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Recruiting

Prevail Global Study

Coronary Artery Disease

The purpose of the study is to evaluate the clinical safety and efficacy of the Prevail DCB.

Начало: 24.02.2025 Край: 01.02.2031 Възраст: от 18 г.

United States Medtronic Vascular NCT06535854

Recruiting

Diagnostic Performance of a Combination of Leukocyte Cell Surface Markers in Predicting the Risk of Severe Bacterial Infection in Febrile Children Under Three Months of Age in the Emergency Department: a Pilot Study.

Children Under 3 Months of Age With Fever

Fever is a frequent reason for emergency department (ED) visits in infants under 3 months of age. Although viral infections are the most common etiologies, the prevalence of severe bacterial infections (SBI) is high (10%). While in infants with SBI, establishing the diagnosis and initiating rapid intravenous antibiotic therapy is necessary, every effort should be made to avoid it in those at low risk of SBI. Clinical examination and biomarkers are still sub-optimal for assessing the risk of SBI. As a result, the vast majority of these children receive inpatient intravenous antibiotic therapy. Flow cytometry is a technique for measuring the expression of biomarkers on the cell surface of leukocytes in response to infection. A French team has identified a combination of some fifteen leukocyte cell surface markers that perform excellently in discriminating between bacterial and viral infections in a population of adults presenting to the emergency department with a suspected infection. However, there are no similar studies in children. The objective of the study is to assess the diagnostic performance of a combination of biomarkers on the cell surface of leukocytes in discriminating between bacterial and viral infection. Infants less than 3 months of age, visiting the ED for fever will have an extra blood sample in order to measure those biomarkers. The performance of those biomarkers to identify SBI will be assessed.

Начало: 24.02.2025 Край: 07.09.2027 Възраст: 7–90 г.

France Assistance Publique - Hôpitaux de Paris NCT06618989

Recruiting Phase 1/2

A Randomized Study of SPK-10001 Gene Therapy in Participants With Huntington's Disease

Huntington Disease

The main goal of this study is to evaluate the safety, tolerability, and preliminary efficacy of SPK-10001 in participants with Huntington's Disease.

Начало: 21.02.2025 Край: 12.01.2035 Възраст: 25–65 г.

United States Hoffmann-La Roche NCT06826612

Recruiting Phase 3

Phase III Trial of Camrelizumab+Apatinib+Eribulin vs. Physician's Choice Chemotherapy in Advanced Triple-Negative Breast Cancer

Breast Cancer Stage IV Triple -Negative Breast Cancer

This study evaluates the efficacy and safety of camrelizumab, apatinib, and eribulin versus physician's choice chemotherapy in advanced TNBC.Primary Objectives: Assess improvements in progression-free survival (PFS) and overall survival (OS).Secondary Objectives: Compare objective response rate (ORR), disease control rate (DCR), clinical benefit rate (CBR), duration of response (DoR), time to response (TTR), two-year OS rate, biomarker analysis, and quality of life (QoL).Safety: Assess and compare adverse event incidence and severity.

Начало: 21.02.2025 Край: 01.06.2029 Възраст: 18–70 г.

China Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University NCT06889688

Recruiting Phase 2

Preoperative Radioimmunotherapy Versus Chemoimmunotherapy in NSCLC

Carcinoma, Non-Small-Cell Lung

The goal of this clinical trial is to learn if Cemiplimab with chemotherapy or Cemiplimab with stereotactic body radiation therapy (SBRT) works as treatment for stages IB, II, and III (N2) Non-Small Cell Lung Cancer (NSCLC). Before surgery to remove their lung cancer, participants will take: 1. Cemiplimab with chemotherapy (Arm A) every 3 weeks for up to 3 doses, OR 2. Cemiplimab every 3 weeks for up to 3 doses with SBRT (Arm B). SBRT will be given on day 1 before taking cemiplimab, then SBRT alone on day 2 and day 3. Four to 12 weeks following surgery, participants in both Arm A and Arm B will receive treatment with cemiplimab for one year.

Начало: 21.02.2025 Край: 01.01.2032 Възраст: от 18 г.

United States Weill Medical College of Cornell University NCT06623656

Recruiting Early Phase 1

Study Brain Mechanisms of Frustration With Magnetoencephalography in Healthy Volunteers

Irritability

Background: Irritability can be defined as an unusually strong response to frustration; these responses may include severe temper outbursts and a constant grumpy mood. Irritability is a common symptom of many mental health disorders. Little is known about how the brain responds to frustration, and few treatments are available for this problem. Researchers want to know more about how the brain responds to frustration. Objective: To learn how the brain responds to frustration. Eligibility: Healthy adults aged 18 to 55 years. They must have been screened through studies 01-M-0254 or 17-M-0181. Design: Participants will have up to 3 study visits in 2 months. Each visit will last up to 4 hours. Visit 1: Participants will be screened. They will have a physical exam. They will complete questionnaires about how often and how easily they get angry or grumpy. They will be trained to use a device that measures hand grip. Visit 2: Participants will have a magnetic resonance imaging (MRI) scan. They will lie on a table that slides into a tube. Padding will hold their head still. Visit 3: Participants will undergo magnetoencephalography (MEG). A cone with detectors will be lowered over their head while they are seated. The MEG will measure the magnetic fields in the participant s brain both while they are resting and while they are doing the frustration task. For the task, they will hold a grip device in each hand. They will use the devices to pick 1 of 2 doors on a computer screen. The task has 3 parts. The participant s face will be filmed during this task.

Начало: 21.02.2025 Край: 31.08.2027 Възраст: 18–55 г.

United States National Institute of Mental Health (NIMH) NCT06484088

Recruiting Phase 3

Study of a Strategy Integrating Adjuvant Radiation Therapy Versus Strategy Based on Monitoring in the Treatment of Carcinomas Spinocellular With High Risk of Recurrence

Cutaneous Squamous Cell Carcinoma (CSCC)

The goal of this clinical trial is to evaluate a strategy integrating adjuvant radiation therapy versus strategy based on monitoring in the treatment of carcinomas spinocellular with high risk of recurrence (SCC). The investigators will compare the disease-free survival (DFS) of patients treated with adjuvant radiation therapy versus surveillance in high risk of recurrence SCC. The main question it aims to answer is: Is DFS different between the "adjuvant radiotherapy" group and the "surveillance" group? Participants will: * be distributed in one of the two arms * will be followed up every 4 months for 2 years, then every 6 months (clinical examination, identification of concomitant treatments, imaging, quality-of-life questionnaire) * followed up until their death or their progression whether local, regional or metastatic

Начало: 21.02.2025 Край: 01.06.2031 Възраст: от 18 г.

France Centre Leon Berard NCT06692556

Recruiting

Investigating New Methods to Study Movement in Children and Young Adults With Movement Disorders.

Cerebral Palsy

Background: Cerebral palsy (CP) is the most common motor disorder that affects children. People with CP have weak muscles; they may have trouble controlling the movements of their arms and legs. Researchers have been developing braces called robotic exoskeletons for people with CP. These devices can adapt to the person s movements and help them move better. This natural history study will explore new technologies that may tell us more about how people with CP move and improve how these exoskeletons work. Objective: To test new technologies to measure people s movements and brain function while they move with and without a robotic exoskeleton. Eligibility: People aged 5 to 25 years with CP. Healthy volunteers are also needed. Design: Participants will have 3 to 5 clinic visits in 2 months. Participants will be fitted with an exoskeleton that will be worn on one of their legs. At each visit, participants will be asked to move their wrist, ankle, and knee while the following measurements are taken: Ultrasound. A bar will be placed against the skin. It will send soundwaves into the body to take pictures of the muscles. Electroencephalography (EEG). Participants will wear a cap with sensors. Their brain waves will be recorded. Electromyography (EMG). Small metal discs will be taped to the skin. They will measure electrical activity of muscle. Participants will flex and extend each joint (wrist, ankle, or knee) on one side of their body. These movements will be done on their own and while assisted by two devices: Functional electrical stimulation (FES). Small adhesive pads will be placed on the skin and electric. Pulses will stimulate muscles to help move the limb. This will be done for the wrist, ankle and knee. Robotic Exoskeleton. A leg brace will be placed on one limb with a motor that will help move the knee. The exoskeleton can be used with or without FES. Participants will also walk on a treadmill at their own pace. Photographs and videos will record how they move.

Начало: 20.02.2025 Край: 31.12.2027 Възраст: 5–25 г.

United States National Institutes of Health Clinical Center (CC) NCT06498596

Recruiting Phase 2

A Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX43 (Anti-PD-L1 ADC) in Patients With Advanced Gynecological Malignant Tumors

Cervical Cancer Ovarian Cancer

The study is being conducted to explore the reasonable dosage and evaluate the efficacy, safety and tolerability of HLX43 (Anti-PD-L1 ADC) in patients with recurrent/metastatic cervical cancer or ovarian cancer failed or intolerance to standard first-line therapy.

Начало: 20.02.2025 Край: 05.06.2027 Възраст: 18–75 г.

China Shanghai Henlius Biotech NCT06769152

Recruiting Phase 3

Lymphocyte-Sparing And Radio-Immunotherapy in Head and Neck Carcinoma

Oropharynx Cancer Larynx Cancer Hypopharynx Cancer Primary Head and Neck Tumor

The aim of this study is to investigate the effect of ATRA (Vesanoid) and the effect of tailored radiotherapy in patients with squamous cell carcinoma of the oropharynx, larynx or hypopharynx.

Начало: 20.02.2025 Край: 01.01.2029 Възраст: от 18 г.

France Centre Leon Berard NCT06706401

Recruiting Phase 2

Psyllium in Pediatric IBS

Irritable Bowel Syndrome

The goal of this clinical trial is to learn if a fiber (psyllium) can change the way bacteria use fructans (a type of sugar) and whether psyllium can help decrease childhood irritable bowel syndrome (IBS) symptoms when eating fructans. The main questions it aims to answer are: Aim 1: The effect of psyllium at two doses given with a fructan meal on microbial fructan fermentation (intracolonic pH; H2 gas production; gut microbiome composition; fecal short-chain fatty acids, lactate, glycomics). Aim 2: Determine the impact of psyllium given with a fructan meal on fructan-induced GI symptoms. Participants will first be asked to eat a specific diet over two three-day periods to determine if fructans worsen their IBS symptoms. Those with worsening symptoms with fructans will be asked to participate in the second part of the study. This includes two weeks of baseline (no change in diet) and two weeks of eating a specific diet with fructans with either psyllium or glucose. Participants will be asked to complete pain and stool diaries, submit stool specimens, swallow a pill to capture gut acid levels, and give breath samples.

Начало: 20.02.2025 Край: 30.09.2027 Възраст: 12–17 г.

United States Dr Bruno Chumpitazi, M.D. NCT06639984

Recruiting Phase 2

A Study to Assess the Safety, Tolerability, and Efficacy of IMVT-1402 in Participants With Cutaneous Lupus Erythematosus (CLE)

Subacute Cutaneous Lupus Erythematosus Chronic Cutaneous Lupus Erythematosus

The primary purpose of this study is to evaluate the efficacy, safety, and tolerability of IMVT-1402 in participants with Cutaneous Lupus Erythematosus. The study will consist of 3 periods: Period 1: eligible participants will be randomized 1:1 to IMVT-1402 Dose 1 or placebo SC QW for 12 weeks. Period 2: participants who completed Period 1 will receive IMVT-1402 Dose 1 SC QW for 14 weeks. Period 3: after completion of Period 2, participants will be re-randomized 1:1 to blinded IMVT-1402 Dose 1 or Dose 2 SC QW for 26 weeks.

Начало: 19.02.2025 Край: 01.04.2027 Възраст: от 18 г.

Argentina, Bulgaria, Canada +10 Immunovant Sciences GmbH NCT06980805

Recruiting Phase 1

A Safety Assessment of Oral Letermovir in Infants With Symptomatic Congenital Cytomegalovirus

Congenital Cytomegalovirus Infection

This is a Phase 1 single-arm open-label study of letermovir in neonates with symptomatic congenital Cytomegalovirus (CMV) disease. There will be two groups enrolled. Group 1 will be comprised of 4 subjects. Following documentation study inclusion and signing of informed consent, Group 1 subjects will receive one dose of oral letermovir (Study Day 0), using the dose bands. A full pharmacokinetics (PK) profile will then be obtained over the next 24 hours, and blood specimens will be shipped immediately to the University of Alabama at Birmingham (UAB) Pharmacokinetic Lab and processed in real time. Within = 7 days, pharmacokinetics (PK) results will be conveyed to the study site. If the Area Under the Curve (AUC24) is =100,000 ngxhr/mL (see footnote a in Table 1), the subject will initiate a 14-day course of once-daily oral letermovir at the same dose as utilized on Dose Finding Day. This duration of letermovir therapy was selected based upon our earlier observation in this population that patients with symptomatic congenital Cytomegalovirus (CMV) disease who achieve viral suppression to =2.5 log by day 14 of valganciclovir therapy and then maintain it over the next 4 months are statistically more likely to have improved hearing across the first two years of life (22). If the observed letermovir exposure of the subject is \> 100,000 ngxhr/mL, the once-daily oral letermovir dose that will be used will be adjusted down in 2.5 mg increments. Oral valganciclovir (16 mg/kg/dose BID) will begin within the first month of life, as standard of care; initiation of valganciclovir can be concomitant with or prior to initiation of the 14-day course of letermovir (but will not start before obtaining the pharmacokinetics (PK) specimens following the single dose of letermovir on the Dose Finding Day). This is similar to the intensification approach that has been evaluated in the management of patients infected with human immunodeficiency virus (23-25). The day that the 14-day course of letermovir begins for Group 1 subjects will be known as Study Day 1. Serial blood samples will be obtained on Study Days 1, 5, 10, and 14 for safety chemistry and hematology labs and for Cytomegalovirus (CMV) viral loads. Cytomegalovirus (CMV) viral load will be followed as well on Study Days 21 and 42 to assess for rebound in Cytomegalovirus (CMV) following cessation of letermovir treatment on Study Day 14. Saliva and urine viral loads will be followed at these timepoint as well. Full pharmacokinetics (PK) profiles for both letermovir and ganciclovir will be obtained on Study Day 10. In addition, sparse pharmacokinetics (PK) sampling will be obtained on Study Days 1, 5, and 14. Adverse events will be assessed at each study visit during treatment, and at Study Days 21 and 42 (4 weeks after the last study drug dose). Subjects then will continue on oral valganciclovir as routine clinical care to complete an anticipated 6 month duration of total therapy. The primary Objective is to determine the systemic exposure (AUC24) of letermovir following administration of oral letermovir granules in infants with symptomatic congenital CMV disease.

Начало: 19.02.2025 Край: 31.08.2026 Възраст: до 90 г.

United States National Institute of Allergy and Infectious Diseases ( NCT06118515

Recruiting Phase 3

Testing the Addition of an Immunotherapy Drug, Cemiplimab (REGN2810), Plus Surgery to the Usual Surgery Alone for Treating Advanced Skin Cancer

Eyelid Squamous Cell Carcinoma Recurrent Eyelid Squamous Cell Carcinoma Recurrent Skin Acantholytic Squamous Cell Carcinoma Recurrent Skin Clear Cell Squamous Cell Carcinoma +16

This phase III trial compares the effect of adding cemiplimab to standard therapy (surgery with or without radiation) versus standard therapy alone in treating patients with stage III/IV squamous cell skin cancer that is able to be removed by surgery (resectable) and that may have come back after a period of improvement (recurrent). The usual treatment for patients with resectable squamous cell skin cancer is the removal of the cancerous tissue (surgery) with or without radiation, which uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Immunotherapy with monoclonal antibodies, such as cemiplimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Cemiplimab has been approved for the treatment of skin cancer that has spread or that cannot be removed by surgery, but it has not been approved for the treatment of skin cancer than can be removed by surgery. Adding cemiplimab to the usual treatment of surgery with or without radiation may be more effective in treating patients with stage III/IV resectable squamous cell skin cancer than the usual treatment alone.

Начало: 18.02.2025 Край: 14.08.2031 Възраст: от 18 г. Treatment

Australia, Canada, United States National Cancer Institute (NCI) NCT06568172

Recruiting Phase 1

A Study of LY4006896 in Healthy Participants and Participants With Parkinson's Disease

Parkinson Disease

The purpose of this study is to generate evidence of the safety, tolerability, and pharmacokinetics/pharmacodynamics of IV LY4006896 compared with placebo in healthy participants and participants with Parkinson's disease.

Начало: 18.02.2025 Край: 01.01.2028 Възраст: 30–85 г.

Japan, United States Eli Lilly and Company NCT06809400

Recruiting Phase 2

Open-label Study of Asciminib for CML-CP or CML-AP Patients With T315I Mutation Who Are Resistant, Intolerant or Ineligible to Ponatinib.

Chronic Myeloid Leukemia (CML)

The objective of this Phase II study is to assess the potential of asciminib in managing CML-CP or CML-AP in patient carrying the T315I mutation. The presence of this mutation introduces treatment difficulties due to the limited available options. The study seeks to collect additional data on the effectiveness and safety of asciminib for these patients. By determining the drug's capacity to manage the disease and enhance patients outcomes, the study is designed to fill the unmet medical need and potentially offer a new therapeutic path for patients at a treatment deadlock.

Начало: 18.02.2025 Край: 18.02.2029 Възраст: 18–99 г.

France Novartis Pharmaceuticals NCT06514534

Recruiting Phase 3

A Study to Evaluate How Well Etavopivat Works in People With Sickle Cell Disease

Sickle Cell Disease

This study is conducted to confirm whether etavopivat works well at reducing the number of Vaso-occlusive crisis VOCs (sickle cell pain crises) caused by obstructions in blood vessels in adults and adolescents living with sickle cell disease. The study will also evaluate how well etavopivat can reduce the damage to different organs, improve your exercise tolerance and reduce fatigue in people with sickle cell disease.The participants will either get etavopivat or placebo. Which treatment the participants will get is decided by chance. Etavopivat is a new medicine and is currently being tested in other studies in addition to this one. The study will last for about 2 years.

Начало: 17.02.2025 Край: 12.03.2029 Възраст: от 12 г. Treatment

Australia, Belgium, Brazil +18 Novo Nordisk A/S NCT06612268

Recruiting

Clinical Trial Evaluating the Safety and Efficacy of Nucleus Pulposus Allograft in Participants With Degenerative Disc Disease

Degenerative Disc Disease Disc Degeneration Lumbar Discogenic Pain

VIA Disc NP is a non-surgical intervention intended to supplement nucleus pulposus tissue in degenerated intervertebral discs. This is a randomized, sham-controlled, multi-center, double-blind clinical trial with an open label roll-in period of one participant per site in which participants with lumbar discogenic pain associated with DDD will receive one VIA Disc NP treatment to each affected level (up to 2 levels). Participants enrolled after the roll-in stage will be randomized on a 2:1 basis to receive either a single VIA Disc NP intradiscal injection at 1 or 2 levels or the sham procedure at 1 or 2 levels. At 12 months, participants in the sham arm with continued symptoms may cross-over, receive VIA Disc NP, and will restart the study visit schedule, completing an additional 12 months of follow-up post-cross-over.

Начало: 17.02.2025 Край: 01.05.2028 Възраст: 22–85 г.

United States VIVEX Biologics, Inc. NCT06778447

Recruiting

French Validation of Schizophrenia Proneness Instrument- Child Youth

Clinical High Risk for Psychosis (CHR)

The clinical concept of a at risk mental state of developing psychosis is based on the identification of attenuated psychotic symptoms during the prodromal phase of psychoses (Schmidt et al., 2015). Early detection and support of these symptoms can delay the risk of transition to a first psychotic episode (van der Gaag, van den Berg, \& Ising, 2019). The Basic Symptom approach enables detection at the earliest stage of the prodromal phase. It postulates that subtle, subjective manifestations predating attenuated psychotic symptoms are present very early in the prodromal phase of psychosis and also have predictive value for the risk of developing psychosis (F. Schultze-Lutter, 2009). Basic symptoms are assessed using the Schizophrenia Proneness Instrument, available in an adult (SPI-A) and child/adolescent (SPI-CY) version. These scales are part of the international recommendations for the assessment of patients with a Clinical State at High Risk of Psychosis (CHR-P) (Schmidt et al., 2015; F Schultze-Lutter et al., 2015). The SPI-A is validated in French under the name "Outil d'Evaluation du Risque Schizophrénique version adulte (OERS-A)" (Schultze-Lutter et al., 2007. French translation by JR. Teyssier with the collaboration of F. Gamma and P. Loulergue), but no French version of the SPI-CY has yet been validated. In collaboration with Dr. Frauke Schultze-Lutter, the investigators have recently published a French translation of the SPI-CY (Schizophrenia Predisposition Instrument - Version for Children and Adolescents, F. Schultze-Lutter, M. Marshall, E. Koch, 2021. French translation by F. Bernardin and C. Dondé). This French translation must now be validated to ensure the inter-rater fidelity of the interview. We therefore propose to study the inter-rater reliability of the French version of the SPI-CY by comparing ratings between clinicians who have undergone training in basic symptoms and in administering the SPI-A and SPI-CY tools by Dr. Schultze-Lutter. This validation will be carried out by comparing, on the one hand, the rating of the SPI-CY by a clinician A who has administered it to the patient and, on the other hand, the blind rating of a clinician B on the basis of the interview recorded by clinician A with his patient. The investigators will also explore the links between the SPI-CY and other clinical scales such as the Multisensory Hallucination SCale (MHASC) (Demeulemeester et al., 2015), the Prodromal Questionnaire 16 (PQ-16) (Lejuste et al., 2021), the Audiograph (Giersch, Huard, Park, \& Rosen, 2021) and the Perceptual and Cognitive Aberrations (PCA) (McDonald et al., 2019).

Начало: 13.02.2025 Край: 01.02.2027 Възраст: 12–17 г.

France Centre Psychothérapique de Nancy NCT06649552

Recruiting Phase 4

Optimization of Beta-lactam Dosing in Critically Ill Patients With Cystatin C (OPTIMIZE-GNI)

Bacterial Infection

The purpose of this study is to evaluate the abilities of Cystatin C (CysC) and CysC-based estimated Glomerular Filtration Rate (eGFR) equations to characterize the pharmacokinetics (PK) profiles of meropenem and cefepime relative to Serum Creatinine (SCR), Serum Creatinine based Equation (SCRE)and iohexol at the population and individual levels in critically ill adult patients with suspected or documented AMR Gram-negative infections. We hypothesize that CysC and CysC-based eGFR equations will characterize the PK profiles of meropenem and cefepime at the population and individual levels with greater accuracy and precision than SCR and SCREs. Iohexol will be administered to patients enrolled in the study and serve as the reference indicator of measured Glomerular Filtration Rate (mGFR), which is the gold standard assessment of kidney function. We hypothesize that the predictive performances of CysC and CysC-based eGFR equations in estimating the PK profiles of meropenem and cefepime at the population and individual levels will be comparable to iohexol. The information obtained in this study will be used to develop PK/pharmacodynamics (PD) optimized meropenem and cefepime dosing schemes based on the renal function biomarker population PK (PopPK) model with the best predictive performance for clinical use in the treatment of critically ill adult patients with suspected or documented AMR Gram-negative infections and varying degrees of renal function. The primary objective of this study is to compare the abilities of renal function biomarkers (CysC, CysC-based eGFR equations, SCR, SCREs) relative to iohexol to characterize the PK profiles of meropenem and cefepime in critically ill adult patients with suspected or documented AMR Gram-negative infections.

Начало: 12.02.2025 Край: 30.10.2026 Възраст: от 18 г.

United States National Institute of Allergy and Infectious Diseases ( NCT06709521

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