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NCT ID: NCT04850391 Not yet recruiting - Obesity Clinical Trials

Interaction of Sleep, Diurnal Eating Pattern, Gut Microbiota, and Obesity

ObeApp
Start date: August 2021
Phase: N/A
Study type: Interventional

The goals of the proposed study are 1) to provide scientific basis for the relationship between subjective sleep quality, diurnal eating pattern, gut microbiome, and obesity, 2) to develop and test a pragmatic, cost-effective new tool to advance lifestyle changes using E-health approach, and 3) to compare differences in subjective sleep quality, diurnal eating pattern and gut microbiome at baseline 4) to compare changes induced by the E-health intervention among the three study groups and participants with different work schedules.

NCT ID: NCT04850144 Not yet recruiting - Healthy Volunteers Clinical Trials

Pharmacokinetic Study Comparing Tiotropium Easyhaler® and Spiriva® HandiHaler®

TESSA
Start date: April 2021
Phase: Phase 1
Study type: Interventional

Absorption of inhaled tiotropium is compared between five Tiotropium Easyhaler product variants and Spiriva capsules inhaled via HandiHaler without charcoal. Absorption of tiotropium is compared between one Easyhaler product variant administered with and without charcoal.

NCT ID: NCT04846933 Recruiting - Clinical trials for High Grade Ovarian Serous Adenocarcinoma

Multi-layer Data to Improve Diagnosis, Predict Therapy Resistance and Suggest Targeted Therapies in HGSOC

DECIDER
Start date: February 1, 2012
Phase:
Study type: Observational

Chemotherapy resistance is the greatest contributor to mortality in advanced cancers and severe challenges remain in finding effective treatment modalities to cancer patients with metastasized and relapsed disease. High-grade serous ovarian cancer (HGSOC) is typically diagnosed at a stage where the disease is already widely spread to the abdomen and current standard of practice treatment consists of surgery followed by platinum-taxane based chemotherapy and maintenance therapy. While 90% of HGSOC patients show no clinically detectable signs of cancer after surgery and chemotherapy, only 43% of the patients are alive five years after diagnosis because of chemoresistant cancer. This prospective, observational trial focuses on revealing major mechanisms causing chemoresistance in HGSOG patients and derive personalized treatment regimens for chemotherapy resistant HGSOC patients. We recruit newly diagnosed advanced stage HGSOC patients who are then thoroughly followed during their cancer treatment. Longitudinal sampling includes digitalized H&E stained histology slides mainly collected during routine diagnostics, fresh tumor & ascites samples for next-generation sequencing/proteomics (WGS, RNA-seq, DNA-methylation, ChIP-seq, mass cytometry, etc.) and ex vivo experiments, plasma samples for circulating tumor DNA (ctDNA) analyses. Broad range of clinical parameters such as laboratory and radiologic parameters (e.g., FDG PET/CT), given cancer treatments and their outcomes are collected. The general objective is to establish a clinically useful precision oncology approach based on multi-level data collected in longitudinal setting, and translate the most potent and validated discoveries into clinical use. DECIDER project will produce AI-powered diagnostic tools, cutting-edge software platforms for clinical decision-making, novel data analysis & integration methods, and high-throughput ex vivo drug screening approaches.

NCT ID: NCT04845074 Not yet recruiting - Clinical trials for Glenohumeral Osteoarthritis

Prosthesis Versus Active Exercise Program in Patients With Glenohumeral Osteoarthritis

PROACT
Start date: April 2021
Phase: N/A
Study type: Interventional

Anatomical total shoulder arthroplasty (TSA) is a well-established treatment for pronounced glenohumeral osteoarthritis. However, the effectiveness of TSA has not been compared to non-surgical treatment in a randomised controlled trial. Shoulder exercises may be an effective treatment for reducing pain and improving function in glenohumeral osteoarthritis. The primary aim of this trial is to examine if TSA followed by standard postsurgical rehabilitation is superior to a 12-week exercise programme in patients with primary glenohumeral OA eligible for unilateral TSA. We hypothesise that surgical intervention followed by standard rehabilitation, results in clinically relevant (18-point, on a scale from 0-100) improvement compared to the exercise intervention.

NCT ID: NCT04842006 Not yet recruiting - Colorectal Cancer Clinical Trials

Systemic Neoadjuvant and Adjuvant Control by Precision Medicine in Rectal Cancer

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

Rectal cancer represents the most complex area of multidisciplinary treatment in bowel surgery. In 2017, there were 1221 new rectal cancers in Finland. The prognosis of colorectal cancer (CRC) patients these days is almost exclusively driven by the occurrence of the metastatic form of the disease. The treatment of rectal cancer often includes a long delay between diagnosis and the initiation of systemic chemotherapy, increasing risk for systemic metastases for those at high risk. On the other hand, the waiting time during pretreatment before surgery enables comprehensive systematic characterization of the primary tumor status before the decisions on adjuvant chemotherapy, opening a window to the use of precision in decision-making. In this randomized controlled treatment trial, outcomes of novel precision methods to select right rectal cancer patients for treatment that they need will be compared to conventional treatment. The study aims to reduce over-treatment of those that most likely do not benefit from additional treatments. With the overall aim to reduce metastatic form of the disease, patients with high-risk features will be randomized to a treatment strategy with early systemic control by chemotherapy followed by circulating tumor DNA (ctDNA) and organoid-guided adjuvant therapy, or to conventional treatment strategy. Both state-of-the-art laboratory practice and routine diagnostic clinical pipelines are introduced to bring future diagnostic models of minimal residual disease and chemoresistance closer to current practice. The outcomes will reveal the clinical benefit of such strategy by recurrence-free survival at highest level of evidence, and produce important clinical outcome data on the application of ctDNA in everyday cancer treatment practice. The translational data on the use of ctDNA organoids to inform treatment decision and regimen selection will build knowledge of the use of such biomarkers as tools for clinical practice and clinical research. The results will be scalable worldwide in the practice of rectal cancer treatment.

NCT ID: NCT04840667 Not yet recruiting - Fabry Disease Clinical Trials

A Study of Replagal in Treatment-naïve Adults With Fabry Disease

Start date: July 9, 2021
Phase: Phase 3
Study type: Interventional

In this study, adults with Fabry Disease who have not had any treatment for this condition will be treated with Replagal. The main aim of the study is to check if Replagal improves kidney function and heart structure of participants with Fabry Disease. Participants will receive one Replagal infusion every other week for up to 104 weeks. They will visit the clinic every 12 to 14 weeks during treatment with a follow-up visit 2 weeks after treatment.

NCT ID: NCT04837261 Recruiting - Clinical trials for Supraventricular Tachycardia

Shortening Duration of Antiarrhythmic Medication for SVT in Infants

Start date: April 1, 2021
Phase:
Study type: Observational

The infants diagnosed with SVT are treated with antiarrhythmic medication to prevent the recurrence of SVT. This prospective observational cohort study evaluates efficacy and safety of shortening duration of antiarrhythmic medication to four months in infants with SVT. Primary outcome is incidence of recurrent SVT in infants after 4 months of antiarrhythmic medication compared to retrospectively reviewed cohort.

NCT ID: NCT04834284 Recruiting - Ischemic Stroke Clinical Trials

HEMS for Mechanical Thrombectomy

Start date: June 1, 2020
Phase:
Study type: Observational [Patient Registry]

Elapsed time from the onset of stroke symptoms to the point of revascularization is the key determinant of the optimal outcome of acute ischemic stroke. Pharmacological treatment is less effective if the thrombus occluding the artery is big enough and mechanical thrombectomy is required to gain recanalization. Mechanical thrombectomy can be done only in comprehensive stroke centres. There are 5 comprehensive stroke centres in Finland which causes regional inequality when it comes to reaching mechanical thrombectomy in a reasonable time limit. The aims of the study is to measure the effect of dispatching a helicopter emergency medical services unit on the treatment delays of a stroke patient with large vessel occlusion. The HEMS unit is dispatched to both: getting patient directly to the comprehensive stroke centre as well as to interfacility tranfers.

NCT ID: NCT04833153 Not yet recruiting - Clinical trials for Nurse-Patient Relations

Continuing Education Intervention Named "Person First - Please"

PFP
Start date: August 30, 2021
Phase: N/A
Study type: Interventional

The aim of this study is to evaluate the effectiveness of the Person-First - Please (PFP) intervention in supporting nurse's competence and collective competence of Person-Centred Care (PCC) in older people Long-Term Care (LTC). The goal is to promote PCC culture in older people LTC. Research question 1: What is the effectiveness of the PFP intervention on the PCC collective competency of nurses in older people LTC? Hypothesis for research question 1 are: 1. Nurses in intervention group will have higher level of competence of PCC than control. 2. Nurse in intervention group will have higher level of collective competence of PCC than control. Research question 2: How PCC climate has been maintained in older people LTC from the point of view of the nurses, next of kin and older people? Hypothesis for research question 2 are: 1. PCC climate will be better in intervention group than control from point of view of the nurses, next of kin and older people. 2. The higher competence of nurses the higher level of PCC climate from point of view of the next of kin and older people. 3. The higher collective competence of the nurses the higher level of the PCC climate from point of view of the next of kin and older people. Research question 3: What is the fidelity of the PFP? Research question 4: What is the feasibility of the PFP?

NCT ID: NCT04831073 Not yet recruiting - Clinical trials for Type A Aortic Dissection

European Registry of Type A Aortic Dissection

ERTAAD
Start date: May 1, 2021
Phase:
Study type: Observational

Acute Stanford type A aortic dissection (TAAD) is a life-threatening condition. Surgery is usually performed as a salvage procedure and is associated with significant postoperative early mortality and morbidity. Understanding the patient's conditions and treatment strategies which are associated with these adverse events is essential for an appropriate management of acute TAAD.