Intratracheal budesonide mixed with surfactant to increase survival free of bronchopulmonary dysplasia in extremely preterm infants: statistical analysis plan for the international, multicenter, randomized PLUSS trial
AbstractBackgroundBronchopulmonary dysplasia (BPD), an inflammatory-mediated chronic lung disease, is common in extremely preterm infants born before 28 weeks’ gestation and is associated with an increased risk of adverse neurodevelopmental and respiratory outcomes in childhood. Effective and safe prophylactic therapies for BPD are urgently required. Systemic corticosteroids reduce rates of BPD in the short term but are associated with poorer ne urodevelopmental outcomes if given to ventilated infants in the first week after birth. Intratracheal administration of corticosteroid admixed with exogenous surfactant could o...
Source: Trials - November 6, 2023 Category: Research Source Type: clinical trials
Dar é Bioscience Announces Additional Positive Data from Phase 2b RESPOND Study of Sildenafil Cream, 3.6% in Women and Proposed Endpoints and Patient Population for Phase 3 Program
Additional Analyses of Phase 2b Data Conducted in Population of Study Participants with Female Sexual Interest/Arousal Disorder (FSIAD), With Primary Complaint of Arousal Dysfunction
Achieved Statistical Significance and Clinically Meaningful... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - November 1, 2023 Category: Pharmaceuticals Source Type: clinical trials
A single-center, single-blinded, randomized, parallel-group, non-inferiority trial to compare the efficacy of a 22-gauge needle versus a 15 blade to perform an Achilles tendon tenotomy in 244 clubfeet —study protocol
AbstractBackgroundAchilles tendon tenotomy is an integral part of the Ponseti method, aimed at correcting residual equinus and lack of dorsiflexion after correction of the adductus deformity in clubfoot. Percutaneous tenotomy using a number 15 scalpel blade is considered the gold standard, resulting in excellent results with minimal complications. The use of a large-bore needle to perform Achilles tendon tenotomies has been described in literature, but a large-scale randomized controlled trial is currently lacking. In this trial, we aim to show the non-inferiority of the needle tenotomy technique compared to the gold stand...
Source: Trials - October 31, 2023 Category: Research Source Type: clinical trials
Reviva Announces Positive Topline Results from Global Pivotal Phase 3 RECOVER Trial of Brilaroxazine in Schizophrenia
Successfully met primary endpoint; brilaroxazine 50 mg delivered a statistically significant and clinically meaningful 10.1-point reduction in Positive and Negative Syndrome Scale (PANSS) total score vs. placebo at week 4,... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - October 30, 2023 Category: Pharmaceuticals Source Type: clinical trials
Deciphera Pharmaceuticals Announces Positive Top-line Results from MOTION Pivotal Phase 3 Study of Vimseltinib in Patients with Tenosynovial Giant Cell Tumor (TGCT) and Updated Results from Phase 1/2 Study of Vimseltinib in TGCT
MOTION Study Met Primary Endpoint with Objective Response Rate (ORR) at Week 25 of 40% Compared to 0% for Placebo (p<0.0001)
MOTION Study Met All Key Secondary Endpoints with Statistically Significant and Clinically Meaningful Improvements at... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - October 30, 2023 Category: Pharmaceuticals Source Type: clinical trials
Novartis Investigational Atrasentan Phase III Study Demonstrates Clinically Meaningful and Highly Statistically Significant Proteinuria Reduction in Patients with IgA Nephropathy (IgAN)
Phase III ALIGN study met its primary endpoint, demonstrating superiority of atrasentan vs. placebo in proteinuria reduction at 36-week interim analysis1; the safety profile of atrasentan was consistent with previously reported data1,2-4
IgAN... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - October 30, 2023 Category: Pharmaceuticals Source Type: clinical trials
Datopotamab Deruxtecan Improved Progression-Free Survival vs. Chemotherapy in Patients with Previously Treated Non-Small Cell Lung Cancer in TROPION-Lung01 Phase III Trial
23 October 2023 -- Positive results from the pivotal TROPION-Lung01 Phase III trial showed that datopotamab deruxtecan (Dato-DXd) demonstrated a statistically significant improvement for the primary endpoint of progression-free survival (PFS)... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - October 23, 2023 Category: Pharmaceuticals Source Type: clinical trials
Datopotamab Deruxtecan Significantly Extended Progression-Free Survival vs. Chemotherapy in Patients with HR-Positive, HER2-Low or Negative Breast Cancer in TROPION-Breast01 Phase III Trial
23 October 2023 -- Positive results from the pivotal TROPION-Breast01 Phase III trial showed that datopotamab deruxtecan (Dato-DXd) demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS)... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - October 23, 2023 Category: Pharmaceuticals Source Type: clinical trials
Safety Study for a Gamma Delta T Cell Product Used With Low Dose Radiotherapy in Patients With Stage 4 Metastatic NSCLC
Conditions: Carcinoma, Non-Small-Cell Lung Interventions: Biological: KB-GDT-01 Sponsors: Kiromic BioPharma Inc.; Stiris Research Inc; Statistics& Data Corporation Not yet recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - October 6, 2023 Category: Research Source Type: clinical trials
The (cost) effectiveness of a very low-energy diet intervention with the use of eHealth in patients with type 2 diabetes and obesity: study protocol for a randomised controlled non-inferiority trial (E-diet trial)
DiscussionWe hypothesise that the E-VLED intervention will be equally effective compared to the usual care VLED but lower in costs due to less time invested by the dietician. This will enable to help more people with type 2 diabetes and obesity to effectively lose weight and improve their health-related quality of life.Trial registrationNetherlands Trial Register, NL7832, registered on 26 June 2019. (Source: Trials)
Source: Trials - October 5, 2023 Category: Research Source Type: clinical trials
Mobile phone text messaging plus motivational interviewing versus usual care: study protocol for a randomized controlled trial to evaluate effects on breastfeeding, child health, and survival outcomes, among women living with HIV (MTI-MI)
DiscussionThe study findings may facilitate decision-making on (1) whether implementation of the breastfeeding policy achieved the desired outcomes, (2) interventions needed to sustain breastfeeding, and (3) whether the interventions do have an impact on child health.Trial registrationClinicalTrials.gov NCT05063240. Pan African Clinical Trial Registry PACTR202110870407786. Oct. 1, 2021. (Source: Trials)
Source: Trials - October 5, 2023 Category: Research Source Type: clinical trials
RedHill and U.S. Army Announce Opaganib's Ebola Virus Disease Survival Benefit in U.S. Army-Funded In-Vivo Study
TEL AVIV, Israel and RALEIGH, NC, Oct. 3, 2023. RedHill Biopharma Ltd. ( " RedHill " or the " Company " ), a specialty biopharmaceutical company, today announced that novel, twice daily, oral opaganib[1], delivered a statistically significant increase in... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - October 3, 2023 Category: Pharmaceuticals Source Type: clinical trials
Novartis Investigational Iptacopan Phase III Study Demonstrates Clinically Meaningful and Highly Statistically Significant Proteinuria Reduction in Patients with IgA Nephropathy (IgAN)
Phase III APPLAUSE-IgAN study met its pre-specified interim analysis primary endpoint, demonstrating superiority of iptacopan vs placebo in proteinuria reduction1
Iptacopan is an investigational, first-in-class, oral factor B inhibitor... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - October 2, 2023 Category: Pharmaceuticals Source Type: clinical trials
Frequency of screening and SBT Technique Trial —North American Weaning Collaboration (FAST-NAWC): an update to the protocol and statistical analysis plan
AbstractBackgroundThis update summarizes key changes made to the protocol for the Frequency of Screening and Spontaneous Breathing Trial (SBT) Technique Trial —North American Weaning Collaborative (FAST-NAWC) trial since the publication of the original protocol. This multicenter, factorial design randomized controlled trial with concealed allocation, will compare the effect of both screening frequency (once vs. at least twice daily) to identify candidat es to undergo a SBT and SBT technique [pressure support + positive end-expiratory pressure vs. T-piece] on the time to successful extubation (primary outcome) in 760 ...
Source: Trials - October 2, 2023 Category: Research Source Type: clinical trials
Datopotamab Deruxtecan Demonstrated Statistically Significant and Clinically Meaningful Progression-Free Survival Benefit in Patients with HR-Positive, HER2-Low or Negative Breast Cancer in TROPION-Breast01 Phase III Trial
22 September 2023 -- Positive high-level results from the TROPION-Breast01 Phase III trial showed datopotamab deruxtecan (Dato-DXd) demonstrated a statistically significant and clinically meaningful improvement for the primary endpoint of... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - September 22, 2023 Category: Pharmaceuticals Source Type: clinical trials
