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NCT ID: NCT03110380 Completed - HIV-1-infection Clinical Trials

Switching to a Fixed Dose Combination of Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) in Human Immunodeficiency Virus Type 1 (HIV-1) Infected Adults Who Are Virologically Suppressed

Start date: June 12, 2017
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to evaluate the efficacy of switching from a regimen of either dolutegravir (DTG) and emtricitabine /tenofovir alafenamide (F/TAF) or DTG and emtricitabine/tenofovir disoproxil fumarate (F/TDF) to a fixed dose combination (FDC) of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus DTG+F/TAF in virologically suppressed HIV-1 infected adults with or without antiretroviral (ARV) resistance.

NCT ID: NCT03108183 Completed - Periapical Diseases Clinical Trials

Apicoectomy Longterm Results

Start date: March 2, 2017
Phase: N/A
Study type: Observational

The purpose of the study is to evaluate the longterm treatment results after micro-surgical root resection of teeth with post and core and crown.

NCT ID: NCT03107494 Completed - Chronic Bronchitis Clinical Trials

Gala FIH Feasibility Study for the Treatment of Chronic Bronchitis

Start date: January 20, 2017
Phase: N/A
Study type: Interventional

Feasibility trial (FIH) to assess the safety and clinical utility in patients with chronic bronchitis.

NCT ID: NCT03105128 Completed - Crohn's Disease Clinical Trials

A Study of the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Crohn's Disease

Start date: May 10, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of risankizumab versus placebo during induction therapy in participants with moderately to severely active Crohn's disease (CD).

NCT ID: NCT03104413 Completed - Crohn's Disease Clinical Trials

A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment

Start date: December 18, 2017
Phase: Phase 3
Study type: Interventional

The objective of Study M15-991 is to evaluate the efficacy and safety of risankizumab versus placebo during induction therapy in participants with moderately to severely active CD.

NCT ID: NCT03102593 Completed - Clinical trials for Primary Immune Thrombocytopenia

A Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of ARGX-113 in Patients With ITP

Start date: March 13, 2017
Phase: Phase 2
Study type: Interventional

The purpose of the study is to determine safety, efficacy, tolerability and Pharmacokinetics of ARGX-113 in Patients with Primary Immune Thrombocytopenia.

NCT ID: NCT03101865 Completed - Clinical trials for Type 1 Diabetes Mellitus

The Artificial Pancreas in Very Young Children With T1D - Pilot (KidsAP01)

Start date: August 8, 2017
Phase: N/A
Study type: Interventional

The suggested clinical trial is part of the KidsAP project funded by the European Commission's Horizon 2020 Framework Programme. The project evaluates the use of the Artificial Pancreas (or closed loop systems) in very young children with type 1 diabetes (T1D) aged 1 to 7 years. The suggested trial is a feasibility study to pilot the setup of a large-scale outcome trial and to address the specific needs of this population. The results of the pilot trial will feed into the design of the outcome study. In this study the investigators will compare closed loop insulin delivery using standard strength insulin to closed loop use with diluted insulin in very young children with T1D. Diluted insulin is a standard treatment approach for children with low insulin requirements. The investigators hypothesize that diluted insulin will lead to more stable glucose levels by reducing inaccuracies accentuated by delivery of minute amounts of insulin (frequently less than 0.1U/h [1μl/h with standard strength insulin] in small children compared to 1U/h in adults). These inaccuracies may result from pump plunger micro-jumps, tissues pressure build-up, and infusion set kinking. This study builds on previous and on-going studies of closed loop systems that have been performed in Cambridge in children and adolescents with T1D in clinical research facilities and in the home setting. The study adopts an open-label, multi-centre, multinational, randomised, two-period crossover design contrasting closed loop glucose control using diluted insulin and closed loop using standard insulin strength under free-living home conditions. The two intervention periods will last 3 weeks each with a 1 to 4 weeks washout period in between. The order of the two interventions will be random. A total of up to 30 young children aged 1 to 7 years with T1D on insulin pump therapy will be recruited through outpatient diabetes clinics at participating clinical centres to allow for 24 completed subjects available for assessment in each of the study arms. Prior to the use of study devices, participants and parents/guardians will receive appropriate training by the research team on the safe use of the study pump and continuous glucose monitoring system, and the hybrid closed loop insulin delivery system. Carers at nursery or school may also receive training by the study team if required. During the intervention periods, subjects and parents/guardians will use the closed loop system for 21 days under free-living conditions in their home and nursery/school environment without remote monitoring or supervision by research staff. The primary outcome is time spent in target range between 3.9 and 10.0 mmol/l as recorded by CGM. Secondary outcomes are the time spent with glucose levels above and below target, as recorded by CGM, and other CGM-based metrics. Safety evaluation comprises the tabulation of severe hypoglycaemic episodes.

NCT ID: NCT03101475 Completed - Colorectal Cancer Clinical Trials

Synergism of Immunomodulation and Tumor Ablation

ILOC
Start date: November 23, 2018
Phase: Phase 2
Study type: Interventional

This is a single-arm, open-label, multi-center early phase II study. This proof of concept study will investigate whether the combined use of local tumor ablation/radiation plus immunomodulating drugs may induce a significant immune response in patient with incurable liver metastases from colorectal cancer (CRC) (+/- limited extrahepatic disease) being stable or in partial remission after completion of 4-6 months first line systemic therapy. The primary objective of the study is to show an overall response rate of lesions not treated by ablation/radiotherapy including the extrahepatic lesions (according to iRECIST criteria) higher than 10%. With the continuation of first line systemic treatment, no further responses are expected. Secondary objectives are: - To establish the feasibility and safety of the combined treatment modalities; - To study the impact of the local technique (RFA/Radiotherapy) on the results; - To investigate biomarkers to predict response to the combined treatment

NCT ID: NCT03100058 Completed - Obesity Clinical Trials

A Study to Evaluate the Change in Weight After 24 Weeks Treatment With LIK066 in Obese or Overweight Adults

Start date: May 6, 2017
Phase: Phase 2
Study type: Interventional

This was a dose-finding study that evaluated the change in weight after 24 weeks treatment with 8 different doses of LIK066 compared to placebo in obese or overweight adults, followed by 24 weeks treatment with 2 doses of LIK066 and placebo.

NCT ID: NCT03098979 Completed - Heart Failure Clinical Trials

A Trial to Study Neladenoson Bialanate Over 20 Weeks in Patients With Chronic Heart Failure With Preserved Ejection Fraction

PANACHE
Start date: May 10, 2017
Phase: Phase 2
Study type: Interventional

The objective of the study is to find the optimal dose of once daily oral neladenoson bialanate (BAY1067197) when given in addition to appropriate therapy for specific comorbidities.