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Набира участници

Expanded Study of the HighLife 28mm Trans-septal Trans-catheter Mitral Valve in Patients With Moderate-severe or Severe Mitral Regurgitation and at High Surgical Risk

Mitral Regurgitation

to evaluate the safety and performance of the HighLife 28mm transcatheter, trans-septal Mitral Valve in patients with moderate-severe or severe mitral regurgitation who are at high risk for surgical treatment.

Начало: 28.05.2019 Край: 15.12.2031 Възраст: от 18 г. Лечение

Australia, Belgium, France +4 HighLife SAS NCT04029363

Набира участници Фаза 3

Phase III DAS181 Lower Tract PIV Infection in Immunocompromised Subjects (Substudy: DAS181 for COVID-19): RCT Study

Lower Respiratory Tract Infection Parainfluenza Immunocompromised COVID-19

This study will seek to enroll immunocompromised patients with Lower Tract parainfluenza infection. It also contains a sub-study to enroll patients with severe COVID-19.

Начало: 23.05.2019 Край: 31.08.2025 Лечение

Australia, China, Denmark +5 Ansun Biopharma, Inc. NCT03808922

Набира участници Фаза 2

Testing the Effectiveness of Two Immunotherapy Drugs (Nivolumab and Ipilimumab) With One Anti-cancer Targeted Drug (Cabozantinib) for Rare Genitourinary Tumors

Bladder Adenocarcinoma Bladder Clear Cell Adenocarcinoma Bladder Mixed Adenocarcinoma Bladder Neuroendocrine Carcinoma +41

This phase II trial studies how well cabozantinib works in combination with nivolumab and ipilimumab in treating patients with rare genitourinary (GU) tumors that has spread from where it first started (primary site) to other places in the body. Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving cabozantinib, nivolumab, and ipilimumab may work better in treating patients with genitourinary tumors that have no treatment options compared to giving cabozantinib, nivolumab, or ipilimumab alone.

Начало: 13.05.2019 Край: 28.02.2027 Възраст: от 18 г.

Puerto Rico, United States National Cancer Institute (NCI) NCT03866382

Набира участници

Feasibility of Endosphenoidal Coil Placement for Imaging of the Sella During Transsphenoidal Surgery

Pituitary Neoplasm

Tumors of the pituitary gland comprise up to 20% of all brain tumors. The central location and the small size of the pituitary gland make the management of tumors particularly challenging. Transsphenoidal surgery (TSS) to resect pituitary tumors is highly successful at achieving complete cure for functional pituitary adenomas. It is most successful when such adenomas can be localized by preoperative MRI of the pituitary. However, in some instances, small functional tumors cannot be visualized. In the case of Cushing s disease (CD), such non-visualization may be as high as 50%. The success of transsphenoidal surgery is substantially reduced in patients with negative MRI, as some of the adenomas that cause CD are so small that they are difficult to find during surgical exploration of the pituitary. Surgical success is also diminished when tumors invade the walls of the cavernous sinus. MRI of the pituitary lacks imaging resolution to detect such invasion and so the surgeon cannot perform a complete resection with surgery based on the preoperative MRI. Signal to noise ratio (SNR) is the primary constraint on achieving high quality high resolution MRI images. SNR can be improved by longer scan times or by increasing the field strength of the MRI magnet. SNR is proportional to the square of imaging time, however, long imaging times are not clinically feasible. SNR is linearly proportional to field strength, however, replacing MRI magnets is cost prohibitive. Another strong determinant of SNR is the proximity of the MRI receiver coil to the tissue being imaged. Placement of a coil in close proximity to the structure of interest dramatically increases SNR, often as much as 10-fold. Clinically this is routinely put into practice for superficial body parts, such as the temporomandibular joints, in which small coils are placed directly over the joints to achieve rapid high-resolution imaging. For deep structures, the use of superficial coils is of no benefit. This has led to the development of endocavitary coils, such as the endorectal coil used to image the prostate gland. Such coils are now in routine clinical use here at the NIH and elsewhere. During routine TSS, the surgical approach to the pituitary provides a route for placement of imaging tools, such as handheld ultrasound and Doppler probes in close proximity to the gland. Extending this model to MRI imaging, we realized that an endocavitary surface coil within the sphenoid sinus will allow for a marked improvement in SNR for imaging the sella. To this end, we have developed an endosphenoidal coil (ESC), demonstrated its MRI safety, and performed preliminary studies in cadaver heads to determine that the ESC can be placed through the transsphenoidal approach. Placement of ESC needs no modification in the surgical TSS approach to the pituitary gland. The goal of this protocol is to examine the safety and feasibility of ESC placement and imaging during TSS.

Начало: 09.05.2019 Край: 01.12.2028 Възраст: 18–85 г.

United States National Institute of Neurological Disorders and Stroke NCT03678389

Набира участници Фаза 2

A Clinical Efficacy and Safety Study of OHB-607 in Preventing Bronchopulmonary Dysplasia in Extremely Premature Infants

Bronchopulmonary Dysplasia Chronic Lung Disease of Prematurity Intraventricular Hemorrhage Retinopathy of Prematurity (ROP)

The purpose of this study is to determine if an investigational drug can prevent Bronchopulmonary Dysplasia, reducing the burden of chronic lung disease in extremely premature infants, as compared to extremely premature infants receiving standard neonatal care alone.

Начало: 09.05.2019 Край: 21.01.2028 Възраст: до 24 г. Превенция

Australia, Canada, Finland +11 OHB Neonatology Ltd. NCT03253263

Набира участници

Negative Pressure Wound Therapy in Healing Abdominal Incision in Obese Patients Undergoing Breast Reconstruction Surgery

Body Mass Index Greater Than or Equal to 30 Malignant Breast Neoplasm Mammoplasty Patient Obesity

This trial studies the safety and how well negative pressure wound therapy works in healing the abdominal incision in obese patients undergoing free flap breast reconstruction surgery. Using negative pressure wound therapy (NPWT) instead of standard dressing (bandages) may improve wound healing at the surgical site in the abdomen where tissue was collected for breast reconstruction surgery.

Начало: 02.05.2019 Край: 30.04.2028 Възраст: от 18 г.

United States M.D. Anderson Cancer Center NCT04003038

Набира участници Ранна Фаза 1

Ivacaftor for Acquired CFTR Dysfunction in Chronic Rhinosinusitis

Chronic Rhinosinusitis (Diagnosis)

The purpose of this pilot study is to explore wither ivacaftor in refractory CRS patients will demonstrate safety and tolerability; restore CFTR-mediated Cl- secretions as measured by EDSPD testing; produce detectable improvements in validated measures of CRS including the SNOT-22 questionnaire, Lund-MacKay CT scan grading, and Lund-Kennedy endoscopic scores; and provide beneficial effects on readily measured markers of sinonasal inflammation and infection (IP-10, IL-8, and Pseudomonas CFUs).

Начало: 02.05.2019 Край: 01.05.2027 Възраст: от 18 г.

United States University of Alabama at Birmingham NCT03439865

Набира участници

COLON-IM : Microbiota and Immune Infiltrate in Normal, Dysplastic and Neoplastic Colorectal Tissue

Colorectal Cancer

The primary objective of COLON-IM is to describe colorectal tissue microenvironment (neutrophils infiltrate) of patients with benign or malignant colorectal lesion (from stage I to III according to Tumor Node Metastasis (TNM)/ Union for International Cancer Control (UICC) classification).

Начало: 02.05.2019 Край: 01.12.2029 Възраст: от 18 г.

France Centre Leon Berard NCT03841799

Набира участници Фаза 1/2

Neratinib + Valproate in Advanced Solid Tumors, w/Expansion Cohort in Ras-Mutated Ca

Solid Tumor, Adult

To determine the recommended phase 2 dose (RP2D) of the combination of neratinib and sodium valproate when given to patients with advanced solid tumors. Then to explore the antitumor effects of the neratinib and sodium valproate combination in advanced solid tumors with attention to RAS-mutated tumors, EGFR-altered GBM, and ocular melanoma, as part of the phase 2 expansion cohort.

Начало: 01.05.2019 Край: 31.01.2031 Възраст: от 18 г.

United States Virginia Commonwealth University NCT03919292

Набира участници

Sensory-Motor Rehabilitation Post Stroke

Acute Stroke

Early after stroke, patients often have significant motor impairment and sensory deficit. Evidence has demonstrated heightened plasticity and significant recovery in the acute phase (first months) post stroke but there has been a lack of effective and practical protocols and devices for early intensive sensorimotor therapy.This research study will conduct a randomized clinical trial of an intensive motor-sensory rehabilitation on patients with acute stroke using a wearable rehabilitation robot. The primary aims are to facilitate sensorimotor recovery, reduce ankle impairments, and improve balance and gait functions. This clinical trial will be conducted on the Study and Control groups of acute stroke survivors.

Начало: 26.04.2019 Край: 31.12.2027 Възраст: 18–80 г.

United States University of Maryland, Baltimore NCT02369770

Набира участници

Medical Record, Physical and Neurological Data That Orient to the Diagnosis of Sacroiliac Joint Dysfunction

Sacroiliac Joint Somatic Dysfunction Low Back Pain

There are many patients coming daily to our office with the complaint of chronic lumbosacral pain radiating or not to the legs that need a proper diagnosis before any treatment is decided. The diagnosis, based mostly on radiological exams, carries a risk of failure to diagnose the sacroiliac joint as the cause of the pain. The study proposes that a quick interrogatory followed by a physical exam with the adequate provocative testing can raise the suspicion of the diagnosis that the pain is originating from the sacroiliac joint. Thereafter, a diagnostic sacroiliac joint block can be performed. The study aims to correlate findings from patient history and physical examination with eventual diagnosis.

Начало: 19.04.2019 Край: 01.12.2026 Възраст: от 18 г.

Spain University of Valencia NCT04381208

Набира участници Фаза 2

Food-Specific and Component IgE Threshold Levels That Predict Food Allergy in People With Elevated Total Serum IgE Levels and Atopic Dermatitis

Milk and/or Peanut Allergy

Background: Atopic dermatitis (AD), also called eczema, makes skin dry, red, and itchy. People with AD are more likely to get a food allergy than people without AD. But some food allergy tests are not always accurate in people with AD. Researchers want to study if people are truly allergic to milk and/or peanuts. Objectives: To improve the ways doctors test for food allergy in people with AD. Eligibility: People ages 3-21 who have had AD; have a high total IgE level (an allergic antibody); might have a milk and/or peanut allergy; and are currently enrolled in another NIH study Design: Participants will be screened under another protocol. Participants will have a physical exam, blood tests, and medical history. Participants will breathe into a plastic device that measures lung strength. Participants may get a small plastic tube inserted in their arm. Participants who have not had an allergic reaction to food in the past 3 years will do 1 or more oral food challenge (OFCs) depending on their allergies. They will eat a little bit of the food they might be allergic to. They will be watched for a reaction. If they have one, they will know for sure they are allergic. They may keep eating bigger portions of the food until they either have a reaction or finish all the food. In some OFCs, participants will get a placebo food. OFCs will last a few hours or 2 days. Participants will repeat all tests at each OFC. Participation can last up to 12 months. ...

Начало: 19.04.2019 Край: 31.12.2027 Възраст: 3–21 г.

United States National Institute of Allergy and Infectious Diseases ( NCT03835767

Набира участници Фаза 1

Safety and Immunogenicity of Ad4-HIV Envelope Vaccine Vectors in Healthy Volunteers

Healthy Volunteer

Background: Researchers want see if three new HIV (human immunodeficiency virus) vaccines are safe. Two vaccines are carried by live adenoviruses, which are natural and typically cause cold symptoms or an eye infection. Researchers want to see if all the vaccines help fight HIV and if the adenoviruses are contagious. Objectives: To test the safety and effects of three new HIV vaccines. Eligibility: Healthy adults 18-49 years old (vaccinees) Their household and intimate contacts 18-65 years old Design: Vaccinees will be screened with: Physical exam Medical history Blood and urine tests Questions about HIV risk Vaccinees will learn how to prevent spreading the viruses and about required contraception during the study. Vaccinees will get consent forms for their household and intimate contacts. All contacts must be age 18-65. All intimate contacts must sign a consent form. Contacts will have 4 visits over 8 months for blood tests and a physical exam. All applicable participants will have a pregnancy test at every visit. Vaccinees will have about 9 visits over 12 months. They will repeat screening tests and get: 1 of the 2 adenovirus vaccines sprayed in the nose at 2 visits The booster vaccine by needle in an arm at 1 visit Nasal swabs taken at some visits Vaccinees will note their temperature and symptoms for at least 1-4 weeks after each vaccine. Vaccinees may choose to have: Leukapheresis. Blood will be removed by needle in a vein in one arm. A machine will remove white blood cells. The rest of the blood will be returned into the other arm. Small pieces of the tonsil removed Sponsoring Institute: National Institute of Allergy and Infectious Diseases ...

Начало: 17.04.2019 Край: 30.11.2028 Възраст: 18–65 г.

United States National Institute of Allergy and Infectious Diseases ( NCT03878121

Набира участници

Children and Adults With Chordoma

Chordoma

Background: Chordoma is a rare type of bone cancer. It occurs in the skull base or spine. Researchers want to study people with chordoma in different ways. They hope this will help them design better future treatments and supportive care studies for this disease. Objective: To learn more about chordoma by looking at its clinical course, how it appears on imagine scans, and how it responds to therapies and treatments. Eligibility: People ages 2 and older with chordoma who are enrolled in NCI protocol 19-C-0016 Design: Participants will be screened with their medical history. Participants will have a visit to examine their disease. This will include: * Physical exam * Neurologic exam * CT scan and MRI: Participants will lie on a table. The table will slide into a machine. The machine will take pictures of the body. Participants will have other tests every 6-12 months: * Smell test * Surveys to assess their emotional, physical, and behavioral well-being and needs * Cognitive function tests Participants or their home doctors will be contacted every 6 12 months. They will be asked to provide information about their disease. This could include test results and imaging evaluations. Some participants may be asked to come to the clinic for more visits. ...

Начало: 16.04.2019 Край: 31.12.2029 Възраст: от 2 г.

United States National Cancer Institute (NCI) NCT03910465

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Pregnancy and Developmental Outcomes After Transfer of Reportedly Aneuploid or Mosaic Embryos

Aneuploidy Mosaicism Pregnancy Outcome

To determine how often embryos reported to be abnormal by preimplantation genetic testing result in liveborn infants. To evaluate whether the pregnancies that result from these embryos are higher risk for complications and whether the resulting babies have higher risk for health or developmental issues in the first five years after birth.

Начало: 11.04.2019 Край: 01.04.2039 Възраст: 18–55 г.

United States Stanford University NCT04109846

Набира участници

Aspirin 50 mg vs. 100 mg in Elderly Cardiovascular Disease Patients

Atherosclerotic Cardiovascular Disease (ASCVD) Secondary Prevention Cardiovascular Diseases

Elderly patients with cardiovascular disease face a high risk of both thrombotic and bleeding events when receiving antithrombotic therapy. The optimal dose of aspirin for secondary prevention in this population remains uncertain, particularly in Chinese elderly individuals. This multicenter, prospective cohort study aims to evaluate the effectiveness and safety of a lower dose of aspirin (50 mg daily) compared with the standard dose (100 mg daily) for secondary prevention of atherosclerotic cardiovascular disease (ASCVD) in Chinese patients aged 60 years and older. The study is an extension of the existing LAPIS cohort (ChiCTR1900021980), which has enrolled 5,448 participants receiving long-term aspirin for secondary prevention. Participants will be followed for an additional 2 years (total follow-up up to approximately 6 years) through telephone, clinic visits, and electronic medical records. The primary effectiveness outcome is the first occurrence of major adverse cardiovascular events (MACE), including non-fatal myocardial infarction, unstable angina, need for revascularization, non-fatal stroke, transient ischemic attack, and cardiovascular death (excluding intracranial bleeding). The primary safety outcome is the first occurrence of bleeding events (classified by BARC criteria). A secondary aim is to develop and validate a risk prediction model (nomogram) for thrombotic and bleeding events specifically for elderly Chinese patients receiving antithrombotic therapy, using LASSO regression and Cox proportional hazards models. The study will provide real-world evidence to guide individualized antithrombotic management in the aging Chinese population.

Начало: 10.04.2019 Край: 31.12.2027 Възраст: от 60 г.

China Peking University First Hospital NCT07542860

Набира участници Фаза 3

A Study of Baricitinib in Participants From 1 Year to Less Than 18 Years Old With Juvenile Idiopathic Arthritis

Juvenile Idiopathic Arthritis

The reason for this study is to see if the study drug baricitinib is safe and effective in the treatment of JIA in participants ages 1 to 17. This study is for participants that have been enrolled in studies I4V-MC-JAHV (NCT03773978) or I4V-MC-JAHU.

Начало: 05.04.2019 Край: 01.07.2031 Възраст: 1–18 г. Лечение

Argentina, Australia, Belgium +15 Eli Lilly and Company NCT03773965

Набира участници Фаза 3

An Open-label Study to Assess Safety and Efficacy of SZC in Paediatric Patients With Hyperkalaemia

Hyperkalaemia

Sodium zirconium cyclosilicate has been shown to be effective and safe in adults for the treatment of hyperkalaemia, and therefore it is expected to be beneficial in children. This study will evaluate the efficacy, safety and tolerability of sodium zirconium cyclosilicate for the treatment of hyperkalaemia in children \

Начало: 02.04.2019 Край: 21.02.2030 Възраст: до 18 г.

Brazil, Canada, China +10 AstraZeneca NCT03813407

Набира участници

Role of "Asthma School" in Disease Management

Asthma

According to the definition provided by the GINA guidelines, asthma is characterized by a variable and reversible limitation of expiratory airflow and by the following symptoms: wheezing, dyspnoea, thoracic constriction and/or cough. The type and the severity of airflow limitation can vary over time (1) depending on external agents, such as physical exercise, polluting agents, climate changes and viral infections. The therapy is mainly based on the use of inhaled corticosteroids and bronchodilators. Patients affected by severe asthma (\~ 10% of total prevalence of asthma and at high risk of exacerbations and/or hospitalization) may not control their symptoms, even if exposed to maximal doses of inhalation therapy.The behavioural sciences can potentially help to find the psychological factors behind scarce adherence and to develop strategies with the aim of improving the interactive processes between patients, medical doctors and health care professionals

Начало: 01.04.2019 Край: 15.12.2026 Възраст: 18–85 г.

Italy Istituti Clinici Scientifici Maugeri SpA NCT04442646

Набира участници

Longitudinal Studies of Patient With FPDMM

Inherited Hematological Diseases Rare Diseases FPDMM

Background: Genes tell the body and its cells how to work. Familial platelet disease (FPD) or FPD with associated malignancies (FPDMM) is caused by a variant in the gene RUNX1. People with this disease may have problems with their blood and bleed for a long time when they are injured. Researchers want to learn more about RUNX1 variants and FPD. Objective: To learn more about FPD in people with RUNX1 variants to lead to better diagnosis, monitoring, and treatment. Eligibility: People any age with a suspected or confirmed RUNX1 variant People who have a family member with the variant Design: All participants will be screened with a phone call and a blood, saliva, or cheek cell sample. Participants with a suspected or confirmed variant will have 1 visit. It will last about 2 days. They will then have visits at least once a year. Visits will include: * Medical history and physical exam * Blood tests or saliva sample * Possible skin biopsy: A small piece of the participant s skin will be removed. * Bone marrow aspiration or biopsy: The participant s bone marrow will be removed by needle from a large bone such as the hip bone. * Possible apheresis: Blood will be removed from the body and certain blood cells will be taken out. The rest of the blood is returned to the body. Between visits, participants with a suspected or confirmed variant will keep a diary of disease symptoms and signs. Samples from all participants may be used for genetic testing

Начало: 28.03.2019 Край: 31.12.2028 Възраст: 1–100 г.

United States National Human Genome Research Institute (NHGRI) NCT03854318

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