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NCT ID: NCT05054465 Not yet recruiting - Clinical trials for Acute Lymphoblastic Leukemia

A Phase 1b-2 Trial to Assess Venetoclax and Navitoclax Consolidation and Post-transplant Maintenance in High-risk Patients With T-ALL

ITALLI001
Start date: October 1, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

This is a national, multicenter, phase II clinical trial to evaluate the potential benefit of pre-transplant consolidation and post-transplant maintenance with navitoclax and venetoclax in patients with T-ALL, LBL and MPAL T/M in first complete remission designated for allogeneic transplantation. Pre-transplantation consolidation with venetoclax and navitoclax: Patients in CR designated for transplantation will be treated with venetoclax 400 mg QD and navitoclax 50mg QD according to the RP2D presented by Pullarkat et al. (Cancer Discov . 2021 Feb 16;candisc.1465.2020. doi: 10.1158/2159-8290.CD-20-1465.) for two 28 day cycles. Following 2 cycles re-staging marrow including MRD assessment and imaging as need will be followed by alloSCT according to local protocol. Post-transplantation maintenance with venetoclax and navitoclax: Within 90 days from alloSCT patients will be started on venetoclax and navitoclax maintenance. Due to lack of data regarding the toxicity of navitoclax and venetoclax in the ALL post alloSCT maintenance setting a dose escalation scheme based on the BOIN design will be applied as outlined (TBD) with a maximal dose of venetoclax 400 mg QD and navitoclax 50mg QD according to the RP2D presented by Pullarkat et al. (Cancer Discov . 2021 Feb 16;candisc.1465.2020. doi: 10.1158/2159-8290.CD-20-1465).

NCT ID: NCT05053139 Not yet recruiting - Haemophilia A Clinical Trials

A Research Study Investigating Mim8 in Adults and Adolescents With Haemophilia A With or Without Inhibitors

Start date: December 3, 2021
Phase: Phase 3
Study type: Interventional

This study is investigating how Mim8 works compared to other medicines in people with haemophilia A, who either have inhibitors or do not have inhibitors. Mim8 is a new medicine that will be used for prevention of bleeding episodes. Mim8 works by replacing the function of the missing clotting factor VIII (FVIII). When and how often participants will receive Mim8 is dependent on their previous treatment - but is otherwise decided by chance. The study will last for 72-124 weeks (17-29 months) depending on how long participants will be followed before it is decided when they start receiving Mim8 - the period before this is decided is called the 'run-in'. Participants will have 13-17 clinic visits. Mim8 will be injected into a skinfold on the stomach with a thin needle either once a week or once a month.

NCT ID: NCT05052905 Not yet recruiting - Clinical trials for Acquired Brain Injury

VR-based Remote Rehabilitation for Pediatric ABI

Start date: October 2021
Phase: N/A
Study type: Interventional

The primary objective of this study is to evaluate the feasibility and effectiveness of an at-home program of VR-based vestibular and oculomotor rehabilitation on improving postural stability, ocular motility and activities of daily living for children with mild to severe ABI

NCT ID: NCT05052385 Recruiting - Clinical trials for Steroid Refractory GVHD

ECP Combination Study

Start date: April 13, 2021
Phase:
Study type: Observational

Extracorporeal photopheresis (ECP) offers an alternative to standard immunosuppression and shows an immunomodulatory rather than an immunosuppressive effect, which is associated with less toxicities and side effects. Additionally ECP has been shown to allow tapering of steroids and immunosuppressant agents which should be a goal of GvHD therapy. ECP has been used for the management of GvHD since first described in 1994 and as its use has continued over the decades. The treatment was incorporated into a number of guidelines as a second line therapy in steroid refractory or steroid dependent GvHD patients. As well as being used in addition and after steroids, it is also used in combination with CNI Inhibitors, MMF and other immunosuppressant agents. However, despite the current widespread use of ECP in the treatment of patients with GvHD, clinical data from randomized studies is limited and small prospective and retrospective trials are the main evidence base .This is also the case for other commonly used immunosuppressant agents, which have been used in GvHD since ECP was introduced. The systematic review concluded that ECP is an effective therapy for oral, skin, and liver SR-cGVHD, with modest activity in lung and gastrointestinal SR-cGVHD. In the USA Ibrutinib is the only FDA approved agent for second line cGvHD therapy once steroid therapy has failed and Ruxolitinib had been approved in the USA for the treatment of steroid refractory GvHD. While studies have shown the effectiveness and safety of ECP in GvHD treatment, there is limited data to show how it is being used in combination with the recently approved agents. Using existing registry data targeting centres where the newer agents are being used and enhancing the capture of treatment data we believe we can undertake a larger scale study, which will include the new treatment protocols. The aim of the current study is to improve the evidence basis on the potential benefit of ECP use as treatment of GVHD.

NCT ID: NCT05048914 Recruiting - Migraine Disorders Clinical Trials

Migraine Abortive Treatment

Start date: September 3, 2019
Phase:
Study type: Observational

Migraine headaches in children and adolescents may cause severe attacks that require abortive treatment. This study evaluated the incidence and efficacy of medications used for relieving migraine headache attacks in the pediatric population in Israel. Children 6-18 years of age who were diagnosed in our pediatric neurology clinic as having migraine headaches were enrolled into the study. Children and their parents filled in questionnaires about their response to abortive treatment two hours after use, during three acute headache attacks. The questionnaire included demographic data, baseline headache intensity, migraine-associated symptoms, medications used, and pain assessment.

NCT ID: NCT05047263 Not yet recruiting - Clinical trials for Non-diabetic Chronic Kidney Disease

A Trial to Learn How Well Finerenone Works and How Safe it is in Adult Participants With Non-diabetic Chronic Kidney Disease

FIND-CKD
Start date: September 21, 2021
Phase: Phase 3
Study type: Interventional

Researchers are looking for a better way to treat people who have non-diabetic chronic kidney disease (non-diabetic CKD). The trial treatment, finerenone, is being developed to help people who have long lasting kidney disease, also known as chronic kidney disease (CKD). It works by blocking a certain hormone called aldosterone that causes injury and inflammation in the heart and kidney which is known to play a role in CKD. In this trial, the researchers want to learn if finerenone helps to slow down the worsening of the participants' non-diabetic CKD compared to a placebo. A placebo looks like a trial treatment but does not have any medicine in it. The trial will include about 1,580 men and women who are at least 18 years old. The participants will take finerenone or a placebo once a day as tablets by mouth. All of the participants will also continue to take their current medicine for their CKD. The participants will be in the trial for up to about 50 months. During the trial, the doctors will collect blood and urine samples and check the participants' health. The participants will also answer questions about how they are feeling and what adverse events they are having. An adverse event is a medical problem that happens during the trial. Doctors keep track of all adverse events that happen in trials, even if they do not think the adverse events might be related to the trial treatments.

NCT ID: NCT05047094 Not yet recruiting - Clinical trials for Head and Neck Squamous Cell Carcinoma

A Safety and Efficacy Study for Combinational Treatment of DaRT and Check Point Inhibitor for Recurrent Unresectable or mHNSCC

Start date: October 2021
Phase: N/A
Study type: Interventional

A unique combinational treatment for cancer employing intratumoral diffusing alpha radiation emitter device with check point inhibitor for recurrent unresectable or metastatic Head and Neck Squamous Cell Carcinoma

NCT ID: NCT05045859 Recruiting - Clinical trials for Psychological Trauma

A Couples' Intervention Protocol for PTSD

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

Posttraumatic stress disorder (PTSD) is a multifaceted disorder resulting from intense and/or life-threatening trauma. PTSD sequelae often have a ripple effect on close others, including spouses and children. Studies report high levels of relationship distress for both those with PTSD and their partners as well as emotional distress. Despite the extensive knowledge on the effects of PTSD on couple relations and vice versa, and the limitations of individual therapies in addressing these issues, there has been a major lag in the development and study of couples' interventions in the context of PTSD. the current study will examine the efficacy of Cognitive Behavioral Conjoint Therapy (CBCT) for PTSD. It will employ an RCT to examine both outcomes and processes of change via multiple methods of assessment, including self-report questionnaires, qualitative interviews and physiological co-regulation measures. Moreover, it will employ a modified procedure via video conference due to COVID-19 in addition to in-person treatment option. The study will therefore contribute to theoretical understandings of the effects of PTSD on couples, to the development of therapies specifically intended for such couples.

NCT ID: NCT05042362 Recruiting - Clinical trials for Vasomotor Symptoms Associated With Menopause

A Study to Learn More About How Well Elinzanetant Works and How Safe it is for the Treatment of Vasomotor Symptoms (Hot Flashes) That Are Caused by Hormonal Changes Over 26 Weeks in Women Who Have Been Through the Menopause

OASIS-1
Start date: August 27, 2021
Phase: Phase 3
Study type: Interventional

Researchers are looking for a better way to treat women who have hot flashes after women have been through the menopause. Hot flashes are caused by the hormonal changes that happen when a woman's body has been through the menopause. Menopause is when women stop having a menstrual cycle, also called a period. During the menopause, the ovaries increasingly produce less sex hormones as a result of the natural ageing process and related hormonal adjustments. The decline in hormone production can lead to various symptoms which, in some cases, can have a very adverse effect on a menopausal woman's quality of life. The study treatment, elinzanetant, was developed to treat symptoms caused by hormonal changes. It works by blocking a protein called neurokinin from sending signals to other parts of the body, which is thought to play a role in starting hot flashes. There are treatments for hot flashes in women who have been through the menopause, but may cause medical problems for some people. In this study, the researchers will learn how well elinzanetant works compared to a placebo in women who have been through the menopause and have hot flashes. A placebo looks like a treatment but does not have any medicine in it. To compare these study treatments, the doctors will ask the participants to record information about the participants' hot flashes in an electronic diary. The researchers will study the number of hot flashes the participants have and how severe the hot flashes are. The researchers will look at the results from before treatment, after 4 weeks, and after 12 weeks of treatment. The participants in this study will take two capsules of either elinzanetant or the placebo once a day. The participants who take elinzanetant will take it for 26 weeks. The participants who take the placebo will take it for 12 weeks and then take elinzanetant for the next 14 weeks. During the study, the participants will visit the site approximately 9 times and perform 1 visit by phone. Each participant will be in the study for approximately 36 weeks. The treatment duration will be 26 weeks. During the study, the participants will: - record information about the participants' hot flashes in an electronic diary - answer questions about the participants' symptoms The doctors will: - check the participants' health - take blood samples - ask the participants questions about what medicines the participants are taking and if the participants are having 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 doctors do not think the adverse events might be related to the study treatments.

NCT ID: NCT05037929 Not yet recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease

A Study to Evaluate the Efficacy and Safety of Astegolimab in Participants With Chronic Obstructive Pulmonary Disease

Start date: September 1, 2021
Phase: Phase 2
Study type: Interventional

This study will evaluate the efficacy, safety, and pharmacokinetics of astegolimab in combination with standard of care chronic obstructive pulmonary disease (COPD) maintenance therapy in patients with COPD who are former or current smokers and have a history of frequent exacerbations.