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NCT ID: NCT03649633 Recruiting - Septic Shock Clinical Trials

Vitamin C, Steroids, and Thiamine, and Cerebral Autoregulation and Functional Outcome in Septic Shock

CORVICTES-??
Start date: September 6, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

This study has been approved as a nested substudy of a multicenter trial (CORVICTES, Clinicaltrials.gov Identifier: NCT03592693). The current, randomized, placebo-controlled study will compare steroids/vitamin C versus placebo/placebo in septic shock, with respect to cerebral autoregulation, biomarkers, and functional outcome. The following hypotheses will be tested: The steroids/vitamin C/thiamine intervention may result in attenuation of the septic shock-associated impairment in cerebral autoregulation; and 2) The increased frequency of intact cerebral autoregulation in the intervention group may result in more neurologic failure free days and ventilator free days during a 60-day follow-up; improved survival to hospital discharge with good functional outcome; and better patient-reported health-related outcomes at 90-day follow-up.

NCT ID: NCT03647124 Recruiting - Clinical trials for Lymphoma, Mantle-Cell

A Study to Evaluate the Relationship of Lenalidomide With Tumor Flare Reaction and High Tumor Burden in Participants With Relapsed or Refractory Mantle Cell Lymphoma

Start date: March 13, 2019
Phase:
Study type: Observational

The purpose of this study is to investigate and characterize the association of lenalidomide with tumor flare reaction and high tumor burden in participants with relapsed or refractory mantle cell lymphoma.

NCT ID: NCT03645928 Recruiting - Clinical trials for Non-small Cell Lung Cancer

Study of Autologous Tumor Infiltrating Lymphocytes in Patients With Solid Tumors

Start date: May 7, 2019
Phase: Phase 2
Study type: Interventional

A prospective, open-label, multi-cohort, non-randomized, multicenter Phase 2 study evaluating adoptive cell therapy (ACT) with TIL LN-144 (Lifileucel)/LN-145 in combination with checkpoint inhibitors or TIL LN-144 (Lifileucel)/LN-145/LN-145-S1 as a single agent therapy.

NCT ID: NCT03642366 Recruiting - Clinical trials for Erectile Dysfunction

Low-intensity Shockwaves Therapy + Tadalafil 5mg for the Treatment of Severe Erectile Dysfunction

Start date: August 27, 2018
Phase: N/A
Study type: Interventional

This is a randomized, double-blind, sham-controlled, 3 parallel arms, clinical trial. All patients will be PDE5I users or ex-users. After 1 month wash-out period, ED patients will be screened, in order to randomize 51 men with vasculogenic ED. Patients will be randomized in 3 groups (17 subjects in each group) to receive shockwave treatments (12 sessions for all subjects, 5000 shockwaves at each session, at energy level 7), three times a week (total of 4 weeks) without treatment interval. One group will be sham-control at energy level 7 whereas 2 groups will receive active treatment.Three identical standard probes (probes A, B, C) will be used for the study, 2 of them active and one sham. Starting at first LiST session and finishing at the final week of LiST sessions, subjects will receive Tadalafil 5mg for 4 weeks daily. Total treatment period = 4 weeks. The IIEF-ED domain will be evaluated at Visit 1 and, consequently, at baseline and all follow up visits together with the SEP diaries.

NCT ID: NCT03626688 Recruiting - Hypertension Clinical Trials

A Study Evaluating the Efficacy and Safety of Ralinepag to Improve Treatment Outcomes in PAH Patients

Start date: August 30, 2018
Phase: Phase 3
Study type: Interventional

Study ROR-PH-301, ADVANCE OUTCOMES, is designed to assess the efficacy and safety of ralinepag when added to pulmonary arterial hypertension (PAH) standard of care or PAH-specific background therapy in subjects with World Health Organization (WHO) Group 1 PAH.

NCT ID: NCT03615287 Recruiting - Clinical trials for Inflammatory Bowel Diseases

Assessing Cardiovascular Dysfunction Pre- & Post-treatment in Inflammatory Bowel Diseases

Start date: January 26, 2018
Phase:
Study type: Observational

The aim of this study is to compare medical and surgery treatment in IBD patients and healthy controls, by assessing the endothelial and cardiac function and the inflammation status.

NCT ID: NCT03607747 Recruiting - Clinical trials for End Stage Renal Disease

Relationship Between Blood Pressure and Pulse Wave Velocity Measurements in Peritoneal Dialysis

Start date: July 18, 2018
Phase:
Study type: Observational

This study evaluates the relationship between Ambulatory Aortic and Branchial blood pressure vs Office blood pressure measurements with the changes in arterial stiffness indices, in long-term Peritoneal Dialysis (PD) patients. These parameters will be monitored both cross-sectionally at the start of the study and prospectively over a 6 month period.

NCT ID: NCT03596060 Recruiting - Hip Fractures Clinical Trials

Regional vs General Anesthesia in Patients With Hip Fracture Under Treatment With Clopidogrel

Start date: October 20, 2017
Phase: N/A
Study type: Interventional

This study compares general to regional anesthesia concerning morbidity and mortality in patients older than or equal to 65 years old who receive clopidogrel and are to be submitted in hip fracture surgery. Half of participants will receive general anesthesia the first 48 hours and the other half will receive regional anesthesia after 5 days of the discontinuation of clopidogrel.

NCT ID: NCT03592732 Recruiting - Atrial Fibrillation Clinical Trials

The Role of Adipokines In Atrial Fibrillation

Start date: March 29, 2018
Phase:
Study type: Observational

The principal aim of the present study is to analyze adiponectin, omentin-1, apelin and visfatin plasma levels in patients with and without AF in an effort to identify their potential role in the development of AF.

NCT ID: NCT03592693 Recruiting - Shock, Septic Clinical Trials

Vitamin C, Hydrocortisone and Thiamine for Septic Shock

CORVICTES
Start date: September 6, 2018
Phase: Phase 2
Study type: Interventional

Prior data has shown that both corticosteroids and vitamin C reduce the activation of nuclear factor ƘB (NFƘB), thereby ultimately attenuating the systemic inflammatory response to sepsis/septic shock and augmenting the responsiveness to vasopressors. Therefore, the current investigators hypothesized that the combined use of vitamin C and stress-dose hydrocortisone may improve the outcomes of patients with septic shock. The investigators intend to perform a randomized, multicenter, parallel group, double-blind, placebo-controlled trial of vitamin C plus stress-dose hydrocortisone or placebo plus placebo for a total of four days after randomization of patients fulfilling the current consensus criteria for septic shock. The primary outcome will be hospital mortality, whereas the scondary outcomes will include 60-day, 28-day mortality, time to vasopressor cessation, procalcitonin clearance and change in the Sequential Organ Failure Assessment score over the first 4 days after randomization, neurologic failure-free days, and length of stay in the intensive care unit (ICU) and the hospital. Target enrollment will be 400 patients.