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NCT ID: NCT04773379 Completed - Clinical trials for Chemotherapy-induced Peripheral Neuropathy

Validation of the PNQ for CIPN Patients.

Start date: April 1, 2019
Phase:
Study type: Observational

The Patient Neurotoxicity Questionnaire (PNQ) represents a diagnostic tool concerning patients with Chemotherapy Induced Peripheral Neuropathy (CIPN). Application of such a tool in the Greek clinical praxis requires validation. Validation consists of three stages: translation, reverse translation, and patient application. 100 oncologic patients were assessed by comparing the PNQ to the NCI-CTCAE at the chemotherapy onset and 2nd, 4th, and 6th sessions. Specific requirements of the diagnostic tool (compliance, validity, concordance, sensitivity, specificity, reliability) were statistically evaluated. Differences between translated texts and between the reverse translation and the original were considered negligible. At the 2nd, 4th and 6th session compliance was 98%, 95% and 93% while Cronbach's α was 0,57 0,69 and 0,81 respectively. Cohen's weighted κ was 0,67 and 0,58, Spearman's ρ was 0,7 and 0,98 while AUC of the ROC was 1 and 0,9 for the sensory and the motor part respectively. The variance's linear regression analysis confirmed CIPN worsening over time (p-value<0,0001). The Greek version remains close to the original. Compliance rates reflect easy PNQ application. Cohen's κ values highlight the physicians' tension to underestimate the patients' condition. Spearman's ρ, Cronbach's α and AUC values reflect good validity, reliability and specificity of the PNQ respectively. Finally, the linear analysis confirmed the PNQ sensitivity over time. The PNQ validation in Greek adds a crucial tool in the physicians' armory. It can now draw the necessary information to modify the chemotherapy and analgesic treatment schemes at both preventive and acute levels.

NCT ID: NCT04777487 Completed - Clinical trials for Periodontal Diseases

Evaluation of Biomarker Levels in Gingival Crevicular Fluid of Patients With Different Periodontal Diseases

Start date: April 1, 2019
Phase: N/A
Study type: Interventional

Objectives: The aim of this study is; detection of peptidyl arginine deiminase4 (PAD4), galectin-3 and tumor necrosis factor alpha (TNF-α) levels in gingival crevicular fluid (GCF) samples of periodontally healthy, gingivitis and periodontitis patients and the possible correlation between these values and clinical parameters of periodontal diseases. Materials and methods: Samples of GCF were obtained from 60systemically healthy non-smoker individuals with periodontitis (P, n=20), gingivitis(G, n=20) and healthy periodontium (S, n=20). Full-mouth clinical periodontal measurements including probing depth (PD), clinical attachment level (CAL), bleeding on probing (BOP), gingival index (GI) and plaque index (PI) were also recorded. Enzyme-linked immunosorbent assay (ELISA) was used to determine PAD4, galectin-3 and TNF-α levels in the biological samples.

NCT ID: NCT04803240 Completed - Dry Eye Clinical Trials

Survey: Evaluation of Ocular Surface Disease Symptoms and Patient Satisfaction With Thealoz® Duo After 84 Days of Daily Treatment

Start date: April 1, 2019
Phase:
Study type: Observational

Multi-centre, international, non-interventional, prospective survey

NCT ID: NCT04803344 Completed - Clinical trials for Health Care Utilization

The Effectiveness of Expressive Writing on a Sample of New Mothers

Start date: April 1, 2019
Phase: N/A
Study type: Interventional

This pilot study aims to evaluate the effects of an expressive writing intervention on a sample of new mothers after the childbirth on the psychological health and on the healthcare costs. The mothers were evaluated also in a follow-up one month after the end of the expressive writing intervention.

NCT ID: NCT04805138 Completed - Clinical trials for Peri-implant Mucositis

Influence of Soft Tissue Thickness Upon Dental Implant Esthetics

Start date: April 1, 2019
Phase:
Study type: Observational

Since the beginning of the implant dentistry, a large variety of materials have been used for restoring single or multiple implants, such as gold, titanium, alumina (Al2O3), and zirconia (ZrO2). Patient physical and esthetic requirements play one of the most important role in making decisions related to which material should be chosen. In fact, long-term stability, compatibility with oral tissues esthetics and costs should be considered. Several studies demonstrated that both titanium and zirconia have an excellent biocompatibility and long-term stability even though something could change in terms of esthetic outcomes. Related to esthetics, the color of the peri-implant mucosa is an essential factor that clinicians have to take in to account. Unfortunately, discoloration of peri-implant mucosa sometimes happens. Some authors hypothesized that titanium abutments could provoke a grayish appearance of the mucosa, and, in order to avoid this problem, other authors suggested to perform augmentation of the peri-implant soft tissue thickness in the esthetic area. A study on pig maxillae found that the type of abutment or crown material and the mucosa thickness have significant influences on color changes of the mucosa. Titanium induced the most prominent color change, and, in patients with thinner mucosa, zirconia induced the least noticeable color changes. Nowadays, to reliably evaluate differences in color in implantology, the most used method is spectrophotometry, due to the capacity of detecting even small color differences and due to the higher reproducibility. Several investigations on pig jaws using spectrophotometric measurements were carried out recently, with the aim of investigating the color changes. It was found that generally titanium abutment lead to a more pronounced discoloration; however, gingival thickness greater than 2 mm did not reveal any difference related to the type of abutments. In addition, an increase in mucosal thickness might minimize the discoloration. The only study on human patients revealed that the color of the peri-implant mucosa presents more dark, green and blue components compared to the natural gingiva. Soft tissue thickness appeared a crucial factor with respect to the spectrophotometrically measured degree of peri-implant mucosal discoloration, with a trend for less pronounced discolorations in patients with thick mucosa. Furthermore, the authors found that peri-implant mucosa was on average 0,5-0,7 mm thicker than natural gingiva. However, this study evaluated the thickness of the gingiva by means of CBCT, which could lead to some errors due to the superimposition of the lips and cheeks, as well as the tongue that occupies the most space of the oral cavity. Moreover, esthetics were evaluated by clinicians visually at a specific distance asking them if discoloration was visible or not visible. Furthermore, no questionnaire was given to patients to evaluate esthetics neither discomfort while brushing. Therefore, The objective of this cross-sectional study is to evaluate the influence of gingival thickness (GT) upon mucosal color (MC) around dental implants measured spectrophotometrically. A secondary goal is to evaluate the correlation between mucosal color changes and type of abutment material around dental implants.

NCT ID: NCT04807855 Completed - Blepharoptosis Clinical Trials

Custom Print Megnetic Levator Prosthesis Pilot Comparison

Start date: April 1, 2019
Phase: Early Phase 1
Study type: Interventional

Study the device feasibility of non-surgical treatment for blepharoptosis (inability to open the eyelid) consisting of a biocompatible magnetic element adhered to the upper eyelid and a second magnet above the eye on a custom 3D-printed eyeglasses frame with a dial to provide adjustable magnetic force to open the eye while still allowing eye closure.

NCT ID: NCT04814966 Completed - Clinical trials for Postoperative Complications

Feasibility of Extended Non-invasive Haemodynamic Monitoring in the PACU

Start date: April 1, 2019
Phase:
Study type: Observational

Post-operative monitoring of all patients after anaesthesia in the post anaesthesia care unit (PACU) is standard of care today. It helps to reduce morbidity and even mortality in high-risk patients. In addition to clinical monitoring by qualified personnel, this monitoring also includes, commonly non-invasive, intermittent, haemodynamic monitoring. This monitoring is also used to evaluate the transferability of patients from the PACU to the ward. The aim of our study is to perform extended monitoring of volume status and haemodynamics with non-invasive monitoring methods such as transthoracic echocardiography and the volume clamp method in the recovery room.

NCT ID: NCT04821492 Completed - Clinical trials for Postmenopausal Women

Relationship Between Homocysteine and BMD

Start date: April 1, 2019
Phase:
Study type: Observational

The association between Homocysteine (Hcy) levels and bone mineral density (BMD) has been debated. Some studies have found a relationship between increased Hcy plasma levels and BMD in contrast; other studies have not found a relationship. The purpose of our study was to investigate whether or not Hcy plasma levels are related to BMD in a group of postmenopausal women.

NCT ID: NCT04822051 Completed - Schizophrenia Clinical Trials

The Effect of Psychoeducation Based on Uncertainty In Illness Theory On Schizophrenia Caregivers

Start date: April 1, 2019
Phase: N/A
Study type: Interventional

The purpose of this study is to determine the effect of the psychoeducation program based on the Uncertainty in Illness Theory on intolerance to uncertainty, psychological well-being and coping styles of caregivers of schizophrenia patients. Sample was 54 (experimental group:27; control group: 27) caregivers. Experimental group received psychoeducation program (5 sessions) based on Mishel's Reconceptualized Uncertainty in Illness Theory while control group did not receive any intervention. Data were collected 2 times: pre test, post test.

NCT ID: NCT04850534 Completed - Liver Cirrhosis Clinical Trials

Systemic Inflammation in Liver Cirrhosis

SILC
Start date: April 1, 2019
Phase:
Study type: Observational

Investigate systemic inflammation in liver cirrhosis patients