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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: NCT04063527 Recruiting - Clinical trials for Epithelial Ovarian Cancer

Phase III Trial of Stage I Ovarian Cancer After Surgery

Start date: July 20, 2012
Phase: Phase 3
Study type: Interventional

To compare the Overall survival of adjuvant chemotherapy versus observation in stage I epithelial ovarian cancer after comprehensive staging surgery

NCT ID: NCT04052243 Recruiting - Clinical trials for Chronic Thromboembolic Pulmonary Hypertension

Hemodynamic Effects of BPA at Rest and During Exercise in CTEPH

EXPERT-BPA
Start date: January 1, 2021
Phase: N/A
Study type: Interventional

Chronic thromboembolic pulmonary hypertension (CTEPH) is characterized by obstruction of the pulmonary vasculature by residual organized thrombi, leading to increased pulmonary vascular resistance (PVR), progressive pulmonary hypertension, and right heart failure. Medical therapy and balloon angioplasty (BPA) are effective treatment alternatives in lowering pulmonary pressures and increasing pulmonary flow. The aim of this study is to assess the hemodynamic effects of BPA or medical therapy on the pressure-flow relationship in the pulmonary vasculature and the pulmonary vascular compliance.

NCT ID: NCT04040361 Recruiting - Clinical trials for Non-small Cell Lung Cancer Stage II

Neoadjuvant Therapy of Pembrolizumab + Ramucirumab for PD-L1 Positive Stage IB-IIIA Lung Cancer (EAST ENERGY)

Start date: November 30, 2019
Phase: Phase 2
Study type: Interventional

The efficacy and safety of the neoadjuvant therapy of pembrolizumab+ ramucirumab

NCT ID: NCT04036682 Recruiting - Clinical trials for Non Small Cell Lung Cancer

A Phase 1/2 Trial of CLN-081 in Patients With Non-Small Cell Lung Cancer

REZILIENT1
Start date: October 31, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

CLN-081-001 is a Phase 1/2, open label, multi-center study of CLN-081 in patients with non-small cell lung cancer (NSCLC) harboring EGFR (epidermal growth factor receptor) exon 20 insertion mutations, to characterize the safety, determine the recommended Phase 2 dose (RP2D), and evaluate efficacy.

NCT ID: NCT04031677 Recruiting - Leiomyosarcoma Clinical Trials

Surgery With or Without Neoadjuvant Chemotherapy in High Risk RetroPeritoneal Sarcoma

STRASS2
Start date: January 20, 2021
Phase: Phase 3
Study type: Interventional

This is a multicenter, randomized, open label phase lll trial to assess whether preoperative chemotherapy, as an adjunct to curative-intent surgery, improves the prognosis of high risk DDLPS (dedifferentiated Liposarcoma) and LMS (Leiomyosarcoma) patients as measured by disease free survival. After confirmation of eligibility criteria, patients will be randomized to either the standard arm or experimental arm.

NCT ID: NCT04027998 Recruiting - Clinical trials for Carpal Tunnel Syndrome

Median Nerve Strain and Applied Pressure Measurement in the Carpal Tunnel Syndrome Patients

Start date: April 3, 2015
Phase:
Study type: Observational

The aim of this study is to investigate diagnostic accuracy of median nerve strain and applied pressure measurement . Idiopathic carpal tunnel syndrome patients and healthy controls will be evaluated by ultrasound. Median nerve strain, pressure applied to the skin will be measured at the proximal part of the carpal tunnel. The parameters will be compared between patients and controls, and before and after the open carpal tunnel release in the patients.

NCT ID: NCT04020055 Recruiting - Fabry Disease Clinical Trials

A Study to Evaluate Migalastat in Fabry Subjects With Amenable GLA Variant and Renal Disease

Start date: October 31, 2022
Phase: Phase 3
Study type: Interventional

An Open-label Study to Evaluate the Safety and Pharmacokinetics of Migalastat HCl in Subjects with Fabry Disease and Amenable GLA Variants and Severe Renal Impairment (SRI) or End Stage Renal Disease (ESRD)

NCT ID: NCT04012242 Recruiting - Ultrasound Clinical Trials

Innovative Liver Elasticity, Attenuation, and Dispersion Ultrasound Study

iLEAD
Start date: June 15, 2019
Phase:
Study type: Observational

The objective of this study is: (1) to investigate the correlation of ultrasound parameters (SW speed, Dispersion slope, Attenuation value, Normalized Local Variance, Liver / Kidney Intensity Ratio) with the pathological parameters (fibrosis, intralobular inflammation, ballooning degeneration and steatosis); (2) to evaluate the diagnostic performance of SW speed for liver fibrosis, Dispersion slope for intralobular inflammation and Attenuation value for steatosis by comparison with the tissue diagnosis by liver biopsy.

NCT ID: NCT04008797 Recruiting - Neoplasms Clinical Trials

A Study of E7386 in Combination With Other Anticancer Drug in Participants With Solid Tumor

Start date: July 11, 2019
Phase: Phase 1
Study type: Interventional

The primary objective of this study is to assess the safety and tolerability and to determine the recommended Phase 2 dose (RP2D) of E7386 in combination with other anticancer drug(s).