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NCT ID: NCT03039686 Completed - Clinical trials for Duchenne Muscular Dystrophy

Clinical Trial to Evaluate the Efficacy, Safety, and Tolerability of RO7239361 in Ambulatory Boys With Duchenne Muscular Dystrophy

Start date: July 6, 2017
Phase: Phase 2/Phase 3
Study type: Interventional

This is a multi-center, randomized, double-blind, placebo-controlled study to assess the efficacy, safety and tolerability of two different weekly doses of RO7239361 in ambulatory boys with Duchenne Muscular Dystrophy (DMD).

NCT ID: NCT03039010 Completed - Clinical trials for Dental Caries in Children

Validation of Data for Dental Health in the SKaPa Registry for Children and Adolescents

Start date: January 1, 2017
Phase:
Study type: Observational

Swedish Quality Registry for dental health care (SKaPa) is a national registry that has since year 2008 gathered dental data. The data is automatically extracted from the patients' electronical dental data records. A vast majority of the public dental health care clinics deliver data on a daily basis (SKaPa, 2013). SKaPa has the purpose to improve and develop the quality of care and patient outcomes for both prevention and reparative/restorative methods concerning caries and periodontal disease. For children and adolescents, it is above all information related to dental caries that is collected (SKaPa, 2013). So far, SKaPa has published seven annual reports. In the report for year 2013 a limited information about the status of children was given, due to uncertainty in the quality of the information that is passed on to SKaPa (SKaPa, 2013). There is therefore a need to examine the validity of the data supplied to SKaPa. Tooth decay is the most common disease in children and adolescents that often lead to invasive interventions and pain. There are reports of great social disparities in dental health in children and adolescents in Sweden (The National Board of Health and Welfare, Socialstyrelsen, 2013). Because tooth decay is a common disease in children, it is important to be able to monitor the occurrence of the disease and also examine how it differs across various groups of children and adolescents. This is now possible through the several registries that are available in the dental and health care. Register-based research will be an important tool to ensure that children and adolescents receive oral health and dental care on the same premise as others, provided the data in the registries are valid. Furthermore, register-based research is important for development and quality assurance of dental care.

NCT ID: NCT03038516 Completed - Clinical trials for Vitamin D Deficiency

'Palliative-D' Vitamin D to Palliative Cancer Patients

Palliative-D
Start date: November 1, 2017
Phase: Phase 2
Study type: Interventional

To test the hypothesis that vitamin D treatment during 12 weeks to palliative cancer patients can decrease opioid consumption, fatigue and infectious burden and increase quality of life.

NCT ID: NCT03038399 Completed - Clinical trials for Duchenne Muscular Dystrophy

Long-term Extension Study to Assess Vamorolone in Boys With Duchenne Muscular Dystrophy (DMD)

Start date: February 2, 2017
Phase: Phase 2
Study type: Interventional

This long-term extension study is an open-label, multiple-dose study to evaluate the long-term safety, tolerability, efficacy and PD of vamorolone administered once daily by liquid oral suspension over a Treatment Period of 24 months to young boys with DMD who participated in the VBP15-002 Phase IIa and VBP15-003 Phase IIa extension core studies.

NCT ID: NCT03038100 Completed - Ovarian Cancer Clinical Trials

A Study of Atezolizumab Versus Placebo in Combination With Paclitaxel, Carboplatin, and Bevacizumab in Participants With Newly-Diagnosed Stage III or Stage IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

IMagyn050
Start date: March 8, 2017
Phase: Phase 3
Study type: Interventional

This is a Phase III, global, double-blind, 2-arm randomized study designed to compare the efficacy and safety of atezolizumab + paclitaxel + carboplatin + bevacizumab versus placebo + paclitaxel + carboplatin + bevacizumab. Study participants will have Stage 3 or 4 ovarian cancer (OC), fallopian tube cancer (FTC), or primary peritoneal cancer (PPC) with macroscopic residual disease postoperatively (i.e., after primary tumor reductive surgery) or who will undergo neoadjuvant therapy followed by interval surgery.

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: NCT03036488 Active, not recruiting - Clinical trials for Triple Negative Breast Neoplasms

Study of Pembrolizumab (MK-3475) Plus Chemotherapy vs Placebo Plus Chemotherapy as Neoadjuvant Therapy and Pembrolizumab vs Placebo as Adjuvant Therapy in Participants With Triple Negative Breast Cancer (TNBC) (MK-3475-522/KEYNOTE-522)

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

The purpose of this study is to evaluate the efficacy and safety of pembrolizumab (MK-3475) plus chemotherapy vs placebo plus chemotherapy as neoadjuvant therapy and pembrolizumab vs placebo as adjuvant therapy in participants who have triple negative breast cancer (TNBC). After a screening phase of approximately 28 days, each participant will receive neoadjuvant study treatment (Pembrolizumab + Chemotherapy OR Placebo + Chemotherapy) based on the randomization schedule for approximately 24 weeks (8 cycles). Each participant will then undergo definitive surgery 3-6 weeks after conclusion of the last cycle of the neoadjuvant study treatment. After definitive surgery, each participant will receive adjuvant study treatment (Pembrolizumab OR Placebo) for approximately 27 weeks (9 cycles). Following adjuvant study treatment, each participant will be monitored for safety, survival and disease recurrence. The primary study hypothesis is that pembrolizumab is superior to placebo, in combination with chemotherapy, as measured by the rate of Pathological Complete Response (pCR) and/or Event-free Survival (EFS), in participants with locally advanced TNBC.

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: NCT03036150 Completed - Clinical trials for Chronic Kidney Disease

A Study to Evaluate the Effect of Dapagliflozin on Renal Outcomes and Cardiovascular Mortality in Patients With Chronic Kidney Disease

Dapa-CKD
Start date: February 2, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the effect of dapagliflozin on renal outcomes and cardiovascular mortality in patients with chronic kidney disease.

NCT ID: NCT03036124 Completed - Clinical trials for Chronic Heart Failure With Reduced Ejection Fraction (HFrEF)

Study to Evaluate the Effect of Dapagliflozin on the Incidence of Worsening Heart Failure or Cardiovascular Death in Patients With Chronic Heart Failure

DAPA-HF
Start date: February 8, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the effect of dapagliflozin on the incidence of worsening heart failure or cardiovascular death in patients with chronic heart failure with reduced ejection fraction