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NCT ID: NCT04620889 Active, not recruiting - Clinical trials for Diseased or Occluded Blood Vessels

LeMaitre LifeSpan® ePTFE Vascular Graft Retrospective Registry

Start date: November 27, 2020
Phase:
Study type: Observational

This is a post-market, single-arm, retrospective registry. The investigator or its representative will identify eligible patients through a medical record search.

NCT ID: NCT04619797 Active, not recruiting - Clinical trials for Non-small Cell Lung Cancer (NSCLC)

A Study of Tiragolumab in Combination With Atezolizumab Plus Pemetrexed and Carboplatin/Cisplatin Versus Pembrolizumab Plus Pemetrexed and Carboplatin/Cisplatin in Participants With Previously Untreated Advanced Non-Squamous Non-Small Cell Lung Cancer

SKYSCRAPER-06
Start date: December 14, 2020
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of tiragolumab in combination with atezolizumab plus pemetrexed and carboplatin/cisplatin (Arm A) compared with placebo in combination with pembrolizumab plus pemetrexed and carboplatin/cisplatin (Arm B) in participants with previously untreated, locally advanced unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC). Eligible participants will be randomized in a 1:1 ratio to receive one of the following treatment regimens during the induction phase: - Arm A: Tiragolumab plus atezolizumab plus pemetrexed and carboplatin or cisplatin - Arm B: Placebo plus pembrolizumab plus pemetrexed and carboplatin or cisplatin Following the induction phase, participants will continue maintenance therapy with either tiragolumab in combination with atezolizumab and pemetrexed (Arm A) or placebo in combination with pembrolizumab and pemetrexed (Arm B).

NCT ID: NCT04619485 Active, not recruiting - Breast Cancer Clinical Trials

Sexual and Vaginal Health in Breast Cancer Women Receiving Aromatase Inhibitors Before and After CO2 Laser Therapy

LIGHT
Start date: October 30, 2020
Phase: N/A
Study type: Interventional

Background: Vulvovaginal health, directly linked to sexual health, is a key factor for female pleasure. BCS receiving AI are likely to present severe GSM and sexual complaints. Innovative options, as vaginal laser therapy, are emerging to treat GSM and sexual dysfunctions. Nowadays, data in BCS is scarce, moreover, few studies included patients receiving AI [16]. Different meta-analysis [17-23] found GSM [24, 25] and sexual function [9, 10] may improve significantly at short-term, however, the body of evidence is of low quality. Therefore, before recommendation of laser therapy for sexual complaints in BCS with GSM, there are unmet needs to be solved: efficacy and safety at long-term, biases related to patients' expectations and a detailed assessment of the complex underpinnings of sexuality. Aims: To evaluate sexual and vaginal health in BCS receiving AI with GSM, before and after CO2 laser therapy compared to a sham-controlled group. Methods: Prospective, randomized, double-blind controlled study with two parallel study arms: 1) Fractional CO2 laser therapy (5monthly sessions). 2) Sham laser therapy (5monthly sessions). After end-treatment, patients are followed up at 1 month and 6 months. BCS treated or undergoing AI with GSM and sexual function impairment, will be suitable. All patients will maintain first-line non-hormonal treatment and sexual assessment (PLISSIT Model) according with usual care. The primary outcome is improvement in sexual function (FSFI total score). As secondary outcomes: resumption sexual activity, sexual activity frequency, dyspareunia (VAS), female sexual dysfunction, sexual dimensions (FSFI), body image (S-BIS), quality of life (SF-12), vaginal pH acidification, maturation index and Vaginal Health Index of Gloria Backmann, adverse events, satisfaction (Likert scale) and adherence to treatment. Expected impact: Emergent, non-invasive, laser therapy has significant benefit for BCS with AI, improving subjective and objective sexual and vaginal health outcomes and adding value to the usual care multidisciplinary approach.

NCT ID: NCT04619056 Active, not recruiting - Clinical trials for Recurrent Soft Tissue Sarcoma

First-in-man Clinical Trial of CEB-01 PLGA Membrane in Recurrent or Locally Advanced Retroperitoneal Soft Tissue Sarcoma

Start date: June 3, 2020
Phase: Phase 1
Study type: Interventional

This is an open label, first-in-man clinical trial to assess safety and tolerability of CEB-01 PLGA membrane in patients with recurrent or locally advanced retroperitoneal soft tissue sarcoma after surgery. The trial will be conducted in 3 dose-escalation cohorts (3 patients each, enrolling patients one by one, after 4 weeks of observation and agreement of Scientific Committee and DMC) and in an expansion cohort, using the highest safe and tolerable dose. The study will follow a 3+3 modified design; dose escalation will follow a modified Fibonacci method. CEB-01 carrying a SN-38 dose between 9 and 36 mg will be placed in the surgical bed at the time of tumor resection.

NCT ID: NCT04619004 Active, not recruiting - Clinical trials for Non-Small Cell Lung Cancer Metastatic

HERTHENA-Lung01: Patritumab Deruxtecan in Subjects With Metastatic or Locally Advanced EGFR-mutated Non-Small Cell Lung Cancer

Start date: February 2, 2021
Phase: Phase 2
Study type: Interventional

This study is designed to evaluate the antitumor activity of patritumab deruxtecan in participants with metastatic or locally advanced NSCLC with an activating EGFR mutation (exon 19 deletion or L858R) who have received and progressed on or after at least 1 EGFR TKI and 1 platinum-based chemotherapy-containing regimen.

NCT ID: NCT04618887 Active, not recruiting - Blepharospasm Clinical Trials

A Comparative Study of GPI's DBS and Pallidotomy in the Treatment of Meige Syndrome

Start date: January 1, 2020
Phase:
Study type: Observational

In this study, we will compare the degree of postoperative symptom improvement, postoperative complication rate, postoperative quality of life improvement degree of patients with Meige syndrome undergoing pallidotomy (unilateral globus palliotomy) and deep brain stimulation (unilateral globus pallidus) ,in order to get the conclusion of the comparison of the clinical efficacy of the two surgical plans. In addition, possible predictive factors such as age, gender, age of onset, length of disease course, scale baseline score, preoperative brain PET-CT function analysis and other possible predictive factors are added for analysis, in order to find predictive factors that can guide the choice of surgical options.

NCT ID: NCT04618601 Active, not recruiting - Clinical trials for Heart Failure; With Decompensation

Diuretic and Natriuretic Effect of High-dose Spironolactone in Patients With Acute Heart Failure

DANAUS-AHF
Start date: October 20, 2020
Phase: Phase 4
Study type: Interventional

This is a prospective, single-center, open-label and randomized trial for evaluation of the effect of a 5-day administration of high doses of spironolactone (≥100mg daily) on diuresis, natriuresis, weight loss and levels of NT-proBNP in hospitalized patients with acute decompensated heart failure (ADHF). Mineralocorticoid receptor antagonists (MRAs) are recommended as standard of care (SOC) in management of heart failure (HF) patients. However, recommended doses of MRAs (up to 50mg daily) have any impact on signs and symptoms of volume overload. Therefore, the proposed study will aim to show the impact of high doses of spironolactone to improve diuresis, natriuresis, weight loss and levels of NT-proBNP in hospitalized patients with ADHF.

NCT ID: NCT04617340 Active, not recruiting - Clinical trials for Drug-Related Side Effects and Adverse Reactions

Effect of a trAnSitional Pharmacist Intervention in geRiatric Inpatients on Hospitals Visits After dischargE

ASPIRE
Start date: February 25, 2021
Phase: N/A
Study type: Interventional

A randomized controlled trial will be performed in geriatric inpatients to investigate the impact of a multifaceted clinical pharmacy intervention on health related outcomes.

NCT ID: NCT04616924 Active, not recruiting - Lung Diseases Clinical Trials

RHB-204 for the Treatment of Pulmonary Mycobacterium Avium Complex Disease

CleaR-MAC
Start date: December 1, 2020
Phase: Phase 3
Study type: Interventional

A 2-part multi-center, Phase 3, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of RHB-204 in adult subjects with underlying nodular bronchiectasis and documented MAC lung infection.

NCT ID: NCT04616534 Active, not recruiting - Clinical trials for Advanced Malignant Solid Neoplasm

Testing the Addition of an Anti-cancer Drug, Elimusertib (BAY 1895344) ATR Inhibitor, to the Chemotherapy Treatment (Gemcitabine) for Advanced Pancreatic and Ovarian Cancer, and Advanced Solid Tumors

Start date: June 1, 2021
Phase: Phase 1
Study type: Interventional

This phase I trial identifies the best dose, possible benefits and/or side effects of gemcitabine in combination with elimusertib (BAY 1895344) in treating patients with pancreatic, ovarian, and other solid tumors that have spread to other places in the body (advanced). Gemcitabine is a chemotherapy drug that blocks the cell from making DNA and may kill tumor cells. elimusertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving gemcitabine and elimusertib in combination may shrink or stabilize cancer.