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NCT ID: NCT04658862 Recruiting - Clinical trials for Urinary Bladder Neoplasms

A Study of TAR-200 in Combination With Cetrelimab Versus Concurrent Chemoradiotherapy in Participants With Muscle-invasive Bladder Cancer (MIBC) of the Bladder

SunRISe-2
Start date: December 7, 2020
Phase: Phase 3
Study type: Interventional

The purpose of study is to compare bladder intact-event free survival (BI-EFS) in participants receiving TAR-200 in combination with intravenous (IV) cetrelimab versus concurrent chemoradiotherapy.

NCT ID: NCT04650165 Recruiting - Clinical trials for Diabetic Retinopathy

10-year Progression of Diabetic Retinopathy: Identification of Signs and Surrogate Outcomes

PROGRESS10
Start date: June 1, 2021
Phase:
Study type: Observational [Patient Registry]

To characterize both functionally and morphologically initial Diabetic Retinopathy (DR) stages and their progression over a period of 10 years.

NCT ID: NCT04650061 Recruiting - Clinical trials for Sleep Apnea, Obstructive

PIMA - Individualized Adherence Improvement Plan

PIMAGASOXMED
Start date: October 1, 2020
Phase: N/A
Study type: Interventional

Continuous positive airway pressure (CPAP) is the first-line treatment for sleep apnoea/hypopnoea syndrome (OSA). The aim of this study is to know the results in adherence to CPAP and health related outcomes in patients with OSA through a comprehensive and multidisciplinary program based on stratification and individualized care plans, including the motivational interview. Methods: A multicenter randomized controlled trial (RCT) is designed. The control group will follow the usual treatment, while the intervention group (PIMA) will follow the treatment according to the stratification label based on a comprehensive assessment. This label determines a personalized treatment plan for each patient, which includes different channels (home, telephone, care center) and the use of the motivational interview in each of the interventions with the patient. The main outcome was adherence. Secondary outcomes were quality of life, emotional state, activities, social relationships, perceived competence and motivation.

NCT ID: NCT04645186 Recruiting - Bone Defects Clinical Trials

Calcium Phosphate Cement as Bone Void Filler

Start date: January 5, 2020
Phase:
Study type: Observational

This is an observational, prospective, non-randomised, post market clinical follow-up study to compile clinical data on performance and safety of the synthetic bone graft substitute and to assess that the performance and safety of the device are maintained until the reaching of its intended use in a commercial clinical setting in long bone and extremity defects.

NCT ID: NCT04644536 Recruiting - Bone Defects Clinical Trials

Retrospective Collection of Safety and Performance Data

Start date: November 25, 2020
Phase:
Study type: Observational

This is a retrospective post market clinical follow-up study to compile real world clinical data on safety and efficacy of the synthetic bone graft substitutes in a commercial clinical setting in long bone and extremity defects and in spinal fusion procedures.

NCT ID: NCT04643002 Recruiting - Clinical trials for Plasma Cell Myeloma Refractory

Isatuximab in Combination With Novel Agents in RRMM - Master Protocol

Start date: January 25, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this umbrella study is to evaluate isatuximab when combined with novel agents with or without dexamethasone in participants with relapsed or refractory myeloma. Substudies 02, 03, and 06 are controlled experimental substudies. Substudies 04 and 05 are independent experimental substudies.

NCT ID: NCT04640623 Recruiting - Clinical trials for Urinary Bladder Neoplasms

A Study of TAR-200 in Combination With Cetrelimab, TAR-200 Alone, or Cetrelimab Alone in Participants With Non-Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Intravesical Bacillus Calmette-Guérin Who Are Ineligible for or Elected Not to Undergo Radical Cystectomy

SunRISe-1
Start date: December 18, 2020
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the overall complete response (CR) rate in participants treated with TAR-200 in combination with cetrelimab (Cohort 1), or TAR-200 alone (Cohort 2), or cetrelimab alone (Cohort 3) with Carcinoma in Situ (CIS), with or without concomitant high-grade Ta or T1 papillary disease; and disease-free survival (DFS) in participants treated with TAR-200 alone with papillary disease only (Cohort 4).

NCT ID: NCT04633655 Recruiting - Quality of Life Clinical Trials

International CIPN Assessment and Validation Study

ICAVS
Start date: June 8, 2020
Phase:
Study type: Observational

This is an observational study of chemotherapy-induced peripheral neurotoxicity (CIPN) patients to be investigated prospectively in order to assess responsiveness of a set of outcome measures in an international multi-center study.

NCT ID: NCT04625907 Recruiting - Rhabdomyosarcoma Clinical Trials

FaR-RMS: An Overarching Study for Children and Adults With Frontline and Relapsed RhabdoMyoSarcoma

FaR-RMS
Start date: September 17, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

FaR-RMS is an over-arching study for children and adults with newly diagnosed and relapsed rhabdomyosarcoma (RMS)

NCT ID: NCT04624204 Recruiting - Clinical trials for Small Cell Lung Cancer

Placebo-controlled, Study of Concurrent Chemoradiation Therapy With Pembrolizumab Followed by Pembrolizumab and Olaparib in Newly Diagnosed Treatment-Naïve Limited-Stage Small Cell Lung Cancer (LS-SCLC) (MK 7339-013/KEYLYNK-013)

Start date: December 8, 2020
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare overall survival (OS) and progression free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR). Hypothesis (H1): Concurrent chemoradiation therapy with pembrolizumab followed by pembrolizumab plus olaparib is superior to concurrent chemoradiation therapy alone with respect to PFS per RECIST 1.1 by BICR. Hypothesis (H2): Concurrent chemoradiation therapy with pembrolizumab followed by pembrolizumab is superior to concurrent chemoradiation therapy alone with respect to PFS per RECIST 1.1 by BICR. Hypothesis (H3): Concurrent chemoradiation therapy with pembrolizumab followed by pembrolizumab plus olaparib is superior to concurrent chemoradiation therapy alone with respect to OS. Hypothesis (H4): Concurrent chemoradiation therapy with pembrolizumab followed by pembrolizumab is superior to concurrent chemoradiation therapy alone with respect to OS.