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NCT ID: NCT06032546 Recruiting - Clinical trials for Human Immuno-deficiency Virus (HIV) Disease

A Study to Assess Change in Disease Activity, Adverse Events, and How the Drug Moves Through the Body in Adult Participants Living With Human Immunodeficiency Virus (HIV) Receiving Intravenous (IV) Infusion of Budigalimab and/or ABBV-382

Start date: October 12, 2023
Phase: Phase 2
Study type: Interventional

Human immuno-deficiency virus (HIV) is the virus that causes Acquired Immuno-Deficiency Syndrome (AIDS). HIV disease is considered to be a chronic disease requiring lifelong therapy. The purpose of this study is to assess change in disease activity, adverse events, tolerability, and how the drug moves through the body. Budigalimab and ABBV-382 are investigational drugs being developed for the treatment of HIV disease. Participants are placed in 1 of 5 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 7 chance that participants will be assigned to placebo (A placebo is not a drug and it is not expected to have any chemical effects on your body and it is not designed to treat any disease or illness). Approximately 140 adult participants living with HIV disease on stable antiretroviral therapy (ART) willing to undergo Analytical Treatment Interruption (ATI) will be enrolled at approximately 90 sites worldwide. Participants will receive 4 doses of IV budigalimab or placebo combined with 3 doses of IV ABBV-382 or placebo for an 8 week dosing period. Participants need to be stable on antiretroviral therapy to participate in the study. If participant qualifies to the study, on the day they receive the first injection, participants will be asked to stop antiretroviral medications (also referred to as analytical treatment interruption or ATI) for 52 weeks or until meeting specific criteria to restart antiretroviral medications. Participants will undergo a closely monitored ART interruption. Protocol-defined ART restart criteria includes participant's request. Participants will be followed for up to approximately 52 weeks. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. There will be an option for virtual or home health visits for some of the follow-up visits. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

NCT ID: NCT06032507 Active, not recruiting - Knee Clinical Trials

Effect of High-pressure Pulsatile Lavage Versus Manual Rinsing on Bone Cement Penetration in Total Knee Arthroplasty

Start date: March 1, 2022
Phase: N/A
Study type: Interventional

Background Bone irrigation is essential in cemented total knee arthroplasty surgical technique in order to improve cement penetration and interdigitation into cancellous bone, that is going to determine the strength of the bone-cement interface. Purpose To report the effect of high-pressure pulsatile lavage versus manual rinsing on bone cement penetration in total knee arthroplasty. Methods This is a single-centre, prospective, randomized, controlled clinical trial. The study included 100 patients undergoing primary total knee arthroplasty. All patients meeting inclusion criteria were randomly assigned to the pulsed lavage or non-pulsed lavage group. The cumulative bone cement penetration was radiologically assessed in antero posterior and lateral radiograph views in 10 zones according to the Knee Society Scoring System. A statistical analysis was performed between both groups comparing bone cement penetration cumulative scores.

NCT ID: NCT06032130 Recruiting - Parkinson Disease Clinical Trials

" Visual Characterization of Parkinson's Patients and Oculomotor or Perceptual Therapy"

Start date: September 29, 2023
Phase:
Study type: Observational

Parkinson's disease (PD) is the second most common neurodegenerative condition worldwide, characterised by motor symptoms, but with other symptoms such as visual impairment. The aim is to compare visual function between PD patients and healthy subjects in order to adequately characterise the visual capabilities of the PD population and perform oculomotor or perceptual therapy to find optometric solutions to slow down the visual impairment they suffer from or minimise their visual symptoms. In the first phase, non-invasive tests will be carried out, such as measuring visual acuity, refraction, pupil diameter in different lighting conditions, sensory dominance, contrast sensitivity, colour vision, stereopsis, reading speed, binocular vision, eye movements and influence on quality of life. In the second, visual oculomotor or perceptual exercises will be performed in a group of PD patients to assess whether there is stabilisation of impairment or improvement of these visual skills. These will be performed in a non-invasive way using simple and easy-to-use instruments or an application on an electronic device could be used. Finally, in the third phase, those visual skills that have been treated will be re-evaluated to assess possible changes, compared with a group of PD patients who have not undergone the visual exercises.

NCT ID: NCT06031766 Recruiting - Malnutrition Clinical Trials

Comparison of CIPA With the GLIM Criteria and Prevalence of Sarcopenia in Inpatients

Start date: January 7, 2022
Phase:
Study type: Observational

Determine the diagnostic quality of the CIPA tool, in inpatients with stays longer than three days, in the observation of risk of malnutrition compared to the gold standard GLIM as a diagnosis of malnutrition.

NCT ID: NCT06031701 Completed - Quality of Life Clinical Trials

Neuro-psychosocial Teleassistance for Neuromuscular Diseases

Start date: November 2, 2021
Phase: N/A
Study type: Interventional

This is a clinical trial to assess the effect of a neuropsychosocial intervention by means of telecare aimed at children and adolescents aged 7-16 years with neuromuscular diseases. The intervention is carried out in groups of 5 participants and is organised in 12 sessions: 1 session per week of 1h duration. The intervention is aimed at strengthening aspects of social cognition, self-esteem, social skills and aims at a reduction of symptomatology and a general improvement of psychological well-being.

NCT ID: NCT06031493 Not yet recruiting - Quality of Life Clinical Trials

A Multimodal Intervention Program to Improve Sexual Health and Self-perceived Quality of Life in Patients Treated for Cervical Cancer (PROVIDENCE)

PROVIDENCE
Start date: January 2025
Phase: Phase 4
Study type: Interventional

The PROVIDENCE Trial aims to explore the improvement of sexual health and self-perceived health related quality of life (measured by Patient Reported Outcome Measures) through a multimodal intervention that includes patient education on healthy habits and the prevention of vaginal dysfunction using vaginal moisturizers and topical estrogens. To achieve this, a randomized design is proposed to assess sexual health and quality of life in patients treated for cervical cancer who undergo this intervention compared to those who receive standard care.

NCT ID: NCT06031064 Recruiting - Microscopic Colitis Clinical Trials

External Validation of a Microscopic Colitis Clinical Scoring System in Patients With Chronic Watery Diarrhoea

Start date: May 15, 2022
Phase:
Study type: Observational

Chronic watery diarrhoea is a very common problem in the population and most of these patients will be referred for colonoscopy. If no macroscopic findings are observed during colonoscopy to justify the diarrhoea, serial colonic biopsies will be taken to rule out Microscopic Colitis (MC). However, it has been estimated that only 10-15% of these patients will be diagnosed with MC after colonoscopy. Therefore, about 80% of the biopsies collected and analysed will not be useful to establish a diagnosis, considerably increasing costs. To predict the risk of developing MC, a new promising clinical scoring system has been recently developed. This score will be useful in the diagnostic work-up of chronic watery diarrhoea to prioritize colonoscopy with stepwise colonic biopsies in patients with a positive highly specific score for MC. In cases with a negative score, colonoscopy plus biopsies should be performed only if other diagnostic tests are negative. The aim of this current study is to externally validate the new scoring system to predict MC in patients with chronic watery diarrhoea.

NCT ID: NCT06031051 Recruiting - Colonic Disease Clinical Trials

Capsule Endoscopy as an Alternative to Colonoscopy

CAPSUCOVID
Start date: December 22, 2021
Phase: N/A
Study type: Interventional

This is a prospective, multicenter, interventional study assessing CE, in patients already scheduled for colonoscopy at tertiary referral hospitals, as a technique to reduce the number of unnecessary colonoscopies and identify patients to prioritize in endoscopy waiting lists.

NCT ID: NCT06031038 Active, not recruiting - Ulcerative Colitis Clinical Trials

Impact of Telemonitoring in the Management of Complex IBD in Spain: M-TECCU

M-TECCU
Start date: July 1, 2020
Phase: N/A
Study type: Interventional

M-TECCU is a study: multicenter, randomized and open. It consists of two parallel groups to compare the efficacy of the TECCU web-based telemonitoring system to achieve and maintain activity remission in patients with moderate-high complexity inflammatory bowel disease compared to usual clinical practice.

NCT ID: NCT06030544 Recruiting - Clinical trials for Type II Diabetes Mellitus

Oleanolic Acid as Therapeutic Adjuvant for Type 2 Diabetes Mellitus (OLTRAD STUDY)

OLTRAD
Start date: February 25, 2022
Phase: Phase 2
Study type: Interventional

Oleanolic acid (OA), is a natural component of many plant food and medicinal herbs, which has shown to exert in experimental models hypoglycemic and hypolipidemic effects, and also a cytoprotective action against oxidative and chemotoxic stress underlying Type II Diabetes Mellitus (T2DM).Today it is known that OA shares mechanisms of action with metformin and other drugs of choice for the treatment of diabetes. Therefore, the OLTRAD (OLeanolic acid TReAtment for type 2 Diabetes) Study, a prospective, parallel group, randomized, double-blind, controlled trial with 100 participants, has been designed to demonstrate that the regular intake of an OA-enriched functional olive oil is effective as an adjuvant to metformin antidiabetic drug therapy. The hypothesis is that the inclusion of this functional olive oil in the diet will enhance the effects of the pharmacological treatment in diabetic patients, and may even reduce the need for prescription of such medications.