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NCT ID: NCT06238310 Recruiting - Acute Kidney Injury Clinical Trials

Comparison of Two Different External Clearance Markers - Mannitol and Iohexol for Measuring Glomerular Filtration Rate

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

GFR is the best parameter of the real kidney function. Measurements, however are time-consuming and have limited capacity. Patients treated in the intensive care units often have more than one organ-insufficiency and acute kidney injury (AKI) has an incidence of up to 70 %. GFR changes dynamically and this is one of the reasons why GFR-measurements have limited indications on the ICU. Retention of medicines or their active metabolites, however can lead to side effects, toxicity and or prolonged ICU-stay. Moreover, patients with allergy to actually standard marker, contrast material iohexol, or gravid patients are not candidate for measuring GFR with iohexol. In this prospective clinical trial two exogen marker substances will be compared, mannitol as a new marker and iohexol as a standard marker for measuring glomerular filtration rate (GFR). Patients in the intensive care units (ICU) and an outpatient group with stable chronic kidney disease (CKD) are included. The main question is, how reliable mannitol-GFR is compared to iohexol-GFR in a wide range of kidney insufficiency. GFR measurements are performed with a bolus injection technique. Patients get mannitol and iohexol bolus at time zero and blood samples are taken three times according to local protocols for iohexol clearance measurements.

NCT ID: NCT06230081 Recruiting - Clinical trials for Osteoarthritis of the Knee or Hip

Comparison Between Blocks or Not in Joint Arthroplasty

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

The purpose of this study is to evaluate the effect on postoperative pain, opioid consumption and function by adding a combination of regional blocks with local anaesthetic before total hip- and knee arthroplasty compared to standard pain management strategies.

NCT ID: NCT06225674 Recruiting - Clinical trials for Osteochondral Defect

Clinical Investigation on the Outcome of Episealer Talus Post-operation for Treatment of Focal Osteochondral Defects

Start date: November 6, 2023
Phase:
Study type: Observational

This is a retrospective, observational, single-arm, multi-centre, post-market clinical investigation designed to verify clinical performance and safety of Episealer Talus post-operation for treatment of focal osteochondral defects on the talus bone in the ankle. This retrospective investigation aims to collect data from patients with focal osteochondral defects treated with Episealer Talus, to provide insight on the potential benefit of Episealer Talus in the treatment of focal osteochondral defects. The aim for the clinical investigation is to collect data from approximately 25 adult subjects who were treated for focal osteochondral defect with Episealer Talus implant in 6 clinics (Sweden and Germany) since January 2020, when the devices were CE-marked. The data collected for each subject will include demographics and data generated in relation to the surgery itself and the post-surgery phases including e.g. focal defect grade and position, collected through medical record review. Each subject will also be asked to complete a set of QoL questionnaires (SEFAS, FAOS and VAS).

NCT ID: NCT06224725 Recruiting - Parkinson Disease Clinical Trials

Acrylamide and Health Outcomes

Start date: January 1, 2024
Phase:
Study type: Observational [Patient Registry]

Acrylamide, a widespread food-processing contaminant, poses a major public health concern due to its high exposure level in the general population and its toxicity. While animal evidence shows that acrylamide causes neurological alterations and may play a role in cardiovascular disease, evidence in humans is lacking. Our project aims to investigate whether dietary acrylamide exposure, measured in blood, increases the risk of dementia, Alzheimer's and Parkinson's diseases and myocardial infarction. In addition, the aim is to improve the understanding of the biological mechanisms underlying these associations integrating small compounds in blood (i.e., OMICS). In two population-based cohorts, the Cohort of 60-Year-Olds and the Swedish Mammography Cohort, acrylamide will be assessed in blood samples using a case-cohort design (around 2145 individuals, 20-year follow-up). The results will be presented in four scientific publications using adequate data analysis. The project will run from 2024-2028. The project´s findings will help improve public health through safer food and better nutrition. If findings indicate that acrylamide increases the risk of these diseases, this will urge interventions to decrease acrylamide exposure via food production and consumption. In turn, this will help to reduce the burden of these diseases. Even findings showing null association will be equally relevant to avoid unnecessary and costly preventive measures.

NCT ID: NCT06223347 Recruiting - Clinical trials for Inflammatory Bowel Diseases

Improved and Simplified Staining Technique for Dysplasia Detection in Colitis

IST-DDC
Start date: January 2024
Phase:
Study type: Observational

Comparing chromoendoscopy to a digital staining technique and White light in patients with IBD attending scheduled surveillance colonoscopy

NCT ID: NCT06223022 Recruiting - Breast Cancer Clinical Trials

Nurse-led Proactive Telephone Follow-up With Patients After Completion of Primary Cancer Treatment

Start date: January 20, 2024
Phase: N/A
Study type: Interventional

The goal of this randomized study is to test and evaluate nurse-led telephone follow-up intervention in patients primarily curatively treated for breast cancer, colorectal cancer, and prostate cancer. The main question aims to answer: Does this nurse-led telephone follow-up improve patients' quality of life? Participants in both groups will be asked to fill in questionnaires regularly. The intervention group will get a telephone follow-up at predetermined intervals, while the control group will get the care as usual.The investigators will compare intervention and control groups to see if predetermined regular nurse-led telephone follow-up improves quality of life.

NCT ID: NCT06220435 Recruiting - Prostate Cancer Clinical Trials

Tumor-directed Radiation Therapy for Patients With the Highest Risk Category of Localized Prostate Cancer

Start date: September 25, 2023
Phase: N/A
Study type: Interventional

HYPO-RT-PC boost is is an open-label, multicentre, phase II trial evaluating safety and efficacy of real-time image-guided tumor-directed ultra-hypofractionated radiation boost and lymph node irradiation for patients with node-negative high risk localized prostate cancer.

NCT ID: NCT06212635 Recruiting - Clinical trials for Inflammation in Decompensated Liver Cirrhosis

Hemostasis in Liver Cirrhosis and Hepatocellular Cancer

HELICS
Start date: December 2, 2022
Phase:
Study type: Observational

Evaluating hemostasis in decompensated liver cirrhosis with novel hemostatic assays.

NCT ID: NCT06211504 Recruiting - Flexible Flatfoot Clinical Trials

Sinus Tarsi Implant as an Adjuvant Procedure to Medial Displacement Calcaneal Osteotomy in the Treatment of Mobile Adult Acquired Flatfoot Deformity

Start date: April 11, 2024
Phase: Phase 4
Study type: Interventional

Background: Adult acquired flatfoot deformity (AAFD) is a deformity of the foot which leads to pain and an altered gait pattern. There are several different surgical interventions available for treatment of AAFD. One of the most common treatments for mobile AAFD is medial displacement calcaneal osteotomy (MDCO) with or without adjuvant soft tissue procedures. However, the medial displacement of the calcaneus only aims to correct the deformity in one plane despite AAFD being a deformity of three planes with hypereversion of the calcaneus, anterior translation of the talus over the calcaneus and tilting/drop of the calcaneal head. Because of these multiple forces, the healing of MDCO in the intended position can sometimes be hard to achieve and medial soft tissue is still stressed leading to recurring deformity. The investigators believe that adjuvant insertion of a sinus tarsi implant (STI) could work as an internal splint, protecting soft tissue procedures on the medial side, reversing anterior translation of the talus, opposing calcaneus eversion, and lifting talar head. This additional procedure will create a better correction of the deformity with enhanced appearance of the foot and better long-term functional results. Methods: This is a multi-center randomized controlled trial designed to assess the efficacy of STI as an adjuvant procedure to MDCO in patients with mobile AAFD (Stage IIA). Patients aged 16 to 75 years, referred to one of the orthopedic centers involved in this study, will be invited to participate if they fulfil the trials eligibility criteria. In total, 130 patients who provide informed consent will be randomized to either MDCO with STI or MDCO without STI (65 patients in each group). The included patients will be clinically and radiographically examined. They will also fill out a form before surgery and 4-5 months, 1 year and 2 years postoperatively. The form will include Self-Reported Foot and Ankle Score (SEFAS) and Euro-QoL 5 Dimensions (EQ-5D). The trials primary outcome will be change in Meary's angle. Secondary outcomes include additional radiographic changes, change in SEFAS score, EQ-5D index, pain according to visual analog scale (VAS), satisfaction assessment, clinical outcome measures, the length of postoperative sick-leave and rate of complications. Discussion: This is the first randomized controlled trial assessing the efficacy of a sinus tarsi implant as an adjuvant procedure to MDCO.

NCT ID: NCT06211049 Recruiting - Clinical trials for Primary Dysmenorrhea

Efficacy of Vitex Agnus-castus BNO 1095 (20 mg) in Women With Primary Dysmenorrhea

Start date: December 12, 2023
Phase: Phase 3
Study type: Interventional

In this Phase III study, the herbal product Vitex agnus-castus BNO 1095 20 mg will be tested. The sponsor would like to find out if treatment with Vitex agnus-castus BNO 1095 20 mg may improve the cramping pain before or during menstruation (primary dysmenorrhea) (without an organic cause) in women and if this treatment is safe. It is tested, if the pelvic pain and other symptoms during menstruation improve in patients who are treated with Vitex agnus-castus BNO 1095 20 mg and if therefore the standard treatments for primary dysmenorrhea, for example pain relief medications will not have to be increased. The study has 2 treatment groups. Patients in one group will receive Vitex agnus-castus BNO 1095 20 mg, and patients in the other group will receive a placebo. Placebo tablets look like Vitex agnus-castus BNO 1095 20 mg tablets but have no active ingredient. Patients will be randomly assigned (like tossing a coin) to one of the 2 groups (this process is called randomization). The chance for the patients to receive Vitex agnus-castus BNO 1095 is 50%. Neither the patients nor the investigators know which product the patients are taking (this method is known as "double-blind").