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NCT ID: NCT05269004 Active, not recruiting - Multiple Sclerosis Clinical Trials

A Rollover Study to Evaluate the Long-Term Safety and Efficacy of Ocrelizumab In Patients With Multiple Sclerosis

OLERO
Start date: May 3, 2022
Phase: Phase 3
Study type: Interventional

This is a Phase IIIb, single-arm, multicenter, OLE study. Participants receiving ocrelizumab as an investigational medicinal product (IMP) in a Roche sponsored Parent study who continue to receive ocrelizumab or are in safety follow-up at the time of the closure of their respective Parent study (WA21092, WA21093 or WA25046) are eligible for enrollment in this extension study. Participants who will continue ocrelizumab treatment will receive IMP based on the dosage and administration received at the time of rollover from the Parent study.

NCT ID: NCT05262023 Active, not recruiting - Clinical trials for Frontotemporal Dementia

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL593 in Healthy Participants and Participants With Frontotemporal Dementia (FTD-GRN)

Start date: February 1, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

This is a Phase 1/2, multicenter, randomized, placebo-controlled, double-blind study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single and multiple doses of DNL593 in two parts followed by an optional open-label extension (OLE) period. Part A will evaluate the safety, tolerability, PK, and PD of single doses of DNL593 in healthy male and healthy female participants of nonchildbearing potential. Part B will evaluate the safety, tolerability, PK, and PD of multiple doses of DNL593 in participants with frontotemporal dementia (FTD) over 25 weeks. Part B will be followed by Part C, an optional 18-month OLE period available for all participants who complete Part B.

NCT ID: NCT05224141 Active, not recruiting - Clinical trials for Small Cell Lung Carcinoma

Pembrolizumab/Vibostolimab (MK-7684A) or Atezolizumab in Combination With Chemotherapy in First Line Treatment of Extensive-Stage Small Cell Lung Cancer (MK-7684A-008, KEYVIBE-008)

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

This study will evaluate the combination of a fixed dose pembrolizumab/vibostolimab co-formulation (MK-7684A) with etoposide/platinum chemotherapy followed by MK-7684A compared to the combination of atezolizumab with etoposide/platinum chemotherapy followed by atezolizumab in the first-line treatment of Extensive-Stage Small Cell Lung Cancer (ES-SCLC). The primary hypothesis is, with respect to overall survival, MK-7684A in combination with the background therapy of etoposide/platinum followed by MK-7684A, is superior to atezolizumab in combination with the background therapy of etoposide/platinum followed by atezolizumab.

NCT ID: NCT05223387 Active, not recruiting - Dental Implants Clinical Trials

Tissue Level vs Bone Level Implants for Plural Restorations : a Multicentre Randomised Controlled Trial

IBERICA
Start date: March 30, 2022
Phase: N/A
Study type: Interventional

Anthogyr Axiom Tissue-Level implants and corresponding Multi-Unit abutments recently enriched the available product range for dental surgeons. This Post-Market Clinical Follow-Up study aims at confirming the safety and performance of these products. The comparison with similar Anthogyr Axiom Bone-level implants will provide additional information on the effect of platform-switching in bone level maintenance for single and two-piece design at the implant level.

NCT ID: NCT05218499 Active, not recruiting - Clinical trials for Liposarcoma, Dedifferentiated

Brightline-1: A Study to Compare Brigimadlin (BI 907828) With Doxorubicin in People With a Type of Cancer Called Dedifferentiated Liposarcoma

Start date: March 25, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

This study is open to people with a type of cancer called dedifferentiated liposarcoma. People with advanced liposarcoma aged 18 or older who are not receiving any other cancer treatment can participate. The purpose of this study is to compare a medicine called brigimadlin (BI 907828) with doxorubicin in people with liposarcoma. Brigimadlin (BI 907828) is a so-called MDM2 inhibitor that is being developed to treat cancer. Doxorubicin is a medicine already used to treat cancer including liposarcoma. During the study, participants get either brigimadlin (BI 907828) or doxorubicin. Every 3 weeks, participants take brigimadlin (BI 907828) as tablets or doxorubicin as an infusion into a vein. Participants can switch to brigimadlin (BI 907828) treatment if they did not benefit from doxorubicin treatment. Participants can continue treatment in the study as long as they benefit from it and can tolerate it. Doctors regularly check the size of the tumour and check whether it has spread to other parts of the body. The doctors also regularly check participants' health and take note of any unwanted effects.

NCT ID: NCT05204238 Active, not recruiting - Heart Failure Clinical Trials

Follow Up of acuTe Heart failUre: a pRospective Echocardiographic and Clinical Study (FUTURE)

FUTURE-HIT
Start date: September 1, 2020
Phase:
Study type: Observational

Acute heart failure (AHF) is defined as rapid onset or rapid worsening of typical signs and symptoms of heart failure (HF) according to the 2016 European Society of Cardiology Guidelines. AHF is the first cause of hospitalization in people over 65 in Western countries, accounting for more than 1 million hospitalizations per year in the USA. This disease has many repercussions not only in terms of mortality and morbidity, but also in terms of resources and infrastructures necessary for these patients' treatment, which constitutes a high economic burden for the national health care system. Even with growing knowledge and means, nowadays, the prognosis of AHF is still poor and there are no proven therapies that lead to long-term benefits in terms of reduced mortality. A better management of the acute phase of decompensation, including the definition of effective diagnostic-therapeutic workup and the use of innovative drugs, could improve the course of the disease, with positive effects on the patient (gain in survival and reduction of admissions), but also on the community (containment of the overall health costs). In recent years, numerous scores have been outlined in various AHF settings, considering only a small number of parameters. Several prognostic models have been developed suggesting how difficult it is to evaluate the AHF patients' prognosis. All this effort towards the development of so numerous prognostic models is justified by the fact that, despite the evolution of treatments, the risk of re-hospitalization and of both intrahospital mortality and after discharge remains high. Several studies have investigated potential prognostic factors that could help evaluating the risk of cardiovascular events, but now there is no accurate and complete prognostic score, particularly for AHF patients. Therefore, to date there are no accurate scores or determinants of short- and medium-term prognosis that allow to improve the management of these patients. This will be an observational, prospective, multicentric, international, non-commercial (non-profit) study. The primary endpoint will be to evaluate the best parameters, among clinical, laboratory and echocardiographic variables assessed within 24 hours from the hospital admission and before discharge, that are able to predict rehospitalization for HF and cardiovascular death at 3 and 6 months, in patients admitted to the cardiology department for acute exacerbation of chronic HF or de novo AHF.

NCT ID: NCT05184361 Active, not recruiting - Obesity Clinical Trials

Effects of Intermittent Versus Continuous Energy Restriction on Metabolic Adaptation in Women With Obesity

BREAK
Start date: January 13, 2022
Phase: N/A
Study type: Interventional

One of the major challenges for treating obesity is to maintain a weight reduced state on the long term due to the high rate of weight regain. Therefore, the aim of this study is to evaluate the effects of an intermittent versus a continuous energy restriction in body composition (body weight, fat mass and fat-free mass) and metabolic adaptation, in women with obesity.

NCT ID: NCT05178810 Active, not recruiting - Clinical trials for Amyotrophic Lateral Sclerosis

Study to Investigate the Efficacy and Safety of FAB122 (Daily Oral Edaravone) in Patients With Amyotrophic Lateral Sclerosis

ADORE
Start date: October 18, 2021
Phase: Phase 3
Study type: Interventional

Multicenter, multinational, double-blind, randomized (2:1), placebo-controlled Phase III study to investigate the efficacy and safety of 100 mg FAB122 once daily as oral formulation in ALS patients.

NCT ID: NCT05170867 Active, not recruiting - Obesity Clinical Trials

The Impact of Hafnia Alvei on Weight Loss and Glycaemic Control After Bariatric Surgery

Start date: January 14, 2022
Phase: N/A
Study type: Interventional

This study aims to investigate the effects of Hafnia alvei HA4597 TM supplementation on weight loss and glycemic control after bariatric surgery. Patients undergoing Roux-en-Y gastric bypass will receive probiotics or placebo, twice a day, for 90 days, one month after surgery. Outcomes will be measured at baseline, and 3, 6, 9 and 12 months after the surgery.

NCT ID: NCT05169619 Active, not recruiting - Asthma Clinical Trials

Prevalence and Characterisation of Asthma Patients According to Disease Severity in Portugal

Epi-Asthma
Start date: April 30, 2021
Phase:
Study type: Observational

This study aims to determine the prevalence of Asthma, Difficult-to-Treat and Severe Asthma in Portugal, and characterize patients to better understand their disease characteristics, treatment profile and health care resource use to improve clinical management of the disease.