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NCT ID: NCT05727644 Completed - Clinical trials for Non-alcoholic Steatohepatitis (NASH)

A Research Study Looking Into Blood and Urine Levels of the Medicine NNC0194-0499 in the Body and How Well it is Tolerated in Participants With Reduced Kidney Function and Normal Kidney Function

Start date: February 15, 2023
Phase: Phase 1
Study type: Interventional

Novo Nordisk is developing the study medicine NNC0194-0499 for the treatment of non-alcoholic steatohepatitis (NASH). NASH is a serious disease where fat, inflammation and scar tissue builds up in the liver. In this study the blood and urine levels of NNC0194-0499 will be compared in people with various degrees of reduced kidney function to the blood and urine levels in people with normal kidney function, after administration of one dose of 30 milligrams (mg) NNC0194-0499. Participant will only get the study medicine in one injection into a skinfold in the thigh (subcutaneous). The study will last for about 66 days including a screening phase of up to 28 days prior to dosing.

NCT ID: NCT05726799 Completed - Clinical trials for Obstructive Hypertrophic Cardiomyopathy

Use of Cryoenergy to Faciltate Myectomy in Hypertrophic Obstructive Cardiomyopathy: Comparison With the Classical Approach

Start date: October 5, 2019
Phase:
Study type: Observational

In some patients, septal hypertrophy extends more distally, from the subaortic portion of the septum to the midventricular portion. In these patients, classic transaortic surgical myectomy may not be effective in removing the midventricular obstruction, resulting in a suboptimal surgical outcome. These patients may present recurrence of symptoms and not have an improvement in the prognosis related to the treatment of hypertrophic cardiomyopathy, in some cases determining the need for reoperation. Since 2015, our Institute has used a surgical technique that allows us to improve transaortic exposure of the interventricular septum, using a probe with application of cryoenergy the hypertrophic portion of the septum is hooked and in this way the myectomy can be extended more distally, performing a more complete removal of the myocardium. The aim of this study is to compare the results obtained with classical myectomy compared to myectomy performed with the aid of cryoenergy. The primary endpoint is the comparison in terms of mortality between patients undergoing classical myectomy versus those undergoing cryoenergy-assisted myectomy. Secondary endpoints are: extent of myectomy, persistence of residual left ventricular outflow tract obstruction, persistence of mitral regurgitation related to systolic anterior motion of the mitral leaflets, occurrence of ventricular defect, and need for PM implantation.

NCT ID: NCT05725798 Completed - Clinical trials for Systemic Inflammatory Response Syndrome

Perioperative Sitagliptin Medication for Reduction of the Inflammatory Response Associated With Cardiopulmonary Bypass

SiCa-Flam
Start date: February 1, 2022
Phase:
Study type: Observational

Sitagliptin is an inhibitor of the enzyme dipeptidylpeptidase-4 (DPP-4) and represents an established drug in type 2 diabetes mellitus treatment. However, Sitagliptin may also have several antiinflammatory properties. Within this study the investigators examine the effects of perioperative Sitagliptin intake on the inflammatory response after cardiopulmonary bypass.

NCT ID: NCT05725278 Completed - Contraception Clinical Trials

Impact Evaluation of Triggerise's Tiko Platform

Start date: February 15, 2021
Phase: N/A
Study type: Interventional

Triggerise designed web and phone based Tiko platform to connect young girls and women to the health products, services and information. The platform uses principles of behaviour economics to motivate positive choices-including rewards, promotions, discounts, coupons, reminders, alerts etc. The platform was implemented in several cities from seven states of India to provide Sexual Reproductive Health (SRH) and maternal and child health (MCH) products and services. The consumers (called Rafikis) use Tiko card to get discounts and to earn 'Tiko miles' rewards at Tiko franchised healthcare providers and pharmacies. Tiko miles are redeemable towards lifestyle products or services (e.g., beauty salons). The local Tiko health promoter (celled Pro agent) can also buy health and hygiene products at bulk discounts and sell them at profit. Triggerise appointed Network for Engineering, Economics Research and Management (NEERMAN) to conduct an independent impact assessment of the Tiko platform with multiple research objectives include health impact evaluation at the Rafiki level. NEERMAN used an ex-post observational design to compare usage of SRH and MCH services and family planning (FP), antenatal care (ANC) and postnatal care (PNC) practices by comparing Users and Non-Users of Tiko platform, and accounting for the selection bias statistically. The structured questionnaire collected data on knowledge, practices, barriers, enablers for SRH and MCH services, exposure o Tiko platform, and how it helped or did not help. The survey participants were approx. 1200 users and 600 non-users being served by approx. 350 pro-agents in their respective operations area. The association between use of Tiko platform and various outcomes were identified using a generalized linear model with fixed effects at pro-agent level and including a set of covariates. To evaluate the effect modification by type of pro agent - government community health worker (CHW) versus others - an interaction model was used. The standard errors were automatically clustered at pro-agent level due to fixed effects. Primary outcomes are proportion of married Rafikis currently using any contraceptives, currently using modern short-term contraceptives, proportion of Rafikis who delivered a child post Jan 2019 and received at least 4 ANC check-ups, consumed at least 100 iron folic acid (IFA( during pregnancy, and received a PNC check-up within 6 weeks of birth.

NCT ID: NCT05725070 Completed - Clinical trials for Metastatic Castration-resistant Prostate Cancer

Phase 0/1 Study of 212Pb-NG001 in mCRPC

Start date: March 6, 2023
Phase: Early Phase 1
Study type: Interventional

The purpose of this study is to evaluate the imaging feasibility and safety of 212Pb-NG001.

NCT ID: NCT05724615 Completed - Clinical trials for Atherosclerotic Cardiovascular Disease

Default Bulk Ordering and Text Messaging to Enhance Outreach for Lipid Screening (Missing Lipids)

Start date: June 5, 2023
Phase: N/A
Study type: Interventional

We aim to evaluate different approaches to increase Lipid screenings among primary care patients at Penn Medicine. A randomized trial will test the effectiveness of bulk ordering, outreach via mailed letters, and text-based reminders with scheduling assistance for patients needing a lipids panel. We will observe the number of completed panels after 3 and 6 months.

NCT ID: NCT05719974 Completed - Clinical trials for Anterior Cruciate Ligament Injuries

Functional Outcomes of a Criterion-based Rehabilitation Protocol for ACL Reconstruction in Amateur Athlete

Start date: March 3, 2020
Phase: N/A
Study type: Interventional

Although current rehabilitation protocols following anterior cruciate ligament reconstruction (ACLR) are based on the graft remodeling process, there is uncertainty about its time schedule. Moreover, there are individual differences in neuromotor learning and flexibility after ACLR. This study was conducted to investigate the effect of a criterion-based rehabilitation protocol on pain intensity, effusion, and knee function in amateur athletes following ACLR. Although current rehabilitation protocols following anterior cruciate ligament reconstruction (ACLR) are based on the graft remodeling process, there is uncertainty about its time schedule. Moreover, there are individual differences in neuromotor learning and flexibility after ACLR. This study was conducted to investigate the effect of a criterion-based rehabilitation protocol on pain intensity, effusion, and knee function in amateur athletes following ACLR.

NCT ID: NCT05719831 Completed - Clinical trials for Helicobacter Pylori Eradication Rate

Optimization of Vonoprazan--amoxicillin Dual Therapy for Eradicating Helicobacter Pyloriinfection

Start date: February 1, 2023
Phase: Phase 3
Study type: Interventional

Helicobacter pylori infection is closely related to gastritis, peptic ulcer, mucosa-associated lymphoid tissue lymphoma and gastric cancer. Eradication of HP can significantly improve and reduce HP-related diseases. International and domestic guidelines recommend a 10-14 day quadruple regimen containing bismuth as first-line treatment, achieving an eradication rate of more than 80%. However, some disadvantages of these quadruple regimens, such as severe adverse reactions, high medical costs and low compliance, prevent their application in clinical practice. Studies at home and abroad have shown that high-dose proton pump inhibitors combined with amoxicillin can be used as the first-line treatment for HP eradication, with good efficacy and compliance and low rate of adverse reactions. And because it is a single antibiotic therapy, we do not expect this regimen to increase antibiotic resistance rates for HP. The maintenance of gastric PH > 6 is one of the key factors for HP eradication. The acid inhibition effect of proton pump mainly depends on the degree of individual metabolism of proton pump. Vonoprazan fumarate, a new competitive potassium acid blocker, is not affected by gene polymorphism, and has the advantage of stronger and longer inhibition effect on gastric acid compared with proton pump inhibitors. In most parts of China, HP is characterized by high infection rate and antibiotic resistance rate, requiring higher eradication rate and safety regimen.This study aimed to evaluate two different amoxicillin dosages (1 g b.i.d. vs. 0.75 g q.i.d.) and two different durations of therapy (14 vs.10 days) to gain insights of the effectiveness of VA dual therapy .

NCT ID: NCT05719675 Completed - Quality of Life Clinical Trials

Healthcare Intervention Program on Treatment Adherence in People With Newly Diagnosed Type 2 Diabetes Mellitus.

Start date: March 1, 2023
Phase: N/A
Study type: Interventional

Type 2 Diabetes Mellitus (T2DM) is a group of metabolic disorders characterized by hyperglycemia in the absence of treatment, positioned in the first places of prevalence and mortality in the Mexican population. Adherence to treatment is a central element to prevent complications of the disease, where the active participation of the patient in his or her treatment is fundamental. Despite institutional healthcare efforts to promote this element, there is no clarity in the Clinical Practice Guidelines aimed at the attention of people with T2DM on how to achieve it. The aim of this project will be to evaluate the effect of an intervention based on Contingency Behavior Analysis on treatment adherence, quality of life and glycemic level in people with newly diagnosed T2DM. Pre-experimental design with pretest and posttest measurements. The Dependent Variable will be an intervention based on Contingency Behavior Analysis. The Independent Variables will be adherence to treatment, quality of life and glycemic level. The power calculation suggests an n = 38, using sequential non-probability sampling. People older than 18 years with less than 5 years of T2DM diagnosis will be included. Pretest and posttest differences, effect size and correlations between measurement variables will be analyzed. It is expected that the intervention based on Contingency Behavior Analysis will encourage the active participation of people with T2DM, improving their adherence to treatment, glycemic level and quality of life. Considering that the Clinical Practice Guidelines emphasize the importance of therapeutic adherence through the active participation of the patient and his/her environment, it is expected that this project will provide the tools for behavioral change that so far are not included in public health in Mexico.

NCT ID: NCT05719311 Completed - Cystic Fibrosis Clinical Trials

Study to Assess an Enteric Microgranule Formulation of Adrulipase in Patients With Cystic Fibrosis

SPAN
Start date: February 1, 2023
Phase: Phase 2
Study type: Interventional

Some cystic fibrosis patients are unable to digest food and absorb nutrition appropriately as they have a condition known as exocrine pancreatic insufficiency (EPI). Currently, these patients take pancreatic enzymes that are obtained from pig pancreas to aid the digestion of food. The goals of this clinical study are to evaluate the safety and efficacy of a novel formulation of a non-porcine lipase, called adrulipase, in patients with EPI due to cystic fibrosis. The main question[s] the study aims to answer are: 1. Is the novel formulation of adrulipase safe to use at the doses being evaluated in the clinical study. 2. Is adrulipase as effective, or more effective, compared to the pig enzymes the patients currently use. Researchers will compare the results obtained with adrulipase to how the patients typically respond to their pig enzymes to see if adrulipase helps patients digest fats adequately and if their stomach feels good (signs and symptoms of malabsorption).