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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: NCT04878510 Active, not recruiting - Clinical trials for Respiratory Insufficiency

Non-invasive Ventilation and Dex in Critically Ill Adults

inDEX
Start date: March 7, 2022
Phase: Phase 3
Study type: Interventional

Non-Invasive ventilation (NIV) is a life saving intervention for patients with acute respiratory failure (ARF). Some patients are not able to tolerate the NIV intervention and ultimately fail, requiring the use of invasive mechanical ventilation (IMV) and intubation. Sedation may improve a patient's NIV tolerance. However, this practice has not been adopted by intensivists as the risk of over-sedation resulting in respiratory depression, inability to protect the airway, and inadvertent need for intubation are all large deterrents of sedative use in NIV. The Non-invasive Ventilation and Dexmedetomidine in Critically Ill Adults: a Vanguard Pragmatic Randomized Controlled Trial (inDEX) is looking to evaluate the effectiveness of dexmedetomidine compared to placebo in reducing non-invasive ventilation failures in patients admitted to the hospital with acute respiratory failure. The results from this pilot trial, will subsequently inform a large, pragmatic, powered trial to definitively address the question.

NCT ID: NCT04860960 Active, not recruiting - Clinical trials for Niemann-Pick Disease, Type C1

Phase 3 Study to Evaluate Intravenous Trappsol(R) Cyclo(TM) in Pediatric and Adult Patients With Niemann-Pick Disease Type C1

TransportNPC
Start date: July 20, 2021
Phase: Phase 3
Study type: Interventional

A prospective, randomized, double-blind, placebo controlled, multi-center therapeutic study for patients age 3 and older with confirmed diagnosis of Niemann Pick disease type C1 (NPC1). The objective of this study is to evaluate the safety, tolerability and efficacy of 2000 mg/kg dose of Trappsol Cyclo (hydroxypropyl betacyclodextrin) administered intravenously compared to standard of care. An open-label sub-study in countries following European Medicines Agency (EMA) guidance will enroll asymptomatic or symptomatic patients from infancy up to age 3 to evaluate safety in that population.

NCT ID: NCT04837664 Active, not recruiting - Cigarette Smoking Clinical Trials

Curcumin; Rose Bengal; Denture Stomatitis

Start date: July 3, 2018
Phase: Phase 3
Study type: Interventional

Cigarette smoking in conjugation with bad oral hygiene is considered a typical predisposing factor for many oral diseases including denture stomatitis. This study investigated the effect of Rose Bengal (RB)-and Curcumin (CUR)-mediated photodynamic therapy (PDT) in comparison with nystatin therapy in the intervention of denture stomatitis in cigarette smokers. Overall, 45 habitual cigarette smokers aged ~58 years having denture stomatitis were categorized into three groups: Group-I - RB-mediated PDT, Group-II - CUR-mediated PDT, and Group-III - Nystatin therapy. The primary outcome of the interest was: counts of Candida colony from denture surface and palatal mucosa, calculated as CFU/mL, whereas the prevalence of Candida species determined in 3 research groups comprised the secondary outcome. Oral swab specimens were gathered from the denture surfaces and palatal mucosa. All clinical assessments were performed at baseline, 6 weeks, and 12 weeks. C. albicans was the most prevalent yeast identified on both denture surfaces and palatal mucosa, followed by C. tropicalis and C. glabrata. A considerable decrease in the CFU/mL scores were observed in Group-I and Group-II at the end of the interventions and on the 12-week follow-up (p<0.05). Group-I, II, and III demonstrated clinical efficacy rates of 53%, 51%, and 49%, respectively. CUR-and RB-mediated PDT was found to be as effective as topical Nystatin therapy for the intervention of denture stomatitis among cigarette smokers.

NCT ID: NCT04835753 Active, not recruiting - Cerebral Palsy Clinical Trials

Shock Wave and Spastic Cerebral Palsy Equines Foot

CP
Start date: January 1, 2021
Phase: N/A
Study type: Interventional

A double-blind randomized controlled study was carried out on 34 children (19 boys and 15 girls) in the age ranged from 7 to 9 years old with spastic hemiplegia were randomly allocated to one of two groups: control or study group. The two groups received traditional therapeutic exercises for 12 weeks. Additionally, study group received rESW (one session/week) on gastrocnemius and soleus muscles (1500 shots/muscle, frequency of 4Hz, energy of 0.030 mJ/mm2). All children were evaluated at baseline, and after 12 weeks by Modified Ashworth Scale, Biodex system 4 isokinetic dynamometer, Gross Motor Function Measure (GMFM-88), dimensions "D" standing and "E" walking, Trost Selective Motor Control Test, and Single Leg Standing Test.

NCT ID: NCT04818502 Active, not recruiting - Clinical trials for Mitral Valve Regurgitation

Real World Study of the Tendyne™ Mitral Valve System to Treat Mitral Regurgitation

RESOLVE-MR
Start date: May 4, 2021
Phase:
Study type: Observational

To evaluate the safety and performance of the Tendyne™ Mitral Valve System when used as intended in a contemporary, real-world setting.

NCT ID: NCT04784715 Active, not recruiting - Clinical trials for Breast Cancer; HER2-positive; Metastatic

Trastuzumab Deruxtecan (T-DXd) With or Without Pertuzumab Versus Taxane, Trastuzumab and Pertuzumab in HER2-positive Metastatic Breast Cancer (DESTINY-Breast09)

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

The study will evaluate the efficacy and safety of trastuzumab deruxtecan (also known as T-DXd, DS-8201a), either alone or in combination with pertuzumab, in treating patients with Human epidermal growth factor receptor 2 (HER2)-positive breast cancer as a first line of treatment in the metastatic setting.

NCT ID: NCT04779476 Active, not recruiting - Pain, Postoperative Clinical Trials

Effectiveness of Alveogyl and Cutanplast Dressing on Postoperative Pain Following Tooth Extraction: A Clinical Trial

Start date: March 4, 2021
Phase:
Study type: Observational

This study aims to assess the post-dental extraction pain following the application of two different dressing materials. Alvogyl® and Absorbable gelatin sponges

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).