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NCT ID: NCT05236504 Recruiting - Sleep Disturbance Clinical Trials

Effects of a Novel Supplement on Sleep, Metabolism, Body Composition and Performance

4BETTSLEEP
Start date: November 28, 2021
Phase: N/A
Study type: Interventional

This study aimed to investigate the effects of a novel dietary supplement, consisting of melatonin and magnesium in a pod (coffee machine capsule) format, on sleep quality, stress, mood, sleepiness, biological rhythms, metabolism, body composition and performance, in individuals with sleep disturbances according with the Pittsburgh Sleep Quality Index. A randomized, double-blind, crossover trial will be conducted to compare the effects of the melatonin and magnesium-containing supplement against a placebo. The protocol comprises 4 weeks of supplementation with an experimental or placebo condition, with a week-long washout period. Biochemical markers of sleep and stress, actigraphy for sleep patterns and sleep hygiene, resting metabolic rate, food and fluid intake, body composition, and handgrip strength measures will be evaluated at baseline and 4 weeks post each randomly assigned intervention. The working hypothesis is that this innovative supplement will provide greater objective and subjective improvements regarding sleep patterns and quality, overall mood, biochemical markers of stress, resting metabolic rate, energy intake, body composition and strength, than the placebo comparator, due to the synergic effects of melatonin and magnesium.

NCT ID: NCT05227287 Recruiting - Clinical trials for Autosomal Dominant Hypocalcemia

ADH1 and ADH2 Disease Monitoring Study (DMS)

CLARIFY
Start date: January 20, 2022
Phase:
Study type: Observational

A global, multi-center, Disease Monitoring Study (DMS) in participants with Autosomal Dominant Hypocalcemia Type 1 (ADH1) or Autosomal Dominant Hypocalcemia Type 2 (ADH2) designed to characterize ADH1 and ADH2 disease presentation and progression through retrospective (past) and longitudinal prospective (over time into the future) data collection.

NCT ID: NCT05223413 Recruiting - Lymphoma Clinical Trials

REmote iSchemic condItioning in Lymphoma PatIents REceiving ANthraCyclinEs

RESILIENCE
Start date: January 18, 2022
Phase: N/A
Study type: Interventional

Multinational, prospective, proof of concept phase II, double-blinded, sham-controlled, randomized clinical trial (RCT) to evaluate the efficacy and safety of Remote Ischaemic PreConditioning (RIPC) in Lymphoma patients receiving anthracyclines.

NCT ID: NCT05221840 Recruiting - Clinical trials for Non-Small Cell Lung Cancer

A Global Study to Assess the Effects of Durvalumab With Oleclumab or Durvalumab With Monalizumab Following Concurrent Chemoradiation in Patients With Stage III Unresectable Non-Small Cell Lung Cancer

PACIFIC-9
Start date: February 7, 2022
Phase: Phase 3
Study type: Interventional

This is a Phase III, randomised, double-blind, multicentre, international study assessing the efficacy and safety of durvalumab (MEDI4736) in combination with oleclumab (MEDI9447) or durvalumab (MEDI4736) with monalizumab (IPH2201) in adults with locally advanced (Stage III), unresectable NSCLC, who have not progressed following platinum-based cCRT.

NCT ID: NCT05219617 Recruiting - Seizures Clinical Trials

Investigate Efficacy and Safety of Carisbamate as Adjunctive Treatment for Seizures Associated With LGS in Children and Adults

Start date: April 28, 2022
Phase: Phase 3
Study type: Interventional

The primary objective is to evaluate the efficacy of carisbamate (YKP509) as adjunctive treatment in reducing the number of drop seizures (tonic, atonic, and tonic-clonic) compared with placebo in pediatric and adult subjects (age 4-55 years) diagnosed with Lennox Gastaut Syndrome (LGS).

NCT ID: NCT05215340 Recruiting - Clinical trials for Metastatic Non Small Cell Lung Cancer

Study of Dato-DXd Plus Pembrolizumab vs Pembrolizumab Alone in the First-line Treatment of Subjects With Advanced or Metastatic NSCLC Without Actionable Genomic Alterations

TROPION-Lung08
Start date: March 4, 2022
Phase: Phase 3
Study type: Interventional

This study is designed to assess the efficacy and safety of datopotamab deruxtecan (Dato-DXd) in combination with pembrolizumab versus pembrolizumab alone in participants with advanced or metastatic non-small cell lung cancer (NSCLC).

NCT ID: NCT05210790 Recruiting - Polycythemia Vera Clinical Trials

A Phase 3 Study of Rusfertide in Patients With Polycythemia Vera

VERIFY
Start date: April 1, 2022
Phase: Phase 3
Study type: Interventional

The study is designed to evaluate the safety and efficacy of rusfertide in subjects with polycythemia vera (PV) in maintaining hematocrit control and in improving symptoms of PV.

NCT ID: NCT05207709 Recruiting - Clinical trials for Metastatic Breast Cancer

Ribociclib vs. Palbociclib in Patients With Advanced Breast Cancer Within the HER2-Enriched Intrinsic Subtype

HARMONIA
Start date: March 28, 2022
Phase: Phase 3
Study type: Interventional

HARMONIA is an international, multicenter, randomized, open-label and phase III study. The primary objective of this study is to demonstrate that the combination of ribociclib with endocrine therapy (letrozole or fulvestrant) is superior to palbociclib with endocrine therapy (letrozole or fulvestrant) in prolonging progression-free survival in patients with advanced HR+/HER2- and HER2-E breast cancer. The study will enroll approximately 456 patients with HER2-E disease from approximately 95 sites worldwide. In addition, the HARMONIA trial will include an exploratory cohort of patients with HR+/HER2- and Basal-like disease treated with paclitaxel +/- Tislelizumab. This cohort does not have a predefined sample size and the objective is only exploratory, given the suggested lack of efficacy of the combinations of hormone therapy and CDK4/6 inhibitors in this subgroup of patients. Enrolment into the basal-like cohort will stop once the HER2-E disease cohort is fully enrolled.

NCT ID: NCT05203172 Recruiting - Solid Tumors Clinical Trials

The FLOTILLA Study: Providing Continued Access to The Study Medicines Encorafenib and Binimetinib for Participants in Prior Clinical Trials

Start date: July 5, 2022
Phase: Phase 4
Study type: Interventional

The purpose of this clinical trial (called the FLOTILLA study) is to give continued access to the study medicines, as well as safety follow-up, for participants in prior clinical trials of encorafenib and/or binimetinib. All participants who took part in earlier encorafenib and/or binimetinib studies may participate the FLOTILLA study if they are still benefiting from the use of the study medicines. This will be determined by the study doctor. People may not participate in the FLOTILLA study if they have not enrolled in a prior study of encorafenib or binimetinib. Participants that had enrolled but had stopped receiving the study treatment in a prior study cannot enrolled in this study. Participants in the FLOTILLA study will receive encorafenib and/or binimetinib at the same dose and frequency as in their prior study, for up to about 5 years.

NCT ID: NCT05200715 Recruiting - Uveitis Clinical Trials

AutoInflammatory Disease Alliance Registry (AIDA)

AIDA
Start date: August 6, 2020
Phase:
Study type: Observational [Patient Registry]

Autoinflammatory diseases (AID) are clinical entities characterized by recurrent inflammatory attacks in absence of infection, neoplasm or deregulation of the adaptive immune system. Among them, hereditary periodic syndromes, also known as monogenic AID, represent the prototype of this disease group, caused by mutations in genes involved in the regulation of innate immunity, inflammation and cell death. Based on recent experimental acquisitions in the field of monogenic AID, several immunologic disorders have been reclassified as polygenic/multifactorial AID, sharing pathogenetic and clinical features with hereditary periodic fevers. This has paved the way to new treatment targets for patients suffering from rare diseases of unknown origin, including Behçet's disease, Still disease, Schnitzler's disease, PFAPA (periodic fever, aphthous stomatitis, pharyngitis and cervical adenitis) syndrome, chronic recurrent multifocal osteomyelitis (CRMO), non-infectious uveitis and scleritis. Gathering information on such rare conditions is made difficult by the small number of patients, along with the difficulty of obtaining an accurate diagnosis in non-specialized clinical settings. In this context, the AIDA project promotes international collaboration among clinical centres to develop a permanent registry aimed at collecting demographic, genetic, clinical and therapeutic data of patients affected by monogenic and polygenic AID, in order to expand the current knowledge of these rare conditions.