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NCT ID: NCT06024785 Not yet recruiting - Spinal Stenosis Clinical Trials

Vertebropexy - Randomized-controlled Trial

VPRCT
Start date: September 2024
Phase: N/A
Study type: Interventional

To assess the need for additional fusion surgery versus the risk of a revision surgery in patients with degenerative lumbar spinal disease and to assess efficacy and risk of the ligamentous fixation technique (vertebropexy)

NCT ID: NCT06023979 Not yet recruiting - Clinical trials for Post Operative Treatment After Unstable Malleolar Fractures

Early Protected Full Weight-bearing vs. Partial Weight-bearing After Surgical Fixation of Unstable Ankle Fractures, Monitored With Bio-feedback Insoles.

Start date: September 1, 2023
Phase: N/A
Study type: Interventional

The purpose of this study is to compare the postoperative results after ORIF (Open Reduction Inner Fixation) with a partial weight-bearing protocol versus an early full weight-bearing protocol. But in addition, we will measure every patient's actual load by the means of walker integrated bio-feedback insoles for the first six postoperative weeks to record the adherence to the protocol.

NCT ID: NCT06012266 Not yet recruiting - Heart Failure Clinical Trials

Repurposing Empagliflozin and Dapagliflozin for Paediatric Heart Failure: Translational Approach and Dose Rationale

Start date: August 2024
Phase: Phase 2
Study type: Interventional

This study aims at exploring the use of Dapagliflozin and Empagliflozin in children and adolescents 6-18 years old with heart failure. These molecules are effective in reducing hospitalisations and mortality in adults with heart failure and are used in adolescents with type 2 diabetes mellitus, but little is known on children with heart failure. Particularly, the best dose to use in this population is currently unknown. This trial aims to: 1. define a dose rationale for this indication and age group (pharmacokinetic study), 2. assess and monitor safety, 3. assess ease-of-swallow, 4. explore middle-term (4-6 weeks) efficacy and efficacy markers. Participants will be asked to attend 4 study visits over 4-6 weeks, and one end-study visit 2-12 weeks thereafter. Visits 1 and 3 will entail an 8h day-hospital stay, while Visits 2, 4 and the end-study visit will be outpatient clinics (approximately 2h). Participants will be asked to take the studied drug once daily during the 4-6 weeks of the study period. All participants will take both Dapagliflozin and Empagliflozin: 6 will start with Dapagliflozin first (Visits 1-2) and then switch to Empagliflozin (Visits 3-4), while 6 will start with Empagliflozin first (Visits 1-2) and then switch to Dapagliflozin (Visits 3-4). No comparison group is foreseen for this study.

NCT ID: NCT05993845 Not yet recruiting - Hip Prosthesis Clinical Trials

Modeling and Workflow Recognition for the Anterior Approach in Total Hip Arthroplasty

Start date: December 11, 2023
Phase:
Study type: Observational

The purpose of this study is to create a systematic and general description of the surgical process for the direct anterior approach (DAA) in total hip arthroplasty (THA). For this purpose a surgical process model with a labeled dataset of THA surgery videos will be segmented into the individual surgical steps and sub-steps using a systematic approach.

NCT ID: NCT05979311 Not yet recruiting - HIV Infections Clinical Trials

A Study to Evaluate the Efficacy, Safety, and Tolerability of Using an Oral Once-daily 2 Drug Regimen Compared to an Oral Once-daily 3 Drug Regimen for the Treatment of Human Immunodeficiency Virus (HIV)-1 in Adults Who Have Not Previously Taken Antiretroviral Therapy

VOGUE
Start date: December 29, 2023
Phase: Phase 3
Study type: Interventional

This study will compare safety, efficacy, participant reported outcomes and implementation outcomes of a fixed dose combination (FDC) of a two-drug regimen dolutegravir (DTG) plus lamivudine (3TC) and a three-drug regimen FDC of bictegravir (BIC), emtricitabine (FTC) and tenofovir alafenamide (TAF) in HIV-1 infected adult participants who have not previously received antiretroviral therapy.

NCT ID: NCT05945654 Not yet recruiting - Swallowing Disorder Clinical Trials

Functional Outcome After Anastomotic Leak After Oesophagectomies

FOAL
Start date: September 1, 2023
Phase:
Study type: Observational

The main surgical treatment for oesophageal cancer is a curative resection, mostly performed according to Ivor Lewis. However, despite careful work and refined surgical techniques, anastomotic leakage (AL) occurs in more than 1/10 of the patients. This severe complication normally requires immediate intervention, while over the last 10 years, endoscopic vacuum therapy (EVT) has become the crucial therapy for broken-down anastomosis. The hypothesis is that despite suffering a severe complication, the subjective swallow function is not impaired in patients treated by EVT after an anastomotic leak, compared to patients without AL.

NCT ID: NCT05940766 Not yet recruiting - Clinical trials for Pediatric Oncology Patients With Risk for Infections

Swiss 2024 Continous Fever Monitoring in Pediatric Oncology Patients

Start date: October 1, 2024
Phase: N/A
Study type: Interventional

In children and adolescents undergoing chemotherapy for cancer, fever in neutropenia (FN) is the most frequent potentially lethal complication of chemotherapy for cancer. Emergency hospitalization and empirical treatment with i.v. broad-spectrum antibiotics have reduced lethality from >50% in certain high risk situations to <1%. Fever without neutropenia is a further complication requiring emergency evaluation and often emergency treatment. Continuous monitoring of fever leads to earlier fever detection compared to the usual discrete fever measurements performed only for clinical reasons. Earlier detection of fever leads to earlier assessment and treatment and thus can reduce the risk of complications. This study primarily aims to assess, in pediatric patients undergoing chemotherapy for cancer, the efficacy of automated fever alerts resulting from continuous fever monitoring (CFM) using a wearable device (WD), measured by the duration of intravenous antibiotics (i.v. AB) given for any cause.

NCT ID: NCT05940662 Not yet recruiting - Complications Clinical Trials

Cost Effectiveness of Various Implant Placement Protocols in the Esthetic Zone

Start date: January 1, 2026
Phase: Phase 4
Study type: Interventional

Loss of teeth in the anterior upper jaw significantly affects both well-being and chewing function. Nowadays, dental implants are the treatment of choice for replacing missing teeth with fixed dental prostheses and are often placed in the anterior upper jaw. Depending on various patient-related factors, protocols for the placement of dental implants involve the following time points after tooth extraction: 1. On the same day (immediate implantation) 2. After 1-4 months (early implantation) 3. After more than 4 months (late implantation). The different treatment protocols have been investigated over long periods. The choice of the individually suitable treatment protocol for dental implantation depends on many factors and is of utmost importance in order to achieve the best possible treatment outcomes. Selecting an inappropriate treatment protocol would otherwise result in an increased risk of failure. After decades of research and development in dental implantology, an expert association (International Team for Implantology, ITI) published an evidence-based decision management tool in 2022. This decision management tool assists dentists in choosing the individually suitable implant treatment protocol for single-tooth replacement in the upper jaw. A structured examination of the tooth to be extracted allows to classify the situation and select the most suitable treatment protocol for the individual situation. The treatment protocols differ in terms of time and material requirements, which are associated with different costs. There is limited data about the cost-effectiveness of these treatment protocols. The present study aims to assess how the costs of the three treatment protocols differ in relation to treatment success.

NCT ID: NCT05927324 Not yet recruiting - Clinical trials for Post-traumatic Stress Disorder

Clinician-Assisted Videofeedback Exposure-Approach Therapy (CAVEAT) Trial

CAVEAT
Start date: September 1, 2023
Phase: N/A
Study type: Interventional

The first study proposed is a small (n= 10 to 12 maximum) open feasibility trial of CAVEAT which is a 16-session manualized brief psychotherapy prototcol that is designed to help mothers of infants and young children, whereby the mothers have been exposed to interpersonal violence (i.e. childhood maltreatment and family violence, intimate and non-intimate partner violence, interpersonal combat and or other forms of terrorism or political violence including physical and sexual assault) and who have developed related post-traumatic stress. The treatment uses an integration and extension of evidence-based techniques: Modified Interaction Guidance, Prolonged Exposure Therapy for PTSD, Child-Parent Psychotherapy, and Minding the Baby, in order to help mothers with post-traumatic dysregulation and difficulty in their maintaining sensitivity during challenging parent-child interactions (i.e. when mothers are confronted with child helpless states, emotion dysregulation, negative affect and child aggression). Outcome measures will initially include: maternal attributions towards her child (i.e. perception of child's personality), maternal-child behavior, and maternal-child symptoms of attachment disturbance and PTSD. This feasibility study is meant to perfect the manual and to prepare for an initial open trial with a larger clinical sample including analysis of pre- and post-intervention measures before further randomized control study can be done.

NCT ID: NCT05926349 Not yet recruiting - Urgent Surgery Clinical Trials

A Study of Andexanet Alfa in Patients Requiring Urgent Surgery or Procedure

ANNEXA-RS
Start date: October 20, 2023
Phase: Phase 3
Study type: Interventional

The study will aim to find out if the drug andexanet alfa is safe and effective in preventing major bleeding during urgent surgery or invasive procedures. The study will compare the use of andexanet alfa to the usual care given at the study center.