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NCT ID: NCT03315312 Active, not recruiting - Clinical trials for Dental Caries in Children

Occlusal Caries Management in First Permanent Molars in Child Dental Care

FISSURE
Start date: February 1, 2017
Phase: Phase 4
Study type: Interventional

Occlusal caries management in first permanent molars: a pragmatic randomized clinical trial in child dental care Aim of the present study is to evaluate the effectiveness of fissure sealants and fluoride varnish in a pragmatic randomized clinical trial and evaluate whether some specific patient groups benefit more from any particular treatment. The high risk children (having a previous caries experience at 5 years of age) from 2009, 2010 and 2011 birth cohorts (6-, 7- and 8-year-olds) from three counties (Østfold, Oppland and Hedmark) are selected. Children with at least two erupted first permanent molars in the same jaw randomly receive resin-based sealant or a fluoride varnish (Duraphat) during a routine dental examination. Children who already developed caries, had restorations or fissure sealants placed in first molars were excluded from the present study. Fluoride varnish and resin-based fissure sealants are randomly applied on contra-lateral teeth where each child serves as its own control. This study uses a natural clinical setting, where clinicians use methods and procedures that are routinely applied in public dental clinics. The study is approved by the Regional Committee for Medical Research Ethics South East (2016/2002/REK sør-øst C). Sample size calculations: Based on the assumption that 80% of the treated teeth do not get caries and that 10% difference in caries development constitutes a clinically meaningful difference, it is required to recruit 180 participants in the study for the split-mouth design. Considering a potential maximum of annual 20% drop-out rate and a 3-years follow-up, the study will need to recruit 400 participants in order to have at least 206 children at the 3 years of follow-up. Treatments are provided by either dentists or dental hygienists during routine dental examinations. Caregivers of eligible children are informed about the study, the participation is voluntary and an informed written parental consent is obtained in accordance with the directions of the Regional Committee for Medical Research Ethics. In this study, a clinician selects a random treatment for the first tooth by choosing one of the two cards, while a collateral tooth receives an alternative treatment. Subsequently, treatments provided and materials used are recorded on a treatment registration form. During this study, clinicians follow their conventional clinical procedures for applying sealants or fluoride varnish. Information on patient's caries experience and quality of oral hygiene are recorded on treatment registration form. Fluoride varnish is applied three times, at baseline, 6 months and 12 months. Caries on occlusal surfaces of first molars detected at later 24 and 36 months follow-ups will be recorded in the follow-up registration form. The main study outcome is caries occurrence on occlusal tooth surfaces.

NCT ID: NCT03314636 Active, not recruiting - Myeloma Clinical Trials

Intensified Treatment With Carfilzomib in Myeloma Patients Still PET-positive After First Line Treatment.

CONPET
Start date: March 16, 2018
Phase: Phase 2
Study type: Interventional

A PET-CT will be performed on patients with myeloma after a standard first-line treatment. The PET-positive patients will receive 4 cycles of Carfilzomb-Revlimid-Dexamethason (KRd), before a new PET-CT will be performed.

NCT ID: NCT03301220 Active, not recruiting - Clinical trials for Smoldering Multiple Myeloma

A Study of Subcutaneous Daratumumab Versus Active Monitoring in Participants With High-Risk Smoldering Multiple Myeloma

Start date: November 7, 2017
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to determine whether treatment with daratumumab administered subcutaneously (SC) prolongs progression-free survival (PFS) compared with active monitoring in participants with high-risk smoldering multiple myeloma (SMM).

NCT ID: NCT03299478 Active, not recruiting - Clinical trials for Non-Small Cell Lung Cancer

Clinical Implementation of TNM-immunoscore in Resected Non-small Cell Lung Cancer

TNM-I
Start date: November 28, 2016
Phase:
Study type: Observational [Patient Registry]

The purpose of this study is to validate TNM-Immunoscore in resected non-small cell lung cancer.

NCT ID: NCT03299270 Active, not recruiting - Elderly Clinical Trials

Geriatric Oncology Surgical Assessment and Functional rEcovery After Surgery

GOSAFE
Start date: February 27, 2017
Phase:
Study type: Observational

Multicenter, international, prospective, observational study, designed to evaluate the postoperative results in terms of quality of life and functional recovery of elderly patients after major cancer surgery. The global expected duration of the study is 3 years, during which cancer patients over 70 years old undergoing major surgery will be evaluated before and after the surgical intervention, at 30 days, 3- and 6-months follow-up. The study is non-for-profit. Given the observational nature of the study, the original treatment plan, as designed by each individual recruiting centre, will not be altered or affected by the study inclusion. Inclusion in the study does not imply any deviation from the current standard of practice, and no change is expected to the perioperative treatment at any point. Patients will be only asked to complete simple screening/assessment tests.

NCT ID: NCT03293342 Active, not recruiting - Dental Fear Clinical Trials

Cognitive Behavioural Therapy and Dental Fear

Start date: September 10, 2017
Phase: N/A
Study type: Interventional

The study is an RCT study comparing a 3-5 intervention treatment with dentist administered Cognitive Behavioural Therapy ( D-CBT) with a control treatment. The control treatment is a "treatment as usual" concept using premedication with benzodiazepines and a common sense approach. The treatment will be performed in a regular dental office. The dentist is working as a regular dentist and is trained in the CBT Method.

NCT ID: NCT03293173 Active, not recruiting - Clinical trials for Lymphoma, Large B-Cell, Diffuse

Biomarker Driven Intensified ChemoImmunotherapy With Early CNS Prophylaxis

Bio-CHIC
Start date: August 4, 2017
Phase: Phase 2
Study type: Interventional

This study is testing whether stratification of the patients according to biological risk factors for different treatment groups will improve the outcome of patients with clinically high diffuse large B-cell lymphoma (DLBCL).

NCT ID: NCT03280602 Active, not recruiting - Olecranon Fracture Clinical Trials

Operative Treatment of Olecranon Fractures

Start date: December 1, 2017
Phase: N/A
Study type: Interventional

The incidence of olecranon fractures is 12 per 100.000. Traditionally, isolated olecranon fractures have been treated with tension band wiring (TBW). There is a trend towards increased use of plate fixation, though TBW has yielded good and comparable patient reported outcomes. The latter method is substantially cost-effective, but higher complication reports have been reported. There are only two randomized controlled trials comparing TBW and plate fixation, and the literature is inconclusive in which fixation method is preferable in the treatment of olecranon fractures. In this multi-center trial, adult patients (18-75 years) with isolated olecranon fractures will be randomized to either TBW or plate fixation.

NCT ID: NCT03270917 Active, not recruiting - Liver Surgery Clinical Trials

ORANGE SEGMENTS: Open Versus Laparoscopic Parenchymal Preserving Postero-Superior Liver Segment Resection

Start date: November 1, 2017
Phase: N/A
Study type: Interventional

The international and multicentre ORANGE SEGMENTS - Trial is a prospective, double blinded, randomized controlled study comparing patients undergoing parenchymal preserving resection of postero-superior liver segments (involving one or two of segments 4a, 7, 8). All patients will be participating in an enhanced recovery programme. Primary outcome is time to functional recovery. Secondary study parameters include hospital length of stay, intraoperative blood loss, operation time, liver specific morbidity, readmission percentage, resection margin, quality of life, body image and cosmesis , reasons for delay of discharge after functional recovery, long term incidence of incisional hernias, hospital and societal costs during one year, time to adjuvant chemotherapy initiation, overall five-year survival.

NCT ID: NCT03267316 Active, not recruiting - Colorectal Cancer Clinical Trials

A First-in-Human Study of CAN04 in Patients With Solid Malignant Tumors

CANFOUR
Start date: September 19, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

This study will evaluate the safety, tolerability, and preliminary antitumor activity of CAN04 both as a monotherapy and in combination with standard of care treatment in subjects with solid cancer tumors. Following completion of the first part, the dose escalation cohorts, and determination of maximum tolerated dose or recommended phase 2 dose (MTD/RP2D), safety and tolerability will be further evaluated in an expanded cohort of subjects with pancreatic or lung cancer, as monotherapy or in combination with the standard of care treatment and to identify the RP2D of CAN04 in combination with standard of care. In addition, early signs of efficacy during treatment with CAN04 will be investigated.