure: Discomfort perceived by the caregiver in static mode (PHASE A) measure: Discomfort perceived by the caregiver in dynamic mode (PHASE B) measure: Discomfort perceived by the caregiver in dynamic mode (PHASE B) measure: Discomfort perceived by the caregiver in dynamic mode (PHASE B) measure: Discomfort perceived by the caregiver in dynamic mode (PHASE B) measure: Safety as perceived by the caregiver/carer in static mode (PHASE A) measure: Safety as perceived by the caregiver/carer in static mode (PHASE A) measure: Safety as perceived by the caregiver/carer in static mode (PHASE A) measure: Safety as perceived by the caregiver/carer in static mode (PHASE A) measure: Safety as perceived by the caregiver/carer in dynamic mode (PHASE B) measure: Safety as perceived by the caregiver/carer in dynamic mode (PHASE B) measure: Safety as perceived by the caregiver/carer in dynamic mode (PHASE B) measure: Safety as perceived by the caregiver/carer in dynamic mode (PHASE B) measure: Average of peak forces exerted on the wheelchair's backrest in static mode (PHASE A) measure: Average of peak forces exerted on the wheelchair's backrest in static mode (PHASE A) measure: Average of peak forces exerted on the wheelchair's backrest in static mode (PHASE A) measure: Average of peak forces exerted on the wheelchair's backrest in static mode (PHASE A) measure: Average of peak forces exerted on the wheelchair's backrest in dynamic mode (PHASE B) measure: Average of peak forces exerted on the wheelchair's backrest in dynamic mode (PHASE B) measure: Average of peak forces exerted on the wheelchair's backrest in dynamic mode (PHASE B) measure: Average of peak forces exerted on the wheelchair's backrest in dynamic mode (PHASE B) measure: Average of peak forces exerted on the wheelchair's seat in static mode (PHASE A) measure: Average of peak forces exerted on the wheelchair's seat in static mode (PHASE A) measure: Average of peak forces exerted on the wheelchair's seat in static mode (PHASE A) measure: Average of peak forces exerted on the wheelchair's seat in static mode (PHASE A) measure: Average of peak forces exerted on the wheelchair's seat in dynamic mode (PHASE B) measure: Average of peak forces exerted on the wheelchair's seat in dynamic mode (PHASE B) measure: Average of peak forces exerted on the wheelchair's seat in dynamic mode (PHASE B) measure: Average of peak forces exerted on the wheelchair's seat in dynamic mode (PHASE B) measure: Sex measure: Age measure: Height measure: Weight measure: Body mass index sex: ALL minimumAge: 16 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06351176 id: 2024-6819 briefTitle: Impact of Glycemic Control on Skeletal Outcomes in Adults With Type 1 Diabetes acronym: DenSiFy cohort overallStatus: ENROLLING_BY_INVITATION date: 2023-07-04 date: 2024-12-22 date: 2025-08-29 date: 2024-04-08 date: 2024-04-08 name: CHU de Quebec-Universite Laval class: OTHER name: Diabetes Canada briefSummary: Background : Type 1 diabetes (T1D) is associated with an increased risk of fractures. The mechanisms accounting for this bone fragility are not yet fully understood. As T1D is often diagnosed in childhood or early adulthood, the lower bone mineral density (BMD) and deteriorated bone microarchitecture observed in T1D may reflect changes in the bone that occurred before or at the time of peak bone mass achievement. There is a lack of high-quality prospective studies to determine whether adults with T1D continue to lose BMD or deteriorate bone quality compared with controls. Moreover, while chronic hyperglycemia is a risk factor for fracture in T1D, it is unknown if better glycemic control affects bone outcomes.
This prospective multicenter cohort study aims: (1) To compare the changes in the following outcomes over 4 years in adults with T1D and controls without diabetes of similar age, sex and body-mass index distribution: BMD by dual-energy X-ray absorptiometry (DXA) at the femoral neck, hip, spine, and radius, trabecular bone score (TBS) by DXA, and serum biochemical markers of bone turnover (BTMs); (2) To evaluate whether long-term glycemic control or the presence of a microvascular complication are independent predictors of the changes in BMD and TBS in people with T1D. conditions: Diabetes Mellitus, Type 1 conditions: Bone Health conditions: Bone Loss conditions: Bone Diseases, Metabolic conditions: Hyperglycaemia Due to Type 1 Diabetes Mellitus studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 163 type: ESTIMATED name: Clinical tests name: Biochemical tests name: DXA scan with TBS and VFA name: AGEReader measure: Change in areal bone mineral density (aBMD) at the femoral neck in g/cm2 measure: Change in areal bone mineral density (aBMD) at the spine in g/cm2 measure: Change in areal bone mineral density (aBMD) at the total hip in g/cm2 measure: Change in areal bone mineral density (aBMD) at the distal third of radius in g/cm2 measure: Change in Trabecular bone score (TBS) (unitless) measure: Glycemic control, assessed with mean glycated hemoglobin (HbA1c) of the past 7 years measure: Glycemic control, assessed with skin advanced glycation end products (AGEs) measure: Presence of a microvascular complication (neuropathy, nephropathy, retinopathy) measure: Areal bone mineral density at the femoral neck, g/cm2 measure: Areal bone mineral density at the femoral neck, T-Score measure: Areal bone mineral density at the femoral neck, Z-Score measure: Areal bone mineral density at the total hip, g/cm2 measure: Areal bone mineral density at the total hip, T-score measure: Areal bone mineral density at the total hip, Z-score measure: Areal bone mineral density at the spine, g/cm2 measure: Areal bone mineral density at the spine, T-Score measure: Areal bone mineral density at the spine, Z-score measure: Areal bone mineral density at the distal third of radius, g/cm2 measure: Areal bone mineral density at the distal third of radius, T-score measure: Areal bone mineral density at the distal third of radius, Z-score measure: Trabecular bone score (TBS) at the lumbar spine (L1-L4) (unitless) measure: Vertebral Fracture Assessment (VFA) from the T4 to L5 vertebrae to detect the presence of vertebral fracture measure: Lean mass (arm, leg, trunk, android, gynoid and total) (g) measure: Fat mass (arm, leg, trunk, android, gynoid and total) (g) measure: C-terminal cross-linking telopeptide of type I collagen (C-telopeptide, CTX) (ng/mL) measure: Procollagen type 1 N-terminal propeptide (P1NP) (ng/mL) measure: Osteocalcin (ng/mL) measure: Sclerostin (pmol/mL) measure: Change in C-terminal cross-linking telopeptide of type I collagen (C-telopeptide, CTX) (ng/mL) measure: Change in osteocalcin (ng/mL) measure: Change in procollagen type 1 N-terminal propeptide (P1NP) (ng/mL) measure: Change in sclerostin (pmol/mL) measure: Skin advanced glycation end-products (AGEs) (arbitrary units) measure: Glycated hemoglobin (HbA1c, %) measure: Fasting glucose (mmol/L) measure: Complete blood count measure: Thyroid-stimulating hormone (TSH) (mU/L) measure: Lipid panel (total cholesterol, LDL-cholesterol, HDL-cholesterol, non-HDL-cholesterol, total cholesterol/HDL-cholesterol ratio, triglycerides, in mmol/L) measure: Creatinine (umol/L) measure: Microalbuminuria (mg/mmol) measure: Liver enzymes (AST, ALT) (U/L) measure: Calcium (mmol/L) measure: Albumine (g/L) measure: Phosphate (mmol/L) measure: 25-hydroxyvitamin D3 (nmol/L) measure: Parathormone (PTH) (ng/L) measure: Antitransglutaminase antibodies (U/mL) measure: Immunoglobulin A (IgA) (g/L) measure: Insulin like growth factor-1 (IGF-1) (ng/mL) measure: Follicle stimulating hormone (FSH, women) (U/L) measure: Total testosterone (men) (nmol/L) measure: Sex hormone-binding globulin (SHBG, men) (nmol/L) sex: ALL minimumAge: 20 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Institut de recherches cliniques de Montréal (IRCM) city: Montréal state: Quebec zip: H2W 1R7 country: Canada lat: 45.50884 lon: -73.58781 facility: Centre de recherche du CHU de Québec-Université Laval city: Quebec City state: Quebec zip: G1V 4G2 country: Canada lat: 46.81228 lon: -71.21454 hasResults: False
<\|newrecord\|> nctId: NCT06351163 id: 1451_03/BVNTW-VNCSKTE briefTitle: Minimally Invasive Surgical Management for Pediatric Intussusception: A Retrospective Cohort Study overallStatus: COMPLETED date: 2016-01 date: 2020-12 date: 2024-03 date: 2024-04-08 date: 2024-04-08 name: National Children's Hospital, Vietnam class: OTHER name: Vinmec Research Institute of Stem Cell and Gene Technology briefSummary: Intussusception is the primary cause of intestinal obstruction in children aged 3 months to 5 years, leading to significant morbidity and mortality rates. Most cases involve the ileocolic region and can often be resolved through air enema, with a success rate of up to 95%. Surgical intervention becomes necessary if pneumatic reduction fails or is not recommended. Traditionally, manual reduction required a large incision on the right side of the abdomen. However, the advancement of minimally invasive techniques, such as the laparoscopic approach (LAP), has become increasingly popular for managing intussusception. LAP offers benefits such as reduced surgical trauma and shorter operative times compared to open procedures. Nevertheless, the adoption of LAP remains controversial due to challenges like limited working space in children and variability in the affected bowel segment. This study aims to investigate the safety and feasibility of LAP and mini-open reduction (MOR) techniques in treating idiopathic intussusception in pediatric patients. conditions: Intussusception studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 181 type: ACTUAL name: Laparoscopic reduction name: Transumbilical mini-open reduction measure: Operating time measure: Intraoperative complications measure: Immediate postoperative complications measure: Time to feed measure: Hospital stays measure: Recurrence rate measure: Long-term complication rate sex: ALL minimumAge: 2 Months maximumAge: 12 Years stdAges: CHILD facility: The National Hospital of Pediatrics city: Hanoi country: Vietnam lat: 21.0245 lon: 105.84117 facility: Vinmec Research Institute of Stem Cell and Gene Technology city: Hanoi country: Vietnam lat: 21.0245 lon: 105.84117 hasResults: False
<\|newrecord\|> nctId: NCT06351150 id: TQG3902-III-01 briefTitle: Efficacy and Safety of Angiotensin II Injection Versus Placebo in Patients With Refractory Distributed Shock overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2027-06 date: 2027-12 date: 2024-04-08 date: 2024-04-08 name: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. class: INDUSTRY briefSummary: A randomized, double-blind, placebo-controlled study on the treatment of refractory distributed shock with angiotensin II injection, with a random ratio of 1:1. Assuming a success rate of 25% for the main therapeutic endpoint in the control group and 50% for the experimental group, a total of 214 subjects will be enrolled, including 107 in the experimental group and 107 in the control group. conditions: Vasodilatory Shock studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 214 type: ESTIMATED name: Angiotensin II Injection name: 0.9% sodium chloride injection measure: Proportion of subjects with blood pressure response at 3 hours after administration of study drug measure: Sequential Organ Failure Assessment (SOFA) total score measure: Cardiovascular SOFA subscore measure: Mortality at Day 7 measure: Mortality at Day 28 measure: Proportion of subjects with blood pressure response at 1 hour after administration measure: Proportion of subjects with blood pressure response at 2 hours after administration measure: Change in background vasoactive agent dose from 0 to 48 hours measure: Absolute change in blood lactate from 0 to 3 hours measure: Absolute change in blood lactate from 3 to 48 hours measure: Absolute change in heart rate from 0 to 3 hours measure: Absolute change in heart rate from 3 to 48 hours measure: Adverse events (AE) measure: Serious adverse events (SAE) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Peking Union Medical College Hospital city: Beijing state: Beijing zip: 100730 country: China name: Yun Long, M.D. role: CONTACT phone: 13911608699 email: yunlongxh@163.com lat: 39.9075 lon: 116.39723 facility: The First Affiliated Hospital of Sun Yat sen University city: Guangzhou state: Guangdong zip: 510062 country: China name: Xiangdong Guan, M.D. role: CONTACT phone: 13802925067 email: guanxiangdong1962@163.com lat: 23.11667 lon: 113.25 facility: Zhujiang Hospital of Southern Medical University city: Guangzhou state: Guangdong zip: 510260 country: China name: Zhanguo Liu, M.D. role: CONTACT phone: 18520711669 email: zhguoliu@163.com lat: 23.11667 lon: 113.25 facility: Qingyuan Hospital Affiliated to Guangzhou Medical University city: Qingyuan state: Guangdong zip: 511518 country: China name: Jingwen Yang, M.D. role: CONTACT phone: 13542498765 email: 00655@qyry.com lat: 23.7 lon: 113.03333 facility: The First Affiliated Hospital of Shantou University Medical College city: Shantou state: Guangdong zip: 515041 country: China name: Yongru Chen, M.D. role: CONTACT phone: 13411969797 email: ongruchen@126.com lat: 23.36814 lon: 116.71479 facility: Liuzhou General Hospital city: Liuzhou state: Guangxi zip: 545026 country: China name: Guangyu Lv, M.D. role: CONTACT phone: 13977210130 email: lgy197823@163.com facility: The Affiliated Hospital of Hebei University city: Baoding state: Hebei zip: 050031 country: China name: Zhanbiao Yu, M.D. role: CONTACT phone: 15188655821 email: daxiang285@sina.com lat: 38.85111 lon: 115.49028 facility: The First Affiliated Hospital of Harbin Medical University city: Harbin state: Heilongjiang zip: 150007 country: China lat: 45.75 lon: 126.65 facility: The First Affiliated Hospital of Bengbu Medical College city: Bengbu state: Henan zip: 233099 country: China name: Yongsheng Zheng, M.D. role: CONTACT phone: 13955252796 email: zsy0916@163.com lat: 32.94083 lon: 117.36083 facility: The First Affiliated Hospital of Henan University of Science and Technology city: Luoyang state: Henan zip: 450052 country: China name: Qizhi Fu, M.D. role: CONTACT phone: 13837944687 email: fuqizhi33@sina.com lat: 34.68361 lon: 112.45361 facility: The First Affiliated Hospital of Zhengzhou University city: Zhengzhou state: Henan zip: 450052 country: China name: Tongwen Sun, M.D. role: CONTACT phone: 13838516916 email: suntongwen@163.com lat: 34.75778 lon: 113.64861 facility: Union Hospital, Tongji Medical College of huazhong university of science and technology city: Wuhan state: Hubei zip: 430022 country: China name: You Shang, M.D. role: CONTACT phone: 15972127819 email: you_shanghust@163.com lat: 30.58333 lon: 114.26667 facility: Xiangya Hospital Central South University city: Changsha state: Hunan zip: 140008 country: China name: Lina Zhang, M.D. role: CONTACT phone: 15874875763 email: zln7095@163.com lat: 28.19874 lon: 112.97087 facility: Jiangsu Province Hospital city: Nanjing state: Jiangsu zip: 210029 country: China name: Quan Cao, M.D. role: CONTACT phone: 13851992695 email: 2004caoquan@163.com lat: 32.06167 lon: 118.77778 facility: The Second Affiliated Hospital of Xi'an Jiaotong University city: Xi'an state: Shaanxi zip: 710004 country: China name: Xiaochuang Wang, M.D. role: CONTACT phone: 13772152935 email: 1585431074@qq.com lat: 34.25833 lon: 108.92861 facility: The First Hospital of Shanxi Medical University city: Taiyuan state: Shanxi zip: 030001 country: China name: Jing Cao, M.D. role: CONTACT phone: 13834691242 email: 13834691242@163.com lat: 37.86944 lon: 112.56028 facility: West China Hospital of Sichuan University city: Chengdu state: Sichuan zip: 610044 country: China name: Yan Kang, M.D. role: CONTACT phone: 13808041931 email: kangyan_hx@163.com lat: 30.66667 lon: 104.06667 facility: Sichuan Provincial People's Hospital city: Chengdu state: Sichuan zip: 610072 country: China name: Xiaobo Huang, M.D. role: CONTACT phone: 18140049936 email: drhuangxb@163.com lat: 30.66667 lon: 104.06667 facility: The First Affiliated Hospital of Xinjiang Medical University city: Ürümqi state: Xinjiang zip: 830054 country: China name: Xiangyou Yu, M.D. role: CONTACT phone: 13009681003 email: yu2796@163.com lat: 43.80096 lon: 87.60046 hasResults: False

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