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NCT ID: NCT03045965 Recruiting - Ovarian Cancer Clinical Trials

Hysterectomy and OPPortunistic SAlpingectomy

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

HOPPSA is a register based randomized controlled trial (R-RCT), with the objective to examine if opportunistic salpingectomy compared with no salpingectomy, at the time of hysterectomy for a benign reason - has no increased risk of complications - has no negative side effects on ovarian function and subsequent cardiovascular disease or incidence of fractures - implies reduced risk of subsequent ovarian cancer Randomization and follow-up will be conducted within national registers.

NCT ID: NCT03040401 Recruiting - Clinical trials for Leukemia, Myelomonocytic, Chronic

A Study of HDC/IL-2 Treatment in Chronic Myelomonocytic Leukemia (CMML)

Start date: February 15, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

Enrolled subjects will receive histamine dihydrochloride (HDC; Ceplene®) and/or IL-2 (Proleukin®) subcutaneously (s.c.) twice daily (BID) in 3-week periods followed by 3- or 6 week rest periods. All subjects will be assigned to one of three consecutive cohorts, each comprising five patients. Cohort 1 will receive HDC without IL-2 for the first treatment cycle, to enable the assessment of short-term impact of HDC alone on clonal and immunological markers. For all remaining cycles the combination of HDC and IL-2 will be given. Cohort 2 will receive the combination of Ceplene and Proleukin in all cycles. After all patients in cohorts 1 and 2 have completed 4 treatment cycles, immunological and clinical response and toxicity will be evaluated. On the basis of the results for the first 4 cycles of cohorts 1 and 2, a third cohort of 5 patients will be enrolled receiving either the combination of HDC/IL-2 or HDC alone. In case of a beneficial response* after 4 cycles, treatment may be continued to a total of 10 cycles. Treatment cycles 5-10 will comprise 3 weeks of treatment and 6-week rest periods. IL-2 will be administered s.c., 1 µg/kg (=16400 IU/kg) body weight twice daily (BID) during treatment periods. Ceplene® will be administered s.c. 0.5 mg BID after IL-2. The patient or a family member/significant other will be instructed to administer injections of both study drugs to allow safe treatment at home.

NCT ID: NCT03037190 Recruiting - Clinical trials for Diabetes Mellitus, Type 1

Preservation of Residual Beta Cell Mass and Prevention of Celiac Disease in Children With Recent Onset Type 1 Diabetes

Diabglut
Start date: December 2015
Phase: N/A
Study type: Interventional

The overall aim of this project is to investigate whether a gluten free diet after the onset of type 1 diabetes (T1D) can better preserve the remaining beta cell mass and at the same time prevent the development of Celiac Disease (CD) in these patients. Specific aims • To study whether gluten free diet during one year after the onset of diabetes influence the appearance and duration of clinical remission in children with Type 1 diabetes. New data show that a gluten free diet is beneficial concerning the insulin production after the onset of diabetes. The investigators want to investigate if gluten is a triggering protein for the destruction of the beta cell function after the onset of diabetes by comparing children who have a normal diet compared to children with a gluten free diet during one year after the onset of the disease. - To study whether a gluten free diet during one year after the onset of diabetes prevent the development of Celiac Disease in these children and the impact of having two diseases It is known that it is almost 10 times more common that children with Type 1 Diabetes (IDDM) develop Celiac Disease (CD) than the general population and that most of these children (6-7 %) develop CD after the onset of Diabetes and within 5 years. Based on our new data that CD is preventable to some extent the investigators plan to perform randomized controlled studies if it is possible to prevent or postpone CD by means after the onset of IDDM. - To investigate the impact of gluten free diet on the regulation of autoimmune responses The investigators will test the hypothesis that gluten free diet in children with recent onset T1D will implement immune regulation and inhibit the activation of potentially autoreactive T cells.

NCT ID: NCT03036228 Recruiting - Cancer Clinical Trials

MTH1, A Phase I, Study on Tumors Inhibition, First in Human, First in Class

MASTIFF
Start date: January 14, 2017
Phase: Phase 1
Study type: Interventional

Primary Objective • To determine the safety and tolerability of Karonudib (TH1579) in escalating doses for the treatment of patients with advanced solid malignant tumours. Secondary Objective - To define DLT and MTD. - To determine a recommended phase 2 dose (RP2D) and schedule. - To determine the pharmacokinetics of Karonudib. - To determine preliminary signs of clinical efficacy of Karonudib. - To determine overall survival.

NCT ID: NCT03022747 Recruiting - Clinical trials for Lymphoblastic Leukemia, Acute, Childhood

Optimizing 6-mercaptopurine Therapy in Pediatric Acute Lymphoblastic Leukemia by Using Allopurinol

Start date: January 2017
Phase: Phase 2
Study type: Interventional

The study will investigate, in children with acute lymphoblastic leukemia during maintenance treatment, if addition of allopurinol to conventional oral 6-mercaptopurine and methotrexate therapy, affects erythrocyte concentrations of 6-thioguanine and 6 methylmercaptopurine. The effect on hematological and liver toxicity parameters in blood will also be investigated as well as clinical toxicity.

NCT ID: NCT03007147 Recruiting - Clinical trials for Acute Lymphoblastic Leukemia

Imatinib Mesylate and Combination Chemotherapy in Treating Patients With Newly Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia

Start date: August 8, 2017
Phase: Phase 3
Study type: Interventional

This randomized phase III trial studies how well imatinib mesylate works in combination with two different chemotherapy regimens in treating patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia (ALL). Imatinib mesylate has been shown to improve outcomes in children and adolescents with Philadelphia chromosome positive (Ph+) ALL when given with strong chemotherapy, but the combination has many side effects. This trial is testing whether a different chemotherapy regimen may work as well as the stronger one but have fewer side effects when given with imatinib. The trial is also testing how well the combination of chemotherapy and imatinib works in another group of patients with a type of ALL that is similar to Ph+ ALL. This type of ALL is called "ABL-class fusion positive ALL", and because it is similar to Ph+ ALL, is thought it will respond well to the combination of agents used to treat Ph+ ALL.

NCT ID: NCT02989181 Recruiting - Clinical trials for Obstructive Sleep Apnea

Continues Positive Airway Pressure Treatment for Patients With Dilated Cardiomyopathy and Obstructive Sleep Apnea

RIDA
Start date: November 2014
Phase: Phase 3
Study type: Interventional

The aim of this randomized controlled study is to investigate the effect of continues positive airway pressure (CPAP) treatment in patients with dilated cardiomyopathy (DCM) and concomitant obstructive sleep apnea (OSA). The primary endpoint is left ventricular function measured by magnetic resonance (improvement of at least 4%) after six months treatment with CPAP. The secondary endpoints include diastolic dysfunction, cardiovascular biomarkers and quality of life.

NCT ID: NCT02988011 Recruiting - Weight Loss Clinical Trials

Improving Glucose and Lipid Metabolism Through Caloric Restriction Using Diet or Surgery (CRUDOS)

CRUDOS
Start date: February 28, 2016
Phase: N/A
Study type: Interventional

In this explorative randomized clinical study, the investigators aim to study metabolic, cellular, and molecular changes that occur during weight loss in obese subjects with and without type 2 diabetes. Using novel "imiomics" (imaging technique using PET/MR bioinformatics) analyses to examine possible metabolic differences between energy restricted diet and gastric by-pass surgery on whole-body and tissue specific insulin sensitivity, glucose tolerance, metabolite and protein profiles, fatty acid metabolism, ectopic fat content, and gene expression in adipose tissue. This study aims to identify novel biomarkers and drug targets for type 2 diabetes as well as validate promising and established biomarkers in an interventional model for improved glucose metabolism.

NCT ID: NCT02979119 Recruiting - Clinical trials for Factor VIII Deficiency

The European Paediatric Network for Haemophilia Management ( PedNet Registry)

PedNet
Start date: June 2014
Phase:
Study type: Observational [Patient Registry]

Rationale: Haemophilia is a rare disease; to improve knowledge international collaboration is needed. Well-defined clinical data will be collected from complete cohorts in order to prevent selection bias. Objective: To collect data on bleeding during neonatal period, endogenous (genetic) and exogenous (treatment-related) determinants of inhibitor development and long term outcome.

NCT ID: NCT02960737 Recruiting - Stroke Clinical Trials

Dysphagia Evaluation After Stroke- Effect Oral Neuromuscular Training on Swallowing Dysfunction

DESIRE
Start date: December 1, 2022
Phase: N/A
Study type: Interventional

The aim of this study is to investigate the effect of a specific rehabilitation program with an oral device used in stroke patients with persistent oral-and pharyngeal dysphagia.