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NCT ID: NCT04741399 Not yet recruiting - Trauma Injury Clinical Trials

Experiences and Attitudes Towards Agitated Behaviours in TBI ICU Patients: a Protocol for an Interprofessional Mixed-method Study

EXSTATIC
Start date: February 10, 2021
Phase:
Study type: Observational

EXSTATIC is a multicenter mixed methods convergent study exploring experiences and attitudes of ICU healthcare professionals caring of agitated traumatic brain injury (TBI) patients. The study aims to explore the experiences and attitudes of ICU nurses and other ICU healthcare professionals on the management of agitation in acute TBI patients. This project includes three qualitative methods and one quantitative method. First step consists in structured observations of the daily routine of ICU healthcare professionals when TBI patient admitted in the ICU develops agitation. This step will allow us to raise emerging research questions from the field and to develop subsequent steps. Secondly, we will conduct semi-structured interviews with ICU nurses. Themes emerged in the interviews are essential to understand nurses' experiences and attitudes towards TBI agitated patients and describe their relational role amongst patients, other professionals and families. A retrospective cohort of TBI patients gathered through medical files will follow aiming to document in which way observations in the two first phases are reflected in the clinical notes. Finally, different ICU healthcare professionals will be invited to participate in focus groups to identify further themes in semi-structured interviews in nurses, compare them and prioritize which are the most relevant to nurses experiences and which ones need to be addressed for their future practice. The integration of the different methods will be done using sequential steps of the research (the previous informing the next one) and by the integration of results for each step. Qualitative data will be evaluated following the grounded theory using thematic analysis. Quantitative data will be analysed using descriptive statistics. Qualitative and quantitative results will be combined in a convergent interactive interpretative design. Race and gender perspective will be integrated in collection, analysis and interpretation of data.

NCT ID: NCT04740749 Not yet recruiting - Clinical trials for Malignant Bone Tumor

Longevity, Functional Status and Quality of Life of the Compress® Compliant Pre-Stress System

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

In the treatment of malignant bone tumors, it may be necessary to remove large areas of the femur. To replace these large parts of missing bone, a prosthesis can be used. One innovative technology developed by Biomet is the Compress® Compliant Pre-Stress System (CPS; Zimmer-Biomet, Warsaw, USA). This fixation device uses compression, via a short traction bar, to stimulate osteointegration at the bone-prosthetic interface, promote hypertrophy of the loaded bone, and avoid stress bypass of the host bone around a stiff intramedullary stem. Young patients cured of tumors have a long life expectancy and a compelling need for prosthetic fixation that is equally durable. Good bone fixation is a prerequisite for implant longevity. Although the initial results are encouraging, there is a need for additional mid- to long-term survival data from larger patient series showing longevity of the system, as well as reporting of functional outcome. Furthermore, to the best of our knowledge, no study examining the survival of the device using prospective data already exists. In addition, no studies were found examining the quality of life of the patients with the CPS system.

NCT ID: NCT04739787 Not yet recruiting - Postoperative Pain Clinical Trials

The Effects of Preoperative Physical Activities on Surgeries

Start date: December 2021
Phase:
Study type: Observational

Recommendation is strong on physical activity (PA) in the prehabilitation of Enhanced Recovery After Surgery (ERAS) for various types of surgeries. The evidence is however weak regarding ERAS protocols. Many studies have showed that physical exercise and PA have hypoalgesic effects on healthy individuals and they have better pain tolerance too. Here the investigators study changes in postoperative pain and postoperative nausea and vomiting for various types of surgical patients after performing preoperative PA at moderate or vigorous intensity Vs non-preoperative PA patients.

NCT ID: NCT04738526 Not yet recruiting - Clinical trials for Endodontically Treated Teeth

One Year Clinical Evaluation of Shade Matching and Patient Satisfaction of New Gradient Technology Monolithic Zirconia (5Y-TZP\3Y-TZP) Compared to Lithium Disilicate Crowns in Dental Esthetic Zone

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

Although zirconia is widely used for fabrication of restorations, the 3Y-TZP zirconia where limited for posterior region for its high strength and bad esthetic. While the 5Y-TZP zirconia is limited for the anterior region due to its good esthetic and low strength. For that reason, the introduction of the new gradient technology zirconia (5Y-TZP\3Y-TZP) (IPS e.max Zircad Prime) has offered a solution to solve this problem be combining the esthetic of 5Y-TZP and the high strength of 3Y-TZP. The aim of the present study is to evaluate shade matching to natural tooth and patient satisfaction of the new gradient technology zirconia (5Y-TZP\3Y-TZP) and lithium disilicate ceramic crowns.

NCT ID: NCT04737005 Not yet recruiting - Clinical trials for Clinical Fit and Clinical Performance

Evaluation of Marginal, Internal Adaptation and Clinical Performance of Endo-crowns Fabricated From Nano Hybrid and Lithium Di-silicate Ceramic Materials.

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

Evaluation of the marginal and internal adaptation using silicon replica technique, which will be measured by digital microscope and clinical Performance using modified USPHS scoring system of Endo-crowns fabricated from Nano-ceramic Hybrid and Lithium di-silicate ceramic materials.

NCT ID: NCT04733703 Not yet recruiting - Anesthesia Clinical Trials

Impact of Postanesthesia Care Unit Delirium on Postoperative Quality of Recovery

Start date: October 2021
Phase:
Study type: Observational

Postanesthesia care unit (PACU) delirium is subtype of postoperative delirium that occurs early after anesthesia and surgery during the recovery period. The consequences of PACU delirium have not been investigated thoroughly. So far it is unknown, whether patients with PACU delirium experience impaired postoperative quality of recovery. The aim of this observational study is to assess the impact of PACU delirium on quality of recovery 24 hours after general anesthesia for elective non-cardiac surgery.

NCT ID: NCT04733521 Not yet recruiting - Clinical trials for Advanced Biliary Tract Cancer

A Phase 1/2 Study of SC-43 in Combination With Cisplatin

Start date: May 1, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

SC-43 is STAT3 inhibitor. Based on the phase I data of SC-43 monotherapy, this is a Phase 1/2, Open-label, Study to Investigate the Safety, Tolerability, and Efficacy of SC-43 Administered in Combination with Cisplatin in Subjects with Advanced or Refractory Non-small Cell Lung Cancer or Biliary Tract Carcinoma

NCT ID: NCT04730765 Not yet recruiting - Clinical trials for Diverticular Disease of Left Side of Colon

Quality of Life (QOL) After Elective Sigmoidectomy for Diverticular Diseases (DIVERTI)

DIVERTI-QDV
Start date: September 15, 2021
Phase:
Study type: Observational

Acute diverticulitis of the left colon is among the most common abdominal disorders. To date, both conservative therapy in uncomplicated stages and emergency surgery in perforated disease with peritonitis are consensual. The best treatment strategy for other situations (i.e., smoldering, healed abscesses, recurrences) is still under debate. On the other hand, the best treatment strategy for complicated disease as well as for recurrent stages is still under debate. In these cases, elective surgery can be proposed on a case-by-case basis. Current French guideline recommendations have been updated in 2017. In theory, the objective of elective surgical treatment is to prevent the recurrence and/or complication of the diverticulitis, that might lead to the creation of a stoma. In France, nearly 12,000 prophylactic colectomies for diverticulitis are performed per year. Importantly, elective surgical treatment is associated with the relevant intrinsic morbidity (9.6% major complications within the Sigma Trial), the potential need for unplanned stoma formation of 1%-14% and a significant risk of persisting postoperative complaints. Up to 25% of patients who have undergone a scheduled sigmoid colectomy suffer from ongoing abdominal symptoms. Levack et al found the risk of faecal incontinence to be 24.8% after a sigmoidectomy. Moreover, faecal urgency occurred in 19.6% of patients, and incompleteness of emptying occurred in 20.8%., altering their quality of life (QOL). To out knowledge, few data are available in the literature concerning the evaluation of QOL after elective sigmoid colectomy. Although QOL was significantly improved after surgery compared to conservative medical treatment, these results were questionable due to the heterogeneity of the studies and the lack of direct comparison of the two therapeutic approaches. Only one recent randomized study reported similar results but this one was prematurely stopped due to inclusion difficulties. The evaluation of digestive and genitourinary functional sequelae is based only on short series, most often retrospective. In summary, evidence on disease-specific characteristics influencing postoperative quality of life is lacking. The aim of this prospective multicenter study is : (i) to evaluate the QOL and functional sequelae at 6 and 12 months in patients operated on for elective left colectomy and, (ii) to compare them to a population of non-operating diverticulitis patients.

NCT ID: NCT04730414 Not yet recruiting - Acne Vulgaris Clinical Trials

Full Spectrum Hemp Observational Study

Start date: February 2021
Phase:
Study type: Observational [Patient Registry]

In westernized societies, acne vulgaris is nearly a universal skin disease afflicting 79% to 95% of the adolescent population; older than 25 years - 40% to 54% have facial blemishes and persists into middle age in 12% of women and 3% of men. Standard treatment modalities present with high risk morbidities. Charlotte's Web hemp blemish product is predicted to significantly reduce the risks mentioned above, while improving efficacy as well as imparting other skin benefits.

NCT ID: NCT04730388 Not yet recruiting - Clinical trials for Advanced Hepatocellular Carcinoma

ATEZOLIZUMAB - BEVACIZUMAB in the Treatment Hepatocellular Carcinoma Inoperable or

HEPATOFIT
Start date: January 18, 2021
Phase:
Study type: Observational

Evaluation of the efficacy and safety of the combination ATEZOLIZUMAB - BEVACIZUMAB in the treatment of locally advanced inoperable or metastatic hepatocellular carcinoma in Finistère