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NCT ID: NCT05206552 Not yet recruiting - Clinical trials for Maternal Care Patterns

The Correlation Between Maternal Infant Bonding, Pain and Postpartum Depression

Start date: January 25, 2022
Phase:
Study type: Observational

The delivery process can be associated with significant maternal pain. which has many long and short term affects. The aim of our study is to assess whether pain during and after childbirth negatively impacts a mother's attachment to her baby (maternal bonding) and the increases the incidence of postpartum depression.

NCT ID: NCT05206357 Not yet recruiting - Clinical trials for Indolent Non-hodgkin Lymphoma

Study of the Adverse Events and Change in Disease State of Pediatric Participants (and Young Adults Between the Ages of 18-25) With Relapsed/Refractory Aggressive Mature B-cell Neoplasms Receiving Subcutaneous (SC) Injections of Epcoritamab

Start date: May 9, 2022
Phase: Phase 1
Study type: Interventional

The most common types of mature B-cell lymphomas (MBLs) in children are Burkitt lymphoma (BL) and diffuse large B-cell lymphoma (DLBCL). Initial treatment cures 90% - 95% of children with these malignancies, leaving a very small population of relapsed/refractory disease with a poor prognosis. The purpose of this study is to assess the safety and tolerability of epcoritamab in pediatric participants with relapsed/refractory aggressive mature B-cell neoplasms and young adult participants with Burkitt's or Burkitt-like lymphoma/leukemia. Adverse events and change in disease activity will be assessed. Epcoritamab is an investigational drug being developed for the treatment of relapsed/refractory aggressive mature B-cell neoplasms. Participants will receive subcutaneous (SC) of epcoritamab. Approximately 15 pediatric participants with a diagnosis of relapsed/refractory aggressive mature B-cell neoplasms and and young adult participants, ages of 18-25, with a diagnosis of Burkitt's or Burkitt-like lymphoma/leukemia will be enrolled at 50 sites globally. Participants will receive subcutaneous epcoritamab in 28-day cycles. Participants will be followed for a minimum of 3 years after enrollment. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.

NCT ID: NCT05205642 Recruiting - COVID-19 Clinical Trials

Exercise Fatigue Parameters and Endothelial Function in Pediatric Patients With a History of COVID-19 Infection or MIS-C

Start date: November 1, 2021
Phase: N/A
Study type: Interventional

Acute coronavirus disease 2019 (COVID-19) infection can include cardiac and pulmonary manifestations as well as post-infectious complications such as multisystem inflammatory syndrome (MIS-C), also known as pediatric inflammatory multisystem syndrome (PIMS / PIMS-TS). The precise etiology for COVID-19 symptoms and MIS-C is still obscure but there is evidence that endothelial damage may play a role. At recovery, symptoms such as dyspnea, fatigue, weakness, myalgia, chest pain and palpitations are prevalent. Data regarding functional capacity, cardiopulmonary and vascular function post COVID-19 infection are scarce. To the best of our knowledge, few studies has evaluated functional capacity of patients recovering from COVID-19 infection and complications using cardiopulmonary exercise testing (CPET), and no study included endothelial function assessment. Aims I. To investigate the effect of COVID-19 infection on cardiovascular and pulmonary function and exercise parameters in the pediatric and adult population. II. To investigate the effect of PIMS on endothelial function in pediatric population. Research hypothesis: 1. After COVID-19 infection, aerobic function is impaired due to cardiac and/or pulmonary limitation 2. Endothelial function in children after PIMS is impaired in comparison to healthy individuals and to patients after COVID infection with mild symptoms. Importance of the study: Cardiovascular and pulmonary assessment of patients recovering from COVID-19 infection using CPET and Peripheral Arterial Tonography (EndoPATâ„¢) has not been reported previously, and will provide new insights into the long term significance of COVID-19 infection.

NCT ID: NCT05202002 Recruiting - Clinical trials for Diabetes Mellitus, Type 2

Decrease Type II Diabetes in Gestational Diabetes Population

Start date: March 1, 2021
Phase: N/A
Study type: Interventional

The goal of the study is to examine the impact of an educational video on the rate of breastfeeding in mothers who had gestational diabetes mellitus, and the rate of type-II diabetes mellitus diagnosed postpartum.

NCT ID: NCT05201404 Not yet recruiting - Clinical trials for Hepatocellular Carcinoma

Namodenoson in the Treatment of Advanced Hepatocellular Carcinoma in Patients With Child-Pugh Class B7 Cirrhosis

LIVERATION
Start date: February 2022
Phase: Phase 3
Study type: Interventional

This is a clinical trial in patients with advanced hepatocellular carcinoma (HCC) and Child-Pugh Class B7 (CPB7) cirrhosis whose disease has progressed on at least 1st-line therapy. The trial will evaluate the efficacy and safety of namodenoson as compared to placebo.

NCT ID: NCT05200650 Not yet recruiting - Clinical trials for Head and Neck Cancer

A Single Arm, Prospective, Open Label, Multi Center, Phase Ib Study to Evaluate the Safety, Tolerability and Initial Efficacy of a Single Intra-tumoral Injection of IntraGel's Polymer-based Cisplatin-loaded Gel (TumoCure) in Subjects With Progressive or Radio-resistant Primary Head and Neck Tumor

Start date: March 15, 2022
Phase: Phase 1
Study type: Interventional

IntraGel's polymer-based Cisplatin loaded Gel (TumoCure) is a single injectable compound, aimed at localized chemotherapy treatment. The treatment is offered to patients who currently have no other available treatment options, either due to inefficacy, intolerability or inapplicability of standard treatment

NCT ID: NCT05196269 Not yet recruiting - Breast Cancer Clinical Trials

Comparing Decision on Aesthetics After Breast Cancer Locoregional Treatment.

CINDERELLA
Start date: June 2022
Phase: N/A
Study type: Interventional

Breast cancer is the most commonly diagnosed cancer, with an estimated 2.3 million new cases per year globally. Approximately 90% of these patients will undergo breast surgery with/without radiation (locoregional treatment). Different surgical techniques can be offered to the patient, each leading to completely different aesthetic outcomes. Moreover, for different patients, undergoing the same surgery, the aesthetic outcome could be completely different based on individual patient's factors (e.g, age, body habitus). In the CINDERELLA trial the investigators will be using the (Breast Locoregional (BreLO) AI system (an artificial intelligence-based tool for classification of aesthetic outcomes and matching data and photographs) integrated in CANKADO (a cloud-based healthcare platform) to create an easy-to-use application that can be used on any electronic device, to simulate visually to the patient the aesthetic outcome of a certain surgery or radiation treatment. In the CINDERELLA trial the investigators plan to compare if the application helped to fulfil the expectations and lead to better quality of life compared with the classical approach. In the classical approach (control arm) doctors usually propose a locoregional treatment and explain theoretically how the result will be. Nurses help by explaining further details about surgery and possible outcomes. In the majority of centers no photographic evaluation is done and expectations are not measured. The CINDERELLA trial will help to overcome any miscommunication and potential boundaries in patient's or physician's understanding of the potential outcomes of locoregional treatment of breast cancer.

NCT ID: NCT05196035 Not yet recruiting - Clinical trials for Chronic Kidney Disease

A Study to Learn More About How Well the Study Treatment Finerenone Works, How Safe it is, How it Moves Into, Through, and Out of the Body, and the Effects it Has on the Body When Taken With an ACE Inhibitor or Angiotensin Receptor Blocker in Children With Chronic Kidney Disease and Proteinuria

FIONA
Start date: January 19, 2022
Phase: Phase 3
Study type: Interventional

Researchers are looking for a better way to treat children who have chronic kidney disease (CKD), which is long-term kidney disease, and proteinuria, a condition in which a person´s kidneys leak protein into the urine. The kidneys filter waste and fluid from the blood to form urine. In children with CKD, the kidney´s filters do not work as well as they should. This can lead to accumulation of waste and fluid in the body and proteinuria. CKD can lead to other medical problems, such as high blood pressure, also known as hypertension. Vice versa, hypertension and proteinuria can also contribute to worsening of CKD. Therefore, the treatment of CKD aims to control blood pressure and proteinuria. There are treatments available for doctors to prescribe to children with CKD and hypertension and/or proteinuria. These include "angiotensin-converting enzyme inhibitors" (ACEI) and "angiotensin receptor blockers" (ARB). Both ACEI and ARB can improve kidney function by helping the renin-angiotensin-aldosterone system (RAAS) to work normally. The RAAS is a system that works with the kidneys to control blood pressure and the balance of fluid and electrolytes in the blood. In people with CKD, the RAAS is often too active, which can stop the kidneys from working properly and cause hypertension and proteinuria. However, ACEI or ARB treatment alone does not work for all patients with CKD as they only target the angiotensin part of the renin-angiotensin-aldosterone system. The study treatment, finerenone, is expected to help control RAAS overactivation together with an ACEI or ARB. So, the researchers in this study want to learn more about whether finerenone given in addition to either an ACEI or ARB can help their kidney function. The main purpose of this study is to learn more about whether finerenone added to either ACEI or ARB can help reduce the amount of protein in the participants' urine more than a placebo. A placebo looks like a treatment but does not have any medicine in it. Participants will also continue to receive their other medications. To see how the treatment work, the doctors will take samples of the participants' urine to measure their protein levels before and during taking treatment and after their last treatment. In addition, blood samples will be taken to monitor kidney function, electrolytes and the amount of finerenone in the blood as well as for other tests. This study will include children with CKD and proteinuria aged from 6 months up to less than 18 years. The participants will take: - either finerenone or the placebo, in addition to - either ACEI or ARB, whichever they take as part of their normal treatment Two visits are required up to 104 days, to check whether a child can take part in the treatment phase of the study. If participants qualify for the treatment phase, they will then undergo treatment for about 180 days. During this time, they will visit the study site at least 7 times. During these visits, the participants will: - have their blood pressure, heart rate, temperature, height and weight measured - have blood and urine samples taken - have physical examinations - have their heart examined by an electrocardiogram and echocardiography (a sonogram of the heart) - answer questions about their medication and whether they have any adverse events , or have their parents or guardians answer - answer questions about how they are feeling, or have their parents or guardians answer - answer question about how they like the study medication, or have their parents or guardians answer The doctors will keep track of any adverse events. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments. The doctors will check the participants' health about 30 days after the participants take their last treatment.

NCT ID: NCT05195749 Recruiting - COVID-19 Clinical Trials

A Prospective, Phase II Study to Evaluate Safety of 101-PGC-005 ('005) for Moderate to Severe COVID-19 Disease Along With Standard of Care

Start date: January 13, 2022
Phase: Phase 2
Study type: Interventional

In December 2019, a novel pneumonia caused by a previously unknown pathogen emerged in Wuhan, China. The pathogen was soon identified as a novel coronavirus (SARS-CoV-2), which is closely related to severe acute respiratory syndrome CoV (SARS-CoV) COVID-19, caused by the SARS-CoV-2 virus, leading to a major global public health threat. Many COVID-19 patients develop acute respiratory distress syndrome (ARDS) leading to death. The recent RECOVERY Trial demonstrated the success of dexamethasone in treating late-stage COVID-19 patients. However, use of dexamethasone increases mortality in the early stage of the disease, and dexamethasone is further limited because the therapeutic dose and duration is insufficient to safely and effectively treat most COVID-19 patients. As the majority of cells have glucocorticoid receptors to which dexamethasone binds, highly toxic doses would be needed to effectively treat COVID-19, which results in increased mortality as well as decreased natural immunity (via T-cell and other immune cell modulation). The investigational product 101-PGC-005 ('005) - a prodrug of dexamethasone that is targeted to only activated macrophages - will address the many safety and efficacy issues that limit dexamethasone. '005 can achieve much higher anti-inflammatory doses and avoid all undesirable immunosuppressive activities caused by standard dexamethasone administration, resulting in an even greater reduction in mortality among hospitalized patients and significantly reducing long term morbidity in patients who survive.

NCT ID: NCT05192863 Not yet recruiting - Crohn's Disease Clinical Trials

A Study of Vedolizumab in Adults With Crohn's Disease (CD)

SUNRISE
Start date: March 31, 2022
Phase:
Study type: Observational

The main aim of this study is to see if adults with CD treated with vedolizumab have less symptoms and inflammation of the bowel assessed by ultrasonography. Participants will be treated with vedolizumab according to their clinic's standard practice.