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Pathologic Processes clinical trials

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NCT ID: NCT05979207 Completed - Inflammation Clinical Trials

Phase 1b MMV367 PK/PD and Safety in Healthy Adult Volunteers Experimentally Infected With Blood Stage P. Falciparum

Start date: August 1, 2023
Phase: Phase 1
Study type: Interventional

This is an open-label, adaptive study using the P. falciparum induced blood stage malaria (IBSM) model to characterise the pharmacokinetic/pharmacodynamic (PK/PD) profile and safety of MMV367 (the IMP). Up to 18 participants will be enrolled in cohorts of up to 6 participants each. The study will proceed as follows for all participants: - Screening period of up to 28 days to recruit healthy adult participants. - Day 0: Intravenous inoculation with approximately 2,800 viable P. falciparum-infected red blood cells. - Days 1-3: Daily follow up via phone call or text message. - Days 4-7: Daily site visits for clinical evaluation and blood sampling to monitor malaria parasite numbers via quantitative polymerase chain reaction (qPCR). - Day 7 PM: Start of confinement within the clinical trial unit. - Day 8: Administration of a single oral dose of the IMP (MMV367). Different doses of MMV367 will be administered across and within cohorts in order to effectively characterise the PK/PD relationship. - Days 8-11: Regular clinical evaluation and blood sampling while confined to monitor malaria parasite numbers and measure MMV367 plasma concentration. - Day 11 AM: End of confinement within clinical trial unit. - Days 12-23: Outpatient follow-up for clinical evaluation and blood sampling. - Day 24: Initiation of compulsory definitive antimalarial treatment with Riamet® (artemether/lumefantrine) and/or other registered antimalarials if required. Treatment will be initiated earlier than Day 24 in the event of: - Insufficient parasite clearance following IMP dosing - Parasite regrowth following IMP dosing Characterising the pharmacokinetic/pharmacodynamic relationship of MMV367 - Participant discontinuation/withdrawal, - Investigator's discretion in the interest of participant safety. - Day 27: End of study visit for final clinical evaluation and to ensure complete clearance of malaria parasites.

NCT ID: NCT05887388 Completed - Clinical trials for Pathologic Processes

Adapting Connect-Home Transitional Care for the Unique Needs of Persons With Alzheimer's Disease and Other Dementias and Their Caregivers

Start date: September 10, 2021
Phase: N/A
Study type: Interventional

This primary purpose of this study will be to (1) examine the feasibility and acceptability of transitional care focusing on care needs of skilled nursing facility (SNF) patients with dementia and their caregivers (primary aim). The secondary purpose will be to describe the effect of the intervention on SNF patient outcomes (preparedness for discharge, quality of life, function and acute care use) and caregiver outcomes (preparedness for the caregiving role, caregiver burden and caregiver distress).

NCT ID: NCT05837364 Completed - Clinical trials for Cardiovascular Diseases

Predicting Risk of Atrial Fibrillation and Association With Other Diseases

FIND-AF
Start date: November 2, 2020
Phase:
Study type: Observational

Atrial fibrillation (AF) is a major public health issue: it is increasingly common, incurs substantial healthcare expenditure, and is associated with a range of adverse outcomes. There is rationale for the early diagnosis of AF, before the first complication occurs. Previous AF screening research is limited by low yields of new cases and strokes prevented in the screened populations. For AF screening to be clinically and cost-effective, the efficiency of identification of newly diagnosed AF needs to be improved and the intervention offered may have to extend beyond oral anticoagulation for stroke prophylaxis. Previous prediction models for incident AF have been limited by their data sources and methodologies. An accurate model that utilises existing routinely-collected data is needed to inform clinicians of patient-level risk of AF, inform national screening policy and highlight opportunities to improve patient outcomes from AF screening beyond that of only stroke prevention. The investigators will use routinely-collected hospital-linked primary care data to develop and validate a model for prediction of incident AF within a short prediction horizon, incorporating both a machine learning and traditional regression method. They will also investigate how atrial fibrillation risk is associated with other diseases and death. Using only clinical factors readily accessible in the community, the investigators will provide a method for the identification of individuals in the community who are at risk of AF, thus accelerating research assessing whether atrial fibrillation screening is clinically effective when targeted to high-risk individuals.

NCT ID: NCT05132894 Completed - Clinical trials for Somatic Dysfunction of Both Sacroiliac Joints

An Osteopathic Assessment of Lower Extremity Somatic Dysfunction in Runners

Start date: November 20, 2021
Phase:
Study type: Observational

Runners often experience acute/chronic pain due to pre-existing structural somatic dysfunction and/or acquired various overuse injuries of the lower extremity, specifically affecting the ligaments, tendons, muscles and bones. Common structural and function dysfunctions include but are not limited to patellofemoral pain syndrome (PFPS), Achilles tendonitis, iliotibial band syndrome (ITBS), ligamentous and muscle tears, muscle sprains/strains, stress fractures, pes planus, plantar fasciitis, and shin splints. The purpose of this study is to assess the correlation between acute and chronic pain, overuse injuries, and observational and palpatory findings upon evaluation. With an understanding of the common trends of somatic dysfunctions and etiology of the pain/injury, modified regimen/routine and improved treatment plans can be developed and recommended for runners to better rehabilitate, minimize relapse and reduce compensatory injuries. No medical or osteopathic treatment will be provided.

NCT ID: NCT04837651 Completed - Multiple Sclerosis Clinical Trials

Humoral and T-Cell Responses to COVID-19 Vaccination in Multiple Sclerosis Patients Treated With Ocrelizumab Treated With Ocrelizumab or Natalizumab

OCR-VAX
Start date: March 2, 2021
Phase:
Study type: Observational

The primary goal of this study is to provide additional data regarding B and T-cell mediated responses to COVID-19 vaccines in MS patients treated with OCR and to determine which clinical and paraclinical variables correlating with vaccine immunogenicity. B-cell mediated humoral responses and adaptive T-cell mediated cellular responses were measured in patients treated with OCR who received any of the available SARS-CoV-2 vaccines, 3-4 weeks after completion of vaccination.

NCT ID: NCT04815109 Completed - Clinical trials for Acute Respiratory Distress Syndrome

Prospective Electroencephalography Evaluation of Sedation in COVID-19

Start date: April 1, 2021
Phase:
Study type: Observational

Sedation of severe COVID-19 disease are often complicated. We try to find a correlate for this observation by encephalographic studies.

NCT ID: NCT04475029 Completed - Pain Clinical Trials

Methadone in Cystectomy Patients

METAMORF
Start date: July 6, 2020
Phase: N/A
Study type: Interventional

The role of a single-dose intraoperative methadone on postoperative pain and opioid consumption in patients undergoing Surgeon Accuracy Robot Assistant cystectomy. A prospective double-blind, randomized controlled trial investigating the effect of a single-dose of intraoperative methadone in patients undergoing robotassisted cystectomy.

NCT ID: NCT04234152 Completed - Lung Diseases Clinical Trials

Complete Shielding of Multivitamins to Reduce Toxic Peroxides in the Parenteral Nutrition: A Pilot Study

C-SMART-PN
Start date: November 23, 2020
Phase: N/A
Study type: Interventional

The purpose of this study is to examine if a new and simple method involving complete photo-protection of multivitamins only (since sampling through infusion) will result in a significant reduction of peroxide contamination of parenteral nutrition compared to standard method of parenteral nutrition preparation and infusion in extremely preterm infants.

NCT ID: NCT04210713 Completed - Inflammation Clinical Trials

Neuroimmune Dysfunction in Alcohol Use Disorder

Start date: February 3, 2020
Phase: Phase 1
Study type: Interventional

The objective of this proposal is to advance medication development for alcohol use disorder by examining the efficacy and mechanisms of action of minocycline, a neuroimmune modulator, as a potential treatment. This study has important clinical implications, as the available treatments for alcohol use disorder are only modestly effective and testing novel medications is a high research priority.

NCT ID: NCT04076020 Completed - Atrial Fibrillation Clinical Trials

Atrial Fibrillation Health Literacy and Information Technology Trial in Rural Pennsylvania Counties

AFibLITT_R
Start date: January 8, 2020
Phase: N/A
Study type: Interventional

Atrial fibrillation (AF) is a highly prevalent, morbid condition. Anticoagulation to prevent thromboembolic strokes is a foremost priority in AF but adherence is challenging for patients and lapses in anticoagulation are common. Chronic disease self-management (CDSM) is a recognized program to enhance self-efficacy and improve adherence, quality of life, and patient-centered health outcomes. Rural patients with AF experience increased vulnerability to adverse outcomes due to geographic and social isolation, poor health care access, and limited health literacy. This study uses an innovative, scalable CDSM intervention to improve anticoagulation adherence in rural patients with AF.