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NCT ID: NCT04449874 Recruiting - Colorectal Cancer Clinical Trials

A Study to Evaluate the Safety, Pharmacokinetics, and Activity of GDC-6036 Alone or in Combination in Participants With Advanced or Metastatic Solid Tumors With a KRAS G12C Mutation

Start date: July 29, 2020
Phase: Phase 1
Study type: Interventional

This is a Phase I dose-escalation and dose-expansion study that will evaluate the safety, pharmacokinetics (PK), and preliminary activity of GDC-6036 in patients with advanced or metastatic solid tumors with a KRAS G12C mutation.

NCT ID: NCT04448587 Recruiting - Clinical trials for Graft Vs Host Disease

Sitagliptin for the Treatment of Grade 3-4 and Refractory Acute Graft-versus-host Disease

GVHD
Start date: October 1, 2020
Phase: Phase 2
Study type: Interventional

The prognosis of severe (grade 3-4) and steroid refractory acute graft-versus-host disease (GVHD) continues to be dismal. Sitagliptin given as GVHD-prophylaxis has recently been shown to reduce the incidence of acute GVHD to less than 10% with an excellent safety profile. In this single center and single arm phase 2 study we aim to explore the safety and efficacy of sitagliptin in the treatment of severe and refractory acute GVHD. Patient with new onset grade 3-4 acute GVHD will receive standard treatment consisting CNI and methylprednisolone 1-2 mg/kg/day or an equivalent dose of prednisone. Patients with refractory grade 2-4 acute GVHD will continue their current treatment; however methylprednisolone dose will be reduced to ≤ 1 mg/kg/day or an equivalent dose of prednisone. Oral sitagliptin will be commenced at a dose of 100 mg BID. The dose will be increased by 100 mg every three days up to a maximal dose of 300 mg BID. In the case of significant drug related side effects or drug intolerance, the last tolerated dose will be resumed. Patients responding well to lower doses of sitagliptin, will not be given higher doses of the drug. Sitagliptin will be provided as long as deemed effective by the treating physician up to three months. The primary end point will be the proportion of patients achieving complete remission(CR), very good partial response (VGPR) or partial response (PR) by day 28.

NCT ID: NCT04447950 Not yet recruiting - Spondylolisthesis Clinical Trials

Randomized Control Trial of Quadratus Lumborum Block for Lumbar Spine Decompression and Fusion Surgery

Start date: June 2020
Phase: N/A
Study type: Interventional

Lumbar spinal decompression and fusion is a commonly performed procedure fro neural impingement and back pain from a variety of pathologies. The importance of pain control in the postoperative period for spinal surgery has been discussed and proven extensively, with both immediate and delayed reduction in complications and improved clinical results. Quadratus lumborum (QL) block was introduced in 2007 and is performed under ultrasound guidance for perioperative pain management in various surgeries.However, the plane for a posterior QL block can be easily reached during open midline spinal surgery. The investigators hypothesize that the posterior QL block is an effective analgesic tool for lumbar laminectomy surgery, because in lumbar laminectomy the quadratus lumborum is already exposed and is in direct visual contact. For that reason it is imperative to test the benefits of this procedure. This is a double blinded randomized control study to assess the results of intra-operative QL block performed for lumbar decompression and fusion.

NCT ID: NCT04447859 Recruiting - Diabetes type2 Clinical Trials

16-week Flexible vs. 8-week Semaglutide Titration

Start date: February 23, 2020
Phase: Phase 3
Study type: Interventional

Semaglutide is a Glucagon Like Peptide 1 (GLP-1) receptor agonist recently approved in Israel to improve glycemic control in patients with type 2 diabetes mellitus. Semaglutide is currently administered as a weekly subcutaneous injection.Treatment with semaglutide is associated with the occurrence of gastrointestinal adverse events (GI-AEs) commonly observed during GLP-1 receptor agonist treatment. The most common adverse reactions, reported in ≥5% of patients treated with semaglutide are nausea, vomiting, diarrhea, abdominal pain and constipation. In this trial we plan to explore the effect of a slower titration regimen of semaglutide vs. the current label-recommended dose escalation regimen on the occurrence of GI-AEs.

NCT ID: NCT04447755 Active, not recruiting - Clinical trials for Relapsed or Refractory Solid Tumors

A Study of Lenvatinib (MK-7902) in Pediatric Participants With Relapsed or Refractory Solid Malignancies (MK-7902-013/E7080)

E7080-G000-231
Start date: July 30, 2020
Phase: Phase 2
Study type: Interventional

The main purpose of this study is to evaluate the antitumor activity and safety of Lenvatinib (MK-7902/E7080) in children, adolescents, and young adults with relapsed or refractory solid malignancies after administration. Participants will be enrolled into initial tumor-specific cohorts which will be expanded based on observed response.

NCT ID: NCT04446117 Active, not recruiting - Clinical trials for Prostate Adenocarcinoma

Study of Cabozantinib in Combination With Atezolizumab Versus Second NHT in Subjects With mCRPC

CONTACT-02
Start date: June 30, 2020
Phase: Phase 3
Study type: Interventional

This is a Phase 3, multi-center, randomized, open-label, controlled study designed to evaluate the safety and efficacy of cabozantinib given in combination with atezolizumab versus a second novel hormonal therapy (NHT) in men with metastatic castration-resistant prostate cancer (mCRPC) who have previously been treated with one, and only one, NHT for their prostate cancer disease.

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: NCT04441606 Recruiting - Clinical trials for Different Types of Cancer

The Role of 68Ga-FAPI-04 PET/CT as a Problem Solving Imaging Modality in Various Malignancies

Start date: June 11, 2020
Phase: N/A
Study type: Interventional

The aim of the suggested study is to assess the added value of 68Ga-FAPI-04 PET/CT over 18F-FDG PET/CT in evaluating the extent of disease in patients with various malignancies, in whom a diagnostic challenge is met, such as inconclusive findings on 18F-FDG PET/CT or other imaging studies, better delineation of tumor extent prior to therapy, and with emphasis on malignancies known to show variable avidity to FDG and at times, no uptake at all. Also patients unable to optimally comply with the required preparation for FDG imaging, such as diabetic patients who struggle in achieving glycemic control.

NCT ID: NCT04439955 Completed - Clinical trials for Chronic Spontaneous Urticaria

Study to Evaluate the Safety, Tolerability and Efficacy of Cannabidiol (CBD) as a Steroid-sparing Therapy in Chronic Spontaneous Urticaria (CSU) Patients

Start date: February 1, 2020
Phase: Phase 2
Study type: Interventional

Each patient will commence the study with a one month run-in period in which he/she will be administered individual patient Standard of Care :anti-histamines and steroids as needed plus placebo (olive oil). After the run-in period, doses of CBD will be incresed during the first six weeks of the study. At the conclusion of the six weeks CBD dose escalation segment of the study, if the 300 mg CBD dose level is deemed safe for two weeks with standard of care doses of anti-histamines, patients will continue receiving 300 mg CBD with Anti-histamines as needed for an additional follow-up period of three month. Each patient will serve as his/her own control.

NCT ID: NCT04438863 Recruiting - COVID 19 Clinical Trials

Daily Home Spirometry for Early Detection of Pulmonary Complications in Patients With COVID19

Start date: August 8, 2020
Phase:
Study type: Observational

The aim of this preliminary study is to describe the potential decline in forced expiratory volume in 1 second (FEV1) or forced vital capacity (FVC) as measured by home spirometry in high-risk subjects infected with COVID-19. We hypothesize that the magnitude of such a decline in FEV1 and/or FVC may be associated with clinical deterioration and hospitalization. The study will ultimately inform a larger subsequent RCT that will evaluate the efficacy of home spirometry in the early detection (pre respiratory symptoms) of respiratory complications and therefore prompt early medical attention which is a key for improving outcome.