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Safety Issues clinical trials

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NCT ID: NCT06114641 Recruiting - Safety Issues Clinical Trials

Effectiveness & Safety of Ovine Enoxaparin Sodium to Originator Enoxaparin in Non-ST-Segment Elevation Acute Coronary Syndrome (NSTEACS) Patients: a Multicenter, Non-randomized, Open-label, Non-inferiority Trial

Start date: June 1, 2023
Phase: Phase 4
Study type: Interventional

The aim of this study is evaluating safety and effectiveness of Ovine Enoxaparin Sodium in Non-ST-Segment Elevation Acute Coronary Syndrome (NSTEACS) Patients

NCT ID: NCT06087913 Recruiting - Safety Issues Clinical Trials

Safety and PK Multi-dose Study of TAF/EVG Vaginal Insert

Start date: November 8, 2023
Phase: Phase 1
Study type: Interventional

MATRIX-001 will examine the safety, PK, modeled PD, and acceptability of inserts containing the combination of TAF and EVG applied vaginally, daily for 3 days, then every other day for 14 days. The inserts are ultimately intended to be the basis of an event-driven, on-demand method for prevention of HIV and HSV sexual infection.

NCT ID: NCT06076512 Recruiting - Chronic Pain Clinical Trials

Pain Clinic Provides Public Health Safety

Start date: February 2, 2018
Phase:
Study type: Observational

Chronic pain is associated with psychological disorders; which may affect a patient's socioeconomic, legal, domestic, and employment situations. This prospective observational study evaluates the impact of pain management on patients' health, social, economic, and employment status. It explores the impact of pain clinic services on patients' mental health, family health, public health, road safety, addiction situation, public safety, injury rehabilitation and employment situation.

NCT ID: NCT05978908 Recruiting - Safety Issues Clinical Trials

Phase1 First in Human Ascending Dose Study to Evaluate the Safety and Tolerability of FC-12738 in Health Adults

Start date: February 20, 2024
Phase: Phase 1
Study type: Interventional

A Phase I, Randomized, Double-Blind, Placebo-Controlled, First-in-human, Single-Ascending-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of retro enversio (RT) thymopentin in Healthy Adult Participants and Patients with Amyotrophic Lateral Sclerosis (ALS)

NCT ID: NCT05967325 Recruiting - Safety Issues Clinical Trials

SVF Combined With Functional Self-assembling Peptide Nanofiber Hydrogels in the Treatment of Spinal Cord Injury

Start date: July 15, 2023
Phase: N/A
Study type: Interventional

Traumatic spinal cord injury (SCI) is a severe medical problem experienced by people worldwide with high mortality and long term morbidity. Although progress has been made in understanding cellular and molecular mechanisms of SCI, treatment and management protocols aimed at ameliorating neurologic damage in patients remain ineffective. Cells and biomaterials offer new hope for the treatment of SCI. Up to now, there have been many studies on the treatment of SCI using cells and biomaterials. Stromal Vascular Fraction (SVF) is a heterogeneous mixture of cells obtained from adipose tissue. These cells include adipose-derived stem cells, endothelial cells, endothelial progenitor cells, pericytes, T cells, and other immune cells. SVF has strong self-renewal, proliferation and differentiation potential, it can replace necrotic cells and synthesize a variety of bioactive factors through paracrine and autocrine, activate cell and vascular regeneration pathways. Therefore, SVF shows significant advantages. The sequence of functional self-assembling peptide nanofiber hydrogels (hereinafter referred to as hydrogels) is HGF(RADA)4RIKVAV (H: histidine; G: Glycine; F: phenylalanine; R: arginine; A: Alanine; D: aspartic acid; I: isoleucine; K: Lysine; V: valerine). The hydrogel is based on the short peptide RADA16 ((RADA)4, which is already available in the product PuramatrixTM for clinical hemostasis and cell culture, but the aqueous solution of PuramatrixTM is acidic which harms cells and tissues upon direct contact. While the hydrogels in this study is pH neutral and does not harm cells and tissues. Articles published by the provider demonstrate that hydrogels can support 3D stem cell growth, have good biocompatibility in vivo (animal spinal cord), and promote neural regeneration after SCI. The chemical structure of the hydrogels is simple and clear, and the degradation product is amino acid. Therefore, SVF and the hydrogel from functional self-assembling peptide are combined for SCI repair in the study.

NCT ID: NCT05916898 Recruiting - Safety Issues Clinical Trials

The Lower Silesia Shockwave Registry

LSSR
Start date: May 1, 2022
Phase:
Study type: Observational [Patient Registry]

Lower Silesia Shockwave Registry (LSSR), is a observational registry collecting all consecutive cases of percutaneous coronary intervention (PCI) performed with the support of shockwave intravascular lithotripsy in two cooperating cardiac centers (Department of Cardiology, The Copper Health Centre, Lubin Poland, and Department of Cardiology, Provincial Specialized Hospital in Legnica, Poland).

NCT ID: NCT05893264 Recruiting - Anesthesia Clinical Trials

Sonographic Predictors of Difficult Epidural Placement.

PREC-EPI
Start date: August 14, 2023
Phase:
Study type: Observational

Epidural placement is a commonly used procedure for pain management during labor, delivery, and surgeries. However, epidural placement is often considered a technically challenging and complex procedure that requires a high level of skill and experience. In cases where the epidural is improperly placed or fails to produce effective analgesia, the discomfort and distress experienced by the patient may be heightened. Hence, the use of predictors, such as sonographic ones, may prove to be a valuable tool for healthcare professionals in the placement of epidurals, ultimately ensuring successful pain management for patients. The present study aims to identify predictors of difficult epidural placement in patients undergoing surgery.

NCT ID: NCT05866978 Recruiting - Mental Health Issue Clinical Trials

An Integrated Approach to Health, Wellbeing, and Productivity at Work

ITASPA
Start date: April 1, 2021
Phase: N/A
Study type: Interventional

The goal of the workplace intervention study 'An Integrated Approach to Health, Wellbeing, and Productivity at Work (ITASPA)' is to examine the effect of the Australian WorkHealth Improvement Network (WIN) program in a Danish context among blue-collar workers. The project is evaluated via its effect on: 1) Musculoskeletal disorders (MSD), 2) Functionality, 3) Psychosocial wellbeing, and 4) Safety culture. Based on identified work health challenges at the included workplace, a group of employees at each worksite will develop and implement their own health promoting activities. Remaining employees will participate in one screening questionnaire prior to the intervention followed by five health checks and interview based questionnaires. All intervention activities and health checks take place at the participants' workplace during paid working hours. In our study design, participants will be compared to themselves and their previous measurements. Furthermore, we will compare the worksites.

NCT ID: NCT05864664 Recruiting - Post Operative Pain Clinical Trials

Safety and Efficacy of Wide Awake Local Anesthesia no Tourniquet Technique (WALANT) in Ankle Removal of Implant Surgery

Start date: April 1, 2022
Phase: N/A
Study type: Interventional

Safety and efficacy of wide awake local anesthesia no torniquet technique (WALANT) in ankle surgery. Studying risks and benefits from WALANT compared to general anesthesia . WALANT expected to decrease in intraoperative/post operative pain at the surgical site and decrease hospital time .

NCT ID: NCT05863936 Recruiting - Safety Issues Clinical Trials

Trial of Belimumab Combined With Multi-target Induction Therapy in Lupus Nephritis

BEAM
Start date: April 1, 2023
Phase: Phase 3
Study type: Interventional

The goal of this single-center, prospective clinical trial is to test the safety and efficacy of belimumab combined with multi-target therapy in the treatment of severe lupus nephritis. The main questions it aims to answer are: lupus nephritis complete remission rate at week 24, and the partial remission rate and safety assessments. Patients with severe lupus nephritis will be enrolled and received pulse methylprednisolone at a dose of 1.5 to 3.0g, followed by intravenous belimumab at a dose of 10mg per kilogram at weeks 2, 4, and 6, and every 4 weeks thereafter. Multitarget therapy will be also administered during the induction phase. Induction therapy will last for 24 weeks. Patients with severe lupus nephritis who only received multi-target therapy during the same period will be enrolled as the control group.