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About 648,730 results

A Study to Evaluate Subcutaneous Daratumumab in Combination With Standard Multiple Myeloma Treatment Regimens
https://clinicaltrials.gov/ct2/show/NCT03412565

Oct 8th, 2021 - The hypothesis is that the addition of daratumumab administered SC to standard MM regimens will improve responses compared to response data observed in completed phase 3 studies without daratumumab. Disease evaluations will include measurements of myeloma proteins, bone marrow examinations, skeletal surveys, assessment of extramedullary plasmacytomas, and measurements of serum calcium corrected...

Lentiviral Gene Transfer for Treatment of Children Older Than Two Years of Age With X-Linked Severe Combined Immunodeficiency (XSCID)
https://clinicaltrials.gov/ct2/show/NCT01306019

Oct 22nd, 2021 - This is a Phase I/II non-randomized clinical trial of ex vivo hematopoietic stem cell (HSC) gene transfer treatment for X-linked severe combined immunodeficiency (XSCID, also known as SCID-X1) using a self-inactivating lentiviral vector incorporating additional features to improve safety and performance. The study will treat 13 patients with XSCID who are between 2 and 40 years of age and who h...

Study Assessing Adult Subjects Affected With Upper and/or Lower Limb Spasticity Treated With Botulinum Neurotoxin Type A
https://clinicaltrials.gov/ct2/show/NCT04340336

Oct 22nd, 2021 - The aim of the study is to describe the long term use of Botulinum Neurotoxin Type A (BoNT-A) in adult subjects affected with upper and/or lower limb spasticity who received treatment with BoNT-A for a minimum of three injections cycles at three Italian centers. The study has a retrospective design and data relating to subjects' injections cycles occurred in the past are collected. Period of ob...

Study to Evaluate the Efficacy and Safety of PF-07055480 / Giroctocogene Fitelparvovec Gene Therapy in Moderately Severe to Severe Hemophilia A Adults
https://clinicaltrials.gov/ct2/show/NCT04370054

Oct 22nd, 2021 - 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 rout...

Phase 1a/1b Study of TPST-1495 as a Single Agent and in Combination With Pembrolizumab in Subjects With Solid Tumors
https://clinicaltrials.gov/ct2/show/NCT04344795

Oct 22nd, 2021 - This is a first-in-human Phase 1a/1b, multicenter, open-label, dose-escalation, dose and schedule optimization, and expansion study of TPST-1495 as a single agent and in combination with pembrolizumab to determine its MTD, safety, tolerability, pharmacokinetics (PD), pharmacodynamics (PK) and preliminary anti-tumor activity in subjects with advanced solid tumors. Subjects with all histologic ty...

The Incidence of Perioperative Deep Venous Thromboses of the Lower Extremities
https://clinicaltrials.gov/ct2/show/NCT01300832

Oct 22nd, 2021 - The study's hypothesis is that there are some patients who come for surgery who have asymptomatic clots in their lower extremities upon their arrival to the hospital for their surgical admission. We will be performing duplex studies of the subjects' legs before their surgery to determine how often clots are present. We will also perform duplex scans of the legs after the subjects' surgeries to ...

Safety and Efficacy Study of Meningococcal Group B Vaccine rMenB+OMV NZ (Bexsero) to Prevent Gonococcal Infection
https://clinicaltrials.gov/ct2/show/NCT04350138

Oct 22nd, 2021 - This is a Phase II, randomized, observer-blind, placebo-controlled, multi-site trial of the FDA licensed rMenB+OMV NZ vaccine, Bexsero. The targeted study population is men and women 18-50 years of age who are disproportionately vulnerable to N. gonorrhoeae infection. Approximately 2,200 participants are expected to be enrolled to achieve at least 202 evaluable participants. Data will be collec...

ACTIV-2: A Study for Outpatients With COVID-19
https://clinicaltrials.gov/ct2/show/NCT04518410

Oct 22nd, 2021 - This is a master protocol to evaluate the safety and efficacy of multiple investigational agents aimed at modifying the host immune response to SARS-CoV-2 infection, or directly enhancing viral control in order to limit disease progression. The study includes both infused and non-infused agents and is a randomized controlled platform that allows agents to be added and dropped during the course ...

Assessment of Children With Tic Onset in the Past 6 Months
https://clinicaltrials.gov/ct2/show/NCT01177774

Oct 22nd, 2021 - Up to 30% of all children will have a tic at some point. However, tics that last a whole year (or more) occur in only 3% of the population. Thus tic persistence may be more unusual than tic onset, yet almost no data exist on which people with recent-onset tics go on to be diagnosable with Tourette syndrome or chronic tic disorder, versus those whose tics are only transient. The overall goal of ...

Pilot Study of Reduced-Intensity Hematopoietic Stem Cell Transplant of DOCK8 Deficiency
https://clinicaltrials.gov/ct2/show/NCT01176006

Oct 22nd, 2021 - Background Mutations in the Dedicator of Cytokinesis-8 (DOCK8) gene are responsible for an immunodeficiency disease characterized by: severe cutaneous and sinopulmonary infections with bacterial organisms; extensive cutaneous viral infections with Herpes simplex, Herpes zoster, Molluscum contagiosum, and Human Papilloma Virus; a marked elevation in serum IgE levels and eosinophilia; homozygous ...

Transcutaneous Intercostal Nerve Stimulation in Spinal Cord Injury
https://clinicaltrials.gov/ct2/show/NCT04506099

Oct 22nd, 2021 - Neuromodulation techniques are safely used as a treatment for neuropathic pain in chronic SCI. Neuromodulation techniques have also been safely and successfully used to strengthen the abdomen in stroke patients.10 Most similar to our TINS protocol is transcutaneous tibial nerve stimulation (TTNS), which has shown to mitigate the development of neurogenic bladder in acute SCI.6 However, neuromod...

A Safety and Preliminary Efficacy Study of CC-99282 in Combination With Obinutuzumab in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
https://clinicaltrials.gov/ct2/show/NCT04434196

Oct 22nd, 2021 - All eligible subjects must be relapsed or refractory to at least 2 prior lines of therapy, one of which must have included an inhibitor of B-cell receptor signaling (approved Bruton's tyrosine kinase inhibitor [BTKi] or Phosphoinositide 3-kinase inhibitor [PI3Ki]) or venetoclax. The dose escalation (Part A) will evaluate the safety, tolerability, and PK of escalating doses of CC-99282 given in ...

Auranofin for Giardia Protozoa
https://clinicaltrials.gov/ct2/show/NCT02736968

Oct 22nd, 2021 - This is a phase IIa, randomized, placebo-controlled, single-blinded superiority treatment study in males and non-pregnant females, 18 to 65 years of age who are in good health. This study is designed to compare placebo to once daily doses of 6mg auranofin for adults with amebiasis or giardiasis. A sample size of 68 subjects enrolled with amebiasis (34 per arm) and 68 with giardiasis (34 per arm...

Prevention of Post Herpetic Neuralgia by Ultrasound Guided Single Nerve Block in the ED
https://clinicaltrials.gov/ct2/show/NCT04530162

Oct 22nd, 2021 - Study Objectives The goal of this study is to evaluate the rate of PHN development in emergency department patients who receive ultrasound guided nerve blocks using bupivacaine and dexamethasone for acute herpes zoster. The investigators will also study the effectiveness of the block in managing acute herpes zoster pain. The primary outcome is the percentage of patients who have significant her...

The Impact of Glomerular Disorders on Bone Quality and Strength
https://clinicaltrials.gov/ct2/show/NCT04528446

Oct 22nd, 2021 - Children and adults with glomerular disease have unique and potentially modifiable risk factors for compromised bone health, but our current understanding of skeletal fragility in glomerular disease is lacking. In the first large population-based cohort study, we recently found that primary glomerular disease was independently associated with an increased risk of incident fracture, and that hip...

Long-term Clinical Correlates of Traumatic Brain Injury
https://clinicaltrials.gov/ct2/show/NCT01132898

Oct 22nd, 2021 - Objective The primary objective is to contribute to the understanding of non-penetrating traumatic brain injury (TBI) through the description of the relationships between neuroimaging, hematological, and extensive functional/cognitive phenotyping measures. We will generate natural history data for cohort-based comparisons and to serve as the basis for future hypothesis-driven protocols. In addi...

Defining the Brain Phenotype of Children With Williams Syndrome
https://clinicaltrials.gov/ct2/show/NCT01132885

Oct 22nd, 2021 - Williams syndrome (WS) is a rare disorder caused by hemizygous microdeletion of approximately 1.6 megabases on chromosomal band 7q11.23, typically by spontaneous mutation. The disorder is characterized by a collection of unique neuropsychiatric manifestations, including marked visuospatial construction deficits and hypersociability. Because the genes involved in WS are known, the study of neura...

Tenofovir Alafenamide (TAF) in Children and Adolescents With Chronic Hepatitis B Virus Infection
https://clinicaltrials.gov/ct2/show/NCT02932150

Oct 22nd, 2021 - The primary objective of Cohort 1 of this study is to evaluate the safety, tolerability, and antiviral activity (HBV DNA < 20 IU/mL) of tenofovir alafenamide (TAF) 25 mg once daily versus placebo through Week 24 in treatment-naive and treatment-experienced adolescents (aged 12 to < 18 years) with chronic hepatitis B (CHB). Cohort 2 will consist of 2 parts: Part A and Part B. Intensive pharmacok...

A Study to Evaluate the Safety and Efficacy of AZD5718 in Participants With Proteinuric Chronic Kidney Disease
https://clinicaltrials.gov/ct2/show/NCT04492722

Oct 22nd, 2021 - The study will be conducted in approximately 118 study centers across 12 countries. The overall study period will be around 28 weeks. Approximately 632 participants comprising of 67% diabetic kidney disease (DKD) and 33% non-DKD participants will be enrolled. After a screening period of up to 4 weeks, the participants will be randomised in a 1:1:1:1 ratio to receive one of the doses of AZD5718 ...

A Trial to Evaluate Safety and Efficacy of Rivaroxaban (COVID-19)
https://clinicaltrials.gov/ct2/show/NCT04504032

Oct 22nd, 2021 - The purpose of this study is to assess safety and clinical efficacy of rivaroxaban in people with mild Coronavirus Disease 2019 who are at increased risk of disease progression.