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NCT ID: NCT04065620 Recruiting - Clinical trials for Heart Failure With Preserved Ejection Fraction

Ambulatory Blood Pressure in HFPEF Outcomes Global Registry

HFPEFGlobal
Start date: March 1, 2020
Phase:
Study type: Observational

Heart failure and preserved ejection fraction (HFPEF) is a disease with increasing prevalence world wide. Due to its etiological and prognostic relationship with hypertension, it is highly interesting to know the characteristics and influence of Blood pressure levels and of the hemodynamic biomarkers, measured by Ambulatory Blood Pressure measurement in the outcome of patients with (HF-PEF), defined by the risk of cardiovascular morbidity and mortality (hospital re-admissions, emergency room visits, functional decline and mortality). The investigators consider other factors such as Frailty, comorbidities, and the baseline functional capacity to asses the prognostic value.

NCT ID: NCT04065399 Recruiting - Clinical trials for Acute Myeloid Leukemia

A Study of Revumenib in R/R Leukemias Including Those With an MLL/KMT2A Gene Rearrangement or NPM1 Mutation

AUGMENT-101
Start date: November 5, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

Phase 1 dose escalation will determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of revumenib in participants with acute leukemia. In Phase 2, participants will be enrolled in 3 indication-specific expansion cohorts to determine the efficacy, short- and long-term safety, and tolerability of revumenib.

NCT ID: NCT04064359 Recruiting - Solid Tumor Clinical Trials

Safety and Preliminary Efficacy of OBT076 in Recurrent/Metastatic CD205+ Solid Tumors

Start date: July 25, 2019
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate OBT076, which is a drug that combines an antibody with an anti-cancer drug. This class of drugs are called Antibody-Drug Conjugates (ADC). Antibodies are normally produced in the human body by the immune system to fight infections but can be designed to target cancer cells and deliver an anti-cancer drug. OBT076 is composed of an antibody that targets the CD205 protein on cancer cells and delivers an anti-cancer drug which can kill them. OBT076 is an "Investigational Drug", which means that it is still being studied and has not yet been approved by the US Food and Drug Administration (FDA), the European Medicines Agency (EMA) or any other regulatory authorities to be prescribed by doctors for the treatment of metastatic or recurrent solid tumors. The use of OBT076 in this study is investigational. This is a Phase I research study designed to look at several dose levels of the study drug to find the highest dose level that is safe and well-tolerated (does not cause unacceptable side effects), and to examine the effects of the study drug in a small group of research participants. The study will also look at the effectiveness of OBT076 as an anti-cancer therapy. Once the optimal dose is determined and safety is assessed, additional research participants will be treated at the optimal dose level to further evaluate safety and effectiveness.

NCT ID: NCT04064060 Recruiting - Beta-thalassemia Clinical Trials

A Study to Evaluate Long-term Safety in Participants Who Have Participated in Other Luspatercept (ACE-536) Clinical Trials

Start date: August 12, 2019
Phase: Phase 3
Study type: Interventional

A Phase 3b, open-label, single-arm, rollover study to evaluate the long-term safety of luspatercept, to the following participants: - Participants receiving luspatercept on a parent protocol at the time of their transition to the rollover study, who tolerate the protocol-prescribed regimen in the parent trial and, in the opinion of the investigator, may derive clinical benefit from continuing treatment with luspatercept - Participants in the follow-up phase previously treated with luspatercept or placebo in the parent protocol will continue into long-term post-treatment follow-up in the rollover study until the follow-up commitments are met - The study design is divided into the Transition Phase, Treatment Phase and Follow-up Phase. Participants will enter transition phase and depending on their background will enter either the treatment phase or the Long-term Post-treatment Follow-up (LTPTFU) phase - Transition Phase is defined as one Enrollment visit - Treatment Phase: For participants in luspatercept treatment the dose and schedule of luspatercept in this study will be the same as the last dose and schedule in the parent luspatercept study. This does not apply to participants that are in long-term follow-up from the parent protocol - Follow-up Phase includes: - 42 Day Safety Follow-up Visit - During the Safety Follow up, the participants will be followed for 42 days after the last dose of luspatercept, for the assessment of safety-related parameters and adverse event (AE) reporting - Long-term Post-treatment Follow-up (LTPTFU) Phase - Participants will be followed for overall survival every 6 months for at least 5 years from first dose of luspatercept in the parent protocol, or 3 years of post-treatment from last dose, whichever occurs later, or until death, withdrawal of consent, study termination, or until a subject is lost to follow-up. Participants will also be monitored for progression to AML or any malignancies/pre-malignancies. New anticancer or disease related therapies should be collected at the same time schedule Participants transitioning from a parent luspatercept study in post-treatment follow-up (safety or LTPTFU) will continue from the same equivalent point in this rollover study. The rollover study will be terminated, and relevant participants will discontinue from the study when all participants fulfill at least 5 years from the first dose of luspatercept in the parent protocol, or 3 years of post-treatment from last dose, whichever occurs later.

NCT ID: NCT04062578 Recruiting - Clinical trials for Anterior Cruciate Ligament Injuries

Effects Provided by a Physiotherapy Treatment Preventing Lower Extremity Injuries in Female Football Players

Start date: September 9, 2019
Phase: N/A
Study type: Interventional

Background and justification: Women's football has a percentage of knee injury of 31.8%, and the anterior cruciate ligament lesion is between 2 and 4 times higher than the male. Injury prevention programs seek to improve the control of the neuromuscular recruitment, dynamic valgus and lumbopelvic stabilization. Recently Cibulka and Bennett have proposed a new prevention theory based on the strengthening of the external abductor and hip rotator muscles. The objective of this study is to design and carry out a physiotherapy program based on the prevention of modifiable risks factors. Design: Controlled clinical trial Methodology: 2 groups were formed, the first or experimental integrated by the female players from football team called CD Oliver (CDO), and control, integrated by the female players of the first team SD Huesca (SDH). The investigators will carried out an initial and final evaluation in which they will be collected data on variables of injury incidence, muscle length and torque. A physiotherapy program will be implemented that will consider three areas of weekly action during training, preventive force sessions, compensatory force sessions and physiotherapy sessions.

NCT ID: NCT04060368 Recruiting - Clinical trials for Non-alcoholic Steatohepatitis (NASH)

Efficacy and Safety of Endoscopic Sleeve Gastroplasty Versus Laparoscopic Sleeve Gastrectomy in Obese Subjects With NASH

TESLA-NASH
Start date: June 1, 2020
Phase: N/A
Study type: Interventional

The primary objectives of this study are to evaluate the effect of ESG with OverStitch® system (Apollo Endosurgery, Austin, TX, USA) compared to LSG on 1) histological improvement in NASH; 2) all-cause mortality and liver-related outcomes In obese subjects with non-alcoholic steatohepatitis (NASH). Condition or disease: Non-alcoholic steatohepatitis (NASH) with or without fibrosis Intervention/treatment: ESG with OverStitch® system vs LSG

NCT ID: NCT04059731 Recruiting - Colorectal Cancer Clinical Trials

Postoperative Diet With Hyperproteic Supplement Versus a Supplement With Imunonutrients, in Colorectal Cancer Surgery

NUTRICOLON
Start date: June 20, 2019
Phase: N/A
Study type: Interventional

The study is a randomized, multicentric, double-blind, controlled with active comparator, parallel groups trial, to demonstrate the non-inferiority in efficacy and therapeutic safety of the postoperative diet with oligomeric-hyperprotéic-normocaloric supplement (group 1) versus a supplement with imunonutrients (group 2), in a multimodal rehabilitation regimen (ERAS) of colorectal surgery for colon cancer and that arrive at surgery in a normal nutritional state or without any intervention on their nutritional status, according to the scale Malnutrition Screening Tool (MST).

NCT ID: NCT04058756 Recruiting - Clinical trials for Advanced Solid Tumors

Rollover Study for Continued Safety and Tolerability in Subjects Treated With Spartalizumab Alone or in Combination With Other Study Treatments

Start date: October 31, 2019
Phase: Phase 1
Study type: Interventional

The purpose of this study is to continue to assess safety and tolerability, and to allow continued access to study treatment for subjects already receiving spartalizumab as single agent or in combination with other study treatments.

NCT ID: NCT04058041 Recruiting - Neuropathic Pain Clinical Trials

Neural Exercises vs Surgery in Patients With Carpal Tunnel Syndrome

Start date: March 12, 2018
Phase: N/A
Study type: Interventional

neural exercise in patients with carpal tunnel syndrome

NCT ID: NCT04057443 Recruiting - Clinical trials for Hematologic Malignancy

Nutritional and Physical Exercise Intervention in Older Patients With Malignant Hemopathies

ICOSENIORHEM
Start date: April 11, 2019
Phase: N/A
Study type: Interventional

Clinical trial to analyze the impact of nutrition and physical exercise intervention program on the completion of treatment in older patients 70 years or older with malignant hemopathology