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NCT ID: NCT04684524 Active, not recruiting - Clinical trials for Allergic Fungal Rhinosinusitis

Dupilumab in Allergic Fungal Rhinosinusitis (AFRS) (LIBERTY-AFRS-AI)

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

Primary Objective: - To evaluate the efficacy of treatment with dupilumab to reduce sinus opacification in a population with allergic fungal rhinosinusitis (AFRS) Secondary Objectives: - To evaluate the efficacy of treatment with dupilumab to reduce sinus opacification in a population with allergic fungal rhinosinusitis (AFRS) at Week 24 - To assess the efficacy of dupilumab to reduce the need for rescue treatments - To evaluate the efficacy of treatment with dupilumab in improving symptoms in AFRS - To evaluate the efficacy of dupilumab to reduce nasal polyp formation in participants with AFRS - To evaluate the efficacy of dupilumab in improving overall symptom severity and quality of life in AFRS - To evaluate the efficacy of dupilumab in improving sense of smell in participants with AFRS - To explore the effect of dupilumab as assessed by three-Dimensional CT volumetric measurement of the paranasal sinuses - To evaluate the safety and tolerability of dupilumab when administered to participants with AFRS - To evaluate the pharmacokinetics (PK) of dupilumab in participants with AFRS - To characterize the effect of dupilumab on total IgE and specific IgE - To assess immunogenicity to dupilumab in participants with AFRS

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: NCT04550962 Active, not recruiting - Asthma Clinical Trials

Description of Characteristics, Such as Age, Previous and Concurrent Treatments, Associated Diseases, of Patients With Asthma Treated With Dupilumab (DUPIXENT)

REVEAL
Start date: November 2, 2020
Phase:
Study type: Observational [Patient Registry]

Primary Objective: The primary objective of the study is to characterize patients initiating DUPIXENT for asthma in a real-world setting, with respect to their medical history, including asthma history and asthma treatment history, socio-demographic, biomarkers (including Fractional exhaled nitric oxide [FeNO]), and concomitant treatments for asthma. Secondary Objectives: The secondary objectives of the study are: - To characterize real-world use patterns of DUPIXENT for asthma (eg, most commonly used regimens, reason for initiation of new asthma treatments, concomitant therapies, treatment durations, and reasons for discontinuation and/or switching) - To assess the effectiveness of DUPIXENT in asthma patients in a real world setting (lung function improvement, exacerbation rate, asthma control) - To assess comorbid type 2 conditions (atopic/allergic) and patterns of use and effects of treatment in comorbid conditions in asthma patients treated with Dupixent - To collect data on HealthCare Resource Utilization (HCRU) - To collect safety data on study participants in the real-world setting.

NCT ID: NCT04494425 Active, not recruiting - Clinical trials for Advanced or Metastatic Breast Cancer

Study of Trastuzumab Deruxtecan (T-DXd) vs Investigator's Choice Chemotherapy in HER2-low, Hormone Receptor Positive, Metastatic Breast Cancer

DB-06
Start date: July 24, 2020
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy, safety and tolerability of trastuzumab deruxtecan compared with investigator's choice chemotherapy in human epidermal growth factor receptor (HER)2-low, hormone receptor (HR) positive breast cancer patients whose disease has progressed on endocrine therapy in the metastatic setting.

NCT ID: NCT04466943 Active, not recruiting - Clinical trials for Bariatric Surgery Candidate

The Impact of Moderate Versus Deep Neuromuscular Blockade on Enhanced Recovery After Bariatric Anesthesia

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

Most published articles suggest that deep neuromuscular blockade is required for bariatric surgery. However, the evidence for such practice is still inconclusive. From the clinical experience at a major bariatric center of volume exceeding six hundred procedures annually, the investigators believe that moderate neuromuscular blockade will provide an adequate surgical condition and significantly facilitate enhanced recovery after bariatric procedures.

NCT ID: NCT04399135 Active, not recruiting - Periodontitis Clinical Trials

Accuracy of Pulp Sensibility Test on Teeth With Deep Periodontal Pocket

Start date: February 25, 2020
Phase: N/A
Study type: Interventional

The aim of this study is to evaluate the accuracy of pulp test in teeth presenting with deep periodontal pocket. The null hypothesis is no significant effect of periodontitis on the accuracy of pulp test.

NCT ID: NCT04394546 Active, not recruiting - Stroke Clinical Trials

CHAMPION-AF Clinical Trial

CHAMPION-AF
Start date: October 15, 2020
Phase: N/A
Study type: Interventional

The primary objective of this study is to determine if left atrial appendage closure (LAAC) with the WATCHMAN FLX device is a reasonable alternative to non-vitamin K oral anticoagulants in patients with non-valvular atrial fibrillation.

NCT ID: NCT04378894 Active, not recruiting - Parenting Clinical Trials

Evaluation of the Mother-Child Educational Program (MOCEP) in Riyadh, Saudi Arabia.

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

The Mother Child Education Program (MOCEP) was developed by the Mother Child Education Foundation (ACEV). MOCEP is implemented in Saudi Arabia through a 25-week program conducted by ACEV-trained groups with a curriculum for the child that is implemented at home by the mothers. The program is designed to (1) promote parenting skills and bolster strategies that support school readiness among mothers of 3-to-6- year-old children, and (2) enhance social cohesion in the family and community. Rigorous evaluations of MOCEP have been conducted in several contexts, but not yet in the context of Saudi Arabia. Thus, the present study aims to rigorously evaluate the impact of MOCEP on child and parent outcomes among families in Riyadh, Saudi Arabia.

NCT ID: NCT04370054 Active, not recruiting - Hemophilia A Clinical Trials

Study to Evaluate the Efficacy and Safety of PF-07055480 / Giroctocogene Fitelparvovec Gene Therapy in Moderately Severe to Severe Hemophilia A Adults

AFFINE
Start date: August 18, 2020
Phase: Phase 3
Study type: Interventional

C3731003 is a pivotal Phase 3 study to evaluate the clinical efficacy and safety of a single IV infusion of PF-07055480 / giroctocogene fitelparvovec (Recombinant AAV2/6 Human Factor VIII Gene Therapy) in adult male participants with moderately severe or severe hemophilia A (FVIII:C≤1%) for the study duration of 5 years. The study will enroll eligible participants who have been followed on routine prophylaxis with FVIII products in the Lead-In study C0371004.

NCT ID: NCT04353492 Active, not recruiting - Clinical trials for Relapsing Multiple Sclerosis

An Open-label Study Evaluating Ofatumumab Treatment Effectiveness and PROs in Subjects With RMS Transitioning From Fumarate-based RMS Approved Therapies or Fingolimod to Ofatumumab

ARTIOS
Start date: July 14, 2020
Phase: Phase 3
Study type: Interventional

Open-label study to evaluate the effectiveness of treatment with ofatumumab in subjects transitioning from any fumarate-based RMS approved therapy or fingolimod due to breakthrough disease.