About 1,112,783 results

Natural History and Development of Spondyloarthritis

Feb 21st, 2023 - The purpose of this protocol is to study the natural history of spondyloarthritis (SpA) in children and adults. Spondyloarthritis encompasses a spectrum of immune-mediated inflammatory diseases that exhibit overlapping features, but differ from other types of inflammatory arthritis in genetic predisposition, pathogenesis, and outcome. Ankylosing spondylitis (AS), the most common form of SpA, fr...

Long-term Safety and Efficacy Extension Study for Participants With Advanced Tumors Who Are Currently on Treatment or in Follow-up in a Pembrolizumab (MK-3475) Study (MK-3475-587/KEYNOTE-587)

Mar 17th, 2023 - The purpose of this study is to evaluate the long-term safety and efficacy of pembrolizumab (MK-3475) in participants from previous Merck pembrolizumab-based parent studies who transition into this extension study. This study will consist of three phases: 1) First Course Phase, 2) Survival Follow-up Phase or 3) Second Course Phase. Each participant will transition to this extension study in one...

AMIStem-H Radiographic Analysis

Mar 17th, 2023 - Total hip replacement (THP) is widely used for hip osteoarthritis treatment. Surgeons are constantly looking to improve all aspects related to this procedure weather is improvement of implant design, instrumentation or surgical technique. Excellent clinical and radiological results were observed at medium and long term in the last years for AMIStem system. This observational study has the objec...

Study of Lung Proteins in Patients With Pneumonia

Mar 17th, 2023 - OBJECTIVE: The objective of this study is to analyze bronchoalveolar lavage (BAL) fluid from patients with lung infiltrates in order to discover new biomarkers and protein/peptide expression patterns that are associated with specific types of pulmonary diseases and infections. Bronchoalveolar lavage (BAL) is a standard method to obtain lower airway samples to evaluate pulmonary infiltrates in o...

Quality of Life in Patients Who Have Undergone Stem Cell Transplant

Mar 17th, 2023 - Clinical research in allogeneic hematopoietic stem cell transplantation (HSCT) documents improvements in disease free intervals, disease free survival, and the severity of treatment related toxicities. Those who survive, however, continue to experience side-effects and psychological difficulties for years following allogeneic HSCT. Long term complications occur as delayed effects of the conditi...

Evaluation of Patients With Immune Function Abnormalities

Mar 17th, 2023 - This protocol is designed for the screening and baseline assessment of and collection of research sample from patients with abnormalities of immune function as manifested by recurrent or unusual infections, recurrent or chronic inflammation, or previous laboratory evidence of immune dysfunction. Abnormalities of immune function may be inherited or may be iatrogenic such as that following hemato...

Urinary Vitamin C Loss in Diabetic Subjects

Mar 17th, 2023 - Several studies have reported that diabetic subjects have lower plasma vitamin C concentrations than non-diabetic subjects. Although urinary vitamin C loss in diabetic subjects was reported to be increased in two studies, these are difficult to interpret due to lack of controlled vitamin C intake, inadequate sampling, lack of control subjects, or methodology uncertainties in vitamin C assay and...

Evaluation and Treatment of Patients With Connective Tissue Disease

Mar 17th, 2023 - This protocol seeks to formalize the application of accepted diagnostic and therapeutic measures in the study of individuals with known or suspected bone-related connective tissue disorders, including Osteogenesis Imperfecta and melorheostosis. It is our intent to attract a broad array of such individuals for the purposes indicated above. This protocol will also serve as a basis for permitting ...

Study of NKTR 255 in Combination With Cetuximab in Solid Tumors

Mar 17th, 2023 - NKTR-255 is a cytokine that is designed to regulate T and natural killer cell activation, proliferation and promote their anti-tumor effects. In the dose escalation (Phase 1/b) phase patients with HNSCC or CRC will be treated with ascending doses of NKTR-255 in combination with cetuximab, until the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) is reached. The recommend...

Post-Market Study of Low-flow ECCO2R Using PrismaLung+

Mar 17th, 2023 - PrismaLung+ is indicated to provide extracorporeal carbon dioxide removal (ECCO2R) as a stand-alone therapy or in combination with continuous renal replacement therapy (CRRT). This study is intended for patients with increased levels of Carbon Dioxide (CO2) in their blood and ≥ 18 years old, and will treat patients with mild or moderate acute respiratory distress syndrome (ARDS) using PrismaLun...

BRCA Mutations in Latinas

Mar 17th, 2023 - BACKGROUND: Mutations in the BRCA1 and BRCA2 genes predispose to breast and ovarian cancer, and are increasingly recognized in prostate and pancreatic cancers. Basal/ Triple negative breast cancer is associated with BRCA mutations in some ethnicities.However the link between BRCA gene mutations and Basil/ triple negative disease in Hispanic/ Latino women is not known. Common recurrent mutations...

Training Protocol on the Natural History of Tuberculosis

Mar 17th, 2023 - Mycobacterium tuberculosis (MTB) is a slow-growing bacterium that establishes latent infection in millions of persons worldwide, but only leads to disease in 10% or less of these individuals. It typically causes pneumonia, however dissemination to almost any other organ is possible. Drug resistance of the organism, co-infection with HIV, and paradoxical reactions upon treatment are all factors ...

Mid-Term Follow-up Assessment After Exposure to Natural Disaster

Mar 17th, 2023 - Description: Assessment 24 months after exposure to a natural disaster of the clinical condition of children and adolescents cared for by medical-psychological emergency teams (CUMP) by measuring the frequency of clinical disorders and the intensity of symptoms and by comparing their clinical condition to that assessed immediately after exposure. Primary endpoint: Semi-structured interview base...

Characterization of Nociception Phenotype in Individuals With Intellectual Disability

Mar 17th, 2023 - STUDY DESCRIPTION: The study aims to evaluate the somatosensory response to innocuous and noxious stimuli in individuals with Intellectual Disability (ID) compared to healthy controls. OBJECTIVES: Primary Objective: To characterize brain activation patterns using electroencephalography (EEG) and cerebral functional-near-infrared spectroscopy (fNIRS) in response to innocuous and noxious stimulat...

Non Interventional Safety Study of NUCEIVA for the Treatment of Moderate-to-Severe Glabellar Lines

Mar 17th, 2023 - This is a prospective, multicentre, non-interventional observational Post Authorisation Safety Study; Safety data will be collected from approximately 750 patients at 20 sites throughout the United Kingdom and the European Union over an 18 month evaluation period. Eligible patients will receive an initial treatment of 20 Units of NUCEIVA. Further treatment will not be specified, recommended or ...

Defining Neurobiological Links Between Substance Use and Mental Illness

Mar 17th, 2023 - Study Description: Tobacco smoking leads to 480,000 deaths and a loss of $300 billion a year in the U.S. Individuals with major depressive disorder (MDD) are more vulnerable for experiencing these burdens as they are twice as likely to use nicotine versus the general population. The current work will explain the neurobiological basis of this enhanced risk and will define potential targets for l...

Adolescents Seeking COVID Vaccination (Teen COVID Vax)

Mar 17th, 2023 - The project will survey a representative sample of US adolescents age 15-17 and English speaking. This age group has been selected because they are likely to currently be High School students and are eligible for vaccination under the current Emergency Use Authorization (EUA) for and approval of the Pfizer-BioNTech COVID vaccine. The Pfizer-BioNTech vaccine received an EUA for those 16 and over...

Improving Caregivers' Ability to Manage Life Stress

Mar 17th, 2023 - The proposed single-arm pilot will examine the feasibility and acceptability of a brief behavioral treatment for reducing suicidal ideation and for increasing reasons for living in caregivers of Veterans with dementia. The proposed study will examine Problem Solving Therapy (PST) using a protocol that teaches skills to address emotional and practical barriers to effective problem solving. The V...

Testing the Addition of the AKT Inhibitor, Ipatasertib, to Treatment With the Hormonal Agent Megestrol Acetate for Recurrent or Metastatic Endometrial Cancers

Mar 17th, 2023 - PRIMARY OBJECTIVES: I. Determine the toxicity of ipatasertib in combination with megestrol acetate in women with metastatic grade 1-2 endometrioid endometrial cancer and establish the recommended phase II dose. (Phase I) II. Compare the progression free survival of the combination of ipatasertib with megestrol acetate to megestrol acetate alone among women with metastatic grade 1-2 endometrioid...

A Multicentre French Prospective Study of Children With Food Protein Induced Enterocolitis Syndrome in Its Acute Form

Mar 17th, 2023 - Food protein induced enterocolitis syndrome (FPIES), is a non-IgE mediated food allergy (FA) which seems to expand, and occurring in infancy. Prevalence of FPIES is unknown. In 2011, Katz published cumulative incidence of cow 'milk FPIES of 3 per 1000 new-borns, from prospective birth cohort in Israel. The offending food depend on the country, probably in relation to eating habits. Cow's milk (...

Optimal Management of Urinary Catheter in Gyn Onc

Mar 17th, 2023 - This is a combined retrospective observational study that will collect data on urinary catheter removal of patients who underwent pelvic surgery by a gynecologic oncologist to assess timing safety and its implications in postoperative care.

The Fuel and Rhythm (FAR) Phase 2 Study

Mar 17th, 2023 - A growing body of evidence indicates the mitochondria have an important role in the etiologies of many chronic diseases as well as the onset of physical disability in older adults. Although it is recognized that the mitochondria have an important role in many functions relevant to healthy aging, the direct assessment of mitochondrial function in humans is complicated and typically involves a mu...

A Trial to Learn if REGN7999 is Safe and Well Tolerated, and How it Works in the Body of Healthy Participants

Mar 17th, 2023 - The primary objective of the study is to evaluate the safety and tolerability of single ascending intravenous (IV) and subcutaneous (SC) doses of REGN7999 in healthy adult participants. The secondary objectives of the study are: To characterize the drug concentration profile of single doses of IV or SC REGN7999 To assess the immunogenicity of single ascending SC or IV doses of REGN7999

Protein and Exercise Training in Chronic KIDNEY Disease

Mar 17th, 2023 - When patients progress to the final stage of chronic kidney disease (CKD) and require hemodialysis treatment, they typically have lost so much muscle function that they are no longer physically independent. However, due to disease- and hemodialysis-related muscle catabolism, dietary protein and exercise interventions are only capable to attenuate the decline in physical function of patients on ...

A Study to Evaluate AB-1001 Striatal Administration in Adults With Early Manifest Huntington's Disease

Mar 17th, 2023 - This is a Phase I/II, first-in-human, open-label study to evaluate the safety, tolerability, and preliminary efficacy signals in subjects with early manifest HD following treatment with one-time intracerebral bilateral injections of AB-1001 within the striatum (caudate and putamen). This study consists of 2 parts: Dose-Finding Part and Expansion Part; each part consists of 3 phases: Screening P...

Evaluation of Non-Invasive Continuous vs Intermittent BloodPressure Monitors in Maintenance Dialysis (BP Dialysis)

Mar 17th, 2023 - Prospective, single center, open label, non-randomized, post-market study of the Tablo Hemodialysis System and VitalStream Monitor in participants with End-Stage KidneyDisease undergoing In-Center Hemodialysis.

An Extension Study to Evaluate the Long-Term Efficacy, Safety and Tolerability of UCB0599 in Study Participants With Parkinson's Disease

Mar 17th, 2023 - The purpose of the study is to estimate the pharmacodynamic effects of UCB0599 on brain pathophysiology in Early-start versus Delayed-start participants originally diagnosed with new onset Parkinson's disease.

The COVID-19 VaccinE Response and Co-Administration in Rheumatology Patients (COVER-CoAd)

Mar 17th, 2023 - The COVID-19 pandemic, caused by the coronavirus SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2), has infected a substantial portion of the world population, leading to millions of deaths since its first description in December of 2019. Recently, several SARS-CoV-2 vaccines have shown excellent efficacy and tolerability in the general population and have been either fully approved ...

QT Changes as Detected From LINQ ECG During and After Antiarrhythmic Loading (LINQ QT)

Mar 17th, 2023 - The purpose of this study is to determine if QT interval changes are detected during and after antiarrhythmic drug loading by the designed QT detection algorithm from LINQ ECG. The QT intervals before and after antiarrhythmic loading will be compared for all patients to analyze QT changes that may be caused due to antiarrhythmic drugs.

Genomics, Environmental Factors and Social Determinants of Cardiovascular Disease in African-Americans Study (GENE-FORECAST): Prospective COVID-19 Natural History Study

Mar 17th, 2023 - STUDY DESCRIPTION The objective is to conduct a prospective natural history study of Coronavirus disease 2019 (COVID-19) among a community-based cohort of African Americans enrolled in GENE-FORECAST for whom we have comprehensive psychosocial, clinical, and genetic data collected at baseline. Participants will be invited to take part in a 20-minute computer-assisted telephone interview (CATI) o...

Showering During Labor

Mar 17th, 2023 - The Effect of Showering During Labor on Perceived Birth Pain, Parenting Behavior and Birth Memory Labor is a natural process in which the fetus and its appendages, which are the product of pregnancy, are expelled from the uterus approximately 40 weeks after the last menstrual bleeding. Birth is a very meaningful and unique experience for the pregnant woman and her family. Although it results in...

Safety and Performance Assessment of the Decongestant Seawater Spray Pocket Valve Enriched With Essential Oils in Patients With Acute Rhinitis Associated With Nasal Obstruction

Mar 17th, 2023 - The purpose of this pre-market clinical investigation is to assess the safety and the performance of decongestant seawater spray pocket valve enriched with essential oils by Gilbert Laboratories. The study will evaluate the results of acute rhinitis associated with nasal obstruction using the decongestant seawaterspray pocket valve enriched with essential oils over a 8 day period.

Pembrolizumab, Endocrine Therapy, and Palbociclib in Treating Postmenopausal Patients With Newly Diagnosed Metastatic Stage IV Estrogen Receptor Positive Breast Cancer

Mar 16th, 2023 - PRIMARY OBJECTIVES: I. To evaluate the objective response rate (ORR), based on Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1), of pembrolizumab in combination with letrozole and palbociclib in patients with newly diagnosed metastatic estrogen receptor (ER) positive (+) human epidermal growth factor receptor (HER)2 negative (-) breast cancer, and determine if the addition of ...

An Observational Study in Adult Patients With Non-dystrophic Myotonic Disorders

Mar 16th, 2023 - This is a non-interventional, prospective, observational, multicentre study to evaluate the long-term safety and effectiveness of Namuscla in adult patients with NDM. Namuscla should be prescribed as per the approved Summary of Product Characteristics (SmPC). Adult patients with non-dystrophic myotonic disorders who have been prescribed Namuscla by the treating physician, and who meet the eligi...

Preserving Compassionate End of Life Care in the Pandemic

Mar 16th, 2023 - This is a mixed-methods formative program evaluation of the adaptations necessitated by the pandemic to the 3 Wishes Project. The adaptations will be studied as implemented in 3 acute care units at St. Joseph's Healthcare Hamilton (medical stepdown unit, medical-surgical ICU and the COVID-19 unit) during the 2020 SARS-CoV-2 pandemic. End-of-life care for patients dying in hospital is profoundly...

Bone Loss Prevention With Zoledronic Acid or Denosumab in Critically Ill Adults

Mar 16th, 2023 - Intensive care patients face health issues that extend beyond their critical illness. A specific area where critical illness may adversely affect the well-being of survivors is increased bone turnover during critical illness, and accelerated bone loss in subsequent years. Critical illness bone loss begins in the first days of critical illness, occurs in both men and women, and is greatest in po...

Laser Ablation of Abnormal Neurological Tissue Using Robotic NeuroBlate System

Mar 16th, 2023 - The NeuroBlate® System (NBS) is a minimally invasive robotic laser thermotherapy tool that is being manufactured by Monteris Medical. Since it received FDA clearance in May 2009, the NBS has been used in over 2600 procedures conducted at over 70 leading institutions across United States. This is a prospective, multi-center registry that will include data collection up to 5 years to evaluate saf...

An "All-Comers" Study of the AgentTM MONORAILTM Paclitaxel-Coated PTCA Balloon Catheter Used in Real-World Clinical Practice in Chinese Patients

Mar 16th, 2023 - The Agent DCB Registry study will enroll 500 subjects at up to 10 investigational sites in Taiwan, Hong-Kong and Singapore. If participants decide to participate in this study, participants will first be asked to sign and date this consent form. If participants sign the consent form, participants will go through a baseline/ procedure process. Information about participants and participants' hea...

Postoperative Pain, Why Still in Hospital and DAOH Following TORS for SCCUP & OSAS

Mar 16th, 2023 - The morbidity after TORS has not yet been fully investigated, but a recent studies suggest that pain is one of the primary causes for unplanned readmission This issue has been investigated by Clayburgh D et al who found that a prolonged dexamethasone regime lowered the pain scores on day three after surgery. The patients treated with the prolonged dexamethasone regime also showed a significant ...

ABemaciclib, ET ± paclItaxel in aGgressive HR+/HER2- MBC trIaL

Mar 16th, 2023 - The ABIGAIL study aims to provide consistent evidence that the combination of abemaciclib with ET -consisting of letrozole or fulvestrant-as first-line regimen is non-inferior to the optimal first-line chemotherapy -consisting of weekly paclitaxel-in terms of early ORR after the first 12 weeks of treatment in patients with HR-positive/HER2-negative ABC and at least one feature of aggressive dis...

Pain in Pediatric Dentistry - a Grounded Theory Study on the Experiences of Dental Professionals and Students

Mar 16th, 2023 - BACKGROUND Pain in conjunction with dental treatment should be avoided, especially when treating children. Many dental procedures may result in procedural and/or postoperative pain. There is a well-documented relationship between perceived pain during dental treatment, and the development of dental fear and anxiety. This may lead to suffering for the patient, avoidance of dental care, and incre...

Medical-economic Evaluation Comparing Intensive Outpatient Monitoring of Neuro-cardiovascular Diseases by Nurses, Doctors and Hospital and Private-sector Pharmacists, Compared to Usual Monitoring.

Mar 16th, 2023 - Cerebral Vascular Accidents (stroke) and Myocardial Infarction (MI), which share the same risk factors, treatments and pathophysiological mechanisms, have become two major public health problems due to the increase in their prevalence rate and the longer survival after such an event in developed countries. International data, including French data and data from our own registries, illustrate th...

Laparoscopic IPOM Plus vs. eTEP Trial

Mar 16th, 2023 - The use of minimally invasive surgery for the treatment of patients with incisional ventral hernias has significant advantages over open surgery. According to the current guidelines, the optimal technique for IPOM repair is a combination of suturing hernia defect and implantation an intraperitoneal anti-adhesive coated mesh prosthesis - the so-called "IPOM plus" technology (R.Bittner et al., 20...

Evaluate Endovascular Treatment of Large Ischemic Stroke With Substantial Penumbra.

Mar 16th, 2023 - The reperfusion of salvageable ischemic tissue (penumbra) to improve functional recovery is the aim of the endovascular treatment (EVT) of acute ischemic stroke (AIS) complicating large cerebral vessel occlusion (LVO). Downstream of an LVO, imaging profiles are highly variable ranging from a large completed infarction within 2 hrs to a small core and a large mismatch at 24 hrs after onset . A l...

iACT for Eating Disorders in Type 1 Diabetes

Mar 16th, 2023 - This project is a randomized controlled trial of iACT, a novel mHealth intervention for eating disorders in type 1 diabetes (ED-T1DM). Participants will be 128 T1DM patients between the ages of 16-45 with binge-purge EDs, including threshold and subthreshold bulimia nervosa, binge eating disorder and purging disorder. Participants will be randomized to either iACT or Usual Care, and complete as...

A Study to Test the Effect of TEV-48574 in Moderate to Severe Ulcerative Colitis or Crohn's Disease

Mar 16th, 2023 - The primary objective is to evaluate the efficacy and dose response of 3 different dose regimens of TEV-48574 in adult participants with IBD (moderate to severe Ulcerative Colitis (UC) or Crohn's Disease (CD)) as assessed by induction of clinical remission (UC) and endoscopic response (CD) at week 14. Secondary objectives: To evaluate the efficacy and dose response of the 3 different dose regim...

Peer Social Support During In Vivo Exposure for PTSD

Mar 15th, 2023 - Veterans (participants and peers) with PTSD will be recruited from the Charleston VA Medical Center catchment area. Participants will have been assigned to exposure therapy for PTSD and either started treatment, or dropped out before treatment; peers will have successfully completed exposure therapy for PTSD. Those eligible to participate will also include Veterans who are identified as "at-ris...

Transforming Research and Clinical Knowledge in Traumatic Brain Injury (TRACK-TBI) Precision Medicine Phase 2 Option 1

Mar 15th, 2023 - In 2009, the multicenter Transforming Research and Clinical Knowledge in Traumatic Brain Injury Consortium was implemented to characterize the clinical, magnetic resonance imaging (MRI), and blood-based biomarker features of TBI to inform design of next-generation precision medicine clinical trials in TBI. Over the past 10+ years, TRACK-TBI has been supported by National Institute of Neurologic...

A Study of SI-B001, an EGFR/HER3 Bispecific Antibody, in Locally Advanced or Metastatic Epithelial Tumors

Mar 15th, 2023 - In phase Ia study, the safety and tolerability of SI-B001 in patients with locally advanced or metastatic epithelial malignancies will be investigated to determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD) of SI-B001. In the phase Ib study, the safety and tolerability of SI-B001 at the phase Ia recommended dose will be further investigated, and recommended phase II dose (RP...

MedJ-01 Ridaforolimus Eluting Coronary Stent System Trial (JNIR)

Mar 15th, 2023 - This study aims to evaluate MedJ-01 safety and efficacy for de novo or restenosis lesion with target vessel diameter of 2.5mm to 4.25, for subjects undergoing coronary artery stent implantation. The target population is subjects undergoing PCI for angina (stable or unstable), silent ischemia (in absence of symptoms a visually estimated target lesion diameter stenosis of ≥70%, a positive non-inv...

Subjective Intraoperative Use of Epidural Steroid Administration Following Discectomy

Mar 15th, 2023 - Intraoperative epidural administration of steroids following discectomy for herniated lumbar disc has been the topic of multiple studies in the literature. The results have been mixed, with the majority of the studies finding some benefit, but outcomes have varied drastically amongst the many studies. The aim of this study is to develop a grading scale for intraoperative assessment of nerve roo...

Evaluation of Safety and Efficacy of IBI318 Monotherapy for Relapsed/Refractory Extranodal NK/T Cell Lymphoma (Nasal Type) Trial

Mar 15th, 2023 - The purpose of this study is to evaluate the safety and efficacy of IBI318 monotherapy for relapsed/refractory extranodal NK/T cell lymphoma (nasal type).

Pilot Study of the Safety and Tolerability of L-DLPFC iTBS rTMS for MDD in MS

Mar 15th, 2023 - The main purpose of this study is to investigate the safety and tolerability of intermittent Theta Burst (iTBS), its effectiveness in alleviating depressive symptoms, concomitant neuropsychiatric symptoms such as anxiety and fatigue in people with MS, as well as its effects on cognition. Although iTBS repetitive transcranial magnetic stimulation (rTMS) is approved for use in major depressive di...

A Study of JNJ-69086420, an Actinium-225-Labeled Antibody Targeting Human Kallikrein-2 (hK2) for Advanced Prostate Cancer

Mar 15th, 2023 - The purpose of this study is to determine the recommended Phase 2 dose(s) (RP2D[s]) of JNJ-69086420 in Part 1 (Dose Escalation) and to determine safety and and preliminary signs of clinical activity at the RP2D(s) in Part 2 (Dose Expansion).

Stereotactic Management of Arrhythmia - Radiosurgery in Treatment of Ventricular Tachycardia

Mar 15th, 2023 - The standard of care for the treatment of Ventricular Tachycardia (VT) comprises of pharmacotherapy, ICD implantation and electrophysiology-guided catheter ablation. The treatment, however, is associated with a relatively high risk of VT recurrence. Given the limited therapeutic options and significant impact on patients quality of life, non-invasive cardiac radiosurgery has been recently gaini...

A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of JNJ-63723283, an Anti-PD-1 Monoclonal Antibody, in Participants With Advanced Cancers

Mar 15th, 2023 - This is a First in Human (FIH), open-label (all people involved know the identity of the intervention), multicenter (more than 1 study site) study in participants with advanced cancers to establish the recommended Phase 2 dose (RP2D[s]) with IV administration for JNJ-63723283 in Part 1, to evaluate the safety and efficacy of the IV RP2D(s) in Part 2, to determine a SC RP2D in Part 3 and Part 4 ...

LY3214996 and Cetuximab Alone or in Combination With Abemaciclib for the Treatment of Unresectable or Metastatic Colorectal Cancer

Mar 15th, 2023 - PRIMARY OBJECTIVES: I. Determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of ERK1/2 inhibitor LY3214996 (LY3214996) administered in combination with cetuximab. (Phase 1b) II. Determine the MTD and RP2D of LY3214996 administered in combination with cetuximab plus abemaciclib. (Phase 1b) III. Assess the preliminary antitumor activity of the treatment combinations based...

Phase I Clinical Study of GNC-038 in Patients With Non-Hodgkin's Lymphoma or Acute Lymphoblastic Leukemia

Mar 15th, 2023 - Phase Ia: To observe the safety and tolerability of GNC-038 in patients with relapsed or refractory non-Hodgkin lymphoma (R/R NHL)/relapsed or refractory acute lymphoblastic leukemia (R/R ALL), To determine the maximum tolerated dose (MTD) or maximum administration dose (MAD) and dose-limiting toxicity (DLT) of GNC-038 without MTD and recommend the dose for subsequent clinical studies. Phase Ib...

MS-553 in Diabetic Retinopathy Patients With Central Involved Macular Edema

Mar 15th, 2023 - This is an open label dose-escalation study to evaluate the safety and treatment benefits of MS-553 in treatment-naive diabetic retinopathy patients with central involved macular edema. Fifteen subjects with diabetic macular edema will be enrolled into each of three dose cohorts and will receive oral administration of MS-553 for 8 weeks.

A Study to Assess Subcutaneous Lirentelimab (AK002) in Chronic Spontaneous Urticaria

Mar 15th, 2023 - This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of subcutaneous lirentelimab (AK002) in adult subjects with H-1 antihistamine refractory chronic spontaneous urticaria. Subjects who complete the randomized, double-blind, placebo-controlled treatment period may have the option to enroll in an open-label extension period and re...

Investigational and Comparative Study in the Management of Diabetic Nephropathy

Mar 15th, 2023 - Diabetic nephropathy(DN) is one of the major micro- vascular complications of diabetes mellitus and the leading cause of end-stage renal disease (ESRD) that require renal replacement therapies. The average incidence of diabetic nephropathy is 3% per year during the first 10 to 20 years after diabetes onset. Diabetic nephropathy occurs in 20-40% of all diabetic patients. Pathogenesis of diabetic...

Phase 1b Study of SL-172154 Administered With Combination Agent(s) in Subjects With Ovarian Cancers

Mar 15th, 2023 - Study SL03-OHD-105 is an open-label, multicenter, phase 1b trial designed to evaluate the safety, pharmacokinetics, pharmacodynamic effects, and preliminary anti-tumor activity of SL-172154 administered in combination with either PLD or MIRV in subjects with platinum-resistant ovarian, primary peritoneal, or fallopian tube cancers. Patients will be appropriate for combination therapy for their ...

Ketorolac Intravenous Regional Analgesia in Lower Limb Surgeries

Mar 15th, 2023 - This is a randomized controlled trial that tests the effecacy of the intravenous regional ketorolac in lower limb orthopedic surgeries with spinal anesthesia. The investigators will compare the effect of 30 mg ketorolac without local anesthetic in the injected intravenously in an isolated lower limb (with torniquet) versus intravenous 30 mg ketorolac administered 10 minutes before toniquet pres...

A Study of Guselkumab Therapy in Participants With Moderately to Severely Active Ulcerative Colitis

Mar 15th, 2023 - UC is a chronic disease of the large intestine, in which the lining of the colon becomes inflamed and develops ulcers. Guselkumab is a fully human immunoglobulin G1 lambda monoclonal antibody (mAb) that binds to human interleukin (IL)-23 with high affinity. The primary hypothesis of this study is that guselkumab SC induction is superior to placebo SC in achieving clinical remission at Week 12 a...

Effect of Bimekizumab in Patients With Psoriasis Vulgaris and Active Psoriatic Arthritis

Mar 15th, 2023 - This study is being conducted to evaluate the effects of bimekizumab administered subcutaneously (SC) to patients with psoriasis vulgaris and who also have active PsA who have an inadequate skin response to anti-interleukin (IL)23 therapy. Approximately 20 adult subjects with psoriasis vulgaris and active PsA who have an inadequate skin response to anti-IL23 will receive bimekizumab 320 mg solu...

Home Transfusion for HEME

Mar 15th, 2023 - This feasibility study will be used to assess the feasibility and acceptability of a hospice-embedded home transfusion program to patients with hematologic malignancies. All enrolled subjects will be patients cared for at Dana Farber Cancer Institute. This study is a single-arm study of 10 patients with advanced hematologic malignancies who have a limited life-expectancy of six months or fewer ...

Innovations in Genicular Outcomes Registry

Mar 15th, 2023 - The registry will capture prospective data on patients receiving pain management for chronic pain due to knee osteoarthritis (OA) or pain optimization for knee arthroplasty due to knee OA. The OA pain therapies may include cryo nerve block, radiofrequency ablation (RFA), intra-articular (IA) corticosteroids, viscosupplementation, opioids, and others (e.g., non-steroidal anti-inflammatory drugs ...

Soft Robotic Sock Intervention for Robot-assisted Ankle-foot Mobility in Post-stroke Patients

Mar 15th, 2023 - Stroke is one of the top medical conditions resulting in high mortality among patients in hospitals, where complications related to immobility such as deep vein thrombosis (DVT) and/or ankle joint contracture can affect patients in their road to recovery. Patients may often take months or even years to fully recover their limb functions, where certain activities of daily living cannot be easily...

Study of AGB101 in Mild Cognitive Impairment Due to Alzheimer's Disease

Mar 14th, 2023 - The primary objective of the study is to evaluate the efficacy of AGB101 on slowing cognitive and functional impairment as measured by changes in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) score as compared with placebo in participants with mild cognitive impairment due to Alzheimer's Disease (MCI due to AD) also known as prodromal AD. Participants will be randomized to receive placebo ...

Efficacy and Safety Study of Intravitreal Triamcinolone to Treat Diffuse Diabetic Macular Edema

Mar 14th, 2023 - Diabetes mellitus and its complications represent nowadays an important issue in Public Health terms. The WHO expectations indicate that around 2025 the European population with diabetes will reach about 12%, and it has been estimated that the percent in the USA will be around 10% (King, 1995). The severe complications of proliferant diabetic retinopathy and its disastrous effects on vision see...

MRI to Assess the Effect of Non-selective Beta-blocker in Patients With Cirrhosis

Mar 14th, 2023 - MR-elastography and Phase Contrast MRI compared to LVC

National Approach to Standardize and Improve Mechanical Ventilation

Mar 14th, 2023 - NASAM is a national collaborative quality improvement project in Saudi Arabia which aims to: Reduce the rate of ventilator-associated events Improve the compliance with NASAM bundle elements Reduce the mortality of mechanically ventilated patients The plan of this quality improvement project is to extend the implementation to a total of 100 ICUs in collaboration with multiple health systems acr...

Cardiac Dysfunction in Childhood Cancer Survivors

Mar 14th, 2023 - Cardiovascular disease including cardiac dysfunction is the leading non-malignant cause of death in childhood cancer survivors. Early detection of cardiac dysfunction is important to identify those in need for medical intervention to improve outcome. This study invites adult childhood cancer survivors to a clinical appointment to the University Hospital Bern, Switzerland. A detailed, standardiz...

SARS-COV2 Pandemic Serosurvey in a Rare Disease Population

Mar 14th, 2023 - It has been demonstrated that respiratory virus outbreaks and pandemics, such as influenza, SARS, MERS, and now the newly emerged SARS-COV2 virus, have a major impact on morbidity and mortality worldwide, as well as having devastating global economic and societal impact. During these outbreaks it is critical to gain a rapid understanding of the exposures and immunity in the general population. ...

Testing and Calibration of Non-Invasive Optical Imaging Technology for Functional Brain Imaging

Mar 14th, 2023 - Objective: to cross-validate our near infrared spectroscopy (NIRS) imaging system with existing functional magnetic resonance imaging (fMRI) and electroencephalogram (EEG) data, and b) to investigate any significant technical issues associated with optode placement and motion artifacts, and to explore techniques that will potentially improve the feasibility and reliability of the system accordi...

Effects of Sucralose in Insulin Sensitivity, Intestinal Microbiota and Postprandial GLP-1

Mar 14th, 2023 - Study design: This is a triple-blind, parallel, placebo-controlled, randomized clinical trial. Sample size: The sample size was calculated to observe a difference of 15% in insulin sensitivity based on two outcomes: glucose rate of appearance (Ra) and glucose rate of disappearance (Rd) obtained from the hyperinsulinemic-euglycemic glucose clamp to measure the liver and skeletal muscle insulin s...

Personalized Treatment

Mar 14th, 2023 - Cognitive behavioral theory proposes that cognitions, behaviors, affect, and physiological symptoms interact with each other to maintain and exacerbate psychiatric disorders (Beck, 2011). Network theory identifies core symptoms that maintain and promote the spread of ED psychopathology within individuals (Borsboom & Cramer, 2013). Once identified, core "trigger" symptoms can be directly targete...

The ASPIRE Trial - Aiming for Safe Pregnancies by Reducing Malaria and Infections of the Reproductive Tract

Mar 14th, 2023 - Title: Effects of metronidazole plus intermittent preventive treatment of malaria in pregnancy on birth outcomes: a randomised controlled trial in Zambia. Short Title: The ASPIRE Trial - Aiming for Safe Pregnancies by Reducing Malaria and Infections of the Reproductive Tract Background and rationale: Current interventions in sub-Saharan Africa to reduce the burden of malaria infection and curab...

Isatuximab in Combination With Novel Agents in RRMM - Master Protocol

Mar 14th, 2023 - Approximately 28 months

Detection of Subclinical Cerebral Suffering Related to Hypertension Using Multimodal MRI

Mar 14th, 2023 - Hypertension is a risk factor for many brain pathologies, such as ischemic and hemorrhagic neurodegenerative diseases or stroke. The literature seems to agree on the relationship between hypertension and brain damage, and on the benefit of the management of hypertension to prevent certain neurological pathologies. However, to our knowledge, no single study has shown signs of subclinical brain d...

Wire Instrumentation Using Radiofrequency Energy to Impact Transseptal Efficiency

Mar 14th, 2023 - The transseptal puncture is one of the most commonly performed procedures in the cardiac electrophysiology and interventional cardiology laboratories. Indeed, every atrial fibrillation ablation, now the predominant electrophysiology procedure performed throughout the world, routinely involves two different transseptal puncture procedures. The investigators previously performed a randomized, com...

Long-term Safety and Efficacy of Efanesoctocog Alfa (BIVV001) in Previously Treated Patients With Hemophilia A

Mar 14th, 2023 - Participants will receive BIVV001 once weekly for a total of at least 100 exposure days to BIVV001 (including exposure during a BIVV001 parent study, if applicable). Participants will have the opportunity to continue in this study for up to 4 years, unless BIVV001 is commercially available in their applicable participating country.

Treatment of Acute ACL Injuries in Young Patients Using a Rebound ACL Brace

Mar 14th, 2023 - A well known treatment of posterior cruciate ligament injuries in the acute phase is a brace which pushes the tibia anteriorly, and the result of the treatment is often successful with healing of the ligament. Similarly, in anterior cruciate ligament injuries, it is suggested that a rebound ACL brace which pushes the tibia posteriorly can facilitate healing of the ACL. It does not have as succe...

A Study of Belantamab Mafodotin in Patients With Relapsed or Refractory AL Amyloidosis

Mar 14th, 2023 - This is an open-label, multicenter, Phase 2 study in subjects with previously treated patients with light chain (AL) amyloidosis in need for therapy. Approximately 35 subjects will receive therapy with belantamab mafodotin. Subject participation will include a Screening Phase, a Treatment Phase, a Post-Treatment Observation Phase, and a Long-term Follow-up Phase. A safety run-in will be conduct...

Repeat or Single Quadratus Lumborum Block for the Reduction of Opioid Prescriptions After Surgery in Retroperitoneal Sarcoma Patients ("RESQU-SARC" Trial)

Mar 14th, 2023 - PRIMARY OBJECTIVE: I. To use a pragmatic phase II randomized controlled trial to compare two standardized bundles of usual care for postoperative pain management to reduce the initial discharge prescription opioid volume. SECONDARY OBJECTIVE: I. To assess which pragmatic arm improves aspects of postoperative recovery including 30-day, 3-month, and 1-year opioid use, patient symptom inventory at...

A Study to Evaluate the Pharmacokinetics, Safety, and Pharmacodynamics of Olpasiran in Participants With Various Degrees of Hepatic Impairment

Mar 14th, 2023 - The primary objective of the study is to evaluate the pharmacokinetics (PK) of a single dose of olpasiran in participants with mild, moderate, or severe hepatic impairment compared to participants with normal hepatic function.

Advancing Vaccine Equity Through Understanding Vaccine Hesitancy, Barriers, and Trust

Mar 14th, 2023 - Objective 1: To identify reasons for vaccine hesitancy, structural barriers to vaccination, vaccine messaging received, and vaccination behavior among medically underserved and vulnerable populations living in the rural south. Objective 2: To assess vaccine messaging from trusted individuals (e.g., clergy/church leaders, community health workers, and community leaders) who serve medically under...

Phage Therapy for the Treatment of Urinary Tract Infection

Mar 14th, 2023 - This is a single-patient, phase I/II clinical trial that aims to evaluate the potential of bacteriophage therapy to treat and prevent the recurrence of a drug-resistant urinary tract infection. This study will follow a minimally invasive phage therapy approach consisting of oral, topical and bladder installations of a 3-phage cocktail comprised of HP3, HP3.1 and ES19. Oral and bladder installat...

Efficacy of Duloxetine Compared to NSIADs in Osteoarthritis of Knee

Mar 14th, 2023 - This will be a 13-week A randomized open labelled clinical trail in Iraqi Kurdistan Region, that will be designed to assess the efficacy of duloxetine tablet compared with other group (Nonsteroidal anti-inflammatory) drug on the reduction of pain caused by osteoarthritis of the knee. Patients will be divided into two groups, first group (case) will receive duloxetine tablet 30mg for two weeks t...

DIStal Versus COnventional Radial Access for COMPLEX Large-bore Percutaneous Coronary Intervention

Mar 14th, 2023 - The radial artery has become the standard vascular access site for most percutaneous coronary interventions (PCI) and is recommended by the most recent 2018 European Society of Cardiology/European Association for Cardio-Thoracic Surgery guidelines on myocardial revascularization, irrespective of clinical presentation. Patients undergoing PCI of complex coronary lesions, such as a chronic total ...

Addressing Vaccine Hesitancy and Increasing COVID-19 Vaccine Uptake Among African American Young Adults in the South

Mar 14th, 2023 - The study staff will recruit and enroll 360 AA-YA from communities in Alabama, Georgia, and North Carolina. After collecting informed consent, participants will be randomized using block randomization to the control condition or TT-C (remote), each with a balanced 180 participants (N=360). The standard of care (SOC) control will be the provision of COVID vaccine materials from the CDC. After sc...

Perception in Parkinson's Disease

Mar 14th, 2023 - For this study, the investigators propose to conduct an online study of PwPD (proposing a total of 60 participants) to examine the relations among variables that may relate to perception in PD. Participants will be recruited via online research platforms such as the Fox Trial Finder, as in our previous studies. Those PwPD who express interest will be sent a link to an online survey (Qualtrics)....

The Effect of NAD Supplementation on Brain Vascular Health in Aging

Mar 14th, 2023 - This study is designed to test the hypothesis that restoration of Nicotinamide Adenine Dinucleotide (NAD) levels with Nicotinamide Riboside (NR) in older adults will improve neurovascular coupling (NVC) responses and micro- and macrovascular endothelial function. This hypothesis will be tested by assessing the effects of treatment with oral NR (1g/day per os for 8 weeks) or placebo (8 weeks) in...

Capsaicin for Cerebral Perfusion Augmentation

Mar 14th, 2023 - Subjects The study is expected to enroll 30 participants who will be recruited from the Internal Medicine outpatient clinic. Those willing to participate will be asked to sign the informed consent form (ICF) and will received the assigned dose of capsaicin. Half of the participants in each dose group will receive stimulation on either left or right side of the palate, but TCD measurements will ...

Treatment of Obstructive Sleep Apnea With Personalized Surgery in Children With Down Syndrome (TOPS-DS)

Mar 14th, 2023 - The overall objective of this randomized clinical trial is to test the effectiveness of a novel personalized approach to the surgical treatment of OSA in children with Down syndrome (DS). DS is a common disorder, affecting 1 in 691 births. The estimated prevalence of obstructive sleep apnea (OSA) in children with DS ranges from 45-83%, compared to 1-6% in the general pediatric population. Untre...

Comparison Study of PET/CT or PET/MRI Imaging to Magnetic Resonance Imaging (MRI) Alone in Men With Prostate Cancer

Mar 13th, 2023 - This is a multi-reader methodological study comparing the diagnostic value of 68Ga-PSMA-HBED-CC PET/CT or 68Ga-PSMA-HBED-CC PET/MRI over MRI alone, using histologic confirmation or serial follow-up for up to 2 years as the gold standard for determination of primary prostate cancer or prostatic cancer recurrence/metastasis. It is hypothesized that this will demonstrate the superiority of 68Ga-PS...

COVID-19 in People With Primary Ciliary Dyskinesia

Mar 13th, 2023 - Background: The current pandemic of Coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2 virus is a public health emergency of international concern. The severity of COVID-19 ranges from asymptomatic to severe. Patients with chronic lung disease such as primary ciliary dyskinesia (PCD) are thought to be at increased risk, but no data support this. Disease course and optimal treatment strate...

Incidence of Allergic Manifestations and Infectious Episodes in Healthy Term Infants at Risk for Dysbiosis

Mar 13th, 2023 - The primary objective of the study is to evaluate the cumulative incidence of atopic dermatitis in healthy infants at risk for dysbiosis at 12 months of age and to identify factors associated with the presence of atopic dermatitis.

Increasing Treatment Efficacy Using SMART Methods for Personalizing Care

Mar 13th, 2023 - The proposed study will determine the feasibility, tolerability, and acceptability of a study that tests: 1) personalized treatment delivery (i.e., module sequencing and treatment discontinuation timing) aimed at increasing the efficiency of care, and 2) the research protocol designed to evaluate the effects of this personalized care. A sample of 60 participants with heterogeneous anxiety disor...

Study of AZD5305 as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Malignancies

Mar 13th, 2023 - This study is a Phase I/IIa modular, open-label, multi-center study of AZD5305 administered orally, either as monotherapy or in combination with other anti-cancer agents in patients with advanced solid malignancies.