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NCT ID: NCT05138094 Recruiting - Neoplasm Metastasis Clinical Trials

LIVACOR Trial: Minimally Invasive LIVer And Simultaneous COlorectal Resection

LIVACOR
Start date: August 6, 2021
Phase: N/A
Study type: Interventional

The LIVACOR - Trial is a European wide, randomized controlled, open-label, multicenter trial. Patients with synchronous colorectal liver metastases (CRLMs) and primary colorectal tumor are considered eligible and will be randomized between minimally invasive (MI) combined or staged colorectal resection (all colectomies, including high anterior resection) and liver resection of up to three segments.

NCT ID: NCT05137054 Recruiting - Multiple Myeloma Clinical Trials

A Study to Examine the Effects of Novel Therapy Linvoseltamab in Combination With Other Cancer Treatments for Adult Patients With Multiple Myeloma That is Resistant to Current Standard of Care Treatments

Start date: August 17, 2022
Phase: Phase 1
Study type: Interventional

This study is researching an experimental drug called linvoseltamab in combination with other drugs for the treatment of a blood cancer called multiple myeloma. Linvoseltamab has previously been studied as a single agent (without other cancer treatments) in participants with multiple myeloma that returned after prior therapies and needed to be treated again. In the initial study, some participants treated with linvoseltamab had improvement of their myeloma, including complete responses (no evidence of myeloma in their bodies). This study is the first time linvoseltamab will be combined with other cancer therapies. The main goal is to understand if linvoseltamab can be given safely with other cancer treatments, and if so, what dose of linvoseltamab should be used for each combination. The study is looking at several other research questions, including: - How many participants treated with linvoseltamab in combination with each of the other cancer treatments have improvement of their multiple myeloma - What side effects may happen from taking linvoseltamab together with another cancer treatment - How much study drug is in the blood at different times - Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)

NCT ID: NCT05136027 Recruiting - Clinical trials for Resistant Depression, Treatment

TReAtment With CombinedExercise in Patients With Resistant Major Depression

TRACE-RMD
Start date: December 30, 2022
Phase: N/A
Study type: Interventional

Major depressive disorder is one of the most prevalent and disabling mental disorders worldwide. Forty percent of people with major depressive disorder are in moderate remission, with the remainder meeting the criteria for treatment-resistant depressive disorder (TRD), with an inadequate response to at least two different antidepressants of adequate dose and duration. Dysfunctionality in these individuals is frequent and severe and its importance contrasts with the absence of drugs to alleviate these deficits. Exercise programs, which were initially developed as interventions aimed at improving physical health in early stages or in mild symptomatology, have shown that they can also improve the symptoms of this disease in more advanced stages There is evidence of new therapeutic interventions for TRD. New pharmacological targets that aim to improve the evolution of depression and its functional repercussions augur that, in the future, new drugs will have to be combined with other therapeutic strategies, including exercise. Therefore, the objectives of this clinical trial with a control group are: 1) to analyze the changes in depressive symptoms in people diagnosed with TRD included in the exercise program compared to a control group; 2) to evaluate the improvement in physical health through cardiovascular risk factors and life expectancy suffered by this sector of the population, and 3) to analyze changes in functional status and quality of life. This is a prospective longitudinal intervention design (three months) in which people with TRD are included in two groups: 1) intervention with exercise (two days/week) and 2) control care with usual treatment. The aim is to find an improvement in mood and functionality with the implementation of exercise, as well as changes in physical areas such as blood pressure or body mass index, which are considered predictive factors of cardiovascular disease.

NCT ID: NCT05135780 Recruiting - Effectiveness Clinical Trials

The Quality of Life in Children at Social Risk, a Case Series Study Protocol

Start date: November 1, 2021
Phase:
Study type: Observational

this case series study has the aim to observe the effect of a multidisciplinary intervention (social accompaniment, school reinforcement and osteopathic treatment) on the quality of life of children with social risk in primary school age.

NCT ID: NCT05135559 Recruiting - Clinical trials for Haemophilia A and B With and Without Inhibitors

A Research Study on How Well Concizumab Works for You if You Have Haemophilia A or B With or Without Inhibitors

Explorer10
Start date: March 24, 2022
Phase: Phase 3
Study type: Interventional

This study will test how well a new medicine called concizumab works for participants who have haemophilia A or B with or without inhibitors. The purpose is to show that concizumab can prevent bleeds and is safe to use. Participants will have to inject the study medicine every day under the skin with a pen-injector. The study will last for at least 2 years and up to about 4 years. The length of time the participant will be in the study depends on if the study medicine will be available for purchase in their country.

NCT ID: NCT05134441 Recruiting - Multiple Sclerosis Clinical Trials

Study to Evaluate the Efficacy, Safety, and Tolerability of IMU-838 in Patients With Relapsing Multiple Sclerosis

ENSURE-1
Start date: November 18, 2021
Phase: Phase 3
Study type: Interventional

Multi-Center, Randomized, Double-Blinded Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of IMU-838 versus Placebo in Adults with Relapsing Multiple Sclerosis (ENSURE-1)

NCT ID: NCT05133531 Recruiting - Clinical trials for Paroxysmal Nocturnal Hemoglobinuria

A Study to Evaluate How Safe Pozelimab + Cemdisiran Combination Therapy is and How Well it Works in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) Who Have Not Recently Received or Have Not Received Complement Inhibitor Treatment

ACCESS-1
Start date: August 1, 2022
Phase: Phase 3
Study type: Interventional

This study is researching a clinical treatment combination with two experimental drugs called pozelimab and cemdisiran. The study is focused on patients with paroxysmal nocturnal hemoglobinuria (PNH). The aim of the study is to see how safe and effective the pozelimab + cemdisiran combination is for patients with PNH and how the combination compares with 2 existing treatments, one called ravulizumab and the other called eculizumab. The pozelimab + cemdisiran combination may be referred to as "study drugs". Ravulizumab and eculizumab may also be called the "comparator drug". The study is looking at several research questions, including: - How effective is the pozelimab + cemdisiran combination compared to ravulizumab? - How effective is pozelimab + cemdisiran combination compared to eculizumab? - What side effects may happen from taking the study drugs? - How much study drugs are in the blood at different times? - Whether the body makes antibodies against the study drugs (which could make the study drugs less effective or could lead to side effects)

NCT ID: NCT05132582 Recruiting - Clinical trials for HER2 Positive Breast Cancer

A Study of Tucatinib or Placebo With Trastuzumab and Pertuzumab for Metastatic HER2+ Breast Cancer

HER2CLIMB-05
Start date: March 7, 2022
Phase: Phase 3
Study type: Interventional

This study is being done to see if tucatinib works better than placebo when given with other drugs to treat participants with HER2-positive breast cancer. A placebo is a pill that looks the same as tucatinib but has no medicine in it. This study will also test what side effects happen when participants take this combination of drugs. A side effect is anything a drug does to the body besides treating your disease. Participants will have cancer that has spread in the body near where it started (locally advanced) and cannot be removed (unresectable) or has spread through the body (metastatic). In this study, all participants will get either tucatinib or placebo. Participants will be assigned randomly to a group. This is a blinded study, so patients and their doctors will not know which group a participant is in. All participants will also get trastuzumab and pertuzumab. These are 2 drugs used to treat this type of cancer.

NCT ID: NCT05131386 Recruiting - Soft Tissue Sarcoma Clinical Trials

Multicohort Trial of Trabectedin and Low-dose Radiation Therapy in Advanced/Metastatic Sarcomas

SYNERGIAS
Start date: May 28, 2021
Phase: Phase 2
Study type: Interventional

Phase II, multicohort, single arm, open-label, multicenter, international clinical trial with three cohorts (cohort A: Soft tissue sarcoma, cohort B: Bone tumors (osteosarcoma, chondrosarcoma and cohort C: Small round-cell sarcomas (Ewing's sarcoma, rhabdomyosarcoma, desmoplastic small round-cell tumors and other small round cell sarcomas)) with 7 sites in Spain. Main objective: To evaluate the overall response rate (ORR) in the irradiated nodules according to RECIST v1.1 criteria. Treatment Medication Trabectedin at 1.5 mg/m2 24-h IV CI along with radiation therapy (30 Gy, 3 Gy/day for 10 days for non-extremity location and 45 Gy, 1.8 Gy/day for 25 days for extremity location of target lesion(s)), starting within 1 hour after the first trabectedin infusion withdrawal (day 2)) will be given every 3 weeks up to progression or intolerance. Premedication 4 mg oral dexamethasone 24h and 12h before trabectedin administration, 20 mg IV dexamethasone 30 minutes before treatment. Ondansetron or analogue will also be given prior to trabectedin.

NCT ID: NCT05131113 Recruiting - Solid Tumor, Adult Clinical Trials

Stratification of Patients in Oncogeriatrics and Personalization of Interventions

ONKO-FRAIL
Start date: January 27, 2022
Phase: N/A
Study type: Interventional

Multicenter randomized controlled trial. Patients will be randomly assigned to the control group or the intervention group in each of the health centers. The control group will receive the usual care, while the intervention group will add an individualized physical exercise program to the usual care. Cancer is a disease of the elderly. More than 65% of all malignancies affect this population. At the same time, the incidence of cancer cases increases and the need to better understand the biological characteristics of the disease, as well as those of the elderly who suffer from it, is highlighted. Oncogeriatrics is the area that addresses the care of the elderly patient with cancer, taking into account that physiological aging causes older people to have their own characteristics that require a differential approach in care. The low inclusion in clinical trials of elderly patients and the few specific trials carried out in this subpopulation together with the progressive aging of the population mean that the development of this area has become a priority in health policies. Therefore, there is a need to focus the research area on supervised physical exercise in older people with cancer in an innovative way, with the aim of generating new hypotheses that overcome existing limitations and facilitate the introduction into the health system of this type of interventions.