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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: NCT04642222 Completed - Pediatric Obesity Clinical Trials

APOLO-Teens, a Web-based Intervention For Adolescents With Overweight/Obesity

Start date: October 1, 2015
Phase: N/A
Study type: Interventional

With the demand for weight-loss interventions likely to continue its upward trend over the next decades, the question remains on how to continuously monitor and support overweight and obese adolescents, particularly in the long-term. Moreover, as the burden of the obesity rates increases in health care centers, the development of alternative delivering strategies gains attention. In an environment of limited resources, the development of new-technology based programs seems a promising area to deliver cost-effective interventions to a wide number of individuals. However, the existing studies present several limitations and a challenging aspect of treating obesity in adolescents is the presence of high rates of disordered eating behaviors. The objective of this study is to develop and test the effectiveness of a web-based Cognitive Behavioral Therapy intervention, for adolescents with overweight/obesity. A Randomized Controlled Trial will compare a control group receiving medical treatment as usual (TAU), and an intervention group receiving TAU plus a psychological/behavioral intervention delivered via the internet.

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: NCT04639895 Completed - Clinical trials for Alcohol Use Disorder (AUD)

Cognitive Rehabilitation Through Personalized Virtual Reality and Paper-and-pencil Interventions in the Alcohol Use Disorder Treatment.

Start date: October 22, 2018
Phase: N/A
Study type: Interventional

Cognitive dysfunction is one of the different consequences of excessive alcohol consumption, affecting many domains associated with prefrontal and temporal lobes, such as attention, verbal fluency, and memory. This study will explore the clinical impact of two cognitive rehabilitation tools to promote cognitive improvements of AUD individuals.

NCT ID: NCT04638153 Terminated - Achondroplasia Clinical Trials

A Study Of Safety, Tolerability And Effectiveness Of Recifercept In Children With Achondroplasia

Start date: December 2, 2020
Phase: Phase 2
Study type: Interventional

Approximately 63 participants will be randomized to one of three doses to receive Recifercept either - Low Dose - Medium Dose - High Dose Participants will will attend the clinic at baseline and at Day 1, 4, 8, 15, 29 & then Month 2, 3 6, 9 & 12. Assessments include safety, blood sampling, physical examination, vital signs, anthropometric body measurements & patient/caregiver quality of life questionnaires Participants will received treatment with Recifercept for 12 months. All participants who complete the study and in the opinion of the investigator, continue to have a positive risk:benefit profile, will be offered to enroll into an open-label extension (OLE) study. A PK cohort will include 12 participants who will randomly receive a single dose of 3 mg/kg of Phase 2 study (process 1c) formulation and a single dose of 3 mg/kg of the proposed Phase 3 (process 2) study formulation in a cross over study. Dose of the cohort could be changed due to emerging safety and efficacy data in the study.

NCT ID: NCT04636307 Active, not recruiting - Clinical trials for Diabetes Mellitus, Type 2

Characterization of Retinal Disease Progression in Eyes With Non Proliferative Diabetic Retinopathy in Diabetes Type 2 Using Non-invasive Procedures (CHART)

CHART
Start date: September 22, 2021
Phase:
Study type: Observational

To identify biomarkers, obtained using non-invasive procedures, that can predict disease progression and progression to sight-threatening stages of the disease and to characterize the retinal changes that occur in Non Proliferative Diabetic Retinopathy (NPDR).

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: NCT04631068 Completed - Cataract Clinical Trials

Clinical Comparison of a Monofocal eDOF IOL With a Monofocal IOL

MonoeDOF
Start date: September 21, 2020
Phase: N/A
Study type: Interventional

Post-market, prospective, randomized, single-masked, multi-center clinical study investigating the safety and effectiveness of the Monofocal Extended Depth of Focus Intraocular Lens (Mono-EDoF IOL) when compared to a Standard Monofocal Intraocular Lens. Primary Objectives: - To evaluate the distance VA of the study IOLs - To evaluate the intermediate VA of the study IOLs - To explore the safety profile with regards to visual disturbances

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.