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NCT ID: NCT05873959 Active, not recruiting - Trauma Clinical Trials

An Observational Study to Evaluate the Safety and Efficacy of Humacyte's HAV for Arterial Replacement or Reconstruction in Ukrainian Patients With Life or Limb-threatening Vascular Trauma

Start date: May 31, 2023
Phase:
Study type: Observational

Humacyte provided HAVs as humanitarian aid to Ukraine. This retrospective observational study is designed to collect data from patients in whom the HAVs have already been implanted on a humanitarian basis between June 2022 and May 2023.

NCT ID: NCT05855629 Active, not recruiting - Acne Vulgaris Clinical Trials

"A Comparative Clinical Evaluation of the Efficacy of Topical Adapalene, Benzoyl Peroxide Gel, Oral Lactobacillus Rhamnosus, D-chiro-inositol, Inulin Capsule, and Their Fixed Combination in Mild to Moderate Acne Vulgaris Patients."

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

The study aims to conduct a comparative clinical evaluation of the effectiveness of a fixed topical combination of adapalene with benzoyl peroxide in the form of a gel, a fixed combination of Lactobacillus rhamnosus, D-chiro-inositol and inulin in the form of capsules and their combination in patients with acne vulgaris of mild and moderate severity and laboratory lipid analysis profile of sebum, lipid metabolism, and IGF-1 (insulin-like growth factor).

NCT ID: NCT05646212 Active, not recruiting - Depression Clinical Trials

Integrating Treatment for Mental Disorders in Methadone Clinics in Ukraine

MEDIUM
Start date: July 1, 2018
Phase: N/A
Study type: Interventional

The MEDIUM study (U01DA045384) is a cluster-randomized trial based in Ukraine. The main goal of the study is to test the implementation strategies for mental health treatment services in OAT clinics. The study enrolled 12 OAT clinics from 12 geographically and epidemiologically diverse regions and randomized them 1:1:1 to three implementation arms: standard of care (SoC), ECHO facilitation, and ECHO plus pay-for-performance (P4P) incentives. Project ECHO, is an evidence-based telehealth intervention, connecting clinicians with national experts for short thematic didactic sessions and case discussions. All sites are provided with a modified Screening, Brief Intervention and Referral to Treatment (mSBIRT) intervention manual for mental disorders and regular supply of two selective serotonin reuptake inhibitors (SSRI) medications. All current and new patients at participating sites (N~2000 at study start) are automatically eligible for SSRI prescription. The main outcomes of the study are the elements of mental health continuum of care (screening, diagnosis, treatment and retention). These outcomes are assessed in the entire patient population using de-personalized data extracted from the electronic medical record system. A sub-sample of patients (N=1,350) was recruited into a cohort and consented to assess prevalence and severity of mental disorders, various factors related to the uptake of and retention in mental health treatment (addiction severity, other substance use, co-morbidities), as well as other important covariates. These assessments are done at baseline, 6, 12, 18 and 24 months after enrollment.

NCT ID: NCT05514652 Active, not recruiting - Clinical trials for Coronary Artery Disease

Anesthesia Standard Operating Procedure During On-pump Coronary Artery Bypass Grafting

Start date: December 1, 2018
Phase: N/A
Study type: Interventional

Background: Despite improvements in surgical and anesthesia procedures over the past 15 years complications during cardiac surgery still remain high. Bridgewater B et al. describes mortality during on-pump coronary artery bypass grafting (CABG) at 2%-3%, and the rate postoperative complications about 20%-30%. At the same time, the standard of care in patients undergoingon-pump CABG is not fully established. Hypothesis, Research Need: Use of multimodal low-dose opioid anesthesia during CABG decreases inflammatory response and the incidence of early postoperative cardiac complications due to a reduction in interleukin-6. Methodology: According to anesthesia standard protocol, all patients were divided into two groups - study group with multimodal low-dose opioid anesthesia (60 patients) and control group with a high-dose opioid anesthesia (60 patients). Primary (IL-6 at the end of the operation) and secondary clinical outcomes (postoperative atrial fibrillation (POAF), low cardiac output syndrome (LCOS), duration of mechanical ventilation (MV), length of intensive care unit (ICU) stay, length of hospital stay) were compared between the groups. Analysis Tools: Clinical observations; instrumental research methods (electrocapdiography, echocardiography); labs (blood gases, hemoglobin, electrolytes); enzyme-linked immunosorbent assay (IL-6); statistical (Student's t-test, Mann-Whitney U test, χ2-test, correlation analysis). Expected Outcomes: Use of multimodal low-dose opioid anesthesia during CABG will decrease inflammatory response (lower levels of IL-6 at the end of the surgery) and the incidence of early postoperative cardiac complications, expressed as lower incidence of LCOS and POAF, lower duration of MV and lower length of ICU stay.

NCT ID: NCT05513950 Active, not recruiting - Clinical trials for Idiopathic Pulmonary Fibrosis

A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Monoclonal Antibody (mAb) in Patients With IPF

Start date: January 25, 2023
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess the safety of CHF10067 (the study drug) and any side effects that might be associated with it. In addition, the study will evaluate how much of the study drug gets into the bloodstream and how long the body takes to remove it. The body's immune response to the study drug will also be evaluated. The study may also evaluate the effect of the study drug on the level of a certain protein in the body. Chiesi is conducting this study on patients affected by idiopathic pulmonary fibrosis (IPF, a lung disease). Chiesi is doing this study to establish the doses suitable for future studies.

NCT ID: NCT05478629 Active, not recruiting - Clinical trials for Regional Anesthesia Morbidity

Safety of Regional Anesthesia in Ukraine: the Survey

Start date: October 25, 2021
Phase:
Study type: Observational

The common using of ultrasound navigation makes an opportunity to develop the regional anesthesia. Regional anesthesia reduces the length of stay in the hospital, reduces the intensity of perioperative pain and decrease opioid using. But systemic toxicity of local anesthetics (LAST) is a significant problem. Prevalence of LAST in Europe range from 0.04 to 1.8 cases per 100 thousand local anesthesia. No similar studies have been provided in Ukraine before, and there are no statistics on the LAST epidemiology. Goal of this survey - evaluation of the prevalence of LAST, the safety of regional anesthesia in Ukraine.

NCT ID: NCT05269004 Active, not recruiting - Multiple Sclerosis Clinical Trials

A Rollover Study to Evaluate the Long-Term Safety and Efficacy of Ocrelizumab In Patients With Multiple Sclerosis

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

This is a Phase IIIb, single-arm, multicenter, OLE study. Participants receiving ocrelizumab as an investigational medicinal product (IMP) in a Roche sponsored Parent study who continue to receive ocrelizumab or are in safety follow-up at the time of the closure of their respective Parent study (WA21092, WA21093 or WA25046) are eligible for enrollment in this extension study. Participants who will continue ocrelizumab treatment will receive IMP based on the dosage and administration received at the time of rollover from the Parent study.

NCT ID: NCT05238974 Active, not recruiting - Clinical trials for Respiratory Syncytial Virus Infections

A Study to Evaluate the Safety and Efficacy of MEDI8897 for the Prevention of Medically Attended RSV LRTI in Healthy Late Preterm and Term Infants

MELODY
Start date: July 23, 2019
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics (PK), and antidrug antibody (ADA) response for MEDI8897 in healthy late preterm and term infants who are 35 weeks or greater gestational age and entering their first RSV season.

NCT ID: NCT05171855 Active, not recruiting - Clinical trials for Endocrine System Diseases

A Trial to Investigate Long Term Efficacy and Safety of Lonapegsomatropin in Adults With Growth Hormone Deficiency

Start date: December 16, 2021
Phase: Phase 3
Study type: Interventional

This is a phase 3 open-label multicenter extension study designed to evaluate the long-term safety and efficacy of Lonapegsomatropin administered once-weekly. The study participants are adults (males and females) with confirmed growth hormone deficiency (GHD) having completed the treatment period in study TCH-306 (foresiGHt).

NCT ID: NCT05117788 Active, not recruiting - Clinical trials for Tuberculosis, Multidrug-Resistant

Bioneer IRONqPCR ™ RFIA Kit Kit Clinical Evaluation

Start date: February 23, 2022
Phase:
Study type: Observational

Evidence of the clinical diagnostic accuracy and operational characteristics of the Bioneer IRONqPCR ™ RFIA Kit is needed to comprehensively evaluate Bioneer RFIA validity and inform global and national policy decision-making. The rapid diagnosis and appropriate treatment of M/XDR-TB is essential to prevent significant morbidity, mortality and further transmission of disease. The FQ are key components of the new bedaquiline-containing 6-9 month regimen, and so it is necessary to rule-out resistance to these compounds prior to treating patients with the shorter regimen. Currently there are no WHO endorsed tests that can identify resistance to both first and second-line drugs in one reaction.