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Tolerability and Safety of Large-Volume Hyaluronidase-Facilitated Subcutaneous Immunoglobulin 10% Administered with or without Dose Ramp-Up: A Phase 1 Study in Healthy Participants
PurposeFacilitated subcutaneous immunoglobulin (fSCIG; immune globulin infusion 10% [human] with recombinant human hyaluronidase [rHuPH20]) permits...
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Safety, Tolerability and Pharmacokinetics of Single-Dose Oral SYHA1402 in Healthy Chinese Subjects
IntroductionTo assess the safety, tolerability and pharmacokinetics of a single dose of SYHA1402 in healthy Chinese subjects.
Methods ...
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Efficacy and tolerability of the Subcutaneous Semaglutide for type 2 Diabetes patients: an updated systematic review and meta-analysis
ObjectivesTo update and assess the efficacy and tolerability of once weekly subcutaneous semaglutide in patients with type 2 diabetes (T2D).
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How do patients interpret and respond to a single-item global indicator of cancer treatment tolerability?
BackgroundThere is increasing interest in patient-reported measures of cancer treatment tolerability. A global measure of bother, the FACT GP5 item...
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Safety and tolerability of long-term treatment with darolutamide in patients with metastatic castration-resistant prostate cancer
BackgroundIn patients with metastatic castration-resistant prostate cancer, darolutamide was well tolerated for 25 months, but minimal long-term...
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Safety, Tolerability, and Outcomes of Tafamidis for the Treatment of Acquired Amyloid Neuropathy in Domino Liver Transplant Recipients
IntroductionAcquired amyloid neuropathy is an iatrogenic disease that appears years after a domino liver transplant. The objectives of our study are...
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A Phase 1 Open-Label Study to Assess the Tolerability, Safety, and Immunogenicity of Hyaluronidase-Facilitated Subcutaneous Immunoglobulin 20% in Healthy Adults
PurposeHyaluronidase-facilitated subcutaneous immunoglobulin (fSCIG) 20% will allow reduced infusion volumes and frequency versus existing...
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SAFE-ROCK: A Phase I Trial of an Oral Application of the ROCK Inhibitor Fasudil to Assess Bioavailability, Safety, and Tolerability in Healthy Participants
BackgroundThe intravenous (IV) formulation of Rho-kinase (ROCK) inhibitor fasudil has been approved for the treatment of subarachnoid haemorrhage...
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Assessing the Long-Term (48-Week) Effectiveness, Safety, and Tolerability of Fremanezumab in Migraine in Real Life: Insights from the Multicenter, Prospective, FRIEND3 Study
IntroductionLong-term (1-year) fremanezumab treatment proved to be effective, safe, and well tolerated in individuals with migraine and < 2...
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Long-term safety and tolerability of ambrisentan treatment for pediatric patients with pulmonary arterial hypertension: An open-label extension study
This open-label, extension study assessed long-term safety, tolerability, and efficacy of ambrisentan in a pediatric population (age 8– < 18 years)...
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Efficacy, safety, and tolerability of antimicrobial agents for complicated intra-abdominal infection: a systematic review and network meta-analysis
BackgroundWhich antimicrobial agents provide the optimal efficacy, safety, and tolerability for the empirical treatment of complicated...
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Efficacy, feasibility and tolerability of ketogenic diet for the treatment of poor response to bariatric surgery
PurposePoor response to bariatric surgery, namely insufficient weight loss (IWL) or weight regain (WR), is a critical issue in the treatment of...
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Safety, Tolerability, Pharmacokinetics, and Immunogenicity of the Anti-IFNAR1 Monoclonal Antibody QX006N: A First-in-Human Single Ascending Dose Study in Healthy Chinese Volunteers
Background and ObjectiveQX006N is a novel, humanized, IgG4κ monoclonal antibody targeting IFNAR1, developed for the treatment of systemic lupus...
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Effectiveness and tolerability of camrelizumab combined with molecular targeted therapy for patients with unresectable or advanced HCC
There is a lack of effective programmed cell death protein 1 (PD-1)‐targeted immunotherapy with good tolerability in patients with advanced...
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Tolerability of N-chlorotaurine in comparison with routinely used antiseptics: an in vitro study on chondrocytes
BackgroundCurrently, povidone-iodine (PVP-I) and hydrogen peroxide (H 2 O 2 ) are frequently used antiseptics in joint infections, but the cytotoxic...
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Safety, Tolerability, and Pharmacokinetics of Oral BI 1358894 in Healthy Japanese Male Volunteers
Background and ObjectivesBI 1358894, a novel small-molecule inhibitor of transient receptor potential canonical ion channels, is under development...
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Safety and tolerability of atogepant for the preventive treatment of migraine: a post hoc analysis of pooled data from four clinical trials
BackgroundConventional, non-specific preventive migraine treatments often demonstrate low rates of treatment persistence due to poor efficacy or...
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Safety and tolerability of long-term apomorphine infusion in advanced Parkinson's disease: an Indian multi-center (APO-IND) experience
Advanced Parkinson’s Disease (APD) is complicated by the emergence of motor and non-motor fluctuations, which are initially predictable and...
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Safety, Tolerability, Bioavailability, and Biological Activity of Inhaled Interferon-α2b in Healthy Adults: The IN2COVID Phase I Randomized Trial
Background and ObjectivesInterferons have been identified as a potential treatment alternative for coronavirus disease 2019. This study assessed the...
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Safety and tolerability of adjunct non-invasive vagus nerve stimulation in people with parkinson’s: a study protocol
BackgroundParkinson’s disease (PD) is the fastest growing neurological condition worldwide. Recent theories suggest that symptoms of PD may arise due...
