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NCT ID: NCT05383352 Recruiting - Clinical trials for Metastatic Pancreatic Adenocarcinoma

A Study to Compare Onivyde Manufactured at Two Different Production Sites in Adult Participants With Advanced Cancer in the Pancreas

SIRACUSA
Start date: May 30, 2022
Phase: Phase 1
Study type: Interventional

The aim of this study is to compare Onivyde manufactured at two different production sites in adult participants with advanced cancer in the pancreas. Adult participants with metastatic pancreatic adenocarcinoma will receive Test Product (TP) and Reference Product (RP) Onivyde in line with its approved indication. The order in which they receive them depends on the group to which they are randomly assigned, this will be referred to as the crossover phase. The average study duration for each participant until end of crossover phase is estimated to be approximately 3 months. After completion of the crossover phase, participants who in the opinion of the investigator will benefit from the treatment will be offered to enter the extension phase where they will receive the commercial Onivyde (RP) until disease progression, withdrawal, unacceptable toxicity or death. Metastatic pancreatic adenocarcinoma is a cancer that has spread (metastasized) beyond the area of the pancreas to other organs of the body. Onivyde is approved for the treatment of metastatic adenocarcinoma of the pancreas after disease progression following gemcitabine-based therapy, in combination with 5-fluorouracil (5-FU) and leucovorin (LV).

NCT ID: NCT05380089 Recruiting - Dehydration Clinical Trials

Effects of Hydration Changes on Neuromuscular Function of Athletes

H2OAthletes
Start date: November 1, 2021
Phase: N/A
Study type: Interventional

Greater muscular strength and power are relevant qualities for athletic success and decreased injury rate. It is known that dehydration impairs muscular strength and power, although the explanation for this association is not entirely clear. Besides morphological factors, strength production also depends on neural factors which in turn can be affected by dehydration. Some studies tested the effects of dehydration on neuromuscular function using electromyography (EMG) analysis. However, there is no consensus among those studies. Additionally, exercise may disturb water balance. This can further lead to dehydration if the athlete does not properly rehydrate. In this sense, the scientific evidence has identified people who are considered low drinkers that may be more susceptible to cellular shrinkage, potentially impairing health and performance. Thus, it would be expected that athletes regularly exposed to lower amounts of water intake would have beneficial effects in both performance and health if higher water ingestion was promoted, namely an improved neuromuscular function via enhanced cellular hydration. However, any potential benefit of increasing water intake on neuromuscular function is still to be determined using well-designed experimental studies and state-of-the-art methods. Lastly, there is no consensus regarding the diagnosis of dehydration in athletes. The identification of simple indices to measure dehydration in athletes is crucial as many may be inaccurately diagnosed.

NCT ID: NCT05376891 Recruiting - Cancer Clinical Trials

Met Non Small Cell Cancer Registry (MOMENT)

Start date: October 4, 2022
Phase:
Study type: Observational

The purpose of this multi-national disease registry is to collect prospectively (with longitudinal follow-up) high-quality, standardized, and contemporaneous data to capture changes in the non-small cell lung cancer (NSCLC) treatment landscape and outcomes over time. The registry will capture data on participants; demographic, clinical characteristics (including biomarker data), treatment patterns, and effectiveness and safety outcomes for advanced NSCLC with mesenchymal-epithelial transition exon 14 (METex14) participants treated with systemic therapy.

NCT ID: NCT05375487 Recruiting - Clinical trials for Functional Constipation

The Effect of Natural Carbonated Mineral Water Consumption on Gastrointestinal Transit and on Gut Microbiota in Subjects With Functional Constipation: A Randomized, Placebo-Controlled Pilot Trial

Start date: May 2022
Phase: N/A
Study type: Interventional

Functional constipation (FC) is a common condition associated with aging, lower socioeconomic status, low physical activity and also with reduced fibre, water and magnesium intakes. Different studies have reported a positive association between the intake of hyper-mineral water containing a high content of bicarbonate, calcium, or magnesium, and the improve of the gastrointestinal transit. There is evidence that magnesium and sulphate, both individually, have a laxative action. However, the impact of other minerals is scarce. It has been described different mechanisms explaining how gut microbiota influence the gastrointestinal transit. Specifically, in FC patients, it is important to understand the particularities of their gut microbiota and understand whether the intake of hyper-mineral water, a natural source of minerals, can modify positively the gut microbiota. The aim of the present randomized placebo-controlled pilot trial is to evaluate, for the first time, the effect of the carbonated mineral water consumption in the gastrointestinal transit and in the gut microbiota of subjects with FC.

NCT ID: NCT05369637 Recruiting - Clinical trials for Transient Ischemic Attack

Multiple Interventions to Accelerate the Return to the Pre-event Level of Functioning After a TIA and Minor Stroke

Start date: May 11, 2022
Phase: N/A
Study type: Interventional

The occurrence of a transient ischemic attack (TIA) or a minor stroke is frequently assumed as a temporary and non-disabling event. Nevertheless, patients can experience subtle but meaningful impairments, including a decreased performance in activities of daily living (ADLs), a high prevalence of depression, cognitive decline, physical deficits, hearing degeneration, with implications in returning to work, social relations and activities. Additionally, it has been described a higher risk of stroke among these patients, which highlights the importance of promoting secondary prevention, soon after these acute episodes. Therefore, this pilot randomized controlled trial (RCT) aims to evaluate the feasibility and the effectiveness of a three-month multidomain intervention program, composed of five non-pharmacological components which may contribute to accelerate the return to the pre-event level of functioning in patients with TIA and minor stroke. The results may guide future clinical practices and health policies aiming to reduce the overall burden of stroke.

NCT ID: NCT05369052 Recruiting - Clinical trials for Diabetic Foot Infection

Safety and Efficacy Study of Contezolid Acefosamil and Contezolid Compared to Linezolid Administered Intravenously and Orally to Adults With Moderate or Severe Diabetic Foot Infections (DFI)

Start date: May 3, 2022
Phase: Phase 3
Study type: Interventional

This is a Phase 3, multicenter, randomized, double-blind, safety and efficacy study of contezolid acefosamil (IV)/contezolid (PO) compared with linezolid (IV and PO) administered for a total of 14 to 28 days in adult subjects with moderate or severe DFI.

NCT ID: NCT05356741 Recruiting - Clinical trials for Locally Advanced or Metastatic HER2-Expressing Cancers

To Access the Safety and Effects of Intravenous Administration of AMX-818 Alone and in Combination With Pembrolizumab in Adult Participants With Locally Advanced or Metastatic HER2-Expressing Cancers

Start date: April 13, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

This first-in-human (FIH) Phase 1 open-label multicenter dose-escalation and dose-expansion study is designed to evaluate the safety, pharmacokinetics, and preliminary activity of AMX-818 as a single agent and in combination with pembrolizumab in participants with HER2+ tumors across multiple tumor types. The study will be conducted in four parts: - Part 1 (dose escalation): Single-agent AMX-818 - Part 2 (dose escalation): AMX-818 plus pembrolizumab - Part 3 (dose expansion): Single-agent AMX-818 - Part 4 (dose expansion): AMX-818 plus pembrolizumab The total length of the study, from screening of the first participant to the end of the study, is expected to be approximately 52 months.

NCT ID: NCT05347095 Recruiting - Clinical trials for Perianal Crohns Disease

A Study of Guselkumab in Participants With Fistulizing, Perianal Crohn's Disease

FUZION CD
Start date: September 27, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this study to evaluate the clinical efficacy of guselkumab in fistulizing, perianal Crohn's disease and to assess the overall safety of guselkumab.

NCT ID: NCT05345171 Recruiting - OTC Deficiency Clinical Trials

Clinical Study of DTX301 AAV- Mediated Gene Transfer for Ornithine Transcarbamylase(OTC) Deficiency

Start date: October 18, 2022
Phase: Phase 3
Study type: Interventional

The primary objective is to evaluate the efficacy of DTX301 on the improvement of ornithine transcarbamylase (OTC) function by maintaining safe plasma ammonia levels with removal of dietary protein restriction and alternative pathway medication.

NCT ID: NCT05330325 Recruiting - Clinical trials for SGA, Turner Syndrome, Noonan Syndrome, ISS

A Research Study to Compare Somapacitan Once a Week With Norditropin® Once a Day in Children Who Need Help to Grow

REAL 8
Start date: August 10, 2022
Phase: Phase 3
Study type: Interventional

The study compares two medicines for treatment of children born small and who stay small, or with Turner Syndrome, Noonan Syndrome, or idiopathic short stature. The purpose of the study is to see how well treatment with somapacitan works compared to treatment with Norditropin®. Somapacitan is a new medicine, and Norditropin® is a medicine doctors can already prescribe in some countries. The study will last for about 3 years. The participants will either get somapacitan once a week for 3 years or Norditropin® once a day for 1 year followed by somapacitan once a week for 2 years. Which treatment the participants get is decided by chance.