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EARLY Intervention in Parent-professional Cooperation in Cerebral Palsy

Cerebral Palsy

Cerebral Palsy (CP) is the most common motor disability in children. It is due to damage that occurs during brain development in the fetus or infant. Early treatment (before 2 years) will allow the child to promote brain plasticity to compensate for the effects of the lesion and reduce the severity of CP. The goals of early intervention are to increase motor, cognitive and communication skills, prevent complications and provide parental support. Most authors agree to recognize the benefit of early care by emphasizing home intervention programs with active parental participation. To date, no recommendations exist in France for the management of cerebral palsy in children under the age of two. It is therefore necessary to conduct scientific studies in this population. Based on published international studies, the PRECOP program (PREcoce intervention in parent-professional COoperation in Cerebral Palsy) consists of individualized care adapted to the specific needs of each child, from the arrival of the infant at home, by a multidisciplinary team during the child's first two years.

Начало: 14.03.2025 Край: 14.09.2029 Възраст: до 3 г.

France Hospices Civils de Lyon NCT06180291

Набира участници Фаза 3

A Study of SHR-A1811 in Subjects With Ovarian Cancer

Ovarian Cancer

This is an open-label study to evaluate the safety and efficacy of SHR-A1811 for injection in subjects with ovarian cancer.

Начало: 13.03.2025 Край: 01.12.2027 Възраст: 18–75 г.

China Jiangsu HengRui Medicine Co., Ltd. NCT06828354

Набира участници

Remote Audiometry to Monitor for Treatment-Related Hearing Loss in Patients With H&N SCC Receiving Cisplatin and/or Radiation

Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 Cutaneous Squamous Cell Carcinoma of the Head and Neck Head and Neck Carcinoma of Unknown Primary Head and Neck Squamous Cell Carcinoma +29

This clinical trial tests the impact of offering hearing tests (audiometry) close to home and remotely on participation in monitoring for treatment-related hearing loss in patients with head and neck squamous cell cancer receiving cisplatin and/or radiation. Cisplatin, a chemotherapy often used to treat head and neck cancers, and radiation given near the ear can cause hearing loss in some patients. Hearing loss can have a major negative impact on quality of life, contributing to social isolation and frustration. Identifying hearing changes may allow treatment changes to prevent further loss. Audiometry measures hearing loss using a graphic record of the softest sounds that a person can hear at various frequencies. It is recommended patients have a hearing test before, during and after treatment to monitor for any hearing loss. This is usually done in the office and performed on the same day as other visits whenever possible, however, patients who live far away or have stage IV cancer, may have more difficulty coming back for hearing tests. Offering close to home and remote audiometry may improve monitoring for hearing loss in patients with head and neck squamous cell cancer receiving cisplatin and/or radiation.

Начало: 12.03.2025 Край: 31.10.2029 Възраст: от 18 г.

United States Emory University NCT06662058

Набира участници Фаза 2

Belumosudil to Block Chronic Lung Allograft Dysfunction (CLAD) in High Risk Lung Transplant Recipients

Lung Transplant

The purpose of this study is to see if taking the study drug, Belumosudil, for 52 weeks in addition to your usual care and medication, will prevent Chronic Lung Allograft Dysfunction (CLAD) in participants who have a lung biopsy that shows evidence of rejection or inflammation to the transplanted lung(s). For this study, biopsies that show evidence of Acute Rejection (AR), Lymphocytic Bronchiolitis (LB), Organizing Pneumonia (OP) or Acute Lung Injury (ALI) are referred to as "Qualifying Biopsies"; patients who had evidence of one or more of these conditions on a recent biopsy are eligible for enrollment in this study. Belumosudil is an investigational drug that blocks a molecule in the body that reduces inflammation and scarring and may play a role in the development and progression of CLAD. Belumosudil is a drug approved by the FDA to treat adults and children 12 years and older with chronic graft-versus-host disease (cGVHD), a condition with some similarities to CLAD. The primary objective it to determine the efficacy of treatment with Belumosudil + maintenance immunosuppression (IS) versus placebo + maintenance IS on preventing the subsequent development of probable or definite CLAD, lung retransplant, or death.

Начало: 12.03.2025 Край: 30.06.2027 Възраст: от 12 г.

Canada, United States National Institute of Allergy and Infectious Diseases ( NCT06476132

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Mitigating the Impact of Stigma and Shame Among People Living With HIV and Substance Use Disorders

Hiv Substance Use Disorders

People living with HIV and substance use disorders (SUDs) are less likely to be virally suppressed, which can lead to HIV transmission and negative health outcomes. This hybrid type 1 study will assess the efficacy, mechanisms, as well as facilitators and barriers to implementing the MATTER intervention, a virtually delivered 5-session text-enhanced psychobehavioral intervention designed to facilitate viral suppression by addressing internalized stigma and shame as barriers to engagement in HIV care among individuals living with HIV and SUDs in two locations with different levels of HIV resources (i.e., the Boston, Massachusetts and Miami, Florida metro areas). MATTER aims to mitigate the negative behavioral consequences of internalized stigma and shame on viral suppression by a) developing behavioral self-care goal setting skills and related self-efficacy, b) increasing metacognitive awareness (i.e., non-judgmental awareness of emotions and cognitions), and c) teaching and reinforcing compassionate self-restructuring (i.e., self- compassion), in addition to providing access to phone-based resource navigation. Scalable interventions such as MATTER are essential to our efforts to end the HIV epidemic in high priority regions.

Начало: 12.03.2025 Край: 01.07.2028 Възраст: от 18 г.

United States Boston University NCT05934305

Набира участници Фаза 1

A Study to Learn About How Safe BAY 3389934 is, Its Suitable Dose, and How it Affects the Participants With Sepsis Induced Coagulopathy

Sepsis Coagulopathy

Researchers are looking for a better way to treat people who have sepsis induced coagulopathy. Sepsis happens when bacteria and their toxins spread in the blood, causing an infection. To overcome the infection the body responds activating the immune system, sometimes this immune response is too active and causes uncontrolled blood clot formation, also called sepsis-induced coagulopathy. Sepsis coagulopathy damages blood vessels and organs and leads to low platelet levels in the body. In severe cases, it can even lead to death. The main purpose of this first in patient study is to learn about how safe BAY 3389934 is, its suitable dose, and how it affects the participants with sepsis induced coagulopathy. For this study, researchers will enroll people receiving treatment for sepsis induced coagulopathy in a hospital intensive care unit (ICU). For this, the researchers will collect the number of participants with medical problems during and after receiving BAY 3389934. These medical problems are also known as "adverse events". Doctors keep track of all medical problems that happen in studies, even if they do not think they might be related to the study treatments. Participants will be divided into 2 groups. The first group will receive the lowest starting dose of BAY3389934. The researcher will carefully monitor how the participant responds to the medication and may adjust the dose, either increasing or decreasing it based on the safety and the tolerability of the drug. If no serious side effects are reported from the first group, the second group will receive higher dose of BAY3389934. Each participant will be in the study for around 28 days. During the study, the doctors and their study team will: * Take blood and urine samples, * Do physical examinations, * Check vital signs such as body temperature, blood pressure and heart rate, * Examine heart health using electrocardiogram (ECG)

Начало: 12.03.2025 Край: 15.02.2027 Възраст: 18–80 г.

Belgium, France, Germany +1 Bayer NCT06854640

Набира участници Фаза 2

A Study of Novel Study Interventions and Combinations in Participants With Colorectal Cancer

Metastatic Colorectal Cancer

The main purpose of this study is to evaluate the safety and efficacy of novel study interventions and combinations in participants with Colorectal Cancer (CRC).

Начало: 12.03.2025 Край: 07.06.2028 Възраст: 18–130 г. Лечение

Australia, Canada, China +9 AstraZeneca NCT06792695

Набира участници Фаза 2

BMS-986489 (Atigotatug + Nivolumab) vs Durvalumab in Limited-stage Small-cell Lung Cancer (TIGOS-LS)

Limited Stage Small Cell Lung Cancer

This is an open-label, randomized study of BMS-986489 (atigotatug + nivolumab fixed-dose combination) vs durvalumab in limited-stage (LS)-small-cell lung cancer (SCLC) participants. The main goals of this study are to: * Evaluate the efficacy of BMS-986489 vs durvalumab * Evaluate the safety profile of BMS-986489

Начало: 11.03.2025 Край: 01.09.2032 Възраст: от 18 г.

United States SCRI Development Innovations, LLC NCT06773910

Набира участници

Hearing Aids for Veterans With Functional Hearing Difficulties

Auditory Processing Disorder

Every year, approximately 100,000 Veterans seek help at VA Audiology clinics for hearing and communication difficulties only to learn that they have normal hearing sensitivity. Unfortunately, there are very few established options to improve hearing and listening for these patients. To address this need, audiologists are increasingly prescribing hearing aids set to provide a small amount of amplification. Patients may benefit from the amplification or from modern hearing aid features such as noise reduction technology and the ability to stream sounds from a desired sound source directly to their ears thus reducing the background noise. This project will help to determine if prescribing hearing aids to patients without hearing loss is, in fact, beneficial and if so, why. It will also help to determine if some patients benefit more from hearing aids than others so that in the future, rehabilitation strategies can be better targeted toward individuals.

Начало: 09.03.2025 Край: 31.03.2028 Възраст: 18–79 г.

United States VA Office of Research and Development NCT06117254

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Clinical and Instrumental Assessment Tools for Neurogenic Dysphagia: Translation and Validation

Dysphagia

This study aims to translate and validate Italian versions of several clinical assessment tools for patients with neurogenic dysphagia. The instruments include: The New Zealand Secretion Severity Scale, which evaluates secretion management; The Reflex Cough Test from the I\&I cranial nerves assessment; The VASES scale used during fiberoptic endoscopic evaluation of swallowing; The Drooling Severity Scale, which measures saliva control. The study will include approximately 100 patients with neurogenic dysphagia. The goal is to provide reliable, standardized tools in Italian to support clinicians in assessing swallowing and oral-motor function in patients with neurological disorders.

Начало: 09.03.2025 Край: 30.12.2028 Възраст: 18–85 г.

Italy IRCCS San Camillo, Venezia, Italy NCT07549724

Набира участници

Inorganic Nitrate Supplementation in Chronic Hypertensive Pregnancies

Hypertension in Pregnancy Hypertension Pregnancy

High blood pressure during pregnancy poses significant risks to both the mother and baby. A combination of factors, including advancing maternal age, rising obesity rates, and metabolic health issues, have amplified the prevalence of this condition. While conventional medicines are available, safety during pregnancy remains a concern. Recent studies suggest that inorganic nitrate might be a safer alternative. The power of nitrate lies in its ability to stimulate the body's production of a compound that aids in dilating and relaxing blood vessels. Preliminary studies conducted on mice and a select group of pregnant women have yielded encouraging results. Early tests indicated that after consuming inorganic nitrate, there was a reduction in blood pressure and an improvement in the health of the mother's uterine artery-a vital vessel responsible for nourishing the fetus. Our study aims to investigate the effects of inorganic nitrate supplementation on pregnant women from the start of their pregnancy and continuing it throughout their term. If our findings are positive, it could revolutionize how we approach blood pressure management during pregnancy, paving the way for healthier futures for both mothers and babies.

Начало: 06.03.2025 Край: 01.07.2027 Възраст: от 18 г.

Brazil University of Sao Paulo NCT06105775

Набира участници Фаза 2

Embryonal Tumor With Multilayered Rosettes

Embryonal Tumor With Multilayered Rosettes Embryonal Tumor With Multilayered Rosettes, Nos

This is an open-label, comprehensive, iterative investigation of evaluating the use of induction chemotherapy, high-dose chemotherapy, and focal radiation therapy in children with newly diagnosed Embryonal Tumor With Multilayered Rosettes (ETMR).

Начало: 06.03.2025 Край: 31.03.2032

United States University of California, San Francisco NCT06861244

Набира участници Фаза 3

Study to Provide Continued Access to Treatment for Patients Completing a Previous Trial With Efanesoctocog Alfa

Haemophilia A (Moderate or Severe)

This is a multinational, prospective, open-label, roll-over study in patients with haemophilia A, ≥6 years of age, who have completed participation in any of the parental studies with efanesoctocog alfa; XTEND-ed study (LTS16294), FREEDOM study (Sobi.BIVV001-001), PK comparison study (Sobi.BIVV001-003) or SHINE study (Sobi.BIVV001-004). The aim of the study is to provide patients with continuous benefit from efanesoctocog alfa treatment and to further continue clinical monitoring for safety and efficacy until efanesoctocog alfa is commercially available in each patient's respective country (or until March 2027, whichever comes first). The study starts with the Baseline Visit, which will be done in connection to the end of treatment at the EoT/EoS visit (or equivalent) in the respective parent study. Subsequent study visits (on site or phone call) will be done approximately every 13 weeks until End of Treatment. An End of Study safety phone call will be done 14 (+7) days after the End of Treatment Visit.

Начало: 06.03.2025 Край: 01.03.2027 Възраст: от 6 г.

Bulgaria, France, Greece +4 Swedish Orphan Biovitrum NCT06716814

Набира участници

The Effect of Hyperbaric Oxygen Therapy on Circulating Hematopoietic Stem Cell Population

Circulating Hematopoietic Stem Cells

Hematopoietic stem cells (HSCs), which govern the production of all blood lineages, transition through a series of functional states characterized by expansion during fetal development, functional quiescence in adulthood, and decline upon aging. Although research on aging has for a long time been relatively descriptive, much progress has been made in the past decade to uncover the molecular drivers of biological aging. One such drivers relates to stem cell exhaustion. The amount and the function of HSCs decline in humans along aging. This decline is characterized by different changes such as signaling, epigenetic, cell surface markers etc. Various studies have been conducted to identify HSCs surface markers using flow cytometry. Exposure to Hyperbaric Oxygen Therapy (HBOT) induce stem cells proliferation mobilization of stem progenitor cells (SPCs) in both animal and humans studies, and the number of SPCs remain elevated in blood over the course of 20 HBOT . Additionally, Heyboer et al have found dose response curve between the HBOT protocol and circulating CD34+ and CD45-dim (stem cells potential markers): increasing the treatment pressure from 2.0 ATA to 2.5 ATA increased the concentration of circulating stem cells. The aim of the current study is to evaluate the effect of HBOT on circulating hematopoietic stem cells, in the peripheral blood of patients who are candidate for HBOT.

Начало: 05.03.2025 Край: 30.12.2027 Възраст: 20–80 г.

Israel Assaf-Harofeh Medical Center NCT06748586

Набира участници Фаза 3

A Study to Investigate the Efficacy and Safety of Sonrotoclax Plus Zanubrutinib Compared With Placebo Plus Zanubrutinib in Adults With Relapsed/Refractory Mantle Cell Lymphoma (CELESTIAL-RRMCL)

Mantle Cell Lymphoma B Cell Lymphoma

The goal of this study is to compare how well sonrotoclax plus zanubrutinib works versus zanubrutinib plus placebo in treating adults with relapsed/refractory (R/R) mantle cell lymphoma (MCL). This study will also look at the safety of sonrotoclax plus zanubrutinib versus zanubrutinib plus placebo.

Начало: 05.03.2025 Край: 30.03.2032 Възраст: от 18 г. Лечение

Argentina, Australia, Austria +14 BeOne Medicines NCT06742996

Набира участници Фаза 2

A Study of TYRA-300 in Children With Achondroplasia: BEACH301

Achondroplasia

The purpose of this study is to evaluate the safety, tolerability, and identify potentially effective dose(s) of TYRA-300 in children with achondroplasia with open growth plates.

Начало: 04.03.2025 Край: 01.06.2030 Възраст: 3–10 г. Лечение

Australia, Canada, Spain +1 Tyra Biosciences, Inc NCT06842355

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Neural and Psychiatric Consequences of Cannabis Use in Adolescents

Cannabis Use Depression

The goal of this study is to investigate the effects of cannabis on brain function among adolescents with depression.

Начало: 04.03.2025 Край: 01.06.2029 Възраст: 14–20 г.

United States University of Miami NCT06941298

Набира участници

Temporal Interference Stimulation for Social Cognition

Healthy Controls

The long-term goal of this project is to evaluate whether a procedure termed transcranial interference stimulation (tIS) may be useful in the future in the treatment of severe neuropsychiatric disorders such as schizophrenia. The purpose of this stage of the project is to evaluate the safety and tolerability of tIS administration in healthy volunteers. This study involves 10 healthy participants without known psychiatric illness X 3 successive doses. Participants may participate in 1-3 doses, yielding a total sample size of 10-30 individuals across doses. The dose of tIS will be escalated progressively across doses. Functional magnetic resonance imaging (fMRI), magnetic resonance spectroscopy (MRS) and side effect checklists will be used to assess tIS safety/tolerability at each dose. In addition, electroencephalogram (EEG) will be collected simultaneously with tIS and used to assess target engagement. Face emotion recognition (FER) data will also be collected, but will be used for feasibility assessment only. If successful, these studies will form the basis for future studies in schizophrenia.

Начало: 03.03.2025 Край: 29.02.2028 Възраст: 18–55 г.

United States Columbia University NCT06607432

Набира участници Фаза 2

A Phase 2 Study of YA-101 in Patients With Multiple System Atrophy

Multiple System Atrophy

This is a Phase 2, double-blind, placebo-controlled, multi-center, Phase II, dose escalation study to evaluate the safety, tolerability, pharmacokinetics and efficacy of Ya-101 in subjects with multiple system atrophy.

Начало: 03.03.2025 Край: 31.12.2026 Възраст: от 30 г.

Japan, Taiwan, United States Dasher Neuroscience Inc. NCT06848231

Набира участници Фаза 1/2

A Study to Evaluate ALN-4324 in Overweight to Obese Healthy Volunteers and in Overweight to Obese Patients With T2DM

Obese or Overweight Healthy Volunteers Type 2 Diabetes Mellitus (T2DM)

The purpose of this study is to: * evaluate the safety and tolerability of single ascending doses of ALN-4324 in healthy volunteers and to characterize the single-dose PK of ALN-4324 * evaluate the efficacy, safety, tolerability, and pharmacodynamics (PD) of multiple doses of ALN-4324 in adult overweight to obese patients with T2DM

Начало: 03.03.2025 Край: 31.08.2027 Възраст: 18–75 г.

Argentina, Canada, Germany +2 Alnylam Pharmaceuticals NCT06845202

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