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NCT ID: NCT04442256 Recruiting - Clinical trials for AERD - Aspirin Exacerbated Respiratory Disease

Effect of Dupilumab on Aspirin Intolerance

Start date: June 1, 2020
Phase: Phase 4
Study type: Interventional

To test the efficacy of dupilumab in patients with AERD regarding the intolerance to salicylic acid after 6 months. This will be evaluated by oral drug provocation testing with low dose salicylic acid after 6 months of dupilumab treatment. Hypothesis: After 6 months of therapy, patients will tolerate aspirin dose levels as tested with different dosages (125mg, 250mg and 500 mg).

NCT ID: NCT04442022 Recruiting - Clinical trials for Relapsed/Refractory Diffuse Large B-cell Lymphoma

A Study of Rituximab-Gemcitabine-Dexamethasone-Platinum (R-GDP) With or Without Selinexor in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma

Start date: September 3, 2020
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this Phase 2/3 study is to evaluate efficacy and safety of the combination of selinexor and R-GDP (SR-GDP) in patients with RR DLBCL who are not intended to receive hematopoetic stem cell transplantation (HSCT) or chimeric antigen receptor T cell (CAR-T) therapy. This study consists of 3 arms each in Phase 2 and 3. Phase 2 portion of the study will assess the two doses of selinexor (40 milligram [mg] or 60 mg) in combination with R-GDP, for up to 6 cycles (21-day per cycle), followed by 60 mg selinexor single agent continuous therapy for those who have reached a partial or complete response. Phase 3 portion of the study will evaluate the selected dose of SR-GDP (identified in Phase 2) versus standard R-GDP + matching placebo, for up to 6 cycles (21-day per cycle), followed by placebo or 60 mg selinexor single agent continuous therapy for those who have reached partial or complete response.

NCT ID: NCT04438889 Recruiting - Myeloid Diseases Clinical Trials

Austrian Myeloid Registry

aMYELOIDr
Start date: July 13, 2020
Phase:
Study type: Observational [Patient Registry]

The Austrian Myeloid Registry (aMYELOIDr) is a non-interventional study. It collects data from patients with the myeloid diseases, primarily myelodysplastic syndromes (MDS), chronic myelomonocytic leukemia (CMML) and acute myeloid leukemia (AML).The aMYELOIDr is multi-center database collecting data at various sites in Austria and potentially also at other centers in other countries in future. The registry has an electronic case report form (eCRF), where all data is entered by clinical trial personnel and/or physicians. It is set up to collect real-world experience in the management of patients with these diseases in Austria.

NCT ID: NCT04438525 Recruiting - Clinical trials for Vespid Venom Allergy

Is the BAT Inhibition Able to Replace Sting Challenges? (BATIRS)

Start date: January 7, 2021
Phase: N/A
Study type: Interventional

Insect venom allergy is the major cause for severe allergic reactions in Europe. Wasps and honeybees are responsible for the majority of these allergic reactions. Symptoms range from generalized skin symptoms (wheals, swellings) to respiratory or cardiovascular problems such as asthma, dizziness, loss of consciousness, or cardiac arrest. The regular administration of insect venom ('venom immunotherapy') over up to 5 years is a well-established therapy, providing long-term protection from further systemic sting reactions in the majority of patients. However, there is no laboratory test which is able to identify patients who will still react to an insect sting. The only reliable method available is stinging patients with living insects ('sting challenges'). The key issue is that only few centers in Europe perform sting challenges and many patients have no access to these tests. Therefore, it is of utmost importance to find a method which is able to identify patients who are still at risk for future allergic sting reactions. The inhibition of the basophil activation test (BAT) could be a potential method to monitor the effectiveness of immunotherapy. Basophils are cells which are activated in acute allergic reactions. The basophil activation of blood donors with vespid venom allergy can be measured after adding sera from allergic patients undergoing immunotherapy. In a preliminary study we found that the activation of basophils could be inhibited in all patients treated with vespid venom, however, results must be confirmed in a larger study. In this study, a total of 219 patients with vespid venom allergy will be included. Those patients who are receiving or who have already finished venom immunotherapy will be sting challenged and blood samples will be taken to perform BAT inhibition experiments. At the same time, donors with confirmed vespid venom allergy, who have not undergone immunotherapy, will be recruited for a blood donation, which is necessary for the BAT inhibition tests. If results of the preliminary study could be confirmed, the BAT inhibition will facilitate monitoring the effectiveness of venom immunotherapy and patients would benefit from an early detection of lacking tolerance and consequently from the increased venom dose preventing future life threatening systemic sting reactions.

NCT ID: NCT04436211 Recruiting - Clinical trials for Osteo Arthritis Knee

Kinematic- Versus Ligament-balanced Mechanical Alignment in TKA

Start date: February 15, 2020
Phase:
Study type: Observational [Patient Registry]

A promising new approach in total knee arthroplasty (TKA) for severe osteoarthritis of the knee joint is the the kinematic aligned procedure (KA). This technique provides prosthesis-positioning based on natural and individual axes of movement. Although first series have shown satisfying results, further verification by prospective studies and final meta-analyses will be required. Thus, the kinematic alignment represents one of the few new developments in TKA. Provided that patients are willing to participate in the study, patients data are collected preoperatively and during routine follow-up examinations and evaluated prospectively. Patients will receive either a conventionally mechanical aligned arthroplasty or a kinematical aligned TKA, according to a randomized procedure. The kinematic alignment will be achieved by the use of custom-made cutting-blocks. Therefore, the patients will undergo a computed tomography of the whole leg on the affected side. This is mandatory in order to provide the individually produced cutting blocks. In order to ensure comparability, patients are stratified regarding their age and gender before inclusion. Outcome will be measured by the use of standard scoring systems regarding function, pain and ROM (range of motion) three, six and 12 months after surgery. This study is a monocentric, prospective, randomized and controlled open study.

NCT ID: NCT04430569 Recruiting - Pulmonary Embolism Clinical Trials

Pulmonary Embolism International THrOmbolysis Study-3

PEITHO-3
Start date: August 4, 2021
Phase: Phase 3
Study type: Interventional

In this study, we will assess the efficacy and safety of a reduced dose of thrombolytic therapy given in addition to low-molecular-weight heparin in patients with intermediate-high-risk acute pulmonary embolism. Half of participants will receive thrombolytic treatment, while the other half will receive a placebo.

NCT ID: NCT04430075 Recruiting - Clinical trials for Mitral Regurgitation

MiCLASP Post Market Clinical Follow-Up (PMCF) Study

MiCLASP
Start date: August 23, 2019
Phase:
Study type: Observational

This is a postmarket clinical follow up study on the safety and effectiveness of the Edwards PASCAL Transcatheter Valve Repair System and the Edwards PASCAL Precision Transcatheter Valve Repair System in transcatheter mitral valve repair.

NCT ID: NCT04428944 Recruiting - Atrial Fibrillation Clinical Trials

STrategies for Catheter Ablation of peRsistent Atrial Fibrlllation

STARAF3
Start date: June 1, 2021
Phase: N/A
Study type: Interventional

The objective of this study is to compare the efficacy of three different ablation strategies in patients with persistent AF: 1. PV antral isolation alone (PVAI) 2. PV antral isolation plus ablation of drivers (PVAI+drivers) 3. PV antral isolation plus isolation of posterior wall (PVAI+box) All three strategies will employ contemporary catheter ablation technology using more efficient open irrigated tip cooling and contact force sensing.

NCT ID: NCT04421924 Recruiting - Liver Cirrhosis Clinical Trials

Periinterventional Coagulation Management of Patients Undergoing a TIPS

TIPSprosp
Start date: May 27, 2020
Phase: N/A
Study type: Interventional

Assess whether a pre-interventional thrombelastography guided algorithm for assessing and correction of coagulation status in cirrhotic patients is safe and effective

NCT ID: NCT04420884 Recruiting - Solid Neoplasms Clinical Trials

A Study of Dazostinag as Single Agent and Dazostinag in Combination With Pembrolizumab in Adults With Advanced or Metastatic Solid Tumors

iintune-1
Start date: July 22, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

The main aim of this study is to check if people with advanced solid tumors have side effects from dazostinag, and to check how much dazostinag they can receive without getting significant side effects from it when given alone and in combination with pembrolizumab. The study will be conducted in two phases including a dose escalation phase and a dose expansion phase. In the dose escalation phase, escalating doses of dazostinag are being tested alone and in combination with pembrolizumab to treat participants who have advanced or metastatic solid tumors. In the dose expansion phase, dazostinag will be studied with pembrolizumab with or without chemotherapy in participants with untreated metastatic or recurrent, unresectable squamous cell carcinoma of head and neck (SCCHN) and in combination with pembrolizumab in third-line or later recurrent locally advanced or metastatic microsatellite instability-high/mismatch repair deficient (MSI-H/dMMR) and third-line recurrent locally advanced or metastatic microsatellite stable/mismatch repair proficient (MSS/pMMR) colorectal cancer (CRC).