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NCT ID: NCT05863247 Active, not recruiting - Presbyopia Clinical Trials

Ocular Biomarkers for Successful Premium Trifocal Intra-ocular Lenses Implantation

Start date: January 1, 2023
Phase:
Study type: Observational

The purpose of this study is to identify ocular biomarkers that can predict the success of phacoemulsification with bilateral AT LISA try 839MP (Carl Zeiss Meditec AG) implantation to achieve satisfactory post-post-operativly spectacle-free vision. Social, biometric and patient reported outcomes will be evaluated.

NCT ID: NCT05862649 Recruiting - Parkinson Disease Clinical Trials

Evaluation of Correlation Between Oculometric Measures and Clinical Assessment in Parkinson's Disease

PALOMA
Start date: August 21, 2023
Phase: N/A
Study type: Interventional

This is a multicenter longitudinal study in about 300 patients with Idiopathic Parkinson's disease, who will be evaluated in several clinical centers with a clinical assessment and an oculometric examination during a time period with specific intervals. This study aims to evaluate the correlation between oculometric measures and clinical assessment over time, as well as the potential to detect early change in clinical status using an oculometric assessment.

NCT ID: NCT05860621 Recruiting - Clinical trials for Breast Cancer Female

Promoting Physical Activity in Breast Cancer Survivors on Aromatase Inhibitors

PAC-WOMAN
Start date: January 5, 2022
Phase: N/A
Study type: Interventional

Aromatase inhibitors (AI) are frequently used to treat hormone-receptor-positive breast cancer, but they have multiple adverse effects (eg, arthralgia), resulting in premature therapy discontinuation/switch. Physical activity (PA) can attenuate these negative effects and improve quality of life (QoL). However, most cancer survivors fail to perform/sustain adequate PA levels, especially in the long-term. Theory-based interventions, using evidence-based behavior change techniques, aimed at promoting long-term behavior change in breast cancer survivors are effective, but remain scarce and fail to promote self-regulatory skills and better-quality motivations associated with sustained PA adoption. PAC-WOMAN will test the long-term effectiveness and cost-effectiveness of two state of the art, group-based interventions encouraging sustained changes in PA, sedentary behavior, and QoL. Additional aims include examining the impact of both interventions on secondary outcomes (eg, body composition, physical function), and key moderators/mediators of short and long-term changes in primary outcomes. A 3-arm pragmatic randomized controlled trial, involving a 4-month intervention and a 12-month follow-up, will be implemented, in a real exercise setting, to compare: 1) brief PA counseling/motivational intervention; 2) structured exercise program vs. waiting-list control group. Study recruitment goal is 122 hormone-receptor-positive breast cancer survivors (stage I-III), on AI therapy (post-primary treatment completion) ≥1 month, performance status 0-1. Outcome measures will be obtained at baseline, 4 months (i.e., post-intervention), 10 and 16 months. Process evaluation, analyzing implementation determinants, will also be conducted. PAC-WOMAN is expected to have a relevant impact on participants PA and QoL, and on the improvement of interventions designed to promote sustained adherence to active lifestyle behaviors, facilitating its translation to community settings.

NCT ID: NCT05860114 Completed - Clinical trials for Drug Drug Interaction

Givinostat and Metabolites Pharmacokinetics in Urine and Plasma (Part 3)

Start date: March 21, 2022
Phase: Phase 1
Study type: Interventional

Primary objective: To evaluate the plasma and urine PK of givinostat following multiple oral doses of givinostat. Secondary objective: To assess the safety and tolerability multiple oral doses of givinostat.

NCT ID: NCT05859022 Recruiting - Obesity Clinical Trials

Metabolic Effects of Bariatric Arterial Embolization vs Bariatric Surgery

BEOD
Start date: June 16, 2021
Phase: N/A
Study type: Interventional

Obesity and Type 2 diabetes mellitus (DMT2) are two of the most common chronic diseases of the Western society. Obesity is one critical factor in DMT2 development, with weight loss having profound beneficial effects on DMT2 and improving the metabolic pathophysiology leading to hyperglycemia. Observational studies reported that surgical intervention of morbid obesity achieved significant improvement of resolution of DMT2, both in short and long-term. Bariatric surgery has been considered the best option for treatment of diabetic obese patients, with the laparoscopic Roux-en-Y Gastric Bypass being the gold standard of the surgical treatment. Bariatric arterial embolization (BAE) technique has proved to be safe effective for weight loss in obese patients, but its metabolic effects have not been studied yet. The hypothesis of the study is that BAE is effective for the resolution of DMT2 inpatients with BMI between 30-43 Kg/m2. The aim is to assess DMT2 remission after BAE and bariatric surgery, to analyze potential conditioning factors, and to compare remission criteria between bariatric surgery and BAE.

NCT ID: NCT05857059 Recruiting - Obesity Clinical Trials

Misoprostol for Induction of Labor in Obese Women: Comparison Between 25 and 50 mcg Oral Administration

Start date: October 15, 2019
Phase: N/A
Study type: Interventional

In recent decades, obesity has become a prevalent issue in Portugal, with 38.6% and 13.8% of the population being overweight or obese, respectively. Obese pregnant women have a higher rate of obstetric complications, including hypertensive complications, gestational diabetes and fetal macrosomia, leading to increased induction of labor (IOL) and cesarean section (CS) rates. To determine the effect of increasing oral misoprostol dose on CS rate in obese pregnant women undergoing IOL, a randomized controlled trial with a sample size of 114 cases in each group was calculated to detect a 15% difference in CS rate. The primary objective is to determine the effect of increasing oral misoprostol dose, with secondary goals being to compare successful IOL rates and their relationship with oral misoprostol dose, as well as to evaluate tolerability and side effects in relation to different doses of oral misoprostol.

NCT ID: NCT05856526 Recruiting - Netherton Syndrome Clinical Trials

A Study to Test Whether Spesolimab Helps People With a Skin Disease Called Netherton Syndrome

Start date: May 15, 2023
Phase: Phase 2/Phase 3
Study type: Interventional

This study is open to people with a skin disease called Netherton syndrome (NS). People can join the study if they are 12 years and older. The purpose of this study is to find out whether a medicine called spesolimab helps people with NS. Participants are divided into a spesolimab and a placebo group. Placebo injections look like spesolimab injections but do not contain any medicine. Every participant has a 2 in 3 chance of being in the spesolimab group. In the beginning, participants get the study medicine as an injection into a vein. Afterwards, they get it as an injection under the skin every month. After 4 months, participants in the placebo group switch to spesolimab treatment. Participants are in the study for about 1 year. During this time, they visit the study site 16 times. Where possible, 4 of 16 visits can be done at the participant's home instead of the study site. The doctors regularly check participants' NS symptoms. The results are compared between the groups to see whether spesolimab works. The doctors also regularly check participants' general health and take note of any unwanted effects.

NCT ID: NCT05855200 Recruiting - Colonic Neoplasms Clinical Trials

Study of Perioperative Dostarlimab in Participants With Untreated T4N0 or Stage III dMMR/MSI-H Resectable Colon Cancer

AZUR-2
Start date: August 2, 2023
Phase: Phase 3
Study type: Interventional

The primary purpose of this study is to evaluate the efficacy of perioperative dostarlimab compared with standard of care (SOC) in participants with untreated T4N0 or Stage III (resectable), defective mismatch repair/ microsatellite instability high (dMMR/MSI-H) colon cancer.

NCT ID: NCT05854888 Completed - Clinical trials for Perineal Tear Resulting From Childbirth

Perineal Massage and Warm Compresses - RCT for Reduce Perineal Trauma During Labor

PeMWaC
Start date: March 1, 2019
Phase: N/A
Study type: Interventional

The aim of this study is to evaluate the effect of a combined perineal massage and warm compresses intervention on the perineum integrity during second stage of labor.

NCT ID: NCT05852275 Recruiting - Clinical trials for Adult Healthy Volunteers

O-LIVE: Impact of a Portuguese Olive Oil in Health Biomarkers

O-LIVE
Start date: September 1, 2022
Phase: N/A
Study type: Interventional

This research project, approved and funded, is part of a larger project, entitled "Healthy Soil for Food", which completes several work packages, one of which is a clinical research submitted to Ethics Committee entitled "O-LIVE: Impact of olive oil Portuguese in biomarkers of healthy volunteers". The main objective of this work is to evaluate the impact of ingestion of an olive oil rich in polyphenols on clinical biomarkers and parameters, such as anthropometric measurements, on inflammatory gene expression regulation and on the composition of the intestinal microbiota.