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NCT ID: NCT03369262 Recruiting - Preterm Labor Clinical Trials

PoC Study of OBE022 in Threatened Preterm Labour

PROLONG
Start date: December 2017
Phase: Phase 2
Study type: Interventional

This is a proof-of-concept study in 2 parts. In Part A, patients will receive OBE022 open-label in order to assess the safety and pharmacokinetics in pregnant women with spontaneous preterm labour with a gestational age between 28 0/7 and 33 6/7 weeks. Part B has a double-blind, randomised, placebo controlled, parallel group and multicentre design and will assess the efficacy, safety and pharmacokinetics in pregnant women with threatened spontaneous preterm labour with a gestational age between 24 0/7 and 33 6/7 weeks. All patients in part A and part B must receive atosiban infusion for 48 hours as standard of care treatment. Patients from Part A will receive OBE022 open label. Patients from Part B will be randomised to receive OBE022 or matching placebo. IMP treatment duration will be up to 7 days. IMP treatment will be stopped in case of delivery prior to Day 7.

NCT ID: NCT03368677 Not yet recruiting - Multiple Sclerosis Clinical Trials

Effect of Teriflunomide Treatment on Microglial Activation in an MS Patient Cohort at Risk of Progression

TERIPET
Start date: December 2017
Phase: N/A
Study type: Observational

To evaluate the effect of teriflunomide treatment on microglial activation in late stage multiple sclerosis.

NCT ID: NCT03364088 Recruiting - Clinical trials for Rheumatoid Arthritis

Outcome After Total Knee Arthroplasty Under General or Spinal Anesthesia

Start date: October 1, 2016
Phase: N/A
Study type: Interventional

Previous retrospective database studies suggest that total knee arthroplasty (TKA) surgery under spinal anesthesia has less complications than when performed under general anesthesia. In general, complications are rare and both anesthesia types are widely accepted. In Finland, total knee arthroplasty has typically been performed under spinal anesthesia. In a recent prospective randomized controlled study, total knee arthroplasty under general anesthesia resulted in less acute postoperative pain (opioid-need measured by patient-controlled anesthesia), less nausea, and faster hospital discharge than that performed under spinal anesthesia. Also the use of surgical tourniquet can affect surgical outcome: it may reduce bleeding and surgery time, but it may also cause weakness of thigh muscles and thus hinder mobilization. In a recent study, both techniques with and without surgical tourniquet appeared equal. The aims of this study are to compare total knee arthroplasty under spinal or general anesthesia, with or without surgical tourniquet, in relation to acute and chronic postoperative pain, nausea, knee function, patient reported quality of life and satisfaction on care, complications, length of stay, and need of surgical unit resources. This randomized controlled study includes 400 patients with informed consent, 18-75-years-of-age, standard primary total knee arthroplasty operation, American Society of Anesthesiologist (ASA) physical status classification I-III, body mass index under 40, and no contraindications for medications or treatments used. The hypothesis of this study are used to reassess best practices of primary total knee arthroplasty operation to enhance quality of care, patient outcomes and satisfaction, and availability of surgery due to better patient flow at surgical unit.

NCT ID: NCT03361072 Recruiting - Food Allergy Clinical Trials

The Effect of Per Oral Immunotherapy in Severe Milk, Peanut and Egg Allergy in Adults

Start date: August 3, 2017
Phase: N/A
Study type: Interventional

The aim is to analyse the results of per oral immunotherapy treatment in severe milk, peanut or egg allergy in adults. This is the second part of the oral immunotherapy study in adults at Skin and Allergy Hospital. The diagnosis of food allergy is verified with positive history, skin prick tests, egg and milk allergen specific IgE (immunoglobulin E) antibodies. In addition, food allergy is verified with an open label (milk allergy) or blind (peanut and egg allergy) allergen specific challenge test. OIT (oral immunotherapy) is performed according to a detailed plan. Lung function parameters are followed before OIT and and a year after OIT.

NCT ID: NCT03358095 Recruiting - Pancreatic Cancer Clinical Trials

Cancer of the Head of the Pancreas: Early Surgery or Preoperative Biliary Drainage?

Start date: November 26, 2017
Phase: N/A
Study type: Interventional

Surgical resection is the only option for cure for patients with a resectable tumor located at the head of the pancreas. At the time of diagnosis, these patients often suffer from jaundice. Studies have suggested, that jaundice might increase the risk of developing a serious postoperative complication. Preoperative biliary drainage is widely used, because it is considered to improve the surgical outcome and reduce the amount of postoperative complications. There are also studies that suggest the opposite. In these studies the overall complication rate with patients who underwent preoperative biliary drainage was higher than in the patients who were operated right away. A significant amount of these complications were related to the biliary drainage process itself. However, preoperative biliary decompression is widely used in many centers as many surgical centers don't possess the needed resources to arrange early surgery. The benefits and risks of this procedure remain unclear. This multicenter trial aims to compare the surgical outcome and the rate of serious complications in patients who proceed directly to early surgery and patients who have preoperative biliary drainage.

NCT ID: NCT03353766 Recruiting - Malocclusion Clinical Trials

Early Crossbite Correction - a Randomized Study

Start date: April 2016
Phase: N/A
Study type: Interventional

The aim of this longitudinal randomized investigation is to determine the long-term effects of early lateral crossbite correction with Quad-Helix appliance, during the deciduous dentition, on craniofacial structures and dental arches, compared to treatment started later, after the first permanent molars have erupted. The hypothesis is that the timing of treatment has significant effects on orthodontic treatment total time, the general outcome of the treatment, and the compliance of the patient. The Age cohort of five-year-old of children living in the community areas of Oulunsalo are screened at the age of 5 years for malocclusions. Of these children 80 children who meet the criteria are chosen for the study after the written consent. The children are randomized into two groups. In the first group the treatment with Quad-Helix appliance is started at the age of 5 to 6 years, before the eruption of the permanent molars. The device is cemented to the second deciduous molars. The treatment is continued and continued until normal lateral occlusion is achieved and the device is kept stable for one year after this. In the second group headgear treatment is started after the first permanent maxillary molars have erupted. The device is cemented to the first permanent molars. The treatment is continued until normal lateral occlusion is achieved and the device is kept stable for one year after this. In both groups dental casts, cephalograms, and standardized 3D facial photographs are taken before treatment (T0), after the first treatment phase (T1), after the second treatment phase (T2) and after the growth (T3). Facial 3D scanning is performed for all the subjects after the treatment to find out the effect of different treatment methods on facial characteristics. The dental casts are scanned to make 3D models of the cast to be used in detailed analysis. A wide multi-level questionnaire is performed before, during and after the study to the parents and the children to find out the comprehensive effects of orthodontic treatment on the well-being of the child. The questionnaire includes the Rutter's child behavioural pattern (Rutter et al., 2001). In both studies, all the guidelines of RCT are applied. Blinding of the clinicians is gained, as the orthodontists or dentists treating the children are not aware of the rationale of the study. Blinding is applied on all measurement of the documents.

NCT ID: NCT03352856 Recruiting - Allergy;Food Clinical Trials

Food Challenge With Barley Starch as Active Comparator

BALA
Start date: October 13, 2017
Phase: N/A
Study type: Interventional

Aim of the present study is to verify in a double-blind placebo controlled food challenge (DBPCFC) test that highly purified barley starch ingredient do not cause allergic reaction in subjects most potential to get allergic reaction due to ingredient. Hypothesis is that none of the cereal (mostly primarily wheat) allergic subject recruited to the study will obtain allergic reaction neither to placebo nor to the test ingredient. Scoring of symptoms during the challenges will be based on PRACTALL.

NCT ID: NCT03352388 Completed - Clinical trials for Nutrition Disorders in Old Age

Effects of Dairy- and Berry-based Snacks on Nutritional and Functional Status and Quality of Life in Older People

MAVIRE1
Start date: September 2015
Phase: N/A
Study type: Interventional

Malnutrition or its risk is common among older people, especially among those receiving home care services. It impairs the quality of life of the older people and results in significant costs to society. To maintain adequate nutrition, increased meal frequency is important. In addition to main meals, regular consumption of tasty, convenient, nutrient- and energy-dense snacks is recommended. The purpose of this study is to investigate the effects of dairy- and berry-based snack consumption on nutritional and functional status and quality of life among vulnerable older people at home care.

NCT ID: NCT03351543 Completed - Clinical trials for Immune System Disorders

Effect of Microbial Exposure on Health, Particularly Immune System

ADELEWP1t4
Start date: March 2016
Phase: Phase 1
Study type: Interventional

The effect of microbial exposure on healthy human subjects will be investigated. Changes in cytokine and IgE and vaccine response will be measured. The hypothesis is that microbial exposure increases the measured responses.

NCT ID: NCT03350763 Recruiting - Pancreatic Cancer Clinical Trials

Biliary Drainage Preceding Possible Pancreaticoduodenectomy. Are Self-expandable Metallic Stents (SEMS) Superior to Plastic Stents?

Start date: November 18, 2017
Phase: N/A
Study type: Interventional

This study looks in to the rate of biliary stent dysfunction for plastic and metallic stents in patients who need biliary drainage due to a tumor in pancreas before possible pancreaticoduodenectomy. Complications related to the biliary decompression, and possible post-surgical complications in all patients are also recorded. This trial aims to confirm whether metallic biliary stents really are superior to plastic stents as some previous studies suggest. Specific patient groups are also evaluated individually to see, whether patients with ongoing cholangitis at the time of diagnosis or patients receiving neoadjuvant treatments have less stent dysfunction cases and complications with metallic stents than with plastic stents.