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NCT ID: NCT04580420 Recruiting - Clinical trials for End Stage Renal Disease

Safety & Efficacy of DCR-PHXC in Patients With PH1/2 and ESRD

PHYOX7
Start date: April 15, 2021
Phase: Phase 2
Study type: Interventional

The aim of this study is to evaluate DCR-PHXC in participants with PH1 or PH2 and severe renal impairment, with or without dialysis.

NCT ID: NCT04578106 Recruiting - Clinical trials for HER2-positive Breast Cancer

Omission of Surgery in Clinically Low-risk HER2positive Breast Cancer With High HER2 Addiction and a Complete Response Following Standard Anti-HER2-based Neoadjuvant Therapy

ELPIS
Start date: September 23, 2020
Phase: Phase 2
Study type: Interventional

This is a prospective, single arm, open-label, unicenter, exploratory study in women with primary operable HER2-positive, HER2-enriched/ERBB2-high breast cancer according to PAM50 intrinsic subtype and a ERBB2 pre-defined cutoff (high vs low ERBB2 expression), to evaluate the omission of surgery and sentinel lymph node dissection in patients with HER2-E and ERBB2 high breast cancer who achieving a complete response following standard anti-HER2-based neoadjuvant therapy with paclitaxel/trastuzumab/pertuzumab. The primary trial objective is to estimate the loco-regional invasive disease-free survival at 3-year of patients who achieve a complete response based on imaging (i.e. Magnetic resonance imaging) and a stereotactic-guided vacuum-assisted breast biopsy, and omit loco-regional surgery.

NCT ID: NCT04576598 Recruiting - Stroke Sequelae Clinical Trials

Sedentarism of Stroke Survivors in the Valencian Community and Development of a Self-management Program

SEDMA_Stroke
Start date: January 10, 2020
Phase: N/A
Study type: Interventional

Stroke is the third leading cause of disability worldwide. Women present a higher incidence of this pathology and prevalence of its risk factors. Similarly, after stroke, women have a poorer functional outcome, higher rates of institutionalization and greater dependence on activities of daily living. People who have suffered a stroke are at increased risk of cardiovascular disease, with an estimated one-third of stroke survivors suffering a new event in the following 5 years. Current scientific literature recommends the promotion of physical activity (PA) and exercise for the prevention of stroke and its sequelae. However, stroke survivors are often insufficiently active. Therefore, changing their behavior with respect to PA and sedentary lifestyle is fundamental. Moreover, gender perspective, should also taken into account. Thus, our aims are to study whether there are differences in women with chronic stroke sequelae compared to men in: 1) the amount of sitting time and its context, as well as the time spent in different intensities of PA; 2) the reduction of sitting time and its effect on health after the completion of the PA self-management program and sedentary lifestyle developed in this project; 3) the presence of sarcopenia, osteoporosis and the state of frailty. To achieve these objectives, the lifestyle habits of 128 subjects (64 women) who live in the community and have chronic sequelae of stroke (≥ 6 months) will be evaluated. In addition, possible differences in the study variables will be verified with control people without sequelae of stroke. Moreover, in order to reduce the risks of stroke survivors, a program of self-management of PA and sedentary lifestyle will be developed. This program will be carried out through several sessions spread over six months that will incorporate: education, goal setting, identification of barriers, self-control and feedback. The feasibility of this intervention will be determined by examining compliance, duration, utility, and safety. At least 64 of the previously studied subjects will participate in this program, analyzing whether it favors the reduction of sitting time and its effect on health thanks to the measurement of different physical capacities. The differences between men and women in response to the program will be determined. Finally, we will explore whether the effect of the program is greater when it is implemented in the subacute than in the chronic phase.

NCT ID: NCT04576156 Recruiting - Myelofibrosis Clinical Trials

A Study Comparing Imetelstat Versus Best Available Therapy for the Treatment of Intermediate-2 or High-risk Myelofibrosis (MF) Who Have Not Responded to Janus Kinase (JAK)-Inhibitor Treatment

Start date: April 12, 2021
Phase: Phase 3
Study type: Interventional

The purpose of the study is to evaluate the overall survival of participants treated with imetelstat compared to best available therapy with intermediate-2 or high-risk Myelofibrosis (MF) who are relapsed/refractory to Janus Kinase (JAK)-Inhibitor treatment.

NCT ID: NCT04575506 Recruiting - Obesity Clinical Trials

Influence of the Diversity and Composition of the Microbiota in the Development of Pediatric Fatty Liver

MicroKid
Start date: November 16, 2020
Phase: N/A
Study type: Interventional

The objectives of the present study are: 1) to identify the intestinal and salivary microbiota associated with the presence and severity of hepatic steatosis in children (Study I: case-control study), and 2) to develop a personalized 12-week intervention program based on diet and exercise to examine its effects on the diversity and composition of the microbiota in children with hepatic steatosis (Study II: intervention study)

NCT ID: NCT04574271 Recruiting - Sarcopenia Clinical Trials

Multidimensional Intervention in Pre-frail Patients Older Than 70 Years

Start date: June 1, 2019
Phase: N/A
Study type: Interventional

Aging represents a huge advance in society and a health and social challenge. Spain has one of the highest life expectancies in the world, but other countries with the same demographic characteristics are ahead of us in quality adjusted life years. Primary care setting has the main drivers of healthy aging, acting on the early stages of pre-frailty and frailty. Therefore, it is proposed a multicomponent intervention (nutritional and prescription of physical exercise) in patients older than 70 years of the Medina del Campo Health Center, with pre-frailty criteria, in order to measure the changes that this intervention produces in their mild dysfunction and whether it is capable of reversing it or delaying the progression to a state of frailty.

NCT ID: NCT04573868 Recruiting - Mortality Clinical Trials

National Study "AEC COVID-19"

Start date: March 1, 2020
Phase:
Study type: Observational [Patient Registry]

Currently there is an important need to know the evolution, results and associated mortality of patients undergoing surgical intervention in Spain during the SARS-CoV-2 pandemic. With a national data collection, information could be obtained to guide the management of this group of complex patients operated on during the COVID-19 pandemic, with the aim of improving their treatment in the event of a second wave. The great spread of the virus and the difficulty in controlling it over time makes it a high priority for the scientific community in order to face new outbreaks. The national study "AEC COVID-19" is a collaborative study (in the style of those carried out at European level such as Eurosurg, Globalsurg, etc.) that aims to know the evolution, results and associated mortality of patients undergoing surgical intervention in Spain during the SARS-CoV-2 pandemic. It is an observational study, with anonymized and coded data, which aims to demonstrate the following hypotheses: - Patients with COVID-19 have high mortality. - Patients with both oncological and benign pathologies have high morbidity. The situation / follow-up at 7 days and 30 days after the intervention will be included in each patient.

NCT ID: NCT04573660 Recruiting - Clinical trials for Acute Myocardial Infarction

Abbott Vascular Medical Device Registry

AV-MDR
Start date: October 25, 2020
Phase:
Study type: Observational

The AV-MDR is a prospective, non-randomized, open-label, multi-center registry. The purpose of the AV-MDR study is to proactively collect and evaluate clinical data on the usage of the devices in scope within their intended use with the aim of confirming safety and performance throughout their expected lifetime, ensuring the continued acceptability of identified risks, detecting emerging risks on the basis of factual evidence, ensuring the continued acceptability of the benefit-risk ratio, and identifying possible systematic misuse or off-label usage such that the intended use can be verified as appropriate.

NCT ID: NCT04573621 Recruiting - Rectal Cancer Clinical Trials

Pelvic Drain After Rectal Resection for Mid-low Rectal Cancer

GECO1
Start date: October 2020
Phase: N/A
Study type: Interventional

This RCT aims at assessing the effects of a pelvic drain after total mesorectal excision for mid-low rectal cancer on the rates of pelvic sepsis and anastomotic leaks.

NCT ID: NCT04573023 Recruiting - Clinical trials for Mucopolysaccharidosis II

A Phase III Study of JR-141 in Patients With Mucopolysaccharidosis II (STARLIGHT)

Start date: February 14, 2022
Phase: Phase 3
Study type: Interventional

A Global Phase III multicenter, randomized, assessor-blinded, active-controlled designed to evaluate safety and efficacy of study drug for the treatment of the MPS II.