About 1,002,963 results

ANTHEM-HFrEF Pivotal Study

Jan 14th, 2022 - ANTHEM-HFrEF is a multi-center, open-label, randomized controlled clinical trial with an adaptive design. Patients with symptomatic heart failure and reduced LVEF will be enrolled and randomized 2:1 to receive VITARIA system implantation on the right cervical vagus nerve in addition to stable guideline-directed medical therapy (therapy), or to continue receiving stable guideline-directed medica...

Renal Actions of Combined Empagliflozin and LINagliptin in Type 2 diabetES

Jan 14th, 2022 - Sodium-glucose linked transporters (SGLT-2) inhibitors and dipeptidyl peptidase-4 (DPP-4) inhibitors are relatively novel glucose-lowering drugs for the treatment of T2DM. These agents seem to exert pleiotropic actions 'beyond glucose control'. SGLT-2 inhibitors decrease proximal sodium reabsorption and decrease glomerular pressure and albuminuria in rodents and type 1 diabetes patients. In add...

An Epidemiologic Study on PD-L1 Expression Combined With Clinical Observation in the Chinese MIUBC Patients.

Jan 14th, 2022 - The primary objective of this observational study is: •To investigate the prevalence of high PD-L1 expression in Chinese MIUBC patients. High PD-L1 expression is defined as ≥25% tumor cell membrane positivity for PD-L1 at any intensity above background staining as noted on the corresponding negative control OR ≥25% tumor associated immune cell positivity for PD-L1 at any intensity above backgro...

Vonoprazan Study in Patients With Erosive Esophagitis to Evaluate Long-term Safety

Jan 14th, 2022 - This is a multicenter, open-label, randomized, parallel-group study to exploratorily evaluate the effect on gastric mucosal tissue and the safety of long-term administration of vonoprazan in maintenance treatment after healed EE, and the curative effect of vonoprazan versus lansoprazole in participants with EE. Participants endoscopically diagnosed with EE of Los Angeles (LA) Classification Gra...

Nasal Versus Oral Midazolam Sedation in Routine Pediatric Dental Care

Jan 14th, 2022 - Prospective, parallel design Study and control group: 100 healthy children (ASA 1), ages: 2-6 years, uncooperative (Frankl 1-2), that needs at least two similar dental treatments. Exclusion criteria: enlarged tonsils (Brodsky's grading scale11 +3 = 50-75% airway obstruction, and +4 = >75% airway obstruction), upper respiratory tract infection or nasal discharge. Randomization: At the first appo...

A Study of Oral LOXO-305 in Patients With Previously Treated CLL/SLL or NHL

Jan 14th, 2022 - This study includes 3 parts: Phase 1 (pirtobrutinib monotherapy dose escalation and dose expansion), Phase 1b (pirtobrutinib combination therapy dose expansion), and Phase 2 (pirtobrutinib monotherapy dose expansion). In Phase 1, patients will be enrolled using an accelerated titration design. The starting dose of pirtobrutinib in oral tablet form is 25 mg/day (e.g., 25 mg once daily [QD]). Onc...

[Trial of device that is not approved or cleared by the U.S. FDA]

Jan 14th, 2022 - [Trial of device that is not approved or cleared by the U.S. FDA] - Full Text View.

Gut-Associated Lymphocyte Trafficking

Jan 14th, 2022 - Pathophysiological study in human subjects, comparative, national, multicentric and prospective. Peripheral blood and intestinal biopsies will be collected.

Maximising Time With a Normal Blood Glucose to Restore the Glucagon Response in Type 1 Diabetes

Jan 14th, 2022 - This is a feasibility pilot study involving 24 participants with type 1 diabetes. Participants will be recruited from the local type 1 diabetes clinic and insulin pump waiting list. Each participant will enter the trial for a period of 8 months. The investigators aim to test if maximising time in glycaemic range (blood glucose 3.9-10 mmol/L) will restore the glucagon response to insulin-induced...

Evaluation of On-eye Optical Performances of the RMY-100 Lens

Jan 14th, 2022 - This is a two-arm parallel, non-masked, bilateral, non-dispensing study with one Test arm and one concurrent, non-randomized Control arm to evaluate the one-eye optical performances of the test soft contact lens and compare with eyes treated with orthokeratology.

Laparoscopic vs Vaginal Hysterectomy for Benign Gynaecological Disease

Jan 14th, 2022 - The current trial evaluates the performance and short-term postoperative outcomes of these two approaches for hysterectomy in Ain Shams University Maternity Hospital, a major tertiary hospital in Greater Cairo, and one of Egypt's leading centers in terms of provision of public medical service. Eighty patients with benign indications, with no contraindications to neither laparoscopic nor vaginal...

Effect of Research Participation Versus Usual Clinical Treatment on Pain in Patients With Musculoskeletal Disorders

Jan 14th, 2022 - Musculoskeletal (MSK) disorders are a major burden on individuals, health systems, and social care systems. Increases in life expectancy and ageing populations are expected to make MSK disorders one of the leading causes of disability by the year 2020. When faced with a potentially life changing diagnosis of a chronic disease, people (in general) develop an organized pattern of perceptions abou...

First Real-world Data on Unresectable Stage III NSCLC Patients Treated With Durvalumab After Chemoradiotherapy

Jan 14th, 2022 - This is a non-interventional/observational study including NSCLC unresectable Stage III patients treated with durvalumab. Patient selection and retrospective data collection will be from participating countries: Australia, Belgium, Israel, Netherlands, Norway France, Germany, Italy, Switzerland, Spain Chart abstractions will occur at specified intervals up to five years after the patient had th...

Effects of Gait Retraining on Lower Extremity Biomechanics

Jan 14th, 2022 - A randomized controlled study design with a waitlist will be used to investigate the effects of a 10-week gait retraining intervention on the knee adduction moment. Participants will be randomly assigned to either the intervention group or the control group. The intervention group will be further split into two groups. One group will consist of participants who reduced knee adduction moment (KA...

Oral Iron Frequency for Childhood Restless Leg Syndrome/Periodic Limb Movement Disorder

Jan 14th, 2022 - The purpose of this research study is to see if the level of serum ferritin differs based on how often oral iron (in the form of ferrous sulfate) is given to children with restless leg syndrome/periodic limb movement disorder.

A Study of Encorafenib Plus Cetuximab With or Without Chemotherapy in People With Previously Untreated Metastatic Colorectal Cancer

Jan 14th, 2022 - The purpose of the study is to evaluate whether encorafenib plus cetuximab (EC), alone or in combination with chemotherapy, can improve clinical outcomes relative to current standard of-care chemotherapy in participants with previously untreated BRAF V600E-mutant mCRC. Since encorafenib has not previously been combined with chemotherapy, the tolerability and PK of EC in combination with mFOLFOX...

VivaSight Double Lumen Tube for Single Lung Ventilation

Jan 14th, 2022 - This prospective, randomized, comparative study is intended to enroll a total of 50 patients undergoing thoracic surgery that necessitates single lung ventilation. The efficacy and performance of the VivaSight DLT will be compared to the conventional double lumen tube. Use of fiberoptic bronchoscopy for initial tube positioning and subsequently during the case will be recorded. The attending th...

A Study To Investigate The Safety, Tolerability And Pharmacokinetics (PK) Of RO7223280 Following Intravenous Administration In Healthy Participants

Jan 14th, 2022 - The Study consists of 2 Parts: Part 1 (Single Ascending Dose/SAD) and Part 2 (Multiple Ascending Dose/MAD). Part 1 will investigate the safety, tolerability and PK of single-ascending intravenous (IV) doses of RO7223280 in healthy participants. Part 2 will investigate the safety, tolerability and PK of multiple-ascending IV doses of RO7223280 in healthy participants. Part 2 will only start afte...

Low-Dose Daunorubicin in Relapsed/Refractory Acute Leukemia

Jan 14th, 2022 - Disease relapse remains the primary challenge in the treatment of acute myeloid leukemia (AML) and acute lymphocytic leukemia (ALL). There is no standard of care treatment option for relapsed acute leukemia, and investigational therapies are recommended. Clinically targeting the leukemia stem cell (LSC) remains an unmet need in both AML and ALL. Therefore, a primary objective of this trial is t...

SARS-COV2 Pandemic Serosurvey in a Rare Disease Population

Jan 14th, 2022 - 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. ...