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NCT ID: NCT04935879 Active, not recruiting - Sickle Cell Disease Clinical Trials

A Study to Assess the Safety and Efficacy of Inclacumab in Participants With Sickle Cell Disease Experiencing Vaso-occlusive Crises

Start date: October 26, 2021
Phase: Phase 3
Study type: Interventional

This Phase 3 study will assess the safety and efficacy of inclacumab, a P-selectin inhibitor, in reducing the frequency of vaso-occlusive crises (VOCs) in approximately 240 adult and adolescent participants (≥ 12 years of age) with sickle cell disease (SCD). Participants will be randomized to receive inclacumab or placebo.

NCT ID: NCT04770779 Active, not recruiting - Clinical trials for Transfusion-dependent Beta-Thalassemia

A Study Evaluating the Efficacy and Safety of Mitapivat in Participants With Transfusion-Dependent Alpha- or Beta-Thalassemia (α- or β-TDT)

ENERGIZE-T
Start date: November 30, 2021
Phase: Phase 3
Study type: Interventional

The primary purpose of this study is to compare the effect of mitapivat versus placebo on transfusion burden in participants with transfusion-dependent alpha- or beta-thalassemia (TDT).

NCT ID: NCT04770753 Active, not recruiting - Clinical trials for Non-Transfusion-dependent Beta-Thalassemia

A Study Evaluating the Efficacy and Safety of Mitapivat in Participants With Non-Transfusion-Dependent Alpha- or Beta-Thalassemia (α- or β-NTDT)

ENERGIZE
Start date: November 8, 2021
Phase: Phase 3
Study type: Interventional

The primary purpose of this study is to compare the effect of mitapivat versus placebo on anemia in participants with alpha- or beta-non-transfusion dependent thalassemia (NTDT).

NCT ID: NCT04659863 Active, not recruiting - Clinical trials for Familial Hypercholesterolemia - Homozygous

Study to Evaluate Efficacy and Safety of Inclisiran in Adolescents With Homozygous Familial Hypercholesterolemia

ORION-13
Start date: February 16, 2021
Phase: Phase 3
Study type: Interventional

This is a pivotal phase III study designed to evaluate safety, tolerability, and efficacy of inclisiran in adolescents with homozygous familial hypercholesterolemia (HoFH) and elevated low density lipoprotein cholesterol (LDL-C).

NCT ID: NCT04652726 Active, not recruiting - Clinical trials for Familial Hypercholesterolemia - Heterozygous

Study to Evaluate Efficacy and Safety of Inclisiran in Adolescents With Heterozygous Familial Hypercholesterolemia

ORION-16
Start date: January 27, 2021
Phase: Phase 3
Study type: Interventional

This is a pivotal phase III study designed to evaluate safety, tolerability, and efficacy of inclisiran in adolescents with heterozygous familial hypercholesterolemia (HeFH) and elevated low density lipoprotein cholesterol (LDL-C).

NCT ID: NCT04631536 Active, not recruiting - Covid19 Clinical Trials

Managing Endothelial Dysfunction in COVID-19 : A Randomized Controlled Trial at LAUMC

MEDIC-LAUMC
Start date: January 10, 2021
Phase: Phase 3
Study type: Interventional

COVID-19 infection was shown to cause endothelial dysfunction . At the level of the endothelium the pathophysiological mechanisms have been hypothesized and were divided into pro-coagulant, pro-inflammatory, anti-fibrinolytics, impaired barrier function, vasoconstrictor and pro-oxidant. So far, the pro-coagulant and pro-inflammatory pathways have been studied and as a result dexamethasone and anticoagulation became part of the standard therapies for the disease. However, so far, no RCT has been evaluated on targeting the vasoconstrictive and antioxidant pathways with an aim of revealing clinical benefit. So, with this trial we intend to provide a regiment composed of several medications we hypothesize will act on several downstream pathways that would improve endothelial function primarily via the increase in NO production and release. At the time of this proposal there has been no randomized trials evaluating or testing the use of cardiovascular drugs targeting endothelial dysfunction in COVID-19 patients. As previously noted there has been a call to study these drugs and their effect after a strong research regarding their theorized effectiveness. For evidence, there was a recently published meta-analysis evaluating the role of statins in COVID-19 with preliminary findings suggested a reduction in fatal or severe disease by 30% and discredited the suggestion of harm, that emphasized on the need of well-designed randomized controlled trial to confirm the role of statins in COVID-19 patients. Our study would help determine the potential therapeutic effect of the endothelial protocol as adjunct to mainstream management. This study seeks to further our knowledge in treating COVID-19 to ultimately improve clinical outcomes and reduce complications.

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.

NCT ID: NCT04343066 Active, not recruiting - Dental Implantation Clinical Trials

Bone Remodeling Around Implants With Two Different Surfaces Placed in Horizontally Augmented Bone

Start date: April 15, 2019
Phase: N/A
Study type: Interventional

The aim of this prospective controlled clinical trial is to evaluate the clinical and radiographical outcomes of two implant surfaces inserted in a crest that has been horizontally augmented at least 6 months prior to the implant placement. The horizontal GBR should be done with a xenogenic graft mixed with autologous bone particles, and a collagen membrane stabilized using tacks or screws.

NCT ID: NCT04338139 Active, not recruiting - Bone Regeneration Clinical Trials

Influence of Bio-Oss Collagen Grafting at Implant Placement on Buccal Bone Volume Regeneration

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

to validate the capacity of bio-oss collagen (xenograft block+ collagen type I) placed solely without a membrane on a thin (0.5-1.8mm) buccal bone wall after delayed implant placement to regenerate bone volume. 30 patients requiring dental implants and presenting a deficient bone ridge (a ridge with reduced marginal bone width ≤ 2mm) were selected. The bone regeneration technique used in this study: - Pre-operatively: - cone beam computed tomography CBCT - 1 minute mouthwash with a 0.12% Chlorhexidine solution - Full thickness muco-periosteal flap and ridge curettage. - Drilling and implant placement (any implant system) - Adjustment and placement of the "Bio-Oss Collagen" in the regeneration site without a fixation membrane. - Hermetic wound closure with U-shaped and simple stitches using 5/0 and 6/0 PGA resorbable material. - Post-operatively: - Medication: - Amoxicilline (1g) or Clindamycine (300mg) - Analgesic, (paracetamol + codeine) - Mouthwash with a solution of 0.12% Chlorhexidine - cone beam computed tomography CBCT - 4 months postoperatively: CBCT Bio-oss collagen is placed on the buccal side after implant placement and adapted to have the bone defect morphology. the full thickness flap is then closed without membrane placement and the bone bock is fixed in place through sutures only. CBCT images were taken immediately postoperatively and at 4 months after bone grafting. Imaging superposition (on ITK software) and measurements of buccal bone gain were effectuated to evaluate the efficiency of this regeneration technique. evaluation of buccal bone regeneration through linear radiographic measurements and evaluation of the % of grafted bone resorption will indicate the success of this technique

NCT ID: NCT04266301 Active, not recruiting - Clinical trials for Myelodysplastic Syndromes

Study of Efficacy and Safety of MBG453 in Combination With Azacitidine in Subjects With Intermediate, High or Very High Risk Myelodysplastic Syndrome (MDS) as Per IPSS-R, or Chronic Myelomonocytic Leukemia-2 (CMML-2)

STIMULUS-MDS2
Start date: June 8, 2020
Phase: Phase 3
Study type: Interventional

This is a Phase III multi-center, randomized, two-arm parallel-group, double-blind, placebo-controlled study of MBG453 or placebo added to azacitidine in adult subjects with intermediate, high or very high-risk myelodysplastic syndrome (MDS) as per IPSS-R, or Chronic Myelomonocytic Leukemia-2 (CMML-2) who are not eligible for intensive chemotherapy or hematopoietic stem cell transplantation (HSCT) according to medical judgment by the investigator. The purpose of the current study is to assess clinical effects of MBG453 in combination with azacitidine in adult subjects with IPSS-R intermediate, high, very high risk MDS and CMML-2.