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NCT ID: NCT06232707 Not yet recruiting - Multiple Myeloma Clinical Trials

A Study to Evaluate Efficacy and Safety of Alnuctamab Compared to Standard of Care Regimens in Participants With Relapsed or Refractory Multiple Myeloma (RRMM)

ALUMMINATE
Start date: March 29, 2024
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of alnuctamab compared to standard of care regimens in participants with relapsed or refractory multiple myeloma (RRMM).

NCT ID: NCT06226311 Not yet recruiting - Clinical trials for Early Childhood, Neurodevelopment

Environmental Pollutants in Pregnancy - IoMumNEXT

IoMumNEXT
Start date: March 1, 2024
Phase:
Study type: Observational

Globally 12.6 million people, including 1.7 million children under the age of 5, die each year from environmental-related illnesses. Prenatal exposure to environmental chemical pollutants has been associated with perinatal mortality, prematurity, low birth weight, congenital malformations, neurobehavioral function disorder and metabolic disorders. This project aims: a) to evaluate exposure to environmental pollutants during pregnancy; and, b) to study the association of this exposure with anthropometry and neurodevelopment of the offspring, up to 6 years of age. This study will be based on a population of 1000 pregnant women whose recruitment has already started under the IoMum project (clinical trials #NCT04010708), previously approved by Ethics Commitee of Centro Hospitalar e Universitário São João/Faculdade de Medicina da Universidade do Porto (#292-17). Maternal urine samples collected in the 1st and 3rd trimesters of pregnancy will be used. Maternal urinary concentrations of toxic metals and pesticide metabolites will be determined and neurodevelopmental outcomes will be evaluated as well as anthropometric parameters of children from birth to 6 years of age. The results of this project will contribute to the characterization of the exposure of Portuguese pregnant women to environmental pollutants as well as to the knowledge on the association between isolated or cumulative exposure to these pollutants and the health of the offspring.

NCT ID: NCT06203210 Not yet recruiting - Clinical trials for Small Cell Lung Cancer

A Study of Ifinatamab Deruxtecan Versus Treatment of Physician's Choice in Subjects With Relapsed Small Cell Lung Cancer

IDeate-Lung02
Start date: June 10, 2024
Phase: Phase 3
Study type: Interventional

This study was designed to compare the efficacy and safety of I-DXd with treatment of physician's choice in participants with relapsed small cell lung cancer (SCLC).

NCT ID: NCT06200779 Not yet recruiting - Clinical trials for Helicobacter Pylori Infection

Tailored vs. Empirical Helicobacter Pylori Infection Treatment

Start date: February 2024
Phase: Phase 4
Study type: Interventional

Helicobacter pylori (Hp) is a gram-negative bacterium that colonizes human gastric mucosa and is associated with chronic gastritis that can progress to severe complications such as peptic ulcer disease, gastric adenocarcinoma and gastric mucosa-associated lymphoid tissue lymphoma. More than half of the world's population is infected with H. pylori and Portugal is one of the countries with the highest Hp burden. All of infected patients should be treated, however, H. pylori treatment is challenged by the continuously rising antibiotic resistance which has reached alarming levels worldwide. For this reason, it is now well accepted that tailoring treatment of H. pylori infection based on systematic antimicrobial susceptibility testing is useful to avoid the increase of antibiotic resistance. Our aims are to determine prospectively the efficacy and safety of first-line H. pylori eradication treatment based on resistance profile (determined by molecular methods) vs. empirical bismuth quadruple therapy, to evaluate the accuracy of H. pylori detection by polymerase chain reaction (PCR) (vs. histopathological examination) and to estimate the prevalence of H. pylori infection and H. pylori resistance to clarithromycin and levofloxacin in Portugal. This prospective study will be the first national study to investigate the benefits of tailored H. pylori eradication treatment. The investigators expect that this project will be able to demonstrate the non-inferiority of susceptibility-guided treatment comparing with empirical therapy, and our results may change H. pylori treatment recommendations by systematically applying antibiotic susceptibility testing before prescribing eradication therapy.

NCT ID: NCT06187220 Not yet recruiting - Acute Liver Failure Clinical Trials

Plasma Exchange for Amanita Toxin-induced Acute Liver Failure

Amanita-Pex
Start date: January 2024
Phase:
Study type: Observational

Retrospective evaluation of the value of additive therapeutic plasma exchange (PEX) compared to standard medical therapy (SMT) in Amanita toxin-associated acute liver failure in children and adolescents within the last 10 years at a international group of liver transplant centers.

NCT ID: NCT06136013 Not yet recruiting - Clinical trials for Diabetes Mellitus, Type 2

Exercise Timing and the Circadian Clock in Individuals With Type 2 Diabetes and Those at Risk

EX-TIMING
Start date: January 2024
Phase: N/A
Study type: Interventional

Many investigations have been done to determine the exercise that can elicit the greatest benefits on glycemic control and metabolic health, with findings suggesting that incorporation of higher intensity and longer duration of exercise prescribed may eliminate much of the "non-response" observed following exercise training. Even with the incorporation of higher intensity exercise into interventions aimed at improving glycemic control in individuals with type 2 diabetes mellitus (T2DM), the investigators and others continue to have mixed results, with not all individuals with T2DM obtaining benefits in insulin sensitivity and glycemic control to a given exercise training program. Many of the metabolic processes involved in glucose homeostasis, such as insulin production and sensitivity, undergo daily circadian rhythms, controlled by cellular clock machinery located both centrally and peripherally (i.e. skeletal muscle). However, in adults with T2DM, these diurnal rhythms are impaired, with reduced insulin sensitivity in the morning, which is thought to contribute to the fasting hyperglycemia (i.e., "dawn phenomenon") observed in these individuals. Exercise may be a non-photic cue that can amplify or alter these metabolic rhythms. It has been suggested that skeletal muscle metabolic inflexibility in metabolic disorders such as overweight/obesity and T2DM is associated with reduced mitochondrial fatty acid oxidative capacity. It has been demonstrated that exercise can increase mitochondrial oxidative capacity by remodeling mitochondrial morphology and dynamics. It is unknown if potential differences in metabolic flexibility can be found in response to exercise at different times of the day. Most of the experimental evidence originates from animal models with only 3 studies performed in humans with T2DM, which displayed conflicting results. To overcome the shortcomings in the literature, the main objective of this research project is to assess the effects of performing exercise at different times of the day on glycemic control and related outcomes on the inter-individual response variability in glycemic control and related metabolic health parameters in two distinct populations: 1) individuals with T2DM on the most common mono-hyperglycemic drug therapy (i.e., metformin); and 2) age-matched sedentary overweight/obese individuals, where glycemic control is known to deteriorate, hence increasing the risk of developing insulin resistance and T2DM.

NCT ID: NCT06102343 Not yet recruiting - Clinical trials for Acne Scars - Mixed Atrophic and Hypertrophic

Safety and Efficacy Investigation on the Effects of ClearSkin Non-ablative ER:Glass 1540nm Laser Module in the Treatment of Acne Scars.

Start date: January 1, 2024
Phase: N/A
Study type: Interventional

The ClearSkin module, Er: Glass 1540nm, is largely used in the treatment of acne vulgaris and acne scars. The non-ablative ER:Glass 1540 nm laser deeply penetrates the skin, causing thermal damage to the sebaceous glands, destroying P. acnes bacteria and reducing sebum production, while leaving the epidermis intact. The integrated vacuum mechanism extracts accumulated sebaceous material from the pores, while contact cooling protects the skin, reducing pain and allowing for safer and more effective treatment of the sebaceous glands within the dermis. Based on this background, the investigators have considered a pilot study aimed at assessing the efficacy and safety of the ClearSkin Module in treating subjects with facial acne scars.

NCT ID: NCT06094309 Not yet recruiting - Parkinson Disease Clinical Trials

Effectiveness of Botulinum Toxin in Freezing of Gate in Parkinson's Disease Walking in Parkinson's Disease.

Start date: June 1, 2024
Phase: N/A
Study type: Interventional

Freezing of gait is a symptom of Parkinson's disease (PD) that becomes more evident with the evolution of the disease, and which presents an important difference compared to the other signs and symptoms: does not respond adequately to dopaminergic therapy, which calls into question its pathophysiology. In this sense, and through empirical experience, it has been noted that freezing responds to cueing techniques (visual, sensory motor, auditory tricks, among others) which suggests a similarity with dystonic pathology. This similarity could be the basis of a common response to botulinum toxin (BT). Objectives: This study aims to understand whether BT is an effective therapy for freezing gait in patients with Parkinson's disease. Methodology: This is a prospective parallel study with therapeutic intervention, controlled by placebo, double blind. The randomization of groups will be stratified. The population will be recruited from from the CHLC movement disorders consultation, and that meets the following inclusion criteria: Parkinson's disease with freezing of gait, scoring > 1 at point 2.13 on the scale MDS-UPDRS and be responsive to cueing techniques, with severity of Parkinson's disease rated 3 or 4 on the Hoehn & Yahr scale. The BT injection will be performed by a doctor with experience in this therapy, with 100 Units (U) of type A BT, bilaterally, in the flexor muscle of the thigh, once, with replacement of the same ampoules with saline in controls. To the Patient assessments will take place over 4 months, weekly by telephone using a questionnaires on freezing and the notion of clinical improvement (FOGQ and SCGIC, respectively) and monthly in person with objective assessments using the MDS-UPDRS scales - part III motor assessment, Timed Up & Go and Two Minute Walk.

NCT ID: NCT06077890 Not yet recruiting - Clinical trials for Arthritis, Rheumatoid

Effectiveness of Digital Rehabilitation (SIMPLI.REHAB) in the Hand Arthritis

Start date: July 2024
Phase: N/A
Study type: Interventional

This study investigates the effectiveness of SIMPLI.REHAB, a digital tool employed as an interface for administering occupational rehabilitation programs to patients diagnosed with Rheumatoid and Psoriatic Arthritis. Both of these conditions are inflammatory joint disorders capable of causing significant morphofunctional alterations in the hands, especially in their advanced stages. The introduction of digital technology emerges as a complementary tool when implementing rehabilitation programs. Utilizing a prospective, longitudinal, single-blinded experimental study, 35 patients will be allocated into two groups: one receiving a complementary digital intervention through SIMPLI.REHAB and the other through a conventional rehabilitation program. Each group consists of six patients and the program spans seven weeks, focusing on therapeutic exercises, training in manual dexterity, and motor coordination, among other interventions, led by a Physiatrist. The study intends to measure outcomes based on functionality scores, pain, disease activity, joint range, grip, pinch strength, and manual dexterity, both before and after each intervention, in order to ascertain the efficacy of integrating dynamic content through the digital tool SIMPLI.REHAB, as a supplementary resource in occupational rehabilitation programs. The potential limitations of the study include potential losses of follow-up and difficulties in assessing adherence to the digital tool precisely. Nonetheless, the digital tool aims to augment functional gains in rehabilitation programs by providing patients with accessible dynamic content of home-based strategies.

NCT ID: NCT06052501 Not yet recruiting - Prosthesis User Clinical Trials

3D Evaluation of the Lip Support in a Full-arch Implant-supported Rehabilitations

Start date: March 30, 2024
Phase:
Study type: Observational [Patient Registry]

The goal of this observational study is to evaluate the impact of a full arch implant-supported prostheses in the lip support. In a complex rehabilitation cases, the process between the diagnosis and the delivery of a prostheses may lead with many clinical and laboratorial choices which influence the final design of the prosthetic work and consequently the facial profile of the patient. The use of 3D facial scanners and advanced superimposition methodology allows the investigators to objectively measure several relevant parameters such as vertical occlusion of dimension and lip support.