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NCT ID: NCT05363085 Not yet recruiting - Clinical trials for Mechanical Ventilation Complication

The Cerebral-Respiratory Interaction in Controlled Mechanically Ventilated Neurosurgical Patients. (The CeRes-CMV Study)

CeRes-CMV
Start date: May 2022
Phase:
Study type: Observational

The impact of mechanical ventilation on intracranial perfusion is still not completely clarified. It is often assumed that raising airway pressure will invariably elevate the intracranial pressure, but this is not always the case. The effects of airway pressure on intracranial pressure can depend on several factors, and among others, an uncontrolled expiration and consequent lung collapse may have an influence on cerebral perfusion. This study will investigate the incidence and the consequences of an uncontrolled expiration and expiratory lung collapse in critically ill neurosurgical patients during controlled mechanical ventilation. Electrical impedance tomography measurements , oesophagus and gastric pressure, electrical activity of the diaphragm and intracranial pressure will be acquired in a synchronised manner during controlled mechanical ventilation. Moreover, airway opening pressure, expiratory flow limitation and recruitment/inflation ratio will be determined during controlled mechanical ventilation, on a daily bases until the patient recover his/her own spontaneous breathing.

NCT ID: NCT05362942 Not yet recruiting - Clinical trials for Refractory Acute Myeloid Leukemia

Combination of Venetoclax, Hypomethylation Agent and Low-dose Cytarabine as a Salvage Therapy for Acute Myeloid Leukemia

Start date: May 1, 2022
Phase: Phase 2
Study type: Interventional

Although studies are ongoing to evaluate the efficiency and safety of venetoclax-based therapy, alone or in combination with hypomethylation agent or low-dose cytarabine, in relapsed/refractory acute myeloid leukemia, data are scarce and heterogenous. In this study, the investigators aimed to assess safety and response to a new venetoclax-based triple-drug combination regimen (venetoclax + hypomethylation agent + low-dose cytarabine) in acute myeloid leukemia patients who had relapsed/refractory disease or positive minimal residual disease.

NCT ID: NCT05361733 Not yet recruiting - Clinical trials for Idiopathic Pulmonary Fibrosis (IPF)

A First-in-human Study of the Safety, Tolerability, and PK of XFB-19 in Healthy Adult Volunteers

Start date: August 5, 2022
Phase: Phase 1
Study type: Interventional

Xfibra, Inc. is conducting a phase 1, randomised, double-blind, placebo-controlled, first-in-human study of the safety, tolerability, and pharmacokinetics of single and multiple ascending doses of XFB-19 in healthy adult volunteers in lung fibrosis.

NCT ID: NCT05359393 Not yet recruiting - Liver Metastasis Clinical Trials

A Combination Therapy Including Anti-PD-1 Immunotherapy in MSS Rectal Cancer With Resectable Distal Metastasis

Miracle-1
Start date: December 1, 2022
Phase: Phase 2
Study type: Interventional

Although patients with locally advanced rectal cancer and resectable liver/pulmonary metastasis could benefit from surgery resection, these patients still have a poorer prognosis compared to those without distal metastasis. Based on previous studies, there is no confirmation of whether these patients could benefit from preoperative immunotherapy combined with conventional chemoradiotherapy. This study proposes a combination therapy, preoperative short-course radiotherapy followed by neoadjuvant chemotherapy and anti-PD-1 immunotherapy, for microsatellite-stable patients with locally advanced rectal cancer and resectable liver/pulmonary metastasis, to assess its impact on tumor retreat, decline of postoperative metastasis and recurrence, and the disease-free survival and overall survival of patients. Besides, this study will provide high-level medical evidence for future clinical treatment of patients with advanced rectal cancer.

NCT ID: NCT05356897 Not yet recruiting - Clinical trials for Stage IV Colorectal Cancer AJCC v8

Tucatinib Combined With Trastuzumab and TAS-102 for the Treatment of HER2 Positive Metastatic Colorectal Cancer in Molecularly Selected Patients, 3T Study

Start date: November 30, 2023
Phase: Phase 2
Study type: Interventional

This phase II trial studies whether tucatinib combined with trastuzumab and TAS-102 works to shrink tumors in patients with HER2 positive colorectal cancer that has spread to other parts of the body (metastatic) and has one of the following gene mutations detected in blood: PIK3CA, KRAS, NRAS, or BRAF V600. Tucatinib is in a class of medications called kinase inhibitors. It works by blocking the action of the abnormal protein that signals tumor cells to multiply. This helps stop or slow the spread of tumor cells. Trastuzumab is a form of targeted therapy because it attaches itself to specific molecules (receptors) on the surface of tumor cells, known as HER2 receptors. When trastuzumab attaches to HER2 receptors, the signals that tell the cells to grow are blocked and the tumor cell may be marked for destruction by the body's immune system. TAS-102 is a combination of 2 drugs; trifluridine and tipiracil. Trifluridine is in a class of medications called thymidine-based nucleoside analogues. It works by stopping the growth of tumor cells. Tipiracil is in a class of medications called thymidine phosphorylase inhibitors. It works by slowing the breakdown of trifluridine by the body. Giving tucatinib, trastuzumab, and TAS-102 together may work better than usual treatment for metastatic colorectal cancer.

NCT ID: NCT05355207 Not yet recruiting - Clinical trials for Chronic Rhinosinusitis With Nasal Polyps

Study to Evaluate Safety and Activity of TRL1068 in Chronic Rhinosinusitis

Start date: January 2024
Phase: Phase 1
Study type: Interventional

TRL1068 is expected to eliminate the pathogen-protecting biofilm in Chronic Rhinosinusitis, thus making these bacteria substantially more susceptible to established antibiotic treatment regimens. This initial study is to assess overall safety and pharmacokinetics (PK) of TRL1068. The goal of the development program is to demonstrate effectiveness of TRL1068 in difficult to treat bacterial infections such as in CRS.

NCT ID: NCT05355155 Not yet recruiting - Clinical trials for Hepatocellular Carcinoma Recurrent

Bevacizumab Biosimilar Plus FOLFOX4 in the Treatment of Recurrent HCC After Liver Transplantation

Start date: May 1, 2022
Phase: Phase 2
Study type: Interventional

This study is a single arm, single center, prospective and open exploratory study. About 15 patients with recurrent hepatocellular carcinoma (HCC) after liver transplantation are expected to be enrolled.Patients will be treated with bevacizumab and FOLFOX4.Treatment was continued until disease progression, development of intolerable toxicities, death, withdrawal of consent, initiation of new antitumor therapy, whichever occurred first.

NCT ID: NCT05354960 Not yet recruiting - Trauma Clinical Trials

PROMs in Lower Limb Reconstruction

Start date: June 1, 2022
Phase:
Study type: Observational

The purpose of the study is to evaluate the validity of PROMS after reconstructive surgery or amputation in the leg region. In this context, the German version of the LIMB-Q, a questionnaire-based "Patient-reported outcome measurement" (PROM), will be validated for the German-speaking region and any necessary cultural adaptations will be made for the future use of the questionnaire. In addition, the aim is to establish a context between the LIMB-Q as a PROM and clinical outcome measurements (Maryland Foot Score, American Orthopedic Foot and Ankle Society Score).

NCT ID: NCT05353582 Not yet recruiting - Colorectal Cancer Clinical Trials

Preoperative Systemic Therapy for Colorectal Cancer Peritoneal Metastases

Start date: June 1, 2022
Phase: Phase 2
Study type: Interventional

This is an open-label, parallel-group, phase 2 randomized trial which randomizes patients with isolated resectable colorectal cancer peritoneal metastases to receive preoperative systematic therapy followed by CRS+HIPEC and postoperative chemotherapy or upfront CRS+HIPEC followed by postoperative chemotherapy.

NCT ID: NCT05351762 Not yet recruiting - Clinical trials for Head and Neck Squamous Cell Carcinoma

Nimotuzumab Combined With Neoadjuvant Chemotherapy in the Treatment of Resectable LA HNSCC

Start date: July 1, 2022
Phase: Phase 2
Study type: Interventional

This study is a prospective, open-label, single-arm study. The trial will be divided into 3 phases: screening/baseline, treatment and follow-up. To initially explore the efficacy and safety of nimotuzumab combined with neoadjuvant chemotherapy (TPF regimen) in the treatment of resectable locally advanced head and neck tumors. Targeted therapy: Nimotuzumab injection 400 mg, once on the 1st day and once on the 21st day, for a total of 2 times. It should be administered by intravenous infusion 1 hour before chemotherapy, and the administration process should last for more than 60 minutes. Chemotherapy (TPF regimen): nab-paclitaxel 175mg/m2, on the 1st day; nedaplatin 100mg/m2, on the 1st day; oral administration of Sigirone on the 1st-14th day, 2/day; a treatment cycle of 21 days, a total of 2 a treatment cycle. After two cycles of chemotherapy, all patients underwent radical surgery according to whether the throat could be preserved and the patient's own wishes. The primary endpoint of the study is the tumor objective response rate (ORR), and the secondary endpoints are the primary tumor pathological complete response (pCR) rate, organ preservation rate, 1-year overall survival (OS) rate, and 1-year disease-free survival (DFS) rate. , quality of life, safety evaluation.