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NCT ID: NCT04681170 Active, not recruiting - Clinical trials for Homozygous Familial Hypercholesterolaemia (HoFH)

Efficacy and Safety of Lomitapide in Paediatric Patients With Homozygous Familial Hypercholesterolaemia (HoFH)

Start date: December 14, 2020
Phase: Phase 3
Study type: Interventional

This is a single arm, open label, multi centre phase III study to evaluate the efficacy and long term safety of lomitapide in paediatric patients with HoFH receiving stable LLT (including LA, when applicable) comprising of the following phases: - Screening Period (starting at Week 12, i.e. ≤12 weeks prior to Baseline for up to 6 weeks) - Stratified Enrolment and Start of Run in Period (starting at minimum at Week 6, i.e., 6 weeks prior to Baseline for a minimum of 6 weeks): - Efficacy Phase (starting at Baseline, i.e. Day [D] 0 for 24 weeks±3 days - Safety Phase (starting at Week 24±3 days for 80±1 weeks)

NCT ID: NCT04680052 Active, not recruiting - Follicular Lymphoma Clinical Trials

A Phase 3 Study to Assess Efficacy and Safety of Tafasitamab Plus Lenalidomide and Rituximab Compared to Placebo Plus Lenalidomide and Rituximab in Patients With Relapsed/Refractory (R/R) Follicular Lymphoma or Marginal Zone Lymphoma.

InMIND
Start date: April 15, 2021
Phase: Phase 3
Study type: Interventional

This is a Phase 3 double-blind, placebo-controlled, randomized study designed to investigate whether tafasitamab and lenalidomide as an add-on to rituximab provides improved clinical benefit compared with lenalidomide as an add-on to rituximab in patients with R/R FL Grade 1 to 3a or R/R MZL.

NCT ID: NCT04680039 Completed - Clinical trials for Hypotension of Hemodialysis

Early Warning of Intradialytic Hypotension in Hemodialysis Patients

Start date: January 15, 2021
Phase:
Study type: Observational

In this study, the investigators will monitor patients undergoing hemodialysis treatment with a non-invasive wearable PPG-based device. Measurements will include blood pressure, heart rate, oxygen saturation, stroke volume, cardiac output, cardiac index and systemic vascular resistance, among others. The aim is to diagnose intradialytic hypotension more rapidly than with current noninvasive methods and prevent related poor outcomes.

NCT ID: NCT04677569 Recruiting - Clinical trials for Mycobacterium Infections, Nontuberculous

Study to Evaluate ALIS (Amikacin Liposome Inhalation Suspension) in Participants With Nontuberculous Mycobacterial Lung Infection Caused by Mycobacterium Avium Complex

ENCORE
Start date: April 1, 2021
Phase: Phase 3
Study type: Interventional

The main objective of this study is to evaluate the efficacy of ALIS (amikacin liposome inhalation suspension) + background regimen (azithromycin [AZI] + ethambutol [ETH]) compared to the ELC (empty liposome control) + background regimen on participant-reported respiratory symptoms at Month 13.

NCT ID: NCT04677543 Completed - Clinical trials for Mycobacterium Infections, Nontuberculous

Validation of Patient Reported Outcome Measures in Participants With Nontuberculous Mycobacterial Lung Infection Caused by Mycobacterium Avium Complex

ARISE
Start date: December 22, 2020
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to generate evidence demonstrating the domain specification (via modern psychometric methods), reliability, validity, and responsiveness (within-subject meaningful change) of the Patient-Reported Outcome (PRO) endpoints.

NCT ID: NCT04677179 Terminated - Colitis, Ulcerative Clinical Trials

A Study of LY3471851 in Adult Participants With Moderately to Severely Active Ulcerative Colitis (UC)

INSTRUCT-UC
Start date: March 22, 2021
Phase: Phase 2
Study type: Interventional

The reason for this study is to determine if the study drug LY3471851 is safe and effective in adult participants with active ulcerative colitis (UC). The study treatment will last about 52 weeks.

NCT ID: NCT04676334 Completed - Ovarian Cancer Clinical Trials

CATCH-R: A Rollover Study to Provide Continued Access to Rucaparib

CATCH-R
Start date: March 22, 2021
Phase: Phase 3
Study type: Interventional

This protocol is designed to provide participants currently benefiting from rucaparib treatment in a Clovis-sponsored clinical study with continued access to treatment for as long as they continue to benefit. Participants in long-term follow-up (LTFU) in a parent study may also enroll in this study for continued data collection, as applicable based on parent study objectives.

NCT ID: NCT04675827 Suspended - Clinical trials for HER2-positive Breast Cancer

De-escalation Adjuvant Chemo in HER2+/ER-/Node-neg Early BC Patients Who Achieved pCR After Neoadjuvant Chemo & Dual HER2 Blockade

Decrescendo
Start date: January 17, 2022
Phase: Phase 2
Study type: Interventional

DECRESCENDO is a multicentre, open-label, dual-phase single-arm phase II de-escalation study evaluating neoadjuvant treatment with 12 administrations of weekly IV paclitaxel 80 mg/m2 (or IV docetaxel 75 mg/m2 every 3 weeks for 4 cycles) combined with subcutaneous (SC) fixed dose combination (FDC) of pertuzumab and trastuzumab (loading dose of 1200 mg pertuzumab and 600 mg trastuzumab, followed by 600 mg pertuzumab and 600 mg trastuzumab) every 3 weeks for 4 cycles. Surgery will be performed according to local guidelines in all subjects after neoadjuvant treatment. After surgery, subjects who achieve a pCR (defined as pT0/Tis pN0) will receive adjuvant pertuzumab and trastuzumab FDC SC for additional 14 cycles. Subjects with residual invasive disease will receive salvage adjuvant trastuzumab emtansine (T-DM1, 3.6 mg/kg, IV every 3 weeks) for 14 cycles. In subjects whose residual invasive disease is classified per RCB score as ≥2, 3 to 4 cycles of anthracycline-based chemotherapy may be administered, at the investigator's discretion, before the 14 cycles of T-DM1. If histopathological analysis finds that the surgical specimen from a subject with residual disease is ER-positive and/or PR-positive, adjuvant endocrine therapy may be administered concomitantly with study treatment, at the investigator's discretion and according to local guidelines. Adjuvant radiotherapy will be mandatory after breast-conserving surgery, whereas it will be performed according to local guidelines after mastectomy, and it will be administered concomitantly with pertuzumab and trastuzumab FDC SC in subjects who achieve a pCR, and concomitantly with T-DM1 in subjects with residual invasive disease (after anthracycline-based chemotherapy in subjects assigned to receive this treatment).

NCT ID: NCT04674761 Completed - Alagille Syndrome Clinical Trials

Efficacy and Safety of Odevixibat in Patients With Alagille Syndrome

ASSERT
Start date: March 19, 2021
Phase: Phase 3
Study type: Interventional

Double-blind, randomized, placebo-controlled, Phase 3 study to investigate the efficacy and safety of odevixibat compared to placebo in Patients with Alagille Syndrome.

NCT ID: NCT04674319 Completed - Parkinson Disease Clinical Trials

Attending to External Cues and Movement Strategies in Parkinson Disease

Start date: March 1, 2019
Phase: N/A
Study type: Interventional

People with Parkinson's disease use compensatory strategies to overcome typical gait disturbances. These strategies rely on attentional mechanisms, however people with Parkinson disease suffer of decline in cognitive function. Therefore, the current study aims at exploring brain engagement and focus of attention process during walking with these compensatory strategies, in people with Parkinson disease. Such exploration would assist in understanding the feasibility of the compensatory strategies in daily lives of people with Parkinson's disease.