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NCT ID: NCT03203005 Completed - Clinical trials for Hepatocellular Carcinoma

IMA970A Plus CV8102 in Very Early, Early and Intermediate Stage Hepatocellular Carcinoma Patients

Start date: September 18, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

This study is being carried out in order to evaluate a new cancer vaccine called IMA970A combined with CV8102, a new adjuvant for the treatment of liver cancer (hepatocellular carcinoma). It will be investigated whether IMA970A and CV8102 is safe and can trigger an immune response against the tumor, which may prevent the tumor (cancer) from recurring or spreading or may even lead to tumor shrinkage following the standard treatments the patients have previously received.

NCT ID: NCT03202134 Completed - Clinical trials for Major and Minor Surgical Complications

Impact of Opioid Free Anesthesia on Outcome After DIEPflap Surgery

DIEPflap
Start date: January 2014
Phase:
Study type: Observational [Patient Registry]

The Deep Inferior Epigastric Perforator free flap (DIEPflap) involves the transfer of abdominal tissue to the breast using microsurgery. Flap failure is rare today, but is devastating. Blood flow in a DIEPflap decreases during the first hours. Many anesthetic factors like low cardiac output, hypothermia and surgical stress cause vasoconstriction or thrombosis. A stable anesthesia during these long procedures improves flap perfusion. Postoperative nausea and vomiting (PONV) is frequent and might have an impact. Opioid free anesthesia (OFA) reduces PONV. The anti-inflammatory and vasodilator effects of the drugs dexmedetomidine and lidocaine might improve free flap perfusion. The primary outcome counted all complications. The secondary outcomes were PONV, pain, opioid consumption, skin flap temperature and length of hospital stay. Patients get according to attending anesthesiologist an opioid or opioid free anesthesia without any randomization but based on availability of competence.

NCT ID: NCT03201419 Completed - Nocturia Clinical Trials

A Trial to Investigate Efficacy, Safety and Tolerability of FE 201836 for Nocturia Due to Nocturnal Polyuria in Adults

Start date: July 27, 2017
Phase: Phase 2
Study type: Interventional

The purpose of this trial was to investigate the efficacy, safety and tolerability of different oral doses of FE 201836, with desmopressin as a benchmark, during 12 weeks of treatment for nocturia due to nocturnal polyuria in adults

NCT ID: NCT03201211 Completed - Clinical trials for Respiratory Disorders

A Long Term Follow-up Study up to 4 Years After Study Vaccination to Assess Immunogenicity and Safety of the Investigational Vaccine in Adults

Start date: June 22, 2017
Phase: Phase 1
Study type: Interventional

The purpose of this long-term follow-up of a Phase I study is to evaluate the kinetics of the antibody response to NTHi-Mcat antigens and long-term safety, in subjects aged between 50-71 years at the time of enrolment in the NTHi-Mcat-001 study. These subjects were previously exposed to two adjuvanted formulations of the NTHi-Mcat vaccine administered according to a 0, 2 months schedule in the NTHi-Mcat-001 (201281) study. The subjects that had received saline placebo controls will also be included in this follow-up study to make comparisons with the investigational vaccines. No vaccinations will be administered in this trial.

NCT ID: NCT03200288 Completed - Knee Osteoarthritis Clinical Trials

A Study to Evaluate the Clinical Performance and Safety of an Intra-articular Hyaluronic Acid in Knee Osteoarthritis

Start date: June 29, 2017
Phase: Phase 3
Study type: Interventional

This is a study to evaluate the Clinical Performance and Safety of a single intra-articular (i.a.) injection of hyaluronic acid product (as HL-01) in the treatment of pain due to osteoarthritis (OA) of the knee.

NCT ID: NCT03197935 Completed - Clinical trials for Triple-negative Breast Cancer

A Study to Investigate Atezolizumab and Chemotherapy Compared With Placebo and Chemotherapy in the Neoadjuvant Setting in Participants With Early Stage Triple Negative Breast Cancer

IMpassion031
Start date: July 24, 2017
Phase: Phase 3
Study type: Interventional

This is a global Phase III, double-blind, randomized, placebo-controlled study designed to evaluate the efficacy and safety of neoadjuvant treatment with atezolizumab (anti-programmed death-ligand 1 [anti-PD-L1] antibody) and nab-paclitaxel followed by doxorubicin and cyclophosphamide (nab-pac-AC), or placebo and nab-pac-AC in participants eligible for surgery with initial clinically assessed triple-negative breast cancer (TNBC).

NCT ID: NCT03197389 Completed - Breast Cancer Clinical Trials

Effect of Pembrolizumab (Keytruda®) on Biomarkers in Early Breast Cancer.

Start date: January 18, 2018
Phase: Early Phase 1
Study type: Interventional

The study consists of 2 parts: a retrospective study, and a prospective clinical study with pembrolizumab (Keytruda®) (Phase 0). 1. Retrospective study (S58910): This is a retrospective analysis to study the expression of PD-L1 in ER/PR negative breast tumors and to correlate this PD-L1 expression with tumor infiltrating lymphocytes (TILs), proliferation, expression of apoptosis and clinical outcome (development of distant metastases). 2. Phase 0 study: This is a Phase 0 single center, open-label, non-randomized, study in patients with early breast cancer. Patients will be treated with one injection of Pembrolizumab (Keytruda®) administered intravenously at 200 mg 10 +/- 4 days before surgery. This phase 0 study will consist of 2 cohorts; cohort A will include patients who are scheduled for upfront surgery. Cohort A1 will include patients with Her2 negative tumors, Cohort A2 patients with Her2 positive tumors and Cohort A3 with ER positive tumours. Cohort B will include patients who received neoadjuvant chemotherapy (with anti-Her2 therapy if Her2 positive) and who have clear signs of residual tumor on imaging after finishing neoadjuvant chemotherapy (i.e. on imaging estimated residual tumor size of at least 10 mm). Cohort B1 will include Her2 negative tumors, Cohort B2 Her2 positive tumors and Cohort B3 ER positive tumors. The injection will be given in the oncological outpatient unit. Patients will be monitored carefully for the development of adverse experiences/events. Adverse experiences/events will be evaluated according to criteria outlined in the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 4.0.

NCT ID: NCT03197077 Completed - Clinical trials for Polycystic Ovary Syndrome

Optimisation of Follicular Recruitment in IVM Cycles

Elonva_IVM
Start date: November 1, 2017
Phase: Phase 3
Study type: Interventional

The study will focus on important aspects related to follicle recruitment using exogenous gonadotropins in patients with polycystic ovaries: 1. Early follicle recruitment in patients with polycystic ovaries using corifollitropin alfa: does administration of this drug result in earlier and higher FSH (follicle stimulating hormone) concentrations above the threshold for follicle recruitment in an IVM (in vitro maturation) cycle preceded by oral contraceptive suppression, in comparison to normal daily administration of rFSH (recombinant follicle stimulating hormone, Puregon)?; 2. The maturation rate of the obtained oocyte-cumulus complexes in standard IVM media registered for clinical use: does stimulation with corifollitropin alfa versus recombinant FSH have an impact on the maturation rate and developmental capacity of the oocytes ?

NCT ID: NCT03196596 Completed - Clinical trials for Aortic Valve Stenosis

Added Value of Patient-specific Computer Simulation in Transcatheter Aortic Valve Implantation (TAVI)

TAVIguide
Start date: May 23, 2017
Phase:
Study type: Observational

Transcatheter aortic valve implantation is increasingly used to treat patients with severe aortic stenosis who are at increased risk for surgical aortic valve replacement and is projected to be the preferred treatment modality. As patient selection and operator experience have improved, it is hypothesised that device-host interactions will play a more dominant role in outcome. This, in combination with the increasing number of valve types and sizes, confronts the physician with the dilemma to choose the valve that best fits the individual patient. This necessitates the availability of pre-procedural computer simulation that is based upon the integration of the patient-specific anatomy, the physical and (bio)mechanical properties of the valve and recipient anatomy derived from in-vitro experiments. Patient-specific computer simulation may improve outcome of TAVI by proposing the valve size that best fits the individual patient. The aim of this study is to assess the added value of patient-specific computer simulation in valve size selection.

NCT ID: NCT03192059 Completed - Cervical Cancer Clinical Trials

Study of Pembrolizumab, Radiation and Immune Modulatory Cocktail in Cervical/Uterine Cancer

PRIMMO
Start date: July 1, 2017
Phase: Phase 2
Study type: Interventional

This is a Phase II study in patients with advanced and/refractory cervical cancer, endometrial carcinoma or uterine sarcoma. Patients will be treated with an immunomodulatory cocktail (Vitamin D, aspirin, Cyclophosphamide and Lansoprazole), followed by pembrolizumab, combined with radiation. In addition, patients will take Curcumin, a food supplement.